System, apparatus, and method for analyte monitoring

Abstract

The applicator includes a housing, a sensor carrier connected to the housing and having a first locking interface, a sheath slidably connected to the housing and having a first locking arm with a distal attachment end and a free proximal end, the free proximal end having a first locking arm interface disposed on an inner surface of the first locking arm and a first sharp edge disposed on an outer surface of the first locking arm, and a cap threadably connected to the housing and having a plurality of first compression ridges on its inner surface, the inner surface of the cap configured to bias the first locking arm inwardly to urge the first locking arm interface into engagement with the first locking interface, the first sharp edge configured to engage the first plurality of compression ridges during an impact event.

Description

Technical Field

[0001] The subject matter described in the present application relates generally to systems, devices, and methods for in vivo analyte monitoring.

Background Art

[0002] The detection, monitoring, or both of analyte values such as glucose, ketones, lactate, oxygen, hemoglobin A1C, etc. can be extremely critical to the health of individuals suffering from diabetes. Patients suffering from diabetes may experience complications such as loss of consciousness, cardiovascular disease, retinopathy, neuropathy, nephropathy, etc. It is common for diabetic patients to need to confirm that their glucose is maintained within a clinically safe range by monitoring their own glucose, and to use this information to determine whether insulin is needed to lower the glucose in their body, when it is needed, or both, or to determine when additional glucose is needed to raise the glucose in their body.

[0003] Increasing clinical data has demonstrated a strong correlation between the frequency of blood glucose monitoring and blood glucose control. However, despite such a correlation, many people diagnosed with diabetes do not monitor their glucose at the required frequency due to overlapping factors such as convenience, freedom of testing, pain associated with blood glucose testing, cost, etc.

[0004] To improve a patient's adherence to a frequent blood glucose monitoring schedule, a biosensor monitoring system can be utilized, where a sensor control device can be worn on the body of an individual who needs analyte monitoring. To improve the comfort and convenience of the individual, the physical form factor of the sensor control device is small and can be assembled and applied by an individual carrying the sensor applicator. The application operation involves inserting a sensor that senses analyte values in the body fluid within the human body and bringing the sensor into contact with the body fluid using an applicator or an insertion mechanism. The sensor control device is configured to transmit analyte data to another device, from which an individual or the person's healthcare provider ("HCP") may be able to examine the data and make treatment decisions.

[0005] Current sensors may be convenient for users, but are also susceptible to malfunction due to improper insertion. Such malfunctions may be caused by user errors, lack of proper training, insufficient user adjustment, overly complex procedures, and other problems. This may be particularly true for biosensor monitoring systems provided with sensors used to measure analyte values in interstitial fluid ("ISF"), where the sensors are inserted using a sharp member (known as an "insertion aid" or "needle"). For example, some prior art systems may overly rely on individual users to precisely assemble and deploy the sensor control device and the applicator. Other prior art systems may utilize an insertion and retraction mechanism for the sharp member that is prone to premature extraction before the sensor is properly embedded. Furthermore, some prior art systems may utilize a sharp member that is not optimally configured to form an insertion path without causing trauma to the surrounding tissue. The above-described and other problems described herein may result in improper insertion or damage to the sensor, which may in turn result in the failure to properly monitor the patient's analyte values. SUMMARY OF THE INVENTION

Problems to be Solved by the Invention

[0006] Therefore, there is a need for a more reliable sensor insertion device, its system, and its method that are easy for patients to use and less prone to errors.

Means for Solving the Problems

[0007] The objectives and advantages of the subject matter of the present disclosure will be apparent from and will be made known from the description hereinafter, but will also be known by implementing the subject matter of the present disclosure. Additional advantages of the subject matter of the present disclosure will be realized and achieved by the methods and systems that are particularly pointed out in the written description and claims of this specification, as well as from the appended drawings.

[0008] To achieve such advantages and other advantages, and in accordance with the objectives of the subject matter of the present disclosure, as embodied and broadly described, the subject matter of the present disclosure is directed to an applicator for delivering a sensor control device. The applicator includes a housing, a sensor carrier connected to the housing and provided with a first locking interface, and a sheath member that is slidably connected to the housing and moves between an extended position and a crimped position and has a first locking arm provided with a mounting-side distal end and a free proximal end. The first locking arm interface of the free proximal end is disposed on the inner surface of the first locking arm, and a first edge, such as a first sharp edge, of the free end is disposed on the outer surface of the first locking arm. The applicator further includes a cap that is screwed and connected to the housing and has a plurality of first protrusions, such as, for example, pressing ridges, provided on its inner surface. When the cap is connected to the housing, its inner surface is configured to bias the first locking arm inwardly, so that the first locking arm interface engages with the first locking interface, and the first sharp edge is configured to engage with the plurality of first pressing ridges during a situation where an impact is applied.

[0009] The sensor carrier may be provided with a second locking interface, and the sheath member may have a second locking arm provided with a mounting-side distal end and a free proximal end. The free proximal end has its second locking arm interface disposed on the inner surface of the second locking arm, and its second edge, for example, a second sharp edge, etc., is disposed on the outer surface of the second locking arm. When the cap is connected to the housing, its inner surface is configured to bias the second locking arm inward, so that the second locking arm interface engages with the second locking interface. The cap may be provided with a plurality of second squeezing ridge portions, and the second sharp edge is configured to engage with the plurality of second squeezing ridge portions during the occurrence of an impact event. The first locking arm interface may be U-shaped. The first locking interface may be disposed around the sensor carrier.

[0010] The applicator is provided with a housing skirt, which is connected to the housing by a plurality of skirt reinforcing rib portions. A used indication functional part may be connected to each of the housing skirt and the cap. The used indication functional part may be a sticker. The housing may be made of a cyclic olefin copolymer. The sheath member may be made of Delrin (i.e., polyoxymethylene, an acetal homopolymer resin). The cap may be made of high-density polyethylene.

[0011] According to the subject matter of the present disclosure, the sensor carrier may include a base composed of a first half body and a second half body. The first sensor holding arm is connected to the first half body of the base at its first end, and its second free end projects toward the second half body of the base. The first sensor holding arm is provided with a first sensor holding function on its inner surface, and the first locking interface can be disposed on the outer surface of the first sensor holding arm.

[0012] The sensor carrier is provided with three equally spaced housing mounting functional parts, which may project upward from the uppermost surface of the base. Each of the housing mounting functional parts includes a housing fastener, a housing positioning functional part, and a housing biasing functional part. The housing is provided with three sensor carrier mounting functional parts, each of which may be configured to fit with another one.

[0013] The cap is provided with a sheath member support surface, which engages with the sheath member and is configured to restrict the movement of the sheath member during the occurrence of an impact event. In addition to or instead of this, the cap is provided with a raised ridge-like portion, which is configured to restrict the movement of the sensor carrier during the occurrence of an impact event.

[0014] According to the subject matter of the present disclosure, a sensor carrier for use in an applicator for delivering a sensor control device is presented. The sensor carrier includes a base composed of a first half body and a second half body, and a first sensor holding arm. The first sensor holding arm is connected to the first half body of the base at its first end, and its second free end projects toward the second half body of the base. The first sensor holding arm is provided with a first sensor holding function on its inner surface and a first locking interface on its outer surface. The sensor carrier further includes a second sensor holding arm. The second sensor holding arm is connected to the first half body of the base at its first end, and its second free end projects toward the second half body of the base. The second sensor holding arm is provided with a second sensor holding function on its inner surface and a second locking interface on its outer surface.

[0015] The sensor carrier is provided with three equally spaced housing mounting functional parts, which may project upward from the uppermost surface of the base. Each of the housing mounting functional parts is provided with a housing fastener, a housing positioning functional part, and a housing biasing functional part. The first housing mounting functional part of the three housing mounting functions can be arranged on the second half body of the base. The second housing mounting functional part and the third housing mounting functional part of the three housing mounting functional parts can be arranged on the first half body of the base.

[0016] The sensor carrier is provided with three equally spaced sharp member carrier locking arms, which project upward from the uppermost surface of the base. Each of the sharp member carrier locking arms may be provided with a sharp member carrier holding mechanism and a ridge portion of the sharp member carrier holding mechanism. The first sharp member carrier locking arm of the three sharp member carrier locking arms can be arranged on the first half body of the base. The second sharp member carrier locking arm and the third sharp member carrier locking arm of the three sharp member carrier locking arms can be arranged on the second half body of the base.

[0017] The sensor carrier may be provided with a first locking shelf portion and a second locking shelf portion. The sensor carrier may be provided with a hole extending through the center of the base.

[0018] According to another aspect of the subject matter of the present disclosure, an applicator for delivering a sensor control device is presented. The applicator includes a housing, a sensor carrier connected to the housing, a sheath member slidably connected to the housing so as to move between an extended position and a crushed position, and a sharp member carrier movable between a distal position with respect to the sheath member and a proximal position with respect to the sheath member. The sheath member further includes a noise attenuator, which is configured to engage with the sharp member carrier and reduce its speed when the sharp member carrier moves from the distal position to the proximal position.

[0019] The noise attenuator may be configured to reduce noise caused by the movement of the pointed member carrier from the distal position to the proximal position. The applicator may include a cap that is screw-connected to the housing.

[0020] In accordance with the subject matter of the present disclosure, an applicator for delivering a sensor control device is presented. The applicator includes a housing, a sensor carrier connected to the housing, a sensor control device freely connected to the sensor carrier for release, a sensor extending from the sensor control device, the sensor having a distal end and a proximal end provided at its tail, a pointed member carrier movable between a distal position with respect to the sensor control device and a proximal position with respect to the sensor control device, and a pointed member disposed inside the pointed member carrier. When the pointed member carrier is in the distal position, the pointed member engages with the proximal end of the tail to bias the distal end of the tail in a direction towards the pointed member. When the pointed member carrier is in the proximal position, the pointed member does not engage with the proximal end of the tail.

[0021] A protrusion may be provided at the proximal end of the sensor. A window is provided in the pointed member. When the pointed member is in the distal position, the proximal end of the tail may protrude inside the window of the pointed member. The pointed member carrier may be in the distal position before delivery. The pointed member carrier may be in the proximal position during delivery of the sensor. The applicator includes a sheath member, and it may be slidably connected to the housing so as to move between an extended position and a crushed position. The pointed member can define a passage. When the pointed member engages with the proximal end of the tail, the distal end of the tail can be received inside the passage of the pointed member.

Brief Description of the Drawings

[0022] The details of the subject matter disclosed in this specification will probably become apparent by considering the accompanying drawings with respect to both its structure and operation, where like reference numerals in the figures refer to like elements. Each element of the drawings is not necessarily to scale, with emphasis instead being placed upon illustrating the principles of the subject matter. Further, all illustrations are for the purpose of conveying concepts, and relative dimensions, shapes, and other detailed attributes may be schematically illustrated rather than literally or precisely.

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MODE FOR CARRYING OUT THE INVENTION

[0023] Before explaining the present subject matter in detail, it should be understood that the present disclosure is not limited to the specific embodiments described and can of course be changed. The terms used in this specification are for the purpose of describing only specific embodiments and are not intended to be limiting, because it should also be understood that the scope of the present disclosure is limited only by each claim of the appended patent claims.

[0024] As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise.

[0025] The various publications discussed herein are presented solely for the reason that their disclosures are prior to the filing date of the present application. It should not be construed that anything in this specification admits that the present disclosure is not entitled to antedate such publications on the grounds of prior disclosure. Further, the published dates presented may be different from the actual publication dates and it is assumed that they need to be individually verified.

[0026] Generally, each embodiment of the present disclosure includes a system, an apparatus, and a method for using an analyte sensor inserter for use in combination with an in vivo analyte monitoring system. The inserter can be provided to the user in a sterile package containing a covering member for the electronics of the sensor control device. In some embodiments, a structure separate from the inserter, such as a container, is provided to the user as a sterile package containing the sensor module and the sharp member module. The user can couple the sensor module to the covering member for the electronics and couple the sharp member to the inserter in an assembly process involving inserting the inserter into the container in a specified manner. In other embodiments, the inserter, the sensor control device, the sensor module, and the sharp member module may be provided in a single package. The inserter can be used to place the sensor control device on the human body such that the sensor is in contact with the body fluid of the device wearer. Each embodiment presented herein is an improvement for reducing the possibility of improper insertion or damage to the sensor and the possibility of inducing a harmful physiological reaction. Other improvements and advantages are presented as well. The various configurations of these devices will be described in detail by way of various embodiments, which are merely examples.

[0027] Furthermore, many embodiments include an in-vivo analyte sensor that is structurally configured such that at least a portion of the sensor is or can be placed within the body of a user to obtain information regarding at least one analyte in the body. It should be noted, however, that each of the embodiments disclosed herein can be used in combination with an in-vivo analyte monitoring system incorporating ex-vivo functionality, as well as a purely ex-vivo analyte monitoring system, i.e., an ex-vivo analyte monitoring system, such as a completely non-invasive system.

[0028] Furthermore, for every embodiment of the methods disclosed herein, systems and devices capable of implementing each of them are within the scope of the present disclosure. For example, embodiments of sensor control devices are disclosed, and these devices can include one or more sensors, one or more analyte monitoring circuits (e.g., analog circuits), one or more storage devices (e.g., for storing instructions), one or more power supplies, one or more communication circuits, one or more transceivers, one or more receivers, one or more arithmetic processing units, one or more control devices (e.g., for executing instructions), or various combinations thereof, so as to be able to implement any method step or facilitate the execution of any method step. Each embodiment of such a sensor control device can be used or is equipped with functions suitable for use to implement the steps executed by a sensor control device based on any of the methods described herein.

[0029] As described above, numerous embodiments of systems, devices, and methods are described herein, which result in an improved integration and use of a sensor insertion device for use in conjunction with an in vivo analyte monitoring system. In particular, some embodiments of the present disclosure are designed to improve the method of sensor insertion with respect to an in vivo analyte monitoring system, and in particular, are designed to prevent premature retraction of the insertion sharp member during the duration of the sensor insertion process. For example, some embodiments include a sensor insertion mechanism that increases the firing speed and delays the retraction of the sharp member. In other embodiments, the sharp member retraction mechanism may be motion-responsive such that the sharp member is not retracted until the user pulls the applicator away from the skin. Therefore, if these embodiments have several advantages, they can reduce the possibility of prematurely pulling out the insertion sharp member during the sensor insertion process, reduce the possibility of improper sensor insertion, and reduce the possibility of damaging the sensor during the duration of the sensor insertion process. Some embodiments of the present disclosure also present an improved insertion sharp member module. Additionally, some embodiments of the present disclosure are designed to prevent the applicator component from undergoing an undesired axial movement, rotational movement, or both during sensor insertion. Therefore, if these embodiments have several advantages, they can reduce the possibility of the placed sensor becoming unstable, the possibility of stimulating the insertion site, and the possibility of damaging the surrounding tissue. In addition, to reduce inaccurate sensor measurements that may be caused by trauma at the insertion site, some embodiments of the present disclosure may reduce the final penetration depth of the needle-like member relative to the sensor tip during insertion.

[0030] However, before describing these aspects of each embodiment in detail, it is desirable to first describe, for example, specific examples of various devices that may be within an in vivo analyte monitoring system, as well as those that can be used in combination with each embodiment described herein, such as their operating examples.

[0031] There are various types of in-vivo analyte monitoring systems. For example, a "continuous analyte monitoring" system (or a "continuous glucose monitoring" system) can continuously, for example, automatically according to a schedule, send data from a sensor control device to a reading device without instructions to the user. As another example, a "flash analyte monitoring" system (or a "flash glucose monitoring" system, or simply a "flash" system) can transfer data from a sensor control device in response to a scan or data request by a use reading device, such as by utilizing a near-field communication (NFC) protocol or a radio frequency identification (RFID) protocol. The in-vivo analyte monitoring system can also operate without requiring a fingerstick biopsy.

[0032] The in-vivo analyte monitoring system is distinguished from an "in-vitro" system, which typically includes a weighing device provided with a port for receiving an analyte test strip that contacts a biological sample outside the body (i.e., "ex-vivo") and holds a body fluid of the user that can be subjected to analysis to determine the user's blood glucose level.

[0033] The in-vivo monitoring system can include a sensor that contacts the user's body fluid and senses the level of the analyte contained therein while being disposed in vivo. The sensor can be made part of a sensor control device resident in the user's body and includes electronics and a power source that enable and control analyte sensing. Some of the sensor control devices and their various variations may be referred to as a "sensor control unit", a "body-worn electronics" device or a "body-worn electronics" unit, a "body-worn" device or a "body-worn" unit, or a "sensor-data communication" device or a "sensor-data communication" unit.

[0034] The in-vivo monitoring system may also be provided with a device that, after receiving the sensed analyte data from the sensor control device, processes the sensed analyte data and displays it to the user in any form, or does both. Some examples of this device and its various variations include "handheld reading device", "reading device" (or simply "reader"), "handheld electronic device" (or simply "handheld"), "portable data processing" device or "portable data processing" unit, "data receiver", "receiver" device or "receiver" unit (or simply "receiver"), or may be referred to as a "remote" device or "remote" unit. Devices other than those mentioned above, such as personal computers, have already been used in combination with or incorporated into in-vivo monitoring systems and in-vitro monitoring systems.

[0035] In-Vivo Analyte Monitoring System with Specific Examples Figure 1 is a conceptual diagram depicting an embodiment of a specific example of an analyte monitoring system 100 including a sensor applicator 150, a sensor control device 102, and a reader device 120. Here, by using the sensor applicator 150, the sensor control device 102 can be delivered to the monitoring site on the user's skin, and at the same site, the sensor 104 is maintained in place by an adhesive patch 105 for a certain period. Although the sensor control device 102 is further illustrated in FIGS. 2B and 2C, it can communicate with the reader device 120 via a communication path 140 using wired or wireless technology. Examples of wireless protocols include Bluetooth (Bluetooth (registered trademark)), Bluetooth Low Energy (Bluetooth Low Energy, i.e., BLE, BTLE, Bluetooth SMART, etc.), Near Field Communication (NFC), and the like. The user can monitor the application installed in the storage device of the reader device 120 using the display screen 122 and the input component 121, and the device battery can be recharged using the power port 123. More details about the reader device 120 will be specified below with respect to FIG. 2A. The reader device 120 can communicate with a local computer system 170 via a communication path 141 using wired or wireless technology. The local computer system 170 preferably includes one or more of a laptop, desktop, tablet, phablet, smartphone, set-top box, video game console, or other computing devices, and the wireless communication preferably includes any of a variety of applicable wireless network protocols such as Bluetooth, Bluetooth Low Energy (BTLE), Wi-Fi (Wi-Fi). The local computer system 170 can communicate with the network 190 via the communication path 143, which is similar to the manner in which the reader device 120 can communicate with the network 190 via the communication path 142 using the wireless or wired technology as described above.Network 190 may be any of a variety of networks, such as a private network and a public network, a local area network or a wide area network. The Trusted Computer System 180 may include a server so as to be able to provide an authentication service and secure data storage, or may communicate with the Network 190 via the communication path 144 by means of a wired technology or a wireless technology.

[0036] Specific Example of a Reader Device FIG. 2A is a block diagram depicting an embodiment of a specific example of a reader device configured as a smartphone. Here, the reader device 120 includes a display screen 122, an input component 121, and a processing core 206. The processing core is provided with a communication processing device 222 connected to a storage device 223 and an application processing device 224 connected to a storage device 225. It may further include a separate storage device 230, a wireless transceiver 228 with an antenna 229 attached, and a power supply 226 provided with a power management module 238. Furthermore, it may further include a multifunctional transceiver 232 capable of communicating via Wi-Fi, NFC, Bluetooth, BTLE, and GPS using an antenna 234. As will be understood by those skilled in the art, the various components described above are electrically connected and communicatively connected in a manner that provides functional devices.

[0037] Specific Sensor Control Device Figures 2B and 2C are block diagrams depicting embodiments of a specific example of the sensor control device 102, which includes an analyte sensor 104 and sensor electronics 160 (including an analyte monitoring circuit) that are mostly ready with processing capabilities suitable for presenting final result data to a user. A single semiconductor chip 161 is depicted in Figure 2B, which may be a dedicated application specific integrated circuit (ASIC). Shown within the ASIC 161 are various high-level functional units, such as an analog front end (AFE) 162, a power management circuit (or power control circuit) 164, an arithmetic processing unit 166, and a communication circuit 168 (which may be implemented as a transmitter, receiver, transceiver, or passive circuit, or otherwise may be realized according to a communication protocol). In this embodiment, both the AFE 162 and the arithmetic processing unit 166 are used as the analyte monitoring circuit, although in other embodiments, either one of the circuits may perform the analyte monitoring function. The arithmetic processing unit 166 may be composed of one or more arithmetic processing units, micro-scale ultra-small arithmetic processing units, control devices, micro-scale ultra-small control devices, or various combinations thereof, each of which may be on a separate chip or may be distributed among a number of chips (some groups of those chips).

[0038] The memory device 163 is also provided within the application-specific integrated circuit (ASIC) 161 and may be shared by various functional units existing within the ASIC 161, or may be distributed among two or more of the functional units. The memory device 163 may be a separate chip. The memory device 163 may be a volatile memory, a non-volatile memory, or a combination of both. In this embodiment, the ASIC 161 is connected to a power supply 170, which may be a coin cell or the like. The analog front end (AFE) 162 acts as an interface with the in-vivo analyte sensor 104, receives measurement data from the sensor, outputs the data in digital form to the arithmetic processing unit 166, and, by extension, the arithmetic processing unit 166 processes the data to reach the final results such as glucose discrete values and trend values. This data is then provided to the communication circuit 168 at that time for transmission to a reading device 120 (not shown) by, for example, an antenna 171. In this case, further minimal processing by a resident software application is required to display the data.

[0039] FIG. 2C is similar to FIG. 2B, but instead includes two separate semiconductor chips 162 and semiconductor chip 174, where both chips may be packaged together or separately. Here, AFE 162 resides on ASIC 161. The arithmetic processing unit 166 is integrated on chip 174 with the power management circuit 164 and the communication circuit 168. AFE 162 includes a storage device 163, and chip 174 includes a storage device 165, and these storage devices may be separate or internally distributed. In one embodiment of a specific example, AFE 162 is integrated together with the power management circuit 164 and the arithmetic processing unit 166 on a single chip, but the communication circuit 168 is on a separate chip. In another embodiment of a specific example, both AFE 162 and the communication circuit 168 are on a single chip, and the arithmetic processing unit 166 and the power management circuit 164 are on another separate chip. It should be noted that combinations of chips other than those composed of three or more chips are possible, and each of them is responsible for a separate function described or shares one or more functions for fail-safe redundancy.

[0040] Integration process of a specific example of a sensor control device The user can obtain the various components of the sensor control device 102 in a state of a plurality of packages, but the user needs to perform final integration before delivering them to the user site. FIGS. 3A to 3D depict an embodiment of a specific example of the integration process of the sensor control device 102 by the user, and the process includes a step of preparing each separate component, which is performed before combining each component to prepare for delivering the sensor. FIGS. 3E to 3F depict an embodiment of a specific example of delivering the sensor control device 102 to an appropriate user site by selecting an appropriate delivery site and applying the device 102 to that site.

[0041] FIG. 3A is a proximal perspective view depicting an embodiment of a specific example in which a user prepares a container 810 configured as a tray (although other groups of packages can also be used) for an assembly process. To achieve this preparation, the user can do so by removing the lid 812 from the tray 810 to expose the platform 808. For example, it can be implemented by peeling off the unbonded portion of the lid 812 from the tray 810 so that the bonded portion of the lid 812 can be removed. As long as the platform 808 is properly exposed inside the tray 810, the removal of the lid 812 may be appropriate in various other embodiments. Thereafter, the lid 812 may be put aside.

[0042] FIG. 3B is a side view depicting an embodiment of a specific example in which a user prepares an applicator device 150 for assembly. The applicator device 150 can be provided in a state of a sterile package sealed by a cap 708. The preparation of the applicator device 150 may include exposing the sheath member 704 by separating the housing 702 from the cap 708 (FIG. 3C). This can be achieved by turning the cap 708 off the housing 702 (or separating it by other means). Thereafter, the cap 708 may be put aside.

[0043] Figure 3C is a proximal perspective view depicting an embodiment of a specific example in which the applicator device 150 is inserted into the tray 810 during the integration by the user. First, after the user aligns the housing orientation function portion 1302 (or a slot or recess) and the tray orientation function portion 924 (an abutment or a detent), the sheath member 704 can be inserted into the platform 808 inside the tray 810. Inserting the sheath member 704 into the platform 808 temporarily releases the locking of the sheath member 704 with respect to the housing 702 and also temporarily releases the locking of the platform 808 with respect to the tray 810. At this stage, when the applicator device 150 is removed from the tray 810, it returns to the same state as before the initial insertion of the applicator device 150 into the tray 810 (that is, if the operations up to this point are reversed and stopped at this point, repeating them will not result in any consequences).

[0044] While the housing 702 is advanced distally to connect with the platform 808 and thereby advance the platform 808 distally with respect to the tray 810, the sheath member 704 can maintain its position with respect to the housing 702 inside the platform 808. This step releases and crushes the locking of the platform 808 inside the tray 810. While the housing 702 continues to advance the platform 808 distally, the sheath member 704 contacts and then disengages from a locking function portion (not shown) inside the tray 810, thereby releasing the locking of the sheath member 704 with respect to the housing 702 and enabling the sheath member 704 to be (relatively) immobile. After the housing 702 finishes advancing distally, a sharp member and a sensor (not shown) inside the tray 810 can be connected to an electronic equipment container (not shown) inside the housing 702. The operations and interactions of the applicator device 150 and the tray 810 will be further described below.

[0045] FIG. 3D is a proximal perspective view depicting an embodiment of a specific example in which the user removes the applicator device 150 from the tray 810 during integration. When the user removes the applicator device 150 from the tray 810, it can be carried out by advancing the housing 702 in the proximal direction with respect to the tray 810, or by other operations that bring about the same final effect as releasing the connection between the applicator 150 and the tray 810. The applicator device 150 is removed with a sensor control device 102 (not shown) that is completely integrated (with a sharp member, sensors, electronics, etc.) inside it, and then positioned in preparation for delivery.

[0046] FIG. 3E is a proximal perspective view depicting an embodiment of a specific example in which the patient applies the sensor control device 102 to a target skin area, such as on the abdomen or other suitable site, using the applicator device 150. By advancing the housing 702 in the distal direction, the sheath member 704 inside the housing 702 is crushed to apply the sensor to the target site, and the adhesive layer on the bottom surface of the sensor control device 102 adheres to the skin. When the housing 702 has completely advanced, the sharp member automatically retracts, but the sensor (not shown) remains in place to measure analyte values.

[0047] FIG. 3F is a proximal perspective view depicting an embodiment of a specific example in which the patient holds the sensor control device 102 in the application position. At this time, the user may remove the applicator 150 from the application site.

