Systems, devices, and methods for specimen sensors

Abstract

The method includes assembling a sensor subassembly including a sensor, a sensor mount, a collar, a sharp, and a sensor cap. The method includes loading the sensor into the sensor mount, dispensing adhesive into a mount channel of the sensor mount, fastening the collar to the sensor mount, and curing the adhesive to secure the collar to the sensor mount. The method can also include inserting the sharp into the sensor mount over the sensor, and attaching a sensor cap to the sensor and sensor sharp to provide a sealed sensor subassembly. Methods of assembling a wearable sensor pack assembly, an applicator assembly, and a sensor including a tail, a flag, and a neck interconnecting the tail and flag, and methods of configuring the sensor are also disclosed.

Description

Technical Field

[0001] 〔Priority〕 This application claims the benefit under "35 U.S.C.§119(e)" of U.S. Provisional Patent Application No. 63 / 078,681, filed on September 15, 2020, and U.S. Provisional Patent Application No. 63 / 081,223, filed on September 21, 2020, which are incorporated herein by reference.

[0002] The subject matter described herein generally relates to systems, devices, and methods for analyte sensors. For example, methods of assembling sensor subassemblies, wearable sensor pack assemblies, and applicator assemblies are disclosed. Also disclosed are sensors including a tail, a flag, and a neck interconnecting the tail and the flag, and methods of constructing the sensors.

Background Art

[0003] The detection and / or monitoring of analyte levels such as glucose, ketones, lactate, oxygen, hemoglobin, or A1C can be extremely important regarding the health of an individual having diabetes. Patients suffering from diabetes mellitus may experience complications including loss of consciousness, cardiovascular disease, retinopathy, neuropathy, and kidney damage. Diabetic patients generally need to monitor their glucose levels to ensure that they are maintained within clinically safe ranges, and also use this information to determine when they need insulin to reduce the glucose level in the body and / or when they need additional glucose to increase the glucose level in the body.

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

[0005] To increase patient adherence to frequent glucose monitoring schedules, in vivo sample monitoring systems may be utilized, which may involve wearing a sensor-controlled device on the body of the individual requiring sample monitoring. To enhance comfort and convenience for the individual, the sensor-controlled device may have a small shape factor and can be assembled by the individual and applied using a sensor applicator. The application process includes inserting a sensor, such as a skin sensor that senses the user's sample level in bodily fluids positioned in the skin layer of the human body, using an applicator or insertion mechanism so that the sensor is in contact with the bodily fluids. The sensor-controlled device may also be configured to transmit sample data to another device from which the individual or their healthcare provider ("HCP") can examine the data and make therapeutic decisions.

[0006] While current sensors may be convenient for users, they are also prone to malfunction due to incorrect insertion. These malfunctions can be caused by user error, lack of proper training, insufficient user coordination, overly complex procedures, and other issues. This may be particularly true for specimen monitoring systems that have skin sensors inserted using a sharp body (also known as an "introducer" or "needle") that is typically smaller in scale and shorter than those used for ISF sensors compared to sensors used to measure specimen levels in interstitial fluid ("ISF"). For example, some prior art systems may rely too heavily on the high-precision assembly and deployment of sensor control devices and applicators by individual users. Other prior art systems may utilize sharp body insertion and withdrawal mechanisms that are prone to premature withdrawal before the sensor can be properly implanted. In addition, with respect to skin sensors, some prior art systems may utilize sharp bodies that are not optimally configured to create an insertion pathway in the dermis without causing trauma to surrounding tissue. These challenges, and others described herein, can lead to incorrectly inserted or damaged sensors and, consequently, failure to properly monitor the patient's specimen levels. [Prior art documents] [Patent Documents]

[0007] [Patent Document 1] U.S. Patent Publication No. 2014 / 0171771 [Patent Document 2] U.S. Patent Publication No. 2014 / 0275907 [Patent Document 3] WO2018 / 136898 [Patent Document 4] WO2019 / 236850 [Patent Document 5] WO2019 / 236859 [Patent Document 6] WO2019 / 236876 [Patent Document 7] U.S. Patent Application No. 16 / 433,931 [Patent Document 8] U.S. Patent Application No. 2020 / 0196919 [Patent Document 9] U.S. Patent Application No. 2013 / 0150691 [Patent Document 10] U.S. Patent Application No. 2016 / 0331283 [Patent Document 11] U.S. Patent Application No. 2018 / 0235520 [Overview of the project] [Problems that the invention aims to solve]

[0008] In other words, there is a need for more reliable sensor insertion devices, systems, and methods that are easy for patients to use and less prone to errors, especially when used in conjunction with skin sensors. There is also a need for manufacturing methods that provide reliable and reproducible sensors and are suitable for expansion. [Means for solving the problem]

[0009] The objectives and advantages of the disclosed subject matter are enumerated in the following description and will be apparent therefrom, as well as will be known through the practice of the disclosed subject matter. Additional advantages of the disclosed subject matter will be realized and obtained by the methods and systems specifically indicated in this specification and its claims, as well as in the accompanying drawings.

[0010] To achieve these and other advantages and in accordance with the objectives of the subject matter of the disclosure of the present invention as specifically and broadly described, the subject matter disclosed is a method for assembling a sensor subassembly comprising a sensor, a sensor mount, a collar, a sharp body, and a sensor cap. The method includes the steps of loading the sensor into the sensor mount, dispensing adhesive into the mounting channel of the sensor mount, fastening the collar to the sensor mount, curing the adhesive to fix the collar to the sensor mount, inserting the sharp body into the sensor mount on the sensor, and attaching the sensor cap to the sensor and sensor sharp body to provide a sealed sensor subassembly. The adhesive may be a chemically curable adhesive, and the method may include the step of curing the adhesive by exposing it to one or more chemical bonding catalysts. The adhesive may be a thermosetting adhesive, and the method may include the step of curing the adhesive by exposing it to heat suitable for curing the adhesive. The adhesive may be an ultraviolet (UV) curable adhesive, and the method may include the step of curing the adhesive using one or more UV light sources. The sensor can be shielded from one or more UV light sources while the adhesive is curing. One or more UV light sources can include UV light-emitting diodes having a light conductor and multiple tilt spot light-emitting diodes. The method can include a step of loading the collar onto the sensor mount. The sharp body can be attached to the sharp body hub, and the step of inserting the sharp body into the sensor mount can include a step of coupling the sharp body hub to the sensor mount. The method can include a step of dispensing adhesive onto the top surface of the sharp body hub and a step of curing the adhesive to seal accidental leaks between the sharp body hub and the sharp body. The method can include a step of inspecting the sealed sensor subassembly for leaks using pressure decay leak testing, vacuum decay leak testing, tracer gas leak testing, trace analysis testing, or mass flow leak testing. The method can include a step of discarding the sealed sensor subassembly when a leak exceeding a predetermined threshold is detected.The method may include a step of sterilizing the sensor subassembly by heat treatment, radiation, electron beam sterilization, gamma sterilization, X-ray sterilization, ethylene oxide sterilization, autoclave steam sterilization, chlorine dioxide gas sterilization, or hydrogen peroxide sterilization. The sensor may include a body temperature sensor, blood pressure sensor, pulse or heart rate sensor, glucose level sensor, specimen sensor, or physical activity sensor. The method may include a step of inspecting the sharp object for defects before inserting it into the sensor mount. The method may include a step of discarding the inspected sharp object when defects exceeding a predetermined threshold are detected. The step of attaching the sensor cap to the sensor and sensor sharp object to provide a sealed sensor subassembly may include a step of twisting the sensor cap into place. The method may include a step of inserting a desiccant into the plug and a step of inserting the plug into the sensor cap before attaching the sensor cap to the sensor and sensor sharp object.

[0011] The subject matter disclosed further relates to a method for assembling a wearable sensor pack assembly, which includes a printed circuit board (PCB), a pack shell cap, and a sensor subassembly including a sensor, a sensor mount, a collar, and a sensor cap. The method may include the steps of: dispensing a first adhesive onto the sensor mount of the sensor subassembly; aligning the PCB with the sensor and the sensor subassembly and then loading the PCB onto the sensor mount of the sensor subassembly; curing the first adhesive to fix the PCB to the sensor mount; dispensing a second adhesive onto the outer diameter of the sensor mount and the inner diameter of the collar of the sensor subassembly; attaching the pack shell cap to the sensor subassembly; and curing the second adhesive to form a wearable sensor pack assembly. The PCB may be a flexible PCB, and the method may include the step of folding the PCB to fit the footprint of the wearable sensor pack assembly. The step of dispensing the first adhesive may further include dispensing the first adhesive to a folding location, a battery location, or a PCB connector location. The PCB may further include wireless components, and the method may further include a step of writing data to the wireless components by reading sensor data from the sensor subassembly, PCB, pack shell cap, or mount supporting the sensor subassembly, and writing the sensor data to the wireless components of the PCB. The step of dispensing a second adhesive onto the outer diameter of the sensor mount and the inner diameter of the collar of the sensor subassembly may include a step of tilting the sensor mount along its axis to a predetermined angle, a step of dispensing adhesive onto the inner diameter of the collar of the sensor subassembly, a step of returning the sensor mount to a substantially horizontal position by tilting the sensor mount along its axis, and a step of dispensing adhesive onto the outer diameter of the sensor mount. The method may further include a step of inspecting the wearable sensor pack assembly for leakage using a pressure decay leak test, a vacuum decay leak test, a tracer gas leak test, a trace analysis test, or a mass flow leak test.The method may further include a step of discarding the wearable sensor pack when leakage exceeding a predetermined threshold is detected. The first or second adhesive may be a chemically curable adhesive, and the step of curing the first or second adhesive may include a step of exposing the adhesive to one or more chemical bonding catalysts. The first or second adhesive may be a thermosetting adhesive, and the step of curing the first or second adhesive may include a step of exposing the adhesive to heat suitable for curing the adhesive. The first or second adhesive may be an ultraviolet (UV) curable adhesive, and the step of curing the first or second adhesive may include a step of using one or more UV light sources.

[0012] The subject matter disclosed further relates to a method for assembling an applicator assembly comprising an inserter, a wearable sensor pack assembly coupled to a pack carrier, a sheath, an applicator housing, and a cap. The method includes the steps of: assembling an inserter by loading a spring into a sharp body carrier, lowering the pack carrier to the sharp body carrier and compressing the spring until it is seated within the sharp body carrier, and locking one or more retaining features of the sharp body carrier to maintain spring compression; coupling the wearable sensor pack assembly to the pack carrier; attaching an adhesive patch to the wearable sensor pack assembly; attaching a sheath to the pack carrier; attaching the sheath to the applicator housing; and coupling a cap to the applicator housing. The step of attaching the sheath to the pack carrier may include loading the sheath into a fixing nest and lowering the pack carrier into the sheath using a compression spring. The step of attaching the sheath to the applicator housing may include loading the applicator housing into the fastener nest and engaging the alignment ribs of the applicator housing with notches in the fastener nest, and lowering the sheath onto the applicator housing and engaging it with the alignment ribs of the applicator housing. The step of attaching the cap to the applicator housing may include lowering the cap onto the applicator housing and screwing the cap onto the applicator housing to a predetermined torque. This method may include loading a desiccant into the cap. This method may include attaching a tamper-evident sticker to the applicator assembly.

[0013] The subject matter disclosed further relates to a sensor comprising a tail, a flag, and a neck interconnecting the tail and the flag. The tail, flag, and neck are aligned along a flat plane having a vertical axis and a horizontal axis, and between the tail and the flag, the neck comprises at least two windings with respect to the vertical axis defining a spring structure, and the flag comprises a substantially flat plane having one or more sensor contacts. At least two windings of the neck can be formed by bending the neck of the sensor. At least two windings of the neck can be formed by laser cutting the sensor. At least two windings of the neck can be formed by punching the sensor out of a material sheet comprising the sensor. At least two windings of the neck can be formed by printing the sensor to include two windings. At least two windings can provide an overlapping layer of the neck with respect to the vertical axis. The overlapping layer of the neck can be oriented vertically. The overlapping layer of the neck can be oriented horizontally.

[0014] The subject matter disclosed further relates to a method for constructing a sensor including a tail, a flag, and a neck interconnecting the tail and the flag. The method may include the steps of heating a portion of the sensor neck to a predetermined temperature and bending the sensor neck to form a first angle between the sensor tail and the sensor flag. The predetermined temperature may be sufficient to improve the malleability of the sensor neck. The predetermined temperature may be any suitable range including, for example, 50 and 60°C, or a specific target temperature within this range. The method may further include the step of verifying the integrity of the sensor after the bending step by inspecting the neck for micro-fractures at the sensor neck. The method may further include the step of disposing of the sensor if the micro-fractures detected at the sensor neck exceed a predetermined value of the micro-fracture threshold. The heating step may be performed by a first component of a heating-bending device, and the bending step may be performed by a second component of a heating-bending device. The step of heating a portion of the neck may include the steps of heating a first component of the heating-bending device using a heating element, and bringing a portion of the neck into contact with the heated first component of the heating-bending device. The heating step can be performed by a heating element integrated into the heating-bending device. Heat can be applied during the bending step. The intensity of the heat applied to the neck can be varied during the bending process.

[0015] Details of the subject matter enumerated herein with respect to both its structure and operation may be revealed by a close examination of the accompanying drawings in which the same reference numbers refer to the same parts. The components of the drawings are not necessarily to scale, and instead the emphasis is on illustrating the principles of the subject matter. Furthermore, all examples are intended to convey concepts, and relative sizes, shapes, and other detailed attributes may be illustrated schematically rather than literally or precisely. [Brief explanation of the drawing]

[0016] [Figure 1]It is a system schematic diagram of a sensor applicator, a reader device, a monitoring system, a network, and a remote system. [Figure 2A] It is a block diagram depicting an exemplary embodiment of a reader device. [Figure 2B] It is a block diagram depicting an exemplary embodiment of a second control device. [Figure 2C] It is a block diagram depicting an exemplary embodiment of a second control device. [Figure 3A] It is a proximal perspective view depicting an exemplary embodiment in which a user prepares a tray for assembly. [Figure 3B] It is a side view depicting an exemplary embodiment in which a user prepares an applicator device for assembly. [Figure 3C] It is a proximal perspective view depicting an exemplary embodiment in which a user inserts an applicator device into a tray during assembly. [Figure 3D] It is a proximal perspective view depicting an exemplary embodiment in which a user removes an applicator device from a tray during assembly. [Figure 3E] It is a proximal perspective view depicting an exemplary embodiment in which a patient attaches a sensor using an applicator device. [Figure 3F] It is a proximal perspective view depicting an exemplary embodiment of a patient having an attached sensor and a used applicator device. [Figure 4A] It is a side view depicting an exemplary embodiment of an applicator device coupled to a cap. <000,0109>It is a side perspective view depicting an exemplary embodiment of a detached applicator device and a cap. [Figure 4C] It is a perspective view depicting an exemplary embodiment of a distal end of an applicator device and an electronic device housing. [Figure 5] It is a proximal perspective view depicting an exemplary embodiment of a tray with a sterilization lid attached. [[ID=,40]] [Figure 6A] It is a proximal perspective broken view depicting an exemplary embodiment of a tray having a sensor delivery component. [Figure 6B]This is a close-up perspective view showing the sensor output components. [Figure 7A] This is a side view illustrating an exemplary embodiment of the housing. [Figure 7B] This is a perspective view illustrating an exemplary embodiment of the distal end of the housing. [Figure 7C] This is a side cross-sectional view illustrating an exemplary embodiment of the housing. [Figure 7D] This is a side cross-sectional view showing the locking rib portion of an exemplary embodiment of the housing together with a portion of the sheath. [Figure 7E] This is a side cross-sectional view showing the locking rib portion of an exemplary embodiment of the housing together with a portion of the sheath. [Figure 7F] This is a side cross-sectional view showing the locking rib portion and a portion of the sheath of another exemplary embodiment of the housing. [Figure 7G] This is a side cross-sectional view showing the locking rib portion and a portion of the sheath of another exemplary embodiment of the housing. [Figure 7H] This is a side cross-sectional view showing the locking rib portion and a portion of the sheath of another exemplary embodiment of the housing. [Figure 7I] This is a side cross-sectional view showing the locking rib portion and a portion of the sheath of another exemplary embodiment of the housing. [Figure 8A] This is a side view illustrating an exemplary embodiment of the sheath. [Figure 8B] This is a perspective view illustrating an exemplary embodiment of the proximal end of the sheath. [Figure 8C] This is an enlarged perspective view illustrating an exemplary distal embodiment of the sheath's retaining snap. [Figure 8D] This is a side view illustrating an exemplary embodiment of the characteristic features of the sheath. [Figure 8E] This is an end view of an exemplary embodiment of the proximal end of the sheath. [Figure 8F] This perspective view depicts another exemplary embodiment of the sheath at various stages of assembly with other applicator components. [Figure 8G]This perspective view depicts another exemplary embodiment of the sheath at various stages of assembly with other applicator components. [Figure 8H] This perspective view depicts another exemplary embodiment of the sheath at various stages of assembly with other applicator components. [Figure 9A] This is a proximal perspective view illustrating an exemplary embodiment of a sensor electronic device carrier. [Figure 9B] This is a distal perspective view illustrating an exemplary embodiment of a sensor electronic device carrier. [Figure 9C] This is a distal perspective view illustrating another exemplary embodiment of a sensor electronic device carrier. [Figure 10A] This is a perspective view of an advanced body carrier based on the subject matter being disclosed. [Figure 10B] Figure 10A is a side cross-section of the sharpened carrier. [Figure 11A] This is a top perspective view illustrating an exemplary embodiment of the sensor module. [Figure 11B] This is a bottom perspective view illustrating an exemplary embodiment of the sensor module. [Figure 12A] This is a perspective view illustrating an exemplary embodiment of a sensor connector. [Figure 12B] This is a perspective view illustrating an exemplary embodiment of a sensor connector. [Figure 13] This is a perspective view illustrating an exemplary embodiment of the sensor. [Figure 14A] This is a bottom perspective view of an exemplary embodiment of a sensor module assembly. [Figure 14B] This is a top perspective view of an exemplary embodiment of a sensor module assembly. [Figure 15A] This is an enlarged partial view of an exemplary embodiment of a sensor module assembly. [Figure 15B] This is an enlarged partial view of an exemplary embodiment of a sensor module assembly. [Figure 15C] This is a side view of an exemplary sensor according to one or more embodiments of the disclosure of the present invention. [Figure 15D] This is a side view of an exemplary sensor according to one or more embodiments of the disclosure of the present invention. [Figure 15E] This is a side view of an exemplary sensor according to one or more embodiments of the disclosure of the present invention. [Figure 15F] This is a side view of an exemplary sensor according to one or more embodiments of the disclosure of the present invention. [Figure 15G] This is a side view of an exemplary sensor according to one or more embodiments of the disclosure of the present invention. [Figure 16A] This is an isometric projection view of an exemplary connector assembly according to one or more embodiments of the disclosure of the present invention. [Figure 16B] This is a partially exploded isometric projection view of an exemplary connector assembly according to one or more embodiments of the disclosure of the present invention. [Figure 16C] Figures 16A and 16B are isometric bottom views of the connector. [Figure 16D] This is an isometric projection view of another exemplary connector assembly according to one or more embodiments. [Figure 16E] This is a partially exploded isometric projection view of another exemplary connector assembly according to one or more embodiments. [Figure 16F] Figures 16D to 16E are isometric bottom views of the connector. [Figure 17A] This is a perspective view illustrating an exemplary embodiment of a cutting-edge module. [Figure 17B] This is a perspective view of another exemplary embodiment of the sharp-edged module. [Figure 17C] Figure 17B is a schematic diagram illustrating the pointed module. [Figure 17D] Figure 17B is a schematic diagram illustrating the pointed module. [Figure 17E] This is a schematic side view of the sensor module and the assembled pointed module shown in Figure 17B. [Figure 17F] This is a top view of the sensor module and the assembled pointed module shown in Figure 17B. [Figure 17G] This is a perspective view of another exemplary embodiment of the sharp-edged module. [Figure 17H] Figure 17G is a schematic side view depicting the pointed module. [Figure 17I] This is a side cross-sectional view of the sensor module and the assembled pointed module shown in Figure 17G. [Figure 17J] This is a side view of the sensor module and the assembled pointed module shown in Figure 17G. [Figure 18A] This is an isometric projection of another exemplary sensor-controlled device. [Figure 18B] This is a side view of another exemplary sensor control device. [Figure 19A] Figures 18A and 18B are exploded isometric top views of the sensor control device. [Figure 19B] Figures 18A and 18B are exploded, isoangled base views of the sensor control device. [Figure 20] This is a cross-sectional side view of a subassembly that has been assembled and sealed according to one or more embodiments. [Figure 21A] These are stepwise cross-sectional side views showing the assembly of the sensor applicator and the sensor control device shown in Figures 18A and 18B. [Figure 21B] These are stepwise cross-sectional side views showing the assembly of the sensor applicator and the sensor control device shown in Figures 18A and 18B. [Figure 21C] These are stepwise cross-sectional side views showing the assembly of the sensor applicator and the sensor control device shown in Figures 18A and 18B. [Figure 22A] A perspective view of the cap post of Figure 21C according to one or more additional embodiments. [Figure 22B] This is a top view of the cap post of Figure 21C according to one or more additional embodiments. [Figure 23] Figures 18A and 18B are cross-sectional side views of the sensor control device. [Figure 24A] This is a cross-sectional side view of a sensor applicator waiting to deploy the sensor control device to the target monitoring location. [Figure 24B] This is a cross-sectional side view of a sensor applicator waiting to deploy the sensor control device to the target monitoring location. [Figure 25A]These are stepwise cross-sectional side views showing the assembly and disassembly of exemplary embodiments of the sensor applicator and the sensor control device shown in Figures 18A and 18B. [Figure 25B] These are stepwise cross-sectional side views showing the assembly and disassembly of exemplary embodiments of the sensor applicator and the sensor control device shown in Figures 18A and 18B. [Figure 25C] These are stepwise cross-sectional side views showing the assembly and disassembly of exemplary embodiments of the sensor applicator and the sensor control device shown in Figures 18A and 18B. [Figure 26A] This is an isometric bottom view of a housing according to one or more embodiments. [Figure 27A] This is an isometric view of a housing having a sheath and other components at least partially arranged therein. [Figure 28] This is an enlarged cross-sectional side view of a sensor applicator in which a sensor control device according to one or more embodiments is mounted. [Figure 29A] This is an isometric top view of a cap according to one or more embodiments. [Figure 29B] This is an enlarged cross-sectional view of the engagement portion between the cap and the housing according to one or more embodiments. [Figure 30A] This is an isometric projection view of a sensor cap according to one or more embodiments. [Figure 30B] This is a color isometric projection drawing according to one or more embodiments. [Figure 31A] This is a side view of an exemplary sensor control device according to one or more embodiments of the disclosure of the present invention. [Figure 31B] This is an isometric projection view of an exemplary sensor control device according to one or more embodiments of the disclosure of the present invention. [Figure 32A] This is an exploded, isometric top view of the sensor control device shown in Figure 2 according to one or more embodiments. [Figure 32B] This is an exploded, isoangular bottom view of the sensor control device shown in Figure 2 according to one or more embodiments. [Figure 33]These are cross-sectional side views of the sensor control devices shown in Figures 31A to 31B and 32A to 32B according to one or more embodiments. [Figure 33A] Figures 31A-31B and 32A-32B are exploded isometric projection views of a portion of another embodiment of the sensor control device. [Figure 34A] Figures 31A-31B and 32A-32B are isometric base views of the mount. [Figure 34B] Figures 31A-31B and 32A-32B are isometric top views of the sensor cap. [Figure 35A] This is a side view of an exemplary sensor applicator according to one or more embodiments. [Figure 35B] This is a cross-sectional side view of an exemplary sensor applicator according to one or more embodiments. [Figure 36A] This is a perspective view of the cap post of Figure 35B according to one or more embodiments. [Figure 36B] This is a top view of the cap post of Figure 35B according to one or more embodiments. [Figure 37] This is a cross-sectional side view of a sensor control device disposed within an applicator cap according to one or more embodiments. [Figure 38] This is a cross-sectional view of a sensor-controlled device illustrating an exemplary interaction between a sensor and a sharp object. [Figure 39A] This is a cross-sectional view illustrating an exemplary embodiment of the applicator during the deployment stage. [Figure 39B] This is a cross-sectional view illustrating an exemplary embodiment of the applicator during the deployment stage. [Figure 39C] This is a cross-sectional view illustrating an exemplary embodiment of the applicator during the deployment stage. [Figure 39D] This is a cross-sectional view illustrating an exemplary embodiment of the applicator during the deployment stage. [Figure 39E] This is a cross-sectional view illustrating an exemplary embodiment of the applicator during the deployment stage. [Figure 39F] This is a cross-sectional view illustrating an exemplary embodiment of the applicator during the deployment stage. [Figure 40A] This diagram shows the steps involved in assembling a sensor subassembly. [Figure 40B] This diagram shows the steps involved in assembling a sensor subassembly. [Figure 40C] This diagram shows the steps involved in assembling a sensor subassembly. [Figure 40D] This diagram shows the steps involved in assembling a sensor subassembly. [Figure 40E] This diagram shows the steps involved in assembling a sensor subassembly. [Figure 40F] This diagram shows the steps involved in assembling a sensor subassembly. [Figure 40G] This diagram shows the steps involved in assembling a sensor subassembly. [Figure 40H] This diagram shows the steps involved in assembling a sensor subassembly. [Figure 41A] This diagram shows the steps involved in assembling a sensor control device. [Figure 41B] This diagram shows the steps involved in assembling a sensor control device. [Figure 41C] This diagram shows the steps involved in assembling a sensor control device. [Figure 41D] This diagram shows the steps involved in assembling a sensor control device. [Figure 41E] This diagram shows the steps involved in assembling a sensor control device. [Figure 41F] This diagram shows the steps involved in assembling a sensor control device. [Figure 41G] This diagram shows the steps involved in assembling a sensor control device. [Figure 41H] This diagram shows the steps involved in assembling a sensor control device. [Figure 41I] This diagram shows the steps involved in assembling a sensor control device. [Figure 41J]This diagram shows the steps involved in assembling a sensor control device. [Figure 42A] This diagram shows the steps involved in assembling the applicator. [Figure 42B] This diagram shows the steps involved in assembling the applicator. [Figure 42C] This diagram shows the steps involved in assembling the applicator. [Figure 42D] This diagram shows the steps involved in assembling the applicator. [Figure 42E] This diagram shows the steps involved in assembling the applicator. [Figure 42F] This diagram shows the steps involved in assembling the applicator. [Figure 42G] This diagram shows the steps involved in assembling the applicator. [Figure 42H] This diagram shows the steps involved in assembling the applicator. [Figure 42I] This diagram shows the steps involved in assembling the applicator. [Figure 42J] This diagram shows the steps involved in assembling the applicator. [Figure 42K] This diagram shows the steps involved in assembling the applicator. [Modes for carrying out the invention]

[0017] Before describing the subject matter of the present invention in detail, it should be noted that the disclosure of the present invention is not limited to the specific embodiments described and is therefore naturally subject to change. Since the scope of the disclosure of the present invention is not limited to the claims, it should also be understood that the terms used herein are solely for the purpose of describing specific embodiments.

[0018] As used herein and in the claims, the singular forms "a," "an," and "the" include plural nouns unless the context otherwise clearly indicates.

[0019] The documents discussed herein are provided solely on the grounds that they disclose information prior to the filing date of this application. Nothing in this specification should be construed as accepting that the disclosure of the present invention does not have prior rights to such documents on the grounds that they are prior disclosures. Furthermore, the dates of the documents provided may differ from the actual publication dates, and these publication dates may need to be independently verified.

