Focused sterilization and sterilization subassemblies for test substance monitoring systems

Abstract

An assembly for delivering a substance sensor, comprising a sensor control device. The sensor control device comprises an electronic component housing having a shell having a first opening and a first interface, and a mount having a second opening and a second interface, the electronic component housing having an internal space. These two interfaces define a first sterile barrier. The electronic component housing further comprises a first mating member, and the sensor control device further comprises a circuit board and a substance sensor. The assembly further comprises an applicator for sensor delivery. The applicator comprises a housing, a cap detachably coupled to the housing and thereby sealing the interior of the applicator, a pointed hub, and a second mating member extending into the first or second opening and mating with the first mating member to define a second sterile barrier. The applicator further comprises a collimator, a third sterile barrier, and a fourth sterile barrier, which define a sterile zone.

Description

Cross-reference of related applications

[0001] This application claims priority to U.S. Provisional Application No. 63 / 451316 filed on 10 March 2023, all of which are expressly incorporated herein by reference, regardless of their purpose. Let's assume that. [Technical Field]

[0002] This application relates, in general, to a system, device, and method for assembling an applicator and sensor control device used in an in vivo test substance monitoring system. [Background technology]

[0003] Diabetes is an incurable chronic disease in which the body does not produce enough insulin, a hormone secreted by the pancreas that regulates blood glucose levels, or does not utilize it properly. For example, when blood glucose levels rise after a meal, insulin works to lower blood glucose levels by moving glucose from the blood into body cells. If the pancreas does not secrete enough insulin (a known condition as type 1 diabetes) or if insulin is not properly utilized in the body (a known condition as type 2 diabetes), blood glucose remains in the blood, which can lead to hyperglycemia (abnormally high blood glucose levels).

[0004] If diabetes symptoms are not carefully monitored and treated, numerous complications can occur, including diabetic ketoacidosis, nonketotic hyperosmolar coma, cardiovascular disease, stroke, renal failure, foot ulcers, eye disorders, and neuropathy. Traditionally, monitoring blood glucose levels required individuals to prick their fingers to draw blood and then test the blood to measure glucose concentration. However, recent technological advancements have made it possible to continuously and long-term monitor blood glucose using biosensors that remain in contact with bodily fluids for several days, weeks, or even longer periods.

[0005] For example, a test substance monitoring system has been developed to assist in the long-term monitoring of test substances in bodily fluids, such as glucose. Typically, a test substance monitoring system includes a sensor applicator configured to set a biosensor in contact with bodily fluids. More specifically, once the sensor is delivered to the user's skin, at least a portion of the sensor is positioned below the skin surface, for example, in the subcutaneous or dermal tissue.

[0006] For devices implanted in the body or placed subcutaneously, sterility at the time of insertion is crucial. Therefore, these devices can be sterilized by any number of treatments that substantially eliminate or kill infectious pathogens such as bacteria, fungi, and viruses. Failure to remove these infectious pathogens from these devices could have significant adverse effects on the user's health and safety.

[0007] In some substance monitoring systems, it may be necessary to sterilize the sensor and the electronic components separately. For example, electron beam sterilization, an example of radiation sterilization, can be used to perform final sterilization on the sensor. However, radiation sterilization may adversely affect the electronic components attached to the sensor. Therefore, electronic components are usually sterilized by chemical gas sterilization using ethylene oxide, etc. However, using ethylene oxide may damage chemical substances applied to the sensor. For this reason, when electronic components and sensors are integrated into a single unit, the sterilization process can become complicated.

[0008] The above problem can be avoided by separating the components of the substance monitoring system into a sensor unit (e.g., a biological substance sensor) and an adapter unit (a unit containing electronic components for data transmission), packaging each in a separate package, and then sterilizing them separately using an appropriate sterilization method. However, this method not only increases the number of required parts, packages, and processing steps, but also leaves the final assembly of the two units to the user, thus inherently carrying the risk of human error. [Overview of the Initiative] [Problems that the invention aims to solve]

[0009] Therefore, there is a need for a test substance monitoring system that can be sterilized without separating its constituent components.

[0010] The purposes and advantages of the subject matter of this disclosure are described below. Such purposes and advantages will be partially apparent from the following description and will be understood by performing the subject matter of this disclosure. Furthermore, any further advantages of the subject matter of this disclosure that the method and system realize and achieve are specifically mentioned in this specification, the claims and the accompanying drawings. [Means for solving the problem]

[0011] To achieve the advantages described above and other advantages, and in accordance with the purpose of the subject matter of this disclosure, the subject matter of this disclosure relates to a substance monitoring system, as embodied and outlined in the embodiments herein. The substance monitoring system comprises a sensor control device, which comprises an electronic component housing. The electronic component housing comprises a shell having a first opening and a first interface surrounding the first opening, and a mount fixed to the shell to define an internal space, the mount having a second opening axially aligned with the first opening and a second interface surrounding the second opening, wherein the first interface fits into the second interface to define a first sterile barrier. The electronic component housing may further comprise a first fitting member extending into at least one of the first and second openings. The sensor control device may further comprise a circuit board and a glucose sensor. Both the circuit board and the glucose sensor are located in the internal space of the electronic component housing. Furthermore, the glucose sensor comprises a proximal portion and a distal portion, with at least a portion of the proximal portion coupled to a circuit board, and the distal portion extending from the bottom of the electronic component housing to measure glucose levels in body fluids beneath the user's skin surface. The substance monitoring system may further comprise an applicator housing, an applicator cap, and a sharp body hub. The applicator housing is configured to fix a sensor control device inside the applicator housing via a sensor carrier. The applicator cap is detachably coupled to the applicator housing so that the applicator cap and applicator housing form a seal. The sharp body hub comprises a sharp body and a second mating member and is detachably coupled to the shell. The second mating member extends into at least one of the first and second openings and is configured to mat with the first mating member to form a second sterile barrier. This test substance monitoring system may further include a collimator, a sterile zone, a third sterile barrier, and a fourth sterile barrier. The collimator is located inside the applicator cap.The sterile zone is configured to receive the distal portion of the sample sensor. A third sterile barrier defines a sealing interface between the collimator and the bottom of the mount. A fourth sterile barrier seals the edges of the sterile zone. Thus, the sterile zone can be configured to be defined by the collimator, the second sterile barrier, the third sterile barrier, and the fourth sterile barrier.

[0012] In some embodiments, the first fitting member may extend from the shell into at least one of the first and second openings. The first fitting member may be a concave surface of the shell. In some embodiments, the first fitting member may extend from the mount into at least one of the first and second openings.

[0013] In other embodiments, the applicator cap is detachably coupled to the applicator housing via a threaded surface, thereby defining a microbial barrier. Alternatively, a microbial barrier can be formed at any other interface between the applicator housing and the applicator cap. Furthermore, the fourth sterile barrier can be configured to prevent moisture from penetrating the fourth sterile barrier and entering the collimator without preventing electron beam radiation from penetrating the fourth sterile barrier and reaching the collimator. In some embodiments, the sterilization zone can be configured to isolate the sample sensor and perform low-energy electron beam sterilization. In other embodiments, the sterilization zone may comprise a first sterilization zone and a second sterilization zone. In yet another embodiment, the first end of the sterilization zone may be demarcated by a sealing portion, and the second end of the sterilization zone may be demarcated by a pointed hub. This sealing portion may be Tyvek®. Alternatively, the first end of the sterilization zone may be demarcated by a mount, and the second end of the sterilization zone may be demarcated by a pointed hub. According to the subject matter of this disclosure, in some embodiments, the shell may further comprise a third interface adjacent to the first outer edge, and the mount may comprise a fourth interface adjacent to the second outer edge, and the third and fourth interfaces may be configured to fit together to form a sealing portion. Furthermore, the first interface may comprise an annular projection, and the second interface may comprise a groove configured to receive the annular projection. According to the subject matter of this disclosure, the first sterile barrier may be defined between the sterilization zone and the natural microbial load in the internal space of the electronic component housing. The second sterile barrier may be a meandering path. Furthermore, the second sterile barrier may be defined between the natural microbial load of the applicator and the sterilization zone. In some embodiments, the first sterile barrier may be sealed with an adhesive. In some embodiments, the third sterile barrier may be adjacent to the proximal portion of the collimator. In some embodiments, the fourth sterile barrier can be located close to the distal portion of the collimator.

[0014] In some embodiments, the circuit board may comprise multiple electronic component modules. To prevent the electronic component modules from being exposed to electron beam radiation, the circuit board may be positioned offset from the central axis of the collimator. In yet another embodiment, the central axis of the circuit board may be positioned approximately offset from the distal portion of the substance sensor. In yet another embodiment, the center point of the circuit board may be positioned so as not to be axially aligned with the collimator. Furthermore, the cross-sectional shape of the collimator may be selected from the group consisting of shapes corresponding to cones, frustocones, pyramids, and cubes, circles, rectangles, and any combination thereof. In such embodiments, the assembly may further comprise a desiccant placed in an applicator cap. The cross-section of the desiccant may be axially aligned with the cross-section of the collimator and may have a cross-sectional shape substantially similar to that of the collimator. In other embodiments, the collimator may have a generally semiconical or semi-cylindrical shape. In such embodiments, the desiccant may be placed in an applicator cap. The cross-section of the desiccant is aligned axially with the cross-section of the collimator and can have a cross-sectional shape substantially similar to that of the collimator.

[0015] According to the subject matter of this disclosure, an electronic component module includes one or more ASICs, and the pointed body may have a U-shaped cross-sectional shape facing away from one or more ASICs.

[0016] According to the subject matter of this disclosure, a method is provided for assembling a substance sensor having the above-described features. Furthermore, according to the subject matter of this disclosure, the method may include a step of preventing moisture from penetrating the seal and entering the collimator without preventing electron beam radiation from penetrating the seal and reaching the collimator. The method may further include a step of isolating the substance sensor for sterilization. Low-energy electron beam sterilization can be used as the sterilization method. To achieve this, in some embodiments, the sensor control device may be positioned at an angle to the axis of the electron beam path during sterilization. The electron beam path is the path through which high-energy electrons capable of causing biological damage travel when sterilizing the sensor control device. In some embodiments, the angle can be in the range of about 20 to 40 degrees. Also disclosed is an assembly for delivering a substance sensor, comprising a sensor control device. The sensor control device comprises an electronic component housing having a shell having a first opening and a first interface, and a mount having a second opening and a second interface, the electronic component housing having an internal space. A first sterile barrier is defined by these two interfaces. The electronic component housing further comprises a first mating member, and the sensor control device further comprises a circuit board and a substance sensor. The assembly further comprises an applicator for sensor delivery. The applicator comprises a housing, a cap detachably coupled to the housing and thereby sealing the interior of the applicator, a pointed hub, and a second mating member extending into the first or second opening and mating with the first mating member to define a second sterile barrier. The applicator further comprises a collimator, a third sterile barrier, and a fourth sterile barrier, which define a sterile zone. [Brief explanation of the drawing]