[0048] System 100, as described in connection with FIGS. 3A-3F and elsewhere in this specification, can reduce or eliminate the potential for accidental breakage, permanent deformation, improper integration of applicator components, etc. compared to prior art systems. While the sheath member 704 is unlocked, the applicator housing 702 engages directly with the platform 808, rather than indirectly via the sheath member 704, so that the relative angle between the sheath member 704 and the housing 702 does not cause breakage or permanent deformation of the arm or other components. The potential for relatively strong forces (such as in conventional devices) to be applied during integration is reduced, and thus the likelihood of integration failure by the user is reduced.

[0049] Specific Example Sensor-Applicator Device FIG. 4A is a side view depicting an exemplary embodiment of an applicator device 150 connected to a screw cap 708. This is an example of the manner in which the applicator 150 is shipped and received by the user prior to integration with the sensor. FIG. 4B is a side perspective view depicting the applicator 150 and cap 708 after disconnection. FIG. 4C is a perspective view depicting, in an exemplary embodiment of the distal end of the applicator device 150, the electronic device covering member 706 with the adhesive patch 105 removed from the position where each would have been held inside the sensor carrier 710 of the electronic device sheath member 704 when the cap 708 was in place.

[0050] Referring to FIGS. 4D through 4G, which are for illustrative purposes and not limiting, the applicator device 20150 can be provided to the user as a single integrated unit. FIG. 4D presents a top perspective view of the applicator device 20150, FIG. 4E presents a bottom perspective view thereof, FIG. 4F presents an exploded view of the applicator device 20150, and FIG. 4G presents a partial side cutaway view thereof. The perspective views show the manner in which the applicator 20150 is shipped and received facing the user. The exploded view and the partial cutaway view illustrate the various components of the applicator device 20150. The applicator device 20150 includes a housing 20702, a gasket 20701, a sheath member 20704, a sharp member carrier 201102, a spring 205612, a sensor carrier 20710 (also referred to as a "pack carrier"), a sharp member hub 205014, a sensor control device (also referred to as a "pack") 20102, an adhesive patch 20105, a desiccant 20502, a cap 20708, a label 20709 such as a serial number, and a used indication feature 20712. What the user can visually see upon receipt is only the housing 20702, the cap 20708, the used indication feature 20712, and the label 20709. The used indication feature 20712 may be, for example, a sticker connecting each of the housing 20702 and the cap 20708, but the used indication feature 20712 can inform the user that the housing 20702 and the cap 20708 have been separated before by being damaged to an irreparable extent, for example, by separating the housing 20702 and the cap 20708. These various functions will be described in detail below.

[0051] Integrated unit of a specific example tray and sensor module FIG. 5 is a proximal perspective view depicting an embodiment of a specific example of a tray 810 and a sterilization lid 812 detachably connected thereto, a proximal perspective view showing an exemplary embodiment of 810, and is presumed to show the pre-integration manner while the package is shipped and received facing the user.

[0052] FIG. 6A is a proximal perspective partial cutaway view depicting the components for sensor delivery inside the tray 810. The platform 808 is slidably connected inside the tray 810. The desiccant 502 is stationary relative to the tray 810. The sensor module 504 is attached inside the tray 810.

[0053] FIG. 6B is a proximal perspective view depicting the sensor module 504 in more detail. Here, the retaining arm overhang portion 1834 of the platform 808 removably secures the sensor module 504 in place. The module 2200 is configured to be removable together as the sensor module 504 during assembly by being connected to the connector 2300, the pointed member module 2500, and a sensor (not shown).

[0054] Applicator housing and cap of a specific example FIG. 7A is a side view depicting an embodiment of a specific example of an applicator housing 702 that has an internal cavity and a plurality of support structure members and is for the purpose of an applicator function. The user can start the applicator integration process by pushing the housing 702 in the distal direction, and then be able to deliver the sensor control device 102. After that, the cavity of the housing 702 can act as a receiving part for sharp members. In the specific example embodiment, various functional parts are illustrated, such as a housing orientation function 1302 for determining the orientation of the device during integration and in use. The used-explicit annular groove 1304 is a recess provided around the outer periphery of the housing 702, distal to the used-explicit annular protection member 1314 and proximal to the used annular fixing member 1304. By the used-explicit annular groove 1304 fixing the used-explicit ring, the user can identify whether the device has been tampered with or separately used. The housing screw 1310 can be implemented by aligning the screw with a complementary cap-side screw and then rotating it clockwise or counterclockwise to fix the housing 702 to a complementary screw cut on the cap (FIGS. 4A and 4B). The side grip zone 1316 of the housing 702 preferably provides an outer surface part where the user can grip it to use the housing 702. The grip flap 1318 is a protrusion slightly raised with respect to the side grip zone 1316, which helps to easily remove the housing 702 from the cap 708. The shark-tooth part 1320 can cut a used-explicit ring (not shown) because a flat surface is arranged at the clockwise end of the raised part, and can hold the used-explicit ring in place after the user unscrews and separates the cap 708 and the housing 702. In the specific example embodiment, four shark teeth 1320 are used, but more or fewer can be adopted as desired.

[0055] Figure 7B is a perspective view depicting the distal end of housing 702. Here, three housing guide structure members (or "guide protrusions") 1321 are arranged at an angle of 120 degrees relative to each other and at an angle of 60 degrees relative to the locking structure member (or "locking protrusion") 1340, with three of the locking structure members being at positions 120 degrees relative to each other. Of course, various other angular orientations, whether symmetric or asymmetric, may be adopted, and any number of one or more of both structure members 1321 and 1340 may be adopted. Here, structure member 1321 and structure member 1340 each have the shape of a flat protrusion member, although other shapes may be adopted. Each guide protrusion 1321 is provided with a guide edge (also referred to as a "sheath member guide rail") 1326, and these can travel along the surface of sheath member 704 (for example, guide rail 1418 described in connection with FIG. 8A). The insertion-time hard stop 1322 provides a surface for the sensor carrier movement limiting surface 1420 (FIG. 8B) of sheath member 704 to abut during use, preventing the sensor carrier movement limiting surface 1420 from advancing in the proximal direction beyond that point. The carrier interface post 1327 passes through the opening 1510 (FIG. 9A) of sensor carrier 710 during integration and continuation. The sensor carrier interface 1328 may be the rounded distal-facing surface of the housing guide protrusion 1321 to serve as the interface with sensor carrier 710.

[0056] FIG. 7C is a longitudinal sectional view depicting an embodiment of a specific example of the housing. In the embodiment of the specific example, the longitudinal sectional profiles of the housing guide protrusion 1321 and the locking protrusion 1340 are illustrated. The locking protrusion 1340 is provided with a sheath member snap - type fitting portion pulling function portion 1330 near its distal end, which flares outward in the distal direction from the central axis 1346 of the housing 702. Each of the sheath member snap - type fitting portion pulling function portions 1330 bends the return - stop snap - type fitting portion curved surface portion 1404 of the return - stop snap - type fitting portion 1402 of the sheath member 704 inward toward the central axis 1346 as the sheath member 704 moves toward the proximal end of the housing 702, as shown in FIG. 8C. The return - stop snap - type fitting portion 1402 of the sheath member 704 is locked in place in the locking groove 1332 once it has passed beyond the distal point of the sheath member snap - type fitting portion pulling function portion 1330. Thus, the fact that the return - stop snap - type fitting portion 1402 cannot be easily moved in the distal direction is due to the surface having a plane that is substantially perpendicular to the central axis 1346, and such a surface is illustrated as the return - stop snap - type fitting portion flat portion 1406 in FIG. 8C.

[0057] As the housing 702 moves further distally towards the skin surface and as the sheath member 704 advances towards the proximal end of the housing 702, the detent snap fitting 1402 changes position and enters the unlocking groove 1334, and the applicator 150 is in a ready-to-use state for the "equipped" position. When the user applies further force to the proximal end of the housing 702, while the sheath member 704 is pressed against the skin, the detent snap fitting 1402 overrides the firing detent 1344 and advances. As a result of the energy stored in the curved detent snap fitting 1402 being released, a series of steps for firing (such as those described in relation to FIGS. 12A to 12D) are initiated, and the fastener moves proximally relative to the skin surface towards the sheath stop ramp 1338, which slopes slightly outwardly relative to the central axis 1346 and reduces the speed of movement of the sheath member 704 during the continuation of the series of steps for firing. The next groove encountered after the detent snap fitting 1402 enters the unlocking groove 1334 is the final blocking recess 1336 into which the detent snap 1402 enters at the end of the stroke or push sequence performed by the end user, and the detent snap fitting enters this groove at the end of a single blow or series of push steps performed by the user. The final blocking recess 1336 is a surface facing in the proximal direction perpendicular to the central axis 1346, and this surface engages with the detent snap fitting flat portion 1406 after the detent snap fastener 1402 has passed through, firmly holding the sheath member 704 in place relative to the housing 702 and preventing the reuse of the device. When the hard stop 1322 is inserted during the insertion of the housing guide protrusion 1321, it engages with the sensor carrier movement limiting surface 1420 to prevent the sheath member 704 from advancing proximally relative to the housing 702.

[0058] Figures 7D and 7E are proximity longitudinal sectional views of an exemplary embodiment when the return snap fitting portion 1402 of the sheath member 704 is moving toward the proximal end of the applicator housing 702 at the locking protrusion 1340 of the applicator housing 702. FIG. 7D illustrates the sheath member 704 in a “locked” state, where the return snap fitting portion curved surface portion 1404 of the return snap fitting portion 1402 has already overcome the sheath member snap fitting portion retraction functional portion 1330 and is located within the locking groove 1332 of the locking protrusion 1340. When a force is applied to the proximal end of the housing 702, the return snap fitting portion curved surface portion 1404 advances in the proximal direction and enters the unlocking groove 1334, allowing the applicator 150 to reach the “ready-to-fire” position. When further force is applied to the proximal end of the housing 702, when the return snap fitting portion curved surface portion 1404 advances proximally from the unlocking groove 1334 and overcomes the firing detent 1344, the applicator 150 is “fired”. Thereafter, as a result of the sheath member 704 advancing further proximally, as illustrated in FIG. 7E, the return snap fitting portion curved surface portion 1404 slides freely on the firing surface 1337. In this embodiment, the firing surface 1337 is generally parallel to the central axis 1346. As the sheath member 704 continues to advance proximally, the return snap fitting portion curved surface portion 1404 reaches the sheath member stop ramp 1338, which reduces the moving speed of the sheath member 704. When the return snap fitting portion curved surface portion 1404 reaches the final blocking recess 1336, the return snap fitting portion flat portion 1406 (not shown) is engaged to firmly hold the sheath member 704 in place relative to the housing 702.

[0059] Figures 7F and 7G are proximal cross-sectional views of an alternative embodiment of a locking projection 2340 designed to improve the firing speed of the tip member from the sensor applicator. Here, an inward retaining ramp 2335 is provided on the locking projection 2340 to reduce the friction between the sheath member 704 and the housing 2702 during firing. The locking projection 2340 is also provided with a sheath member stop ramp 2338 at the proximal end of the firing surface 2337. In Figure 7F, the sheath member 704 is illustrated as initially being in a "locked" state, where the retaining snap fit curved surface portion 1404 of the retaining snap fit 1402 has already passed through the sheath member snap fit retraction functional portion 2330 and is in position within the locking groove 2332. When a force is applied to the proximal end of the housing 2702, the retaining snap fit curved surface portion 1404 advances into the unlocking groove 2334, causing the applicator 150 to reach the "ready-to-fire" position. When further force is applied to the proximal end of the housing 2702, when the retaining snap fit curved surface portion 1404 clears the firing stop 2344, the applicator 150 is "fired".

[0060] As illustrated in FIG. 7G, the return snap fitting curved surface portion 1404 then travels in a “free flight” state toward the proximal end of the housing 2702, where the return snap fitting curved surface portion 1404 passes through the inward return stop inclined portion 2335. The return snap fitting curved surface portion 1404 may not be connected to the inward return stop inclined portion 2335 and the launch surface 2337 while traveling in the “free flight” state in the proximal direction, that is, it may not be in contact with both portions. In this regard, since there is little or no frictional force between the return snap fitting curved surface portion 1404 and the inward return stop inclined portion 2335, and between the former and the launch surface 2337, the return snap fitting curved surface portion 1404 can be advanced easily and quickly, and such circumstances improve the launch speed of the pointed member from the applicator. The sheath member stop inclined portion 2338 is positioned further proximally along the locking projection portion 2340 compared to the embodiments illustrated in FIGS. 7D and 7E, but is provided with a certain kind of edge to frictionally engage with the return snap fitting curved surface portion 1404 in an attempt to reduce the moving speed of the sheath member 704. The sheath member stop inclined portion 2338 may be formed in an inclined shape so as to increase frictional contact as the return snap fitting curved surface portion 1404 advances in the proximal direction. Finally, when the return snap fitting curved surface portion 1404 reaches the final blocking recess 2336, a return snap fitting flat portion 1406 (not shown) engages to firmly hold the sheath member 704 in place with respect to the housing 2702. This embodiment exhibits a high launch speed compared to the embodiments depicted in FIGS. 7A and 7E and also helps to prevent the pointed member from being prematurely withdrawn.

[0061] FIG. 7H is a proximal longitudinal sectional view of an alternative embodiment of a locking projection 6340 designed to maintain a downward force applied to the sheath member 6704 during firing and, by extension, to prevent the sheath member 6704 from making unwanted movements during the sensor insertion process. Here, the sheath member 6704 is illustrated in a "locked" state, with the return snap fit curved surface portion 6404 of the return snap fit 6402 seated in the locking groove 6332. When a force is applied to the proximal end of the housing 6702, the return snap fit curved surface portion 6404 advances into the unlocking groove 6334, placing the applicator in the "ready" position. When further force is applied to the proximal end of the housing 6702, the applicator is "fired" and the return snap fit curved surface portion 6404 travels along the inclined firing surface 6338 towards the proximal end of the housing 6702. By providing the inclined firing surface 6338 with a gradient towards the central axis 1346, it is intended that the downward force resulting on the sheath member 6704 increases as the return snap fit curved surface portion 6404 travels in the proximal direction. In the illustrated embodiment, the return snap fit curved surface portion 6404 is in contact with the inclined firing surface 6338. The blocking recess 6336 prevents the return snap fit curved surface portion 6404 and the sheath member 6704 from moving back, i.e., moving distally. This embodiment exhibits a lower firing speed compared to the previous embodiments, but may be used in combination with, for example, the motion-responsive sharp member retraction process described with respect to FIGS. 14A to 14C and FIGS. 15A and 15B.

[0062] Figure 7I is a proximal cross-sectional view of another alternative embodiment designed such that at the locking protrusion 7340 and also to maintain the downward force applied to the sheath member 6704 during firing, and thus to prevent the sheath member 6704 from making unwanted movements during the sensor insertion process. Here, the sheath member 6704 is illustrated in the "fired" state, and the retaining snap-fit curved surface portion 6404 of the retaining snap-fit portion 6402 is in position within the bi-directional blocking recess 7336. As soon as the retaining snap-fit curved surface portion 6404 advances and enters the bi-directional blocking recess 7336, the sheath member 6704 can no longer move either proximally or distally. This can reduce unwanted movement of the sheath member 6704 during the sensor insertion process. Further, in some embodiments, as will be described in connection with FIGS. 14A through 14C and FIGS. 15A and 15B, there are those in which the bi-directional blocking recess 7336 immobilizes the sheath member 6704 even during the operation-sensing sharp member retraction process. As can be seen in FIG. 7I, the inclined firing surface 7338 is configured to increase the downward force that results in being applied to the sheath member 6704 as the retaining snap-fit curved surface portion 6404 advances proximally by providing a gradient towards the central axis 1346. In the illustrated embodiment, the retaining snap-fit curved surface portion 6404 is in contact with the inclined firing surface 7338.

[0063] Referring to FIGS. 7J to 7L, the housing 20702 according to the subject matter of the present disclosure is presented for illustrative purposes without any intention of limitation. The housing 20702 may be made of a suitable variety of materials such as cyclic olefin copolymer or others, such as polycarbonate or high-density polyethylene (HDPE). The housing 20702 may be provided with one or more of the functional parts described in relation to those that can perform functions similar to the functional parts described in the present application among various housings. For example, the housing 20702 may be provided with a grip rib portion 20702A that allows the user to firmly hold the housing 20702. The housing 20702 may be provided with an additional grip rib portion 20702A. For example, two grip rib portions 20702A may be located on both sides of the housing 20702. The housing 20702 may be provided with a side grip zone 20702B directly below the grip rib portion 20702A. The side grip zone 20702B may improve the grip of the user by processing the texture. The housing 20702 may be provided with an additional side grip zone 20702B. For example, two side grip zones 20702B may be located on both sides of the housing 20702, and each of them may be arranged directly below the grip rib portion 20702A.

[0064] The housing 20702 may be provided with a housing skirt portion 20702C such that the skirt portion becomes the surface of the used indication functional portion 20712. The housing skirt portion 20702C may be supported by a plurality of skirt reinforcing rib portions 20702D. The skirt reinforcing rib portions 20702D support the housing skirt portion 20702C and can be used to protect the applicator device 20150 during the occurrence of impact events such as dropping. Further, the skirt reinforcing rib portions 20702D can also be used to support the housing 20702 during manufacturing. The housing skirt portion 20702C and the skirt reinforcing rib portions 20702D can provide rigidity to resist the force caused by the compression of the gasket and can also be used to maintain the compression of the gasket 20701 throughout the storage life. The housing 20702 may include a gasket holding ring 20702E and a plurality of gasket holding pockets 20702F, which can hold the gasket 20701 with respect to the housing 20702. For example, the gasket holding ring 20702E can prevent the movement of the gasket 20701 in the lateral direction, the axial direction, or both directions, and the gasket holding pocket 20702E can prevent the gasket 20701 from rotating. The housing 20702 may include a plurality of gasket holding pockets, for example, 14 gasket holding pockets 20702E. The gasket sealing surface 20702N can press the gasket 20701 to perform sealing. The housing 20702 may be additionally or alternatively provided with an applicator cap sealing lip portion 20702U, which can act as an interface with the cap 20708 as will be described in more detail below. The housing 20702 may be provided with an inner surface 20702T that can receive the sheath member 20704.

[0065] The housing 20702 may be provided with a screw 20702G configured to be screwed with a screw 20708D cut in the cap 20708. The screw may be provided with a radial restriction functional portion 20702H, and the functional portion can restrict the cap 20708 (for example, each part such as 20708D, 20708F, 20708G, etc.) from deforming in the radial direction during the occurrence of an impact event such as dropping. The housing 20702 may be provided with a plurality of radial restriction functional portions 20702H. For example, six radial restriction functional portions 20702H may be provided. The radial restriction functional portion 20702H may be a plurality of protrusions extending from the housing and can block the gap of the screw 20708D cut in the cap. This can restrict the cap 20708 from deforming into an ellipse during the occurrence of an impact event such as dropping. Preventing the elliptical deformation of the cap 20708 can, in turn, ensure that the locking arm 20704J of the sheath member 20704 remains locked between the cap 20708 and the sensor carrier 20710 (for example, the locking shelf-shaped portion 20710N), and can restrict the movement of the sheath member 20704 before removing the cap 20708 (as will be described in detail below). The housing 20702 may be further provided with a relief notch 20702I for releasing the sheath member arm during firing.

[0066] Inside the housing 20702, a plurality of sensor carrier mounting functional parts are provided, which receive the sensor carrier 20710, align it, and attempt to restrict the movement of the carrier. For example, the housing 20703 may be provided with a sheath member guide rail 20702J. This rail is useful for aligning and guiding the sheath member 20704 when the sheath member 20704 moves relative to the housing 20702. The housing 20702 may be provided with a plurality of sensor carrier mounting slots 20702K that can engage with and hold the sensor carrier 20710, and a sensor carrier rigid stop portion 20702L that can restrict the axial movement of the sensor carrier 20710 relative to the housing 20702. The housing 20702 may also be provided with a sensor carrier biasing functional part 20702M that can eliminate the inclination between the sensor carrier 20710 and the housing 20702 after integration, and a sensor carrier radial restriction functional part 20702O that can keep the sensor carrier in a radially aligned state relative to the housing 20702. Each flat horizontal surface between the sensor carrier mounting slot 20702K and the sensor carrier radial restriction functional part 20702O can be used to stop the sheath member 20704 at the end of a single strike. Various functional parts on the sheath member 20704 similar to these may interact with the above-mentioned respective surfaces. The sensor carrier biasing functional part 20702M can further restrict the rotation of the sensor carrier 20710 relative to the housing 20702. The housing 20702 may be provided with one or more of the sheath member guide rail 20702J, the sensor carrier mounting slot 20702K, the sensor carrier rigid stop portion 20702L, the sensor carrier radial restriction functional part 20702O, and the sensor carrier biasing functional part 20702M. For example, three of each may be provided.

[0067] Inside the housing 20702, a plurality of sheath member protrusions 20702S are further provided. As described in this specification, it is provided for insertion by engaging with the sheath member 20704. One or more sheath member protrusions 20702S may be provided on the housing 20702. For example, three may be provided. Each of the sheath member protrusions 20702S may be provided with a sheath member snap - type fitting portion retraction functional portion 20702P. The retraction functional portion is configured to initially retract the return - stop snap - type fitting portion 20704A of the sheath member 20704 to the correct position. A firing return - stop 20702Q may be provided on the housing 20702. After the return - stop snap - type fitting portion 20704A of the sheath member 20704 passes through the firing return - stop 20702Q, a series of steps for firing can be started, and the sheath member 20704 can move toward the sheath member stop inclined portion 20702R. The sheath member stop inclined portion 20702 can reduce the speed of the sheath member 20704 at the end of firing.

[0068] Referring to FIGS. 7M through 7U, for purposes of illustration, a specific example of a cap 20708 is presented. The cap 20708 may be provided with one or more of the functional portions described in relation to those that can exhibit the actions as described in this application for functional portions similar to those described in this application among various caps. The cap 20708 may be made of a suitable material such as high - density polyethylene (HDPE) or other materials such as polypropylene or low - density polyethylene (LDPE). The cap 20708 may be provided with a label surface 20708A configured to receive a label 20709. The cap 20708 is provided with ridge - like portions 20708B, which can provide strength and can provide a better gripping surface for the user. The cap 20708 may be provided with a used - label - indicating ring 20708C, which may be able to receive a used - indication functional portion 20712. The cap 20708 may be provided with a gasket - sealing surface 20708G configured to engage with the gasket 20701.

[0069] On the inner side, the cap 20708 may be provided with a screw 20708D so that it can be screwed with the screw 20702G cut in the housing 20702. The cap 20708 is provided with a sealing interface 20708E, and it may be configured to seal between the housing 20702 and the cap 20709 by receiving the applicator cap sealing lip portion 20702U.

[0070] Figures 7P to 7S are enlarged longitudinal sectional views of the interface between the housing 20702 and the cap 20708. As shown, the applicator-cap sealing lip portion 20702U of the housing 20702 is provided with a first axis-direction expansion portion 2002a, and the sealing interface 20708E of the cap 20708 is provided with a cavity portion 2002d, and the cavity portion is fitted with the first axis-direction expansion portion 2002a. In the illustrated embodiment, the diameter of the cavity portion 2002d formed from the second axis-direction expansion portion 2002b and the third axis-direction expansion portion 2002c of the cap 20708 is dimensioned to receive the diameter of the first axis-direction expansion portion 2002a of the housing 20702 therein. For example, as shown in FIG. 7R, the axis-direction expansion portion 2002a may have a height H1 and a thickness D1 when measured from its distal end. Similarly, the second axis-direction expansion portion 2002c may have a height H3 and a thickness D5 when measured from the proximal end of the cap 20708, and the cavity portion 2002d may have heights H2, H3, and H4 and thicknesses D2, D3, and D4, respectively, when measured from the proximal end of the cap 20708. In one embodiment, the thickness D1 is rated at 1 mm with a tolerance of ±0.03 mm. D2, D3, and D4 may be any dimensions as long as they are suitable, but the height H1 is rated at 1.66 mm with a tolerance of ±0.1 mm, H2 is rated at 8.25 mm with a tolerance of ±0.1 mm, H3 is rated at 9.25 mm with a tolerance of ±0.1 mm, and H4 is rated at 9.75 mm with a tolerance of ±0.1 mm. However, in other embodiments, reversed values may be adopted, but in that case, the diameter of the first axis-direction expansion portion 2002a may be dimensioned to receive the diameter of the second axis-direction expansion portion 2002b without departing from the scope of the present disclosure.

[0071] In various embodiments, the two radial blocking portions 2004 and 2006 may be defined at the interface between the first axial expansion portion 2002a and the second axial expansion portion 2002b, or may be provided in another manner. However, the radial blocking portions 2004 and 2006, regardless of the axial direction, help prevent the movement of fluid and contaminants across the interface. Further, the double radial blocking portions described in the present application can accommodate tolerance variations and thermal variations in combination with stress relaxation due to unnecessary blocking measures. In the illustrated embodiment, the double radial blocking portions 2004 and 2006 utilize the "wedge" effect to effectively seal between the first axial expansion portion 2002a and the second axial expansion portion 2002b.

[0072] The cap 20708 may be provided with one or more ridge-like portions 20708F (see FIG. 7N). For example, two sets of ridge-like portions 20708F may be provided. The squeezing ridge-like portion 20708F is configured to engage with the edge 20704N of the locking arm 20704J during an impact event such as a drop, as will be described in more detail below (e.g., see FIG. 8N). According to many embodiments, the edge 20704N may be a sharp edge.

[0073] In accordance with the subject matter of the present disclosure, the cap 20708 is provided with one or more desiccant holding clips 20708H to hold the desiccant 20502 within the cap 20708 and to attempt to limit the rotation of the desiccant 20502. By providing the cap 20708 with a detent 20708I, which will be described in more detail later, when the cap 20708 is removed from the housing 20702, the detent is configured to engage the sensor-cap to enable removal of the sensor-cap. The cap 20708 may be provided with a plurality of protrusions 20708J that provide strength.

[0074] Referring to FIGS. 7T and 7U, without intending to limit by way of example, in accordance with the subject matter of the present disclosure, the cap 20708 is provided with one or more surfaces that engage with other components of the applicator device 20150, so as to provide support, i.e., to be able to limit movement, in the event of an impact event such as a drop. For example, the cap may be provided with a sheath member support surface 20708K configured to support the sheath member 20704 during the occurrence of an impact event. The sheath member support surface 20708K can limit the distal movement of the sheath member 20704 during the impact event. Thereby, the stress applied to the sensor carrier 20710 and the sensor control device 20102 can be reduced, and the risk of the sensor control device 20102 coming off the sensor carrier 20710 can be reduced. In addition to or instead of this, the cap 20708 may be provided with a raised protrusion 20708L. The raised protrusion 20708L may be aligned with a plug 9130A such as the elastomeric plug 9130A (the interface is connected to, for example, a sensor-cap or a desiccant cap). Thereby, the raised protrusion 20708L can also support the sharp member carrier 1102, the sensor carrier 20710, and the sensor control device 20102, and thus, the sensor control device 20102 can be prevented from coming off the sensor carrier 20710 during the occurrence of an impact event. Further, additional support for the elastomeric plug 9130A and other functional parts can increase the stress applied to various sealing parts of the applicator device 20150, thereby improving the sealing state before removing the cap 20708 from the housing.