[0020] Generally, embodiments of the disclosure of the present invention include systems, devices, and methods for the use of a sample sensor insertion applicator suitable for use in conjunction with an in vivo sample monitoring system. The applicator can be provided to the user in a sterile package containing an electronic housing for a sensor control device. In some embodiments, a structure such as a container separate from the applicator can also be provided to the user as a sterile package containing a sensor module and a sharp body module. The user can couple the sensor module to the electronic housing and further couple the sharp body to the applicator by an assembly process having insertion of the applicator into the container in a specified manner. In other embodiments, the applicator, sensor control device, sensor module, and sharp body module can be provided in a single package. The applicator can be used to position the sensor control device on the human body in such a way that the sensor is in contact with the wearer's bodily fluids. Embodiments provided herein are improvements that reduce the possibility of the sensor being improperly inserted, damaged, or inducing harmful physiological reactions. Other improvements and advantages are also provided. Various configurations of these devices will be described in detail using embodiments that are merely examples.

[0021] Furthermore, many embodiments include in vivo specimen sensors structurally configured so that at least a portion of the sensor can be placed on or allowed to be placed on the user's body to acquire information about at least one specimen of the body. However, it should be noted that the embodiments disclosed herein can be used in conjunction with in vivo specimen monitoring systems that incorporate in vitro functionality, as well as purely in vitro or in vitro specimen monitoring systems, including entirely non-invasive systems.

[0022] Furthermore, the disclosure of the present invention includes systems and devices for having the function of performing each of each of the embodiments of each of the methods disclosed herein. For example, embodiments of sensor control devices are disclosed, which may have one or more sensors, sample monitoring circuits (e.g., analog circuits), memory (e.g., for storing instructions), power supply, communication circuits, transmitters, receivers, processors, and / or controllers (e.g., for executing instructions) that can perform or facilitate the performance of any or all of the steps of the methods. These sensor control device embodiments may be used to perform and have the function of performing the steps performed by the sensor control device from any or all of the methods described herein.

[0023] As described above, this specification describes some embodiments of systems, devices, and methods for enabling improved assembly and use of skin sensor insertion devices suitable for use in combination with in vivo sample monitoring systems. In particular, some embodiments of the disclosure of the present invention improve sensor insertion methods with respect to in vivo sample monitoring systems, and are designed in particular to prevent premature retraction of the insertion tip during the sensor insertion process. Some embodiments include, for example, a skin sensor insertion mechanism having a high firing velocity and slow tip retraction. In other embodiments, the tip retraction mechanism can be motion-activated such that the tip does not retract until the user pulls the applicator away from the skin. As a result, these embodiments can reduce the possibility of premature retraction of the insertion tip during the sensor insertion process, reduce the possibility of incorrect sensor insertion, and reduce the possibility of damaging the sensor during the sensor insertion process. Some embodiments of the disclosure of the present invention also enable improvements to the insertion tip module that take into account the smaller scale of skin sensors and the relatively shallow insertion paths present in the skin layer of the subject. Furthermore, some embodiments of the disclosure of the present invention are designed to prevent undesirable axial and / or rotational movement of applicator components during sensor insertion. Therefore, these embodiments offer several advantages, including the potential for instability of the positioned skin sensor, irritation at the insertion site, damage to surrounding tissue, and disruption of capillaries leading to contamination of skin fluid with blood. Furthermore, to mitigate inaccurate sensor readings that may be caused by trauma at the insertion site, some embodiments of the disclosure of the present invention can shorten the terminal depth of the needle relative to the sensor tip during insertion.

[0024] However, before describing in detail the above-described aspects of the embodiments, it is desirable to first describe, for example, examples of devices that may be present in an in vivo sample monitoring system that can be used in conjunction with all embodiments described herein, and examples of their operation.

[0025] Various types of in vivo sample monitoring systems exist. A "continuous sample monitoring" system (or "continuous glucose monitoring" system) can, for example, automatically transmit data continuously from a sensor control device to a reader device without requiring an acknowledgment, for example, according to a schedule. Another example is an "intermittent sample monitoring system" (or "intermittent glucose monitoring" system, or simply an "intermittent" system) which can transfer data from a sensor control device in response to scanning or data requests by a reader device using protocols such as Near Field Communication (NFC) or Radio Frequency Identification (RFID). In vivo sample monitoring systems can also operate without the need for fingertip puncture calibration.

[0026] In vivo sample monitoring systems can be distinguished from "in vitro" systems, which typically have a port for accepting a sample test strip containing the user's bodily fluids that can be analyzed to determine the user's blood glucose level after coming into contact with a biological sample outside the body (or "outside the body").

[0027] An in vivo monitoring system may include a sensor that comes into contact with the user's bodily fluids while positioned on the body and senses the level of a sample contained therein. The sensor may be part of a sensor control device located on the user's body, which includes electronic equipment and a power supply that enable and control the sample sensing. Sensor control devices and their variations may be referred to, to name a few examples, as a "sensor control unit," a "body electronic device" device or "body electronic device" unit, a "body" device or "body" unit, or a "sensor data communication" device or "sensor data communication" unit.

[0028] In vivo monitoring systems may include devices that receive and process sensing sample data from sensor control devices and / or display it to the user in any number of forms. These devices and their variations may be referred to, to a limited number of examples, as “handheld reader devices,” “reader devices” (or simply “readers”), “handheld electronic devices” (or simply “handheld”), “portable data processing” devices or “portable data processing” units, “data receivers,” “receivers” devices or “receivers” units (or simply “receivers”), or “remote” devices or “remote” units. Other devices, such as personal computers, may also be used in conjunction with or incorporated into in vivo or in vitro monitoring systems.

[0029] Exemplary Embodiment of an In vivo Sample Monitoring System Figure 1 is a conceptual diagram illustrating an exemplary embodiment of a sample monitoring system 100, which includes a sensor applicator 150, a sensor control device 102, and a reader device 120. Here, the sensor applicator 150 can be used to deliver the sensor control device 102 to a monitoring location on the user's skin, where the sensor 104 is held in place for a period of time by an adhesive patch 105. The sensor control device 102 will be described in more detail in Figures 2B and 2C, and the sensor control device 102 can communicate with the reader device 120 through a communication path 140 using wired or wireless technology. Exemplary wireless protocols include Bluetooth®, Bluetooth® Low Energy (BLE, BTLE, Bluetooth Smart, etc.), Near Field Communication (NFC), and others. The user can monitor applications installed in the memory on the reader device 120 using the screen 122 and input 121, and the device's battery can be recharged using the power port 123. More detailed information regarding the reader device 120 will be provided below with reference to Figure 2A. The reader device 120 can communicate with the local computer system 170 through a communication path 141 using wired or wireless technology. The local computer system 170 may include one or more of the following: laptop, desktop, tablet, phablet, smartphone, set-top box, video game console, or other computer devices, and the wireless communication may include any of the applicable wireless network connectivity protocols, including Bluetooth®, Bluetooth® Low Energy (BTLE), Wi-Fi, and others. The local computer system 170 can communicate with the network 190 through a communication path 143 using wired or wireless technology as described above, in a manner similar to how the reader device 120 can communicate with the network 190 through communication path 142.Network 190 can be any of the following networks: private network and public network, local area network, or wide area network. The highly reliable computer system 180 may include a server, provide authentication services and secure data storage, and communicate with network 190 through a communication path 144 using wired or wireless technology.

[0030] Exemplary Embodiments of a Reader Device Figure 2A is a block diagram illustrating an exemplary embodiment of a reader device configured as a smart phone. Here, the reader device 120 may include a display 122, an input component 121, a processing core 206 including a communication processor 222 coupled to memory 223, and an application processor 224 coupled to memory 225. Similarly, it may include a separate memory 230, an RF transceiver 228 with an antenna 229, and a power supply 226 with a power management module 238. Furthermore, it may include a multifunction transceiver 232 that can communicate via Wi-Fi, NFC, Bluetooth®, BTLE, and GPS using the antenna 234. As will be understood by those skilled in the art, these components are electrically and communicatively coupled to produce a functional device.

[0031] Exemplary Embodiments of Sensor-Controlled Devices Figures 2B and 2C are block diagrams illustrating exemplary embodiments of a sensor control device 102, which comprises a sample sensor 104 and sensor electronic equipment 160 (including a sample monitoring circuit) that can have most of the processing functions necessary to prepare the final result data for display to the user. Figure 2B shows a single semiconductor chip 161, which can be a custom application-specific integrated circuit (ASIC). Within the ASIC 161 are shown certain high-level functional units, including an analog front-end (AFE) 162, a power management (or control) circuit 164, a processor 166, and a communication circuit 168 (which can be implemented as a transmitter, receiver, transceiver, passive circuit, or otherwise according to a communication protocol). In this embodiment, both the AFE 162 and the processor 166 are used as sample monitoring circuits, but in other embodiments, either circuit can perform the sample monitoring function. The processor 166 may include one or more processors, microprocessors, controllers, and / or microcontrollers, each of which may be a separate chip or distributed among several different chips (and portions thereof).

[0032] The ASIC 161 also includes a memory 163, which can be shared by various functional units present within the ASIC 161, or distributed among two or more of these functional units. The memory 163 can be a separate chip. The memory 163 can be volatile memory and / or non-volatile memory. In this embodiment, the ASIC 161 is coupled to a power supply 170, which can be a coin cell battery or the like. The AFE 162 interconnects with the in vivo sample sensor 104, receives measurement data from it, and outputs this data in digital form to the processor 166, which further processes this data to produce final results such as individual glucose values ​​and glucose trend values. These data can then be supplied to a communication circuit 168 via an antenna 171 to send to, for example, a reader device 120 (not shown), which requires little further processing by a resident software application to display the data.

[0033] Figure 2C is similar to Figure 2B but includes two separate semiconductor chips 162 and 174 that can be packaged together or separately. Here, the AFE 162 resides on the ASIC 161. The processor 166 is integrated with the power management circuit 164 and the communication circuit 168 on chip 174. The AFE 162 includes memory 163, and chip 174 includes memory 165 that can be isolated or distributed within it. In one exemplary embodiment, the AFE 162 is combined with the power management circuit 164 and the processor 166 on one chip, while the communication circuit 168 is on a separate chip. In another exemplary embodiment, both the AFE 162 and the communication circuit 168 are on one chip, while the processor 166 and the power management circuit 164 are on separate chips. It should be noted that other chip combinations are possible, each performing the individual function described or including three or four or more chips that share one or more functions to achieve fail-safe redundancy.

[0034] Exemplary Embodiment of Assembly Process for Sensor Control Devices The components of the sensor control device 102 are available to the user in multiple packages that require final assembly by the user before being delivered to a suitable user location. Figures 3A to 3D illustrate exemplary embodiments of the user assembly process for the sensor control device 102, including the preparation of individual components before coupling them together to provide a sensor for delivery. Figures 3E to 3F illustrate exemplary embodiments of the delivery of the device 102 to a suitable user location by selecting a suitable delivery location and applying the sensor control device 102 to this location.

[0035] Figure 3A is a proximal perspective view illustrating an exemplary embodiment in which a user prepares a container 810, which in this case is configured as a tray for the assembly process (although other packages can be used). The user can achieve this preparation by removing the lid 812 from the tray 810 to expose the platform 808, for example by peeling the non-adhesive portion of the lid 812 from the tray 810 so that the adhesive portion of the lid 812 can be removed. Removal of the lid 812 can be appropriate in various embodiments as long as the platform 808 is sufficiently exposed within the tray 810. The lid 812 can then be set aside.

[0036] Figure 3B is a side view illustrating an exemplary embodiment in which a user prepares the applicator device 150 for assembly. The applicator device 150 can be supplied in a sterile package sealed by a cap 708. Preparation of the applicator device 150 may include the step of detaching the housing 702 from the cap 708 to expose the sheath 704 (Figure 3C). This detachment can be achieved by twisting the cap 708 off (or otherwise detaching) it from the housing 702. The cap 708 can then be set aside.

[0037] Figure 3C is a proximal perspective view illustrating an exemplary embodiment in which a user inserts the applicator device 150 into the tray 810 during assembly. First, the user can insert the sheath 704 into the platform 808 inside the tray 810 after aligning the housing directional feature 1302 (or slot or recess) with the tray directional feature 924 (contact or stopper). By inserting the sheath 704 into the platform 808, the sheath 704 is temporarily unlocked from the housing 702, and the platform 808 is also temporarily unlocked from the tray 810. At this stage, removing the applicator device 150 from the tray 810 will result in the same state as before the initial insertion of the applicator device 150 into the tray 810 (i.e., this process can be reversed or interrupted at this point and then repeated without effect).

[0038] While the housing 702 is advanced distally, the sheath 704 maintains its position relative to the housing 702 within the platform 808, coupling with the platform 808 and allowing the platform 808 to advance distally relative to the tray 810. This stage unlocks and crushes the platform 808 within the tray 810. The sheath 704 contacts and releases a locking feature (not shown) within the tray 810, thereby unlocking the sheath 704 from the housing 702 and preventing the sheath 704 from moving (relatively) while the housing 702 advances distally to the platform 808. At the end of the advancement of the housing 702 and the platform 808, the sheath 704 is permanently unlocked from the housing 702. At the end of the distal advancement of the housing 702, the sharp body and sensor (not shown) within the tray 810 can be coupled with the electronic housing (not shown) within the housing 702. The operation and interaction between the applicator device 150 and the tray 810 will be described in more detail below.

[0039] Figure 3D is a proximal perspective view illustrating an exemplary embodiment in which a user removes the applicator device 150 from the tray 810 during assembly. The user can remove the applicator 150 from the tray 810 by advancing the housing 702 proximal to the tray 810, or by other movements that have the same terminating effect as separating the applicator 150 from the tray 810. The applicator device 150, along with the fully assembled sensor control device 102 (sharp body, sensor, electronics) inside it, is removed and positioned for delivery.

[0040] Figure 3E is a proximal perspective view illustrating an exemplary embodiment in which a patient attaches the sensor control device 102 to a target area of ​​skin on, for example, the abdomen or another suitable location using the applicator device 150. By advancing the housing 702, the sheath 704 is compressed distally within it, and the sensor is attached to the target location so that the adhesive layer on the bottom surface of the sensor control device 102 adheres to the skin. The pointed body automatically retracts when the housing 702 is fully advanced, and the sensor (not shown) is left in place to measure the sample level.

[0041] Figure 3F is a proximal perspective view depicting an exemplary embodiment of a patient having a sensor control device 102 at the attachment site. The user can then remove the applicator 150 from the attachment site.

[0042] System 100, as described with respect to Figures 3A to 3F and further described elsewhere in this specification, can result in a reduction or elimination of the possibility of accidental damage, permanent deformation, or incorrect assembly of applicator components compared to prior art systems. Since the applicator housing 702 engages directly with the platform 808 rather than indirectly through the sheath 704 while the sheath 704 is unlocked, the relative inclination between the sheath 704 and the housing 702 will not result in damage or permanent deformation of the arm or other components. The potential for relatively strong forces during assembly (as in conventional devices) is reduced, thereby reducing the possibility of user assembly failure.

[0043] Exemplary Embodiments of Sensor Applicator Devices Figure 4A is a side view illustrating an exemplary embodiment of the applicator device 150 coupled to the screw cap 708. This figure illustrates an example of how the applicator 150 is shipped and received by the user before assembly with the sensor. Figure 4B is a side perspective view illustrating the applicator 150 and cap 708 after they have been detached. Figure 4C is a perspective view illustrating an exemplary embodiment of the distal end of the applicator device 150 with the electronic housing 706 and adhesive patch 105 removed from the position where the cap 708 is presumably held within the sensor electronics carrier 710 of the sheath 704 when the cap 708 was in place.

[0044] Exemplary Embodiment of Tray and Sensor Module Assembly Figure 5 shows an exemplary embodiment of a tray 810 having a removablely coupled sterile lid 812, and is a proximal perspective view that can illustrate how the package is shipped to the user and how it is received by the user before assembly.

[0045] Figure 6A is a proximal perspective break drawing showing the sensor delivery components within the tray 810. The platform 808 is slidably coupled into the tray 810. The desiccant 502 is fixed to the tray 810. The sensor module 504 is mounted inside the tray 810.

[0046] Figure 6B is a proximal perspective view showing the sensor module 504 in more detail. Here, the retaining arm extension 1834 of the platform 808 removably secures the sensor module 504 in place. Module 2200 is coupled with a connector 2300, a pointed body module 2500, and a sensor (not shown), so that they can be removed as the sensor module 504 during assembly.

[0047] Exemplary Embodiment of Applicator Housing Figure 7A is a side view illustrating an exemplary embodiment of an applicator housing 702 that may include an internal cavity with a support structure for applicator functionality. A user can initiate the applicator assembly process by pushing the housing 702 distally, which can also trigger the ejection of the sensor control device 102, after which the cavity of the housing 702 can function as a receptacle for a sharp object. In this exemplary embodiment, various features are shown, including a housing oriented feature 1302 for oriented the device during assembly and use. The tamper-evident ring groove 1304 may be a recess located around the outer circumference of the housing 702 distal to the tamper-evident ring protector 1314 and proximal to the tamper-evident ring retainer 1306. The tamper-evident ring groove 1304 can hold the tamper-evident ring, so that a user can identify whether the device has been tampered with or otherwise used. The housing threads 1310 can be used to secure the housing 702 to the complementary cap threads (Figures 4A and 4B) on the cap 708 by aligning them with these complementary threads and rotating them clockwise or counterclockwise. The side gripping zone 1316 of the housing 702 can provide an external location from which a user can grip the housing 702 for use. The gripping protrusion 1318 is a slightly raised ridge relative to the side gripping zone 1316, which can contribute to the ease of removing the housing 702 from the cap 708. The shark-tooth section 1320 has a flat side positioned on the clockwise edge and can be a raised section that holds the tamper-evident ring (not shown) in place after the user has screwed the cap 708 and housing 702 apart. In this exemplary embodiment, four shark-tooth-like portions 1320 are used, but more or fewer shark-tooth-like portions 1320 may be used as needed.

[0048] Figure 7B is a perspective view showing the distal end of the housing 702. Here, three housing guide structures (or “guide ribs”) 1321 are positioned at 120-degree angles to each other and at 60-degree angles to the rocking structures (or “rocking ribs”) 1340, and there are also three rocking structures 1321, each positioned at 120-degree angles to each other. Whether symmetrical or asymmetrical, other angular orientations can be used with one or more structures 1321 and 1340. Here, each structure 1321 and 1340 is configured as a planar rib, but other shapes can also be used. Each guide rib 1321 includes a guide edge (also called a “sheath guide rail”) 1326 (e.g., guide rail 1418 as described in relation to Figure 8A) that can follow the surface of the sheath 704. The insertion difficulty stop 1322 can be the flat distal-facing surface of the housing guide rib 1321 located near the proximal end of the housing guide rib 1321. The insertion difficulty stop 1322 provides a surface to which the sensor electronic equipment carrier advance limiting surface 1420 of the sheath 704 (Figure 8B) abuts during use, preventing it from moving further in the proximal direction. The carrier interface post 1327 passes through the opening 1510 (Figure 9A) of the sensor electronic equipment carrier 710 during assembly. The sensor electronic equipment carrier interface 1328 can be a round distal-facing surface of the housing guide rib 1321 that interfaces with the sensor electronic equipment carrier 710.

[0049] Figure 7C is a side cross-sectional view illustrating an exemplary embodiment of the housing. In this exemplary embodiment, the side cross-sectional profiles of the housing guide rib 1321 and the locking rib 1340 are shown. The locking rib 1340 includes a sheath snap introduction feature 1330 located near its distal end, which expands outward distally from the central axis 1346 of the housing 702 in a bell-shaped manner. Each sheath snap introduction feature 1330 bends the rounded portion 1404 of the retaining snap 1402 of the sheath 704, as shown in Figure 8C, inward toward the central axis 1346 as the sheath 704 moves toward the proximal end of the housing 702. The retaining snap 1402 of the sheath 704 locks into place in the lock groove 1332 after passing the distal point of the sheath snap introduction feature 1330. Therefore, the retaining snap 1402 cannot easily move distally due to a plane having a surface that is substantially perpendicular to the central axis 1346, which is shown as the retaining snap flat portion 1406 in Figure 8C.

[0050] As the housing 702 moves further proximal toward the skin surface and the sheath 704 advances toward the distal end of the housing 702, the retaining snap 1402 slides into the unlock groove 1334, and the applicator 150 becomes ready for use in the "armed" position. If the user applies further force to the proximal end of the housing 702 while the sheath 704 is pressed against the skin, the retaining snap 1402 passes over the firing retainer 1344. This passage results in a firing sequence due to the release of energy stored within the deflected retaining snap 1402 (as described, for example, with respect to Figures 12A–12D), and the retaining snap 1402 advances proximal toward the skin surface toward the sheath stop ramp 1338, which expands slightly outward in a bell-shaped manner relative to the central axis 1346 and slows the movement of the sheath 704 during the firing sequence. The next groove that the retaining snap 1402 encounters after the unlock groove 1334 is the final lockout groove 1336 into which the retaining snap 1402 enters at the end of a stroke or press sequence performed by the user. The final lockout recess 1336 is perpendicular to the central axis 1346 and can be a proximal-facing surface that engages with the retaining snap flat 1406 after the retaining snap 1402 has passed through, preventing the device from being reused by firmly holding the sheath 704 in place relative to the housing 702. The insertion difficulty stop 1322 of the housing guide rib 1321 prevents the sheath 704 from advancing proximal to the housing 702 by engaging with the sensor electronic equipment carrier advance limiting surface 1420.

[0051] Figures 7D and 7E are enlarged side views of an exemplary embodiment of the locking rib 1340 of the applicator housing 702, showing the retaining snap 1402 of the sheath 704 moving toward the proximal end of the housing 702. Figure 7D illustrates the sheath 704 in a “locked” state, where the retaining round portion 1404 of the retaining snap 1402 is positioned in the locking groove 1332 of the locking rib 1340, having already passed over the sheath snap introduction feature 1330. When force is applied to the proximal end of the housing 702, the retaining round portion 1404 advances proximally into the unlock groove 1334, placing the applicator 150 in the “armed” position. When further force is applied to the proximal end of the housing 702, and the retaining round portion 1404 advances proximally out of the unlock groove 1334 and passes over the firing retaining 1344, the applicator 150 is “fired.” Subsequently, as shown in Figure 7E, the sheath 704 is advanced further proximal to allow the stopper round portion 1404 to slide forward on the launch surface 1337. In this embodiment, the launch surface 1337 is substantially parallel to the central axis 1346. As the sheath 704 continues to advance proximal, the stopper round portion 1404 reaches a sheath stop ramp 1338 that slows the movement of the sheath 704. When the stopper round portion 1404 reaches the final lockout recess 1336, a stopper snap flat portion 1406 (not shown) engages to firmly hold the sheath 704 in place relative to the housing 702.

[0052] Figures 7F and 7G are enlarged side views of an alternative embodiment of the locking rib 2340 designed to improve the firing velocity of the sharp object from the sensor applicator. Here, the locking rib 2340 includes an inward-facing stop ramp 2335 that reduces friction between the sheath 704 and the housing 2702 during firing. The locking rib 2340 further includes a sheath stop ramp 2338 at the proximal end of the firing surface 2337. In Figure 7F, initially, the stopper round portion 1404 of the stopper snap 1402 is shown already having passed over the sheath snap introduction feature portion 2330, and the sheath 704 is shown in a “locked” state positioned in the lock groove 2332. When a force is applied to the proximal end of the housing 2702, the stopper round portion 1404 advances into the unlock groove 2334 and places the applicator 150 in the “armed” position. When further force is applied to the proximal end of the housing 2702, the applicator 150 is "launched" by the return stopper circular portion 1404 passing over the launch stopper 2344.

[0053] As shown in Figure 7G, the stopper round section 1404 then advances toward the proximal end of the housing 2702 in a “free flight” state, passing over the inward stopper ramp 2335. While advancing proximal in a “free flight” state, the stopper round section 1404 may be discontinuous with or not in contact with the inward stopper ramp 2335 and the launch surface 2337. In this regard, since there is little to no friction between the stopper round section 1404 and the inward stopper ramp 2335 and the launch surface 2337, the stopper round section 1404 can be advanced easily and quickly, thereby improving the launch speed of the sharp object from the applicator. Compared to the embodiments shown in Figures 7D and 7E, a sheath stop ramp 2338 located proximal along the locking rib 2340 further provides an edge portion for frictionally engaging with the stopper round section 1404 to slow the movement of the sheath 704. The sheath stop ramp 2338 has an inclined shape that allows for strong frictional contact when the stopper round portion 1404 advances proximal. Finally, when the stopper round portion 1404 reaches the final lockout recess 2336, the stopper snap flat portion 1406 (not shown) engages to firmly hold the sheath 704 against the housing 2702. The lockout recess 2336 prevents the stopper round portion 1404 and the sheath 704 from moving in the reverse or distal direction. This embodiment reflects a higher rate of fire compared to the embodiments depicted in Figures 7D and 7E and also helps prevent premature withdrawal of the sharp body.

[0054] Figure 7H is an enlarged side view of an alternative embodiment 6340 of the locking rib, designed to maintain a downward force on the sheath 6704 during firing, thereby preventing undesirable movement of the sheath 6704 during the sensor insertion process. Here, the sheath 6704 is shown in a “locked” state with the retaining round portion 6404 of the retaining snap 6402 positioned in the locking groove 6332. When a force is applied to the proximal end of the housing 6702, the retaining round portion 6404 advances proximal into the unlocking groove 6334, placing the applicator in the “armed” position. When further force is applied to the proximal end of the housing 6702, the applicator is “fired,” and the retaining round portion 6404 advances toward the proximal end of the housing 6702 over the inclined firing surface 6338. The inclined launch surface 6338 can be angled toward the central axis 1346 such that the downward force on the sheath 6704 is increased when the stopper round section 6404 advances proximally. In the embodiment shown, the stopper round section 6404 is in continuous contact with the inclined launch surface 6338. The lockout recess 6336 prevents the stopper round section 6404 and the sheath 6704 from moving backward or distally. This embodiment reflects a lower launch velocity compared to the embodiments described above and can be used, for example, in a motion-actuated sharp body retraction process described with reference to Figures 14A-14C and 15A-15B.

[0055] Figure 7I is an enlarged side view of yet another alternative embodiment 7340 of the locking rib, which is similarly designed to maintain a downward force on the sheath 6704 during firing, thereby preventing undesirable movement of the sheath 6704 during the sensor insertion process. Here, the sheath 6704 is shown in the "fired" state with the retaining round portion 6404 of the retaining snap 6402 positioned in the bidirectional lockout recess 7336. Once the retaining round portion 6404 advances and enters the bidirectional lockout recess 7336, any further movement of the sheath 6704 in either the proximal or distal direction can be prevented. This can reduce undesirable movement of the sheath 6704 during the sensor insertion process. Furthermore, in some embodiments, as described with reference to Figures 14A-14C and 15A-15B, the bidirectional lockout recess 7336 can enable immobilization of the sheath 6704 during the motion-operated sharp body retraction process. As can be seen in Figure 7I, the inclined launch surface 7338 can be angled toward the central axis 1346 such that the downward force on the sheath 6704 is increased as the stopper round section 6404 advances proximally. In the embodiment shown, the stopper round section 6404 is in continuous contact with the inclined launch surface 7338. This embodiment can be used to reflect lower launch velocities and, for example, in motion-actuated sharp body retraction processes described with reference to Figures 14A-14C and 15A-15B.