[0017] The following figures are included to illustrate certain aspects of the present disclosure and should not be construed as limiting the present disclosure to these embodiments. The subject matter of the present disclosure is capable of various modifications, changes, combinations, and equivalents in form and function without departing from the scope of the present disclosure. [Figure 1] A diagram conceptually showing an example of a test substance monitoring system incorporating one or more embodiments of the present disclosure [Figure 2A] A process diagram showing the assembly and installation of a system adopting the two-piece configuration shown in FIG. 1 [Figure 2B] A process diagram showing the assembly and installation of a system adopting the two-piece configuration shown in FIG. 1 [Figure 2C] A process diagram showing the assembly and installation of a system adopting the two-piece configuration shown in FIG. 1 [Figure 2D] A process diagram showing the assembly and installation of a system adopting the two-piece configuration shown in FIG. 1 [Figure 2E] A process diagram showing the assembly and installation of a system adopting the two-piece configuration shown in FIG. 1 [Figure 2F] A process diagram showing the assembly and installation of a system adopting the two-piece configuration shown in FIG. 1 [Figure 2G] A process diagram showing the assembly and installation of a system adopting the two-piece configuration shown in FIG. 1 [Figure 3A] An isometric view showing an example of a sensor control device [Figure 3B] A side view showing an example of a sensor control device [Figure 4A] An isometric view of the plug assembly shown in FIGS. 3A and 3B [Figure 4B] A side view of the plug assembly shown in FIGS. 3A and 3B [Figure 5A] An exploded view of the electronic component housing shown in FIGS. 3A and 3B [Figure 5B] An isometric bottom view of the electronic component housing shown in FIGS. 3A and 3B [Figure 6A] A side view showing the sensor applicator shown in FIG. 1 with the cap shown in FIG. 2B coupled [Figure 6B] A side cross-sectional view of the sensor applicator shown in Figure 1, with the cap shown in Figure 2B attached. [Figure 7A] Enlarged cross-sectional view showing the sensor control device shown in Figure 6B installed inside the cap shown in Figure 6B. [Figure 7B] An enlarged cross-sectional view showing the sensor control device shown in Figure 6B installed inside the sensor applicator shown in Figure 6B, according to another embodiment. [Figure 8] A schematic diagram showing an example external sterilization assembly according to one or more embodiments of the present disclosure. [Figure 9] A schematic diagram showing an example external sterilization assembly according to one or more embodiments of the present disclosure. [Figure 10] A schematic diagram showing an example external sterilization assembly according to one or more embodiments of the present disclosure. [Figure 11] A schematic diagram showing an example external sterilization assembly according to one or more embodiments of the present disclosure. [Figure 12] A schematic diagram showing an example external sterilization assembly according to one or more embodiments of the present disclosure. [Figure 13] Isometric view showing an example of a sensor control device. [Figure 14A] Side view of the sensor applicator shown in Figure 1. [Figure 14B] Side cross-sectional view of the sensor applicator shown in Figure 14A. [Figure 15] Side cross-sectional view showing the sensor applicator shown in Figure 14A and other exemplary embodiments of the external sterilization assembly shown in Figure 14B, according to one or more additional embodiments. [Figure 16] Side cross-sectional view showing the sensor applicator shown in Figure 14A and other exemplary embodiments of the external sterilization assembly shown in Figure 14B, according to one or more additional embodiments. [Figure 17A] An isometric top view showing an example of an external sterilization assembly shown in Figure 14B, according to one or more embodiments. [Figure 17B] An isometric view showing an example of an external sterilization assembly shown in Figure 14B, according to one or more embodiments. [Figure 18] Isometric view showing an example of a sensor control device. [Figure 19A] Side view of the sensor applicator shown in Figure 1. [Figure 19B] Partial side cross-sectional view showing a portion of the sensor applicator shown in Figure 3A. [Figure 20A] Equilateral top view showing the applicator insert shown in Figure 19B, according to one or more embodiments of this disclosure. [Figure 20B] Equiangular bottom view showing the applicator insert shown in Figure 19B, according to one or more embodiments of the present disclosure. [Figure 20C] Equilateral cross-sectional view showing the applicator insert shown in Figure 19B, according to one or more embodiments of the present disclosure. [Figure 21] Figure 19A shows another side cross-sectional view of the sensor applicator 102, according to one or more embodiments of the present disclosure, and illustrates a hybrid sterilization assembly. [Figure 22A] Eiso-angle side views showing other embodiments of the applicator insert shown in Figures 20A to 20C. [Figure 22B] Side cross-sectional views showing other embodiments of the applicator insert shown in Figures 20A to 20C. [Figure 23] A schematic diagram showing an example internal sterilization assembly according to one or more embodiments of the present disclosure. [Figure 24] A schematic diagram showing an example internal sterilization assembly according to one or more additional embodiments of the present disclosure. [Figure 25] A schematic diagram showing an internal sterilization assembly as another example, according to one or more additional embodiments of the present disclosure. [Figure 26A] Isometric view showing an example of a sensor control device. [Figure 26B] Side view showing an example of a sensor control device. [Figure 27A] Isometric views of the plug assembly shown in Figures 26A and 26B. [Figure 27B] Side view of the plug assembly shown in Figures 26A and 26B. [Figure 27C]Exploded isometric view showing the plug and protective vial. [Figure 28A] Exploded views of the electronic component housing shown in Figures 26A and 26B. [Figure 28B] Isometric bottom views of the electronic component housing shown in Figures 26A and 26B. [Figure 29A] A side view of the sensor applicator shown in Figure 1, with the cap shown in Figure 2B attached. [Figure 29B] A side cross-sectional view of the sensor applicator shown in Figure 1, with the cap shown in Figure 2B attached. [Figure 30] Perspective views showing exemplary embodiments of the caps shown in Figures 29A and 29B. [Figure 31] Side cross-sectional view showing the sensor control device positioned inside the cap. [Figure 32A] Isometric view showing an example of a sensor control device. [Figure 32B] Side view showing an example of a sensor control device. [Figure 33A] Figures 32A and 32B show exploded perspective top views of the sensor control device. [Figure 33B] Figures 32A and 32B show exploded perspective bottom views of the sensor control device. [Figure 34A] A side view of the sensor applicator shown in Figure 1, with the cap shown in Figure 2B attached. [Figure 34B] A side cross-sectional view of the sensor applicator shown in Figure 1, with the cap shown in Figure 2B attached. [Figure 35] Enlarged cross-sectional view showing the sensor control device installed inside the sensor applicator. [Figure 36] Lower enlarged cross-sectional view showing the sensor control device mounted on top of the cap post. [Figure 37A] Isometric view showing an example of a sensor control device. [Figure 37B] Side view showing an example of a sensor control device. [Figure 37C] A bottom view showing an example of a sensor control device. [Figure 38A]Figures 37A to 37C show exploded top views of the sensor control device. [Figure 38B] Figures 37A to 37C show exploded bottom views of the sensor control device. [Figure 39A] Figures 37A to 37C show a step-by-step example of the assembly process for the sensor control device shown in Figures 37A to 37C. [Figure 39B] Figures 37A to 37C show a step-by-step example of the assembly process for the sensor control device shown in Figures 37A to 37C. [Figure 39C] Figures 37A to 37C show a step-by-step example of the assembly process for the sensor control device shown in Figures 37A to 37C. [Figure 39D] Figures 37A to 37C show a step-by-step example of the assembly process for the sensor control device shown in Figures 37A to 37C. [Figure 40A] Figures 37A to 37C show a side view of the sensor applicator with the pre-assembled sensor control device installed inside. [Figure 40B] Figures 37A to 37C show side cross-sectional views of a sensor applicator with the pre-assembled sensor control device installed inside. [Figure 41A] An enlarged cross-sectional view showing a sensor control device during radiation sterilization as an example. [Figure 41B] An enlarged cross-sectional view showing a sensor control device during radiation sterilization as an example. [Figure 42] A graph showing an approximate value of the electron beam penetration depth as a function of the electron beam energy level in single-sided electron beam sterilization (or irradiation) treatment. [Figure 43] Side cross-sectional views showing a sensor applicator with a pre-assembled sensor control device, as shown in Figures 37A to 37C, installed inside, according to one or more additional embodiments. [Figure 44] Side view showing an example of a sensor control device. [Figure 45] Figure 44 shows an exploded view of the sensor control device. [Figure 46A] Side cross-sectional view showing an assembled sealed subassembly, as shown in Figure 45, according to one or more embodiments. [Figure 46B]Figure 44 is a side cross-sectional view showing the completed assembly of the sensor control device. [Figure 47A] A side view showing an exemplary embodiment of the sensor applicator shown in Figure 1, with the cap shown in Figure 2B attached. [Figure 47B] A side cross-sectional view showing an exemplary embodiment of the sensor applicator shown in Figure 1, with the cap shown in Figure 2B attached. [Figure 48] Perspective views showing exemplary embodiments of the caps shown in Figures 47A and 47B. [Figure 49] Side cross-sectional view showing the sensor control device positioned inside the cap shown in Figures 47A and 47B. [Figure 50A] Isometric projection showing other examples of sensor-controlled devices. [Figure 50B] Side view showing another example of a sensor control device. [Figure 51A] Figures 50A and 50B show exploded, isometric top views of the sensor control device. [Figure 51B] Exploded isometric views of the sensor control device shown in Figures 50A and 50B. [Figure 52] Side cross-sectional view showing a sealed subassembly in an assembled state according to one or more embodiments. [Figure 53A] Side cross-sectional views illustrating the step-by-step process of assembling the sensor control device shown in Figures 50A and 50B into a sensor applicator. [Figure 53B] Side cross-sectional views illustrating the step-by-step process of assembling the sensor control device shown in Figures 50A and 50B into a sensor applicator. [Figure 53C] Side cross-sectional views illustrating the step-by-step process of assembling the sensor control device shown in Figures 50A and 50B into a sensor applicator. [Figure 54A] A perspective view showing a cap post, as shown in Figure 53C, according to one or more additional embodiments. [Figure 54B] A top view showing a cap post, as shown in Figure 53C, according to one or more additional embodiments. [Figure 55]Side cross-sectional view showing the sensor control devices shown in Figures 50A and 50B arranged inside the cap shown in Figure 2B. [Figure 56A] Side cross-sectional view showing a sensor applicator ready to send the sensor control device to a predetermined monitoring location. [Figure 56B] Side cross-sectional view showing a sensor applicator ready to send the sensor control device to a predetermined monitoring location. [Figure 57A] Side cross-sectional views illustrating the step-by-step assembly and disassembly process for an exemplary embodiment of the sensor applicator of the sensor control device shown in Figures 50A and 50B. [Figure 57B] Side cross-sectional views illustrating the step-by-step assembly and disassembly process for an exemplary embodiment of the sensor applicator of the sensor control device shown in Figures 50A and 50B. [Figure 57C] Side cross-sectional views illustrating the step-by-step assembly and disassembly process for an exemplary embodiment of the sensor applicator of the sensor control device shown in Figures 50A and 50B. [Figure 58A] Equiangular base view showing a housing according to one or more embodiments [Figure 58B] Equiangular bottom view showing the sheath and at least some of the other components positioned within the housing. [Figure 59] Enlarged cross-sectional view showing a sensor control device installed inside a sensor applicator according to one or more embodiments. [Figure 60A] Equilateral top view showing a cap according to one or more embodiments [Figure 60B] Enlarged cross-sectional view showing the engagement portion between the cap and the housing according to one or more embodiments. [Figure 61A] Isometric view showing a sensor cap according to one or more embodiments. [Figure 61B] Isometric projection showing color according to one or more embodiments. [Figure 62] Equilateral top view showing an example sensor control device according to one or more embodiments of the present disclosure. [Figure 63]Side schematic diagram showing an example sensor applicator according to one or more embodiments of the present disclosure. [Figure 64A] Exploded isometric views of the sensor applicator and the sensor control device shown in Figures 62 and 63. [Figure 64B] Exploded isometric views of the sensor applicator and the sensor control device shown in Figures 62 and 63. [Figure 65A] Side cross-sectional views illustrating, step-by-step, an example of the process of sending a sensor control device to a usage position using the sensor applicator shown in Figures 63, 64A, and 64B, according to one or more embodiments. [Figure 65B] Side cross-sectional views illustrating, step-by-step, an example of the process of sending a sensor control device to a usage position using the sensor applicator shown in Figures 63, 64A, and 64B, according to one or more embodiments. [Figure 65C] Side cross-sectional views illustrating, step-by-step, an example of the process of sending a sensor control device to a usage position using the sensor applicator shown in Figures 63, 64A, and 64B, according