[0075] Specific example of an applicator sheath member Figures 8A and 8B are respectively a side view and a perspective view depicting an embodiment of a specific example of the sheath member 704. In this embodiment of the specific example, the sheath member 704 can perform a final operation confirmation of the sensor control device 102 before use above the skin surface of the user. The sheath member 704 may have functions of holding a sharp member at a position for appropriately applying the sensor, determining the force required for sensor application, and assisting in guiding the sheath member 704 with respect to the housing 702 during application. The retaining snap - type fitting portion 1402 is near the proximal end of the sheath member 704 and will be further described below with respect to FIG. 8C. The sheath member 704 generally has a cylindrical cross - section, and the first radius of its proximal - side section (the side closer to the upper end of the figure) is shorter than the second radius of its distal - side section (the side closer to the lower end of the figure). A plurality of retaining gaps 1410 are also shown, and in the embodiment of the specific example, there are three. One or more retaining gaps 1410 may be provided in the sheath member 704, and each of them may be a cut - out portion having a space for the sheath member snap - type fitting portion retracting functional portion 1330 to pass in the distal direction until the distal - side surface of the locking protrusion 1340 contacts the proximal - side surface of the retaining gap 1410.

[0076] The guide rail 1418 is disposed between the sensor carrier movement restricting surface 1420 at the proximal end of the sheath member 704 and the cut - out portion around the locking arm 1412. Each of the guide rails 1418 may be a groove between two raised lines, and the guide edge 1326 of the housing guide protrusion 1321 can slide in the distal direction with respect to the sheath member 704 in the groove.

[0077] The locking arm 1412 is arranged near the distal end of the sheath member 704, and it is preferably provided with a mounting side distal end and a free proximal end. The free proximal end is preferably provided with a locking arm interface 1416. When the locking interface 1416 of the locking arm 1412 engages with the locking interface 1502 of the sensor carrier 710, the locking arm 1412 can lock the sensor carrier 710 to the sheath member 704. The locking arm reinforcing ridge 1414 is preferably arranged near the central position of each locking arm 1412. Without it, it acts as a point to strengthen the vulnerable points of each locking arm 1412, so that the locking arm 1412 will not be bent excessively or damaged.

[0078] The return stop reinforcement mechanism 1422 is preferably arranged along the distal section of the return stop snap - fitting part 1402, and it can reinforce the return stop snap - fitting part 1402. The alignment notch 1424 is a cut - out part near the distal end of the sheath member 704, which provides an opening so that the user can align with the sheath member orientation functional part of the platform 808. The reinforcing protrusion 1426 may be provided with a retaining wall - like part. Here, it is in a triangular shape and can support the return stop base 1436. The housing guide rail gap 1428 is preferably a cut - out part that allows the distal surface of the housing guide protrusion 1321 to slide during use.

[0079] Figure 8C is a proximity perspective view depicting an embodiment of a specific example of the return stop snap - fitting part 1402 of the sheath member 704. The return stop snap - fitting part 1402 is preferably provided with a return stop snap - fitting part bridging part 1408 at or near its proximal end. The return stop snap - fitting part 1402 may also be provided with a return stop snap - fitting part flat part 1406 on the distal side of the return stop snap - fitting part bridging part 1408. The outer surface of the return stop snap - fitting part bridging part 1408 may be provided with a return stop snap - fitting part curved surface part 1404. The curved surface part is a rounded surface, so that the return stop snap - fitting part bridging part 1408 can cut across the inner surface of the housing, such as the locking protrusion 1340, etc., and move more easily.

[0080] FIG. 8D is a side view depicting an embodiment of a specific example of the sheath member 704. Here, the alignment notch 1424 may be located relatively close to the retaining gap 1410. The retaining gap 1410 is at a relatively proximal part of the distal portion of the sheath member 704.

[0081] FIG. 8E is an end view depicting an embodiment of a specific example of the proximal end of the sheath member 704. Here, by the back wall of the guide rail 1446 acting as a groove, it can be slidably connected to the housing guide protrusion 1321 of the housing 702. The sheath member rotation limiting member 1448 may be a plurality of notches, but these reduce or prevent the rotation of the sheath member 704.

[0082] FIGS. 8F to 8H are perspective views of various stages of integrating an alternative embodiment of the sheath member 6704 with various components of the applicator. As illustrated in FIG. 8F, the sheath member 6704 may have most of the same functional parts as the sheath member 704, but these have already been described in relation to FIGS. 8A to 8C. For example, the sheath member 6704 includes one or more retaining snap - fit portions 6404, to which one or more retaining curved surface portions 6402 are attached. However, the overall length of the sheath member 6704 may be shorter compared to the sheath member 704. In addition, one or more inner sheath member ridge - like portions 6425 may be provided on the inner surface of the sheath member 6704, and they may protrude inwardly toward the central axis of the sheath member 6704.

[0083] Referring to FIG. 8G, a perspective view illustrates a stage where the sheath member 6704 is integrated with the applicator housing 6702 and the sensor carrier 6710. One or more inner sheath member ridge portions 6425 of the sheath member 6704 may be aligned with one or more corresponding counter-ridge notches 6519 of the sensor carrier 6710. An interface that fits precisely between the corresponding ridge portions 6425 and notches 6519 helps maintain the axial alignment of the sheath member 6704 and the sensor carrier 6710 during the sensor insertion process. Further, the interface between the ridge portions 6425 and the notches 6519 can reduce lateral movement and rotational movement between various components of the applicator, and thus, can reduce the possibility of improper sensor insertion.

[0084] Referring to FIG. 8H, a perspective view illustrates a stage where the sheath member 6704 is integrated with the applicator housing 6702 and the electronics cover member 706, and the cover member has already been completely inserted into the sensor carrier 6710. The inner sheath member ridge portion 6425 is also illustrated.

[0085] Six inner sheath member ridge portions 6425 and six corresponding counter-ridge notches 6519 are depicted, but it should be noted that any number of ridges and notches fall completely within the scope of the present disclosure. Further, although the ridge portion 6425 is depicted as having a rounded surface edge, in other embodiments, the shape of the ridge portion 6425 may be rectangular or triangular, and the counter-ridge notch 6519 may be adapted to the ridge portion 6425 by having a receiving shape corresponding thereto. Additionally, although the ridge portion 6425 is depicted as being disposed on the inner circumferential surface of the sheath member 6704, it may be disposed on any surface or part of the sheath member 6704 as long as it is disposed on a surface or portion that contacts the sensor carrier.

[0086] Referring to FIGS. 8I through 8O, which are for illustrative purposes and not intended to be limiting, a sheath member 20704 is presented in accordance with the subject matter of the present disclosure. The sheath member 20704 may be made of Delrin or various other suitable materials, such as various low-friction polymers other than the above. The sheath member 20704 is described in relation to one or more of the functional parts described such that it can exhibit an action similar to the functional parts described in the present application among various enclosures. For example, the sheath member 20704 includes a retaining snap-fit portion 20704A having a free proximal end, which is configured to engage with a sheath member protrusion 20702S during firing. FIG. 8J illustrates a close-up view of the free proximal end of the retaining snap-fit portion 20704A. The retaining snap-fit portion 20704A may be provided with a curved surface portion 20704B for engaging with the sheath member protrusion 20702S and a flat portion 20704C for performing final cutoff on the housing 20704 after use. The curved surface portion 20704B may be provided with a molded split line mismatch portion 20704D that can prevent becoming a burr of force return during firing. The retaining snap-fit portion 20704A may be connected to the sheath member 20704 at its overhanging distal end 20704E, and the overhanging distal end can support the retaining snap-fit portion 20704. A plurality of retaining snap-fit portions 20704A may be provided on the sheath member 20704, for example, three. The sheath member 20704 may be provided with a plurality of, for example, three housing void portions 20704F, which allow the sheath member 20704 to empty the housing 20702 at the end of firing. In accordance with the subject matter of the present disclosure, the sheath member 20704 may be further provided with a plurality of (for example, six) reinforcing protrusions P, which can reinforce the sheath member 20704.

[0087] A plurality of guides 20704G are provided on the sheath member 20704 so that it may engage with the sheath member guide rail 20702J of the housing 20702. The sheath member 20704 is further provided with a slot 20704H, and the stopper 20704I at its distal end is configured to engage with the sheath member guide rail 20702J of the sheath member 20702, thereby preventing the sheath member 20704 from moving further in the proximal direction with respect to the housing 20702 at the end of firing. A gap 20704T is also provided in the sheath member 20704 so that it can pass through the sensor carrier biasing functional portion 20702M disposed on the sheath member guide rail 20702J of the housing 20702.

[0088] According to the disclosed subject matter, the sheath member 20704 may include a locking arm 20704J. The locking arm 20704J may be configured to engage with the sensor carrier 20710 to restrict movement of the sensor carrier 20710 or the sheath member 20704 before launch. The locking arm 20704J is provided with a free proximal end 20704K and a mounting side distal end 20704L. The free proximal end 20704K is provided with a locking arm interface 20704M, which is disposed on the inner surface of the locking arm 20704J. The locking arm interface 20704M can engage with a locking ledge 20710N on the sensor carrier 20710. For example, when the cap 20708 is connected to the housing 20702, the cap 20708 can urge the locking arm 20704J inward and engage the locking arm interface 20704M with the sensor carrier 20710. That is, the locking arm 20704J can act as a wedge between the cap 20708 and the sensor carrier 20710. Therefore, when the cap 20708 is connected to the housing 20702, the locking arm 20704J can restrict the proximal movement of the sheath member 20704. By engaging in this way, the movement of the sheath member 20704 during an impact event such as a drop can be restricted. The locking arm interface 20704M may be triangular in side view (e.g., FIG. 8N) and "U" shaped in top view (e.g., FIG. 8K). The above shape of the locking arm interface 20704M may provide benefits during manufacturing. For example, due to the above shape of the locking arm interface 20704M, the sheath member 20704 can be forced out of the mold during its manufacture. By forcing the sheath member 20704 out, for example, the manufacturing process can be further simplified by using a simplified core design and cavity design, and additional molding parting lines can be eliminated for the purpose of creating a non-releaseable shape portion of the plastic member, or complex lifters, slides, or both can be dispensed with. A surface lacking smoothness caused by the molding parting line may catch on the sensor carrier 20710 during launch, and the molding parting line may potentially become a return burr of the launch force.Accordingly, the mold design, which has been made easier by utilizing forced ejection, facilitates the creation of a smoother locking arm interface 20704M and can prevent potential flash caused by the forming parting line from occurring due to the return of the ejection force.

[0089] It is preferable that an edge 20704N (such as a sharp edge, etc.) is further provided on the outer surface at the proximal free end of the locking arm 20704J. The sharp edge 20704N is preferably configured to engage with the ridge-like portion 20708F (which may be composed of a plurality of pressing ridge-like portions, for example) disposed on the cap 20708 during the occurrence of an impact event. The sharp edge 20704N can be thrusted against the pressing ridge-like portion 20708F to permanently deform the pressing ridge-like portion 20708F, thereby absorbing energy during the occurrence of an impact event and preventing the sheath member 20704 from being crushed. The formed locking arm interface 20704M may also be beneficial for preventing falls. Its inclined portion can move the locking arm 20704J in the radial direction when the sheath member 20704 is in a crushed state during the occurrence of a fall. This enables the sharp edge 20704N to be thrusted against the pressing ridge-like portion 20708F and helps prevent the sheath member 20704 from being crushed. The sheath member 20704 may include a plurality of locking arms 20704J, but it is preferable to include, for example, two locking arms 20704J.

[0090] In addition to, or alternatively to, the sheath member 20704 may be provided with a rib portion 20704U, which is configured to engage with a locking interface 20710F of a sensor holding arm 20710B on the sensor carrier 20710. The rib portion 20704U can, for example, prevent the sensor holding arm 20710B from bending outward during the occurrence of an impact event, and thus can prevent the sensor control device 20102 from moving during the occurrence of an impact event. The height of the rib portion 20704U (i.e., the length in the long axis direction) is selected such that even when the sheath member 20704 moves in the proximal or distal direction during the occurrence of an impact event, the rib portion 20704U continues to engage with the locking interface 20710F of the sensor holding arm 20710B on the sensor carrier, so that the sensor control device 20102 does not become detached from the sensor carrier 20710.

[0091] The sheath member 20704 may be provided with a noise attenuation member 20704O. When the sharp member carrier 201102 retracts and its moving speed decreases, the noise attenuation member 20704O may be configured to engage with the sharp member carrier 201102, thereby reducing the noise generated by the sharp member carrier 201102 engaged with the sheath member 20704. In each embodiment of the specific example, the attenuation member 20704O is provided with an inclined portion with a gradient protruding from the inner surface of the sheath member 20704, but various other suitable shapes may also be adopted.

[0092] According to the subject matter of the present disclosure, the sheath member 20704 may be provided with a slot 20704Q, which is configured to receive a sharp member carrier holding function 20710L disposed on the sensor carrier 20710 and, thereby (as will be described in more detail later in the subsequent stage), to be able to partially retract the sharp member carrier 201102 during deployment. The sheath member 20704 may also be provided with a cap retraction portion 20704R, an alignment notch 20704S, and a skin interface 20704T.

[0093] Sensor carrier of specific example FIG. 9A is a proximal perspective view depicting an embodiment of a specific example of a sensor carrier 710 capable of holding sensor electronics within an applicator 150. This can also hold the sharp member carrier 2102 together with the sharp member module 2500. In the embodiment of the specific example, the sensor carrier 710 is hollow, round and flat but generally presents a cylindrical shape, in which one or more (e.g., three) deflectable sharp member carrier locking arms 1524 project proximally from the proximal side surface and surround a spring alignment protrusion 1516 at the central position for maintaining the alignment of the spring 1104. Each of the locking arms 1524 has a retaining or holding function portion placed at or near its proximal end. The impact locking member 1534 may be a knob-shaped member disposed on the outer periphery of the sensor carrier 710 and projecting outwardly, but can fix the sensor carrier 710 for further safety before firing. The rotation limiting member 1506 may be a relatively short protrusion projecting proximally on the proximal side surface of the sensor carrier 710, which limits the rotation of the sensor carrier 710. Although it will be described with reference to FIGS. 10A to 10E hereinafter, the sharp member carrier locking arm 1524 can be aligned with the sharp member carrier 2102.

[0094] FIG. 9B is a distal perspective view of the sensor carrier 710. Here, one or more (e.g., three) sensor electronics holding spring - arms 1518 are normally biased towards the illustrated position, but a retaining stop 1519 is provided, which, if housed inside the recess or cavity 1521, will be able to pass over the distal side surface of the electronics covering member 706 of the device 102. In certain embodiments, after using the applicator 150 to affix the sensor control device 102 to the skin, the user pulls the applicator 150 in the proximal direction, i.e., away from the skin. The adhesive force holds the sensor control device 102 on the skin and overcomes the lateral force applied by the spring - arm 1518. As a result, the spring - arm 1518 deflects radially outward, disengaging the retaining stop 1519 from the sensor control device 102, thereby releasing the sensor control device 102 from the applicator 150.

[0095] FIG. 9C is a perspective view of an alternative embodiment of the sensor carrier 6710. As illustrated in FIG. 9C, the sensor carrier 6710 may comprise most of the same functional parts as the sensor carrier 710 described above with respect to FIGS. 9A and 9B. Further, one or more pairs of notch ribs 6519 are also provided along the outer peripheral surface of the sensor carrier 6710. As best seen in FIGS. 8F through 8H, the pair of notch ribs 6519 is configured to align with the inner sheath member protrusion 6425, the purpose of which is to maintain the axial alignment of the sheath member and the sensor carrier and to reduce the lateral and rotational movement between the respective components of the applicator during the sensor insertion process.

[0096] Referring to FIGS. 9D and 9E, a specific example of a sensor carrier 20710 is presented without intending to limit by way of example. The sensor carrier 20710 may be provided with one or more of the functional parts described in relation to those capable of exerting an action such that the functional parts similar to the various functional parts described in the present application among the various sensor carriers are described in the present application. For example, the sensor carrier 20710 may be provided with a base 20710A and first and second holding arms 20710B. Each of the holding arms 20710B may be provided with a first end 20710C connected to the base 20710A and a free end 20710D. For example, each of the holding arms 20710B may be connected to the base 20710A as the first half of the base 20710A, but the free end 20710D may extend toward the second half of the base 20710A. Each of the holding arms 20710B may be provided with a sensor holding functional part 20710E on its inner surface. The sensor holding functional part 20710E may be provided at the free end 20710D. The sensor holding function 20710E may be configured to hold the sensor control device 20102 inside the housing 20702. The sensor holding functional part 20710E may be provided with a formed dividing line with a conical surface and a gradient, by which the sensor control device 20102 can be released during delivery. Each of the holding arms 20710B may be provided with a locking interface 20710F on its outer surface. The locking interface 20710F can engage with the rib part 20704U on the sheath member 20704. As described above, the rib part 20704U can prevent the sensor holding arm 20710B from bending outward, for example, during the occurrence of an impact event, and thus can maintain the sensor holding functional part 20710E in an engaged state with the sensor control device 20102, thereby preventing the sensor control device 20102 from moving during the occurrence of an impact event.

[0097] The sensor carrier 20710 may be provided with a plurality of housing attachment functional parts 20710F1. Depending on the embodiment, for example, the sensor carrier 20710 may be provided with three housing attachment functional parts 20710F1. In other embodiments, the number of housing attachment functional parts 20710F1 provided on the sensor carrier 20710 may be two, four, five, six, or more. Each housing attachment functional part 20710F1 may be arranged at equal intervals on the sensor carrier 20710, but may protrude upward from the upper surface of the sensor carrier 20710. Each sensor housing attachment functional part 20710F1 may include a housing snap - type fitting part 20710G, a housing positioning functional part 20710H, a biasing functional part 20710I, and a housing stopper 20710J. The housing positioning functional part 20710H can perform axial positioning of the sensor carrier 20710 with respect to the housing 20702 when the two are connected together. The housing snap - type fitting part 20720G can engage with the sensor carrier attachment slot 20702K on the housing 20702 to connect the sensor carrier 20710 to the housing 20702. The biasing functional part 20710I can engage with the sensor carrier biasing functional part 20702M on the housing 20702, and this functional part is configured to eliminate the inclination between the sensor carrier 20710 and the housing 20702. The housing stopper 20710J can axially position the sensor carrier 20710 with respect to the housing 20702.

[0098] The sensor carrier 20710 further includes a plurality of sharp member carrier locking arms 20710K, for example, it may include three sharp member carrier locking arms 20710K. The sharp member carrier locking arms 20710K are preferably arranged at equal intervals on the sensor carrier 20710 and preferably project upward from the upper surface of the sensor carrier 20710. Each of the sharp member carrier locking arms 20710K is preferably provided with a sharp member carrier holding function 20710L and a ridge-shaped portion 20710M. The ridge-shaped portion 20710M can engage with the inner surface of the sheath member 20704, which, as will be described in more detail later, biases the sharp member carrier locking arm 20710K inward and enables the sharp member carrier holding mechanism 20710L to hold the sharp member carrier 201102. The carrier holding mechanism 20710L preferably has a triangular shape when viewed in a side view and presents a "U" shape when viewed in a top view.

[0099] According to the subject matter of the present disclosure, as already described herein, the sensor carrier 20710 is provided with a plurality of locking shelf-shaped portions 20710N, which are preferably configured to engage with the locking arm interface 20704M of the sheath member 20704. For example, the sensor carrier 20710 may be provided with two locking shelf-shaped portions 20710N. The sensor carrier 20710 has a recessed portion 20710O disposed proximal to each of its locking shelf-shaped portions 20710N to receive the locking arm interface 20704M during firing, so that the locking arm 20704J does not engage with the housing 20702 during firing. The sensor carrier 20710 is preferably provided with an opening 20710P that extends through the center of the base 20710A. The opening 20710P can guide the sharp member hub 205014 and limit its movement during insertion. In addition to this, or instead of this, the sensor carrier 20710 may be provided with a spring positioning member 20710Q.

[0100] Reinforcing rib portions 20710R and sensor positioning ridge portions 20710S may be provided on the bottom surface of the sensor carrier 20710, whereby planar movement of the sensor control device 20102 with respect to the sensor carrier 20710 can be restricted. A sensor support surface 20710T configured to support the sensor control device 20710 may be provided on the bottom surface of the sensor carrier 20710.

[0101] Specific example of the sharp member carrier FIGS. 10A and 10B are a proximal perspective view and a longitudinal sectional view, respectively, depicting an embodiment of a specific example of the sharp member carrier 2102. The sharp member carrier 2102 can grip and hold the sharp member module 2500 inside the applicator 150. As a result of one or more springs varying from a pre-loaded and compressed state to an expanded state during the insertion process, which will be described in connection with FIGS. 39A to 39F, the module may be automatically retracted. An anti-rotation slot 1608 is provided near the distal end of the sharp member carrier 2102, whereby the sharp member carrier 2102 is prevented from rotating when positioned within the central region (as shown in FIG. 9A) of the sharp member carrier locking arm 1524. The anti-rotation slot 1608 may be positioned between respective sections of the sharp member carrier base chamfer portion 1610, whereby when retracting the sharp member carrier 2102 at the end of the deployment procedure, it can be ensured that the sharp member carrier 2102 passes through the sheath member 704 and retracts completely.

[0102] As shown in FIG. 10B, a plurality of sharp holding arms 1618 may be arranged around the central axis inside the sharp member carrier 2102, and sharp holding clips 1620 may be provided at the distal end of each of the arms. The sharp holding clip 1620 is provided with a proximal side surface that is substantially perpendicular to the central axis and can abut against the distal side opposing surface of the sharp member hub 2516 (FIG. 17A).

[0103] Referring to FIGS. 10C and 10D, without intending to limit by way of example, the tip member carrier 201102 of a specific example is presented. The tip member carrier 201102 may be provided with one or more functional parts that have been described in relation to those capable of exerting functions similar to the various functional parts described in the present application among various tip member carriers. For example, the tip member carrier 201102 may be provided with a series of functional parts for engaging with the three tip member carrier locking arms 20710K of the sensor carrier 20710. These functional parts may be provided with a partially retracted front holding surface 201102A and a partially retracted rear holding surface 201102B. For example, before partial retraction occurs, such as during shipping or storage, the partially retracted front holding surface 201102A may be engaged with the tip member carrier holding functional part 20710L. After partial retraction has occurred, the partially retracted rear holding surface 201102B may be engaged with the tip member carrier holding functional part (arm) 20710L. For example, when the sheath member 20704 first moves in the proximal direction relative to the sensor carrier 20710, the ridge portion 20710M of the holding arm 20710L can engage with the slot 20704Q of the sheath member 20704, whereby the holding arm 20720L can be moved radially outward, and the partially retracted front holding surface 201102A can be passed through the tip member carrier holding functional part (arm) 20710L to engage with the partially retracted rear holding surface 201102B. The height difference between the end of the partially retracted front holding surface 201102A and the start of the partially retracted rear holding surface 201102 is the distance of partial retraction. The moving surface 201102C may be disposed immediately below the partially retracted rear holding surface 201102B, but when the tip member carrier 201102 retracts, it can slide against the pressure of the holding arm 20710L. The alignment wall 201102D helps to keep the tip member carrier 201102 aligned with the sensor carrier 20704 during the continuation of partial retraction. The tip member carrier 201102 may be provided with a chamfered portion 201102F, and a rotation prevention slot 201102E for engaging with the holding arm 20710L on the sensor carrier 20710 may be provided therein.

[0104] Looking inside, the tip member carrier 201102 is provided with tip holding arms 201102G, and these are provided with a retraction surface 201102I and a tip member hub contact surface 201102H. The holding arm 201102G can receive and hold the tip member hub 205014. The spring stopper 201102J can engage with the holding spring 205612.

[0105] Specific example of a sensor module Figures 11A and 11B are respectively a top perspective view and a bottom perspective view depicting an embodiment of a specific example of the sensor module 504. The module 504 can hold a connector 2300 (Figures 12A and 12B) and a sensor 104 (Figure 13). The module 504 can be firmly connected to the housing 706 of electronic devices. One or more deflectable arms or module snap - fit portions 2202 can be snap - fitted into corresponding functional portions 2010 of the housing 706. The sharp slot 2208 can provide a site where the tip 2502 can pass through but the sharp shaft 2504 will temporarily stay. The sensor shelf - like portion 2212 can define the sensor position in the horizontal plane, prevent the sensor from lifting the connector 2300 and falling off the post portion, and further can maintain the sensor 104 parallel to the plane of the connector blocking portion. The shelf - like portion may also define the bending shape and the minimum bending radius of the sensor. The shelf - like portion can prevent the tower - like portion from protruding above the surface of the housing of electronic devices by restricting the vertical movement of the sensor, and may also define the length of the sensor tail under the patch curved surface. The sensor wall 2216 can restrain the sensor and may define the sensor bending shape and the minimum bending radius.

[0106] Figures 12A and 12B are perspective views depicting embodiments of specific examples of the connector 2300 in an open state and a closed state, respectively. The connector 2300 can be made of silicone rubber, but encapsulates a flexible carbon-impregnated polymer module that acts as the conductive contact 2302 between the sensor 104 and the electrical circuit contacts of the electronic devices within the housing 706. The connector can also act as a moisture barrier for the sensor when in a compressed state due to assembly after being transferred from the container to the applicator and after being attached to the user's skin. The plurality of sealing surfaces 2304 can provide a watertight seal for the electrical contacts and the sensor contacts. One or more hinges 2308 can connect the two portions of the distal and proximal parts of the connector 2300.

[0107] Figure 13 is a perspective view depicting an embodiment of a specific example of the sensor 104. The neck portion 2406 may be a region that allows the sensor to be folded back, for example, by 90 degrees. The membrane of the tail portion 2408 can cover the active analyte sensing element of the sensor 104. The tail portion 2408 may be the portion of the sensor 104 that resides subcutaneously in the user after insertion. The flag portion 2404 may include each contact and the sealing surface. The biasing tower portion 2412 may be a knob-like member that biases the tail portion 2408 into the sharp slot 2208. The biasing fulcrum 2414 may be the widened portion of the biasing tower portion 2412, but by contacting the inner surface of the needle, it biases the tail portion into the slot. The biasing adjustment portion 2416 can reduce local bending at the connection portion of the tail and prevent damage to the sensor passage mark. Each contact 2418 can electrically connect the active site of the sensor to the connector 2300. The communication loop-shaped branch line 2420 can convert the electrical path by 90 degrees from the vertical direction and engage with the sensor shelf portion 2212 (Figure 11B).

[0108] Figures 14A and 14B are respectively a bottom perspective view and a top perspective view depicting embodiments of a specific example of a sensor module assembly including a sensor module 504, a connector 2300, and a sensor 104. According to one aspect of the foregoing embodiments, during or after insertion, the sensor 104 receives an axial force that pushes it proximally against the force F1 shown in Figure 14A and enters the sensor module 504. In some embodiments, as a result, a counteracting force F2 is applied to the neck portion 2406 of the sensor 104, and in turn, is converted into a counteracting force F3 and applied to the communication loop-like branch line 2420 of the sensor 104. In some embodiments, the axial force F1 is caused by a sensor insertion mechanism or a tip member retraction mechanism during insertion that presses the sensor itself through tissue according to the sensor design, or is caused by a physiological reaction generated by the tissue surrounding the sensor 104 (e.g., after insertion).