[0056] Exemplary Embodiment of an Applicator Sheath Figures 8A and 8B are a side view and a perspective view, respectively, illustrating exemplary embodiments of the sheath 704. In this exemplary embodiment, the sheath 704 can be mounted above the user's skin surface before attachment. The sheath 704 may include features that help hold the sharp body in a position suitable for proper attachment of the sensor, determine the force required for sensor attachment, and guide the sheath 704 against the housing 702 during attachment. The retaining snap 1402 is located near the proximal end of the sheath 704, as will be described in more detail below with respect to Figure 8C. The sheath 704 may have a substantially cylindrical cross-section with a first radius in the proximal section (closer to the top of the figure) and a second radius in the distal section (closer to the bottom of the figure) where the first radius is shorter than a second radius. Similarly, a plurality of retaining clearances 1410, of which there are three, are also shown in this exemplary embodiment. The sheath 704 may include one or more retaining clearances 1410, each of which may be a notch providing room for the sheath snap introduction feature 1330 to enter distally until the distal surface of the locking rib 1340 contacts the proximal surface of the retaining clearance 1410.

[0057] The guide rails 1418 are positioned between the sensor electronic equipment carrier advance limiting surface 1420 at the proximal end of the sheath 704 and the notches around the lock arm 1412. Each guide rail 1418 can be a channel between two ridges, through which the guide edge 1326 of the housing guide rib 1321 can slide distally relative to the sheath 704.

[0058] The lock arm 1412 may include a distal end positioned and mounted near the distal end of the sheath 704, and a free proximal end which may include a lock arm interface 1416. The lock arm 1412 can lock the sensor electronic equipment carrier 710 to the sheath 704 when its lock arm interface 1416 engages with the lock interface 1502 of the sensor electronic equipment carrier 710. The lock arm reinforcing rib 1414 may be positioned at the center of each lock arm 1412 and may act as a reinforcement point against other weak points of each lock arm 1412 to prevent the lock arm 1412 from bending or breaking excessively.

[0059] The retaining snap reinforcement feature 1422 can be positioned along the distal section of the retaining snap 1402 and can provide reinforcement to the retaining snap 1402. The alignment notch 1424 can be a notch near the distal end of the sheath 704 and provides an opening for user alignment with the sheath-oriented feature of the platform 808. The reinforcing rib 1426 may include a triangular buttress in this case to provide support for the retaining base 1436. The housing guide rail clearance 1428 can be a notch for the distal surface of the housing guide rib 1321 to slide during use.

[0060] Figure 8C is an enlarged perspective view illustrating an exemplary embodiment of a retaining snap 1402 of the sheath 704. The retaining snap 1402 may include a retaining snap bridge 1408 located at or near its proximal end. The retaining snap 1402 may further include a retaining snap flat portion 1406 distal to the retaining snap bridge 1408. The outer surface of the retaining snap bridge 1408 may include a retaining snap round portion 1404, which is a rounded surface that allows for easier movement of the retaining snap bridge 1408 across the inner surface of the housing 702, such as a locking rib 1340.

[0061] Figure 8D is a side view illustrating an exemplary embodiment of the sheath 704. Here, the alignment notch 1424 can be relatively close to the retaining clearance 1410. The retaining clearance 1410 is located relatively proximal on the distal portion of the sheath 704.

[0062] Figure 8E is an end view illustrating an exemplary embodiment of the proximal end of the sheath 704. Here, the rear wall 1446 for the guide rail can provide a channel for slidably coupling with the housing guide rib 1321 of the housing 702. The sheath rotation limiter 1448 can be a notch that reduces or prevents rotation of the sheath 704.

[0063] Figures 8F to 8H are perspective views of alternative exemplary embodiments of the sheath 6704 at various stages of assembly with other components of the applicator. As shown in Figure 8F, the sheath 6704 may have many of the same features as the sheath 704 described with respect to Figures 8A to 8C. The sheath 6704 may include, for example, one or more retaining snaps 6402 to which one or more retaining round portions 6404 are attached. However, the sheath 6704 may have a shorter overall length compared to the sheath 704. Furthermore, the sheath 6704 may include one or more inner sheath ribs 6425 positioned on its inner surface and projecting inward toward the central axis of the sheath 6704.

[0064] Moving to Figure 8G, the sheath 6704 is shown in the assembly stage with the applicator housing 6702 and the sensor electronic equipment carrier 6710. One or more inner sheath ribs 6425 of the sheath 6704 can interface with corresponding rib notches 6519 in the sensor electronic equipment carrier 6710. The adapted interface between the corresponding ribs 6425 and notches 6519 can help maintain axial alignment between the sheath 6704 and the sensor electronic equipment carrier 6710 during the sensor insertion process. Furthermore, the interface between the ribs 6425 and notches 6519 can reduce lateral and rotational movement between applicator components, which in turn can reduce the possibility of incorrect sensor insertion.

[0065] Moving to Figure 8H, the sheath 6704 is shown in the assembly stage with the sensor electronic equipment housing 706 inserted into the applicator housing 6702 and the sensor electronic equipment carrier 6710. The inner sheath rib 6425 is also shown.

[0066] Six inner sheath ribs 6425 and six corresponding rib notches 6519 are shown, but it should be noted that any number of ribs and notches is entirely within the disclosure of the present invention. Furthermore, a rib 6425 having a rounded surface edge is shown, but in other embodiments, the rib 6425 may have a rectangular or triangular shape, and the rib notches 6519 may have a corresponding receiving shape for interface with the rib 6425. Furthermore, a rib 6425 positioned on the inner circumferential surface of the sheath 6704 is shown, but the rib 6425 may be positioned on any other surface or portion thereof of the sheath 6704 that is in contact with the sensor electronic device carrier 6710.

[0067] Exemplary Embodiments of Sensor Electronic Device Carriers Figure 9A is a proximal perspective view depicting an exemplary embodiment of a sensor electronics carrier 710 capable of holding sensor electronics within an applicator 150. The sensor electronics carrier 710 can hold a sharp body carrier 1102 having a sharp body module 2500. In this exemplary embodiment, the sensor electronics carrier 710 generally has a hollow round flat cylindrical shape and may include one or more (e.g., three) deflectable sharp body carrier locking arms 1524 that extend proximal to the proximal surface, surrounding a spring alignment ridge 1516 positioned at the center to maintain alignment of the spring 1104. Each locking arm 1524 has a return feature or holding feature 1526 positioned at its proximal end. An impact lock 1534 may be a tab positioned on the outer circumference of the sensor electronics carrier 710 and extending outward, which can lock the sensor electronics carrier 710 with additional safety before firing. The rotation limiter 1506 can be a relatively short projection extending proximally on the proximal surface of the sensor electronic device carrier 710, thereby limiting the rotation of the carrier 710. The sharp body carrier lock arm 1524 can interface with the sharp body carrier 1102, as described below with reference to Figures 10A to 10E.

[0068] Figure 9B is a distal perspective view of the sensor electronic equipment carrier 710. Here, one or more (e.g., three) sensor electronic equipment retaining spring arms 1518 are pressed perpendicularly toward the illustrated position and housed in a recess or cavity 1521, and a retaining arm 1519 is included that can pass over the distal surface of the electronic equipment housing 706 of the device 102. In certain embodiments, after the sensor control device 102 is attached to the skin using the applicator 150, the user pulls the applicator 150 proximal, i.e., away from the skin. This adhesive force holds the sensor control device 102 on the skin and overcomes the lateral force applied by the spring arms 1518. As a result, the spring arms 1518 deflect radially outward, detaching the retaining arm 1519 from the sensor control device 102, thereby releasing the sensor control device 102 from the applicator 150.

[0069] Figure 9C is a perspective view of an alternative exemplary embodiment of the sensor electronic device carrier 6710. As shown in Figure 9C, the sensor electronic device carrier 6710 may have many of the same features as the sensor electronic device carrier 710 described with respect to Figures 9A to 9B. Furthermore, the sensor electronic device carrier 6710 further includes one or more notched ribs 6519 arranged along its outer circumferential surface. As is most clearly seen in Figures 8F to 8H, the notched ribs 6519 are configured to interface with the inner sheath ribs 6425 to maintain axial alignment between the sheath and the sensor electronic device carrier and to reduce lateral and rotational movement between applicator components during the sensor insertion process.

[0070] Exemplary Embodiments of Sharp Body Carriers Figures 10A and 10B are a proximal perspective view and a side cross-sectional view, respectively, illustrating an exemplary embodiment 1102 of the sharp body carrier. The sharp body carrier 1102 can grip and hold the sharp body module 2500 within the applicator 150. The sharp body module 2500 can be automatically retracted as a result of one or more spring changes from a pre-loaded compressed state to an expanded state during the insertion process, as described with respect to Figures 40A to 40F. An anti-rotation slot 1608 may be present to prevent the sharp body carrier 1102 from rotating when it is positioned within the central area of ​​the sharp body carrier lock arm 1524 (shown in Figure 9A) near the distal end of the sharp body carrier 1102. The anti-rotation slot 1608 may be positioned between sections of the sharp body carrier base chamfered surface 1610 to ensure complete retraction of the sharp body carrier 1102 through the sheath 704 when the sharp body carrier 1102 retracts at the end of the deployment procedure.

[0071] As shown in Figure 10B, the sharp body holding arms 1618 can be positioned around the central axis within the sharp body carrier 1102, and each arm 1618 may include a sharp body holding clip 1620 at its distal end. The sharp body holding clip 1620 can be substantially perpendicular to the central axis and may have a proximal surface that can abut against the distal surface of the sharp body hub 2516 (Figure 11A).

[0072] Exemplary Embodiment of a Sensor Module Figures 11A and 11B are a top perspective view and a bottom perspective view, respectively, illustrating exemplary embodiments of the sensor module 504. The module 504 can hold the connector 2300 (Figures 12A and 12B) and the sensor 104 (Figure 13). The module 504 is designed to be firmly coupled to the electronic equipment housing 706. One or more deflectable arms or module snaps 2202 can snap into corresponding feature portions 2010 of the housing 706. The pointed body slot 2208 can provide a temporary location for the pointed body shaft 2504 through which the pointed body tip 2502 passes. The sensor ledge 2212 can define the sensor position in a horizontal plane, prevent the sensor from detaching the connector 2300 from the post, and keep the sensor 104 parallel to the plane of the connector seal. Furthermore, the sensor ledge 2212 can define the bending shape and bending radius of the sensor. The sensor ledge 2212 restricts the vertical movement of the sensor, prevents the tower from protruding above the electronic housing, and can define the length of the sensor tail below the patch surface. The sensor wall 2216 constrains the sensor and can define the sensor's bending shape and minimum bending radius.

[0073] Figures 12A and 12B are perspective views illustrating exemplary embodiments of the connector 2300 in an open and closed state, respectively. The connector 2300 can be manufactured from silicone rubber, enclosing a flexible carbon-impregnated polymer module that acts as a conductive contact 2302 between the sensor 104 and the electrical circuit contacts for the electronic equipment in the housing 706. The connector can act as a moisture barrier to the sensor 104 when assembled in a compressed state after transfer from the container to the applicator and after application to the user's skin. Multiple sealing surfaces 2304 can provide a watertight seal to the electrical contacts and sensor contacts. One or more hinges 2208 can connect the two distal and proximal portions of the connector 2300.

[0074] Figure 13 is a perspective view illustrating an exemplary embodiment of the sensor 104. The neck 2406 can be a zone that allows the sensor to be folded, for example, 90 degrees. A thin layer on the tail 2408 can cover the active sample sensing element of the sensor 104. The tail 2408 can be the portion of the sensor 104 that is located under the user's skin after insertion. The flag 2404 can include a contact and a sealing surface. The biasing tower 2412 can be a tab that biases the tail 2408 into the sharp body slot 2208. The biasing pivot 2414 can be a branch of the biasing tower 2412 that contacts the inner surface of the needle to bias the tail into the slot. A biasing regulator 2416 can reduce localized bending of the tail connection and prevent damage to the sensor trace. The contact 2418 can electrically connect the active portion of the sensor to the connector 2300. The service loop 2420 can change the electrical path by 90 degrees from the vertical direction and engage with the sensorledge 2212 (Figure 11B).

[0075] Referring again to Figure 13, the sensor 104 may be configured to have a neck 2406 that interconnects the flag 2404 and the tail 2408, and allows the sensor 104 to bend between the flag 2404 and the tail 2408. In one example, the neck 2406 can be bent about 90 degrees to facilitate contact 2418 of the flag 2404 with the sensor ledge 2212 (Figure 11B). However, the sensor 104 may be manufactured in a relatively flat configuration with substantially no bends in the neck 2406 of the sensor 104 so that the flag 2404, neck 2406, and tail 2408 can form a substantially flat surface, and in some embodiments it may even be shipped or stored in that configuration. To include the sensor 104 in the illustrated embodiment, the neck 2406 must be bent. However, by bending the neck 2406, the sensor 104 is generally subjected to stress, particularly the neck 2404, and these stresses may weaken or break the sensor 104, or cause micro-fractures, or reduce the efficiency and effectiveness of the sensor 104. The techniques described below in this specification can be bent to a desired angle while simultaneously reducing damage to the sensor 104 and its components.

[0076] One exemplary technique for reducing damage caused by bending the neck 2406 of sensor 104 is to apply a sufficient amount of heat for a sufficient amount of time at a time close in time to the time when the neck 2406 will be bent. These factors, such as the degree of heat, the length of exposure time, and the proximity of heat application to the time when bending occurs, can generally be determined based on the type of material used in sensor 104, particularly the neck 2406, which provides appropriate examples below. For example, care must be taken to avoid damaging the thin covering the contacts 2418 and tail 2408.

[0077] The application of heat can be controlled by the manufacturing components used to bend the neck 2406. In one embodiment, the neck 2406 can be bent or folded by heating a portion of this neck 2406 of the sensor 104 to a predetermined temperature and bending the neck 2406 to form an angle between the tail 2408 of the sensor 104 and the flag 2404 of the sensor. As described above, the predetermined temperature and predetermined length of heating can be determined based on the properties of one or more of the materials including the neck 2406 of the sensor 104. The heating temperature and time can be selected based on whether it is sufficient to improve the malleability of the neck 2406 of the sensor 104 without damaging the rest of the sensor. In some embodiments, the appropriate temperature may be in the temperature range between 50 and 60°C, including boundary values, and the appropriate heating length may be nominally specified as 1.8 seconds or around that. For example, the temperature can be specified as a target temperature within a suitable range having a specified degree of dispersion, e.g., ±2°C, e.g., 53°C, 55°C, or 57°C. The step of heating the neck 2406 of the sensor 104 may include a step of heating only the area of ​​the neck 2406 of the sensor 104, a step of heating substantially the entire neck 2406, or a step of heating one or more other components of the sensor 104.

[0078] The heating and bending stages can be performed by one or more heating-bending devices. For example, the sensor 104 can be inserted into a heating-bending device of a first configuration that includes a separate dedicated component for heating and bending the neck 2406. The next step in configuring the sensor 104 includes heating the neck 2406 using the first component for heating the neck 2406, and then passing the sensor 104 to a second component for bending the neck 2406 to a desired angle. The step of heating the neck 2406 can be performed by a heating element of the heating device. The heating element can be increased to a desired temperature and can further increase the temperature of the neck 2406 by contacting or bringing it close to a designated portion of the neck 2406 for a set period of time. Furthermore, the neck 2406 can be indirectly heated by increasing the local temperature around the sensor 104 without directly contacting the neck 2406 with the heating element.

[0079] Furthermore, the heating and bending stages can be performed by an integrated heating-bending device in which the components necessary for heating the neck 2406 are integrated into the components for bending the neck 2406. Thus, heat can be applied before or after the bending process is completed, as well as during bending. The degree of heat, for example, the temperature applied to the neck 2406, can remain constant during the heating and / or heating-bending process by ensuring that the temperature of the heating element remains substantially constant and the distance between the heating element and the neck 2406 remains substantially constant. Alternatively, the temperature of the neck 2406 can be changed during the bending process. For example, the temperature of the neck can be increased to a set threshold temperature before applying the bend and then decreased to a set threshold, and then increased again after the bending process (for example, to avoid micro-fracture). When the heating element is incorporated into the bending device, the process may include a step of increasing or decreasing the temperature of the neck 2406 while the neck 2406 is being bent.

[0080] In addition, after bending the neck 2406 to form a desired angle, the manufacturing or handling of the sensor 104 may include a step to verify the integrity of the sensor 104 by inspecting the neck 2406 for micro-fractures after bending. In some embodiments, the neck 2406 can be inspected for micro-fractures by using capacitance testing to determine whether the capacitance of the neck 2406 under test has changed from a reference capacitance. If the number or intensity of micro-fractures exceeds a predetermined threshold, the sensor may be discarded. Other integrity tests may include a step to inspect the delicate components of the sensor 104 to ensure that they remain in a form that conforms to their intended function and have not deteriorated during the bending process.

[0081] Figures 14A and 14B are a bottom perspective and a top perspective, respectively, illustrating exemplary embodiments of a sensor module assembly including a sensor module 504, a connector 2300, and a sensor 104. In one aspect of the embodiments described above, during or after insertion, the sensor 104 may be subjected to an axial force that pushes it proximal into the sensor module 105, as shown by force F1 in Figure 14A. In some embodiments, this axial force may result in a harmful force F2 applied to the neck 2406 of the sensor 104, and consequently, a harmful force F3 transferred to the service loop 2420 of the sensor 104. In some embodiments, for example, the axial force F1 may arise as a result of a sensor insertion mechanism designed to push the sensor itself through tissue, a sharp body retraction mechanism during insertion, or as a physiological response achieved by the tissue surrounding the sensor 104 (e.g., after insertion).

[0082] Figures 15A and 15B are enlarged sub-views of exemplary embodiments of a sensor module assembly having certain axially reinforced features. In a general sense, the embodiments described herein relate to mitigating the effects of axial forces on a sensor as a result of an insertion and / or retraction mechanism or from physiological responses to a sensor in the body. As can be seen in Figures 15A and 15B, in one aspect of these embodiments, the sensor 3104 includes a proximal portion having a hook feature 3106 configured to engage with a catch feature 3506 of the sensor module 3504. In some embodiments, the sensor module 3504 may further include a clearance area 3508 to allow the distal portion of the sensor 3104 to bend during assembly in order to allow the assembly of the hook feature 3106 of the sensor 3104 to overlap and enter the catch feature 3506 of the sensor module 3504.

[0083] In another embodiment of the above-described model, the hook feature and catch feature 3106, 3506 operate in the following manner. The sensor 3104 includes a proximal sensor portion coupled to the sensor module 3504 as described above, and a distal sensor portion positioned beneath the skin surface in contact with bodily fluids. As can be seen in Figures 15A and 15B, the proximal sensor portion includes a hook feature 3106 adjacent to the catch feature 3506 of the sensor module 3504. During or after sensor insertion, one or more forces are applied proximal to the sensor 3104 along its longitudinal axis. In response to one or more forces, the hook feature 3106 engages with the catch feature 3506, preventing proximal displacement of the sensor 3104 along its longitudinal axis.

[0084] In another aspect of the above-described embodiment, the sensor 3104 can be assembled with the sensor module 3504 in the following manner. The sensor 3104 is loaded into the sensor module 3504 by laterally displacing the proximal sensor portion to bring the hook feature portion 3106 closer to the catch feature portion 3506 of the sensor module 3504. More specifically, the step of laterally displacing the proximal sensor portion involves moving the proximal sensor portion into the clearance area 3508 of the sensor module 3504.

[0085] Figures 15A and 15B show the hook feature 3106 as part of the sensor 3104 and the catch feature 3506 as part of the sensor module 3504, but those skilled in the art will recognize that the hook feature 3106 can instead be part of the sensor module 3504, and likewise the catch feature 3506 can instead be part of the sensor 3106. Similarly, those skilled in the art will recognize that other mechanisms (e.g., locks, latches, fasteners, screws, etc.) implemented on the sensor 3104 and the sensor module 3504 to prevent axial displacement of the sensor 3104 are possible and also within the disclosure of the present invention.

[0086] Figure 15C is a side view of an exemplary sensor 11900 according to one or more embodiments of the disclosure of the present invention. The sensor 11900 can be similar in some respects to any of the sensors described herein and can therefore be used in a sample monitoring system for detecting a specific sample concentration. As shown, the sensor 11900 includes a tail 11902, a flag 11904, and a neck 11906 interconnecting the tail 11902 and the flag 11904. The tail 11902 contains an enzyme or other chemical or biological agent, and in some embodiments a thin layer can cover the chemical agent. During use, the tail 11902 is received transdermally under the user's skin, and the chemical agent contained on the tail 11902 helps facilitate sample monitoring in the presence of body fluids.

[0087] The tail 11902 can be received within a hollow or recessed portion of a pointed body (not shown) that at least partially surrounds the tail 11902 of the sensor 11900. As shown, the tail 11902 can extend at a location offset by an angle Q from the horizontal. In some embodiments, the angle Q can be about 85°. Thus, in contrast to other sensor tails, the tail 11902 does not extend vertically from the flag 11904, but instead can extend at a location offset by an angle from the vertical. This angle offset can be demonstrated to be advantageous in that it helps to keep the tail 11902 within a recessed portion of the pointed body.

[0088] The tail 11902 includes a first end or bottom end 11908a and an upper end 11908b opposite to it. A tower 11910 may be provided at or near the upper end 11908b, which allows the neck 11906 to extend vertically in an improved direction from where it interconnects the tail 11902 with the flag 11904. If the pointed body moves laterally during operation, the tower 11910 will help pivot the tail 11902 toward the pointed body and otherwise keep it within the recessed portion of the pointed body. Furthermore, in some embodiments, the tower 11910 may provide or otherwise specify a projection 11912 extending laterally from there. When the sensor 11900 is mated with the pointed body and the tail 11902 extends within the recessed portion of the pointed body, the projection 11912 may engage with the inner surface of the recessed portion. During operation, the projection 11912 can help keep the tail 11902 within the recessed portion.

[0089] Flag 11904 may include a substantially flat surface on which one or more sensor contacts 11914 are positioned. The sensor contacts 11914 may be configured to align with a corresponding number of flexible carbon-impregnated polymer modules enclosed within the connector.

[0090] In some embodiments, as shown in the figure, the neck 11906 may provide a recess or bend 11916 extending between the flag 11904 and the tail 11902, or may be otherwise defined. The bend 11916 may demonstrate advantages in that it adds flexibility to the sensor 11900 and helps prevent bending of the neck 11906.

[0091] In some embodiments, a notch 11918 (shown by a dashed line) can be optionally defined near the neck 11906 within the flag. The notch 11918 can add flexibility and tolerance to the sensor 11900 when it is mounted. More specifically, the notch 11918 can help absorb any interference forces that may occur when the sensor 11900 is mounted.

[0092] In some embodiments, as shown in Figures 15D to 15G, the neck may include or be otherwise defined a nonlinear configuration such as recesses or bends 11920a to 11920d having multiple windings, for example, 11921a, 11921b, between the flag 11904 and the tail 11902. The bends 11920a to 11920d can be advantageous in reducing the positional rigidity of the sensor 11900 by adding flexibility to the sensor 11900 in both the vertical and horizontal directions. The added flexibility can provide a multidirectional spring-like structure within the sensor 11900 that helps limit the deformation of the neck 11906 while ensuring that the tail 11902 and flag 11904 can remain in their expected or fixed positions. The spring-like structure also increases the flexibility of the sensor 11900 while reducing stress on the overall structure.

[0093] Generally, a sensor can be understood as comprising a tail, a flag, and a neck aligned along a flat plane having a vertical axis and a horizontal axis. A spring-like structure can be formed by windings in various orientations at the bend of the sensor's neck. Between the tail and the flag, the neck can include at least two windings relative to the vertical axis to give a spring-like structure. At least two windings can provide an overlapping layer of the neck structure with respect to the axis of the flat plane shared by the tail, the flag, and the neck, where the neck itself remains undamaged. These overlapping windings constitute the spring-like structure. In some embodiments, the overlapping layer of the neck is oriented vertically. In some embodiments, the overlapping layer of the neck is oriented horizontally.

[0094] Figure 15D shows one embodiment of a sensor 11900 that includes a neck having a bent portion 11920a with windings 11921a and 11921b between the flag 11904 and the tail 11902. In the illustrated embodiment, at least one winding 11921a abuts the upper end of the tail or optionally the tower 11910 of the sensor 11900. This orientation can be advantageous in reducing the overall footprint of the sensor, even considering yet another material used to generate the bent portion 11920a. This arrangement can provide multiple overlapping horizontal layers that are vertically aligned between the windings.

[0095] Figure 15E shows another embodiment of the sensor 11900, which includes a neck having a bend 11920b that substantially forms a vortex winding pattern between the flag 11904 and the tail 11902, including at least windings 11923a, 11923b, and 11923c. In this embodiment, the windings also abut the upper end of the tail or the tower 11910 of the sensor 11900. In addition to maintaining the overall footprint of the sensor, this orientation can allow for additional balancing of horizontal and vertical stresses. The overlapping layers in this winding arrangement are substantially balanced along both the horizontal and vertical axes.

[0096] Figure 15F shows another embodiment of the sensor 11900, which includes a neck having a bend 11920c with windings 11925a, 11925b, and 11925c between the flag 11904 and the tail 11902. In the illustrated embodiment, winding 11925c connects the portion of the sensor's tail 11902 closer to its upper end or tower 11910 to the remainder of the bend 11920c. In addition to reducing the overall footprint of the sensor, this orientation can provide additional flexibility along a horizontally oriented axis. This arrangement can provide multiple overlapping vertical layers horizontally aligned between the windings.

[0097] Figure 15G shows another embodiment of the sensor 11900, which includes a neck having a bend 11920d with windings 11927a, 11927b, and 11927c between the flag 11904 and the tail 11902. In the illustrated embodiment, the bend 11920d occurs primarily within the tail 11902 of the sensor, connecting the tail 11902 to the tower 11910, with the extension of the sensor between the tower 11910 and the flag 11904 being substantially continuous. Winding 11927a connects the tower 11910 entirely to the remainder of the bend 11920d, and winding 11927c connects the tail 11902 to the remainder of the bend 11920d. This orientation can provide additional flexibility with vertically oriented axes. This arrangement can provide multiple overlapping vertical layers horizontally aligned between the windings.

[0098] The neck winding can be formed by folding or bending the sensor neck from a larger neck structure, laser cutting the sensor from a sheet or layer of material comprising the sensor, printing a sensor having a winding configuration onto a sheet or layer of material comprising the sensor, punching out the sensor from a sheet or layer of material comprising the sensor, or other manufacturing process suitable for providing a high-precision bend within the neck.

[0099] Figures 16A and 16B are isometric and partially exploded isometric views of an exemplary connector assembly 12000 according to one or more embodiments. As shown, the connector assembly 12000 may include a connector 12002, and Figure 17C is an isometric bottom view of the connector 12002. The connector 12002 may include injection-molded portions used to help secure one or more flexible carbon-impregnated polymer modules 12004 (four shown in Figure 16B) to the mount 12006. More specifically, the connector 12002 can help secure the module 12004 in place so as to be adjacent to the sensor 11900 and in contact with the sensor contact 11914 (Figure 15C) provided on the flag 11904 (Figure 15C). Module 12004 can be made of a conductive material to provide conductive communication between sensor 11900 and corresponding circuit contacts (not shown) provided in mount 12006.

[0100] As is most clearly seen in Figure 16C, the connector 12002 may define a pocket 12008 sized to receive the module 12004. Furthermore, in some embodiments, the connector 12002 may further define one or more recesses 12010 configured to mate into one or more corresponding flanges 12012 (Figure 16B) on the mount 12006. By mating the recesses 12010 with the flanges 12012, the connector 12002 can be secured to the mount 12006 by a crimp fit or the like. In other embodiments, the connector 12002 can be secured to the mount 12006 using adhesive or by ultrasonic welding.