to one or more embodiments. [Figure 65D] Side cross-sectional views illustrating, step-by-step, an example of the process of sending a sensor control device to a usage position using the sensor applicator shown in Figures 63, 64A, and 64B, according to one or more embodiments. [Figure 66] Enlarged cross-sectional view showing the engagement portion between the sensor holder and the sensor control device shown in Figures 65A to 65D, according to one or more embodiments. [Figure 67] Exploded isometric view showing other sensor applicators and the sensor control device shown in Figure 62, according to one or more additional embodiments. [Figure 68A] A side cross-sectional view illustrating, step-by-step, an example of the process of sending a sensor control device to a usage position using the sensor applicator shown in Figure 67, according to one or more embodiments. [Figure 68B] A side cross-sectional view illustrating, step-by-step, an example of the process of sending a sensor control device to a usage position using the sensor applicator shown in Figure 67, according to one or more embodiments. [Figure 68C]A side cross-sectional view illustrating, step-by-step, an example of the process of sending a sensor control device to a usage position using the sensor applicator shown in Figure 67, according to one or more embodiments. [Figure 68D] A side cross-sectional view illustrating, step-by-step, an example of the process of sending a sensor control device to a usage position using the sensor applicator shown in Figure 67, according to one or more embodiments. [Figure 69A] Enlarged schematic diagram showing the pointed hub and the fingers of the sensor holder. [Figure 69B] Enlarged schematic diagram showing how the finger interacts with the upper part of the needle shroud. [Figure 69C] Enlarged schematic diagram showing how the finger interacts with the upper part of the needle shroud. [Figure 70A] Enlarged side cross-sectional view showing an example of the engagement portion between a sensor holder and a sensor control device according to one or more embodiments. [Figure 70B] Enlarged side cross-sectional view showing an example of the engagement portion between a sensor holder and a sensor control device according to one or more embodiments. [Figure 71A] Equilateral side view showing an example sensor holder according to one or more embodiments. [Figure 71B] Side cross-sectional view showing an example sensor holder according to one or more embodiments. [Figure 72A] Enlarged cross-sectional view showing the sensor holder holding the sensor control device, as shown in Figures 71A and 71B. [Figure 72B] Enlarged cross-sectional view showing the sensor holder holding the sensor control device, as shown in Figures 71A and 71B. [Figure 73A] Side view showing an example sensor applicator according to one or more embodiments. [Figure 73B] Side cross-sectional view showing an example sensor applicator according to one or more embodiments. [Figure 74A] Isometric top view of the inner cover of the applicator shown in Figure 73B. [Figure 74B] Isometric bottom view of the inner cover of the applicator shown in Figure 73B. [Figure 75]An isometric view showing an example of a sensor cap as shown in Figure 73B, according to one or more embodiments. [Figure 76] Equilateral cross-sectional views showing the sensor cap shown in Figure 75 being received in the inner cover of the applicator shown in Figures 74A and 74B, according to one or more embodiments. [Figure 77] This figure shows, step-by-step, the process of removing the applicator cap shown in Figure 73A and the inner applicator cover shown in Figures 74A and 74B from the sensor applicator shown in Figures 73A and 73B, according to one or more embodiments. [Figure 78] A schematic diagram illustrating an example sensor applicator according to one or more additional embodiments of the present disclosure. [Figure 79] Exploded view showing an example sensor control device according to one or more additional embodiments. [Figure 80] Figure 79 is a bottom view showing one embodiment of the sensor control device. [Figure 81A] Isometric drawings showing a sensor control device according to one or more embodiments of the present disclosure. [Figure 81B] Side view showing a sensor control device according to one or more embodiments of the present disclosure. [Figure 82] Figure 81A shows an exploded top view of the sensor control device. [Figure 83] A side cross-sectional view showing an example of a sensor control device assembly, with the sensor control device shown in Figure 81A, which is compatible with the substance monitoring system shown in Figure 1, installed inside the sensor applicator. [Figure 84] Enlarged cross-sectional view of the sensor control device assembly shown in Figure 83. [Figure 85] Figure 83 is a bottom view showing some components of the sensor control device assembly, including the sensor control device held in the sensor carrier of the sensor applicator. [Figure 86] A schematic diagram showing an example of a sterilization assembly according to one or more embodiments of this disclosure. [Figure 87] A schematic diagram showing a sterile assembly as another example according to one or more embodiments of this disclosure. [Figure 88A] A schematic bottom view showing a sterilization assembly as another example, according to one or more embodiments of the present disclosure. [Figure 88B] A schematic bottom view showing an alternative embodiment of the sterilization assembly shown in Figure 88A, according to one or more additional embodiments of the present disclosure. [Figure 88C] A schematic bottom view showing an alternative embodiment of the sterilization assembly shown in Figure 88A, according to one or more additional embodiments of the present disclosure. [Figure 89] A schematic isometric view showing an example sensor control device according to one or more embodiments. [Figure 90] A schematic diagram showing a sterilization assembly as another example according to one or more embodiments. [Figure 91A] Side view showing an example sensor control device according to one or more embodiments of the present disclosure. [Figure 91B] Isometric view showing an example sensor control device according to one or more embodiments of the present disclosure. [Figure 92A] Exploded isoangle top views of the sensor control devices shown in Figures 2A to 2G, according to one or more embodiments. [Figure 92B] Exploded isoangular base views of the sensor control devices shown in Figures 2A to 2G according to one or more embodiments. [Figure 93] Side cross-sectional views of the sensor control device shown in Figures 91A, 91B, 92A, and 92B according to one or more embodiments. [Figure 93A] Exploded isometric views showing some of other embodiments of the sensor control device shown in Figures 91A, 91B, 92A, and 92B. [Figure 94A] Equiangular base views of the mount shown in Figures 91A, 91B, 92A, and 92B. [Figure 94B] Equiangled top views of the sensor cap shown in Figures 91A, 91B, 92A, and 92B. [Figure 95A] Side view showing an example sensor applicator according to one or more embodiments. [Figure 95B] Side cross-sectional view showing an example sensor applicator according to one or more embodiments. [Figure 96A] Perspective view showing the cap post shown in Figure 95B, according to one or more embodiments. [Figure 96B] A top view showing a cap post, as shown in Figure 95B, according to one or more additional embodiments. [Figure 97] Side cross-sectional view showing a sensor control device, according to one or more embodiments, placed inside an applicator cap. [Figure 98] Cross-sectional view of a sensor control device showing an example of interaction between a sensor and a sharp object. [Figure 99] Side cross-sectional view showing an example enclosure for a substance monitoring system, used to house at least a portion of a sensor control device. [Figure 100A] Figure 99 shows a magnified side cross-sectional view of the connection between the sensor applicator and the cap, enclosed by a dashed line. [Figure 100B] Figure 99 shows a magnified side cross-sectional view of the connection between the sensor applicator and the cap, enclosed by a dashed line, during or after chemical gas sterilization. [Figure 101] A side cross-sectional view showing another example of a housing for a substance monitoring system used to accommodate at least a portion of the sensor control device shown in Figure 1. [Figure 102A] As an example, this figure shows the finite element analysis results corresponding to the interface between the housing and the cap during chemical gas sterilization. [Figure 102B] As an example, this figure shows the finite element analysis results corresponding to the interface between the housing and the cap during chemical gas sterilization. [Figure 102C] As an example, this figure shows the finite element analysis results corresponding to the interface between the housing and the cap during chemical gas sterilization. [Figure 103] Isometric view showing an example of a sensor control device. [Figure 104A] Exploded isometric view of the sensor control device shown in Figure 103, according to one or more embodiments. [Figure 104B] Exploded isometric view of the sensor control device shown in Figure 103, according to one or more embodiments. [Figure 105]Side cross-sectional views showing the assembled sensor control devices shown in Figures 104A and 104B, according to one or more embodiments. [Figure 106] Isometric view showing another example of a sensor control device. [Figure 107A] Exploded isometric view of the sensor control device shown in Figure 106, according to one or more embodiments. [Figure 107B] Exploded isometric view of the sensor control device shown in Figure 106, according to one or more embodiments. [Figure 108] Side cross-sectional views showing the assembled sensor control device shown in Figures 107A and 107B, according to one or more embodiments. [Figure 109] Isometric view showing an example of a conversion process for manufacturing a sensor control device in accordance with the principles of this disclosure. [Figure 110A] Figure 109 shows how the sensor control device shown in Figure 109 is manufactured in stages according to one or more embodiments. [Figure 110B] Figure 109 shows how the sensor control device shown in Figure 109 is manufactured in stages according to one or more embodiments. [Figure 110C] Figure 109 shows how the sensor control device shown in Figure 109 is manufactured in stages according to one or more embodiments. [Figure 110D] Figure 109 shows how the sensor control device shown in Figure 109 is manufactured in stages according to one or more embodiments. [Figure 110E] Figure 109 shows how the sensor control device shown in Figure 109 is manufactured in stages according to one or more embodiments. [Figure 111A] A top view showing the sensor control device shown in Figure 109, according to one or more embodiments, in a state of preparation before pressure testing and / or vacuum sealing. [Figure 111B] Figure 109 is a side cross-sectional view showing the sensor control device with a compressor attached. [Figure 112] A partial side cross-sectional view showing a part of an example sensor control device according to one or more embodiments. [Figure 113]Side cross-sectional view showing an example sensor applicator according to one or more embodiments. [Figure 114A] Top perspective view showing exemplary embodiments of the plug shown in Figures 27A and 27B. [Figure 114B] Bottom perspective view showing exemplary embodiments of the plug shown in Figures 27A and 27B. [Figure 115A] Figures 27A and 27B show an exemplary embodiment of the connector in an open state. [Figure 115B] Figures 27A and 27B show an exemplary embodiment of the connector in a closed state (perspective view). [Figure 116] Perspective views showing exemplary embodiments of the sensors shown in Figures 27A and 27B. [Figure 117A] Bottom perspective view showing an exemplary embodiment of the sensor module assembly. [Figure 117B] Top perspective view showing an exemplary embodiment of a sensor module assembly. [Figure 118A] Partially enlarged view showing an exemplary embodiment of the sensor plug shown in Figures 114A and 114B, which has an axial stiffening structure. [Figure 118B] Partially enlarged view showing an exemplary embodiment of the sensor plug shown in Figures 114A and 114B, which has an axial stiffening structure. [Figure 119] Side view showing an example sensor according to one or more embodiments of this disclosure. [Figure 120A] Diagram showing a simple applicator assembly for sterilizing a test substance sensor system. [Figure 120B] Diagram showing a simple applicator assembly for sterilizing a test substance sensor system. [Figure 120C] Diagram showing a simple applicator assembly for sterilizing a test substance sensor system. [Figure 120D] Diagram showing a simple applicator assembly for sterilizing a test substance sensor system. [Figure 120E] Diagram showing a simple applicator assembly for sterilizing a test substance sensor system. [Figure 120F] Diagram showing a simple applicator assembly for sterilizing a test substance sensor system. [Figure 120G] Diagram showing a simple applicator assembly for sterilizing a test substance sensor system. [Figure 120H] Diagram showing a simple applicator assembly for sterilizing a test substance sensor system. [Figure 120I] Diagram showing a simple applicator assembly for sterilizing a test substance sensor system. [Figure 120J] Diagram showing a simple applicator assembly for sterilizing a test substance sensor system. [Figure 120K] Diagram showing a simple applicator assembly for sterilizing a test substance sensor system. [Figure 120L] Diagram showing a simple applicator assembly for sterilizing a test substance sensor system. [Figure 120M] Diagram showing a simple applicator assembly for sterilizing a test substance sensor system. [Figure 120N] Diagram showing a simple applicator assembly for sterilizing a test substance sensor system. [Figure 120P] Diagram showing a simple applicator assembly for sterilizing a test substance sensor system. [Figure 120Q] Diagram showing a simple applicator assembly for sterilizing a test substance sensor system. [Figure 120R] Diagram showing a simple applicator assembly for sterilizing a test substance sensor system. [Figure 120S] Diagram showing a simple applicator assembly for sterilizing a test substance sensor system. [Figure 120T] Diagram showing a simple applicator assembly for sterilizing a test substance sensor system. [Figure 121A] Dose distribution map of high-energy electron beams in water [Figure 121B] Dose distribution map of low-energy electron beams in water [Modes for carrying out the invention]