[0109] Figures 15A and 15B are proximity partial views of embodiments of a specific example of a sensor module assembly having an axial reinforcement function portion. In a general sense, each embodiment described herein is intended to reduce the influence of an axial force applied to the sensor as a result of an insertion mechanism, a retraction mechanism, or both, or due to a physiological reaction to the sensor placed in the body. As can be seen in Figures 15A and 15B, according to one aspect of the embodiments, the sensor 3104 is provided with a hook function portion 3106 at its proximal portion, which is configured to engage with a catch function portion 3506 of the sensor module 3504. In some embodiments, a void region 3508 is provided in the sensor module 3504 so that the distal portion of the sensor 3104 can swing backward during assembly, allowing the hook function portion 3106 of the sensor 3104 to overcome the catch function portion 3506 of the sensor module 3504 and be assembled therein.

[0110] According to another aspect of the embodiment, the hook function unit 3106 and the catch function unit 3506 operate in the following manner. As described above, the sensor 3104 includes a proximal sensor unit connected to the sensor module 3504 and a distal sensor unit disposed under the skin surface in contact with the body fluid. As can be seen in FIGS. 15A and 15B, the proximal sensor unit includes a hook function unit 3106 adjacent to the catch function unit 3506 of the sensor module 3504. During or after the insertion of the sensor, one or more forces are applied in the proximal direction along the long axis of the sensor 3104. In response to the one or more forces, the hook function unit 3106 engages with the catch function 3506 to prevent the sensor 3104 from being displaced in the proximal direction along the long axis.

[0111] According to another aspect of the embodiment, the sensor 3104 may be integrated with the sensor module 3504 in the following manner. The sensor 3104 is loaded into the sensor module 3504 by displacing the proximal sensor unit laterally to place the hook function unit 3106 proximal to the catch function unit 3506 of the sensor module 3504. More specifically, by displacing the proximal sensor unit laterally, the proximal sensor unit enters the gap region 3508 of the sensor module 3504.

[0112] FIGS. 15A and 15B depict the hook function unit 3106 as part of the sensor 3104 and the catch function unit 3506 as part of the sensor module 3504. However, those skilled in the art will correctly recognize that the hook function unit 3106 may alternatively be part of the sensor module 3504, and similarly, the catch function unit 3506 may alternatively be part of the sensor 3106. Similarly, those skilled in the art will recognize that various mechanisms other than the above (e.g., detents, latches, fasteners, screws, etc.) that prevent the sensor 3104 from being displaced axially when implemented in the sensor 3104 and the sensor module 3504 may also be utilized and fall within the scope of the present disclosure.

[0113] FIG. 15C is a side view of a sensor 11900 of an example according to 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 thus can be used in an analyte monitoring system for the purpose of detecting a specific analyte concentration. As shown, the sensor 11900 is provided with a tail portion 11902, a flag portion 11904, and a neck portion 11906 that interconnects the tail portion 11902 and the flag portion 11904. The tail portion 11902 contains an enzyme or other chemical or biological substance, and in some embodiments, the membrane may coat the chemical substance. In use, the tail portion 11902 is transcutaneously received under the skin of the user, and the chemical substance contained in the tail portion helps to facilitate analyte monitoring where body fluid is present.

[0114] By receiving the tail portion 11902 inside the hollow portion or recess of a sharp member (not shown), at least a part of the tail portion 11902 of the sensor 11900 will be surrounded. As shown, the tail portion 11902 may extend at a relative correction angle Q from the horizontal. In some embodiments, the angle Q may be about 85°. Thus, in contrast to other sensor tails, the tail portion 11902 may not extend vertically from the flag portion 11904, but instead may form an angle that is relatively corrected with respect to the vertical. It is presumed that this is advantageous in helping to maintain the tail portion 11902 inside the recess of the sharp member.

[0115] The tail portion 11902 is provided with a first end or a lower end 11908a and a second end or an upper end 11908b on the side opposite to the lower end 11908a. The tower portion 11910 can be provided at the upper end 11908b or in the vicinity thereof, and the neck portion 11906 may extend upward in the vertical direction from the portion where the tail portion 11902 interconnects the flag portion 11904. During operation, when the pointed member moves laterally, the tower portion 11910 helps the tail portion 11902 to pivot towards the pointed member, or otherwise stay inside the recess of the pointed member. Further, depending on the embodiment, the tower portion 11910 may be provided with a protrusion 11912 extending laterally therefrom, or may be separately defined. When the sensor 11900 fits with the pointed member and the tail portion 11902 projects inside the recess of the pointed member, the protrusion 11912 may engage with the inner surface of the recess. During operation, the protrusion 11912 serves to hold the tail portion 11902 inside the recess.

[0116] The flag portion 11904 is provided with a generally flat surface, and one or more sensor contacts 11914 may be arranged thereon. The sensor contact(s) 11914 may be configured to align with a corresponding number of flexible carbon-impregnated polymer modules encapsulated in the connector.

[0117] Depending on the embodiment, as shown in the figure, the neck portion 11906 may be provided with a downward slope or a bent portion 11916, or may be separately defined, which projects between the flag portion 11904 and the tail portion 11902. It is presumed that it is understood that the bent portion 11916 is advantageous in terms of adding bendability to the sensor 11900 and also serving to prevent bending of the neck portion 11906.

[0118] Depending on the embodiment, there is also a case where a notch 11918 (shown by a broken line) is selectively defined in a flag-shaped portion close to the neck portion 11906. When the sensor 11900 is attached to the pedestal portion, the notch 11918 can add bendability and resistance to the sensor 11900. More specifically, the notch 11918 helps to absorb the interference force that may occur when the sensor 11900 is attached inside the pedestal portion.

[0119] Depending on the embodiment, as illustrated in FIGS. 15D to 15G, the neck portion has non-linear shaped portions such as downwardly inclined portions or bent portions 11920a to 11920d having a plurality of direction-changing portions such as 11921a and 1102b, etc., provided in a state of protruding between the flag-shaped portion 11904 and the tail portion 11902, or separately defined. The bent portions 11920a to 11920d are advantageous for reducing the in-situ rigidity of the sensor 11900 by adding bendability to the sensor 11900 in both vertical and horizontal orientations. The bendability thus added can provide a spring-like structure to the sensor 11900 in multiple directions, which helps to limit the deformation of the neck portion 11906 while ensuring that the tail portion 11902 and the flag-shaped portion 11904 remain in their respective expected or fixed positions. The spring-like structure also increases the flexibility of the sensor 11900 while reducing the stress applied to the entire structure.

[0120] Generally speaking, it may be understood that a tail part, a flag part, and a neck part are provided in the sensor in an aligned state along a plane having a vertical axis and a horizontal axis. The spring-like structure may be created by diversifying the orientation of the direction-changing part at the bent part of the neck part of the sensor. Between the tail part and the flag part, at least two direction-changing parts may be provided in the neck part with respect to the vertical axis, providing a spring-like structure. With at least two direction-changing parts, a neck part with a structure of overlapping layers that continues seamlessly with respect to the axis of the flat surface shared by the tail part, the flag part, and the neck part itself can be provided. These overlapping direction-changing parts constitute the spring-like structure. Depending on the embodiment, the neck part of the overlapping layers may be vertically oriented. Depending on the embodiment, the neck part of the overlapping layers may also be horizontally oriented.

[0121] FIG. 15D illustrates an embodiment in which the sensor 11900 includes a neck part having a direction-changing part 11921a and a direction-changing part 11921b provided at the bent part 11920a between the flag part 11904 and the tail part 11902. In the illustrated embodiment, at least one direction-changing part 11921a abuts against the uppermost end of the tail part of the sensor 11900 or, in some cases, the uppermost end of the tower part 11910. This orientation is advantageous because it reduces the total mounting area of the sensor even when considering creating the bent part 11920a using additional members. With this configuration, a plurality of overlapping horizontal layers aligned in the vertical direction can be provided between the direction-changing part and another direction-changing part.

[0122] FIG. 15E illustrates an embodiment in which the sensor 11900 includes a neck portion that is located between the flag portion 11904 and the tail portion 11902 and has at least three turning portions 11923a, 11923b, and 11923c provided in a bent portion 11920b that forms an overall spiral pattern. In this embodiment, the turning portions also abut here against the uppermost end of the tail of the sensor 11900 or the uppermost end of the tower portion 11910. This orientation can provide a further state of equilibrium between the horizontal stress and the vertical stress in addition to maintaining the entire mounting area of the sensor. The overlapping layers with the turning portions arranged in this way are generally in equilibrium along both the horizontal axis and the vertical axis.

[0123] FIG. 15F illustrates another embodiment of the sensor 11900 that includes a neck portion having turning portions 11925a, 11925b, and 11925c provided in a bent portion 11920c that is located between the flag portion 11904 and the tail portion 11902. In the illustrated embodiment, the turning portion 11925c connects a region of the tail portion 11902 that is near the uppermost end of the tail of the sensor or the uppermost end of the tower portion 11910 to a subsequent portion of the bent portion 11920c. In addition to reducing the entire mounting area of the sensor, this orientation is considered to provide further bendability to the horizontal orientation axis. This arrangement can provide a plurality of overlapping vertically aligned horizontal layers between the turning portion and another turning portion.

[0124] FIG. 15G illustrates yet another embodiment of a sensor 11900 having a neck portion between a flag portion 11904 and a tail portion 11902 and having turning portions 11927a, 11927b, 11927c provided in a bent portion 11920d. In the illustrated embodiment, the bent portion 11920d mainly occurs at the tail portion 11902 of the sensor and connects the tail portion 11902 and the tower portion 11910, but the spread of the sensor between the tower portion 11910 and the flag portion 11904 is generally not interrupted. The turning portion 11927a generally connects the tower portion 11910 to a subsequent portion of the bent portion 11920d, while the turning portion 11927c connects the tail portion 11902 to a subsequent portion of the bent portion 11920d. This orientation appears to provide additional bendability about the vertical orientation axis. In this arrangement, a plurality of overlapping horizontally aligned vertical layers can be provided between the turning portions and another turning portion.

[0125] The turning portions of the neck portion may be created by folding the neck portion of the sensor from a larger neck structure, laser cutting the sensor from a sheet-like material partially including the sensor, printing a sensor having a shape provided with a plurality of turning portions, or punching and forming the sensor from a sheet-like material partially including the sensor, or alternatively, by other manufacturing processes suitable for providing a highly accurate bent portion in the neck portion.

[0126] Figures 16A and 16B are isometric and partial exploded isometric views of a specific example of a connector assembly 12000 according to one or more embodiments. As shown, the assembly 12000 may be provided with a connector 12002, and FIG. 17C is an isometric bottom view of the connector 12002. The connector 12002 comprises an injection-molded member, which is used for the purpose of assisting in fixing one or more flexible carbon-impregnated polymer modules 12004 (four are shown in FIG. 16B) to a base portion 12006. More specifically, the connector 12002 serves to fix the module 12004 in place adjacent to the sensor 11900 and in contact with sensor contacts 11914 (FIG. 15C) provided on a flag portion 11904 (FIG. 15C). The module 12004 may be made of a conductive material, which is for providing conductive communication between the sensor 11900 and corresponding circuit contacts (not shown) provided within the base portion 12006.

[0127] As best seen in FIG. 16C, the connector 12002 may be defined with a pocket 12008 sized to receive the module 12004. Further, depending on the embodiment, the connector 12002 may be further defined with one or more depressions 12010, some of which are configured to mate with one or more corresponding flanges 12012 (FIG. 16B) on the base portion 12006. By mating the depression 12010 with the flange 12012, the connector 12002 can be fixed to the base portion 12006 by interference fit or the like. In other embodiments, the connector 12002 may be fixed to the base portion 12006 using an adhesive or by ultrasonic welding.

[0128] Figures 16D and 16E are isometric and partial exploded isometric views of another specific example of a connector assembly 12100 according to one or more embodiments. As shown, the connector assembly 12100 may be provided with a connector 12102, and FIG. 16F is an isometric bottom view of the connector 12102. The connector 12102 includes an injection-molded member, which is used for the purpose of helping to keep one or more flexible metal contacts 12104 (four are shown in FIG. 16E) pressing and fixing the sensor 11900 on the pedestal 12006. More specifically, the connector 12102 helps to fix the contacts 12104 in contact with the sensor contacts 11914 (FIG. 15C) provided on the flag portion 11904 and in place adjacent to the sensor 11900. The contacts 12104 may be made of a punched conductive material, which provides conductive communication between the sensor 11900 and a circuit contact (not shown) provided in the pedestal 12106 corresponding thereto. In some embodiments, for example, the contacts 12104 may be soldered to a PCB (not shown) disposed in the pedestal 12106.

[0129] As best seen in FIG. 16F, the connector 12102 may be defined with a pocket 12108 sized to receive the contacts 12104. Further, in some embodiments, the connector 12102 may be further defined with one or more depressions 12110, which are configured to mate with one or more corresponding flanges 12112 (FIG. 16E) on the pedestal 12006. Mating the depressions 12110 with the flanges 12112 helps to fix the connector 12102 to the pedestal 12106 by interference fit or the like. In other embodiments, the connector 12102 may be fixed to the pedestal 12106 using an adhesive or by ultrasonic welding.

[0130] Specific Example of the Sharp Member Module FIG. 17A is a perspective view depicting an embodiment of a specific example of the tip member module 2500 before integration within the sensor module 504 (FIG. 6B). The tip member 2502 may be provided with a distal tip 2506 that can penetrate the skin, while supporting a sensor within the hollow or recessed portion of the tip shaft 2504 to bring the active surface of the sensor tail into contact with body fluid. The hub push cylinder portion 2508 can provide a surface against which the tip member carrier presses during insertion. The hub small cylinder portion 2512 can provide a space for the overhang of the tip member hub contact surface 1622 (FIG. 10B). The hub snap claw positioning cylinder portion 2514 can provide a surface facing the distal side of the hub snap claw 2516 against which the tip member hub contact surface 1622 abuts. The hub snap claw 2516 may be provided with a conical surface that causes the clip 1620 to open during attachment of the tip member module 2500.

[0131] Figures 17B through 17H illustrate embodiments of various specific examples of the sharp member modules at various stages of assembly and prepared for use in the insertion of a skin analyte sensor. According to one aspect of the embodiment, by providing a gradient with respect to a reference point on the sensor, the insertion tip member, or both, the tip of the insertion needle and the tip of the sensor can be co-localized, and further, a single contact point can be provided on the skin surface. In this way, when the sensor is inserted into the subject, the sharp member becomes the leading edge on the skin surface, thereby forming an insertion path into the dermis layer for the sensor. In some embodiments, for example, the sharp sensor, the skin sensor, or both sensors can be provided with a gradient with respect to a reference point for insertion (e.g., with respect to each other, with respect to the surface of the skin, or with respect to the base of the applicator), in which case the gradient of the sharp member is different from the gradient of the sensor. For example, the reference point may be the skin surface that is breached for dermal insertion, or may be a reference of the sensor-applicator set or one of its components. In some embodiments, the sharp member can be arranged at an angle with respect to the sensor. For example, if the sharp member is designed to be angled with respect to the sensor, the needle becomes the leading edge of the sensor during operation of the applicator set. Further, depending on the design of the needle itself and the positioning of the needle with respect to the sensor, any desired configuration can be achieved, including all of the configurations disclosed in U.S. Patent Application Publication No. 2014 / 0171771, which is hereby incorporated by reference in its entirety for all purposes as part of this application.

[0132] Furthermore, while most of the embodiments of the specific examples described with respect to Figures 17B through 17J refer to a skin analyte sensor and skin insertion, those skilled in the art will understand that any of these embodiments can be sized and shaped to be suitable for use with an analyte sensor that is placed within (or completely through) the subcutaneous tissue (e.g., depending on the site on the body's skin, 3 mm to 10 mm below the skin surface) beyond the skin space.

[0133] FIG. 17B is a perspective view depicting an embodiment of a specific example of the sharp member module 2550 that can be used for insertion of the skin sensor. The sharp member module 2550 is illustrated in the figure before being integrated with the sensor module 504 (FIG. 6B), and has constituent members similar to those of the embodiment described with respect to FIG. 17A, for example, the sharp member 2552, the sharp shaft 2554, the distal tip 2556, the hub pressing cylinder portion 2558, the hub small cylinder portion 2562, the hub snap claw 2566, and the hub snap claw positioning cylinder portion 2564, etc. It is preferable that the sharp member 2552 is located inside the sharp member module 2550 and is installed at an eccentric position with respect to the long axis line 2545 that extends through the centers of the hub snap claw 2566, the hub small cylinder portion 2562, and the hub pressing cylinder portion 2558. In addition to this, the sharp member module 2550 preferably includes a sharp spacer 2568 that is parallel to and adjacent to a part of the sharp member 2552. The sharp spacer 2568 may be installed along the proximal portion of the sharp member 2552 between the sensor 104 (not shown) and the sharp member 2552, but it can be ensured that the sensor 104 and the sharp member 2552 are maintained in a separated state at the proximal portion of the sharp member 2552. The sharp member 2552 may be placed at an eccentric position during an integral molding process with the hub constituent members 2558, 2562, 2566, but each of these constituent members is preferably made of a rigid plastic material.

[0134] Figures 17C and 17D are two side views depicting the tip member 2552, spacer 2568, hub pressing cylinder portion 2558, hub small cylinder portion 2562, and hub snap claw 2566 provided in the tip member module 2550 before integration with the sensor module 504 (FIG. 6B). Depending on the embodiment, the relative distances between the tip member 2552 and various components of the hub may be arranged as follows. For example, the distance S1 between the tip member 2552 and the midpoint of the radius of the hub may be in the range of 0.50 mm to 1 mm (e.g., 0.89 mm). The height S2 of the tip spacer 2568 may be in the range of 3 mm to 5 mm (e.g., 3.26 mm). The height S3 of the hub may be in the range of 5 mm to 10 mm (e.g., 6.77 mm). The length S4 of the tip member 2552 may be in the range of 1.5 mm to 25 mm (e.g., 8.55 mm), but is presumed to be determined according to the position of the insertion site of the subject.

[0135] Figure 17E is a longitudinal sectional view of the tip member module 2550 when integrated with the sensor module 504, including the tip member 2552, spacer 2568, and various components of the hub (hub snap claw 2566, hub small cylinder portion 2562, and hub pressing cylinder portion 2558). As can be seen in Figure 17E, the tip member 2552 is positioned inside the tip slot 2208 of the sensor module 504, and the module has a curved inner surface 2250 provided at the distal end position. By the curved inner surface 2250 of the sensor module 504 contacting and deflecting a part of the tip member 2552, the distal tip 2556 can be oriented towards the central longitudinal axis 2545. As can be best seen in Figure 17H, when positioning the tip member 2552, the range between its distal portion and the central longitudinal axis 2545 is preferably 5° to 20°, but an acute angle S θ should be formed. Depending on the embodiment, for example, S θ may be in the range of 5° to 17° or 7° to 15°, or in the range of 9° to 13°, for example, 9°, 10°, 11°, 12°, or 13°.

[0136] Referring further to FIG. 17E, there is a protrusion 2251 near the distal end of the sensor module 504, which can promote the perfusion of body fluids such as skin fluid. Although illustrated as a curved surface in FIG. 17E, the protrusion 2251 may be formed in any desired manner. In addition to this, in some embodiments, there may be a plurality of protrusions. U.S. Patent Application Publication No. 2014 / 0275907, which is hereby incorporated by reference in its entirety, describes various sensor devices with various protrusion shapes, each of which can be realized using the embodiments described herein. Most of such embodiments described herein illustrate a needle protruding out from the protrusion, but in other embodiments, the needle exits from the sensor device base adjacent to the protrusion and extends beyond the tip of the sensor 104 from that position.

[0137] Referring further to FIGS. 17E and 17F, the sensor 104 is a skin sensor, and the sensor tail 2408 may be positioned on the distal end side of the sensor 104. Also, the sensor tail may be positioned in an orientation generally parallel to the central longitudinal axis 2545. The distal end of the sensor tail 2408 is proximal to the distal tip 2556 and may be spaced from, placed on, or stationary while pressing against a part of the sharp shaft 2554. Further, as depicted in FIG. 17E, the sharp spacer 2568 provides a spaced relationship between the proximal part of the sharp member 2552 and the sensor 104 so as to prevent them from contacting each other. The sensor module 504 may further include a sensor connector 2300 for accommodating the proximal part of the sensor 104 that is relatively perpendicular to the distal end of the sensor 104.

[0138] FIG. 17F is a schematic view from above to below of the sensor module 504. The sensor module 504 may be provided with one or more sensor module snap-fit portions 2202 for connection to a covering member (not shown) of the sensor control device 102. The sensor module 504 may be provided with a sensor connector 2300, which preferably has sensor contacts 2302 for connection to the proximal portion of the sensor 104. The sensor connector 2300 can be made of silicone rubber, but encloses a flexible carbon-impregnated polymer module that acts as the conductive contact 2302 between the sensor 104 and the electrical circuit contacts of the electronic devices within the sensor control device 102. The connector can also act as a moisture barrier for the sensor 104 when in a compressed state due to assembly after transfer from the container to the applicator and after attachment to the user's skin. Three contacts 2302 are depicted, but it should be understood that the number of contacts of the connector 2300 may be less than this (e.g., two), or more than this (e.g., four, five, six, etc.), depending on the particular type or configuration of the sensor 104. The sensor connector 2300 is preferably further connected to the sensor module 504, which is by means of installing two connector struts 2206 through the same number of openings provided in the connector 2300. Two struts 2206 are depicted, but it should be understood that any number of connector struts 2206 may be used for the purpose of connecting the connector 2300 to the sensor module 504.

[0139] FIG. 17G and FIG. 17H are respectively a perspective view and a side view of another specific example embodiment of the sharp member module 2600 that can be used for the insertion of the skin sensor. In this figure, the sharp member module 2600 is illustrated in a state before being integrated with the sensor module 504 (FIG. 6B), but it is of the same type as each embodiment described with respect to FIGS. 17A and 17B. For example, it may include various components similar to the sharp member 2602, the sharp shaft 2604, the sharp distal tip 2606, the hub pressing cylinder portion 2608, the hub small cylinder portion 2612, the hub snap claw 2616, the hub snap claw positioning cylinder portion 2614, etc. In some embodiments, the sharp member 2602 may be a "pre-bent" needle, in which case a proximal portion 2603 is provided that starts from a point outside the sharp member module 2600 and intersects the center point of the hub at a certain angle (e.g., passing through the hub pressing cylinder portion 2608). The sharp member 2602 may be provided with a distal portion 2605, which extends from a point near the distal portion of the hub in a distal direction at a certain angle to the insertion site of the user's skin. As illustrated in FIG. 17H, the sharp member 2602 may be provided with a bent portion 2607 at a site outside the hub pressing cylinder portion 2608, and this portion may be generally at an angle of 90° between the proximal portion 2603 and the distal portion 2605 of the sharp member 2602. The sharp member module 2600 is also provided with a bent portion fin guide 2620 for maintaining the "pre-bent" sharp member 2602 in place during integration, during use, or both, and it is preferably configured to prevent lateral movement or rotational movement of the sharp member 2602 relative to the components of the hub. The proximal portion 2603 of the sharp member 2602 is "trimmed" from the hub after the molding process is completed and before the sharp member module 2600 is integrated with the sensor module 504.

[0140] Figures 17I and 17J respectively illustrate a longitudinal sectional view and a side view of the tip member module 2600 (including the hub snap claw 2616, the hub small cylindrical portion 2612, the hub pressing cylindrical portion 2608, etc.) when integrated with the sensor module 504. As can be seen from Figure 17I, the sensor module 504 is provided with a sharp slot 2208, and through this, the tip member 2602 may extend in a distal direction at a certain angle. As described above, the proximal portion of the tip member 2602 passes through the bent portion fin guide 2620, and the guide is connected to the distal portion of the sensor module 504. The sensor module 504 may include the sensor 104, and this may be a skin sensor. As can be seen from Figure 17I, the tip member 2602 and the sensor tail 2408 form an acute angle S θ at a point where their respective long axes converge. The angle S θ may range between 5° and 20°. According to embodiments, for example, S0 may range from 5° to 17° or from 7° to 15°, or in the range from 9° to 13°, for example, 9°, 10°, 11°, 12°, or 13°. According to embodiments, the distal tip 2606 is placed at a distance S6, which is proximal to the end of the sensor tail 2408. The distance S6 may be in the range between 0.02 mm and 0.10 mm, for example, 0.05 mm, 0.06 mm, or 0.07 mm.

[0141] Referring further to Figures 17I and 17J, the sensor module 504 may also include a sensor connector 2300 for accommodating the proximal portion of the sensor 104 that is relatively perpendicular to the distal end of the sensor 104. The sensor module 504 may be further provided with one or more sensor module snap - type fitting portions 2202 for connecting to a covering member (not shown) of the sensor control device 102. The sensor connector 2300 may have the same various structures as those described with respect to Figure 17F.

[0142] In each of the above embodiments, the sharp member is made of stainless steel or a similar flexible material (e.g., the material used to manufacture needles), and its dimensions are set such that the applicator can insert at least a part of the skin sensor into the dermis but not penetrate the dermis. According to one embodiment, the sharp member has a cross-sectional diameter (width) of from 0.1 mm to 0.5 mm. For example, the sharp member may have a diameter of from 0.1 mm to 0.3 mm, and may have a diameter such as from 0.15 mm to 0.25 mm, or, for example, a diameter such as from 0.16 mm to 0.22 mm. A given sharp member may have a constant width, i.e., a uniform width, over its entire length, or alternatively, the width may vary, i.e., be different, over a part of its length, such as the tip used to pierce the surface of the skin. For example, with respect to the embodiment illustrated in FIG. 17I, the width of the sharp member 2602 may be narrower along the distal portion between the bent fin guide 1620 and the distal sharp tip 2606.