[0101] Figures 16D and 16E are isometric and partially exploded isometric views of another exemplary connector assembly 12100 according to one or more embodiments. As shown, the connector assembly 12100 may include a connector 12102, and Figure 16F is an isometric bottom view of the connector 12102. The connector 12102 may include injection-molded portions used to help keep one or more flexible metal contacts 12104 (four shown in Figure 16E) fixed in contact with the sensor 11900 on the mount 12106. More specifically, the connector 12102 can help fix the contacts 12104 in place so as to be adjacent to the sensor 11900 and in contact with the sensor contact 11914 (Figure 15C) provided on the flag 11904. The contact 12104 can be manufactured from a punched conductive material that provides conductive communication between the sensor 11900 and a corresponding circuit contact (not shown) located within the mount 12106. In some embodiments, for example, the contact 12104 can be soldered to a PCB (not shown) located within the mount 12106.

[0102] As is most clearly seen in Figure 16F, the connector 12102 may have a pocket 12108 sized to receive the contact 12104. Furthermore, in some embodiments, the connector 12102 may further have one or more recesses 12110 configured to mate into one or more corresponding flanges 12112 (Figure 120B) on the mount 12006. Machining the recesses 12110 with the flanges 12112 helps to secure the connector 12102 to the mount 12106 by a press fit or the like. In other embodiments, the connector 12102 may be secured to the mount 12106 using adhesive or by ultrasonic welding.

[0103] Exemplary Embodiment of a Sharp Body Module Figure 17A is a perspective view depicting an exemplary embodiment of the sharp body module 2500 before assembly into the sensor module 504 (Figure 6B). The sharp body 2502 may include a distal tip 2506 that can penetrate the skin while transporting the sensor within the hollow or recessed portion of the sharp body shaft 2504 to bring the active surface of the sensor tail into contact with bodily fluids. The hub pressing cylinder 2508 may provide a surface for the sharp body carrier to press against during insertion. The hub small cylinder 2512 may provide space for the extension of the sharp body hub contact surface 1622 (Figure 10B). The hub snap claw positioning cylinder 2514 may provide a distally facing surface of the hub snap claw 2516 for the sharp body hub contact surface 1622 to contact. The hub snap claw 2516 may include a conical surface that opens the clip 1620 during installation of the sharp body module 2500.

[0104] Figures 17B to 17H illustrate exemplary embodiments of a pointed body module at various assembly stages suitable for use during insertion of a skin specimen sensor. In one aspect of these embodiments, angling the sensor and / or insertion pointed body relative to a reference point can enable colocalization of the tip of the insertion needle and the tip of the sensor, and further, can create a single contact point on the skin surface. Thus, the pointed body can create a leading edge on the skin surface to form an insertion path for the sensor into the dermis when the sensor is inserted into the subject. In some embodiments, for example, the pointed body and / or skin sensor can be angled relative to a reference point (e.g., each other, a skin surface, or the base of the applicator) so that the angle of the pointed body is different from the angle of the sensor, making it suitable for insertion. For example, the reference point can be a skin surface to be opened for skin insertion, or a reference part or component of a sensor applicator set. In some embodiments, the pointed body can be positioned at a certain angle to the sensor. For example, when the pointed body is designed to be angled relative to the sensor, the needle generates a leading edge for the sensor during operation of the applicator set. Furthermore, the needle design itself and the positioning of the needle relative to the sensor can be implemented in any desirable configuration, including all of the configurations disclosed in U.S. Patent Publication No. 2014 / 0171771, the entire content of which is incorporated herein by reference for all purposes.

[0105] Furthermore, while many of the exemplary embodiments described with respect to Figures 17B to 17J are described in relation to skin specimen sensors and skin insertions, those skilled in the art will understand that all of these embodiments can be sized and configured to be suitable for use with specimen sensors that can be positioned in (or even beyond) the skin space, such as in subcutaneous tissue (e.g., 3 to 10 mm below the skin surface depending on the location of the skin on the body) or even completely penetrating it.

[0106] Figure 17B is a perspective view depicting an exemplary embodiment of a pointed body module 2550 that can be used for inserting a skin sensor. This figure shows the pointed body module 2550 before assembly with the sensor module 504 (Figure 6B), and the pointed body module 2550 may include components similar to those of the embodiment described with respect to Figure 17A, including a pointed body 2552, a pointed body shaft 2554, a pointed body distal tip 2556, a hub pressing cylinder 2558, a hub mini cylinder 2562, a hub snap claw 2566, and a hub snap claw positioning cylinder 2564. The pointed body 2552 can be positioned within the pointed body module 2550 at an eccentric location with respect to the longitudinal axis 2545 extending through the centers of the hub snap claw 2566, the hub mini cylinder 2562, and the hub pressing cylinder 2558. Furthermore, the pointed body module 2550 may include a pointed body spacer 2568 that is parallel to and adjacent to a portion of the pointed body 2552. The pointed body spacer 2568 can be positioned between the sensor 104 (not shown) and the pointed body 2552 along the proximal portion of the pointed body 2552, ensuring that the sensor 104 and the pointed body 2552 remain separated at the proximal portion of the pointed body 2552. The pointed body 2552 can be positioned at an eccentric location during the molding process with hub components 2558, 2562, and 2566, each of which may be made of rigid plastic material.

[0107] Figures 17C and 17D are two side views depicting the pointed body module 2550 before assembly with the sensor module 504 (Figure 6B), which includes the pointed body 2552, a spacer 2568, a hub pressing cylinder 2558, a hub small cylinder 2562, and a hub snap claw 2566. In some embodiments, the relative distances between the pointed body 2552 and the hub components can be arranged as follows: For example, the distance Si between the pointed body 2552 and the radial center of the hub can range from 0.50 mm to 1 mm (e.g., 0.89 mm). The height S2 of the pointed body spacer 2568 can range from 3 mm to 5 mm (e.g., 3.26 mm). The height S3 of the hub can range from 5 mm to 10 mm (e.g., 6.77 mm). The length S4 of the pointed body 2552 can range from 1.5 mm to 25 mm (e.g., 8.55 mm) and can be based on the location of the insertion site on the subject.

[0108] Figure 17E shows a cross-sectional side view of the sharp body module 2550 assembled with the sensor module 504, including the sharp body 2552, the sharp body spacer 2568, and the hub components (hub snap claw 2566, hub small cylindrical body 2562, and hub pressing cylindrical body 2558). As can be seen in Figure 17E, the sharp body 2552 is positioned within the sharp body slot 2208 of the sensor module 504, which includes a curved inner surface 2250 located at its distal end. The curved inner surface 2250 of the sensor module 504 is in contact with a portion of the sharp body 2552, which can result in a deflection such that the distal tip 2556 of the sharp body is oriented toward the central longitudinal axis 2545. As is most clearly seen in Figure 17H, the sharp body 2552 can be positioned to form an acute angle So where the distal portion and the central longitudinal axis 2545 can span a range between 5° and 20°. In some embodiments, for example, So can range from 5° to 17°, 7° to 15°, or 9° to 13°, for example, 9°, 10°, 11°, 12°, or 13°.

[0109] Continuing with Figure 17E, near the distal end of the sensor module 504 is a projection 2251 that can facilitate the perfusion of bodily fluids such as dermal fluid. Although shown as a curved surface in Figure 17E, the projection 2251 can be shaped in any desired manner. Furthermore, in some embodiments, multiple projections may be present. U.S. Patent Publication 2014 / 0275907, whose entire contents are incorporated herein by reference for all purposes, describes sensor devices having various projection configurations, each of which can be implemented in the embodiments described herein. Many of the embodiments described herein show a needle that emerges from the projection, while in other embodiments, the needle may be drawn out from the base of the sensor device adjacent to the projection and extend from this position over the tip of the sensor 104.

[0110] Continuing to refer to Figures 17E and 17F, the sensor 104 can be a skin sensor and may include a sensor tail 2408 positioned at the distal end of the sensor 104 and oriented substantially parallel to the central longitudinal axis 2545. The distal end of the sensor tail 2408 may be located proximal to the distal tip 2556 of the sharp body shaft 2554 in a static separation relationship, either within or in contact with a portion of the sharp body shaft 2554. As further shown in Figure 17E, the sharp body spacer 2568 provides a separation relationship between the proximal portion of the sharp body 2552 and the sensor 104 so that the proximal portion of the sharp body 2552 does not come into contact with the sensor 104. The sensor module 504 may further include a sensor connector 2300 for housing the proximal portion of the sensor 104 that is relatively perpendicular to the distal end of the sensor 104.

[0111] Figure 17F is a top cross-sectional view of the sensor module 504. The sensor module 504 may include one or more sensor module snaps 2202 for coupling with a housing (not shown) of the sensor control device 102. The sensor module 504 may further include a sensor connector 2300 which may have sensor contacts 2302 for coupling with the proximal portion of the sensor 104. The sensor connector 2300 may be made of silicone rubber enclosing a flexible carbon-impregnated polymer module that acts as a conductive contact 2302 between the sensor 104 and the electrical circuit contacts for the electronics in the sensor control device 102. The connector may act as a moisture barrier to the sensor 104 when assembled in a compressed state after transfer from the container to the applicator and after application to the user's skin. Although three contacts 2302 are shown, it should be understood that the connector 2300 may have fewer (e.g., two) or more (e.g., four, five, six, etc.) contacts depending on the particular type or configuration of the sensor 104. The sensor connector 2300 can be further coupled to the sensor module 504 by two connector posts 2206 arranged to pass through a similar number of openings inside it. Although two connector posts 2206 are shown, it should be understood that any number of connector posts 2206 can be used to couple the connector 2300 to the sensor module 504.

[0112] Figures 17G and 17H are perspective and side views, respectively, of another exemplary embodiment 2600 of a pointed body module that can be used for inserting a skin sensor. These figures show the pointed body module 2600 before assembly with sensor module 504 (Figure 6B), and the pointed body module 2600 may include components similar to those described with respect to Figures 17A and 17B, including a pointed body 2602, a pointed body shaft 2604, a pointed body distal tip 2606, a hub pressing cylinder 2608, a hub small cylinder 2612, a hub snap claw 2616, and a hub snap claw positioning cylinder 2614. In some embodiments, the pointed body 2602 may be a “pre-bent” needle that extends from an external point of the pointed body module 2600 and intersects at an angle at the center point of the hub (e.g., through the hub pressing cylinder 2608) and includes a proximal portion 2603. The pointed body 2602 may further include a distal portion 2605 that extends distally at an angle from a point near the distal portion of the hub toward the insertion point of the user's skin. As shown in Figure 17H, the pointed body 2602 may include a bent portion 2607 positioned outside the hub pressing cylinder 2608, which may have a substantially 90° angle between the proximal portion 2603 and the distal portion 2605 of the pointed body 2602. The pointed body module 2600 may further include a bend fin guide 2620 for maintaining the “pre-bent” pointed body 2602 in place during assembly and / or use, which can prevent lateral or rotational movement of the pointed body 2602 relative to the hub components. The proximal portion 2603 of the pointed body 2602 may be “trimmed” from the hub after the molding process is complete and before assembly of the pointed body module 2600 with the sensor module 504.

[0113] Figures 17I and 17J are a side cross-sectional view and a side view, respectively, of the pointed body module 2600 (including a hub snap claw 2616, a hub small cylindrical body 2612, and a hub pressing cylindrical body 2608) assembled with the sensor module 504. As can be seen in Figure 17I, the sensor module 504 includes a pointed body slot 2208 that allows the pointed body 2602 to extend through the inclined distal direction. As described above, the proximal portion of the pointed body 2602 passes through a bent fin guide 2620 coupled to the distal portion of the sensor module 504. The sensor module 504 may further include a sensor 104 which can be a skin sensor. As shown in Figure 17I, the pointed body 2602 and the sensor tail 2408 can form an acute angle So at the point where their respective longitudinal axes converge. The angle So can range between 5° and 20°. In some embodiments, for example, So can range from 5° to 17°, 7° to 15°, or 9° to 13°, e.g., 9°, 10°, 11°, 12°, or 13°. In some embodiments, the distal sharp tip 2606 is located at a distance S6 proximal to the end of the sensor tail 2408. The distance S6 can range from 0.02 mm to 0.10 mm, e.g., 0.05 mm, 0.06 mm, or 0.07 mm.

[0114] Continuing with reference to Figures 17I and 17J, the sensor module 504 may further include a sensor connector 2300 for housing the proximal portion of the sensor 104, which is relatively perpendicular to the distal end of the sensor 104. The sensor module 504 may include one or more sensor module snaps 2202 for coupling with a housing (not shown) of the sensor control device 102. The sensor connector 2300 may include the same structure as described with respect to Figure 17F.

[0115] In the embodiments described above, the pointed body is manufactured from stainless steel or a similar flexible material (e.g., a material used to manufacture acupuncture needles) and can be sized to allow the applicator to insert at least a portion of the skin sensor into the cutaneous layer of the skin but not penetrate it. In certain embodiments, the pointed body has a cross-sectional diameter (width) of 0.1 mm to 0.5 mm. For example, the pointed body can have a diameter of 0.1 mm to 0.3 mm, such as 0.15 mm to 0.25 mm, or a diameter of 0.16 mm to 0.22 mm. A given pointed body can have a constant, i.e., uniform width along its entire length, or it can have a varying, i.e., variable width along at least a portion of its length, such as the tip portion used to penetrate the surface of the skin. For example, in relation to the embodiment shown in Figure 17I, the width of the pointed body 2602 can be reduced along the distal portion between the bent fin guide 1620 and the distal pointed body tip 2606.

[0116] The pointed body can have a length that allows the skin sensor to be inserted only slightly into the skin layer, but not further. The insertion depth can be controlled by the length of the pointed body, the configuration of the base and / or other applicator components that limit the insertion depth. The pointed body can have lengths between 1.5 mm and 25 mm. For example, the pointed body can have lengths 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, 23 mm to 25 mm, or longer than 25 mm. The pointed body can have lengths up to 25 mm, but in certain embodiments, it will be understood that the entire length of the pointed body will not be inserted into the subject, as it is thought to extend beyond the skin space. The non-insertable pointed body length allows for handling and manipulation of the pointed body in the applicator set. Therefore, the sharpened body can have a length of up to 25 mm, but in certain embodiments described above, the insertion depth of the sharpened body into the skin on the subject is limited to the dermal layer, and will be limited to about 1.5 mm to 4 mm depending on the location of the skin, for example, as will be described in more detail below. However, in all embodiments disclosed herein, the sharpened body can be configured to extend beyond the skin space, such as into the subcutaneous tissue (for example, 3 mm to 10 mm below the skin surface, depending on the location of the skin on the body). Furthermore, in some exemplary embodiments, the sharpened body described herein may include a hollow or partially hollow insertion needle having an internal space or lumen. However, in other embodiments, the sharpened body described herein may include a solid insertion needle without an internal space or lumen. Furthermore, the sharpened body of the subject applicator set may be bladed or bladeless.

[0117] Similarly, in the embodiments described above, the skin sensor is sized such that at least a portion of it is positioned in the dermis and not beyond it, and in the transdermal positioning embodiments, a portion of it extends outside the skin. That is, the skin sensor is sized such that when it is fully or substantially fully inserted into the dermis, the distal portion of the sensor (insertion portion or insertion length) is positioned within the subject's dermis, and when the sensor is operably positioned in the skin, no portion of the sensor is inserted beyond the subject's dermis.

[0118] Since the depth and thickness of the epidermis and dermis vary to some extent depending on the location of the skin, the dimensions of the sensor (e.g., length) can be selected according to the body part of the subject into which the sensor is inserted. For example, the epidermis is only about 0.05 mm thick in the eyelids, but about 1.5 mm thick in the palms and soles of the feet. The dermis is the thickest of the three layers of skin, ranging in thickness from about 1.5 mm to 4 mm depending on the location of the skin. When implanting the distal end of the sensor, which enters the dermal layer of the subject but does not penetrate it, the length of the insertion portion of the skin sensor must be longer than the thickness of the epidermis, but must not exceed the combined thickness of the epidermis and dermis. This method includes the steps of determining the insertion site on the user's body, determining the depth of the dermal layer at that site, and selecting an applicator of a size appropriate for that site.

[0119] In certain embodiments, the sensor is an elongated sensor having a maximum dimension (or "length") of 0.25 mm to 4 mm. The length of the inserted sensor ranges from 0.5 mm to 3 mm, such as 1 mm to 2 mm, in embodiments where only a portion of the sensor is inserted into the skin, for example, 1.5 mm. The dimensions of the sensor can be expressed using the aspect ratio of the sensor. In certain embodiments, the skin sensor has a length-to-width (diameter) aspect ratio ranging from about 30:1 to about 6:1. For example, the aspect ratio can range from about 25:1 to about 10:1, including 20:1 and 15:1. The inserted portion of the skin sensor contains a sensing chemical substance.

[0120] However, all embodiments disclosed herein are configured such that at least a portion of the sensor is positioned beyond the cutaneous layer, for example, in (or through) the subcutaneous tissue (or fat). For example, the sensor can be sized such that when it is fully or substantially fully inserted into the body, its distal portion (insertion portion or insertion length) is positioned in the subcutaneous tissue (beyond the dermis of the subject), and when the sensor is operably positioned, no portion of the sensor is inserted beyond the subcutaneous tissue of the subject. As described above, the subcutaneous tissue is generally located in the region 3 mm to 10 mm below the epidermis, depending on the location of the skin on the body.

[0121] Exemplary Embodiments of Applicators and Sensor Control Devices for One-Piece Architectures Referring again briefly to Figures 1 and 3A-3G, in a two-piece architecture system, the sensor tray 202 and sensor applicator 102 are provided to the user as separate packages, and therefore the user is required to unpack each package and ultimately assemble the system. In some applications, these separate sealed packages allow the sensor tray 202 and sensor applicator 102 to be sterilized in separate sterilization processes that are unique to the contents of each package and cannot be shared with the contents of others. More specifically, the sensor tray 202, which includes the sensor 110 and the plug assembly 207 containing the sharp body 220, can be sterilized using radiation sterilization such as electron beam (or "e-beam") irradiation. However, radiation sterilization may damage the electrical components located within the electronic housing of the sensor control device 102. Consequently, if the sensor applicator 102, which includes the electronic housing of the sensor control device 102, needs to be sterilized, it can be sterilized by another method, such as gas chemical sterilization using ethylene oxide. However, gas chemical sterilization may damage enzymes or other chemical and biological agents contained on the sensor 110. Due to this sterilization non-shared nature, the sensor tray 202 and sensor applicator 102 are typically sterilized in separate sterilization processes and then individually packaged, requiring the user to assemble the components for final use.

[0122] In embodiments of the disclosure of the present invention, the sensor control device 102 can be modified to provide a one-piece architecture that can offer sterilization technology specifically designed for a one-piece architecture sensor control device. The one-piece architecture allows the sensor applicator 150 and the sensor control device 102 to be shipped to the user in a single sealed package that does not require any final user assembly stage. In other words, the user only needs to unpack one package and then deliver the sensor control device 102 to the target monitoring location. The one-piece system architecture described herein can be demonstrated to be advantageous by eliminating component parts, various processing stages, and user assembly stages. As a result, packaging and waste are reduced, and user error or system contamination is mitigated.

[0123] Figures 18A and 18B are isometric and side views, respectively, of another exemplary sensor control device 5002 according to one or more embodiments of the disclosure of the present invention. The sensor control device 5002 can be similar in some respects to the sensor control device 102 of Figure 1, and can therefore be best understood by referring to it. Furthermore, the sensor control device 5002 can replace the sensor control device 102 of Figure 1, and can therefore be used in conjunction with the sensor applicator 102 of Figure 1, which can deliver the sensor control device 5002 to a target monitoring location on the user's skin.

[0124] However, unlike the sensor control device 102 in Figure 1, the sensor control device 5002 can have a one-piece system architecture that does not require the user to unpack multiple packages and finally assemble the sensor control device 5002 before attachment. In other words, upon receiving the package from the user, the sensor control device 5002 is already fully assembled and properly positioned within the sensor applicator 150 (Figure 1). To use the sensor control device 5002, the user only needs to open one barrier (e.g., the applicator cap 708 in Figure 3B) before immediately sending the sensor control device 5002 to the target monitoring location for use.

[0125] As shown in the figure, the sensor control device 5002 includes an electronic equipment housing 5004 which may be substantially disc-shaped and have a circular cross-section. However, in other embodiments, the electronic equipment housing 5004 may exhibit other cross-sectional shapes, such as oval or polygonal, without departing from the scope of the disclosure of the present invention. The electronic equipment housing 5004 may be configured to house or otherwise enclose various electrical components used to operate the sensor control device 5002. In at least one embodiment, an adhesive patch (not shown) may be placed at the bottom of the electronic equipment housing 5004. The adhesive patch may be similar to the adhesive patch 105 in Figure 1 and thus can help to adhere the sensor control device 5002 to the user's skin for use.

[0126] As shown in the figure, the sensor control device 5002 includes an electronic housing 5004 which includes a shell 5006 and a mount 5008 to which it can be mated. The shell 5006 can be fastened to the mount 5008 by a variety of methods such as snap engagement, interlocking fit, ultrasonic welding, one or more mechanical fasteners (e.g., screws), gaskets, adhesives, or any combination thereof. In some cases, the shell 5006 can be fastened to the mount 5008 such that a sealed interface is created between the two mounts 5008.

[0127] The sensor control device 5002 may further include a sensor 5010 (partially visible) and a pointed body 5012 (partially visible) used to help deliver the sensor 5010 transcutaneously under the user's skin during attachment of the sensor control device 5002. As shown in the figure, the corresponding portions of the sensor 5010 and the pointed body 5012 extend distally from the bottom of the electronic equipment housing 5004 (e.g., mount 5008). The pointed body 5012 may include a pointed body hub 5014 configured to fix and support it. As is most clearly seen in Figure 18B, the pointed body hub 5014 may include a mating member 5016 or otherwise be defined. To connect the pointed body 5012 to the sensor control device 5002, the pointed body hub 5014 engages with the upper surface of the shell 5006, allowing the fitted member 5016 to advance the pointed body 5012 axially through the electronic equipment housing 5004 until it extends distally from the bottom of the mount 5008. Once the pointed body 5012 penetrates the electronic equipment housing 5004, the exposed portion of the sensor 5010 can be received into the hollow or recessed (arc-shaped) portion of the pointed body 5012. The remainder of the sensor 5010 is then positioned within the electronic equipment housing 5004.

[0128] The sensor control device 5002 may further include a sensor cap 5018, which is shown in Figures 18A and 18B as being disassembled or detached from the electronic housing 5004. The sensor cap 5016 may be removably coupled to the sensor control device 5002 (e.g., the electronic housing 5004) at or near the bottom of the mount 5008. The sensor cap 5018 may help provide a sealing barrier that surrounds and protects the exposed portions of the sensor 5010 and the sharp body 5012 from gas chemical sterilization. As shown, the sensor cap 5018 may include a substantially cylindrical body having a first end 5020a and a second end 5020b opposite it. The first end 5020a may be made open to provide access to an inner chamber 5022 defined within the body. In contrast, the second end 5020b may be closed to provide an engaging feature 5024 or otherwise defined. As described herein, the engaging feature 5024 can assist in fitting the sensor cap 5018 onto the cap of the sensor applicator (e.g., the sensor applicator 150 in Figures 1 and 3A to 3G) (e.g., the applicator cap 708 in Figure 3B), and can assist in removing the sensor cap 5018 from the sensor control device 5002 when removing the cap from the sensor applicator.

[0129] The sensor cap 5018 can be detachably coupled to the electronic equipment housing 5004 at or near the bottom of the mount 5008. More specifically, the sensor cap 5018 can be detachably coupled to a mating member 5016 extending distally from the bottom of the mount 5008. In at least one embodiment, for example, the mating member 5016 may define a set of male threads 5026a (Figure 18B) that can mate with a set of female threads 5026b (Figure 18A) defined by the sensor cap 5018. In some embodiments, the male and female threads 5026a, 5026b may include a square thread design (e.g., lacking helical curvature) which can demonstrate advantages in forming these parts. Alternatively, the male and female threads 5026a, 5026b may include a helical thread engagement. Accordingly, the sensor cap 5018 can be screw-connected to the sensor control device 5002 at the location of the mating member 5016 of the sharp body hub 5014. In other embodiments, the sensor cap 5018 can be removably connected to the mating member 5016 by an interlocking fit, a friction fit, or other types of engagement including, but not limited to, fragile members or materials that can be broken by a small disengaging force (e.g., axial or rotational force).

[0130] In some embodiments, the sensor cap 5018 may include a single, integrally formed structure extending between a first end 5020a and a second end 5020b. However, in other embodiments, the sensor cap 5018 may include two or more component parts. In the illustrated embodiment, for example, the sensor cap 5018 may include a seal ring 5028 positioned at the first end 5020a and a desiccant cap 5030 positioned at the second end 5020b. The seal ring 5028 may help seal the inner chamber 5022, as will be described in more detail below. In at least one embodiment, the seal ring 5028 may include an elastomer O-ring. The desiccant cap 5030 may contain or provide a desiccant that helps maintain a preferred humidity level within the inner chamber 5022. Furthermore, the desiccant cap 5030 may define or otherwise provide the engaging feature portion 5024 of the sensor cap 5018.

[0131] Figures 19A and 19BF are exploded isometric top and bottom views, respectively, of the sensor control device 5002 according to one or more embodiments. The shell 5006 and mount 5008 act as opposing clamshell halves that enclose or substantially enclose various electronic components of the sensor control device 5002. More specifically, the electronic components may include, but are not limited to, a printed circuit board (PCB), one or more resistors, transistors, capacitors, inductors, diodes, and switches. The data processing unit and battery may be mounted on the PCB or may interact with the PCB. The data processing unit may include, for example, an application-specific integrated circuit (ASIC) configured to perform one or more functions or routines relating to the operation of the sensor control device 5002. More specifically, the data processing unit may be configured to perform data processing functions, where such functions may include, but are not limited to, filtering and encoding of multiple data signals, each corresponding to a user sample level. The data processing unit further includes an antenna for communicating with the reader device 120 (Figure 1) or may otherwise communicate with it. The battery can power the sensor control device 5002, more specifically the electronic components of the PCB. Although not shown, the sensor control device 5002 may include an adhesive patch that can be attached to the bottom 5102 (Figure 19BF) of the mount 5008 to help adhere the sensor control device 5002 to the user's skin for use.

[0132] The sensor control device 5002 provides, or may otherwise provide, a sealed subassembly including, among its constituent components, a shell 5006, a sensor 5010, a sharp body 5012, and a sensor cap 5018. The sealed subassembly of the sensor control device 5002 can help isolate the sensor 5010 and the sharp body 5012 within the inner chamber 5022 (Figure 19A) of the sensor cap 5018 during gas sterilization processes that may otherwise adversely affect chemical substances provided on the sensor 5010.

[0133] Sensor 5010 may include a tail 5104 extending from an opening 5106 (Figure 19BF) defined within the mount 5008 and received percutaneously under the user's skin. The tail 5104 may contain enzymes or other chemical agents that help facilitate sample monitoring. The pointed body 5012 may include a pointed tip 5108 that can extend through an opening 5110 defined by the shell 5006, the opening 5110 can be coaxially aligned with the opening 5106 of the mount 5008. Once the pointed tip 5108 penetrates the electronic housing 5004, the tail 5104 of sensor 5010 can be received in the hollow or recessed portion of the pointed tip 5108. The pointed tip 5108 may be configured to penetrate the skin while carrying the tail 5104, bringing the activating chemical agent of the tail 5104 into contact with bodily fluids.