[0018] Figure 1 is a conceptual diagram showing an example of a test substance monitoring system 100 (hereinafter, "System 100") that can incorporate one or more embodiments of the present disclosure. By using System 100, various test substances can be detected and quantified. Target test substances include, but are not limited to, acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA, fructosamine, glucose, glutamine, growth hormone, various other hormones, ketones (e.g., ketone bodies), lactic acid, oxygen, peroxides, prostate-specific antigen, prothrombin, RNA, thyroid-stimulating hormone, and troponin. The concentration of various drugs can also be measured. Target drugs include, but are not limited to, antibiotics (e.g., gentamicin, vancomycin, etc.), digitoxin, digoxin, substances related to drug abuse, theophylline, warfarin, etc.

[0019] As shown in the figure, system 100 comprises a sensor applicator 102 (also called an "inserter"), a sensor control device 104 (also called an "in vivo analyte sensor control device"), and a reading device 106. The sensor applicator 102 is used to deliver the sensor control device 104 to a predetermined monitoring location on the user's skin (e.g., the user's upper arm). After delivery, the sensor control device 104 is held in place on the skin by an adhesive patch 108 attached to the bottom of the sensor control device 104. A portion of the sensor 110 extends from the sensor control device 104, and this portion is arranged to be positioned transcutaneously beneath the surface of the user's skin during the monitoring period and to be held in place by some means, including such transcutaneous placement.

[0020] The sensor control device 104 may further include an introducer to assist in the introduction of the sensor 110 into the tissue. The introducer may consist of, for example, a needle. In many places, this needle is called a "sharp." Alternatively, the introducer may consist of other types of devices such as a sheath or a blade. The introducer may be configured to be temporarily placed near the sensor 110 before insertion into the tissue and withdrawn after insertion. While the introducer is in place, an access path is formed for the sensor 110 to pass through, thereby facilitating insertion of the sensor 110 into the tissue. For example, by penetrating the epidermis, the introducer can secure an access path to the dermis, making it possible to implant the sensor 110 subcutaneously. After the formation of the access path is complete, the introducer can be withdrawn (retracted) to prevent it from causing any harm while the sensor 110 is in place. In exemplary embodiments, the introductory device may be solid or hollow, chamfered or not, and have a circular or non-circular cross-sectional shape. In more specific embodiments, a suitable introductory device may have, for example, a cross-sectional diameter and tip structure equivalent to that of an acupuncture needle with a cross-sectional diameter of approximately 250 micrometers, or both. However, it should be noted that the cross-sectional diameter of a suitable introductory device may be larger or smaller than the above, depending on the needs of the specific application.

[0021] In some embodiments, (in configurations where an introducer is provided) the tip of the introducer can be inclined relative to the end of the sensor 110 so that the introducer penetrates the tissue before the sensor 110, forming an access path for the sensor 110. In other exemplary embodiments, the sensor 110 can be placed in the lumen or groove of the introducer, and in such configurations, the introducer can similarly form an access path for the sensor 110. In all cases, the introducer is withdrawn after the sensor 110 has been inserted. Furthermore, the introducer (sharp body) can be made of various materials such as various metals and plastics.

[0022] When the sensor control device 104 is correctly assembled, the sensor 110 will be in communication or connection (e.g., electrical communication, mechanical connection, etc.) with one or more electrical components or sensor electronic components included in the sensor control device 104. For example, in some applications, the sensor control device 104 may be configured to include a printed circuit board (PCB) on which a data processor (e.g., an application-specific integrated circuit: ASIC) is mounted, with the sensor 110 operably coupled to the data processor, and further, the data processor may be coupled to an antenna and a power supply.

[0023] The sensor control device 104 and the reading device 106 are configured to communicate with each other via a local communication channel (local communication link) 112. The local communication channel (local communication link) 112 may be wired or wireless, may be one-way or two-way communication, and may be encrypted or not. According to some embodiments, the reading device 106 can display the concentration of the substance being tested, identified by the sensor 110 or the processor associated with the sensor 110, as well as alerts or notifications, and can also constitute an output medium for receiving one or more user inputs. The reading device 106 may be a multipurpose smartphone or a dedicated electronic reading device. Although only one reading device 106 is shown in the illustration, in certain cases there may be multiple reading devices 106.

[0024] Furthermore, the reading device 106 can communicate with a remote terminal 114 via a communication channel (communication link) 118 and with a trusted computer system 116 via a communication channel (communication link) 120. The communication channels (communication links) 118 and 120 may be wired or wireless, one-way or two-way communication, and may be encrypted or unencrypted. In addition to or instead of the above, the reading device 106 can also communicate with a network 122 (e.g., a mobile phone network, the internet, or a cloud server) via a communication channel (communication link) 124. Furthermore, the network 122 may be configured to be communicably coupled to the remote terminal 114 via a communication channel (communication link) 126, to the trusted computer system 116 via a communication channel (communication link) 128, or both.

[0025] Alternatively, the sensor control device 104 can be configured to communicate directly with the remote communication terminal 114 or the trusted computer system 116 without the need for the reading device 106. For example, according to some embodiments, the sensor 110 can communicate with the remote communication terminal 114 or the trusted computer system 116 via a direct communication link with the network 122. Such configurations are described in U.S. Patent No. 1,0136816, the full contents of which are incorporated herein by reference.

[0026] Each of these communication channels (communication links) can use any appropriate electronic communication protocol, such as near-field communication (NFC), radio frequency identification (RFID), Bluetooth®, Bluetooth Low Energy, and WiFi. In some embodiments, the remote communication terminal 114, the trusted computer system 116, or both can be configured to be accessible by persons other than the principal user who have an interest in the user's test substance levels. The reading device 106 may include a display 130 and may further include an input component 132 as needed. In some embodiments, the display 130 may have a touch panel screen interface.

[0027] In some embodiments, the sensor control device 104 can be configured to automatically transfer data to the reading device 106. For example, it can be configured to automatically and periodically communicate the concentration data of the substance being tested at a set data acquisition frequency or after a set period of time, and to store the data in memory until transmission (for example, every minute, every five minutes, or at predetermined intervals). In other embodiments, the sensor control device 104 can be configured to communicate with the reading device 106 non-automatically, without following a predetermined schedule. For example, using RFID technology, the sensor control device 104 can be configured to communicate data when the sensor electronic component enters the communication range of the reading device 106. In this case, the data can be stored in the memory of the sensor control device 104 until it is communicated to the reading device 106. Therefore, the patient does not need to keep the reading device 106 close to them at all times and can upload data at a time convenient for them. In yet another embodiment, a data transmission configuration that combines automatic and non-automatic transmission can also be implemented. For example, the system can be configured to automatically continue transmitting data as long as the reading device 106 is within the communication range of the sensor control device 104.

[0028] In many cases, the sensor control device 104 is supplied in a so-called "two-piece" configuration, combined with the sensor applicator 102. In this configuration, the sensor 110 can only be successfully delivered to a predetermined monitoring location after final assembly by the user. More specifically, the sensor 110 and its associated electrical components included in the sensor control device 104 are supplied to the user in multiple (two) packages. Before the user can deliver the sensor 110 to the predetermined monitoring location using the sensor applicator 102, the user must open the packaging and manually assemble these components according to the instruction manual.

[0029] However, in recent years, improvements in the design of sensor control devices and sensor applicators have made it possible to create a one-piece architecture for this system. A one-piece architecture allows the system to be shipped to the user in a single, sealed package, eliminating the need for the user to perform any final assembly. In this case, the only tasks required of the user are to open the package and then deliver the sensor control device to the designated monitoring location. Such a one-piece system offers advantages in that it eliminates the need for components, various manufacturing processes, and user assembly. Furthermore, it reduces packaging materials and waste, and lowers the risk of user error and system contamination.

[0030] In the illustrated embodiment, the system 100 may have a so-called "two-piece" configuration in which the sensor 110 can only be successfully delivered to a predetermined monitoring location after final assembly by the user. More specifically, the sensor 110 and its associated electrical components, included in the sensor control device 104, are provided to the user in multiple (two) packages. Each package may or may not be sealed with a sterile barrier, but is at least enclosed in packaging. Before the user can deliver the sensor 110 to the predetermined monitoring location using the sensor applicator 102, the user must open the packaging and manually assemble these components according to the instruction manual.

[0031] Figures 2A to 2G are process diagrams showing the assembly and installation of system 100, which employs a two-piece configuration. Figure 2A shows the first package, and Figure 2B shows the second package, which are provided to the user, who then performs the final assembly. More specifically, Figure 2A shows a sensor container (sensor tray) 202 with a removable lid 204. The user prepares the sensor tray 202 for use by removing the lid 204. The lid 204 protects the contents inside the sensor tray 202 and functions as a sterile barrier to maintain a sterile environment inside. When the lid 204 is removed, a platform 206 located inside the sensor tray 202 is exposed. A plug assembly 207 (partially shown in Figure 2A) is arranged inside the platform 206 and incorporated in the correct positional relationship. The plug assembly 207 comprises a sensor module (not shown) and a sharp body module (not shown). The sensor module carries the sensor 110 (Figure 1), and the sharp body module carries the attached sharp body. This sharp body can be configured to assist in the transcutaneous delivery of the sensor 110 to the subcutaneous tissue of the user when the sensor control device 104 (Figure 1) is attached.

[0032] Figure 2B shows a sensor applicator 102 and a user preparing the sensor applicator 102 for final assembly. The sensor applicator 102 comprises a housing 208 sealed at one end by an applicator cap 210. In some embodiments, the interface between the housing 208 and the applicator cap 210 can be sealed by a sealing gasket of a type such as an O-ring. In at least one embodiment, an O-ring or sealing gasket can be molded onto either the housing 208 or the applicator cap 210. The applicator cap 210 acts as a barrier to protect the internal contents of the sensor applicator 102. Specifically, the sensor applicator 102 incorporates an electronic component housing (not shown) that holds electrical components for a sensor control device 104 (Figure 1), and the applicator cap 210 may or may not maintain a sterile environment for these electrical components. Preparing the sensor applicator 102 includes the step of removing the housing 208 from the applicator cap 210. This removal can be performed by twisting the applicator cap 210 off the housing 208. The applicator cap 210 can then be disposed of or set aside.

[0033] Figure 2C shows the user inserting the sensor applicator 102 into the sensor tray 202. The sensor applicator 102 is equipped with a sheath 212. When the sheath 212 is inserted into the platform 206, the locking of the sheath 212 to the housing 208 is temporarily released, and the locking of the platform 206 to the sensor tray 202 is also temporarily released. A plug assembly 207 (Figure 2A) comprising a sensor module and a sharp body module is disposed inside the sensor tray 202, and an electronic component housing is disposed inside the sensor applicator 102. When the housing 208 is inserted into the sensor tray 202, the plug assembly 207 is coupled to the electronic component housing.