[0143] The sharp member may also have a length suitable for inserting the skin sensor just slightly into the dermis layer. The insertion depth may be restricted by the length of the sharp member, the shape of the base, other applicator components that restrict the insertion depth, or various combinations thereof. The sharp member may have a length between 1.5 mm and 25 mm. For example, the sharp member may have a length of 1 mm to 3 mm, 3 mm to 5 mm, 5 mm to 7 mm, 7 mm to 9 mm, 9 mm to 11 mm, 11 mm to 13 mm, 13 mm to 15 mm, 15 mm to 17 mm, 17 mm to 19 mm, 19 mm to 21 mm, 21 mm to 23 mm, or 23 mm to 25 mm, or may even have a length exceeding 25 mm. The sharp member may have a length up to 25 mm, but in certain embodiments, it will be correctly recognized that the entire length of the sharp member is not inserted into the subject because it will penetrate deeper into the skin space. The non-inserted length of the sharp member can be provided for the operation and manipulation of the sharp member in the applicator set. Thus, the sharp member may have a length up to 25 mm, but in each of the above specific embodiments, the insertion depth of the sharp member into the subject's subcutaneous tissue is limited to the dermis layer, for example, limited to about 1.5 mm to 4 mm, which is determined according to the skin site, as will be described in more detail below. However, in all embodiments disclosed herein, the sharp member may be configured to penetrate deeper into the skin space, for example, may be configured to extend into (or even completely penetrate) the subcutaneous tissue (specifically, 3 mm to 10 mm subcutaneously depending on the skin site of the body). Additionally, depending on the specific example embodiments, the sharp member described herein may be a hollow insertion needle or a partially hollow insertion needle provided with an internal space or lumen in some cases. However, in other embodiments, the sharp member described herein may be a solid insertion needle, which is not provided with an internal space, lumen, or both. Further, the sharp member of the applicator set of the present subject matter may or may not be blade-shaped.

[0144] Similarly, in each of the above embodiments, the dimensions of the skin sensor are set such that at least a part of the sensor is installed at a position corresponding to the dermis layer, and in the embodiment where it is installed transdermally, a part remains outside the skin. That is, the dimensions of the skin sensor are such that when the whole or substantially the whole of the skin sensor is inserted into the dermis layer, the most distal part (insertion part or insertion length) of the sensor is disposed within the dermis of the subject, and when the sensor is operably disposed on the skin, no part of the sensor is inserted deeper than the dermis layer of the subject.

[0145] The dimensions of the sensor (e.g., length) may be selected according to the body part of the subject into which the sensor is inserted, because the depth and thickness of the epidermis and dermis show some variation depending on the part of the skin. For example, the epidermis is about 0.05 mm thick on the eyelid, but about 1.5 mm thick on the palm and sole. The dermis is the thickest of the three layers of the skin and ranges from about 1.5 mm to 4 mm, depending on the part of the skin. To ensure that the distal end of the sensor is embedded in but does not penetrate the dermis layer of the subject, it is natural that the length of the inserted part of the skin sensor is greater than the thickness of the epidermis, but it is prohibited from exceeding the total thickness of the epidermis and dermis. As a method, after determining the insertion site on the user's body, select an applicator set appropriately sized for that site.

[0146] In a particular aspect, the sensor is a longitudinal sensor having a maximum dimension (or "length") from 0.25 mm to 4 mm. In an embodiment where only a part of the sensor is inserted into the skin, the length of the inserted sensor ranges from 0.5 mm to 3 mm, specifically in a range such as 1 mm to 2 mm, for example, 1.5 mm. The dimensions of the sensor can also be represented by its aspect ratio. In each particular embodiment, the skin sensor has an aspect ratio of the length to the width (diameter) of about 30:1 to about 6:1. For example, the aspect ratio may be about 25:1 to about 10:1, for example, 20:1 and 15:1, etc. The inserted part of the skin sensor contains a sensitive chemical substance.

[0147] However, in all of the embodiments disclosed herein, at least a part of the sensor may be configured to be disposed at a position deeper than the cortex, for example, in (or beyond) subcutaneous tissue (or fat). For example, when the sensor is inserted entirely or generally entirely into the body, it may be dimensioned such that its most distal portion (insertion portion or insertion length) is disposed within the subcutaneous tissue (deeper than the subject's dermis), and further, when the sensor is operably disposed, it may be dimensioned such that no part of the sensor is inserted deeper than the subject's subcutaneous tissue. As described above, subcutaneous tissue is typically in the region 3 mm to 10 mm below the outer skin surface of the body, which depends on the part of the body's skin.

[0148] Applicator and sensor control device for a specific example of a one-piece structure Referring again briefly to FIGS. 1 through 3A through 3G, to make a two-piece structure system, the sensor tray 202 and the sensor applicator 102 are provided to the user as separate packages, so the user needs to open each package and finally assemble the system. Depending on the application example, by making separate sealed packages, the sensor tray 202 and the sensor applicator 102 can be sterilized by a separate disinfection process specific to the contents of each package, but otherwise the disinfection process would be unsuitable for the contents of the other. More specifically, the sensor tray 202 includes a plug assembly 207 that includes the sensor 110 and the pointed member 220, and it may be sterilized using radiation disinfection such as electron beam (or "e-beam") irradiation. However, radiation disinfection may damage the electrical components located inside the electronic equipment covering member of the sensor control device 102. As a result, the sensor applicator 102 includes the electronic equipment covering member of the sensor control device 102, and if sterilization is required, it may be sterilized by another method, for example, gas chemical disinfection using ethylene oxide or the like. However, gas chemical disinfection may destroy the enzymes or other chemical or biological substances contained in the sensor 110. Due to such disinfection incompatibility, the sensor tray 202 and the sensor applicator 102 are generally sterilized by separate disinfection processes and then packaged separately, which thus requires the user to finally assemble each package in preparation for use.

[0149] According to an embodiment of the present disclosure, the sensor control device 102 can result in a one-piece structure by modification, and this structure can receive a disinfection technique specially designed for the one-piece structure sensor control device. Due to the one-piece structure, when the sensor applicator 150 and the sensor control device 102 are shipped to the user, they can be in the state of a single sealed package that does not require any assembly process by the end user at all. On the contrary, the user only needs to open one package and then deliver the sensor control device 102 to the target monitoring site. The one-piece system structure described in this specification can be shown to be advantageous in eliminating a plurality of components, various manufacturing process steps, and the assembly process by the user. As a result, packaging materials and waste are reduced, and the potential for user errors and system contamination is reduced.

[0150] Figures 18A and 18B are respectively an isometric view and a side view of another specific example of the sensor control device 5002 according to one or more embodiments of the present disclosure. The sensor control device 5002 may be similar to the sensor control device 102 of FIG. 1 in some respects, and thus can be best understood by referring to the control device. Further, since the sensor control device 5002 can be replaced with the sensor control device 102 of FIG. 1, it can be used in combination with the sensor applicator 102 of FIG. 1 that can deliver the sensor control device 5002 to the target monitoring site on the user's skin.

[0151] However, different from the sensor control device 102 of FIG. 1, the sensor control device 5002 is composed of a one-piece system structure, and there is no need for the user to open a plurality of packages and finally assemble the sensor control device 5002 before application. On the contrary, at the time when the user receives it, the sensor control device 5002 is already completely assembled and properly arranged in the sensor applicator 150 (FIG. 1). To use the sensor control device 5002, all the user needs to do is to open one barrier (for example, the applicator cap 708 of FIG. 3B) before immediately delivering the sensor control device 5002 to the target monitoring site for use.

[0152] As shown in the figure, the sensor control device 5002 includes an electronic device covering member 5004, which appears to be generally disk-shaped and have a circular cross-section. However, in other embodiments, the electronic device covering member 5004 may exhibit various cross-sectional shapes other than the above, such as oval or polygonal, without departing from the scope of the present disclosure. The electronic device covering member 5004 may be configured to store or separately house various electrical components used to operate the sensor control device 5002. In at least one embodiment, an adhesive patch (not shown) may be disposed on the bottom surface of the electronic device covering member 5004. The adhesive patch may be similar to the adhesive patch 105 of FIG. 1, and thus, it is useful for adhering the sensor control device 5002 to the user's skin in preparation for use.

[0153] As shown in the figure, the sensor control device 5002 includes an electronic device covering member 5004, which is provided with a shell 5006 and a pedestal portion 5008 that can be fitted to the shell 5006. When fixing the shell 5006 to the pedestal portion 5008, it may be carried out by snap-fit engagement, interference fit, ultrasonic welding, one or more mechanical fasteners (e.g., screws, etc.), gaskets, adhesives, or some combination thereof. In some cases, by fixing the shell 5006 to the pedestal portion 5008, a sealing interface may be generated between the two.

[0154] The sensor control device 5002 further includes a sensor 5010 (partially visible in the figure) and a sharp member 5012 (partially visible in the figure), which are used to assist in delivering the sensor 5010 transcutaneously under the user's skin during the application of the sensor control device 5002. As shown in the figure, the corresponding portions of the sensor 5010 and the sharp member 5012 extend distally from the bottom surface (e.g., the pedestal portion 5008) of the electronic device covering member 5004. The sharp member 5012 may include a sharp member hub 5014 configured to fix and hold it. As best seen in FIG. 18B, the sharp member hub 5014 may be provided with or otherwise defined with a fitting member 5016. To connect the sharp member 5012 to the sensor control device 5002, the sharp member 5012 may be advanced axially until the sharp member hub 5014 engages the upper surface of the shell 5006 and until the fitting member 5016 projects distally from the bottom surface of the pedestal portion 5008 and passes through the electronic device covering member 5016. When the sharp member 5012 pierces through the electronic device covering member 5004, the exposed portion of the sensor 5010 is received inside the hollow portion or the recessed (bow-shaped) portion of the sharp member 5012. The remaining portion of the sensor 5010 is disposed inside the electronic device covering member 5004.

[0155] The sensor control device 5002 further includes a sensor cap 5018, which is shown in a disassembled state in FIGS. 18A and 18B, that is, in a state removed from the electronic device covering member 5004. The sensor cap 5018 may be detachably connected to the sensor control device 5002 (e.g., the electronic device covering member 5004) at the bottom surface of the pedestal portion 5008 or in the vicinity thereof. The sensor cap 5018 serves to provide a sealed barrier that surrounds both exposed portions of the sensor 5010 and the pointed member 5012 to protect them from gas chemical sterilization. As shown in the figure, the sensor cap 5018 may include a generally cylindrical body having a first end portion 5020a and a second end portion 5020b on the opposite side of the first end portion 5020a. The first end portion 5020a may be in an open state so as to be accessible to an internal chamber 5022 defined within the body. In contrast, the second end portion 5020b may be in a closed state and may be provided with an engagement functional portion 5024 or may be separately defined. As described herein, the engagement functional portion 5024 serves to fit the sensor cap 5018 onto the cap (e.g., the applicator cap 708 in FIG. 3B) of the sensor applicator (e.g., the sensor applicator 105 in FIGS. 1 and 3A to 3G), and also serves to remove the sensor cap 5018 from the sensor control device 5002 when removing the sensor cap 5018 from the sensor applicator.

[0156] The sensor cap 5018 may be detachably connected to the electronic device covering member 5004 at or near the bottom surface of the pedestal portion 5008. More specifically, the sensor cap 5018 may be detachably connected to a fitting member 5016 that projects distally from the bottom surface of the pedestal portion 5008. In at least one embodiment, for example, the fitting member 5016 may define a set of male threads 5026a (FIG. 18B) that can be mated with a set of female threads 5026b (FIG. 18A) defined by the sensor cap 5018. In some embodiments, the male threads 5026a and the female threads 5026b are composed of a flat thread design (e.g., lacking a helical curvature), which has been shown to be advantageous when molding each component. As an alternative example, the male threads 5026a and the female threads 5026b may be composed of a helical thread engagement portion. Accordingly, the sensor cap 5018 can be screwed onto the sensor control device 5002 with the fitting member 5016 of the pointed member hub 5014. In other embodiments, the sensor cap 5018 can be detachably connected to the fitting member 5016 by various other types of engagement, such as interference fit, friction fit, or a frangible (brittle) member or frangible material that can be broken with a minimal separating force (e.g., an axial force or a rotational force), but is not limited thereto.

[0157] In some embodiments, the sensor cap 5018 may be composed of an integrated (single) structure that extends between a first end 5020a and a second end 5020b. However, in other embodiments, the sensor cap 5018 may be composed of two or more components. In the illustrated embodiment, for example, the sensor cap 5018 may include a seal ring 5028 disposed at the first end 5020a and a desiccant cap 5030 disposed at the second end 5020b. The seal ring 5028 may be configured to help seal the internal chamber 5022, as will be described in more detail below. In at least one embodiment, the seal ring 5028 may be composed of an elastomeric O-ring. The desiccant cap 5030 may store or contain a desiccant so as to help maintain a preferred humidity level within the internal chamber 5022. The desiccant cap 5030 may also define or otherwise provide the engagement functional portion 5024 of the sensor cap 5018.

[0158] FIG. 19A and FIG. 19B are, respectively, an exploded isometric top view and a bottom view of a sensor control device 5002 according to one or more embodiments. The shell 5006 and the pedestal portion 5008 act as two half-shells facing each other, and they surround or otherwise generally enclose various electronic components of the sensor control device 5002. More specifically, each electronic component includes, but is not limited to, a printed circuit board (PCB), one or more resistors, one or more transistors, one or more capacitors, one or more inductors, one or more diodes, and one or more switches. A data processing unit and a battery are mounted on the printed circuit board or can interact separately. The data processing unit may include, for example, an application-specific integrated circuit (ASIC) configured to implement one or more functions or routines associated with the operation of the sensor control device 5002. More specifically, the data processing unit may be configured to perform various data processing functions, such as, but not limited to, filtering and encoding data signals, each corresponding to the user's sampled analyte level. The data processing unit may also include an antenna for communicating with the reader device 120 (FIG. 1) or may be otherwise communicable. The battery can supply power to the sensor control device 5002, particularly to the electronic components of the printed circuit board. Although not shown, the sensor control device 5002 may be provided with an adhesive patch, which is applied to the bottom surface 5102 (FIG. 19B) of the pedestal portion 5008 to help adhere the sensor control device 5002 to the user's skin in preparation for use.

[0159] The sensor control device 5002 is provided with a sealed sub-assembly or separately includes the sub-assembly. Among the components other than those described above, particularly, the shell 5006, the sensor 5010, the sharp member 5012, the sensor cap 5018, etc. can be mentioned. The sealed sub-assembly of the sensor control device 5002 helps to isolate the sensor 5010 and the sharp member 5012 within the internal chamber 5022 (FIG. 19A) of the sensor cap 5018 during the gas chemical disinfection process. Otherwise, it may adversely affect the chemical substances provided on the sensor 5010.

[0160] The sensor 5010 preferably has a tail portion 5104, which projects out from the opening 5106 (FIG. 19B) defined in the pedestal portion 5008 and can be percutaneously received under the skin of the user. The tail portion 5104 contains an enzyme or other chemical substances thereon and helps to facilitate the monitoring of the analyte. The sharp member 5012 preferably has a pointed end portion 5108 that can project through the opening 5110 (FIG. 19A) defined by the shell 5006, and the opening 5110 is preferably coaxially aligned with the opening 5106 of the pedestal portion 5008. When the pointed end portion 5108 pierces through the electronic device covering member 5004, the tail portion 5104 of the sensor 5010 is received inside the hollow portion or the recessed portion of the pointed end portion 5108. By being configured to pierce through the skin while the pointed end portion 5108 holds the tail portion 5104, the active chemical substances of the tail portion 5104 can be brought into contact with the body fluid.

[0161] The pointed member hub 5014 engages the upper surface of the shell 5006, and the pointed end 5108 can pass through the electronic device covering member 5004 and advance until the fitting member 5016 projects out of the opening 5106 in the bottom surface 5102 of the gantry portion 5008. In some embodiments, a member (not shown), such as an O-ring or a seal ring, is interposed between the pointed member hub 5014 and the upper surface of the shell 5006 to serve to seal the interface between these two components. In some embodiments, the seal member includes separate components, or instead may form an integral part of the shell 5006, such as a co-molded component or an over-molded component.

[0162] The sealed subassembly further includes a collar 5112, which is disposed inside the electronic device covering member 5004 and at least partially projects into the opening 5106. The collar 5112 is preferably a generally annular structure, but defines or otherwise provides an annular raised portion 5114 on its uppermost surface. In some embodiments, as shown, a groove 5116 is defined within the annular raised portion 5114, but may be configured to receive a portion of the sensor 5010 that extends laterally inside the electronic device covering member 5004, or otherwise receive it.

[0163] When integrating the sealed sub-assembly, the bottom surface 5118 of the collar 5112 is exposed at the opening 5106 and then sealingly engages with the first end 5020a of the sensor cap 5018, and more specifically, can sealingly engage with the seal ring 5028. In contrast, the annular ridge 5114 at the top of the collar 5112 can sealingly engage with the inner surface (not shown) of the shell 5006. In at least one embodiment, a seal member (not shown) may be interposed between the annular ridge 5114 and the inner surface of the shell 5006 to form a sealed interface. In such an embodiment, the seal member may also protrude (flow) into the defined groove 5116 of the annular ridge 5114, thereby sealing around the sensor 5010 that extends laterally inside the electronic device covering member 5004. The seal member may be composed of, for example, an adhesive, a gasket, or ultrasonic welding, and helps to isolate the enzyme and other chemicals contained in the tail 5104.

[0164] FIG. 20 is a longitudinal sectional view of an assembled sealed sub-assembly 5200 according to one or more embodiments. The sealed sub-assembly 5200 forms part of the sensor control device 5002 of FIGS. 18A and 18B and FIGS. 19A to 20B and may be composed of various parts such as the shell 5006, the sensor 5010, the sharp member 5012, the sensor cap 5018, the collar 5112, etc. The sealed sub-assembly 5200 can be integrated in various ways. In one integration process, when connecting the sharp member 5012 to the sensor control device 5002, the pointed end 5108 is passed through the opening 5110 defined at the top of the shell 5006, and then the sharp member hub 5014 is engaged with the top of the shell 5006 until the fitting member 5016 protrudes distally from the shell 5006 by advancing the sharp member 5012. In some embodiments, as described above, a seal member 5202 (e.g., an O-ring or a seal ring) is interposed between the sharp member hub 5014 and the upper surface to help seal the interface between these two components.

[0165] Next, after color 5112 is received over (around) fitting member 5016, it may be advanced toward inner surface 5204 of shell 5006 so that annular ridge 5114 can engage inner surface 5204. Since seal member 5206 is interposed between annular ridge 5114 and inner surface 5204, a sealed interface can be formed. Seal member 5206 also projects (flows) into defined groove 5116 (FIGS. 19A through 20B) of annular ridge 5114, thereby sealing around sensor 5010 that extends laterally inside electronic device covering member 5004 (FIGS. 19A through 20B). However, in other embodiments, color 5112 may first be sealed against inner surface 5204 of shell 5006, and subsequently, as described above, pointed member 5012 and pointed member hub 5014 may be passed through opening 5110.

[0166] Sensor cap 5018 may be removably connected to sensor control device 5002 by screwing its female thread 5026b onto male thread 5026a of fitting member 5016. By tightly tightening (rotating) the fitting engagement between sensor cap 5018 and fitting member 5016, the first end 5020a of sensor cap 5018 can be urged to engage in a sealed manner with bottom surface 5118 of color 5112. Further, by tightly tightening the fitting engagement between sensor cap 5018 and fitting member 5016, the interface seal between pointed member hub 5014 and the top of shell 5006, and the interface seal between annular ridge 5114 and inner surface 5204 of shell 5006 can be improved.

[0167] The internal chamber 5022 may be dimensioned or otherwise configured to receive the tail portion 5104 and the tip portion 5108. Further, by enclosing the internal chamber 5022, the tail portion 5104 and the tip portion 5108 can be isolated from various substances that may have a harmful interaction with the chemicals in the tail portion 5104. In some embodiments, a desiccant 5208 (illustrated by the dashed line) is placed within the internal chamber 5022 to maintain an appropriate humidity level.

[0168] Once properly assembled, the sealed subassembly 5200 may be subjected to any of the various radiation sterilization processes mentioned herein to properly sterilize the sensor 5010 and the sharp member 5012. This sterilization process may be initiated separately from the remaining portions of the sensor control device (Figs. 18A and 18B and Figs. 19A to 20B) to prevent damage to sensitive electrical components. The sealed subassembly 5200 may be subjected to radiation sterilization either before or after connecting the sensor cap 5018 to the sharp member hub 5014. When sterilizing after connecting the sensor cap 5018 to the sharp member hub 5014, the sensor cap 5018 may be made of a material that allows radiation to pass through it. In some embodiments, the sensor cap 5018 may be transparent or translucent, but otherwise may be opaque without departing from the scope of the present disclosure.

[0169] Figures 21A through 21C are progressive longitudinal sectional views showing the integration of the sensor applicator 102 provided with the sensor control device 5002 according to one or more embodiments. When the sensor control device 5002 is fully integrated, it is loaded into the sensor applicator 102. Referring to FIG. 21A, the tip member hub 5014 may be provided with hub snap claws 5302 configured to assist in connecting the sensor control device 5002 to the sensor applicator 102, or may be separately defined. More specifically, the sensor control device 5002 may be advanced into the sensor applicator 102, and the hub snap claws 5302 may be received by the arms 5304 corresponding to the snap claws of the tip member carrier 5306 disposed within the sensor applicator 102.

[0170] In FIG. 21B, it is illustrated that the sensor control device 5002 is received by the tip member carrier 5306 and thus fixed inside the sensor applicator 102. When the sensor control device 5002 is loaded into the sensor applicator 102, the applicator cap 210 can be connected to the sensor applicator 102. In some embodiments, the applicator cap 210 and the housing 208 are provided with a plurality of sets of screws 5308 that can be fitted to face each other, and the applicator cap 210 can be screwed onto the housing 208 in the clockwise (or counterclockwise) direction to cover and fasten it, thereby fixing the applicator cap 210 to the sensor applicator 102.

[0171] As shown in the figure, the sheath member 212 is also installed inside the sensor applicator, and the sensor applicator 102 may be provided with a sheath member locking mechanism 5310 configured to ensure that it does not prematurely crush during the occurrence of an impact event. In the illustrated embodiment, the sheath member locking mechanism 5310 may include a threaded engagement portion between the applicator cap 210 and the sheath member 212. More specifically, one or more female threads 5312a may be defined or separately provided on the inner surface of the applicator cap 210, and further, one or more male threads 5312b may be defined or separately provided on the sheath member 212. The female threads 5312a and the male threads 5312b may be configured to fit in a screwed manner when the applicator cap 210 is screwed onto the sensor applicator 102 at the threaded portion 5308. The female threads 5312a and the male threads 5312b may have the same thread pitch as the threaded portion 5308, so that the applicator cap 210 can be screwed onto the housing 208 and fastened thereon.

[0172] In FIG. 21C, an example is shown in which the applicator cap 210 is fully screwed (fastened) onto the housing 208. As shown in the figure, the applicator cap 210 may be further provided or separately defined with a cap support 5314, which is disposed at the center within the internal range of the applicator cap 210 and projects proximally from the bottom surface of the cap. The cap support 5314 may be configured to receive at least a part of the sensor cap 5018 when the applicator cap 210 is screwed onto the housing 208 and fastened thereon.

[0173] With the sensor control device 5002 loaded within the sensor applicator 102 and the applicator cap 210 properly secured, the sensor control device 5002 can be subjected to gas chemical sterilization, which is configured to sterilize the electronic component covering member 5004 of the sensor control device 5002 and any other exposed portions. Since each portion on the distal side of the sensor 5010 and the tip member 5012 are sealed inside the sensor cap 5018, the various chemical agents used during the gas chemical sterilization process cannot interact with the enzyme, chemical substances, and biological substances applied on the tail 5104, as well as other sensor components such as the membrane coating that regulates the inflow of the analyte.

[0174] Figures 22A and 22B are, respectively, a perspective view and a top view of a cap support 5314 according to one or more additional embodiments. In the illustrated figures, a portion of the sensor cap 5018 is received inside the cap support 5314. More specifically, the desiccant cap 5030 of the sensor cap 5018 is disposed inside the cap support 5314.

[0175] As shown in the figure, the cap support column 5314 may be considered to define the receiving functional part 5402, which is configured to connect the applicator cap 210 (Fig. 21C) to the sensor applicator 102 (Figs. 21A to 21C) (for example, by screwing and fastening) and at the same time receive the engaging functional part 5024 of the sensor cap 5018. However, when the applicator cap 210 is removed from the sensor applicator 102, the receiving functional part 5402 prevents the engaging functional part 5024 from moving in the reverse direction, and thus can prevent the sensor cap 5018 from separating from the cap support column 5314. Instead, by removing the applicator cap 210 from the sensor applicator 102, at the same time, the sensor cap 5018 is disconnected from the sensor control device 5002 (Figs. 18A and 18B and Figs. 21A to 21C), thereby exposing both distal portions of the sensor 5010 (Figs. 21A to 21C) and the sharp member 5012 (Figs. 21A to 21C).

[0176] Without departing from the scope of the present disclosure, a receiving functional part 5402 with a number of design variations may be adopted. In the illustrated embodiment, the receiving functional part 5402 includes one or more (two in the figure) flexible members 5404, which are extensible or highly flexible enough to receive the engaging functional part 5024 (Figs. 18A and 18B). The engaging functional part 5024 may preferably be composed of, for example, an enlarged head portion, and the flexible member(s) 5404 may preferably be composed of a collet-type device provided with a plurality of flexible finger portions configured to receive the enlarged head portion by bending radially outwardly.

[0177] The flexible member 5404 is further provided with inclined surfaces corresponding thereto, or separately defined, and the inclined surfaces are configured to interact with one or more cam surfaces 5408 provided on the outer wall of the engaging functional portion 5024 facing thereto. Regarding the shape and alignment of the inclined surface(s) 5406 and the opposing cam surface(s) 5408, the applicator cap 210 is set to be rotatable in a first direction A (e.g., clockwise) with respect to the sensor cap 5018. However, when the applicator cap 210 is rotated in a second direction B (e.g., counterclockwise), it is implemented in such a manner that the cap support 5314 presses and fixes the sensor cap 5018. More specifically, when the applicator cap 210 (and thus the cap support 5314) rotates in the first direction A, the cam surface 5408 engages with the inclined surface 5406, thereby causing the flexible member 5404 to bend radially outward or be otherwise deflected, resulting in a ratchet effect. However, by rotating the applicator cap 210 (and thus the cap support 5314) in the second direction B, the angled surface 5410 of the cam surface 5408 is pushed into the angled surface 5412 of the opposing inclined surface 5406, resulting in the sensor cap 5018 pressing and fixing the flexible member(s) 5404.

[0178] FIG. 23 is a longitudinal sectional view of a sensor control device 5002 disposed inside an applicator cap 210 according to one or more embodiments. As shown, the opening to the receiving function portion 5402 exhibits a first diameter D3, while the engaging function portion 5024 of the sensor cap 5018 exhibits a second diameter D4, which is larger than the first diameter D3 and larger than the outer diameter of each of the remaining portions of the sensor cap 5018. When the sensor cap 5018 projects into the cap support 5314, the flexible member 5404 of the receiving function portion 5402 can be bent (expanded) radially outward to receive the engaging function portion 5024. In some embodiments, as shown, the engaging function portion 5024 has an angled outer surface or a frustoconical outer surface, or is separately defined, and this outer surface serves to bias the flexible member 5404 radially outward. If the engaging function portion 5024 slips through the receiving function portion 5402, the flexible member(s) 5404 can contract and return (or tend to return) to its natural state, thus enabling the sensor cap 5018 to be locked inside the cap support 5314.