[0134] The pointed tip 5108 can be advanced through the electronic equipment housing 5004 until the pointed hub 5014 engages with the upper surface of the shell 5006 and the mating member 5016 extends from the opening 5106 in the bottom 5102 of the mount 5008. In some embodiments, a sealing member (not shown), such as an O-ring or seal ring, may be sandwiched between the pointed hub 5014 and the upper surface of the shell 5006 to help seal the interface between these two components. In some embodiments, the sealing member may include a separate component part, but instead, it may form a single component of the shell 5006, such as a co-molded or overmolded component part.

[0135] The sealing subassembly may further include a collar 5112 positioned within the electronic equipment housing 5004 and extending at least partially into the opening 5106. The collar 5112 may be a substantially annular structure on which an annular ridge 5114 is defined or otherwise provided on its upper surface. In some embodiments, as shown, a groove 5116 may be defined within the annular ridge 5114, which may be configured to accommodate or otherwise receive a portion of the sensor 5010 that extends laterally within the electronic equipment housing 5004.

[0136] When assembling the sealed subassembly, the bottom 5118 of the collar 5112 can be exposed at the opening 5106, and the bottom 5118 can seal-engage with the first end 5020a of the sensor cap 5018, more specifically with the seal ring 5028. In contrast, the annular ridge 5114 at the top of the collar 5112 can seal-engage with the inner surface (not shown) of the shell 5006. In at least one embodiment, a sealing member (not shown) can be sandwiched between the annular ridge 5114 and the inner surface of the shell 5006 to form a sealed interface. In such an embodiment, the sealing member can extend (flow) into a groove 5116 defined within the annular ridge 5114, thereby sealing around the sensor 5010 that extends laterally within the electronic housing 5004. The sealing member may include, for example, an adhesive, a gasket, or an ultrasonic weld, and can help isolate enzymes and other chemical substances contained on the tail 5104.

[0137] Figure 20 is a cross-sectional side view of an assembled and sealed subassembly according to one or more embodiments. The sealed subassembly 5200 can form part of the sensor control device 5002 shown in Figures 18A-18B and 19A-20B and may include parts of the shell 5006, sensor 5010, pointed body 5012, sensor cap 5018, and collar 5112. The sealed subassembly 5200 can be assembled in various ways. In one assembly process, the pointed body 5012 can be coupled to the sensor control device 5002 by extending the pointed body tip 5108 through an opening 5110 defined on the top of the shell 5006 and advancing the pointed body 5012 through the shell 5006 until the pointed body hub 5014 engages with the top of the shell 5006 and the mating member 196 extends distally from the shell 5006. In some embodiments, as described above, the sealing member 5202 (e.g., an O-ring or a sealing ring) can be sandwiched between the pointed body hub 5014 and the upper surface of the shell 5006 to help seal the interface between these two components.

[0138] Next, the collar 5112 can be received on (around) the mating member 5016 and advanced toward the inner surface 5204 of the shell 5006, allowing the annular ridge 5114 to engage with the inner surface 5204. The sealing member 5206 can be sandwiched between the annular ridge 5114 and the inner surface 5204, thereby forming a sealing interface. The sealing member 5206 can extend (flow) into a groove 5116 (Figures 19A-20B) defined within the annular ridge 5114, thereby sealing around the sensor 5010 that extends laterally within the electronic equipment housing 5004 (Figures 19A-20B). However, in other embodiments, the collar 5112 can first seal against the inner surface 5204 of the shell 5006, and thereafter the pointed body 5012 and pointed body hub 5014 can extend through the opening 5110 as described above.

[0139] The sensor cap 5018 can be removably coupled to the sensor control device 5002 by screw-fitting the female thread 5026b of the sensor cap 5018 with the male thread 5026a of the fitting member 5016. By tightening (rotating) the mating engagement between the sensor cap 5018 and the fitting member 5016, the first end 5020a of the sensor cap 5018 can be pressed into a sealing engagement with the bottom 5118 of the collar 5112. Furthermore, by tightening the mating engagement between the sensor cap 5018 and the fitting member 5016, the sealing interfaces between the pointed hub 5014 and the upper part of the shell 5006, and between the annular ridge 5114 and the inner surface 5204 of the shell 5006 can be improved.

[0140] The inner chamber 5022 is sized to accommodate the tail 5104 and the pointed tip 5108, or can otherwise be configured to do so. Furthermore, the inner chamber 5022 can be sealed to isolate the tail 5104 and the pointed tip 5108 from substances that may potentially interact harmfully with the chemical agents of the tail 5104. In some embodiments, a desiccant 5208 (shown by the dashed line) may be present inside the inner chamber 5022 to maintain an appropriate humidity level.

[0141] Figures 40A–40H illustrate the steps of a manufacturing process for producing a sensor subassembly, also called a sealed subassembly, such as the sealed subassembly 5200 (see Figure 40H, Figure 20). In a particular embodiment, the assembled sensor subassembly 5200 may include a sensor 5010, a sensor mount 5008, a collar 5112, a pointed body 5012, and a sensor cap 5018. As described herein, the sensor 5012 may include a body temperature sensor, a blood pressure sensor, a pulse or heart rate sensor, a glucose level sensor, a specimen sensor, or a physical activity sensor. A variety of sensors may be included and adapted to these techniques using the sealed subassembly manufacturing techniques described herein, based on the electrical or chemical treatments used on the sensor to be applied or selected.

[0142] In the exemplary manufacturing step shown in Figure 40A, the sensor 5010 is mounted in the sensor mount 5008. Depending on the configuration of the sensor 5010, the sensor mount may include components that interfere with and stabilize the sensor 5010, such as flanges 4020, 12112 (see Figure 16E), 12104, etc., as described herein.

[0143] As shown in Figure 40B, the manufacturing process may include a step of dispensing adhesive into the mounting channel 4025 of the sensor mount 5008. The adhesive can be dispensed manually or using a suitable automated tool. For example, a specially configured tool having a dispensing valve for dispensing a predetermined amount of adhesive into the mounting channel 4025 can be used.

[0144] As shown in Figure 40C, the manufacturing process may include a step of loading the collar 5112 onto the sensor mount 5008. In particular, the collar 5112 is loaded so as to fit into the mounting channel 4025 of the sensor 5008. The collar can be loaded manually or using appropriate manufacturing tools, including a manually operated loading arm or robotic loading arm, a vacuum gripping arm or suction gripping arm, a magnetic gripping arm, an adaptive gripping arm or attachment, or other appropriate tools. The collar 5112 can then be fastened to the sensor mount 4025 to ensure that the collar 5112 seats properly within the sensor mount 4025 and to distribute adhesive through the sensor mount 4025 and the collar 5112. The collar 5112 can be fastened to the sensor mount 4025 using appropriate fastening tools, including linear slides, including manual fasteners, ratchet fasteners, electric slides, pneumatic slides, ball screw linear adapters, etc.

[0145] Next, as shown in Figure 40D, the adhesive is cured to fix the collar 5112 to the sensor mount 5008. The adhesive can include various curable adhesives suitable for use in high-throughput manufacturing environments. The adhesive used can be selected based on the curing method and curing time. For example, the adhesive can be selected to shorten the curing time and at the same time limit the exposure of the sensor 5010's chemically active materials or electronic components to excessive heat, chemicals, radiation, or excessive infrared or ultraviolet (and UV) light, which could impair the sensor's effectiveness. As an example, the adhesive can be a chemically curable adhesive. Here, the step of curing the adhesive is thought to include exposing the adhesive to one or more chemical bonding catalysts. As another example, the adhesive can be an aerobically curable adhesive. Here, the step of curing the adhesive is thought to include exposing the adhesive to a sufficient amount of air before the collar 5112 is mounted or before proceeding to the next step. As yet another example, the adhesive can be a thermosetting adhesive. Here, the step of curing the adhesive is considered to include a step of exposing the adhesive to ambient heat or a heating element for a predetermined amount of time. As another example, the adhesive may be a UV-curable adhesive. Here, the step of curing the adhesive is considered to include a step of using one or more UV light sources. The UV light sources may include, for example, UV light-emitting diodes (LEDs) arranged to cure the adhesive using a light conductor and multiple tilt spot LEDs. Figure 40D shows the locations where the adhesive is cured from above and below the sensor mount 5008 using multiple curing agent sources 4010.

[0146] In certain embodiments, during the curing of the adhesive, the collar 5112 and sensor mount 5008 can function to shield the sensor 5010 from exposure to the curing agent, which could otherwise damage the sensor 5010 or other components of the sealing subassembly 5200. Furthermore, the sensor 5010 can be further protected using other temporary components. For example, the collar 5112 can prevent exposure to chemical agents, heat, or UV light sources during the curing of the adhesive. Moreover, depending on the adhesive and curing method, the material including the sensor mount 5008 or the collar 5112 can be selected to partially allow the curing agent to selectively pass through to the adhesive.

[0147] As shown in Figure 40E, the manufacturing process may include a step of fitting the sharp body hub 5014 into the sensor mount 5008 and covering and fitting the sensor 5010. The step of fitting the sharp body hub 5014 into the sensor mount 5008 may include passing part or all of the sharp body 5012 through the opening 5110 and collar 5112 in the sensor mount 5008. In some embodiments, the manufacturing process may further include a step of inspecting the sharp body 5012 for defects. The inspection may be performed before or after inserting the sharp body hub 5014 into the sensor mount 5008. The inspection may be performed manually, for example, by loading the sharp body into a microscope or other magnifying device, allowing a human operator to check the condition of the sharp body. Alternatively, the inspection may be performed automatically, for example, by imaging the sharp body using a high-resolution camera, X-ray imaging, etc. Once the sharpened body 5012 has been imaged, the computer vision system can compare these images to acceptable sharpened bodies, or apply a machine learning model to the images to check the condition of the sharpened bodies. If the sharpened body is deemed to have defects, it can be discarded. In some embodiments, defects that may cause the sharpened body to be discarded include, but are not limited to, damage to the tip of the sharpened body (e.g., resulting in burrs or bites), debris on the sharpened body, and other similar damage.

[0148] As shown in Figure 40F, the manufacturing process may include the step of attaching the sensor cap 5018 to the sensor mount 5008 to cover the sensor 5010 and the sharp body 5012, thereby providing a sealed sensor subassembly 5200. In certain embodiments, the sensor cap 5018 may include a single structure. In other embodiments, the sensor cap 5018 may include multiple component parts. For example, as discussed herein, the sensor cap 5018 may include a desiccant cap 5030 or desiccant plug that contains a desiccant for controlling moisture exposure of the sensor 5010 and the sharp body 5012. The manufacturing process may include the step of assembling the sensor cap 5018 by inserting the desiccant into the desiccant cap 5030 and attaching the desiccant cap 5030 to the sensor cap 5018.

[0149] The step of attaching the sensor cap 5018 to the sensor mount 5008 can be performed by forcibly mating the sensor cap 5018 to the sensor mount 5008. For example, the sensor mount 5008 or the pointed body hub 5104 may define a set of male threads that can mate with the set of female threads defined by the sensor cap 5018. The male and female threads may include a square thread design (e.g., lacking helical curvature) which can demonstrate an advantage in forming these parts. The sensor cap 5018 may be removably coupled to the sensor mount 5018 by an interlocking fit or friction fit, or by other types of engagement including, but not limited to, fragile members or materials that can be broken by a small disengaging force (e.g., axial force or rotational force). The sensor cap 5018 may be manually locked in place, or it may be locked using a mechanical tool such as a pneumatic actuator, linear servo motor, or multi-axis servo motor to forcibly mate the sensor cap 5018 to the sensor mount 5008.

[0150] As shown in Figure 40G, the step of attaching the sensor cap 5018 to the sensor mount 5008 may include a step of twisting the sensor cap into place. The male and female threads may include a helical thread engagement. Thus, the sensor cap 5018 can be screwably coupled to the sensor mount 5008 or to the mating member of the pointed body hub 5014. Figure 40G shows the completed sensor subassembly 5200.

[0151] The manufacturing process may include a step of dispensing adhesive onto one or more surfaces of the sharp body hub 5014. For example, the manufacturing process may include a step of dispensing adhesive onto the upper surface of the sharp body hub 5014 while viewing the sensor subassembly 5200 with the sharp body cap 5018 facing downwards. The manufacturing process may include a step of dispensing adhesive onto the area of ​​the sharp body hub 5014 that interfaces with the sensor mount 5008. The process may further include a step of curing the adhesive. The curing of the adhesive allows the sharp body hub 5014 to be fixed to the sensor mount 5008. The curing of the adhesive can seal the sharp body hub to reduce leakage between the sharp body hub 5014 and the sharp body, improve the barrier between the sharp body and the environment, thereby creating a sterile barrier. The adhesive can be dispensed and cured in a manner similar to that in which the adhesive is dispensed into the mount channel 4025 and then cured. The adhesive can be used to secure the pointed hub 5014 to the sensor mount 5008. When cured, the adhesive can further improve the sealing of the sensor subassembly 5200.

[0152] The manufacturing process may further include a step of inspecting the sealed sensor subassemblies 5200 for leakage. The inspection can be performed using pressure decay leakage testing, vacuum decay leakage testing, tracer gas leakage testing, trace analysis testing, or mass flow leakage testing. In certain embodiments, the leakage testing can be automated using specialized mechanical tools to facilitate the inspection of individual sealed sensor subassemblies 5200 or the simultaneous inspection of multiple sealed sensor subassemblies. If a sealed sensor subassembly fails the leakage test, it can be discarded.

[0153] In a properly assembled state, the sealed subassembly 5200 can be subjected to a sterilization process such as one of the radiation sterilization processes referred to herein to properly sterilize the sensor 5010 and the sharp body 5012. The sterilization process may further include heat treatment, electron beam sterilization, gamma sterilization, X-ray sterilization, ethylene oxide sterilization, autoclave steam sterilization, chlorine dioxide gas sterilization, and hydrogen peroxide sterilization. In particular, the sterilization process may be configured with appropriate mechanical tools to facilitate the simultaneous sterilization of multiple sealed subassemblies 5200. For example, multiple sealed subassemblies 5200 can be loaded into a tray for subsequent sterilization.

[0154] This sterilization step can be carried out excluding the remainder of the sensor control device (Figures 18A-18B and 19A-20B) to prevent damage to delicate electrical components. The sealed subassembly 5200 can be sterilized before or after the sensor cap 5018 is coupled to the sharp body hub 5014. If the sensor cap 5018 is sterilized after it is coupled to the sharp body hub 5014, the sensor cap 5018 can be manufactured from a material that allows penetration and propagation of the sterilization element. In some embodiments, the sensor cap 5018 can be transparent or translucent, but can otherwise be opaque without departing from the scope of the disclosure of the present invention.

[0155] Figures 41A to 41J show the steps of an exemplary process for manufacturing the sensor control device 5002. In particular, Figures 41A to 41J show the steps for manufacturing the electronic equipment housing 5004. The sensor control device 5002 can be attached to the user's skin using an adhesive patch (e.g., adhesive patch 105) for use, while also housing the sensor 5010, and the sensor control device 5002 may optionally be called a wearable sensor pack assembly. The electronic equipment housing 5004 shown in Figures 41A to 41J includes a printed circuit board (PCB) 4100, a shell cap 5006, a sensor subassembly 5200, a sensor subassembly 5200 containing the sensor 5010, a sensor mount 5008 matable with the shell cap 5006, a collar 5112, and a sensor cap 5018.

[0156] Figures 41A and 41B show an exemplary PCB 4100 that can be used in the electronics housing 5004 of a wearable sensor pack assembly. PCB 4100 may include components such as an ASIC 4101, a battery 4103, and an antenna 4105. As shown, PCB 4100 can be a foldable or flexible PCB, but a non-foldable PCB can also be used. In a foldable PCB embodiment, the manufacturing process may include a step of folding PCB 4100 at folding points 4110 to fit the footprint of the mount 5008 and shell cap 5006 that define the overall footprint of the electronics housing 5004. Figure 41B shows PCB 4100 in the folding process. By folding PCB 4100, connections can be made between components of PCB 4100, for example, the battery 4103 can be connected to the appropriate battery terminals.

[0157] As shown in Figure 41C, the manufacturing process may include a step of dispensing adhesive 4120 onto the sensor mount 5008 of the sensor subassembly 5200. For example, the adhesive may be dispensed onto locations corresponding to components of the PCB 4100, such as folding sections, battery locations, or PCB connectors. The adhesive may be dispensed manually or using appropriate automated tools. For example, a specially configured tool having a dispensing valve for dispensing a predetermined amount of adhesive to designated locations on the sensor mount 5008 may be used. As described herein, the dispensing valve may be used in combination with other components for manipulating the sensor mount 5008 as needed before, during, and after dispensing. For example, the sensor mount 5008 may be rotated by a rotary motor to facilitate even distribution of the adhesive.

[0158] As shown in Figure 41D, the manufacturing process may include the step of aligning the PCB 4100 with the sensor 5010 and the sensor subassembly 5200, and then loading the PCB 4100 onto the sensor mount 5008 of the sensor subassembly 5200. For example, the PCB 4100 may include one or more openings 4102 that are sized to fit onto the pointed body hub 5014 of the sealed sensor subassembly 5200. Figure 41E shows the PCB 4110 positioned on the sealed subassembly 5200.

[0159] As shown in Figure 41F, the manufacturing process may include a step of curing a first adhesive to secure the PCB to the sensor mount. This adhesive and curing process may include any of the features described herein. Figure 41G shows the PCB 4100 in a folded state, secured to the sensor mount 5008.

[0160] As shown in Figure 41H, the manufacturing process may include steps of dispensing a second adhesive 4135 onto the outer diameter 4130 of the sensor mount 5008 (e.g., channel 9206 shown in Figure 33) and onto the inner diameter 4131 of the sensor mount 5008 or onto the collar 5112 of the sensor subassembly 5200 (e.g., collar channel 9220 shown in Figure 33). The adhesive can be dispensed manually or using an appropriate automated tool. For example, a specially configured tool having a dispensing valve for dispensing a predetermined amount of adhesive onto the outer diameter 4130 and inner diameter 4131 can be used. As discussed herein, the dispensing valve may be used in combination with other components for manipulating the sensor mount 5008 as needed before, during, and after dispensing.

[0161] As shown in Figure 41H-1 for illustrative purposes only and not limiting, the step of dispensing the second adhesive 4135 onto the outer diameter 4130 of the sensor mount 5008 and onto the inner diameter 4131 of the sensor mount 5008 or onto the collar 5112 of the sensor subassembly 5200 may include the step of tilting the sensor mount 5200 to a predetermined angle 4145 along the axis 4140 before dispensing the second adhesive 4145 onto the inner diameter 4131 of the sensor mount 5008 or onto the collar 5112 of the sensor subassembly 5200. In some embodiments, tilting the sensor mount 520 before dispensing the second adhesive 4145 can allow the nozzle to reach the inner diameter 4131 of the sensor mount 5008 or the collar 5112 of the sensor subassembly 5200 more accurately by facilitating the nozzle of the dispensing device and other actuators used to dispense the adhesive to avoid the sharp body hub. This tilt may be used in any of the adhesive dispensing steps described herein. As shown in Figure 41H-2, before dispensing the second adhesive 4135 onto the outer diameter 4130 of the sensor mount 5008, the sensor mount 5008 and the sensor subassembly 5200 are returned to a substantially horizontal position by tilting the sensor mount 5008 along the axis 4140.

[0162] As shown in Figure 41I, the manufacturing process includes the step of attaching the shell cap 5006 to the sensor subassembly 5200 via the sensor mount 5008. Before the shell cap 5006 is lowered onto the mount 5008, the opening 4150 within the shell cap 5006 is aligned with the pointed body hub 5014. The shell cap 5006 can be attached to the sensor subassembly 520 manually, or using appropriate gripping or fastening tools, including but not limited to a manually operated loading arm or robotic loading arm, a vacuum gripping arm or suction gripping arm, a magnetic gripping arm, an adaptive gripping arm or attachment, or other appropriate tools.

[0163] As shown in Figure 41J, the manufacturing process includes a step of curing a second adhesive to form a wearable sensor pack assembly. The first adhesive 4130 or the second adhesive 4135 can include a variety of curable adhesives suitable for use in high-throughput manufacturing environments. The adhesive used can be selected based on the curing method and curing time. For example, the adhesive can be selected to shorten the curing time and at the same time limit the exposure of the chemically active materials or electronic equipment or PCB 4100 of the sensor subassembly 5200 to excessive heat, chemicals, radiation, or excessive infrared or UV light. As an example, the adhesive selected for the first adhesive 4130 or the second adhesive 4135 can be a chemically curable adhesive. Here, the step of curing the adhesive is thought to include a step of exposing the first adhesive 4130 or the second adhesive 4135 to one or more chemical bonding catalysts. As another example, the adhesive can be an aerobically curable adhesive. Here, the step of curing the first adhesive 4130 or the second adhesive 4135 is considered to include, for example, exposing the adhesive to air for a sufficient amount of time before the shell cap 5006 is lowered to the mount 5008 or before proceeding to the next step in the manufacturing process. As another example, the adhesive of choice may be a thermosetting adhesive. Here, the step of curing the first adhesive 4130 or the second adhesive 4135 is considered to include exposing the adhesive to ambient heat or a heating element for a predetermined amount of time sufficient to cure the adhesive. As another example, the adhesive of choice may be a UV-curable adhesive. Here, the step of curing the first adhesive 4130 or the second adhesive 4135 is considered to include exposing the adhesive to UV light by one or more UV light sources. The UV light sources may include, for example, UV light-emitting diodes (LEDs) arranged to cure the adhesive using a light conductor and a plurality of tilt spot LEDs. Figures 41F and 41J show, in one embodiment, the locations where the curing agent supply source 4155 is used to cure the first adhesive 4130 and the second adhesive 4135 from above and below the sensor mount 5008.

[0164] In certain embodiments, the sensor mount 5008 and shell cap 5006 include a material that partially allows the curing agent to selectively pass to the first adhesive 4130 and the second adhesive 4135. The sensor mount 5008 and shell cap 5006 can function to shield the sensor 5010, PCB 4100, and other components of the electronic equipment housing 5004 from exposure to the curing agent, which could otherwise damage components of the electronic equipment housing 5004 and the sealing subassembly 5200. Furthermore, these components can be further protected using other temporary components.

[0165] In some embodiments, the PCB4100 includes a wireless component, and the manufacturing process further includes a step of writing data to the wireless component of the PCB4100. For example, the data to be written to the wireless component of the PCB4100 can be read from the sensor subassembly 5200, the PCB4100, the shell cap 5004, the mount 5006, or other components associated with the electronic equipment housing 5004. This data can then be written to the wireless component of the PCB4100.

[0166] In some embodiments, the manufacturing process may further include a step of inspecting the electronic equipment housing 5004 (e.g., a wearable sensor pack assembly) for leakage. The inspection may include a step using pressure decay leakage testing, vacuum decay leakage testing, tracer gas leakage testing, trace analysis testing, or mass flow leakage testing. If the wearable sensor pack assembly fails the leakage test, it may be discarded.

[0167] Figures 21A to 21C are stepwise cross-sectional side views showing the assembly of a sensor applicator 102 and a sensor control device 5002 according to one or more embodiments. When the sensor control device 5002 is fully assembled, it can be loaded into the sensor applicator 102. Referring to Figure 21A, the pointed body hub 5014 may include or otherwise define a hub snap claw 5302 configured to help couple the sensor control device 5002 to the sensor applicator 102. More specifically, the sensor control device 5002 can be advanced into the sensor applicator 102, and the hub snap claw 5302 can be received by the corresponding arm 5304 of the pointed body carrier 5306 located inside the sensor applicator 102.

[0168] Figure 21B shows a sensor control device 5002 received by a sharp body carrier 5306 and thus fixed inside the sensor applicator 102. With the sensor control device 5002 loaded inside the sensor applicator 102, the applicator cap 210 can be coupled to the sensor applicator 102. In some embodiments, the applicator cap 210 and the housing 208 may have a set of counter-fitting threads 5308 that allow the applicator cap 210 to be twisted onto the housing 208 in a clockwise (or counter-clockwise) direction, thereby fixing the applicator cap 210 to the sensor applicator 102.

[0169] As shown in the illustration, the sheath 212 is further positioned within the sensor applicator 102, and the sensor applicator 102 may include a sheath locking mechanism 5310 configured to ensure that the sheath 212 does not collapse prematurely during an impact event. In the illustrated embodiment, the sheath locking mechanism 5310 may include a screw engagement between the applicator cap 210 and the sheath 212. More specifically, one or more female threads 5312a may be defined or provided on the inner surface of the applicator cap 210, and one or more male threads 5312b may be defined or provided on the sheath 212. The female threads 5312a and male threads 5312b may be configured to screw-fit together when the applicator cap 210 is screwed into the sensor applicator 102 with threads 5308. The female and male threads 5312a and 5312b may have the same thread pitch as the threads 5308, which allow the applicator cap 210 to be screwed onto the housing 208.

[0170] Figure 21C shows the applicator cap 210 fully screwed (connected) to the housing 208. As shown, the applicator cap 210 may further provide or otherwise provide a cap post 5314 that is centrally located inside it and extends proximal to the bottom of the applicator cap 210. The cap post 5314 may be configured to receive at least a portion of the sensor cap 5018 when the applicator cap 210 is screwed onto the housing 208.

[0171] With the sensor control device 5002 loaded into the sensor applicator 102 and the applicator cap 210 properly secured, the sensor control device 5002 can then be subjected to gas chemical sterilization configured to sterilize the electronic housing 5004 and any other exposed parts of the sensor control device 5002. Since the distal portions of the sensor 5010 and the sharp body 5012 are sealed inside the sensor cap 5018, the chemicals used during the gas chemical sterilization process cannot interact with the enzymes, chemical agents, and biological agents provided on the tail 5104, as well as other sensor components such as the membrane coating that regulates sample inflow.

[0172] Figures 22A and 22B are perspective and top views of the cap post 5314 according to one or more additional embodiments. In the illustrated figures, a portion of the sensor cap 5018 is received inside the cap post 5314, and more specifically, the desiccant cap 5030 of the sensor cap 5018 is positioned inside the cap post 5314.

[0173] As shown in the figure, the cap post 5314 can define a receptor feature portion 5402 configured to receive the engagement feature portion 5024 of the sensor cap 5018 when the applicator cap 210 (Figure 21C) is coupled (e.g., screwed) to the sensor applicator 102 (Figures 21A-21C). However, when the applicator cap 210 is removed from the sensor applicator 102, the receptor feature portion 5402 can prevent the engagement feature portion 914 from reversing direction, thereby preventing the sensor cap 5018 from separating from the cap post 5314. Conversely to this separation, by removing the applicator cap 210 from the sensor applicator 102, the sensor cap 5018 is simultaneously separated from the sensor control device 5002 (Figures 18A-18B and 21A-21C), thereby exposing the distal portions of the sensor 5010 (Figures 21A-21C) and the pointed body 5012 (Figures 21A-21C).

[0174] Many design variations of the receptor feature 5402 can be adopted without departing from the scope of the disclosure of the present invention. In the illustrated embodiment, the receptor feature 5402 includes one or more flexible members 5404 (two shown) that are expandable or flexible to receive the engagement feature 5024 (Figures 18A-18B). The engagement feature 5024 may include, for example, an expanding head, and the flexible members 5404 may include a collet-type device that includes a plurality of flexible fingers configured to curve radially outward to receive the expanding head.

[0175] The flexible member 5404 may further provide or otherwise specify a corresponding ramp surface 5406 configured to interact with one or more opposing cam surfaces 5408 provided on the outer wall of the engagement feature portion 5024. The configuration and alignment of the ramp surface 5406 and the opposing cam surfaces 5408 are such that the applicator cap 210 can rotate relative to the sensor cap 5018 in a first direction A (e.g., clockwise), but the cap post 5314 engages with the sensor cap 5018 when the applicator cap 210 is rotated in a second direction B (e.g., counterclockwise). More specifically, when the applicator cap 210 (and therefore the cap post 5314) rotates in the first direction A, the cam surface 5408 engages with the ramp surface 5406, and this engagement presses the flexible member 5404 so that it curves radially outward or deflects otherwise, resulting in a ratchet effect. However, by rotating the applicator cap 210 (and therefore the cap post 5314) in the second direction B, the inclined surface 5410 of the cam surface 5408 is driven to collide with the opposing inclined surface 5412 of the ramp surface 5406, and as a result, the sensor cap 5018 connects to the flexible member 5404.