[0034] In Figure 2D, the user removes the sensor applicator 102 from the sensor tray 202 by pulling the housing 208 back from the sensor tray 202 so that it is closer to the body.

[0035] Figure 2E shows the bottom (inside) of the sensor applicator 102 after it has been removed from the sensor tray 202 (Figure 2D). When the sensor applicator 102 is removed from the sensor tray 202, the assembly of the sensor control device 104 is completed inside the sensor applicator 102 and it is set in a position suitable for delivery to a predetermined monitoring location. At this time, as shown in the figure, the pointed body 220 extends from the bottom of the sensor control device 104 and carries a part of the sensor 110 in its hollow or recessed portion. The pointed body 220 is configured to penetrate the user's skin and be positioned to bring the sensor 110 into contact with bodily fluids.

[0036] Figures 2F and 2G show an example of how the sensor control device 104 is delivered to a predetermined monitoring location 222, such as the back of the user's upper arm. Figure 2F shows the user advancing the sensor applicator 102 toward the predetermined monitoring location 222. When the sheath 212 engages with the skin at the predetermined monitoring location 222, the sheath 212 retracts toward the housing 208, thereby advancing the sensor control device 104 (Figures 2E and 2G) to a position where it can engage with the skin. Then, with the help of the pointed body 220 (Figure 2E), the sensor 110 (Figure 2E) is inserted percutaneously at the predetermined monitoring location 222 and introduced into the patient's skin.

[0037] Figure 2G shows the state in which the user has successfully attached the sensor control device 104 to the user's skin and is pulling back the sensor applicator 102 from a predetermined monitoring position. The adhesive patch 108 (Figure 1) attached to the bottom of the sensor control device 104 adheres to the skin, fixing the sensor control device 104 in place. The pointed body 220 (Figure 2E) is configured to be automatically pulled back when the housing 208 is advanced to its maximum extent at the predetermined monitoring position 222, at which point the sensor 110 (Figure 2E) remains in place and is ready to measure the level of the substance being tested.

[0038] In a two-piece system, the sensor tray 202 (Figure 2A) and the sensor applicator 102 (Figure 2B) are provided to the user in separate packages, requiring the user to open each package and perform the final assembly of the system. In some applications, this separate, sealed packaging allows the sensor tray 202 and sensor applicator 102 to be sterilized using separate sterilization processes, making it possible to employ sterilization processes specific to the contents of one package that are not suitable for the contents of the other package.

[0039] More specifically, the sensor tray 202, which includes a plug assembly 207 (Figure 2A) comprising a sensor 110 (Figures 1 and 2E) and a sharp body 220 (Figure 2E), can be sterilized by radiation sterilization, such as electron beam ("e-beam") irradiation. However, radiation sterilization may damage the electrical components located within the electronic component housing of the sensor control device 104. Therefore, if the sensor applicator 102, which houses the electronic component housing of the sensor control device 104, needs to be sterilized, it can be sterilized by another method, such as chemical gas sterilization (e.g., sterilization using ethylene oxide). However, chemical gas sterilization may damage chemical substances and biological materials such as enzymes contained on the sensor 110. Thus, there may be incompatibility in sterilization methods between the sensor tray 202 and the sensor applicator 102, in which case both can be sterilized using separate sterilization processes and then packaged in separate packages. However, in this case, the user receiving these packages would need to perform the final assembly of the parts.

[0040] According to embodiments of the disclosure of the present invention, system 100 (Figure 1) may have a one-piece configuration incorporating a sterilization technology specifically designed for one-piece configurations. This one-piece configuration allows system 100 to be shipped to the user in a single sealed package that requires no final assembly process by the user. In this case, the only tasks required of the user are to open one package and then deliver the sensor control device to the designated monitoring location, as generally shown in the description with reference to Figures 2E to 2G above. Such a one-piece system is advantageous in that it eliminates the need for constituent parts, various manufacturing processes, and user assembly work. Furthermore, this reduces packaging materials and waste, and also reduces the risk of human error by the user or contamination of the system.

[0041] Focused electron beam sterilization using a collimator Figures 3A and 3B illustrate an example of a sensor control device 302 according to one or more embodiments of the present disclosure, where Figure 3A is an isometric view and Figure 3B is a side view. The sensor control device 302 (also called the “puck”) can be similar in some respects to the sensor control device 104 shown in Figure 1, and therefore it is most appropriate to understand it by referring to Figure 1. The sensor control device 302 can be used in place of the sensor control device 104 shown in Figure 1. Therefore, by using the sensor control device 302 in combination with the sensor applicator 102 (Figure 1), the sensor control device 302 can be delivered to a predetermined monitoring location on the user’s skin.

[0042] However, the sensor control device 302 can be incorporated into a one-piece system. Unlike a two-piece system, this configuration eliminates the need for the user to open multiple packages and perform the final assembly of the sensor control device 302. In other words, upon receiving the device, the sensor control device 302 is already assembled and set in the correct position within the sensor applicator 102. When using the sensor control device 302, the user only needs to break one barrier (for example, the applicator cap 210 shown in Figure 2B), which allows the sensor control device 302 to be quickly delivered to the designated monitoring location.

[0043] As shown in the figure, the sensor control device 302 includes an electronic component housing 304. The electronic component housing 304 is generally disc-shaped and may have a circular cross-sectional shape. On the other hand, in other embodiments, without departing from the scope of the present disclosure, the cross-sectional shape of the electronic component housing 304 may be other shapes such as oval (e.g., tablet-shaped), squircle, or polygonal. The electronic component housing 304 may be configured to house or enclose various electrical components for operating the sensor control device 302.

[0044] The electronic component housing 304 may comprise a shell 306 and a mount 308 configured to fit into the shell 306. The shell 306 can be fixed to the mount 308 by various methods such as snap-fit ​​engagement, interlocking, ultrasonic welding, or one or more mechanical fasteners (e.g., screws). In some cases, fixing the shell 306 to the mount 308 can form a sealing interface between them. In such embodiments, a sealing material of the type of gasket can be placed on or near the outer diameter (periphery) of the shell 306 and the mount 308. In this case, when the shell 306 and the mount 308 are fixed to each other, the gasket is compressed, forming a sealing interface. In other embodiments, an adhesive can be applied to the outer diameter (periphery) of one or both of the shell 306 and the mount 308. The adhesive fixes the shell 306 to the mount 308, thereby providing structural integrity and sealing the interface between them, which can isolate the inside of the electronic component housing 304 from external contamination. Furthermore, when the sensor control device 302 is assembled under a controlled environment, it becomes unnecessary to perform a final sterilization treatment on the internal electrical components. In other words, by bonding with adhesive, a sufficient sterile barrier can be formed around the electronic component housing 304 once the assembly is complete.

[0045] Furthermore, the sensor control device 302 may further comprise a plug assembly 310 that can be coupled to the electronic component housing 304. The plug assembly 310 may be similar in some respects to the plug assembly 207 shown in Figure 2A. For example, the plug assembly 310 may comprise a sensor module 312 (partially illustrated) that can be interconnected with a pointed body module 314 (partially illustrated). The sensor module 312 may be configured to carry or have a sensor 316 (partially illustrated), and the pointed body module 314 may be configured to carry or have a pointed body 318 (partially illustrated). The pointed body 318 may be configured to assist in the transcutaneous delivery of the sensor 316 to the subcutaneous tissue of the user when the sensor control device 302 is mounted. As shown, a portion of the sensor 316 and a corresponding portion of the pointed body 318 extend from the electronic component housing 304, more specifically from the bottom of the mount 308. The exposed portion of the sensor 316 can be housed within the hollow or recessed portion of the pointed body 318. Meanwhile, the rest of the sensor 316 is located inside the electronic component housing 304.

[0046] Figures 4A and 4B illustrate a plug assembly 310 according to one or more embodiments, where Figure 4A is an isometric view and Figure 4B is an exploded view. The sensor module 312 may comprise a sensor 316, a plug 402, and a connector 404. The plug 402 may be designed to receive and support both the sensor 316 and the connector 404. As shown, a groove 406 for receiving a portion of the sensor 316 may also be defined to pass through the plug 402. Furthermore, the plug 402 may be provided with one or more flexible arms 407. These flexible arms 407 are configured to snap-engage with corresponding shapes provided at the bottom of the electronic component housing 304 (Figures 3A and 3B).

[0047] The sensor 316 comprises a tail portion 408, a flag-shaped portion 410, and a neck portion 412 that connects the tail portion 408 and the flag-shaped portion 410 to each other. The tail portion 408 can be configured so that at least a portion of it extends distally from the plug 402 through a groove 406. The tail portion 408 contains a chemical substance or biomaterial such as an enzyme, and in some embodiments, this chemical substance can be coated with a membrane. When in use, the tail portion 408 is inserted percutaneously under the skin of the user, and the chemical substance contained in the tail portion 408 facilitates the monitoring of the test substance in the presence of body fluids.

[0048] The flag-shaped portion 410 has a substantially flat surface, and one or more (three in Figure 4B) sensor contacts 414 can be arranged on this substantially flat surface. Each sensor contact 414 can be configured to be aligned with a flexible carbon-impregnated polymer module (not shown) sealed inside the connector 404. The number of carbon-impregnated polymer modules is provided to correspond to the number of sensor contacts 414.

[0049] The connector 404 is equipped with one or more hinges 418, which allow the connector 404 to transition between an open state and a closed state. Figures 4A and 4B show the connector 404 in a closed state, but the connector 404 can be opened by pivoting, thereby allowing the flag-shaped portion 410 and the flexible carbon-impregnated polymer module to be received inside the connector 404. The flexible carbon-impregnated polymer module provides electrical contacts 420 (three are shown in the figures). Corresponding circuit contacts are provided within the electronic component housing 304 (Figures 3A and 3B), and the electrical contacts 420 are configured to ensure conductive connections between the sensor 316 and the circuit contacts. The connector 404 can be made of silicone rubber and can function as a moisture barrier for the sensor 316 while assembled in a compressed state and after being attached to the user's skin.

[0050] The pointed body module 314 comprises a pointed body 318 and a pointed body hub 422 that supports the pointed body 318. The pointed body 318 has an elongated shaft 424 and a pointed end 426 provided at the distal end of the shaft 424. The shaft 424 can be configured to extend distally from the plug 402 through a groove 406. Furthermore, the shaft 424 can have a hollow portion or recess 428 that surrounds at least a portion of the tail portion 408 of the sensor 316. The pointed end 426 can be configured to penetrate the skin while supporting the tail portion 408, thereby bringing the active chemical substance present on the tail portion 408 into contact with body fluids.

[0051] The pointed hub 422 may include a small-diameter cylindrical hub portion 430 and a hub snap claw 432. Both of these can be configured to contribute to the coupling of the plug assembly 310 (and by extension the entire sensor control device 302) to the sensor applicator 102 (Figure 1).

[0052] Figures 5A and 5B show an electronic component housing 304 according to one or more embodiments, with Figure 5A being an exploded view and Figure 5B being an isometric bottom view. The shell 306 and mount 308 are configured like a pair of opposing bivalve shells and function to surround or substantially enclose the various electronic components contained in the sensor control device 302 (Figures 3A and 3B).

[0053] The printed circuit board (PCB) 502 can be placed inside the electronic component housing 304. Multiple electronic component modules (not shown) can be mounted on the printed circuit board 502. Mountable electronic component modules include, but are not limited to, data processing units, resistors, transistors, capacitors, inductors, diodes, and switches. The data processing unit may include, for example, an application-specific integrated circuit (ASIC) configured to implement one or more functions or routines related to the operation of the sensor control device 302. More specifically, the data processing unit may be configured to perform data processing functions. Data processing functions include, but are not limited to, filtering and encoding of data signals corresponding to the values ​​of the test substance collected by the user. Furthermore, the data processing unit may be configured to include an antenna for communicating with the reading device 106 (Figure 1), or may be configured to communicate with such an antenna.