[0179] When the applicator cap 210 is screwed onto the housing 208 (FIGS. 21A - 21C) in a first direction A, the cap support 5314 rotates in the same direction accordingly, and the sensor cap 5018 is gradually introduced into the cap support 5314. As the cap support 5314 rotates, the inclined surface 5406 of the flexible member 5404 is gradually moved by a detent that presses against the cam surface 5408 of the sensor cap 5018 facing it. In some examples, this ratchet operation may occur over two full rotations of the applicator cap 210 before the applicator cap 210 reaches its final position.

[0180] To remove the applicator cap 210, rotate the applicator cap 210 in the second direction B, and accordingly rotate the cap support 5314 in the same direction, so that the cam surface 5408 (i.e., the angled surface 5410 in FIGS. 22A and 22B) presses against the inclined surface 5406 (i.e., the angled surface 5412 in FIGS. 22A and 22B) and is fixed. As a result, by continuously rotating the applicator cap 210, the sensor cap 5018 is rotated in the same direction accordingly, thereby being disengaged from the fitting member 5016, and the sensor cap 5018 can be removed from the sensor control device 5002. By disconnecting the sensor cap 5018 from the sensor control device 5002, both distal portions of the sensor 5010 and the sharp member 5012 are exposed. Therefore, the sensor control device 5002 is arranged in place and prepared for firing (use).

[0181] FIGS. 24A and 24B are longitudinal sectional views of a sensor applicator 102 in a state where a sensor control device 5002 is ready to be deployed at a target monitoring position according to one or more embodiments. More specifically, FIG. 24A depicts the sensor applicator 102 in a state where the sensor control device 5002 is ready to be deployed (fired), and FIG. 24B depicts the sensor applicator 102 in the process of deploying (firing) the sensor control device 5002. As shown, the applicator cap 210 (FIGS. 21A to 21C and 23) has been completely removed, and accordingly, by removing the sensor cap 5018 (FIGS. 21A to 21C and 23), the tail portion 5104 of the sensor 5010 and the tip portion 5108 of the sharp member 5012 are exposed as described above. Together with the sheath member 212 and the sharp member carrier 5306, the sensor applicator 102 also includes a sensor carrier 5602 (also referred to as a "pack" carrier), which serves to arrange and fix the sensor control device 5002 inside the sensor applicator 102.

[0182] First, referring to FIG. 24A, as shown, the sheath member 212 is provided with one or more sheath member arms 5604 (not shown), and the arms are configured to interact with one or more (one in the figure) detents 5606 defined within the interior of the corresponding housing 208. The detent(s) 5606 is also alternatively referred to as a "firing" detent. When the sensor control device 5002 is first installed in the sensor applicator 102, the sheath member arm 5604 is received inside the detent 5606, thereby placing the sensor applicator 102 in the firing position. In the firing position, the mating member 5016 projects distally beyond the bottom surface of the sensor control device 5002. As discussed below, the process of firing the sensor applicator 102 involves retracting the mating member 5016 so that the member does not contact the user's skin.

[0183] The sensor carrier 5602 is provided with one or more (one in the figure) carrier arms 5608 (one in the figure), and the arms are preferably configured to interact with one or more (one in the figure) grooves 5610 defined on the corresponding sharp member carrier 5306. A spring 5612 is preferably disposed inside the cavity defined by the sharp member carrier 5306, but the sharp member carrier 5306 can be passively biased upward inside the housing 208. When the carrier arm(s) 5608 is properly received in the groove(s) 5610, the sharp member carrier 5306 is maintained in place and prevented from moving upward. The carrier arm(s) 5608 is interposed between the sheath member 212 and the sharp member carrier 5306, and the radially defined shoulder 5614 on the sheath member 212 is dimensioned to maintain the carrier arm(s) 5608 fitted into the groove(s) 5610, thereby maintaining the sharp member carrier 5306 in place.

[0184] In FIG. 24B, the sensor applicator 102 is in the process of firing. As discussed herein with reference to FIGS. 3E and 3F, this can be accomplished by advancing the sensor applicator 102 toward the target monitoring site until the sheath member 212 engages the user's skin. By continuously applying pressure to the sensor applicator 102 pressed against the skin, the sheath member arm(s) 5604 is disengaged from its corresponding detent(s) 5606, whereby the sheath member 212 collapses and enters the housing 208. When the sheath member 212 begins to collapse, the radial shoulder 5614 eventually disengages from the radial engagement with the carrier arm(s) 5608, whereby the carrier arm(s) 5608 can disengage from the groove(s) 5610. The passive spring force of the spring 5612 is released here to push the sharp member carrier 5306 upward, thereby forcibly disengaging the carrier arm(s) 5608 from the engagement with the groove(s) 5610, whereby the sharp member carrier 5306 can move slightly upward inside the housing 208. Depending on the embodiment, the design of the spring 5612 may include reducing the number of coils incorporated to increase the spring force required to overcome the engagement between the carrier arm(s) 5608 and the groove(s) 5610. In at least one embodiment, providing a slope to one or both of the carrier arm(s) 5608 and the groove(s) 5610 helps facilitate disengagement.

[0185] When the sharp member carrier 5306 moves upward inside the housing 208, accordingly, the sharp member hub 5014 moves in the same direction, so that the fitting member 5016 is partially retracted, enabling the fitting member to be flush with, generally flush with, or semi-flush with the bottom surface of the sensor control device 5002. As will be appreciated, this prevents the fitting member 5016 from contacting the user's skin, which could otherwise negatively affect sensor insertion, cause excessive pain, or prevent an adhesive patch (not shown) disposed on the bottom surface of the sensor control device 5002 from properly adhering to the skin.

[0186] Figures 25A through 25C are progressive longitudinal cross-sectional views showing the assembly and disassembly of an alternative embodiment of the sensor applicator 102 having the sensor control device 5002 according to one or more additional embodiments. The fully assembled sensor control device 5002 can be loaded into the sensor applicator 102 by connecting the hub snap claw 5302 to the inside of the arm 5304 of the sharp member carrier 5306 disposed within the sensor applicator 102.

[0187] In the illustrated embodiment, the sheath member arm 5604 of the sheath member 212 may be configured to interact with a first detent 5702a and a second detent 5702b defined inside the housing 208. The first detent 5702a may alternatively be referred to as a "locking" detent, and the second detent 5702b may alternatively be referred to as a "firing" detent. When the sensor control device 5002 is first installed in the sensor applicator 102, the sheath member arm 5604 is received within the first detent 5702a. As described below, the sheath member 212 may be actuated to move the sheath member arm 5604 to the second detent 5702b, thereby positioning the sensor applicator 102 in the firing position.

[0188] In Fig. 25B, the applicator cap 210 is aligned with the housing 208 and then advanced toward the housing 208 so that the sheath member 212 is received inside the applicator cap 210. Instead of rotating the applicator cap 210 with respect to the housing 208, the applicator cap 210 may be connected to the housing 208 by snap-fitting the threaded portion of the applicator cap 210 onto the corresponding threaded portion of the housing 208. By means of an axially defined cutout or slot 5703 (one in the figure) defined in the applicator cap 210, each part near the threaded portion of the applicator cap 210 can be bent outward so as to be in a snap-engagement state with the threaded portion of the housing 208. When the applicator cap 210 is snap-fastened to the housing 208, the sensor cap 5018 can be snap-fastened into the cap support 5314 accordingly.

[0189] Similar to the embodiments of FIGS. 21A to 21C, the sensor applicator 102 may be provided with a sheath member locking mechanism, which may be configured to ensure that the sheath member 212 does not prematurely crush during the occurrence of an impact event. In the illustrated embodiment, the sheath member locking mechanism has one or more (one in the figure) protrusions 5704 defined near the base of the sheath member 212 and is configured to interconnect with one or more (two in the figure) protrusions 5706, and a shoulder 5708 is defined near the base of the applicator cap 210. The protrusion 5704 may be configured to interlock between the protrusion 5706 and the shoulder 5708 with the applicator cap 210 attached to the housing 208. More specifically, when the applicator cap 210 is snap - fastened onto the housing 208, the applicator cap 210 can be rotated (e.g., clockwise), and by placing the protrusion 5704 of the sheath member 212 between the protrusion 5706 and the shoulder 5708 of the applicator cap 210, the applicator cap 210 is "locked" until the user rotates the applicator cap 210 counter - clockwise to remove it in preparation for use. The engagement of the protrusion 5704 between the protrusion 5706 and the shoulder 5708 of the applicator cap 210 can also prevent the sheath member 212 from prematurely crushing. 0291 In FIG. 25C, the applicator cap 210 has been removed from the housing 208. Similar to the embodiments of FIGS. 21A to 21C, the applicator cap 210 can be removed by rotating it counter - clockwise, and accordingly, as outlined previously, the cap support 5314 is rotated in the same direction to disengage the sensor cap 5018 from the mating member 5016. Further, by removing the sensor cap 5018 from the sensor control device 5002, both distal portions of the sensor 5010 and the sharp member 5012 are exposed. When the applicator cap 210 is unscrewed from the housing 208, each protrusion 5704 defined on the sheath member 212 can slidably engage with the top of the protrusion 5706 defined on the applicator cap 210. The top of the protrusion 5706 is provided with a corresponding inclined surface. As a result, when the applicator cap 210 rotates, the sheath member 212 is displaced upward. By moving the sheath member 212 upward, the sheath member arm 5604 bends and disengages from the engagement with the first return stop 5702a and is received inside the second return stop 5702b. When the sheath member 212 moves to the second return stop 5702b, the radial shoulder 5614 disengages from the radial engagement with the carrier arm(s) 5608. Thereby, the passive spring force of the spring 5612 pushes up the sharp member carrier 5306 and forces the carrier arm(s) 5608 to disengage and move out of the groove(s) 5610. As the sharp member carrier 5306 moves upward inside the housing 208, accordingly, the fitting member 5016 can retreat until it is flush with the bottom surface of the sensor control device 5002, until it is substantially flush, or until it is semi-flush. At this point, the sensor applicator 102 is in the firing position. Therefore, in this embodiment, by removing the applicator cap 210, the fitting member 5016 is accordingly retracted.

[0190] FIG. 26A is an isometric bottom view of a housing 208 according to one or more embodiments. As shown, it is preferable that one or more (four in the figure) longitudinally extending rib portions 5802 are defined within the interior of the housing 208. The rib portions 5802 may be spaced equidistant or non-equidistant from each other and extend generally parallel to the central axis of the housing 208. The first return stop 5702a and the second return stop 5702b may be provided on one or more of the rib portions 5802 that are longitudinally long in the major axis direction.

[0191] FIG. 27A is an isometric bottom view showing that in the housing 208, a sheath member 212 and other components are at least partially disposed inside thereof. As shown in the figure, the sheath member 212 is provided with, or alternatively defined separately, one or more slots 5804 that are longitudinally disposed in the longitudinal axis direction of the housing 208 and are configured to fit with the longitudinally ribbed portion 5802. As outlined above, when the sheath member 212 is crushed and enters the housing 208, the ribbed portion 5802 is received in the slot 5804, which helps to maintain the sheath member 212 in an aligned state with the housing during its movement. As will be correctly understood, this allows for more precise alignment in the circumferential and radial directions inside the housing 208 with the same dimensional limitations and the same tolerance limitations.

[0192] In the illustrated embodiment, the sensor carrier 5602 may be configured to hold the sensor control device 5002 in place in both the axial direction (e.g., after the sensor cap 5018 is removed) and the circumferential direction. To achieve this, the sensor carrier 5602 may be provided with, or alternatively defined separately, one or more support ridge portions 5806 and one or more flexible arms 5808. The support ridge portions 5806 project radially inwardly to provide radial support to the sensor control device 5002. A part of the flexible arm 5808 extends around the periphery of the sensor control device 5002, and the end of the flexible arm 5808 may be received inside a groove 5810 defined on the side surface of the sensor control device 5002 corresponding thereto. Accordingly, the flexible arm 5808 may be configured to provide axial and radial support to the sensor control device 5002. In at least one embodiment, the end of the flexible arm 5808 is biased to enter the groove 5810 of the sensor control device 5002, or otherwise may be locked in place using a sheath member locking projection 5812 provided on the sheath member 212 corresponding thereto.

[0193] In some embodiments, the sensor carrier 5602 may be ultrasonically welded to the housing 208 at one or more points 5814. However, in other embodiments, the sensor carrier 5602 may instead be connected to the housing 208 by snap-fit engagement without departing from the scope of the present disclosure. This helps to hold the sensor control device 5002 in place during transportation and launch.

[0194] FIG. 28 is an enlarged longitudinal cross-sectional view of the sensor applicator 102 with the sensor control device 5002 attached, according to one or more embodiments. As described above, the sensor carrier 5602 may desirably be provided with one or more (two in the figure) carrier arms 5608 that can engage the tip member carrier 5306 in corresponding grooves 5610. In at least one embodiment, the groove 5610 may desirably be defined by a plurality of pairs of protrusions 5902 provided on the tip member carrier 5306. Receiving the carrier arm 5608 inside the groove 5610 helps to stabilize the tip member carrier 5306 and prevent undesirable tilting during all stages of retraction (launch).

[0195] In the illustrated embodiment, the arm 5304 of the tip member carrier 5306 may desirably have sufficient rigidity to more finely control the radial and two-axis movement of the tip member hub 5014. In some embodiments, for example, the gap between the tip member hub 5014 and each arm 5304 may be more strongly constrained in both directions of the two axes, which may be due to the relative control of the height of the tip member hub 5014 being more important for the design.

[0196] In the illustrated embodiment, the sensor carrier 5602 is defined with or otherwise provided with a central boss 5904 sized to receive the tip member hub 5014. In some embodiments, as illustrated, the tip member hub 5014 may be provided with one or more (two in the figure) radial protrusions 5906. In at least one embodiment, the inner diameter of the central boss 5904 serves to provide radial and tilt support to the tip member hub 5014 over the product life duration, operation, and pre-integration stages of the sensor applicator 102. Further, having a plurality of radial protrusions 5906 increases the length-to-width ratio of the tip member hub 5014 and improves the support against tilting.

[0197] FIG. 29A is an isometric top view of an applicator cap 210 according to one or more embodiments. In the illustrated embodiment, two axial slots 5703 are depicted, which separate the upper portions of the applicator cap 210 near the threaded portion of the cap. As described above, the slots 5703 serve to snap-engage the applicator cap 210 with the housing 208 (FIG. 25B) as the applicator cap 210 is bent outward. In contrast, the applicator cap 210 is removed from the housing 208 by the end user by turning it (unscrewing it).

[0198] FIG. 29A also depicts that the protrusion 5706 (the first one visible in the figure) is defined on the applicator cap 210. By interlocking with the protrusion 5704 (FIG. 25C) defined on the sheath member 212 (FIG. 25C), the protrusion 5706 helps to lock the sheath member 212 in all directions so that it will not be prematurely crushed in the event of an impact or a drop. As previously outlined, the sheath member 212 can be unlocked when the user twists the applicator cap 210 off the housing. As described herein, corresponding inclined surfaces 6002 are provided at the tops of the respective protrusions 5706, and when the applicator cap 210 is rotated to release the screw engagement with the housing 208, the protrusion 5704 defined on the sheath member 212 can slidably engage with the inclined surface 6002, and as a result, the sheath member 212 is displaced upward and enters the housing 208.

[0199] In some embodiments, an additional functional part is provided within the internal scope of the applicator cap 210 to hold a desiccant component that maintains an appropriate moisture level over the shelf life. Such additional functional parts are presumed to include snap fasteners, press-fit posts, heat caulking parts, ultrasonic welding parts, and the like.

[0200] FIG. 29B is an enlarged cross-sectional view of the engagement between the applicator cap 210 and the housing 208 according to one or more embodiments. As shown, the applicator cap 210 may define a set of female threads 6004, and the housing 208 may define a set of male threads 6006 that are threadable with the female threads 6004. As mentioned herein, the applicator cap 210 can be snap-fitted over the housing 208, and in achieving this, it is implemented by advancing the female threads 6004 axially beyond the male threads 6006 in the direction indicated by the arrow, whereby the applicator cap 210 bends outward. To assist in facilitating this transition, as shown, the corresponding surfaces 6008 of the female threads 6004 and the male threads 6006 may be curved, angled, or chamfered. Corresponding flat surfaces 6010 are provided on each of the threads 6004 and 6006, and the applicator cap 210 may be configured to snap-fit properly into a predetermined position of the housing 208 or to fit into an engaging manner. As the user twists and unscrews the applicator cap 210 to remove it from the housing 208, the flat surfaces 6010 can engage while sliding relative to each other.

[0201] The threaded engagement between the applicator cap 210 and the housing 208 results in a sealed engagement that protects the internal components from moisture, dust, etc. In some embodiments, a stabilization feature 6012 may be defined or otherwise provided in the housing 208 and may be configured to be received inside a groove 6014 defined in the applicator cap 210 corresponding thereto. As the applicator cap 210 is snap-fitted over the housing 208, the stabilization feature 6012 helps to stabilize and reinforce the applicator cap 210. This also helps to increase the removal torque of the applicator cap 210.

[0202] Figures 30A and 30B are isometric views of sensor cap 5018 and color 5112, respectively, according to one or more embodiments. Referring to FIG. 30A, in some embodiments, sensor cap 5018 may be formed from an injection molded part. This is shown to be advantageous for molding with female threads 5026a defined inside internal chamber 5022, as opposed to attaching a threaded core or threading the inside of internal chamber 5022. In some embodiments, one or more locking protrusions 6102 (visible in the figure) are defined inside internal chamber 5022 to prevent the cap from moving excessively relative to fitting member 5016 of pointed member hub 5014 (FIGS. 18A and 18B).

[0203] Referring to both FIGS. 30A and 30B, in some embodiments, one or more (two in the figure) protrusions 6104 are defined on first end 5020a of sensor cap 5018 and are configured to mate with one or more (two in the figure) indentations 6106 defined on corresponding color 5112. However, in other embodiments, alternatively, without departing from the scope of the present disclosure, protrusions 6104 may be defined on color 5112 and indentations 6106 may be defined on sensor cap 5018.

[0204] The protrusion 6104 and the indentation 6106 that fit into each other advantageously prevent the sensor cap 5018 from unintentionally twisting off the color 5112 (and thus from the sensor control device 5002) during the product life of the sensor applicator 102 and during the pre - integration stages of operation by rotationally locking the sensor cap 5018. In some embodiments, as shown, the indentation 6106 may be formed in the overall shape of a lentil or may be separately defined. This is advantageous in allowing the sensor cap 5018 to rotate somewhat excessively with respect to the color 5112. As an alternative example, the same advantage can be achieved by a threaded engagement of the flat end between the two parts.

[0205] Each embodiment of the present disclosure includes the following: A. A sensor control device comprising: an electronic device covering member; a sensor disposed within the electronic device covering member and having a tail extending from the bottom surface of the electronic device covering member; a pointed member extending through the electronic device covering member and having a pointed end extending from the bottom surface of the electronic device covering member; and a sensor cap removably connected to the bottom surface of the electronic device covering member and defining a sealed internal chamber for receiving the tail and the pointed member.

[0206] B. A analyte monitoring system comprising a sensor applicator, a sensor control device disposed within the sensor applicator and having an electronic device covering member, a sensor disposed within the electronic device covering member and having a tail extending from the bottom surface of the electronic device covering member, a sharp member extending through the electronic device covering member and having a tip extending from the bottom surface of the electronic device covering member, and a sensor cap detachably connected to the bottom surface of the electronic device covering member and defining a sealed internal chamber for receiving an engagement functional portion and the tail and the sharp member. The analyte monitoring system further comprises a cap provided with a cap support pillar that defines a receiving functional portion and is connected to the sensor applicator. The receiving functional portion receives the engagement functional portion when the cap is connected to the sensor applicator, and by removing the cap from the sensor applicator, the sensor cap is detached from the electronic device covering member, thereby exposing the tail and the tip.

[0207] C. In a method of preparing an analyte monitoring system, the method includes loading a sensor control device into a sensor applicator. The sensor control device includes an electronic device covering member, a sensor disposed within the electronic device covering member and having a tail extending from the bottom surface of the electronic device covering member, a sharp member extending through the electronic device covering member and having a tip extending from the bottom surface of the electronic device covering member, and a sensor cap detachably connected to the bottom surface of the electronic device covering member and defining a sealed internal chamber for receiving the tail and the sharp member. The method further includes fixing a cap to the sensor applicator, sterilizing the sensor control device by gaseous chemical disinfection while the sensor control device is disposed within the sensor applicator, and isolating the tail and the tip inside the internal chamber from the gaseous chemical disinfection.

[0208] Embodiment A, Embodiment B, and Embodiment C may each have any combination of one or more of the following additional elements. Element 1) The sensor cap consists of a cylindrical main body, which has a first end that is open to access the internal chamber, and a second end on the opposite side of the first end, provided with an engaging functional part that can engage with the cap of the sensor applicator. When the cap is removed from the sensor applicator, accordingly, the sensor cap is removed from the electronic device covering member, thereby exposing the tail part and the tip part. Element 2) The electronic device covering member includes a shell that can be fitted with the gantry part, and the sensor control device further includes a sharp member - sensor positioning member defined on the inner surface of the shell and a collar received around the sharp member - sensor positioning member. The sensor cap is detachably connected to the collar. Element 3) The sensor cap is detachably connected to the collar by one or more of interference fit, threaded engaging part, frangible member, frangible substance, etc. Element 4) An annular ridge surrounds the sharp member - sensor positioning member, and the collar is provided with a columnar member and an annular shoulder projecting radially outward from the columnar member. A seal member is interposed between the annular shoulder and the annular ridge to form a sealed interface. Element 5) The annular ridge defines a groove, a part of the sensor is placed in the groove, and the seal member projects into the groove to seal around the part of the sensor. Element 6) The seal member is a first seal member, and the sensor control device further includes a second seal member that is interposed between the annular shoulder and a part of the gantry part to form a sealed interface. Element 7) The electronic device covering member includes a shell that can be fitted with the gantry part, and the sensor control device further includes a sharp member hub that holds the sharp member and can engage with the uppermost surface of the shell, and a fitting member defined by the sharp member hub and projecting from the bottom surface of the electronic device covering member. The sensor cap is detachably connected to the fitting member. Element 8) It further includes a collar that can be at least partially received in the opening defined in the gantry part and engages with the inner surfaces of the sensor cap and the shell in a sealed manner. Element 9) The seal member is interposed between the collar and the inner surface of the shell to form a sealed interface.Element 10) The color defines a groove, a part of the sensor is placed in the groove, and the seal member projects into the groove to seal around the part of the sensor.

[0209] Element 11) The receiving functional part includes one or more flexible members that receive the engaging functional part by bending, and the one or more flexible members prevent the engaging functional part from coming out of the cap strut when the cap is removed from the sensor applicator. Element 12) It further includes an inclined surface defined in at least one of the one or more flexible members and one or more cam surfaces provided by the engaging functional part and engageable with the inclined surface. The inclined surface and the one or more cam surfaces enable the cap and the cap strut to rotate in a first direction with respect to the sensor cap, but prevent the cap and the cap strut from rotating in a second direction opposite to the first direction with respect to the sensor cap. Element 13) The electronic equipment covering member includes a shell that can be fitted with the gantry part. The sensor control device further includes a sharp member hub that holds the sharp member and can engage with the top surface of the shell, and a fitting member defined by the sharp member hub and projecting from the bottom surface of the electronic equipment covering member. The sensor cap is detachably connected to the fitting member, and when the cap is rotated in the second direction, the sensor cap is removed from the fitting member. Element 14) The electronic equipment covering member includes a shell that can be fitted with the gantry part. The sensor control device further includes a sharp member - sensor positioning member defined on the inner surface of the shell and a collar received around the sharp member - sensor positioning member. The sensor cap is detachably connected to the collar.

[0210] Element 15) The cap is provided with a cap support pillar that defines a receiving functional part, the sensor-cap defines an engaging functional part, and the method further includes receiving the engaging functional part together with the receiving functional part when the cap is fixed to the sensor applicator. Element 16) Further includes removing the cap from the sensor applicator and removing the sensor-cap from the electronic device covering member and exposing the tail part and the tip part by engaging the engaging functional part on the receiving functional part when the cap is removed. Element 17) Before loading the sensor control device into the sensor applicator, sterilize the tail part and the tip part by radiation sterilization and seal the tail part and the tip part inside the inner chamber.

[0211] As non-limiting examples, the following are listed as combinations of specific examples applicable to Embodiment A, Embodiment B, and Embodiment C. Element 2 combined with Element 3, Element 2 combined with Element 4, Element 4 combined with Element 5, Element 4 combined with Element 6, Element 7 combined with Element 8, Element 8 combined with Element 9, Element 9 combined with Element 10, Element 11 combined with Element 12, and Element 15 combined with Element 16.

[0212] Embodiment of a specific example of a seal configuration for an analyte monitoring system FIG. 31A and FIG. 31B are respectively a side view and an isometric view of a specific example of a sensor control device 9102 according to one or more embodiments of the present disclosure. The sensor control device 9102 may be similar to the sensor control device 102 of FIG. 1 in some respects, and thus can be best understood by referring to the same figure. Further, the sensor control device 9102 may replace the sensor control device 102 of FIG. 1, and thus can be used in combination with the sensor applicator 102 of FIG. 1, and the applicator can deliver the sensor control device 9102 to a target monitoring site on the user's skin.

[0213] As shown in the figure, the sensor control device 9102 includes an electronic device covering member 9104, which may be substantially disk-shaped and have a circular cross-section. However, in other embodiments, the electronic device covering member 9104 may exhibit a cross-sectional shape other than the above, such as oval, elliptical, polygonal, etc., without departing from the scope of the present disclosure. The electronic device covering member 9104 includes a shell 9106 and a pedestal portion 9108 that can be fitted with the shell 9106. The shell 9106 can be fixed to the pedestal portion 9108 by various methods such as snap-fit engagement, interference fit, ultrasonic welding, laser welding, one or more mechanical fasteners (e.g., screws, etc.), gaskets, adhesives, or some combination thereof. In some cases, by fixing the shell 9106 to the pedestal portion 9108, a sealed interface may be formed between the two. The adhesive patch 9110 may be disposed under the pedestal portion 9108 or attached separately. Similar to the adhesive patch 108 in FIG. 1, the adhesive patch 9110 may be configured to fix and maintain the sensor control device 9102 in place on the user's skin during operation.

[0214] The sensor control device 9102 may further include a sensor 9112 and a sharp member 9114 used to assist in transdermally delivering the sensor 9112 subcutaneously to the user during the process of attaching the sensor control device 9102. The corresponding portions of the sensor 9112 and the sharp member 9114 project distally from the bottom surface of the electronic device covering member 9104 (e.g., the gantry portion 9108). The sharp member hub 9116 may be overmolded on the sharp member 9114 and configured to fixedly hold the sharp member 9114. As best seen in FIG. 31A, the fitting member 9118 may be provided on or separately defined for the sharp member hub 9116. When modifying the sharp member hub 9114 to the sensor control device 9102, the sharp member hub 9114 may be advanced axially to pass through the electronic device covering member 9104 until the sharp member hub 9116 engages the upper surface of the electronic device covering member 9104 or the inner component of the member, or until the fitting member 9118 projects distally from the bottom surface of the gantry portion 9108. As described below in this specification, in at least one embodiment, the sharp member hub 9116 can engage hermetically with the upper part of the sealing member overmolded on the gantry portion 9108. When the sharp member 9114 penetrates the electronic device covering member 9104, the exposed portion of the sensor 9112 is received inside the hollow portion or the concave (arcuate) portion of the sharp member 9114. The remaining portion of the sensor 9112 is disposed within the interior of the electronic device covering member 9104.