[0176] Figure 23 is a cross-sectional side view of a sensor control device 5002 positioned within an applicator cap 210 according to one or more embodiments. As shown, the opening to the receptor feature portion 5402 has a first diameter D3, with respect to the engagement feature portion 5024 of the sensor cap 5018 having a second diameter D4 which is larger than the first diameter D3 and larger than the remaining outer diameter of the sensor cap 5018. As the sensor cap 5018 extends into the cap post 5314, the flexible member 5404 of the receptor feature portion 5402 can be curved (expanded) radially outward to receive the engagement feature portion 5024. In some embodiments, as shown, the engagement feature portion 5024 may provide an inclined or truncated conical outer surface that helps to press the flexible member 5404 radially outward, or may be otherwise defined. When the engagement feature portion 5024 advances beyond the receptor feature portion 5402, the flexible member 5404 can bend back to its natural state (or toward it), that is, the sensor cap 5018 is locked into the cap post 5314.

[0177] As the applicator cap 210 is screwed (twisted into place) onto the housing 208 (Figures 21A-21C) in a first direction A, the cap post 5314 rotates correspondingly in the same direction, gradually introducing the sensor cap 5018 into the cap post 5314. As the cap post 5314 rotates, the ramp surface 5406 of the flexible member 5404 contacts the opposing cam surface 5408 of the sensor cap 5018, creating a ratchet action. This action continues until the applicator cap 210 is fully screwed (twisted into place) onto the housing 208. In some embodiments, the ratchet action may occur over two full rotations of the applicator cap 210 until it reaches its final position.

[0178] To remove the applicator cap 210, the applicator cap 210 is rotated in a second direction B, and the cap post 5314 rotates in the same direction accordingly, so that the cam surface 5408 (i.e., the inclined surface 5410 in Figures 22A-22B) engages with the ramp surface 5406 (i.e., the inclined surface 5412 in Figures 22A-22B). As a result, the continued rotation of the applicator cap 210 in the second direction B causes the sensor cap 5018 to rotate in the same direction accordingly, thereby unscrewing from the fitting member 5016 and allowing the sensor cap 5018 to detach from the sensor control device 5002. By detaching the sensor cap 5018 from the sensor control device 5002, the distal portions of the sensor 5010 and the pointed body 5012 are exposed, so that the sensor control device 5002 is positioned for firing (use).

[0179] Figures 24A and 24B are cross-sectional side views of a sensor applicator 102 waiting to deploy a sensor control device 5002 according to one or more embodiments at a target monitor location. More specifically, Figure 24A shows the sensor applicator 102 waiting to deploy (launch) the sensor control device 5002, and Figure 24B depicts the sensor applicator 102 in the process of deploying (launching) the sensor control device 5002. As shown, the applicator cap 210 (Figures 21A to 21C and 55) is removed, and accordingly the sensor cap 5018 (Figures 21A to 21C and 55) is detached, thereby exposing the tail 5104 of the sensor 5010 and the tip 5108 of the sharp body 5012 as described above. With respect to the sheath 212 and the sharp body carrier 5306, the sensor applicator 102 further includes a sensor carrier 5602 (referred to as the "pack" carrier instead) which helps to position and secure the sensor control device 5002 within the sensor applicator 102.

[0180] Referring first to Figure 24A, as shown, the sheath 212 includes one or more sheath arms 5604 (shown one) configured to interact with one or more corresponding retainers 5606 (shown one) defined within the housing 208. Alternatively, the retainers 5606 will be referred to as the "launch" retainers. When the sensor control device 5002 is first mounted within the sensor applicator 102, the sheath arms 5604 can be received into the retainers 5606, thereby placing the sensor applicator 102 in the launch position. In the launch position, the mating member 5016 extends distally beyond the bottom of the sensor control device 5002. As will be discussed below, the process of launching the sensor applicator 102 involves retracting the mating member 5016 so that it does not come into contact with the user's skin.

[0181] The sensor carrier 5602 may further include one or more carrier arms 5608 (shown here) configured to interact with one or more corresponding grooves 5610 (shown here) defined on the sharp body carrier 5306. A spring 5612 can be placed in the cavity defined by the sharp body carrier 5306, and the spring 5612 can passively press the sharp body carrier 5306 upward within the housing 208. However, once the carrier arms 5608 are properly received in the grooves 5610, the sharp body carrier 5306 is held in place and prevented from moving upward. The carrier arms 5608 are sandwiched between the sheath 212 and the sharp body carrier 5306, and radial shoulders 5614 defined on the sheath 212 can be sized to maintain the carrier arms 5608 engaged in the grooves 5610, thereby keeping the sharp body carrier 5306 in place.

[0182] In Figure 24B, the sensor applicator 102 is in the firing phase. As discussed herein with reference to Figures 3F–3G, this firing can be achieved by advancing the sensor applicator 102 toward the target monitoring location until the sheath 212 engages with the user's skin. Continued pressure on the sensor applicator 102 in contact with the skin can cause the sheath arm 5604 to disengage from the corresponding retainer 5606, thereby allowing the sheath 212 to collapse into the housing 208. As the sheath 212 begins to collapse, the radial shoulder 5614 eventually disengages from its radial engagement with the carrier arm 5608, thereby allowing the carrier arm 5608 to be released from the groove 5610. Next, the passive spring force of the spring 5612 pushes the pointed body carrier 5306 freely upward, thereby forcing the carrier arm 5608 out of engagement with the groove 5610, thereby allowing the pointed body carrier 5306 to move slightly upward within the housing 208. In some embodiments, some coils can be incorporated into the design of the spring 5612 to increase the spring force required to overcome the engagement between the carrier arm 5608 and the groove 5610. In at least one embodiment, one or both of the carrier arm 5608 and the groove 5610 can be angled to help facilitate release.

[0183] As the pointed body carrier 5306 moves upward within the housing 208, the pointed body hub 5014 can move correspondingly in the same direction, thereby causing a partial retraction of the mating member 5016 so that it becomes flush, substantially flush, or nearly flush with the bottom of the sensor control device 5002. As understood, such flushness ensures that the mating member 5016 does not come into contact with the user's skin, which is thought to potentially adversely affect sensor insertion, cause excessive pain, or prevent an adhesive patch (not shown) placed on the bottom of the sensor control device 5002 from properly adhering to the skin.

[0184] Figures 25A - 25C are sequential cross - sectional side views showing the assembly and disassembly of an alternative embodiment of the sensor applicator 102 and the sensor control device 5002 according to one or more additional embodiments. As outlined schematically above, the fully assembled sensor control device 5002 can be loaded into the sensor applicator 102 by coupling the hub snap claw 5302 into the arm 5304 of the pointed body carrier 5306 disposed within the sensor applicator 102.

[0185] In the illustrated embodiment, the sheath arm 5604 of the sheath 212 can be configured to interact with a first detent 5702a and a second detent 5702b defined within 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 initially attached within the sensor applicator 102, the sheath arm 5604 can be received within the first detent 5702a. As described below, the sheath 212 can be actuated to move the sheath arm 5604 to the second detent 5702b, thereby placing the sensor applicator 102 in the firing position.

[0186] In FIG. 25B, the applicator cap 210 is aligned with the housing 208 and advanced toward the housing 208 so that the sheath 212 can be received within the applicator cap 210. Instead of rotating the applicator cap 210 relative to the housing 208 to couple the applicator cap 210 to the housing 208, the threads of the applicator cap 210 can be snap - locked onto the corresponding threads of the housing 208. An axially defined cut or slot 5703 (one shown) within the applicator cap 210 can enable the portion of the applicator cap 210 near its helical portion to bend outward and be snap - locked into engagement with the helical portion of the housing 208. When the applicator cap 210 is snap - locked to the housing 208, the sensor cap 5018 can correspondingly be snap - engaged into the cap post 5314.

[0187] Similar to the embodiments shown in Figures 21A to 21C, the sensor applicator 102 may include a sheath locking mechanism configured to ensure that the sheath 212 does not collapse prematurely during an impact event. In the illustrated embodiment, the sheath locking mechanism includes one or more ribs 5706 (two shown) and one or more ribs 5704 (one shown) configured to interact with the shoulder 5708 and one or more ribs 5706, which are located near the base of the sheath 212 and near the base of the applicator cap 210. The rib 5704 may be configured to interlock between the rib 5706 and the shoulder 5708 while the applicator cap 210 is mounted to the housing 208. More specifically, once the applicator cap 210 is snapped onto the housing 208, the applicator cap 210 can be rotated (for example, clockwise), and this rotation positions the rib 5704 of the sheath 212 between the rib 5706 and shoulder 5708 of the applicator cap 210, thereby "locking" the applicator cap 210 in place until the user rotates it in the reverse direction to remove it for use. The engagement of the rib 5704 between the rib 5706 and shoulder 5708 of the applicator cap 210 prevents the sheath 212 from collapsing prematurely.

[0188] In Figure 25C, the applicator cap 210 has been removed from the housing 208. As in the embodiments shown in Figures 21A to 21C, the applicator cap 210 can be removed by rotating it in the reverse direction, which in turn rotates the cap post 5314 in the same direction, causing the sensor cap 5018 to unscrew from the fitting member 5016 as schematically described above. Furthermore, by detaching the sensor cap 5018 from the sensor control device 5002, the distal portions of the sensor 5010 and the pointed body 5012 are exposed.

[0189] As the applicator cap 210 is unscrewed from the housing 208, the rib 5704 defined on the sheath 212 can slide and engage with the upper part of the rib 5706 defined on the applicator cap 210. The upper part of the rib 5706 can cause an upward displacement of the sheath 212 when the applicator cap 210 is rotated, moving the sheath 212 upward and providing a corresponding ramp surface that curves the sheath arm 5604, disengaging it from the first stopper 5702a and allowing it to be received into the second stopper 5702b. As the sheath 212 moves into the second stopper 5702b, the radial shoulder 5614 disengages from its radial engagement with the carrier arm 5608, thereby allowing the passive spring force of the spring 5612 to push the sharp body carrier 5306 upward, forcing the carrier arm 5608 to disengage from the groove 5610. As the sharp body carrier 5306 moves upward within the housing 208, the fitting member 5016 can retract accordingly until it is flush, substantially flush, or nearly flush with the bottom of the sensor control device 5002. At this point, the sensor applicator 102 is in the firing position. Therefore, in this embodiment, the fitting member 5016 retracts accordingly by removing the applicator cap 210.

[0190] Figure 26A is an isometric bottom view of a housing 208 according to one or more embodiments. As shown, one or more longitudinal ribs 5802 (four shown) can be defined within the housing 208. These ribs 5802 can be spaced equidistant or unequal from each other and can extend substantially parallel to the centerline of the housing 208. First and second retainers 5702a, 5702b can be defined on one or more of the longitudinal ribs 5802.

[0191] Figure 27A is an isometric bottom view of the housing 208 having a sheath 212 and other components at least partially located therein. As shown, the sheath 212 may provide or otherwise provide one or more longitudinal slots 5804 configured to fit into longitudinal ribs 5802 of the housing 208. As schematically described above, the ribs 5802 can be received into the slots 5804 to help maintain the sheath 212 in an aligned state with the housing during its movement as the sheath 212 is compressed into the housing 208. As understood, this receiving can result in tighter circumferential and radial alignment within the same dimensional and tolerance constraints as the housing 208.

[0192] In the illustrated embodiment, the sensor carrier 5602 can be configured to hold the sensor control device 5002 in a fixed position axially (for example, after the sensor cap 5018 has been removed) and also to hold it circumferentially. To achieve this holding, the sensor carrier 5602 may include or otherwise define one or more support ribs 5806 and one or more flexible arms 5808. The support ribs 5806 extend radially inward to provide radial support to the sensor control device 5002. The flexible arms 5808 partially extend around the circumference of the sensor control device 5002, and the ends of the flexible arms 5808 can be received in corresponding grooves 5810 defined on the sides of the sensor control device 5002. Thus, the flexible arms 5808 have the potential to provide both axial and radial support to the sensor control device 5002. In at least one embodiment, the end of the flexible arm 5808 is biased into a groove 5810 of the sensor control device 5002 and can be locked in place together with a corresponding sheath locking rib 5812 provided separately by the sheath 212.

[0193] In some embodiments, the sensor carrier 5602 can be ultrasonically welded to the housing 208 at one or more points 5814. However, in other embodiments, without departing from the scope of the disclosure of the present invention, the sensor carrier 5602 can instead be coupled to the housing 208 by a snap-type engagement. This coupling can help to hold the sensor control device 5002 in place during transport and firing.

[0194] Figure 28 is an enlarged cross-sectional side view of a sensor applicator 102 in which a sensor control device 5002 according to one or more embodiments is mounted. As discussed above, the sensor carrier 5602 may include one or more carrier arms 5608 (two shown) that can engage with the sharp body carrier 5306 at the location of the corresponding groove 5610. In at least one embodiment, the groove 5610 may be defined by a pair of projections 5902 defined on the sharp body carrier 5306. Receiving the carrier arms 5608 into the groove 5610 can help stabilize the sharp body carrier 5306 from undesirable tilting during all stages of retraction (launch).

[0195] In the illustrated embodiment, the arm 5304 of the pointed body carrier 5306 can be made sufficiently rigid to control the radial and biaxial motion of the pointed body hub 5014 with greater precision. In some embodiments, relative control of the height of the pointed body hub 5014 may be more important to the design, so for example, the clearance between the pointed body hub 5014 and the arm 5304 can be more strictly limited in both axial directions.

[0196] In the illustrated embodiment, the sensor carrier 5602 defines or otherwise provides a central boss 5904 sized to receive the pointed body hub 5014. In some embodiments, as shown, the pointed body hub 5014 may provide one or more radial ribs 5906 (two shown). In at least one embodiment, the inner diameter of the central boss 5904 helps to provide radial and inclined support to the pointed body hub 5014 throughout the life of the sensor applicator 102 and throughout all phases of operation and assembly. Furthermore, having multiple radial ribs 5906 increases the length-to-width ratio of the pointed body hub 5014, thereby further improving the support against inclination.

[0197] Figure 29A is an isometric top view of the applicator cap 210 according to one or more embodiments. In the illustrated embodiment, two axial slots 5703 are shown separating the upper portion of the applicator cap 210 near its threaded portion. As described above, the slots 5703 can help the applicator cap 210 curve outward so that it snaps into engagement with the housing 208 (Figure 25B). In contrast, the applicator cap 210 can be unscrewed (unthreaded) from the housing 208 by the end user.

[0198] Figure 29A further illustrates the rib 5706 (one is visible) defined by the applicator cap 210. By engaging with the rib 5704 (Figure 25C) defined on the sheath 212, the rib 5706 can help lock the sheath 212 in all directions to prevent premature crushing during impact or drop events. The sheath 212 can be unlocked when the user unscrews the applicator cap 210 from the housing, as schematically described above. As described herein, the upper part of each rib 5706 can provide a corresponding ramp surface 6002, and when the applicator cap 210 is rotated and removed from the housing 208, the rib 5704 defined on the sheath 212 slides and engages with the ramp surface 6002, resulting in an upward displacement of the sheath 212 into the housing 208.

[0199] In some embodiments, additional features can be provided within the applicator cap 210 for holding desiccant components that maintain an appropriate moisture level over their effective shelf life. Such additional features may be snaps or posts suitable for press-fitting, heat riveting, ultrasonic welding, etc.

[0200] Figure 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 have a set of female threads 6004, and the housing 208 may have a set of male threads 6006 that can engage with the female threads 6004. As described herein, the applicator cap 210 can be snap-locked onto the housing 208, which can be achieved by advancing the female threads 6004 in the direction indicated by the arrows so that the male threads 6006 pass axially, thereby curving the applicator cap 210 outward. As shown, to help facilitate this displacement, the corresponding faces 6008 of the female and male threads 6004, 6006 may be curved, beveled, or chamfered. Each screw thread 6004, 6006 is provided with corresponding flat surfaces 6010, which can be configured to engage when the applicator cap 210 is properly snapped into place on the housing 208. These flat surfaces 6010 can slide and engage with each other when the user unscrews the applicator cap 210 from the housing 208.

[0201] The threaded engagement between the applicator cap 210 and the housing 208 provides a sealed engagement that protects the internal components from moisture, dust, and the like. In some embodiments, the housing 208 may define or otherwise provide a stabilization feature 6012 configured to be received in a corresponding groove 1914 defined on the applicator cap 210. The stabilization feature 6012 can help stabilize and reinforce the applicator cap 210 when it is snapped into place on the housing 208. The stabilization feature 6012 can demonstrate its advantage in providing additional drop robustness to the sensor applicator 102. Furthermore, the stabilization feature 6012 can help increase the removal torque of the applicator cap 210.

[0202] Figures 30A and 30B are isometric projections of the sensor cap 5018 and collar 5112 according to one or more embodiments, respectively. Referring to Figure 30A, in some embodiments, the sensor cap 5018 may include an injection-molded portion. This can be demonstrated to be advantageous by molding a female thread 5026a defined within the inner chamber 5022, rather than mounting a threaded core or threading the inner chamber 5022. In some embodiments, one or more stop ribs 6102 (one is visible) may be defined within the inner chamber 5022 to prevent over-movement of the pointed body hub 5014 (Figures 18A-18B) relative to the mating member 5016.

[0203] Referring to both Figures 30A and 30B, in some embodiments, one or more projections 6104 (shown as two) can be defined on the first end 5020a of the sensor cap 5018 and configured to fit into one or more corresponding recesses 6106 (shown as two) defined on the collar 5112. However, in other embodiments, without departing from the scope of the disclosure of the present invention, the projections 6104 can instead be defined on the collar 5112 and the recesses 6106 can be defined on the sensor cap 5018.

[0204] The mating projection 6104 and recess 6106 can be demonstrated to be advantageous by rotationally locking the sensor cap 5018 to prevent unintended twisting off of the sensor cap 5018 from the collar 5112 (and thus from the sensor control device 5002) throughout the life of the sensor applicator 102 and throughout all phases of operation / assembly. In some embodiments, as shown, the recess 6106 may be formed in a general bean shape or otherwise defined. This shape can be demonstrated to be advantageous by allowing partial over-rotation of the sensor cap 5018 relative to the collar 5112. Alternatively, the same advantage can be achieved by a flat end screw engagement between the two parts.

[0205] Embodiments disclosed herein include: A. A sensor control device comprising an electronic housing; a sensor disposed within the electronic housing and having a tail extending from the bottom of the electronic housing; a pointed body extending through the electronic housing and having a pointed tip extending from the bottom of the electronic housing; and a sensor cap detachably coupled to the bottom of the electronic housing and defining a sealed inner chamber for receiving the tail and the pointed body.

[0206] B. A sample monitoring system comprising a sensor applicator and a sensor control device positioned within the sensor applicator, the sensor control device comprising an electronic housing, a sensor disposed within the electronic housing having a tail extending from the bottom of the electronic housing, a pointed body extending through the electronic housing having a pointed tip extending from the bottom of the electronic housing, and a sensor cap detachably coupled to the bottom of the electronic housing, the sensor cap defining an engagement feature portion and a sealed inner chamber for receiving the tail and the pointed body. The sample monitoring system may further include a cap coupled to the sensor applicator, the cap providing a cap post defining a receptor feature portion for receiving the engagement feature portion when the cap is coupled to the sensor applicator, the sensor cap being detached from the electronic housing by removing the cap from the sensor applicator, thereby exposing the tail and the pointed tip.

[0207] A method of preparing a specimen monitoring system that includes loading a sensor control device into a sensor applicator, the sensor control device comprising an electronic device housing, a sensor disposed within the electronic device housing, the sensor having a tail extending from the bottom of the electronic device housing, a sharp body extending through the electronic device housing and having a sharp body tip extending from the bottom of the electronic device housing, and a sensor cap removably coupled to the bottom of the electronic housing, the sensor cap defining a sealed inner chamber for receiving the tail and the sharp body. The method further includes fixing the cap to the sensor applicator, sterilizing the sensor control device through gas chemical sterilization while the sensor control device is positioned within the sensor applicator, and isolating the tail and the sharp body tip from the gas chemical sterilization within the inner chamber.

[0208] Each of embodiments A, B, and C may have one or more of the following additional elements in any combination: Element 1: The sensor cap includes a cylindrical body having a first end that is open for access to an inner chamber and a second end opposite to the first end that provides an engaging feature that can engage with the cap of the sensor applicator, and by removing the cap from the sensor applicator, the sensor cap is correspondingly removed from the electronic housing, thereby exposing the tail and the tip of the pointed body. Element 2: The electronic housing includes a shell that can be mated with a mount, and the sensor control device further includes a pointed body and a sensor locator defined on the inner surface of the shell, and a collar that is received around the pointed body and the sensor locator, and the sensor cap is removably coupled to the collar. Element 3: The sensor cap is removably coupled to the collar by one or more of the following: a press fit, a screw engagement, a fragile member, and a fragile material. Element 4: An annular ridge surrounding the pointed body and sensor locator and collar provides a cylinder and an annular shoulder extending radially outward from the cylinder, and a sealing member is sandwiched between the annular shoulder and the annular ridge to form a sealing interface. Element 5: The annular ridge defines a groove in which a portion of the sensor is seated, and a sealing member extends into the groove to seal around this portion of the sensor. Element 6: The sealing member is a first sealing member, and the sensor control device further includes a second sealing member sandwiched between the annular shoulder and a portion of the mount to form a sealing interface. Element 7: The electronic equipment housing includes a shell matable with the mount, and the sensor control device further includes a pointed body hub that carries the pointed body and is matable with the upper surface of the shell, and a mating member defined by the pointed body hub and extending from the bottom of the electronic equipment housing, and a sensor cap is detachably coupled to the mating member. Element 8: Further includes a collar that is at least partially receivable within an opening defined within the mount and seals and engages the sensor cap with the inner surface of the shell. Element 9: A sealing member is sandwiched between the collar and the inner surface of the shell to form a sealing interface.Element 10: A collar defines a groove, a portion of the sensor is seated in the groove, and a sealing member extends into the groove to seal around this portion of the sensor.

[0209] Element 11: The receptor feature portion includes one or more flexible members that curve to receive the engagement feature portion, the one or more flexible members preventing the engagement feature portion from disengaging from the cap post when the cap is removed from the sensor applicator. Element 12: Further includes a ramp surface defined on at least one of the one or more flexible members, and one or more cam surfaces provided by the engagement feature portion and capable of engaging with the ramp surface, the ramp surface and the one or more cam surfaces enabling the cap and cap post to rotate in a first direction relative to the sensor cap, but preventing the cap and cap post from rotating in a second direction opposite to the first direction relative to the sensor cap. Element 13: The electronic equipment housing includes a shell that can be mated with a mount, and the sensor control device further includes a pointed body hub that can carry a pointed body and engage with the upper surface of the shell, and a mating member that is determined by the pointed body hub and extends from the bottom of the electronic equipment housing, and a sensor cap is removably coupled to the mating member, and the sensor cap is detached from the mating member by rotating the cap in a second direction. Element 14: The electronic equipment housing includes a shell that can be mated with a mount, and the sensor control device further includes a pointed body and a sensor locator determined on the inner surface of the shell, and a collar that is received around the pointed body and the sensor locator, and a sensor cap is removably coupled to the collar.

[0210] Element 15: The cap provides a cap post that defines a receptor feature, the sensor cap defines an engagement feature, and the method further includes the step of receiving the engagement feature by the receptor feature when the cap is fixed to the sensor applicator. Element 16: The method further includes the step of removing the cap from the sensor applicator, and the step of engaging the engagement feature on the receptor feature when the cap is removed, thereby separating the sensor cap from the electronic housing and exposing the tail and the tip of the sharp body. Element 17: The step of loading the sensor control device into the sensor applicator is preceded by the steps of sterilizing the tail and the tip of the sharp body by radiation sterilization and sealing the tail and the tip of the sharp body in an inner chamber.

[0211] As a non-limiting example, exemplary combinations applicable to A, B, and C include element 2 having element 3, element 2 having element 4, element 4 having element 5, element 4 having element 6, element 7 having element 8, element 8 having element 9, element 9 having element 10, element 11 having element 12, and element 15 having element 16.

[0212] Exemplary Embodiment of Seal Arrangement for Sample Monitoring System Figures 31A and 31B are a side view and an isometric projection view, respectively, of an exemplary sensor control device 9102 according to one or more embodiments of the disclosure of the present invention. The sensor control device 9102 can be similar in some respects to the sensor control device 102 of Figure 1, and is therefore best understood by referring to it. Furthermore, the sensor control device 9102 can replace the sensor control device 102 of Figure 1, and is therefore used in conjunction with the sensor applicator 102 of Figure 1, which can deliver the sensor control device 9102 to a target monitoring location on the user's skin.

[0213] As shown in the figure, the sensor control device 9102 includes an electronic housing 9104 which may be substantially disc-shaped and have a circular cross-section. However, in other embodiments, the electronic housing 9104 may exhibit other cross-sectional shapes such as oval, elliptical, or polygonal without departing from the scope of the disclosure of the present invention. The electronic housing 9104 includes a shell 9106 and a mount 9108 to which it can be mated. The shell 9106 can be secured to the mount 9108 by a variety of methods such as snap engagement, interlocking fit, ultrasonic welding, laser welding, one or more mechanical fasteners (e.g., screws), gaskets, adhesive, or any combination thereof. In some cases, the shell 9106 can be secured to the mount 9108 such that a sealed interface is created between it and the mount 9108. An adhesive patch 9110 can be positioned or otherwise attached to the underside of the mount 9108. Similar to the adhesive patch 105 in Figure 1, the adhesive patch 9110 can 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 pointed body 9114 used to help deliver the sensor 9112 transcutaneously under the user's skin during attachment of the sensor control device 9102. The corresponding portions of the sensor 9112 and the pointed body 9114 extend distally from the bottom of the electronic housing 9104 (e.g., mount 9108). The pointed body hub 9116 may be overmolded onto the pointed body 9114 and configured to fix and support the pointed body 9114. As is most clearly seen in Figure 31A, the pointed body hub 9116 may include a fitting member 9118 or otherwise be defined. During the stage of incorporating the pointed body 9114 into the sensor control device 9102, the pointed body hub 9116 engages with the upper surface of the electronic housing 9104 or an internal component of the electronic housing 9104, allowing the pointed body 9114 to advance axially through the electronic housing 9104 until the mating member 9118 extends distally from the bottom of the mount 9108. As described below, in at least one embodiment, the pointed body hub 9116 can be sealed-engaged to the upper portion of the sealed overmolded portion onto the mount 9108. As the pointed body 9114 penetrates the electronic housing 9104, the exposed portion of the sensor 9112 can be received in the hollow or recessed (arc-shaped) portion of the pointed body 9114. The remainder of the sensor 9112 is positioned within the electronic housing 9104.

[0215] The sensor control device 9102 may further include a sensor cap 9120, shown in Figures 31A and 31B where it is separated from the electronic housing 9104. The sensor cap 9120 can help provide a sealing barrier that surrounds and protects the exposed portions of the sensor 9112 and the sharp body 9114. As shown, the sensor cap 9120 may include a substantially cylindrical body having a first end 9122a and a second end 9122b opposite it. The first end 9122a may be made open to provide access to an inner chamber 9124 defined within the body. In contrast, the second end 9122b may be closed and provide or otherwise define an engagement feature 9126. As will be explained in more detail below, the engagement feature portion 9126 can help to fit the sensor cap 9120 onto the applicator cap of the sensor applicator (for example, the sensor applicator 102 in Figure 1), and can also help to remove the sensor cap 9120 from the sensor control device 9102 when removing the sensor cap from the sensor applicator.