[0054] As shown in the figures, the shell 306, mount 308, and printed circuit board 502 each have corresponding central openings 504, 506, and 508 defined in them. When the electronic component housing 304 is assembled, the central openings 504, 506, and 508 are coaxially aligned, and the plug assembly 310 (Figures 4A and 4B) can be inserted into these coaxially aligned central openings. The electronic component housing 304 can also house a battery 510, which can be configured to supply power to the sensor control device 302.

[0055] As shown in Figure 5B, a plug receptacle 512 can be defined at the bottom of the mount 308. The plug receptacle 512 can function as a mounting point for receiving the plug assembly 310 (Figures 4A and 4B) and connecting it to the electronic component housing 304. By housing the plug assembly 310 in the plug receptacle 512, the assembly of the sensor control device 302 (Figures 3A and 3B) can be completed. The external shape of the plug 402 (Figures 4A and 4B) can be a shape that fits (is complementary to) the plug receptacle 512. The plug receptacle 512 may also be provided with one or more (two in the illustration) snap engagement ledges 514. The snap engagement ledges 514 are configured to engage with and receive the flexible arm 407 (Figures 4A and 4B) of the plug 402. The plug assembly 310 can be coupled to the electronic component housing 304 by inserting the plug 402 into the plug receptacle 512, thereby engaging each flexible arm 407 with the corresponding snap engagement ledge 514. Once the plug assembly 310 (Figures 4A and 4B) is properly coupled to the electronic component housing 304, one or more (three in the illustration) circuit contacts 516 defined on the underside of the printed circuit board 502 can be electrically connected to the electrical contacts 420 (Figures 4A and 4B) of the connector 404 (Figures 4A and 4B).

[0056] Figures 6A and 6B show the sensor applicator 102 with the applicator cap 210 attached, with Figure 6A being a side view and Figure 6B being a side cross-sectional view. More specifically, Figures 6A and 6B show the state of the sensor applicator 102 at the time of shipment to the user and at the time of receipt by the user, according to at least one embodiment. In some embodiments, the sensor applicator 102 can be further sealed in a bag (not shown) and delivered to the user in that state. This bag can be made of various materials that help to suppress the intrusion of moisture into the sensor applicator 102, which may adversely affect the sensor 316. For example, in at least one embodiment, the sealed back portion of the bag can be made of foil material. Any sensor applicator described herein can be sealed in such a bag and delivered to the user in that state.

[0057] As shown in Figure 6B, according to this disclosure, the sensor control device 302 is already assembled and installed in the sensor applicator 102 before being delivered to the user. The applicator cap 210 is screwed onto the housing 208 and may be equipped with a tamper-evident ring 602. When the applicator cap 210 is rotated relative to the housing 208 (for example, by twisting it off), the tamper-evident ring 602 is sheared, and the applicator cap 210 can be removed from the sensor applicator 102. The user can then deliver the sensor control device 302 to a predetermined monitoring location, generally as shown in the description with reference to Figures 2E to 2G above.

[0058] In some embodiments, as described above, the applicator cap 210 can be fitted to the housing 208 by sealing engagement in order to protect the internal components of the sensor applicator 102. In at least one embodiment, the interface between the housing 208 and the applicator cap 210 can be sealed by a sealing gasket of the type such as an O-ring. The O-ring or sealing gasket may be provided as a separate component, or it may be molded onto either the housing 208 or the applicator cap 210.

[0059] The housing 208 can be constructed from various rigid materials. In some embodiments, for example, the housing 208 can be constructed from a thermoplastic polymer such as polyketone. In other embodiments, the housing 208 can also be constructed from a cyclic olefin copolymer (COC), which is thought to contribute to suppressing the intrusion of moisture into the sensor applicator 102. As will be understood by those skilled in the art, any housing described herein can be constructed from polyketone or COC.

[0060] Referring particularly to Figure 6B, the sensor control device 302 can be loaded into the sensor applicator 102 by fitting the pointed hub 422 onto the sensor carrier 604 built into the sensor applicator 102. After fitting the sensor control device 302 with the sensor carrier 604, the applicator cap 210 can be attached to the sensor applicator 102.

[0061] In the illustrated embodiment, the collimator 606 is positioned within the applicator cap 210. Typically, the collimator 606 can be configured to assist in supporting the sensor control device 302 enclosed within the sensor applicator 102. In some embodiments, the collimator 606 can be configured as an integral part (extension part) with the applicator cap 210, for example, by molding it integrally with the applicator cap 210 or by overmolding it onto the applicator cap 210. In other embodiments, without departing from the scope of this disclosure, the collimator 606 can be configured as a separate structure from the applicator cap 210 and fitted or attached within the applicator cap 210. In yet another embodiment, as will be described later, the collimator 606 may be used in the sterilization and shipping preparation process of the sensor applicator 102 but may not be included in the package received by the user.

[0062] The collimator 606 can be designed to receive and protect components of the sensor control device 302 that require a sterile state, and to isolate the sterile components of the sensor applicator 102 from microbial contamination that may arise from other areas within the sensor control device 302. To achieve such a design, the collimator 606 may be provided with a defined or equipped sterile zone 608 (also called a "sterile barrier enclosure" or "sterile sensor pathway") configured to receive the sensor 316 and the sharp body 318 extending from the bottom of the electronic component housing 304. The sterile zone 608 can be mainly composed of holes (passages) that extend through at least a portion of the collimator 606 body. In the illustrated embodiment, the sterile zone 608 extends through the entire collimator 606, but alternatively, without departing from the scope of this disclosure, it may be configured to extend through only a portion of the collimator 606.

[0063] With the sensor control device 302 loaded into the sensor applicator 102, when the applicator cap 210 equipped with a collimator 606 is attached to the sensor applicator 102, the sensor 316 and the sharp body 318 can be positioned within the sealed area 610. At least a portion of the sealed area 610 is defined by a sterile zone 608. The sealed area 610 is configured to isolate the sensor 316 and the sharp body 318 from external contamination and may include (contain) a selected portion of the interior of the electronic component housing 304 and the sterile zone 608 in the collimator 606.

[0064] The assembled sensor control device 302 can be subjected to radiation sterilization 612 while it is placed inside the sensor applicator 102. Examples of radiation sterilization 612 include electron beam irradiation, but other sterilization methods can also be used. Other sterilization methods include, but are not limited to, low-energy X-ray irradiation. In some embodiments, radiation sterilization 612 can be performed by either continuous irradiation or pulsed beam irradiation. In pulsed beam irradiation, the beam for radiation sterilization 612 is focused at a predetermined target position, and the component or device to be sterilized is moved to this target position. Then, a radiation pulse is irradiated to perform radiation sterilization 612. After that, radiation sterilization 612 is stopped, the next component or device to be sterilized is moved to the target position, and the same process is repeated.

[0065] The collimator 606 can be configured to focus the radiation (e.g., beam, wave, energy, etc.) used for radiation sterilization 612 toward components that require sterility (e.g., the sensor 316 and the sharp body 318). More specifically, the radiation can reach and collide with the sensor 316 and the sharp body 318 through the holes (passages) of the sterilization zone 608, thereby sterilizing them, while the rest of the collimator 606 is configured to prevent (block) the propagating radiation from affecting or damaging the electrical components within the electronic component housing 304.

[0066] The sterilization zone 608 can have any suitable cross-sectional shape necessary to properly focus radiation onto the sensor 316 and the sharp body 318 for sterilization. For example, in the illustrated embodiment, the sterilization zone 608 is conical or frustoconical in shape. On the other hand, in other embodiments, without departing from the scope of the disclosure, the cross-sectional shape of the sterilization zone 608 can be a polygon, such as a square (corresponding to a cubic structure), a rectangle (e.g., a parallelogram), or a pyramidal structure.

[0067] In the illustrated embodiment, the sterilization zone 608 has a first opening 614a at a first end and a second opening 614b at a second end opposite to the first end. The first opening 614a can be configured for inserting the sensor 316 and the sharp body 318 into the sterilization zone 608. The second opening 614b, on the other hand, is configured to allow radiation (e.g., a beam, wave, etc.) used in radiation sterilization 612 to enter the sterilization zone 608 and to allow the entering radiation to collide with the sensor 316 and the sharp body 318.

[0068] In embodiments where the sterilization zone 608 is conical or frustoconical, the diameter of the first opening 614a can be smaller than the diameter of the second opening 614b. For example, in such embodiments, the size (diameter) of the first opening 614a can be in the range of about 0.5 mm to about 3.0 mm, and the size (diameter) of the second opening 614b can be in the range of about 5.0 mm to about 16.0 mm. However, as will be understood by those skilled in the art, the diameters of the first opening 614a and the second opening 614b can be set to be larger or smaller than the above ranges depending on the application, as long as they do not deviate from the scope of this disclosure. In practice, the diameters of the first opening 614a and the second opening 614b only need to be large enough to allow a sufficient dose of radiation to hit the sensor 316 and the sharp body 318. Furthermore, in at least one embodiment, the sterilization zone 608 can be cylindrical in shape, and the diameters of the first opening 614a and the second opening 614b can be the same.

[0069] The body of the collimator 606 is configured to reduce or block the transmission of radiation used in radiation sterilization 612 so that the radiation does not penetrate the body material and damage the electrical components in the electronic component housing 304. To achieve this, in some embodiments, the collimator 606 can be made of a material with a mass density of more than 0.9 grams per cubic centimeter (g / cc). Polyethylene is an example of a material used for the collimator 606, but it can also be made of any material having a mass density equal to or greater than that of polyethylene. For example, in some embodiments, metals (e.g., lead, stainless steel) or high-density polymers can be used as the material for the collimator 606, but are not limited to these.

[0070] In at least one embodiment, the design of the collimator 606 can be modified so that even if the collimator 606 is constructed using a material with a mass density of less than 0.9 grams per cubic centimeter (g / cc), it can still reduce or prevent the radiation used for radiation sterilization 612 from striking the electrical components in the electronic component housing 304. To achieve such a configuration, in some embodiments, the size (e.g., length) of the collimator 606 can be increased to increase the amount of material that electrons generated and propagated by radiation sterilization 612 must pass through before striking the delicate electronic components. By increasing the amount of material that must pass through, the dose intensity of radiation sterilization 612 is more easily absorbed or dissipated, so that the delicate electronic components are not adversely affected by radiation sterilization 612. On the other hand, in other embodiments, the opposite relationship may hold true. That is, if the mass density of the material used for the collimator 606 is sufficiently high, the size (e.g., length) of the collimator 606 can be reduced.

[0071] In addition to providing radiation shielding properties to the collimator 606 body, in some embodiments, one or more (one in the illustration) shielding bodies 616 can be placed inside the electronic component housing 304 to protect delicate electronic components from radiation while the sensor control device 302 is undergoing radiation sterilization 612. For example, the shielding body 616 can be positioned between the data processing unit 618 and the radiation source (e.g., an electron beam accelerator). In such embodiments, the shielding body 616 can be positioned adjacent to the data processing unit 618, or aligned on a straight line connecting the data processing unit 618 and the radiation source. This makes it possible to block or reduce radiation exposure to the delicate electronic circuits within the data processing unit 618 so that they are not exposed to radiation (e.g., electron beam radiation or its energy) and damaged.