[0215] The sensor control device 9102 may further include a sensor cap 9120, which is illustrated in FIGS. 31A and 31B in a state removed from the electronic device covering member 9104. The sensor cap 9120 can help provide a sealed barrier that surrounds and protects the exposed portion of the sensor 9112 and the sharp member 9114. As shown in the figure, the sensor cap 9120 includes a substantially cylindrical body, which is provided with a first end 9122a and a second end 9122b on the opposite side of the first end 9122a. The first end 9122a may be in an open state so as to be able to approach the inside of an internal chamber 9124 defined inside the body. In contrast, the second end 9122b is in a closed state and may be provided with or separately defined with an engagement functional portion 9126. As will be described in more detail below, the engagement functional portion 9126 helps the sensor cap 9120 to fit into the applicator cap of a sensor applicator (e.g., the sensor applicator 102 in FIG. 1), and at the same time helps to remove the sensor cap from the sensor applicator and also helps to remove the sensor cap 9120 from the sensor control device 9102.

[0216] The sensor cap 9120 may be detachably connected to the electronic device covering member 9104 at or near the bottom surface of the pedestal portion 9108. More specifically, the sensor cap 9120 may be detachably connected to the fitting member 9118, and the cap projects distally from the bottom surface of the pedestal portion 9108. In at least one embodiment, for example, the fitting member 9118 may define a set of male threads 9128a (FIG. 31A) that can be fitted with a set of female threads 9128b (FIG. 31B) defined inside the internal chamber 9124 of the sensor cap 9120. In some embodiments, the male threads 9128a and the female threads 9128b may be composed of a flat thread design (e.g., lacking a helical curvature), but in alternative examples, they may be provided with a helically threaded engagement portion. Accordingly, in at least one embodiment, the sensor cap 9120 may be screwed to the sensor control device 9102 with the fitting member 9118 of the pointed member hub 9116. In other embodiments, when the sensor cap 9120 is detachably connected to the fitting member 9118, other types of engagement portions may be used, such as interference fits or friction fits, or frangible (brittle) members or frangible substances (e.g., wax, adhesive, etc.) that can be broken with a minimal separation force (e.g., axial force or rotational force), but are not limited thereto.

[0217] In some embodiments, the sensor cap 9120 may be composed of an integrated (single) structure that extends between a first end 9122a and a second end 9122b. However, in other embodiments, the sensor cap 9120 may be composed of two or more components. In the illustrated embodiment, for example, the main body of the sensor cap 9120 may have a desiccant cap 9130 disposed at the second end 9122b. The desiccant cap 9130 stores or contains a desiccant, which helps maintain a preferred humidity level within the internal chamber 9124. Further, an engagement functional portion 9126 of the sensor cap 9120 may be defined on the desiccant cap 9130 or provided separately. In at least one embodiment, the desiccant cap 9130 may be composed of an elastomeric plug, which may be inserted into the lower end of the sensor cap 9120.

[0218] Figures 32A and 32B are, respectively, an exploded isometric top view and an exploded isometric bottom view of a sensor control device 9102 according to one or more embodiments. The shell 9106 and the pedestal portion 9108 act as two halves of a shell facing each other, surrounding or generally enclosing various electronic components (not shown) of the sensor control device 9102. Specific examples of electronic components that can be disposed between the shell 9106 and the pedestal portion 9108 include, but are not limited to, a battery, a resistor, a transistor, a capacitor, an inductor, a diode, a switch, etc.

[0219] The shell 9106 may define a first opening 9202a, and the pedestal portion 9108 may define a second opening 9202b. However, when the shell 9106 is properly attached to the pedestal portion 9108, the openings 9202a and 9202b are aligned. As best seen in FIG. 32A, the pedestal portion 9108 may be provided with a pedestal 9204 that protrudes from the inner surface of the pedestal portion 9108 at the second opening 9202b, or may be separately defined. The pedestal 9204 may define at least a portion of the second opening 9202b. Further, a channel 9206 may be defined on the inner surface of the pedestal portion 9108 and may surround the pedestal 9202. In the illustrated embodiment, the channel 9206 is circular in shape, but in an alternative example, it may have a shape other than the above, such as an oval, an egg shape, or a polygon.

[0220] The pedestal portion 9108 may be composed of a molded part made of a rigid material such as a plastic material or a metal. In some embodiments, a seal portion 9208 may be overmolded on the pedestal portion 9108 and may be made of an elastomer, rubber, polymer, or other suitable flexible material that facilitates interface sealing. In an embodiment where the pedestal portion 9108 is made of a plastic material, the pedestal portion 9108 may be molded in a first "shot" of injection molding, and the seal portion 9208 may be overmolded on the pedestal portion 9108 in a second "shot" of injection molding. Accordingly, the pedestal portion 9108 may be referred to as a "two-shot pedestal portion" or may have another characteristic expression.

[0221] In the illustrated embodiment, the seal portion 9208 may be over-molded on the pedestal 9204 onto the gantry portion 9108, and may also be over-molded on the bottom surface of the gantry portion 9108. More specifically, the seal portion 9208 defines, or is separately provided with, a first seal member 9210a over-molded on the pedestal 9204, and a second seal member 9210b (FIG. 32B) that is interconnected (together) with the first seal member 9210a and over-molded on the gantry portion 9108 at the bottom surface of the gantry portion 9108, or may be separately provided. Depending on the embodiment, one or both of the seal members 9210a and 9210b may also serve to form respective portions (each section) of the second opening 9202b corresponding thereto. Although the seal portion 9208 is described herein as being over-molded on the gantry portion 9108, one or both of the seal members 9210a and 9210b may be composed of elastomeric components such as O-rings or gaskets that are independent of the gantry portion 9208.

[0222] The sensor control device 9102 may further include a collar 9212, which may be a generally annular structure defining a central opening 9214. The central opening 9214 may be sized to receive the first seal member 9210a and may be aligned with both the first opening 9202a and the second opening 9202b when the sensor control device 9102 is properly assembled. The shape of the central opening 9214 may generally conform to the shape of the second opening 9202b and the shape of the first seal member 9210a.

[0223] In some embodiments, the collar 9212 has an annular flange 9216 defined on its bottom surface, or may be provided separately. The annular flange 9216 is dimensioned to fit into or be received by a channel 9206 defined on the inner surface of the pedestal 9108, or may be configured separately to be so. In some embodiments, a groove 9218 is defined on the annular flange 9216 and is configured to accommodate or separately receive a portion of the sensor 9112 extending laterally inside the pedestal 9108. In some embodiments, the collar 9212 has an additional annular channel 9220 (FIG. 32A) defined on its upper surface, or may be provided separately, and its dimensions are set to receive or separately fit an annular ridge 9222 (FIG. 32B) defined on the inner surface of the shell 9106 when the sensor control device 9102 is properly integrated.

[0224] The sensor 9112 is provided with a tail 9224 which projects through a second opening 9202b defined in the pedestal 9108 and is received percutaneously under the skin of the user. The tail 9224 contains an enzyme or other chemical substance thereon, which helps to facilitate the monitoring of the analyte. The sharp member 9114 is provided with a tip 9226 which projects through a first opening 9202a defined in the shell 9106. When the tip 9226 penetrates the electronic device covering member 9104, the tail 9224 of the sensor 9112 is received inside the hollow or recessed portion of the tip 9226. The tip 9226 is configured to penetrate the skin while holding the tail 9224, so that the active chemical substance of the tail 9224 can be brought into contact with the body fluid.

[0225] The sensor control device 9102 is provided with a sealed sub-assembly, which includes, among other components, a shell 9106, a sensor 9112, a tip member 9114, a seal 9208, a collar 9212, a sensor cap 9120, etc. The sealed sub-assembly serves to isolate the sensor 9112 and the tip member 9114 inside the internal chamber 9124 (Fig. 32A) of the sensor cap 9120. When assembling the sealed sub-assembly, the tip member hub 9116 is advanced through the electronic device covering member 9104 until it engages with the seal portion 9208, more specifically, until it engages with the first seal member 9210a. The fitting member 9118 provided on the bottom surface of the tip member hub 9116 can protrude outside the second opening 9202b on the bottom surface of the pedestal portion 9108, and the sensor cap 9120 can be connected to the tip member hub 9116 by the fitting member 9118. By connecting the sensor cap 9120 to the tip member hub 9116 with the fitting member 9118, the first end 9122a of the sensor cap 9120 can be hermetically engaged with the seal portion 9208, more specifically, hermetically engaged with the second seal member 9210b at the bottom of the pedestal portion. Depending on the embodiment, when the sensor cap 9120 is connected to the tip member hub 9116, a part of the first end 9122a of the sensor cap 9120 may pierce (engage) while pressing the bottom surface of the pedestal portion 9108, but the sealed engagement portion between the sensor hub 9116 and the first seal member 9210a can withstand any variation in tolerance between the functional parts.

[0226] FIG. 33 is a longitudinal sectional view of a sensor control device 9102 according to one or more embodiments. As shown previously, the sensor control device 9102 may include, or alternatively incorporate, a sealed subassembly 9302, which is useful for isolating the sensor 9112 and the sharp member 9114 inside the internal chamber 9124 of the sensor cap 9120. To assemble the sealed subassembly 9302, when arranging the sensor 9112 inside the pedestal 9108, the tail portion 9224 may be made to project through the second opening 9202b in the bottom surface of the pedestal 9108. In at least one embodiment, a positioning functional portion 9304 is defined on the inner surface of the pedestal 9108, and the sensor 9112 defines a groove 9306 that can be fitted with this positioning functional portion 9304, so that the sensor 9112 can be properly positioned inside the pedestal 9108.

[0227] Once the sensor 9112 is properly positioned, the collar 9212 can be attached to the pedestal 9108. More specifically, when positioning the collar 9212, the first seal member 9210a of the seal portion 9208 is received inside the central opening 9214 defined by the collar 9212, and the first seal member 9210a is installed so as to press the collar 9212 in the central opening 9214 to cause a radial seal. Further, the annular flange portion 9216 defined on the collar 9212 is received inside the channel 9206 defined on the pedestal 9108, and by aligning the groove 9218 defined through the annular flange portion 9216, the portion of the sensor 9112 that transversely crosses the channel 9206 inside the pedestal 9108 can be received. In some embodiments, the collar 9212 can be fixed to the pedestal 9108 by injecting an adhesive into the channel 9206. The adhesive can also facilitate sealing of the interface between the two components and create a sealed portion around the sensor 9112 in the groove 9218, thereby isolating the tail portion 9224 from the electronic equipment covering member 9104.

[0228] Next, the shell 9106 may be fitted to the pedestal portion 9108 or separately connected. Depending on the embodiment, as shown in the figure, in order to fit the shell 9106 to the pedestal portion 9108, there are some that can be implemented by the protruding end - groove engaging portion 9308 on the outer peripheral edge of the electronic device covering member 9104. By injecting (coating) an adhesive into the groove portion of this engaging portion 9308, the shell 9106 can be fixed to the pedestal portion 9108, and furthermore, a sealed engaging interface may be provided. By fitting the shell 9106 to the pedestal portion 9108, the annular ridge portion 9222 defined on the inner surface of the shell 9106 can be received in the annular channel 9220 defined on the upper surface of the collar 9212. Depending on the embodiment, there are also those in which by injecting an adhesive into the annular channel 9220, the shell 9106 can be fixed to the collar 9212, and furthermore, the sealing of the interface between the two components at that position can be facilitated. When the shell 9106 is fitted to the pedestal portion 9108, the first seal member 9210a can extend at least partially through (into) the first opening 9202a defined in the shell 9106.

[0229] Next, to connect the sharp member 9114 to the sensor control device 9102, it can be implemented by passing through the first opening 9202a and the second opening 9202b, which are defined in the shell 9106 and the pedestal portion 9108 respectively and are aligned with each other, through the tip portion 9226. The sharp member 9114 may be advanced until the sharp member hub 9116 engages with the seal portion 9208, more specifically, until it engages with the first seal member 9210a. When the sharp member hub 9116 engages with the first seal member 9210a, the fitting member 9118 can protrude outside the second opening 9202b on the bottom surface of the pedestal portion 9108.

[0230] Next, the sensor cap 9120 can be detachably connected to the sensor control device 9102 by screwing the female thread 9128b of the sensor cap 9120 with the male thread 9128a of the fitting member 9118. The internal chamber 9124 may be dimensioned or otherwise configured to receive the tail portion 9224 and the tip portion 9226 in a state of protruding from the bottom surface of the gantry portion 9108. Further, by blocking the internal chamber 9124, the tail portion 9224 and the tip portion 9226 can be isolated from substances that may have a harmful interaction with the chemical substance of the tail portion 9224. In some embodiments, a desiccant (not shown) is present inside the internal chamber 9124 to maintain an appropriate humidity level.

[0231] By tightly tightening (rotating) the fitting engagement between the sensor cap 9120 and the fitting member 9118, the first end portion 9122a of the sensor cap 9120 can be urged to engage in a sealed manner axially (e.g., along the center lines of the openings 9202a and 9202b) with the second seal member 9310b, and the interface seal between the sharp member hub 9116 and the first seal member 9210a can be further improved axially. Further, by tightly tightening the fitting engagement between the sensor cap 9120 and the fitting member 9118, the first seal member 9210a can be compressed, which results in an improved radially sealed engagement in the central opening 9214 between the first seal member 9210a and the collar 9212. Thus, in at least one embodiment, the first seal member 9210a serves to facilitate axially and radially sealed engagements.

[0232] As described above, the first seal member 9210a and the second seal member 9210b may be over-molded on the gantry portion 9108, or may be physically connected or separately interconnected. As a result, by allowing one shot of injection molding to flow through the second opening 9202b of the gantry portion 9108, both ends of the seal portion 9208 can be formed. This shows that it is advantageous in that it can produce a large number of sealed interfaces with only one shot of injection molding. A further advantage of the two-shot molding design is that, in contrast to using multiple separate elastomeric components (such as O-rings, gaskets, etc.), the interface between the first shot and the second shot of injection is a more reliable joint than a mechanical seal. For this reason, the effective number of mechanical seal barriers is effectively reduced by half. Furthermore, it is also expected that the two-shot molding member including one shot of elastomer will minimize the number of two-shot molding members required to achieve all the necessary aseptic barriers. If properly assembled, the sealed subassembly 9302 can undergo a radiation sterilization process to sterilize the sensor 9112 and the sharp member 9114. The sealed subassembly 9302 can be subjected to radiation sterilization either before or after connecting the sensor cap 9120 to the sharp member hub. When sterilizing after coupling the sensor cap 9120 to the sharp member hub 9116, the sensor cap 9120 may be made of a material that allows the propagation of radiation passing through it. Depending on the embodiment, the sensor cap 9120 may be transparent or translucent, but may also be opaque without departing from the scope of the present disclosure.

[0233] FIG. 33A is an exploded isometric view of a further alternative embodiment of the sensor control device 9102 of FIGS. 31A and 31B and FIGS. 32A and 32B. In the description of each embodiment included in the previous ones, the pedestal portion 9108 and the seal portion 9208 are manufactured by a two-shot injection molding process. However, in other embodiments, as already briefly described, one or both of the seal members 9210a and 9210b of the seal portion 9208 may include elastomeric components independent of the pedestal portion 9208. In the illustrated embodiment, for example, the first seal member 9210a may be overmolded onto the collar 9212, and the second seal member 9210b may be overmolded onto the sensor cap 9120. As an alternative example, the first seal member 9210a and the second seal member 9210b may comprise separate components such as gaskets or O-rings that are respectively installed onto the collar 9212 and the sensor cap 9120. Tightening (rotating) the fitting engagement between the sensor cap 9120 and the fitting member 9118 enables the second seal member 9210b to engage in a sealed manner axially with the bottom surface of the pedestal portion 9108, and also enables improvement of the axial interface sealing between the tip member hub 9116 and the first seal member 9210a.

[0234] FIG. 34A is an isometric bottom view of the pedestal portion 9108, and FIG. 34B is an isometric top view of the sensor cap 9120, in accordance with one or more embodiments. As shown in FIG. 34A, the pedestal portion 9108 may be provided with, or otherwise define, one or more indentations or pockets 9402 at or near the opening to the second opening 9202b. As illustrated in FIG. 34B, the sensor cap 9120 may be provided with, or otherwise define, one or more protrusions 9404 at or near its first end 9122a. When the sensor cap 9120 is connected to the sharp member hub 9116 (FIGS. 32A and 32B and FIG. 33), the protrusions 9404 are received inside the pockets 9402. More specifically, as described above, when the sensor cap 9120 is connected to the mating member 9118 of the sharp member hub 9116 (FIGS. 32A and 32B and FIG. 33), the first end 9122a of the sensor cap 9120 will engage in a sealed manner with the second seal member 9210b. In this process, the protrusions 9404 are also received inside the pockets 9402, which helps to prevent the sensor cap 9120 from being prematurely unscrewed from the sharp member hub 9116.

[0235] FIGS. 35A and 35B are respectively a side view and a longitudinal cross-sectional view of an exemplary sensor applicator 9502, according to one or more embodiments. The sensor applicator 9502 may be similar in some respects to the sensor applicator 102 of FIG. 1 and may therefore be designed to deliver (launch) a sensor control device such as the sensor control device 9102. FIG. 35A depicts the sensor applicator 9502 as it is shipped and received by the user, and FIG. 35B depicts the sensor control device 9102 disposed within the interior of the sensor applicator 9502.

[0236] As shown in FIG. 35A, the sensor applicator 9502 includes a housing 9504 and an applicator cap 9506 detachably connected to the housing 9504. In some embodiments, the applicator cap 9506 may be screwed onto the housing 9504 and may include a used indicator ring (tamper ring) 9508. When the applicator cap 9506 is rotated relative to the housing 9504 (e.g., unscrewed), the used indicator ring 9508 shears, thereby releasing the applicator cap 9506 from the sensor applicator 9502.

[0237] In FIG. 35B, the sensor control device 9102 is disposed inside the sensor applicator 9502. When fully integrated, the sensor control device 9102 can be loaded into the sensor applicator 9502 and the applicator cap 9506 can be connected to the sensor applicator 9502. In some embodiments, the applicator cap 9506 and the housing 9504 are provided with a set of male and female mating screws by which the applicator cap 9506 can be screwed clockwise (or counterclockwise) onto the housing 9504, thereby fixing the applicator cap 9506 to the sensor 9502.

[0238] By fixing the applicator cap 9506 to the housing 9504, the second end 9122b of the sensor cap 9120 is received inside the cap post 9510, which is disposed inside the applicator cap 9506 and projects proximally from its bottom surface. The cap post 9510 is preferably configured to receive at least a portion of the sensor cap 9120 when the applicator cap 9506 is connected to the housing 9504.

[0239] Figures 36A and 36B are perspective and top views, respectively, of a cap post 9510 according to one or more further embodiments. In the depicted illustration, a portion of the sensor cap 9120 is received inside the cap post 9510, and more specifically, the desiccant cap 9130 of the sensor cap 9120 is disposed inside the cap post 9510. The cap post 9510 may be defined to have a receiving function portion 9602, which function is configured to receive the engaging function portion 9126 of the sensor cap 9120 when the applicator cap 9506 (FIG. 35B) is connected (e.g., screwed) to the sensor applicator 9502 (FIGS. 35A and 35B). However, when the applicator cap 9506 is removed from the sensor applicator 9502, the receiving function portion 9602 prevents the engaging function portion 9126 from moving in the reverse direction, and thus can prevent the sensor cap 9120 from separating from the cap post 9510. Alternatively, removing the applicator cap 9506 from the sensor applicator 9502 simultaneously disconnects the sensor cap 9120 from the sensor control device 9102 (FIGS. 31A and 31B and FIGS. 32A and 32B), thereby exposing the distal portion of the sensor 9112 (FIGS. 32A and 32B) and the pointed member 9114 (FIGS. 32A and 32B).

[0240] Without departing from the scope of the present disclosure, a number of design variations of the receiving function portion 9602 may be employed. In the illustrated embodiment, the receiving function portion 9602 is provided with one or more (two in the figure) flexible members 9604, which are extensible or flexible enough to receive the engaging function portion 9126. The engaging function portion 9126 may include, for example, an enlarged head, and the flexible member(s) 9604 may include a collet-type device having a number of flexible finger portions configured to receive the enlarged head by bending radially outwardly.

[0241] One or more compliant members 9604 may be further provided with corresponding inclined surfaces 9606 or may be separately defined, and the inclined surfaces are configured to interact with one or more opposing cam surfaces 9608 provided on the outer wall of the engagement functional portion 9126. Regarding the configuration and alignment of the inclined surface(s) 9606 and the opposing cam surface(s) 9608, the applicator cap 9506 can rotate relative to the sensor cap 9120 in a first direction A (e.g., clockwise), but when the applicator cap 9506 is rotated in a second direction B (e.g., counterclockwise), it is implemented in such a manner that the cap post 9510 presses and secures the sensor cap 9120. More specifically, when the applicator cap 9506 (and thus the cap post 9510) rotates in the first direction A, the cam surface 9608 engages the inclined surface 9606, whereby the compliant member 9604 is bent radially outwardly or is otherwise deflected, resulting in a ratchet effect. However, by rotating the applicator cap 9506 (and thus the cap post 9510) in the second direction B, the angled surface 9610 of the cam surface 9608 is pushed into the angled surface 9612 of the opposing inclined surface 9606, such that the sensor cap 9120 presses and secures the compliant member(s) 9604.

[0242] FIG. 37 is a longitudinal cross-sectional view of a sensor control device 9102 disposed within an applicator cap 9506 according to one or more embodiments. As shown, the opening to the receiving function portion 9602 presents a first diameter D3, while the engaging function portion 9126 of the sensor cap 9120 presents a second diameter D4, which is larger than the first diameter D3 and larger than the outer diameter of each of the remaining portions of the sensor cap 9120. As the sensor cap 9120 extends inside the cap support 9510, the flexible member(s) 9604 of the receiving mechanism 9602 can be bent (expanded) radially outward to receive the engaging mechanism 9126. In some embodiments, as shown, the engaging function portion 9126 is provided with or otherwise defines an angled outer surface that serves to bias the flexible member(s) 9604 radially outward. Once the engaging mechanism 9126 has passed through the receiving function portion 9602, the flexible member(s) 9604 can bend back to (or toward) their natural state, thus locking the sensor cap 9120 inside the cap support 9510.

[0243] When the applicator cap 9506 is screwed onto the housing 9504 (FIGS. 35A and 35B) in a first direction A, the cap support 9510 rotates in the same direction accordingly, and the sensor cap 9120 is gradually introduced into the cap support 9510. As the cap support 9510 rotates, the inclined surface 9606 of the flexible member 9604 is gradually moved by a detent that presses against the cam surface 9608 of the sensor cap 9120 that faces it. This continues until the applicator cap 9506 is fully screwed onto the housing 9504. In some examples, this ratchet operation may occur over a full two rotations of the applicator cap 9504 before the applicator cap 9506 reaches its final position.

[0244] To remove the applicator cap 9506, rotate the applicator cap 9506 in the second direction B, and accordingly rotate the cap support 9510 in the same direction, so that the cam surface 9608 (i.e., the angled surface 9610 in FIGS. 36A and 36B) presses against and secures to the inclined surface 9606 (i.e., the angled surface 9612 in FIGS. 36A and 36B). As a result, by continuously rotating the applicator cap 9506, the sensor cap 9120 is rotated in the same direction accordingly, thereby being disengaged from the fitting member 9118 and enabling the sensor cap 9120 to be removed from the sensor control device 9102. By disconnecting the sensor cap 9120 from the sensor control device 9102, both distal portions of the sensor 9112 and the sharp member 9114 are exposed. Thus, the sensor control device 9102 is disposed in place in preparation for firing (use).

[0245] FIG. 38A is a cross-sectional view showing a specific example of the interaction between the sensor and the sharp member in the sensor control device 9800. After integrating the sharp member, the sensor needs to be placed in the channel defined in the sharp member. The sensor control device of FIG. 9 does not depict the situation where the sensor is deflected inward or is completely aligned with the sharp member separately, but it may be the case at the time of complete integration because the sensor may be subject to a slight biasing force at each position indicated by the two arrows A. The reason why it is advantageous to bias the sensor to press against the sharp member is that no matter what relative movement there is between the sensor and the sharp member during subcutaneous insertion, the tip (i.e., the tail) of the sensor will not be exposed outside the sharp channel, because if it is exposed, it may potentially cause the insertion to fail.

[0246] Figures 38B through 38D show a specific example of a sharp member hub 205014 and a sharp member 209114 configured to bias sensor 11900 during subcutaneous delivery (Figure 38C) and not to bias sensor 11900 before subcutaneous delivery, such as during shipping and storage (Figure 15B). By storing and shipping the sensor in an unbiased (relaxed, i.e., unstressed) position, the storage life of the sensor can be extended and overall stress can be reduced. Further, by storing and shipping the sensor in an unbiased position, stress relaxation over the years of storage can be reduced, and thus loss of the biasing force due to stress relaxation can be limited. Accordingly, the predictability of the biasing force during subcutaneous delivery of the sensor is increased, and the bias during subcutaneous delivery is as designed. Window 209114A may be provided in sharp member 209114. Prior to use, window 209114A can be aligned with protrusion 11912 on the uppermost end 11908b of sensor 11900, and protrusion 11912 can extend through window 209114. In such a configuration, the lowermost end 11908a is not biased toward the sharp member, and thus sensor 11900 is in a relaxed state. During firing, needle carrier 201102 can be partially retracted, thereby pulling sharp member 209114 to a partially retracted position. The occurrence of the partial rear end is the point in time when sheath member 20704 first moves proximally relative to sensor carrier 20710 during firing. When the ridge portions 20710M of holding arms 20710L engage the slots 20704Q (see Figure 8M) of respective sheath members 20704, the sharp member carrier locking arms 20710K (see Figure 9D) of sensor carrier 20710 can each project radially outward, whereby the sharp member carrier holding functional portion (holding arm) 20710L can pass through the pre-partial-retraction holding surface 201102A and engage the post-partial-retraction holding surface 201102B (see Figure 10C) of sharp member carrier 201102. In the partially retracted position, window 209114A no longer receives protrusion 11912, but sharp member 209114 engages protrusion 11912, thereby biasing the lowermost end 11908a toward sharp member 209114 and placing it in a position suitable for subcutaneous delivery as described above.