[0216] The sensor cap 9120 can be removably coupled to the electronic component housing 9104 at or near the bottom of the mount 9108. More specifically, the sensor cap 9120 can be removably coupled to a mating member 9118 extending distally from the bottom of the mount 9108. In at least one embodiment, for example, the mating member 9118 may define a set of female threads 9128b (Figure 31B) and a set of male threads 9128a (Figure 31A) that can mate within the inner chamber 9124 of the sensor cap 9120. In some embodiments, the male and female threads 9128a, 9128b may include a square thread design (e.g., lacking helical curvature), but instead may include a helical thread engagement. Thus, in at least one embodiment, the sensor cap 9120 can be screwably coupled to the sensor control device 9102 at the location of the mating member 9118 on the pointed body hub 9116. In other embodiments, the sensor cap 9120 may be removably coupled to the mating member 9118 by other types of engagement, including but not limited to, a fragile member or material (such as wax or adhesive) that can be broken by an interlocking fit, a friction fit, or a slight disengaging force (e.g., an axial or rotational force).

[0217] In some embodiments, the sensor cap 9120 may include a single, integrally formed structure extending between a first end 9122a and a second end 9122b. However, in other embodiments, the sensor cap 9120 may include two or more component parts. In the illustrated embodiment, for example, the body of the sensor cap 9120 may include a desiccant cap 9130 located at the second end 9122b. The desiccant cap 9130 may contain or provide a desiccant that helps maintain a preferred humidity level within the inner chamber 9124. Furthermore, the desiccant cap 9130 may define or otherwise provide an engagement feature portion 9126 of the sensor cap 9120. In at least one embodiment, the desiccant cap 9130 may include an elastomer plug inserted into the bottom end of the sensor cap 9120.

[0218] Figures 32A and 32B are exploded isometric top and bottom views, respectively, of a sensor control device 9102 according to one or more embodiments. The shell 9106 and mount 9108 act as opposing clamshell halves that enclose or substantially enclose various electronic components (not shown) of the sensor control device 9102. Exemplary electronic components that may be placed between the shell 9106 and mount 9108 include, but are not limited to, batteries, resistors, transistors, capacitors, inductors, diodes, and switches.

[0219] The shell 9106 can define a first opening 9202a, and the mount 9108 can define a second opening 9202b, and the openings 9202a and 9202b can be aligned when the shell 9106 is properly mounted on the mount 9108. As is most clearly seen in Figure 32A, the mount 9108 may provide or otherwise define a base 9204 that protrudes from the inner surface of the mount 9108 at the second opening 9202b. The base 9204 may define at least a portion of the second opening 9202b. Furthermore, a channel 9206 may be defined on the inner surface of the mount 9108, and the channel 9206 may surround the base 9202. In the illustrated embodiment, the channel 9206 is circular in shape, but it is conceivable that it could instead be of another shape, such as elliptical, oblong, or polygonal.

[0220] The mount 9108 may include a molded portion made of a rigid material such as plastic or metal. In some embodiments, a seal 9208 can be overmolded onto the mount 9108, and the seal 9208 may be made of an elastomer, rubber, polymer, or other easily moldable material suitable for facilitating a sealing interface. In embodiments where the mount 9108 is made of plastic, the mount 9108 may be molded in a first "shot" of injection molding, and the seal 9208 may be overmolded onto the mount 9108 in a second "shot" of injection molding. Thus, the mount 9108 may be referred to as a "two-shot mount" or otherwise characterized as such.

[0221] In the illustrated embodiment, the seal 9208 is overmolded onto the mount 9108 at the base 9204 and can also be overmolded onto the bottom of the mount 9108. More specifically, the seal 9208 may be defined or otherwise provided as a first seal element 9210a overmolded onto the base 9204 and a second seal element 9210b interconnected thereto and overmolded onto the mount 9108 at the bottom of the mount 9108 (Figure 32B). In some embodiments, one or both of the seal elements 9210a and 9210b may help form a corresponding portion (section) of the second opening 9202b. Although the seal 9208 is described herein as being overmolded onto the mount 9108, it is also conceivable that one or both of the seal elements 9210a and 9210b may include an elastomer component independent of the mount 9208, such as an O-ring or gasket.

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

[0223] In some embodiments, the collar 9212 may define or otherwise provide an annular lip 9216 on its bottom surface. The annular lip 9216 may be sized or otherwise configured to fit into or receive into a channel 9206 defined on the inner surface of the mount 9108. In some embodiments, a groove 9218 may be defined on the annular lip 9216 and may be configured to accommodate or otherwise receive a portion of the sensor 9112 that extends laterally within the mount 9108. In some embodiments, the collar 9212 may further define or otherwise provide a collar channel 9220 (Figure 32A) on its top surface that is sized to receive or otherwise fit into an annular ridge 9222 (Figure 32B) defined on the inner surface of the shell 9106 when the sensor control device 9102 is properly assembled therein.

[0224] The sensor 9112 may include a tail 9224 that extends through a second opening 9202b defined within the mount 9108 and is received percutaneously under the user's skin. The tail 9224 may have enzymes or other chemical agents contained on the tail to help facilitate sample monitoring. The sharp body 9114 may include a sharp body tip 9226 that is extendable through a first opening 9202a defined by the shell 9106. When the sharp body tip 9226 penetrates the electronic component housing 9104, the tail 9224 of the sensor 9112 may be received in a hollow or recessed portion of the sharp body tip 9226. The sharp body tip 9226 may be configured to penetrate the skin while carrying the tail 9224 in order to bring the activating chemical agent of the tail 9224 into contact with bodily fluids.

[0225] The sensor control device 9102 can provide a sealed subassembly that includes, among its constituent parts, the shell 9106, the sensor 9112, the pointed body 9114, the seal 9208, the collar 9212, and the sensor cap 9120. The sealed subassembly can help isolate the sensor 9112 and the pointed body 9114 within the inner chamber 9124 (Figure 32A) of the sensor cap 9120. During the assembly of the sealed subassembly, the pointed body tip 9226 is advanced through the electronic component housing 9104 until the pointed body hub 9116 engages with the seal 9208, more specifically with the first seal element 9210a. A mating member 9118 provided at the bottom of the pointed body hub 9116 can extend out of a second opening 9202b within the bottom of the mount 9108, and the sensor cap 9120 can be coupled to the pointed body hub 9116 at the location of the mating member 9118. By coupling the sensor cap 9120 to the pointed hub 9116 at the location of the fitting member 9118, the first end 9122a of the sensor cap 9120 can be pressed into a sealed engagement with the seal 9208, more specifically, with the second seal element 9210b on the bottom of the mount 9108. In some embodiments, when the sensor cap 9120 is coupled to the pointed hub 9116, a portion of the first end 9122a of the sensor cap 9120 can be abutted (engaged) with the bottom of the mount 9108, and the sealed engagement between the pointed hub 9116 and the first seal element 9210a may be able to absorb any tolerance changes between the feature parts.

[0226] Figure 33 shows a cross-sectional side view of a sensor control device 9102 according to one or more embodiments. As described above, the sensor control device 9102 may include or otherwise incorporate a sealing subassembly 9302 which can be advantageous in isolating the sensor 9112 and the pointed body 9114 within the inner chamber 9124 of the sensor cap 9120. To assemble the sealing subassembly 9302, the sensor 9112 can be positioned within the mount 9108 such that the tail 9224 extends through a second opening 9202b at the bottom of the mount 9108. In at least one embodiment, a positioning feature 9304 can be defined on the inner surface of the mount 9108, and the sensor 9112 may have a groove 9306 that can engage with the positioning feature 9304 to properly position it within the mount 9108.

[0227] With the sensor 9112 properly positioned, the collar 9212 can be mounted on the mount 9108. More specifically, the collar 9212 can be positioned such that the first sealing element 9210a of the seal 9208 is received in a central opening 9214 defined by the collar 9212, and the first sealing element 9210a creates a radial seal with respect to the collar 9212 in the central opening 9214. Furthermore, the annular lip 9216 defined on the collar 9212 can be received in a channel 9206 defined on the mount 9108, and the groove 9218 defined to pass through the annular lip 9216 can be aligned to receive the portion of the sensor 9112 that crosses the channel 9206 within the mount 9108. In some embodiments, adhesive can be injected into the channel 9206 to fix the collar 9212 to the mount 9108. The adhesive facilitates a sealing interface between these two components, creating a seal around the sensor 9112 at the location of the groove 9218, thereby isolating the tail 9224 from the inside of the electronic component housing 9104.

[0228] Next, the shell 9106 can be mated with the mount 9108 or otherwise coupled. In some embodiments, as shown, the shell 9106 can be mated with the mount 9108 through the grooved engagement portion 9308 around the outer perimeter of the electronic component housing 9104. To secure the shell 9106 to the mount 9108 and to further create a sealed engagement interface, adhesive can be injected (added) into the groove portion of the engagement portion 9308. By mating the shell 9106 to the mount 9108, the annular ridge 9222 defined on the inner surface of the shell 9106 can be received into the collar channel 9220 defined on the upper surface of the collar 9212. In some embodiments, adhesive can be injected into the collar channel 9220 to secure the shell 9106 to the collar 9212 and to further facilitate a sealed interface between the two components at this location. When the shell 9106 is fitted onto the mount 9108, the first sealing element 9210a can extend at least partially through (into) the first opening 9202a defined within the shell 9106.

[0229] Next, the pointed body 9114 can be coupled to the sensor control device 9102 by extending the pointed body tip 9226 through the first and second openings 9202a and 9202b, which are defined within the shell 9106 and the mount 9108, respectively. The pointed body 9114 can be advanced until the pointed body hub 9116 engages with the seal 9208, more specifically with the first seal element 9210a. The mating member 9118 can extend (project) out of the second opening 9202b at the bottom of the mount 9108 when the pointed body hub 9116 engages with the first seal element 9210a.

[0230] Next, the sensor cap 9120 can be removably coupled to the sensor control device 9102 by screw-fitting the female thread 9128b of the sensor cap 9120 with the male thread 9128a of the mating member 9118. The inner chamber 9124 may be sized or otherwise configured to receive the tail 9224 and the pointed tip 9226 extending from the bottom of the mount 9108. Furthermore, the inner chamber 9124 can be sealed to isolate the tail 9224 and the pointed tip 9226 from substances that may potentially interact harmfully with the chemical agents of the tail 9224. In some embodiments, a desiccant (not shown) may be present inside the inner chamber 9124 to maintain an appropriate humidity level.

[0231] By tightening (rotating) the fitting engagement portion between the sensor cap 9120 and the fitting member 9118, the first end 9122a of the sensor cap 9120 can be pressed into an axial sealing engagement (e.g., along the centerlines of the openings 9202a and 9202b) with the second sealing element 9210b, and the axial sealing interface between the pointed body hub 9116 and the first sealing element 9210a can be strengthened. Furthermore, by tightening the fitting engagement portion between the sensor cap 9120 and the fitting member 9118, the first sealing element 9210a can be compressed, thereby providing a strong radial sealing engagement between the first sealing element 9210a and the collar 9212 at the central opening 9214. Thus, in at least one embodiment, the first sealing element 9210a can help facilitate axial and radial sealing engagements.

[0232] As described above, the first and second sealing elements 9210a and 9210b can be overmolded onto the mount 9108 and can be physically connected or interconnected with each other. Thus, a single injection molding shot can pass through the second opening 9202b of the mount 9108 to produce both ends of the seal 9208. This can be demonstrated to be advantageous in that multiple sealing interfaces can be generated by only a single injection molding shot. An additional advantage of the two-shot molding design is that the interface between the first and second shots is a more reliable bond than a mechanical seal, in contrast to using separate elastomer components (e.g., O-rings, gaskets). Thus, the number of effective mechanical sealing barriers is substantially halved. Furthermore, two-shot components made by a single elastomer shot also have the implication of minimizing the number of two-shot components required to achieve all the necessary sterile barriers. In a properly assembled state, the sealing subassembly 9302 can undergo a radiation sterilization process to sterilize the sensor 9112 and the sharp body 9114. The sealed subassembly 9302 can be subjected to radiation sterilization before or after the sensor cap 9120 is coupled to the sharp body hub 9116. If the sensor cap 9120 is sterilized after it is coupled to the sharp body hub 9116, the sensor cap 9120 can be manufactured from a material that allows radiation to propagate through it. In some embodiments, the sensor cap 9120 can be transparent or translucent, but can otherwise be opaque without departing from the scope of the disclosure of the present invention.

[0233] Figure 33A shows an exploded isometric projection of a portion of another embodiment of the sensor control device 9102 shown in Figures 31A-31B and 32A-32B. The embodiments described above illustrate that the mount 9108 and seal 9208 are manufactured by a two-shot injection molding process. However, in other embodiments, as briefly shown above, one or both of the sealing elements 9210a, 9210b of the seal 9208 may include elastomer components independent of the mount 9208. In the illustrated embodiment, for example, the first sealing element 9210a may be overmolded onto the collar 9212, and the second sealing element 9210b may be overmolded onto the sensor cap 9120. Alternatively, the first and second sealing elements 9210a, 9210b may include separate components such as gaskets or O-rings positioned on the collar 9212 and the sensor cap 9120, respectively. By tightening (rotating) the fitting engagement portion between the sensor cap 9120 and the fitting member 9118, the second seal element 9210b can be pressed into an axial sealing engagement with the bottom of the mount 9108, thereby reinforcing the axial sealing interface between the pointed body hub 9116 and the first seal element 9210a.

[0234] Figure 34A shows an isometric bottom view of a mount 9108 according to one or more embodiments, and Figure 34B shows an isometric top view of a sensor cap 9120 according to one or more embodiments. As shown in Figure 34A, the mount 9108 may provide one or more recesses or pockets 9402 in or near the opening to the second opening 9202b, or otherwise specified. As shown in Figure 34B, the sensor cap 9120 may provide one or more protrusions 9404 in or near its first end 9122a, or otherwise specified. The protrusions 9404 can be received into the pockets 9402 when the sensor cap 9120 is coupled to the pointed hub 9116 (Figures 32A-32B and 93). More specifically, as described above, when the sensor cap 9120 is coupled to the fitting member 9118 of the pointed body hub 9116 (Figures 32A-32B and 93), the first end 9122a of the sensor cap 9120 is placed into a sealed engagement with the second sealing element 9210b. In this process, the projection 9404 can be received into the pocket 9402, which helps prevent the sensor cap 9120 from being prematurely unscrewed from the pointed body hub 9116.

[0235] Figures 35A and 35B are a side view and a cross-sectional side view, respectively, of an exemplary sensor applicator 9502 according to one or more embodiments. The sensor applicator 9502 can be similar in some respects to the sensor applicator 102 of Figure 1, and can therefore be designed to deliver (launch) a sensor control device such as the sensor control device 9102. Figure 35A shows the state in which the sensor applicator 9502 is expected to be shipped to the user and the state in which the user may receive it, and Figure 35B depicts the sensor control device 9102 located inside the sensor applicator 9502.

[0236] As shown in Figure 35A, the sensor applicator 9502 includes a housing 9504 and an applicator cap 9506 detachably coupled thereto. In some embodiments, the applicator cap 9506 can be screwed onto the housing 9504 and may include a tamper-evident ring 9508. When the applicator cap 9506 is rotated (e.g., twisted off) relative to the housing 9504, the tamper-evident ring 9508 is unscrewed, thereby releasing the applicator cap 9506 from the sensor applicator 9502.

[0237] In Figure 35B, the sensor control device 9102 is located within the sensor applicator 9502. Once the sensor control device 9102 is fully assembled, it can then be loaded into the sensor applicator 9502, and the applicator cap 9506 can be coupled to the sensor applicator 9502. In some embodiments, the applicator cap 9506 and the housing 9504 may have opposing sets of mating threads that allow the applicator cap 9506 to be screwed onto the housing 9504 in a clockwise (or counterclockwise) direction, thereby securing the applicator cap 9506 to the sensor applicator 9502.

[0238] By securing the applicator cap 9506 to the housing 9504, the second end 9122b of the sensor cap 9120 can be positioned within the applicator cap 9506 and received in a cap post 9510 that extends proximal from the bottom of the applicator cap 9506. The cap post 9510 can be configured to receive at least a portion of the sensor cap 9120 when the applicator cap 9506 is coupled to the housing 9504.

[0239] Figures 36A and 36B are perspective and top views, respectively, of the cap post 9510 according to one or more additional embodiments. In the illustrated depiction, a portion of the sensor cap 9120 is received within the cap post 9510, more specifically, the desiccant cap 9130 of the sensor cap 9120 is positioned within the cap post 9510. The cap post 9510 may have a receptor feature 9602 configured to receive the engagement feature 9126 of the sensor cap 9120 when the applicator cap 9506 (Figure 35B) is coupled (e.g., screwed) to the sensor applicator 9502 (Figures 35A-35B). However, when the applicator cap 9506 is removed from the sensor applicator 9502, the receptor feature 9602 can prevent the engagement feature 9126 from reversing direction, thereby preventing the sensor cap 9120 from separating from the cap post 9510. Alternatively, by removing the applicator cap 9506 from the sensor applicator 9502, the sensor cap 9120 is simultaneously separated from the sensor control device 9102 (Figures 31A-32B and 32A-32B), thereby exposing the distal portions of the sensor 9112 (Figures 32A-32B) and the pointed body 9114 (Figures 32A-32B).

[0240] Many design variations of the receptor feature portion 9602 can be adopted without departing from the scope of the disclosure of the present invention. In the illustrated embodiment, the receptor feature portion 9602 includes one or more flexible members 9604 (two shown) that are extensible or flexible in order to receive the engagement feature portion 9126. The engagement feature portion 9126 may include, for example, an expanding head, and the flexible members 9604 may include a collet-type device that includes a plurality of flexible fingers configured to curve radially outward in order to receive the expanding head.

[0241] The flexible member 9604 may further provide or otherwise specify a corresponding ramp surface 9606 configured to interact with one or more opposing cam surfaces 9608 provided on the outer wall of the engagement feature portion 9126. The configuration and alignment of the ramp surface 9606 and the opposing cam surfaces 9608 are such that 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), the cap post 9510 engages with the sensor cap 9120. More specifically, when the applicator cap 9506 (and therefore the cap post 9510) rotates in the first direction A, the cam surface 9608 engages with the ramp surface 9606, thereby pressing the flexible member 9604 to curve radially outward or otherwise deflect, resulting in a ratchet effect. However, by rotating the applicator cap 9506 (and therefore the cap post 9510) in the second direction B, the inclined surface 9610 of the cam surface 9608 is driven to collide with the opposing inclined surface 9612 of the ramp surface 9606, and as a result, the sensor cap 9120 connects to the flexible member 9604.

[0242] Figure 37 is a cross-sectional side 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 receptor feature portion 9602 has a first diameter D3, with respect to the engagement feature portion 9126 of the sensor cap 9120 having a second diameter D4 which is larger than the first diameter D3 and larger than the remaining outer diameter of the sensor cap 9120. As the sensor cap 9120 extends into the cap post 9510, the flexible member 9604 of the receptor feature portion 9602 can be curved (expanded) radially outward to receive the engagement feature portion 9126. In some embodiments, as shown, the engagement feature portion 9126 may provide an inclined outer surface that helps bias the flexible member 9604 radially outward, or may be otherwise defined. When the engagement feature portion 9126 advances beyond the receptor feature portion 9602, the flexible member 9604 can bend back to its natural state (or toward it), thereby locking the sensor cap 9120 into the cap post 9510.

[0243] As the applicator cap 9506 is screwed (twisted into place) onto the housing 9504 (Figures 35A-35B) in a first direction A, the cap post 9510 rotates correspondingly in the same direction, gradually introducing the sensor cap 9120 into the cap post 9510. As the cap post 9510 rotates, the ramp surface 9606 of the flexible member 9604 ratches against the opposing cam surface 9608 of the sensor cap 9120. This action continues until the applicator cap 9506 is fully screwed (twisted into place) onto the housing 9504. In some embodiments, the ratcheting action may occur over two full rotations of the applicator cap 9506 until it reaches its final position.

[0244] To remove the applicator cap 9506, the applicator cap 9506 is rotated in a second direction B, and the cap post 9510 rotates in the same direction accordingly, so that the cam surface 9608 (i.e., the inclined surface 9610 in Figures 36A-36B) engages with the ramp surface 9606 (i.e., the inclined surface 9612 in Figures 36A-36B). Thus, the continued rotation of the applicator cap 9506 in the second direction B causes the sensor cap 9120 to rotate in the same direction accordingly, thereby unscrewing from the fitting member 9118 and allowing the sensor cap 9120 to detach from the sensor control device 9102. By detaching the sensor cap 9120 from the sensor control device 9102, the distal portions of the sensor 9112 and the pointed body 9114 are exposed, thus placing the sensor control device 9102 in a fixed position suitable for firing (use).

[0245] Figure 38 is a cross-sectional view of a sensor control device 9800 illustrating an exemplary interaction between a sensor and a sharp body. After assembly of the sharp body, the sensor must seat within the channel defined by the sharp body. The sensor control device in Figure 9 does not show a sensor deflected inward and otherwise fully aligned with the sharp body, but such deflection and alignment may occur in the case of full assembly, where the sensor can receive some bias at the locations indicated by the two arrows A. Biasing the sensor against the sharp body may have the advantage of preventing any relative movement between the sensor and the sharp body during subcutaneous insertion from causing exposure of the sensor tip (i.e., tail) outside the sharp body channel, which could potentially lead to insertion failure.

[0246] Figures 42A to 42K show exemplary steps of the process for manufacturing an applicator assembly (e.g., an applicator device 150). The applicator assembly includes an inserter 4200, a wearable sensor pack assembly (e.g., a sensor control device 5002) coupled to a pack carrier 710 (e.g., the sensor electronic equipment carrier 710 in Figure 4A or the sensor carrier 5602 in Figures 21A to 21C), a sheath 704, an applicator housing 702, and a cap 708.

[0247] As shown in Figures 42A and 42B, the manufacturing process includes assembling the inserter 4200 by loading the spring 5612 onto the sharp body carrier 704 and lowering the pack carrier 710 onto the sharp body carrier 704 and compressing it until it is seated within the sharp body carrier 704. The spring 5612 can be compressed manually or using a suitable compression tool, including but not limited to a manually operated loading arm or robotic loading arm, a vacuum gripping arm or suction gripping arm, a magnetic gripping arm, an adaptive gripping arm or attachment, a pneumatically guided actuator or servo actuator, or other suitable tool. After the spring 5612 is compressed, the process includes locking one or more retaining features 4205 of the pack carrier 710 with the sharp body carrier 704 to retain the compression of the spring. The locking step can be performed while fastening the pack carrier 710 to the sharp body carrier 704 using any suitable fastening mechanism.

[0248] As shown in Figure 42C, the manufacturing process may include a step of coupling the wearable sensor pack assembly 5002 to the pack carrier 710. For example, a mount holding feature can be aligned with the arms of the pack carrier 710, allowing the pack assembly 5002 to advance until it snaps into place. As shown in Figure 42D, the manufacturing process may include a step of attaching an adhesive patch 105 (or adhesive patch 9110) to the wearable sensor pack assembly or pack carrier. The adhesive patch may be attached manually, or using gripping mechanical tools or applicator mechanical tools, vacuum gripping arms or suction gripping arms, magnetic gripping arms, adaptive gripping arms or attachments, pneumatically guided actuators or servo actuators, or other suitable tools. Before attaching the adhesive patch, the wearable sensor pack assembly (including the pack carrier) and the adhesive patch may be loaded into a suitable holding tool. The adhesive patch may be configured to fit the shape and components of the wearable sensor pack assembly; for example, the adhesive patch may include a hold to receive a sharp body cap. The adhesive patch can be aligned with the wearable sensor pack assembly (for example, manually, using an optical conductor alignment arm, a spring-loaded alignment tool, etc.) and lowered onto the wearable sensor pack assembly manually or using appropriate mechanical tools as discussed herein. As shown in Figures 42E and 42F, once the adhesive patch 105 is attached to the wearable sensor pack assembly 5002 or pack carrier 710, the manufacturing process may include, for example, a step of removing the tabs 4210a and 4210b of the adhesive patch 105 to expose the surface 4220 of the adhesive patch 150 that will be attached to the wearer's body, by fixing the exposed corner of the liner and peeling it off manually or using an automated machine.

[0249] As shown in Figure 42G, the manufacturing process may include a step of attaching the sheath 704 to the pack carrier 710. The step of attaching the sheath to the pack carrier may include a step of loading the sheath into a fastener nest (not illustrated) and a step of lowering the pack carrier 710 into the sheath 704 using a compression spring. The manufacturing process may further include a step of attaching the sheath 704 to the applicator housing 708. The step of attaching the sheath 704 to the applicator housing 708 may include a step of loading the applicator housing 708 into a fastener nest (not illustrated) and a step of engaging the alignment ribs of the applicator housing 708 with notches in the fastener nest. Next, the sheath 704 is lowered onto the applicator housing 708 until the sheath 704 engages with the alignment ribs of the applicator housing 708. The sheath 704 and the pack carrier 710 can be operated manually or using mechanical tools for forcibly mounting the components, such as pneumatically guided actuators, as discussed herein.

[0250] As shown in Figure 42H, the manufacturing process may include a step of loading a desiccant 502 into the cap 702. The desiccant 502 can be used to control moisture exposure of the wearable sensor pack assembly 5002 and the adhesive patch 105. The desiccant can be loaded manually or using appropriate tools such as a manually operated loading arm or robotic loading arm, a vacuum gripping arm or suction gripping arm, a magnetic gripping arm, an adaptive gripping arm or attachment, a pneumatically guided actuator, or other suitable tools.

[0251] As shown in Figure 42I, the manufacturing process may include a step of joining the cap 702 to the applicator housing 708. The step of joining the cap 702 to the applicator housing 708 may include a step of lowering the cap 702 onto the applicator housing 708. As shown in Figure 42J, the step of joining the cap 702 to the applicator housing 708 may include a step of lowering the cap 702 onto the applicator housing 708 and a step of screwing the cap 702 onto the applicator housing 708 to a predetermined torque. The cap 702 can be screwed onto the applicator housing 708 manually or using appropriate automation tools, and the cap 702 can be rotated to an appropriate motor torque using, for example, a servo rotary actuator.

[0252] In certain embodiments, a tamper-evident sticker or other method for detecting that the applicator housing 702 has been opened may be added to the inside or outside of the applicator housing 708. As shown in Figure 42K, the manufacturing process may include a step of adding a label 4220 to the outside of the assembled applicator housing 708.

[0253] Embodiments disclosed herein include the following:

[0254] D. An electronic housing including a shell defining a first opening and a mount defining a second opening alignable to the first opening when the shell is coupled to the mount; a seal overmolded on the mount in a second opening including a first seal element overmolded on a pedestal protruding from the inner surface of the mount and a second seal element interconnected with the first seal element and overmolded on the bottom of the mount; a sensor disposed within the electronic housing, the sensor having a tail extending through the second opening and past the bottom of the mount; and a sharp body extending through the first and second openings and past the bottom of the electronic housing.