[0072] The shielding 616 can be made of any material having the ability to block (or substantially block) the transmission of radiation. Suitable materials for the shielding 616 include, but are not limited to, lead, tungsten, ferrous metals (e.g., stainless steel), copper, tantalum, osmium, or any combination thereof. Applicable metals include corrosion-resistant, austenitic, and nonmagnetic metals with a density in the range of approximately 5 grams (g / cc) to approximately 15 g / cc per cubic centimeter. The shielding 616 can be manufactured by a variety of manufacturing techniques. These techniques include, but are not limited to, stamping, casting, injection molding, sintering, two-shot molding, or any combination thereof.

[0073] In other embodiments, the shielding body 616 may be made of a metal-filled thermoplastic polymer. Examples of such thermoplastic polymers include, but are not limited to, polyamide, polycarbonate, and polystyrene. In such embodiments, the shielding body 616 can be manufactured by mixing a shielding material with an adhesive base material and extruding the mixture onto a predetermined molded part, or by extruding it directly onto the data processing unit 618. Furthermore, in such embodiments, the shielding body 616 may also be configured as a casing that encloses (or substantially encloses) the data processing unit 618.

[0074] In some embodiments, the sterilization zone 608 and, consequently, the sealed area 610 can be sealed by attaching a collimator seal 620 to the end of the collimator 606. As shown in the figure, the collimator seal 620 can seal the second opening 614b. The collimator seal 620 can be configured to be attached before or after radiation sterilization 612. In embodiments where the collimator seal 620 is attached before the start of radiation sterilization 612, the collimator seal 620 can be made of a microbial barrier material that is permeable to radiation, and radiation can pass through the collimator seal 620 and propagate. The placement of the collimator seal 620 in place maintains a sterile environment in the sealed area 610 for the assembled sensor control device 302 until the user removes (twists off) the applicator cap 210.

[0075] In some embodiments, the collimator sealing section 620 may consist of two or more layers made of different materials. The first layer may be made of a synthetic material such as a microbial barrier (e.g., flash-spun high-density polyethylene fiber). Exemplary microbial barrier materials include tape, paper, plastic, or a combination thereof. For example, but not limited to, when gas sterilization and radiation sterilization are used in combination, "Tyvek" provided by DuPont can be used as a microbial barrier. "Tyvek" has excellent durability and puncture resistance and is also permeable to vapor. This "Tyvek" layer may be attached before or after radiation sterilization 612. Furthermore, after radiation sterilization 612, a layer of vapor-resistant and moisture-resistant material such as foil can be sealed (e.g., heat-sealed) on top of this "Tyvek" layer to prevent the intrusion of contaminants and moisture into the sterilization zone 608 and the sealed area 610. On the other hand, in other embodiments, the collimator sealing portion 620 can be a single-layer protective layer, and this single-layer protective layer can be attached to the end of the collimator 606. In such embodiments, the single-layer protective layer can permeate gas during sterilization, while providing protection against harmful elements such as moisture after sterilization is complete. Therefore, the collimator sealing portion 620 can function as a barrier layer against moisture and contaminants, as long as it does not deviate from the scope of this disclosure.

[0076] It should be noted that while the sensor 316 and the pointed body 318 are configured to extend from the bottom of the electronic component housing 304 and within a sterilization zone 608 that extends substantially concentrically with the sensor applicator 102 and applicator cap 210, this specification also intends to include configurations with eccentric arrangements. More specifically, in at least one embodiment, the sensor 316 and the pointed body 318 can be configured to extend from the bottom of the electronic component housing 304 in an eccentric arrangement from the centerline of the sensor applicator 102 and applicator cap 210. In such an embodiment, without departing from the scope of this disclosure, the sterilization zone 608 can also be configured with an eccentric arrangement to accommodate the sensor 316 and the pointed body 318 by modifying the design of the collimator 606, etc.

[0077] In some embodiments, the collimator 606 may include a first collimator, i.e., an "internal" collimator. This internal collimator may be housed within the applicator cap 210 or in other locations within the sensor applicator 102, as generally described above. Furthermore, a second collimator, i.e., an "external" collimator (not shown), which contributes to the sterilization of the sensor applicator 102, may be provided or used in the assembly (manufacturing) process. In such embodiments, the external collimator is located outside the sensor applicator 102 and applicator cap 210 and, when used in conjunction with the internal collimator 606, can help focus the radiation sterilization 612 onto the sensor 316 and the sharpened body 318.

[0078] For example, in one embodiment, the external collimator may be configured to receive radiation sterilization 612 first. The external collimator may have or define a hole (passage) that extends through its interior, similar to the internal collimator 606. The beam of radiation sterilization 612 may be focused by passing through the passage in the external collimator, and this focused beam may be guided through a second opening 614b to the sterilization zone 608 of the internal collimator 606. Thus, the external collimator may be configured to perform preliminary focusing of the radiation energy, and the internal collimator 606 may completely focus this radiation energy and irradiate the sensor 316 and the sharp body 318.

[0079] In some embodiments, the internal collimator 606 can be omitted if the external collimator has the ability to properly and completely focus radiation so that the sensor 316 and the sharp body 318 can be properly sterilized by radiation sterilization 612. In such embodiments, the sensor applicator can be placed adjacent to the external collimator and subjected to radiation sterilization 612. In this case, the external collimator can prevent the radiation energy from damaging the delicate electronic components in the electronic component housing 304. Furthermore, in such embodiments, the sensor applicator 102 can be delivered to the user in a configuration in which the internal collimator 606 is not located in the applicator cap 210, thereby simplifying the configuration in manufacturing and use.

[0080] Figure 7A is an enlarged side cross-sectional view showing the sensor control device 302 mounted inside the applicator cap 210 according to one or more embodiments. As described above, a portion of the sensor 316 and a portion of the sharp body 318 can be configured to be disposed within a sealed area 610 to isolate them from external contamination. The sealed area 610 may include (encompass) a selected portion of the interior of the electronic component housing 304 and the sterilization zone 608 in the collimator 606. In one or more embodiments, the sealed area 610 may be defined or formed by at least a first sealing portion 702a, a second sealing portion 702b, and a collimator sealing portion 620.

[0081] The first sealing portion 702a can be positioned to seal the interface between the pointed hub 422 and the upper part of the electronic component housing 304. More specifically, the first sealing portion 702a can be configured to seal the interface between the pointed hub 422 and the shell 306. Furthermore, the first sealing portion 702a is provided to surround the first central opening 504 defined in the shell 306, thereby preventing contaminants from entering the interior of the electronic component housing 304 through the first central opening 504. In some embodiments, the first sealing portion 702a can be formed as part of the pointed hub 422. For example, the first sealing portion 702a can be overmolded onto the pointed hub 422. In other embodiments, the first sealing portion 702a can also be overmolded onto the upper surface of the shell 306. In further embodiments, without departing from the scope of the present disclosure, the first sealing portion 702a may be made of a separate structure such as an O-ring, and this can be interposed between the pointed hub 422 and the upper surface of the shell 306.

[0082] The second sealing portion 702b can be arranged to seal the interface between the collimator 606 and the bottom of the electronic component housing 304. More specifically, the second sealing portion 702b can be arranged to seal the interface between the mount 308 and the collimator 606, or the interface between the bottom of the plug 402 received at the bottom of the mount 308 and the collimator 606. In a configuration in which the plug 402 is provided as shown in the figure, the second sealing portion 702b can be configured to seal or surround the plug receptacle 512. On the other hand, in an embodiment in which the plug 402 is not provided, the second sealing portion 702b can instead be configured to surround the second central opening 506 (Figure 5A) defined in the mount 308. In this way, the second sealing portion 702b prevents contaminants from entering the sterilization zone 608 of the collimator 606, and also prevents contaminants from entering the interior of the electronic component housing 304 through the plug receptacle 512 (or the second central opening 506).

[0083] In some embodiments, the second sealing portion 702b may be formed as part of the collimator 606. For example, the second sealing portion 702b may be overmolded onto the top of the collimator 606. In other embodiments, the second sealing portion 702b may also be overmolded onto the plug 402 or the bottom of the mount 308. In yet another embodiment, without departing from the scope of the disclosure, the second sealing portion 702b may be made of a separate structure such as an O-ring, which may be interposed between the collimator 606 and the bottom of the plug 402 or the mount 308.

[0084] When the sensor control device 302 is loaded into the sensor applicator 102 (Figure 6B) and the applicator cap 210 is attached to the sensor applicator 102, the first sealing portion 702a and the second sealing portion 702b are compressed, and the corresponding interfaces are sealed. The first sealing portion 702a and the second sealing portion 702b can be made of various materials that have the function of sealing the interface between opposing structures with themselves in between. Suitable materials for the first sealing portion 702a and the second sealing portion 702b include, but are not limited to, silicone, thermoplastic elastomer (TPE), polytetrafluoroethylene (PTFE or Teflon®), or any combination thereof.

[0085] As described above, the collimator sealing portion 620 can be configured to seal the bottom of the sterilization zone 608, and consequently the bottom of the sealed area 610. Therefore, the first sealing portion 702a, the second sealing portion 702b, and the collimator sealing portion 620 form a barrier at their respective sealing positions. By combining these sealing portions 702a, 702b, and 620, it becomes possible to perform a final sterilization treatment on the sealed area 610 that encloses the sensor 316 and the sharp body 318.

[0086] Figure 7B is an enlarged side cross-sectional view showing the sensor control device 302 mounted within the sensor applicator 102 as another example of one or more embodiments. More specifically, Figure 7B shows alternative embodiments of the first sealing portion 702a and the second sealing portion 702b. In this embodiment as well, the first sealing portion 702a is arranged to seal the interface between the pointed body hub 422 and the upper part of the electronic component housing 304, more specifically, to seal the first central opening 504 defined in the shell 306. However, in the illustrated embodiment, the first sealing portion 702a may be configured to provide sealing in two directions: axial and radial. More specifically, when the sensor control device 302 is inserted into the sensor applicator 102, the pointed body hub 422 is received by the sensor carrier 604. In this configuration, the first sealing portion 702a can be pressed against one or more members 704 extending in the axial direction of the sensor carrier 604 and one or more members 706 extending in the radial direction of the sensor carrier 604, thereby biasing them simultaneously. This biasing engagement from two directions compresses the first sealing portion 702a from both the axial and radial directions, thereby enabling the first sealing portion 702a to apply a sealing effect to the upper part of the electronic component housing 304 from both the axial and radial directions.

[0087] In this embodiment as well, the second sealing portion 702b is arranged to seal the interface between the collimator 606 and the bottom of the electronic component housing 304, more specifically, the interface between the mount 308 and the collimator 606, or the interface between the bottom of the plug 402 received at the bottom of the mount 308 and the collimator 606. However, in the illustrated embodiment, the second sealing portion 702b extends into the sterilization zone 608 and is configured to define or form a cylindrical well (vertical recess) 708. The size of this well 708 is set to accommodate the sensor 316 and the sharp body 318 extending from the bottom of the mount 308. In some embodiments, a desiccant 710 can be placed in the cylindrical well 708 to help maintain a low humidity environment suitable for moisture-sensitive biological components.

[0088] In some embodiments, the second sealing portion 702b can be omitted, and the collimator 606 can be directly coupled to the electronic component housing 304. More specifically, in at least one embodiment, the collimator 606 can be screw-coupled to the lower surface of the mount 308. In such embodiments, a threaded opening is defined at the bottom of the mount 308, and a threaded extension is formed or defined on the collimator 606, and the extension of the collimator 606 can be fitted into the opening of the mount 308. By screwing the collimator 606 into the mount 308 in this way, the interface between the collimator 606 and the bottom of the electronic component housing 304 is sealed, thereby isolating the sealed region 610. Furthermore, in such embodiments, the pitch and size of the threads formed on the collimator 606 and the mount 308 can be matched to the pitch and size of the threads used for the screw engagement between the applicator cap 210 and the sensor applicator 102. This allows the collimator 606 to be screwed into or unscrewed into the electronic component housing 304 in conjunction with the operation of screwing the applicator cap 210 onto or off the sensor applicator 102.