[0247] Each embodiment of the present disclosure includes the following: D. The sensor control device includes an electronic device covering member, and the covering member is provided with a shell defining a first opening and a pedestal portion defining a second opening. When the shell is fitted with the pedestal portion, the second opening can be aligned with the first opening. The sensor control device further includes a seal portion overmolded at the position of the second opening on the pedestal portion. The seal portion is composed of a first seal member overmolded on a pedestal protruding from the inner surface of the pedestal portion and a second seal member overmolded on the bottom surface of the pedestal portion and interconnected with the first seal member. The sensor control device further includes a sensor, and the sensor is disposed inside the electronic device covering member, and its tail passes through the second opening and protrudes beyond the bottom surface of the pedestal portion. The sensor control device further includes a sharp member, and the sharp member passes through the first opening and the second opening and protrudes beyond the bottom surface of the electronic device covering member.

[0248] The assembly includes a sensor applicator and a sensor control device disposed within the sensor applicator. The sensor control device includes an electronic device covering member. The covering member is provided with a shell defining a first opening and a pedestal portion defining a second opening. When the shell is fitted with the pedestal portion, the second opening can be in an aligned state with the first opening. The sensor control device further includes a seal portion overmolded at the position of the second opening on the pedestal portion. The seal portion is composed of a first seal member overmolded on a pedestal protruding from the inner surface of the pedestal portion and a second seal member overmolded on the bottom surface of the pedestal portion and interconnected with the first seal member. The sensor control device further includes a sensor. The sensor is disposed inside the electronic device covering member, and its tail passes through the second opening and protrudes beyond the bottom surface of the pedestal portion. The sensor control device further includes a pointed member. The pointed member passes through the first opening and the second opening and protrudes beyond the bottom surface of the electronic device covering member. The assembly further includes a sensor cap. The sensor cap is detachably connected to the sensor control device at the bottom surface of the pedestal portion and defines a sealed internal chamber for receiving the tail and the pointed member. The assembly further includes an applicator cap connected to the sensor applicator.

[0249] Embodiment D and Embodiment E may each have one or more of the following further elements in any combination. Element 1) The pedestal part includes a first injection molded part molded in the first shot, and the seal part includes a second injection molded part overmolded in the second shot on the first injection molded part. Element 2) The assembly further includes a sharp member hub that holds a sharp member and engages with the first seal member in a sealed manner. The assembly further includes a sensor cap that is detachably connected to the sharp member hub at the bottom surface of the pedestal part and engages with the second seal member in a sealed manner, and defines an internal chamber for receiving the tail part and the sharp member. Element 3) The sharp member hub is provided with a fitting member that projects beyond the bottom surface of the pedestal part, and the sensor cap is detachably connected to the fitting member. Element 4) It further includes one or more pockets defined at the position of the second opening on the bottom surface of the pedestal part and one or more protrusions defined at the end of the sensor cap, and the protrusions can be received inside the one or more pockets when the sensor cap is connected to the sharp member hub. Element 5) It further includes a collar disposed inside the electronic device covering member and defining a central opening, and the central opening receives the first seal member and engages with it in a radially sealed manner. Element 6) It further includes a channel defined on the inner surface of the pedestal part and surrounding the pedestal, an annular flange portion defined below the collar and capable of fitting with the channel, and an adhesive applied to the channel to fix and seal the collar at the position of the channel of the pedestal part. Element 7) It further includes a groove defined through the annular flange portion and for accommodating a part of the sensor extending horizontally inside the pedestal part. Element 8) It further includes an annular channel defined on the upper surface of the collar, an annular ridge portion defined on the inner surface of the shell and capable of fitting with the annular channel, and an adhesive applied to the annular channel to fix and seal the shell to the collar. Element 9) One or both of the first seal member and the second seal member define at least a part of the second opening. Element 10) When the shell is connected to the pedestal part, the first seal member projects at least partially through the first opening.

[0250] Element 11) The sensor control device further includes a tip member hub, which holds a tip member and engages hermetically with a first seal member. The sensor cap is removably connected to the tip member hub at the bottom surface of the pedestal portion and engages hermetically with a second seal member. Element 12) The sensor control device further includes one or more pockets defined at the position of a second opening on the bottom surface of the pedestal portion and one or more protrusions defined at an end of the sensor cap. When the sensor cap is connected to the tip member hub, the protrusions can be received inside the one or more pockets. Element 13) The sensor control device further includes a collar disposed inside the electronic equipment covering member and defining a central opening. The central opening receives the first seal member and engages with it hermetically in the radial direction. Element 14) The sensor control device further includes a channel defined on the inner surface of the pedestal portion and surrounding the pedestal, an annular flange defined on the lower surface of the collar and capable of fitting with the channel, and an adhesive applied to the channel to fix and seal the collar at the position of the channel of the pedestal portion. Element 15) The sensor control device further includes a groove defined through the annular flange and accommodating a part of the sensor extending horizontally inside the pedestal portion. The adhesive seals around the sensor at the position of the groove. Element 16) The sensor control device further includes an annular channel defined on the upper surface of the collar, an annular ridge defined on the inner surface of the shell and capable of fitting with the annular channel, and an adhesive applied to the annular channel to fix and seal the shell to the collar. Element 17) One or both of the first seal member and the second seal member define at least a part of the second opening. Element 18) The first seal member projects at least partially through the first opening.

[0251] As non-limiting specific examples, the following are examples of combinations applicable to Embodiment D and Embodiment E. Element 2 combined with Element 3, Element 2 combined with Element 4, Element 5 combined with Element 6, Element 6 combined with Element 7, Element 5 combined with Element 8, Element 11 combined with Element 12, Element 13 combined with Element 14, Element 14 combined with Element 15, and Element 13 combined with Element 16.

[0252] Exemplary firing mechanisms for one-piece and two-piece applicators Figs. 39A through 39F illustrate details of an example embodiment of the internal device mechanism that includes "firing" the applicator 216 to apply the sensor control device 222 to the user and retracting the sharp member 1030 safely back into the used applicator 216. Collectively, these drawings represent a sequence of examples that drive the sharp member 1030 (which supports a sensor connected to the sensor control device 222) into the user's skin, leave the sensor in operative contact with the user's interstitial fluid and then withdraw the sharp member, and further attach the sensor control device to the skin with an adhesive. Modifying such activities for use with each embodiment and various components of alternative applicator assemblies can be properly appreciated by those skilled in the art with reference to these drawings. Further, the applicator 216 may be a sensor-applicator having a one-piece or two-piece structure as disclosed herein.

[0253] Turning now to Fig. 39A, the sensor 1102 is inside the sharp member 1030 and is supported directly above the user's skin 1104. By providing (optionally three) rails 1106 in the upper guide section 1108, the movement of the applicator 216 relative to the sheath member 318 can be controlled. The sheath member 318 is held in the retaining function portion 1110 inside the applicator 216 such that the resistance provided by the retaining function 1110 is overcome by an appropriate downward force along the long axis of the applicator 216, resulting in the sharp member 1030 and the sensor control device 222 translating along the long axis and moving under (and over) the user's skin 1104. In addition, the carrier arm 1112 of the sensor carrier 1022 engages the sharp member storage assembly 1024 to maintain the sharp member 1030 in place relative to the sensor control device 222.

[0254] In FIG. 39B, a user's force is applied to overcome or release the control of the detent function unit 1110, causing the sheath member 318 to collapse and enter the housing 314, and translating the sensor control device 222 (along with the associated components) downward along the major axis as indicated by arrow L. The inner diameter of the upper guide section 1108 of the sheath member 318 constrains the position of the carrier arm 1112 throughout the entire stroke of the sensor and sharp member insertion process. By holding the stop surface 1114 of the carrier arm 1112 against the complementary surface 1116 of the sharp member storage assembly 1024, the return spring 1118 is fully biased and the positions of the various members are maintained.

[0255] In FIG. 39C, the sensor 1102 and the sharp member 1030 have reached their full insertion depth. By doing so, the carrier arm 1112 extends beyond the inner diameter of the upper guide section 1108. Next, the compressive force of the coil return spring 1118 pushes the angled stop surface 1114 radially outward and releases the force, causing the sharp member carrier 2102 of the sharp member storage assembly 1024 to actuate and pull the sharp member 1030 (which has slots or other configurations) away from the user and also away from the sensor 1102, as indicated by arrow R in FIG. 39D.

[0256] When the sharp member 1030 is fully retracted as shown in FIG. 39E, the upper guide section 1108 of the sheath member 318 is fixed by the final locking mechanism 1120. As can be seen in FIG. 39F, the used applicator assembly 216 is removed from the insertion site, the sensor control device 222 is left behind, and the sharp member 1030 is safely fixed inside the applicator assembly 216. At this point, the used applicator assembly 216 is ready for disposal.

[0257] When the applicator 216 is attached with the sensor control device 222, its operation is designed to give the user the impression that both the insertion and retraction of the sharp member 1030 are automatically executed by the internal mechanism of the applicator 216. In other words, the present invention avoids the user experiencing the feeling of manually driving the sharp member 1030 into their skin. Thus, when the user applies sufficient force to overcome the resistance from the latching function portion of the applicator 216, the resulting operation of the applicator 216 is perceived as an automatic reaction to the "trigger being pulled" of the applicator. The user does not notice that additional force is being supplied to drive the sharp member 1030 to pierce the skin, even though all the driving force is provided by the user and no additional biasing / driving means are used to insert the sharp member 1030. As detailed earlier in FIG. 39C, the retraction of the sharp member 1030 is automated by the coil return spring 1118 of the applicator 216.

[0258] From the very beginning, any one of the embodiments of the applicator described in this specification, including but not limited to its various components, such as the sharp member, the sharp member module, and the sensor module, etc., regarding any of them, those skilled in the art will understand that the dimensions and configurations of the above embodiments can be set to be suitable for use in combination with various sensors configured to sense the analyte level in the body fluid in the epidermis, dermis, or subcutaneous tissue of the subject. Depending on the embodiment, for example, both the sharp member and the distal portions of the analyte sensor disclosed in this specification can have their dimensions and configurations set to be positioned at a specific end - point depth (i.e., the deepest penetration point in the tissue or layer of the subject's body, such as in the epidermis, dermis, or subcutaneous tissue). Regarding a particular embodiment of the applicator, those skilled in the art will understand that the dimensions and configuration of a particular embodiment of the sharp member can be set to be positioned at a different end - point depth in the subject's body compared to the final end - point depth of the analyte sensor. Depending on the embodiment, for example, before retraction, the sharp member can be positioned at a first end - point depth within the epidermis of the subject, while the distal portion of the analyte sensor can be positioned at a second end - point depth within the dermis of the subject. In other embodiments, before retraction, the sharp member can be positioned at a first end - point depth within the dermis of the subject, while the distal - side portion of the analyte sensor can be positioned at a second end - point depth in the subcutaneous tissue of the subject. In yet another embodiment, before retraction, the sharp member can be positioned at a first end - point depth and the analyte sensor can be positioned at a second end - point depth, where in this case, both the first end - point depth and the second end - point depth are in the same layer or the same tissue of the subject's body.

[0259] In addition, with respect to any of the embodiments of the applicator described herein, the analyte sensor may, from the start, include one or more structural components connected thereto, such as, but not limited to, one or more spring mechanisms, which can be arranged within the applicator at an eccentric position with respect to one or more axes of the applicator, as would be understood by those skilled in the art. In one embodiment of the applicator, for example, the analyte sensor and the spring mechanism can be arranged at a first eccentric position with respect to the axis of the applicator on a first side of the applicator, and the sensor electronics can be arranged at a second eccentric position with respect to the axis of the applicator on a second side of the applicator. In other embodiments of the applicator, the analyte sensor, the spring mechanism, and the sensor electronics can be arranged at an eccentric position with respect to the axis of the applicator on the same side. All possible arrangements and configurations of the analyte sensor, the spring mechanism, the sensor electronics, and any other components of the applicator other than those described above, whether arranged at a central position or an eccentric position with respect to one or more axes of the applicator, are contemplated and are fully within the scope of the present disclosure, as would be understood by those skilled in the art.

[0260] A number of deflectable structures are described herein, such as, but not limited to, the deflectable detent snap fit 1402, the deflectable locking arm 1412, the pointed member carrier locking arm 1524, the pointed member retaining arm 1618, and the module snap fit 2202. These deflectable structures are composed of elastic materials such as plastics, metals (and others), and operate in manners well known to those skilled in the art. Each of the deflectable structures has a stationary state or a stationary position to which the elastic material settles after being deflected. When a force is applied to deflect or displace the structure from this stationary state or position, when such force is removed (or weakened), the structure returns to the stationary state or position due to the deflection of the elastic material. In many cases, these structures are configured as arms provided with detents or snap fits, but other various structures and configurations can also be utilized that maintain the same properties of deflectability and the ability to return to a stationary position, such as legs, clips, fasteners, supports, etc., but are not limited thereto.

[0261] Suitable devices, systems, methods, components, and their operations, along with their associated characteristics, are described in greater detail in International Publication No. WO 2018 / 135898, published by Rao et al., International Publication No. WO 2019 / 236850, published by Thomas et al., International Publication No. WO 2019 / 236859, published by Thomas et al., International Publication No. WO 2019 / 236876, published by Thomas et al., and U.S. Patent Application Publication No. 2020 / 0196919, filed on Jun. 6, 2019, each of which is hereby incorporated by reference in its entirety. Further details regarding various applicators, their respective components, and embodiments of their various variations are described in U.S. Patent Application Publication Nos. 2013 / 0150691, 2016 / 0331283, and 2018 / 0235520, each of which is hereby incorporated by reference in its entirety. Further details regarding the tip member module, tip members, their respective components, and embodiments of their various variations are described in U.S. Patent Application Publication No. 2014 / 0171771, the entire disclosure of which is hereby incorporated by reference in its entirety.

[0262] In any of the embodiments presented in this specification, it should be noted that all features, elements, components, functions, and steps described in relation thereto can be freely combined with, and can also be substituted for, those from any other embodiments. If a certain feature, element, component, function, or step is described only in relation to one embodiment, it should be understood that the feature, element, component, function, or step can be used in relation to all other embodiments described in this specification, unless it is explicitly stated otherwise. Therefore, this paragraph always serves as a prerequisite and written support for each claim in the claims of the patent scope that combines features, elements, components, functions, and steps from different embodiments, or for each claim in the claims of the patent scope that substitutes a feature, element, component, function, and step from one embodiment with those of another embodiment, even if the description following the introductory part does not explicitly state that such various combinations and substitutions are possible in a specific case. Therefore, the description up to the previous paragraph of a specific embodiment of the disclosed subject matter is presented for illustrative and explanatory purposes. In particular, considering that those skilled in the art can easily notice the permissibility of each such combination and substitution, it is clearly recognized that explicitly listing all possible combinations and substitutions would be unduly burdensome.

[0263] While various modifications and alternative forms are possible for each embodiment, specific examples thereof are shown in the drawings and described in detail herein. It will be apparent to those skilled in the art that various modifications and changes can be made in the disclosed subject matter's methods and systems without departing from the spirit or scope of the disclosed subject matter. Accordingly, it is intended that the disclosed subject matter include modifications and variations within the scope of the appended claims and their equivalents. Further, any feature, function, step, or element of any embodiment, whether or not included within the claims, can be listed or added to the claims in the same manner as a negative limitation that defines the scope of the invention in the claims by features, functions, steps, or elements not included within the claims. The following describes the preferred embodiments of the present invention item by item. Embodiment 1 In an applicator for delivering a sensor control device, the applicator includes a housing, a sensor carrier connected to the housing and provided with a first locking interface A sheath member slidably connected to the housing and moving between an extended position and a crushed position, the sheath member having a first locking arm provided with a mounting-side distal end and a free proximal end, the free proximal end having a first locking arm interface disposed on the inner surface of the first locking arm and a first sharp edge disposed on the outer surface of the first locking arm, the sheath member, and, A cap threadedly engaged with the housing and having a plurality of first squeezing ridge portions provided on the inner surface, Comprising, The inner surface of the cap is configured to bias the first locking arm inwardly when the cap is connected to the housing, so that the first locking arm interface engages with the first locking interface, The first sharp edge is configured to engage with the plurality of first squeezing ridge portions during the occurrence of an impact event. Embodiment 2 The sensor carrier further comprises a second locking interface, and, The sheath member further has a second locking arm provided with a mounting-side distal end and a free proximal end, the free proximal end having a second locking arm interface disposed on the inner surface of the second locking arm and a second sharp edge disposed on the outer surface of the second locking arm, The inner surface of the cap is configured to bias the second locking arm inwardly when the cap is connected to the housing, so that the second locking arm interface engages with the second locking interface, the applicator according to Embodiment 1. Embodiment 3 The cap is further provided with a plurality of second squeezing ridge portions, and, The second sharp edge is configured to engage with the plurality of second squeezing ridge portions during the occurrence of an impact event, the applicator according to Embodiment 2. Embodiment 4 The first locking arm interface has a U-shaped configuration, the applicator according to Embodiment 1. Embodiment 5 The first locking interface is disposed on the peripheral portion of the sensor carrier, the applicator according to Embodiment 1. Embodiment 6 Further comprising a housing skirt portion connected to the housing by a plurality of skirt reinforcing rib portions, the applicator of Embodiment 1. Embodiment 7 Further comprising a used indication function portion connected to each of the housing skirt portion and the cap, the applicator according to Embodiment 6. Embodiment 8 Examples of the used indication function portion include stickers and the like, the applicator according to Embodiment 7. Embodiment 9 The applicator according to Embodiment 1, wherein the housing is made of a cyclic olefin copolymer. Embodiment 10 The applicator according to Embodiment 1, wherein the sheath member is made of Delrin (i.e., polyoxymethylene, an acetal homopolymer resin). Embodiment 11 The applicator according to Embodiment 1, wherein the cap is made of high-density polyethylene. Embodiment 12 The sensor carrier is a base provided with a first half body and a second half body, and a first sensor holding arm connected to the first half body of the base, having a first end connected to the first half body and a second free end extending toward the second half body of the base, and the first sensor holding arm is provided with a first sensor holding functional portion on its inner surface. The applicator according to Embodiment 1 further includes a first sensor holding arm. The applicator according to Embodiment 1, wherein the first locking interface is disposed on the outer surface of the first sensor holding arm. Embodiment 13 The sensor carrier further includes three equally spaced housing mounting functional portions protruding upward from the uppermost surface of the base, and each of the housing mounting functional portions is a housing snap-fit portion, a housing positioning functional portion, and a housing biasing functional portion. The applicator according to Embodiment 12. Embodiment 14 The applicator according to Embodiment 13, wherein the housing includes three sensor carrier mounting functional portions, each of which is configured to engage with one of the sensor carrier mounting functional portions. Embodiment 15 The applicator according to Embodiment 1, wherein the cap further includes a sheath member support surface configured to engage with the sheath member and restrict the movement of the sheath member during the occurrence of an impact event. Embodiment 16 The applicator according to Embodiment 1, wherein the cap further includes a raised protrusion configured to restrict the movement of the sensor carrier during the occurrence of an impact event. Embodiment 17 In a sensor carrier used in an applicator to deliver a sensor control device, the sensor carrier is a base provided with a first half body and a second half body A first sensor holding arm connected to the first half body of the base, having a first end connected to the first half body and a second free end extending toward the second half body of the base, wherein the first sensor holding arm is provided with a first sensor holding functional portion on its inner surface and a first locking interface on its outer surface, the first sensor holding arm, and, A second sensor holding arm connected to the first half body of the base, having a first end connected to the first half body and a second free end extending toward the second half body of the base, wherein the second sensor holding arm is provided with a second sensor holding functional portion on its inner surface and a second locking interface on its outer surface, and comprising the second sensor holding arm. Embodiment 18 Further comprising three equally spaced housing mounting functional portions projecting upward from the uppermost surface of the base, each of the housing mounting functional portions being, A housing snap - type fitting portion, A housing positioning functional portion, and, A housing biasing functional portion, the sensor carrier according to Embodiment 17. Embodiment 19 Among the three housing mounting functional portions, the first housing mounting functional portion is disposed on the second half body of the base, and, Among the three housing mounting functional portions, the second housing mounting functional portion and the third housing mounting functional portion are disposed on the first half body of the base, the sensor carrier according to Embodiment 18. Embodiment 20 Further comprising three equally spaced sharp - member carrier locking arms projecting upward from the uppermost surface of the base, the sensor carrier according to Embodiment 17. Embodiment 21 Each of the sharp - member carrier locking arms comprises a sharp - member carrier holding functional portion and a sharp - member carrier holding rib portion, the sensor carrier according to Embodiment 20. Embodiment 22 Among the three sharp - member carrier locking arms, the first sharp - member carrier locking arm is disposed on the first half body of the base, the sensor carrier according to Embodiment 17. Embodiment 23 Among the three sharp - member carrier locking arms, the second sharp - member carrier locking arm and the third sharp - member carrier locking arm are disposed on the second half body of the base, the sensor carrier according to Embodiment 22. Embodiment 24 Further comprising a first locking shelf - like portion and a second locking shelf - like portion, the sensor carrier according to Embodiment 17. Embodiment 25 The sensor carrier according to Embodiment 17, further comprising an opening extending through the middle of the base portion. Embodiment 26 In an applicator for delivering a sensor control device, the applicator comprises: a housing, a sensor carrier connected to the housing, a sheath member slidably connected to the housing and moving between an extended position and a collapsed position, and a sharp member carrier movable between a position distal to the sheath member and a position proximal to the sheath member, and the sheath member further comprises a noise attenuation portion configured to engage the sharp carrier and reduce the speed of the sharp member carrier when the sharp member carrier moves from the distal position to the proximal position. Embodiment 27 The applicator according to Embodiment 26, wherein the noise attenuation portion is configured to mitigate noise caused by the sharp carrier moving from the distal position to the proximal position. Embodiment 28 The applicator according to Embodiment 27, further comprising a cap screwed and connected to the housing. Embodiment 29 In an applicator for delivering a sensor control device, the applicator comprises: a housing, a sensor carrier connected to the housing, a sensor control device detachably connected to the sensor carrier, a sensor having a tail extending from the sensor control device and provided with a distal end and a proximal end, a sharp member carrier movable between a position distal to the sensor control device and a position proximal to the sensor control device, and a sharp member disposed inside the sharp member carrier, and when the sharp member carrier is in the distal position, the sharp member engages the proximal end of the tail to deflect the distal end of the tail towards the sharp member, and when the sharp member carrier is in the proximal position, the sharp member does not engage the proximal end of the tail. Embodiment 30 The applicator according to Embodiment 29, wherein the proximal end of the sensor is provided with a protrusion. Embodiment 31 The sharp member comprises a window, and when the sharp member is in the distal position, the proximal end of the tail protrudes inside the window of the sharp member. Embodiment 32 Before delivering the sensor, the sharp member carrier is in the distal position, the applicator according to Embodiment 29. Embodiment 33 During the delivery of the sensor, the sharp member carrier is in the proximal position, the applicator according to Embodiment 29. Embodiment 34 The applicator according to embodiment 29, further comprising a sheath member slidably connected to the housing and moving between an extended position and a crushed position. Embodiment 35 The applicator according to embodiment 29, wherein the sharp member defines a channel. Embodiment 36 The applicator according to embodiment 35, wherein when the sharp member engages the proximal portion of the tail portion, the distal portion of the tail portion is received in the channel of the sharp member.

Explanation of Symbols

[0264] 9202a First opening 9202b Second opening 9204 Pedestal 9206 Channel (ditch) 11900 Sensor 20105 Adhesive patch 201102 Sharp member carrier 20150 Applicator device 205014 Sharp member hub 20702 Housing 20702C Housing skirt part 20702D Skirt reinforcing rib part 20702G Screw 20704 Sheath member 20704J Locking arm 20704M Locking arm interface 20704N Sharp edge 20708 Cap 20708D Screw 20708E Sealing interface 20708F Squeezing ridge part 20708H Desiccant holding clip 20708I Stop 20708J Protrusion 20710 Sensor carrier 20710B Sensor holding arm 20710K Sharp member carrier locking arm 20710N Locking shelf part 20712 Used indication functional part 209114 Sharp member

Claims

1. In an applicator for delivering a sensor control device, the applicator comprises: a housing, a sensor carrier connected to the housing and provided with a first locking interface, a sheath member slidably connected to the housing and movable between an extended position and a crushed position, the sheath member having a first locking arm provided with a mounting-side distal end and a free proximal end, the free proximal end having a first locking arm interface disposed on the inner surface of the first locking arm and a first sharp edge disposed on the outer surface of the first locking arm, and a cap screwed to the housing and provided with a plurality of first squeezing ridges on its inner surface, wherein the inner surface of the cap is configured such that when the cap is connected to the housing, it biases the first locking arm inwardly, so that the first locking arm interface engages with the first locking interface, the first sharp edge is configured to engage with the plurality of first squeezing ridges during the occurrence of an impact event.

2. The sensor carrier further comprises a second locking interface, and the sheath member further has a second locking arm provided with a mounting-side distal end and a free proximal end, the free proximal end having a second locking arm interface disposed on the inner surface of the second locking arm and a second sharp edge disposed on the outer surface of the second locking arm, the inner surface of the cap is configured such that when the cap is connected to the housing, it biases the second locking arm inwardly, so that the second locking arm interface engages with the second locking interface, according to the applicator of Claim 1.

3. The cap is further provided with a plurality of second squeezing ridges, and the second sharp edge is configured to engage with the plurality of second squeezing ridges during the occurrence of an impact event, according to the applicator of Claim 2.

4. The first locking arm interface has a U-shaped configuration, according to the applicator of Claim 1.

5. The first locking interface is disposed on the peripheral portion of the sensor carrier, according to the applicator of Claim 1.

6. The applicator of Claim 1 further comprises a housing skirt portion connected to the housing by a plurality of skirt reinforcing rib portions.

7. The applicator of Claim 6 further comprises a used indication function portion connected to each of the housing skirt portion and the cap.

8. The used indication functional part is the applicator according to claim 7, including a sticker.

9. The applicator according to claim 1, wherein the housing is made of a cyclic olefin copolymer.

10. The applicator according to claim 1, wherein the sheath member is made of polyoxymethylene.

11. The applicator according to claim 1, wherein the cap is made of high density polyethylene.

12. The sensor carrier is a base provided with a first half body and a second half body, and a first sensor holding arm connected to the first half body of the base, having a first end connected to the first half body and a second free end extending toward the second half body of the base, and the first sensor holding arm is provided with a first sensor holding functional part on its inner surface, and further includes the first sensor holding arm. The applicator according to claim 1, wherein the first locking interface is disposed on the outer surface of the first sensor holding arm.

13. The sensor carrier further includes three equally spaced housing mounting functional parts projecting upward from the uppermost surface of the base, and each of the housing mounting functional parts is a housing snap-fit part, a housing positioning functional part, and a housing biasing functional part. The applicator according to claim 12.

14. The applicator according to claim 13, wherein the housing includes three sensor carrier mounting functional parts, each of which is configured to engage with one of the sensor carrier mounting functional parts.

15. The applicator according to claim 1, wherein the cap further includes a sheath member support surface configured to engage with the sheath member and limit the movement of the sheath member during the occurrence of an impact event.

16. The applicator according to claim 1, wherein the cap further includes a raised protrusion configured to limit the movement of the sensor carrier during the occurrence of an impact event.

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