[0255] E. An assembly comprising a sensor applicator and a sensor control device positioned within the sensor applicator, the assembly comprising an electronic housing including a shell defining a first opening and a mount defining a second opening alignable to the first opening when the shell is fitted into the mount; a seal overmolded on the mount at a second opening, including a first seal element overmolded on a pedestal protruding from the inner surface of the mount and a second seal element interconnected with the first seal element and overmolded on the bottom of the mount; a sensor disposed within the electronic housing, the sensor having a tail extending through the second opening and past the bottom of the mount; and a sensor control device comprising a pointed body extending through the first and second openings and past the bottom of the electronic housing. The assembly further comprises a sensor cap removably coupled to the sensor control device at the bottom of the mount, the sensor cap defining a sealed inner chamber for receiving the tail and the pointed body; and an applicator cap coupled to the sensor applicator.

[0256] Each of embodiments D and E may have one or more of the following additional elements in any combination: Element 1: The mount includes a first injection-molded portion formed in a first shot, and the seal includes a second injection-molded portion overmolded on the first injection-molded portion in a second shot. Element 2: Further includes a sharp body hub that carries a sharp body and engages in a seal with the first seal element, and a sensor cap that is removably coupled to the sharp body hub at the bottom of the mount and engages in a seal with the second seal element, the sensor cap defining an inner chamber that receives the tail and the sharp body. Element 3: The sharp body hub provides a mating member that extends through the bottom of the mount, and the sensor cap is removably coupled to the mating member. Element 4: further comprising one or more pockets defined on the bottom of the mount by a second opening, and one or more projections defined on the end of the sensor cap that can be received into one or more pockets when the sensor cap is coupled to the pointed body hub. Element 5: further comprising a collar disposed within the electronic housing, the collar having a central opening that radially receives and seals with the first sealing element. Element 6: further comprising a channel defined on the inner surface of the mount surrounding a base, an annular lip defined on the underside of the collar that can mate with the channel, and adhesive provided within the channel to secure and seal the collar to the mount at the location of the channel. Element 7: further comprising a groove defined to pass through the annular lip to receive a laterally extending portion of the sensor within the mount, with adhesive sealing around the sensor at the location of the groove. Element 8: further comprising a collar channel defined on the upper surface of the collar, an annular ridge defined on the inner surface of the shell that can mate with the collar channel, and adhesive provided within the collar channel to secure and seal the shell to the collar. Element 9: One or both of the first and second sealing elements define at least a portion of the second opening. Element 10: The first sealing element extends at least partially through the first opening when the shell is coupled to the mount.

[0257] Element 11: The sensor control device further includes a pointed body hub that carries a pointed body and seals with a first sealing element, and a sensor cap that is removably coupled to the pointed body hub at the bottom of the mount and seals with a second sealing element. Element 12: The sensor control device further includes one or more pockets defined on the bottom of the mount at a second opening, and one or more projections defined on the end of the sensor cap that can be received into one or more pockets when the sensor cap is coupled to the pointed body hub. Element 13: The sensor control device further includes a collar disposed within the electronic housing, the collar having a central opening that radially receives and seals with the first sealing element. Element 14: The sensor control device further includes a channel defined on the inner surface of the mount surrounding a base, an annular lip defined on the underside of the collar that can mate with the channel, and an adhesive provided within the channel to secure and seal the collar to the mount at the location of the channel. Element 15: Further includes a groove defined to pass through an annular lip to receive a laterally extending portion of the sensor within the mount, with adhesive sealing around the sensor at the location of the groove. Element 16: Further includes a collar channel defined on the upper surface of the collar, an annular ridge defined on the inner surface of the shell and matable with the collar channel, and adhesive provided within the collar channel to secure and seal the shell to the collar. Element 17: One or both of the first and second sealing elements define at least a portion of the second opening. Element 18: The first sealing element extends at least partially through the first opening.

[0258] As a non-limiting example, exemplary combinations applicable to D and E include element 2 having element 3, element 2 having element 4, element 5 having element 6, element 6 having element 7, element 5 having element 8, element 11 having element 12, element 13 having element 14, element 14 having element 15, and element 13 having element 16.

[0259] Further details regarding appropriate devices, systems, methods, components, and their operation, along with relevant features, are described in International Publication No. WO2018 / 136898 assigned to Rao et al., International Publication No. WO2019 / 236850 assigned to Thomas et al., International Publication No. WO2019 / 236859 assigned to Thomas et al., International Publication No. WO2019 / 236876 assigned to Thomas et al., and U.S. Patent Application No. 16 / 433,931 filed June 6, 2019, the entire contents of each of these documents are incorporated herein by reference.

[0260] Embodiments disclosed herein include the following:

[0261] F. A method for assembling a sensor subassembly comprising a sensor, a sensor mount, a collar, a sharpened body, and a sensor cap. The method includes the steps of: loading the sensor into the sensor mount; dispensing adhesive into the mounting channel of the sensor mount; fastening the collar to the sensor mount; curing the adhesive to fix the collar to the sensor mount; inserting the sharpened body into the sensor mount on the sensor; and attaching the sensor cap to the sensor and the sensor sharpened body to provide a sealed sensor subassembly.

[0262] G. A method for assembling a wearable sensor pack assembly comprising a printed circuit board (PCB), a pack shell cap, and a sensor subassembly including a sensor, a sensor mount, a collar, and a sensor cap. The method may include the steps of: dispensing a first adhesive onto the sensor mount of the sensor subassembly; aligning the PCB with the sensor and the sensor subassembly and then loading the PCB onto the sensor mount of the sensor subassembly; curing the first adhesive to fix the PCB to the sensor mount; dispensing a second adhesive into the outer diameter of the sensor mount and the inner diameter of the collar of the sensor subassembly; attaching the pack shell cap to the sensor subassembly; and curing the second adhesive to form a wearable sensor pack assembly.

[0263] H. A method for assembling an applicator assembly comprising an inserter, a wearable sensor pack assembly coupled to a pack carrier, a sheath, an applicator housing, and a cap. The method includes the steps of: assembling the inserter by loading a spring into a sharp body carrier, lowering the pack carrier to the sharp body carrier and compressing the spring until it is seated inside the sharp body carrier, and locking one or more retaining features of the sharp body carrier to maintain the compression of the spring; coupling the wearable sensor pack assembly to the pack carrier; attaching an adhesive patch to the wearable sensor pack assembly; attaching the sheath to the pack carrier; attaching the sheath to the applicator housing; and coupling the cap to the applicator housing.

[0264] I. A sensor comprising a tail, a flag, and a neck interconnecting the tail and the flag. The tail, the flag, and the neck are aligned along a flat surface having a vertical axis and a horizontal axis, the neck includes at least two windings that define a spring structure with respect to the vertical axis between the tail and the flag, and the flag includes a substantially flat surface having one or more sensor contacts.

[0265] A method for configuring a sensor including a tail, a flag, and a neck connecting the tail and the flag. The method may include the steps of heating a portion of the sensor neck to a predetermined temperature and bending the sensor neck to form a first angle between the sensor tail and the sensor flag.

[0266] Each of embodiments F, G, H, I, and J may have one or more of the following additional elements in any combination: Element 1: The adhesive is a chemically curable adhesive, and the method further includes a step of curing the adhesive by exposing the adhesive to one or more chemical bonding catalysts. Element 2: The adhesive is a thermosetting adhesive, and the method further includes a step of curing the adhesive by exposing the adhesive to heat suitable for curing the adhesive. Element 3: The adhesive is an ultraviolet (UV) curable adhesive, and the method further includes a step of curing the adhesive using one or more UV light sources. Element 4: The sensor is shielded from one or more UV light sources while the adhesive is curing. Element 5: One or more UV light sources include UV light-emitting diodes (LEDs) having a light conductor and a plurality of tilt spot LEDs. Element 6: The method further includes a step of loading the color onto the sensor mount. Element 7: The sharp body is attached to the sharp body hub, and the step of inserting the sharp body into the sensor mount includes the step of coupling the sharp body hub to the sensor mount, the method further includes the steps of dispensing adhesive onto the upper surface of the sharp body hub and curing the adhesive to seal the sharp body hub. Element 8: The method further includes the step of inspecting the sealed sensor subassembly for leakage using pressure decay leakage testing, vacuum decay leakage testing, tracer gas leakage testing, trace analysis testing, or mass flow leakage testing. Element 9: The method further includes the step of discarding the sealed sensor subassembly when leakage exceeding a predetermined threshold is detected. Element 10: The method further includes the step of sterilizing the sensor subassembly. Element 11: The sterilization step is performed through heat treatment, radiation, electron beam sterilization, gamma sterilization, X-ray sterilization, ethylene oxide sterilization, autoclave steam sterilization, chlorine dioxide gas sterilization, or hydrogen peroxide sterilization. Element 12: The sensor includes a body temperature sensor, blood pressure sensor, pulse or heart rate sensor, glucose level sensor, sample sensor, or physical activity sensor. Element 13: Further includes a step of inspecting the sharp object for defects before inserting it into the sensor mount. Element 14: Further includes a step of discarding the sharp object when a defect exceeding a predetermined threshold is detected.Element 15: The step of attaching the sensor cap to the sensor and the sensor tip to provide a sealed sensor subassembly includes the step of twisting the sensor cap into place. Element 16: The step of inserting a desiccant into the plug and further including the step of inserting the plug into the sensor cap before attaching the sensor cap to the sensor and the sensor tip.

[0267] Element 17: The PCB is a flexible PCB, and the method further includes a step of folding the PCB to fit the footprint of a wearable sensor pack assembly. Element 18: The step of dispensing a first adhesive further includes a step of dispensing the first adhesive to a folding location, a battery location, or a PCB connector location. Element 19: The PCB includes a wireless component, and the method further includes a step of writing data to the wireless component of the PCB by reading sensor data from a sensor subassembly, the PCB, a pack shell cap, or a mount carrying the sensor subassembly and writing the sensor data to the wireless component of the PCB. Element 20: The step of dispensing the second adhesive onto the outer diameter of the sensor mount and the inner diameter of the collar of the sensor subassembly includes the steps of tilting the sensor mount along its axis to a predetermined angle, dispensing the second adhesive onto the inner diameter of the collar of the sensor subassembly, returning the sensor mount to a substantially horizontal position by tilting the sensor mount along this axis, and dispensing the second adhesive onto the outer diameter of the sensor mount. Element 21: The step of inspecting the wearable sensor pack assembly for leakage using a pressure decay leak test, a vacuum decay leak test, a tracer gas leak test, a trace analysis test, or a mass flow leak test. Element 22: The step of discarding the wearable sensor pack assembly when leakage exceeding a predetermined threshold is detected. Element 23: The first or second adhesive is a chemically curable adhesive, and the method further includes the step of curing the first or second adhesive by exposing the adhesive to one or more chemical bonding catalysts. Element 24: The first adhesive or the second adhesive is a thermosetting adhesive, and the method further includes a step of curing the first adhesive or the second adhesive by exposing the adhesive to a heat suitable for curing the first adhesive or the second adhesive. Element 25: The first adhesive or the second adhesive is an ultraviolet (UV) curable adhesive, and the method further includes a step of curing the first adhesive or the second adhesive using one or more UV light sources.

[0268] Element 26: The step of attaching the sheath to the pack carrier includes the steps of loading the sheath into a fastener nest and lowering the pack carrier into the sheath using a compression spring. Element 27: The step of attaching the sheath to the applicator housing includes the steps of loading the applicator housing into a fastener nest and engaging the alignment ribs of the applicator housing with notches in the fastener nest and lowering the sheath onto the applicator housing and engaging with the alignment ribs of the applicator housing. Element 28: The step of coupling the cap to the applicator housing includes the steps of lowering the cap onto the applicator housing and screwing the cap onto the applicator housing to a predetermined torque. Element 29: Further includes the step of loading a desiccant into the cap. Element 30: Further includes the step of adding a tamper-evident sticker to the applicator assembly.

[0269] Element 31: At least two windings of the neck are formed by bending the neck of the sensor. Element 32: At least two windings of the neck are formed by laser cutting the sensor. Element 33: At least two windings of the neck are formed by punching the sensor out of a material sheet containing the sensor. Element 34: At least two windings of the neck are formed by printing the sensor to include at least two windings. Element 35: At least two windings relative to the vertical axis provide an overlapping layer of the neck. Element 36: The overlapping layer of the neck is oriented vertically. Element 37: The overlapping layer of the neck is oriented horizontally.

[0270] Element 38: A predetermined temperature is sufficient to improve the malleability of the sensor neck. Element 39: The predetermined temperature is between 50 and 60°C, including a boundary value. Element 40: After the bending step, the process further includes verifying the integrity of the sensor by inspecting the neck for micro-fractures within the sensor neck. Element 41: The process further includes disposing of the sensor if the micro-fractures detected within the sensor neck exceed a predetermined micro-fracture threshold. Element 42: Heating is performed by a first component of the heating-bending device, and bending is performed by a second component of the heating-bending device. Element 43: The step of heating a portion of the neck includes heating a first component of the heating-bending device using a heating element, and bringing a portion of the neck into contact with the heated first component of the heating-bending device. Element 44: Heating is performed by a heating element integrated into the heating-bending device, and heat is applied during bending. Element 45: The intensity of the heat applied to the neck changes during the bending process.

[0271] As a non-limiting example, exemplary combinations applicable to Embodiment F include: element 1 having any of elements 6 to 16, element 2 having any of elements 6 to 16, element 3 having any of elements 4 to 16, element 4 having any of elements 3 and 5 to 16, element 5 having any of elements 3 to 4 and 6 to 16, element 6 having any of elements 1 to 5 and 7 to 16, element 7 having any of elements 1 to 6 and 8 to 16, element 8 having any of elements 1 to 7 and 9 to 16, element 1 It includes element 9 having any of elements ~8 and 10~16, element 10 having any of elements 1~9 and 11~16, element 11 having any of elements 1~10 and 12~16, element 12 having any of elements 1~11 and 13~16, element 13 having any of elements 1~12 and 14~16, element 14 having any of elements 1~13 and 15~16, element 15 having any of elements 1~14 and 16, and element 16 having any of elements 1~15.

[0272] As a non-limiting example, exemplary combinations applicable to Embodiment G include element 17 having any of elements 18 to 25, element 18 having elements 17 and any of elements 29 to 25, element 19 having any of elements 17 to 18 and any of elements 20 to 25, element 20 having any of elements 17 to 19 and any of elements 21 to 25, element 21 having any of elements 17 to 20 and any of elements 22 to 25, element 21 having any of elements 17 to 20 and any of elements 22 to 25, element 22 having any of elements 17 to 21 and any of elements 23 to 25, element 23 having any of elements 17 to 22 and any of elements 24 to 25, element 24 having any of elements 17 to 23 and any of elements 25, and element 25 having any of elements 17 to 24.

[0273] As a non-limiting example, exemplary combinations applicable to Embodiment H include element 26 having any of elements 27-30, element 27 having elements 26 and any of elements 28-30, element 28 having any of elements 26-27 and 29-30, element 29 having any of elements 26-28 and 30, and element 30 having any of elements 26-29.

[0274] As a non-limiting example, exemplary combinations applicable to Embodiment I include element 31 having any of elements 34 to 37, element 32 having any of elements 34 to 37, element 33 having any of elements 34 to 37, element 34 having any of elements 35 to 37, element 35 having any of elements 31 to 34 and 36 to 37, element 36 having any of elements 31 to 35 and 37, and element 37 having any of elements 31 to 36.

[0275] As a non-limiting example, exemplary combinations applicable to Embodiment J include element 38 having any of elements 39 to 45, element 39 having any of elements 38 and 40 to 45, element 40 having any of elements 38 to 39 and 41 to 45, element 41 having any of elements 38 to 40 and 42 to 45, element 42 having any of elements 38 to 41, element 43 having any of elements 38 to 42, element 44 having any of elements 38 to 41 and 45, and element 45 having any of elements 38 to 41 and 44.

[0276] In addition to or instead of the above, any element and combination applicable to embodiments F, G, H, I, and J is equally applicable to any other element and combination applicable to embodiments F, G, H, I, and J.

[0277] Exemplary embodiments of one-piece and two-piece applicator launching mechanisms Figures 39A–39F illustrate exemplary details of an embodiment of an internal device mechanism that “launches” an applicator 216 to attach a sensor control device 222 to a user, including the step of safely retracting the pointed body 1030 into the applicator 216 being used. All of these drawings illustrate exemplary sequences of the steps of pressing the pointed body 1030 (supporting the sensor coupled to the sensor control device 222) into the user’s skin, retracting the pointed body while leaving the sensor in working contact with the user’s interstitial fluid, and adhering the sensor control device to the user’s skin using an adhesive. Those skilled in the art will recognize by this sequence alternative embodiments of applicator assemblies and modifications of such activities suitable for use with components. Furthermore, the applicator 216 may be a sensor applicator having a one-piece architecture or a two-piece architecture as disclosed herein.

[0278] Now, moving to Figure 39A, the sensor 1102 is supported within the pointed body 1030 just above the user's skin 1104. Rails 1106 (optionally three rails) can be provided in the upper guide section 1108 to control the movement of the applicator 216 relative to the sheath 318. The sheath 318 is held by the pointed body 1030 within the applicator 216 by the pointed body 1110 so that an appropriate downward force along the longitudinal axis of the applicator 216 overcomes the resistance force provided by the retaining feature 1110, thereby allowing the pointed body 1030 and the sensor control device 222 to move parallel to (and over) the user's skin 1104 along the longitudinal axis. Furthermore, to maintain the pointed body 1030 in position relative to the sensor control device 222, the locking arm 1112 of the sensor carrier 1022 engages with the pointed body retraction assembly 1024.

[0279] In Figure 39B, a user force is applied to overcome or overcome the retaining feature 1110, causing the sheath 318 to collapse into the housing 314 and drive the sensor control device 222 to move downward in parallel as shown by arrow L along the longitudinal axis (along with the relevant parts). The inner diameter of the upper guide section 1108 of the sheath 318 constrains the position of the carrier arm 1112 throughout the full stroke of the sensor / tip body insertion process. The holding of the stop surface 1114 of the carrier arm 1112 against the complementary surface 1116 of the tip body retraction assembly 1024 maintains the position of these members when the return spring 1118 is maximally pressed.

[0280] In Figure 39C, the sensor 1102 and the sharp body 1030 reach their maximum insertion depth. As they do so, the carrier arm 1112 passes through the inner diameter of the upper guide section 1108. Next, the compressed force of the coil return spring 1118 drives the inclined stop surface 1114 radially outward, releasing the force to drive the sharp body carrier 1102 of the sharp body retraction assembly 1024 to pull the sharp body 1030 (slotted or otherwise configured) away from the user and from the sensor 1102, as shown by arrow R in Figure 39D.

[0281] As shown in Figure 39E, once the pointed body 1030 is fully retracted, the upper guide section 1108 of the sheath 318 is secured by the final locking feature 1120. As shown in Figure 39F, the used applicator assembly 216 is removed from the insertion site with the sensor control device 222 remaining and the pointed body 1030 securely fixed inside the applicator assembly 216. At this point, the used applicator assembly 216 can be disposed of at any time.

[0282] The operation of the applicator 216 when the sensor control device 222 is attached is designed to give the user the sensation that both the insertion and retraction of the sharp body 1030 are performed automatically by the internal mechanism of the applicator 216. In other words, the present invention avoids the user having the sensation that they are manually pushing the sharp body 1030 into their skin. Thus, the operation of the applicator 216 obtained after the user has applied sufficient force to overcome the resistance from the return feature of the applicator 216 is perceived as an automatic response to the applicator being "triggered". Despite all driving force being supplied by the user and no auxiliary biasing / driving means being used to insert the sharp body 1030, the user is not aware that they are supplying additional force to drive the sharp body 1030 to penetrate their skin. As detailed above in Figure 39C, the retraction of the sharp body 1030 is automated by the coil return spring 1118 of the applicator 216.

[0283] With respect to any of the applicator embodiments described herein, and with respect to any of the components of the applicator embodiments, including embodiments of the sharpened body, sharpened body module, and sensor module, those skilled in the art will understand that these embodiments can be sized and configured to be suitable for use with a sensor configured to sense the level of a sample in bodily fluids within the epidermis, dermis, or subcutaneous tissue of a subject. In some embodiments, for example, both the sharpened body and the distal portion of the sample sensor disclosed herein can be sized and configured to be positioned at a specific terminal depth (i.e., the deepest point of penetration into the tissue or layer of the subject's body, e.g., the epidermis, dermis, or subcutaneous tissue). With respect to some applicator embodiments, those skilled in the art will understand that certain embodiments of the sharpened body can be sized and configured to be positioned at a terminal depth in the subject's body that differs from the final terminal depth of the sample sensor. In some embodiments, for example, the sharpened body can be positioned at a first terminal depth in the subject's epidermis before retraction, while the distal portion of the sample sensor can be positioned at a second terminal depth in the subject's dermis. In another embodiment, the pointed body can be positioned at a first distal depth in the dermis of the subject before retraction, while the distal portion of the specimen sensor can be positioned at a second distal depth in the subcutaneous tissue of the subject. In yet another embodiment, the pointed body can be positioned at a first distal depth before retraction, and the specimen sensor can be positioned at a second distal depth, where both the first and second distal depths are within the same layer or tissue of the subject's body.

[0284] In addition, with respect to any of the applicators described herein, those skilled in the art will understand that the sample sensor and one or more structured components coupled to the sample sensor, including but not limited to one or more spring mechanisms, can be positioned eccentrically with respect to one or more axes within the applicator. In some applicator embodiments, for example, the sample sensor and spring mechanism can be positioned eccentrically on the first side of the applicator with respect to the axis of the applicator, and the sensor electronics can be positioned eccentrically on the second side of the applicator with respect to the axis of the applicator. In other applicator embodiments, the sample sensor, spring mechanism, and sensor electronics can be positioned eccentrically on the same side with respect to the axis of the applicator. Those skilled in the art will understand that other reconfigurations and configurations are possible, and are entirely within the disclosure of the present invention, in which any or all of the sample sensor, spring mechanism, sensor electronics, and other components of the applicator can be positioned centrally or eccentrically with respect to one or more axes of the applicator.

[0285] This specification describes some deflectable structures, including but not limited to deflectable retaining snaps 1402, deflectable locking arms 1412, sharp body carrier locking arms 1524, sharp body holding arms 1618, and module snaps 2202. These deflectable structures include elastic materials such as plastic or metal (or other) and operate in a manner known to those skilled in the art. Each deflectable structure has a stationary state or position that biases the elastic material toward it. When a force is applied to deflect or move the structure from this stationary state or position, this bias of the elastic material returns the structure to this stationary state or position when this force is removed (or weakened). In many cases, these structures are configured as arms with retaining or snaps, but other structures or configurations having the same characteristics of deflection and the ability to return to a stationary position can be used, including but not limited to legs, clips, catches, and contacts on the deflectable member.

[0286] Appropriate devices, systems, methods, components, and additional details regarding their operation, along with relevant features, are described in International Publication No. WO2018 / 136898 assigned to Rao et al., International Publication No. WO2019 / 236850 assigned to Thomas et al., International Publication No. WO2019 / 236859 assigned to Thomas et al., International Publication No. WO2019 / 236876 assigned to Thomas et al., and U.S. Patent Publication No. 2020 / 0196919 filed June 6, 2019, the entire contents of each of these documents are incorporated herein by reference. Additional details regarding applicators, embodiments of their components, and variations thereof are described in U.S. Patent Publication No. 2013 / 0150691, No. 2016 / 0331283, and No. 2018 / 0235520, the entire contents of these documents are incorporated herein by reference for all purposes. Additional details relating to the sharpened module, the sharpened body, embodiments of its components, and variations thereof are described in U.S. Patent Publication No. 2014 / 0171771, the entire contents of which are incorporated herein by reference for all purposes.

[0287] It should be noted that all features, elements, components, functions, and steps described in relation to any embodiment provided herein are intended to be freely combined and interchangeable with any other embodiment. Even when certain features, elements, components, functions, or steps are described in relation to only one embodiment, it should be understood that, unless otherwise expressly stated, such features, elements, components, functions, or steps can be used in all other embodiments described herein. Accordingly, this paragraph serves as a basis and written support prior to the introduction of claims that combine features, elements, components, functions, and steps from various embodiments or replace features, elements, components, functions, and steps from one embodiment with another, even if the following description does not expressly state that such combinations or substitutions are possible in a particular case. Accordingly, the above description of specific embodiments of the subject matter disclosed is presented for illustrative and explanatory purposes only. In particular, it should be clearly recognized that an explicit enumeration of all possible combinations and substitutions would be undue, given that the permissible range of each such combination and substitution will be readily apparent to those skilled in the art.

[0288] The embodiments described above are subject to various modifications and alternative forms, specific examples of which are shown in the drawings and described in detail herein. Those skilled in the art will see that various modifications and changes can be made to the methods and systems of the disclosed subject matter without departing from the spirit or scope of the disclosed subject matter. Accordingly, the disclosed subject matter is intended to include modifications and variations within the claims and their equivalents. Furthermore, any features, functions, steps, or elements of any of the embodiments described above, as well as any features, functions, steps, or elements not present in the invention, may be enumerated or added to the claims to negatively limit the scope of the claims of the invention.

Claims

1. A method for assembling a sensor subassembly comprising a sensor, a sensor mount, a collar, a pointed body, and a sensor cap, The stage of loading the sensor into the sensor mount, The steps include dispensing an ultraviolet-curing adhesive into the mounting channel of the sensor mount, The steps include fastening a collar to the sensor mount and distributing the adhesive between the sensor mount and the collar, The steps include curing the adhesive using one or more ultraviolet sources to fix the color to the sensor mount, The steps include inserting a sharp object into the sensor mount on the sensor, The steps include: providing a sealed sensor subassembly by attaching a sensor cap to the sensor and the sensor tip, Equipped with, A method characterized in that the collar and sensor mount are configured to cure the adhesive but to shield the sensor from one or more ultraviolet sources.

2. The method according to claim 1, characterized in that the one or more UV light sources include UV light-emitting diodes (LEDs).

3. The method according to 1 or 2, further comprising the step of loading the aforementioned color onto the sensor mount.

4. The sharp body is attached to the sharp body hub, and the step of inserting the sharp body into the sensor mount includes the step of coupling the sharp body hub to the sensor mount. The method is The steps include dispensing adhesive onto the upper surface of the pointed hub, The steps include curing the adhesive to seal the aforementioned sharp hub, It also has, The method according to any one of claims 1 to 3, characterized by...

5. The method according to any one of claims 1 to 4, further comprising the step of inspecting the sealed sensor subassembly for leakage using a pressure decay leakage test, a vacuum decay leakage test, a tracer gas leakage test, a trace analysis test, or a mass flow leakage test.

6. The method according to 5, further comprising the step of discarding the sealed sensor subassembly when leakage exceeding a predetermined threshold is detected.

7. The method according to any one of claims 1 to 6, further comprising the step of sterilizing the sensor subassembly.

8. The method according to 7, characterized in that the sterilization step is carried out through heat treatment, radiation, electron beam sterilization, gamma sterilization, X-ray sterilization, ethylene oxide sterilization, autoclave steam sterilization, chlorine dioxide gas sterilization, or hydrogen peroxide sterilization.

9. The method according to any one of claims 1 to 8, characterized in that the sensor comprises a body temperature sensor, a blood pressure sensor, a pulse or heart rate sensor, a glucose level sensor, a sample sensor, or a physical activity sensor.

10. The method according to any one of claims 1 to 9, further comprising the step of examining the sharp body for defects before inserting the sharp body into the sensor mount.

11. The method according to 10, further comprising the step of discarding the sharp body when a defect exceeding a predetermined threshold is detected.

12. The method according to any one of claims 1 to 11, wherein the step of attaching the sensor cap to the sensor tip to provide a sealed sensor subassembly is characterized by comprising the step of twisting the sensor cap into a fixed position.

13. The step of inserting the desiccant into the plug, Before attaching the sensor cap to the sensor and the sensor tip, the plug is inserted into the sensor cap. The method according to any one of claims 1 to 12, further comprising the above.

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