[0089] Embodiments disclosed herein include the following:

[0090] Embodiment A A substance monitoring system comprising a sensor applicator and a sensor control device disposed within the sensor applicator. The sensor control device comprises an electronic component housing, a sensor extending from the bottom of the electronic component housing, a pointed body hub disposed adjacent to the top of the electronic component housing, and a pointed body supported by the pointed body hub and extending from the bottom of the electronic component housing through the electronic component housing. Furthermore, this substance monitoring system comprises a cap coupled to the sensor applicator and a collimator disposed within the cap, the collimator defining a sterilization zone that receives the sensor and pointed body extending from the bottom of the electronic component housing.

[0091] Embodiment B A method for preparing a system for monitoring a substance under test. This method includes the step of loading a sensor control device into a sensor applicator. The sensor control device comprises an electronic component housing, a sensor extending from the bottom of the electronic component housing, a sharp body hub positioned adjacent to the top of the electronic component housing, and a sharp body supported by the sharp body hub and extending from the bottom of the electronic component housing through the electronic component housing. The method further includes the step of attaching a cap to the sensor applicator. A collimator is disposed within the cap and defines a sterilization zone that receives the sensor and the sharp body extending from the bottom of the electronic component housing. The method further includes the steps of sterilizing the sensor and the sharp body by radiation sterilization while they are positioned within the sterilization zone, and using the collimator to prevent the radiation used for radiation sterilization from damaging the electronic components within the electronic component housing.

[0092] Embodiment C A method for preparing a system for monitoring a substance under test. This method includes the step of loading a sensor control device into a sensor applicator. The sensor control device comprises an electronic component housing, a sensor extending from the bottom of the electronic component housing, a pointed body hub positioned adjacent to the top of the electronic component housing, and a pointed body supported by the pointed body hub and extending from the bottom of the electronic component housing through the electronic component housing. The method further includes the steps of positioning the sensor applicator adjacent to a collimator, sterilizing the sensor and the pointed body with radiation, and using a collimator to prevent the radiation used for radiation sterilization from damaging the electronic components in the electronic component housing.

[0093] Furthermore, each embodiment of Embodiments A, B, and C may include one or more of the following additional elements in any combination: [Element 1] The sterilization zone consists of a passage that extends through at least a portion of the collimator. [Element 2] The cross-sectional shape of the sterilization zone is selected from the group consisting of shapes corresponding to cones, frustums of cones, cubes, and pyramids, rectangles, and any combination thereof. [Element 3] The sterilization zone is frustoconical in shape, with a first opening defined at the first end of the sterilization zone and a second opening defined at the second end of the sterilization zone, the first opening receiving a sensor and a sharp object extending from the bottom of the electronic component housing, and a sealing portion provided in the second opening. [Element 4] The substance monitoring system further comprises a sealed area encompassing the sterilization zone and a portion of the interior of the electronic component housing, wherein the sealed area is defined by a first sealing portion sealing the interface between the pointed body hub and the top of the electronic component housing, a second sealing portion sealing the interface between the collimator and the bottom of the electronic component housing, and a third sealing portion sealing the end of the sterilization zone. [Element 5] A first sealing portion is provided so as to surround a central opening defined at the top of the electronic component housing, preventing contaminants from entering a portion of the interior of the electronic component housing through the central opening, and a second sealing portion is provided so as to surround an opening defined at the bottom of the electronic component housing, preventing contaminants from entering a portion of the interior of the electronic component housing through the opening. [Element 6] The first sealing portion provides either or both axial sealing and radial sealing. [Element 7] The second sealing portion extends into the sterilization zone and defines a cylindrical well for receiving the sensor and the sharp object. [Element 8] The substance monitoring system further comprises a printed circuit board disposed within an electronic component housing, a data processing unit mounted on the printed circuit board, and a shielding body placed within the electronic component housing to protect the data processing unit from radiation used in radiation sterilization. [Element 9] The shielding material is composed of a non-magnetic metal selected from the group consisting of lead, tungsten, iron, stainless steel, copper, tantalum, osmium, and any combination thereof, or a thermoplastic polymer mixed with a non-magnetic metal.

[0094] [Element 10] The method further includes the step of forming a sealed area encompassing the sterilization zone and a portion of the interior of the electronic component housing when the cap is attached to the sensor applicator. [Element 11] The step of forming a sealed area includes: sealing the interface between the pointed hub and the upper part of the electronic component housing with a first sealing portion; sealing the interface between the collimator and the bottom of the electronic component housing with a second sealing portion; and sealing the end of the sterilization zone with a third sealing portion. [Element 12] The step of sealing the interface between the pointed hub and the upper part of the electronic component housing with a first sealing portion includes the step of providing either or both of axial sealing and radial sealing with the first sealing portion. [Element 13] The collimator includes an internal collimator, and the step of sterilizing the sensor and sharp object by radiation sterilization further includes the steps of positioning the sensor applicator adjacent to an external collimator disposed outside the sensor applicator; focusing the radiation with the external collimator and directing it into the internal collimator; and preventing the radiation from damaging electronic components in the electronic component housing using the external and internal collimators. [Element 14] The sterilization zone comprises defining a first opening at the first end of the collimator and a second opening at the second end of the collimator, and the step of sterilizing the sensor and the sharp object comprises introducing radiation into the sterilization zone through the second opening. [Element 15] A step to prevent radiation used in radiation sterilization from damaging electronic components includes a step of blocking the radiation with collimator material. [Element 16] A printed circuit board is disposed within an electronic component housing, a data processing unit is mounted on the printed circuit board, and the method further includes the step of protecting the data processing unit from radiation used in radiation sterilization by a shielding body disposed within the electronic component housing.

[0095] [Element 17] The step of positioning the sensor applicator adjacent to the collimator includes the step of positioning the collimator such that the collimator is located outside the sensor applicator during radiation sterilization.

[0096] Examples of exemplary combinations of elements applicable to embodiments A, B, and C include the combination of element 2 and element 3, the combination of element 4 and element 5, the combination of element 4 and element 6, the combination of element 4 and element 7, the combination of element 8 and element 9, the combination of element 10 and element 11, and the combination of element 11 and element 12.

[0097] External sterilization assembly Referring back to Figure 1, the sensor control device 104 needs to be sterilized to ensure that no living microorganisms are present before it is delivered to the end user. Generally, the sensor 110 is sterilized by radiation sterilization, such as electron beam irradiation. However, since radiation sterilization may damage the electronic components within the sensor control device 104, these electronic components are generally sterilized by chemical gas sterilization (for example, sterilization using ethylene oxide). However, chemical gas sterilization may damage enzymes and other chemical substances and biological materials contained on the sensor 110.

[0098] Thus, the problem of incompatibility in sterilization methods between the sensor 110 and the electronic components has conventionally been avoided by separating the sensor 110 and the electronic components and sterilizing each individually. However, this method increases the number of required parts, packages, and processes, and since the final assembly work must be performed by the user, there is a risk of human error by the user. According to this disclosure, any device requiring final sterilization, such as the sensor control device 104, can be properly sterilized by using an external sterilization assembly. This external sterilization assembly is designed to focus sterilization radiation (e.g., beam, wave, energy, etc.) toward the components that require sterilization, while simultaneously preventing delicate electronic components from being affected or damaged by the propagation of said radiation.

[0099] Figure 8 is a schematic diagram showing an example external sterilization assembly 800 according to one or more embodiments of the present disclosure. The external sterilization assembly 800 (hereinafter, "assembly 800") may be designed or configured to assist in the sterilization process of a medical device 802. The medical device 802 may include, for example, a sensor control device similar in some respects to the sensor control device 104 shown in Figure 1, but may also include other types of medical devices, healthcare products, or systems having specific components that require final sterilization. Examples of medical devices or healthcare products to which the principles of the present disclosure can be applied include, but are not limited to, ingestible products, cardiac rhythm management (CRM) devices, subcutaneous sensing devices, externally attached medical devices, or any combination thereof.

[0100] The medical device 802 may comprise a housing 804, a component requiring sterilization (hereinafter referred to as "sterilization-required component") 806, and one or more radiation-sensitive components 808. In the illustrated embodiment, the radiation-sensitive component 808 can be mounted on a printed circuit board (PCB) 810 located within the housing 804, and the housing 804 may include an electronic component housing for a sensor control device. The radiation-sensitive component 808 may include one or more electronic component modules. Examples of such electronic component modules include, but are not limited to, data processing units (e.g., application-specific integrated circuits (ASICs)), resistors, transistors, capacitors, inductors, diodes, and switches. In other embodiments, as will be described later with reference to Figure 12, the radiation-sensitive component 808 may include a radiation-sensitive chemical solution or test substance.

[0101] In some embodiments, component 806 may include a sensor (e.g., sensor 110 shown in Figure 1) extending from the housing 804. Component 806 may extend inclined from the bottom of the housing 804, as shown; however, it may also extend perpendicularly to the bottom of the housing 804, or from a surface of the housing 804 other than the bottom. Furthermore, in at least one embodiment, component 806 may further include a pointed body. This pointed body assists in the subcutaneous implantation of the sensor by the user and may be configured to require sterilization. In some embodiments, as shown, component 806 may be sealed with a cap 812. The cap 812 acts as a sealing barrier, protecting the exposed portion of component 806 (e.g., the sensor and any associated pointed body) until the need arises to use component 806.

[0102] To properly sterilize the component 806 in preparation for use, the medical device 802 can be subjected to radiation sterilization 814. Suitable radiation sterilization 814 treatments include, but are not limited to, electron beam irradiation, gamma ray irradiation, X-ray irradiation, or any combination thereof. In embodiments where a cap 812 is provided, the cap 812 can be made of a material through which radiation 814 can penetrate and propagate, thereby enabling radiation sterilization of the component 806 through the cap 812. Suitable materials for the cap 812 include, but are not limited to, non-magnetic metals (e.g., aluminum, copper, gold, silver, etc.), thermoplastics, ceramics, rubber (e.g., ebonite), composite materials (e.g., fiberglass, carbon fiber reinforced polymer, etc.), epoxy, or any combination thereof. In some embodiments, the cap 812 may be transparent or translucent, but may be opaque, as long as it does not depart from the scope of this disclosure.

[0103] Assembly 800 may include a radiation shield 816. The radiation shield 816 is located outside the medical device 802 and is configured to contribute to the sterilization of component 806 while simultaneously preventing (blocking) radiation-sensitive components 808 from being affected or damaged by the propagation of radiation 814. To achieve this configuration, a collimator 818 can be provided in the radiation shield 816. The collimator 818 can mainly consist of a hole (passage) that extends through at least a portion of the main body of the radiation shield 816. This collimator 818 defines a sterilization zone 820 configured to help focus radiation 814 toward component 806. In the illustrated embodiment, component 806 is received within the sterilization zone 820 for sterilization.

[0104] The radiation shield 816 can be made of a material that focuses radiation 814 (e.g., beam, wave, energy, etc.) toward component 806, while reducing or blocking the transmission of such radiation so that it does not penetrate the material of the radiation shield 816 and damage radiation-sensitive components 808 within the housing 804. In other words, the radiation shield 816 can be made of a material with sufficient density to absorb the dose of the delivered beam energy. In some embodiments, for example, the radiation shield 816 can be made of a material with a mass density greater than 0.9 grams per cubic centimeter (g / cc). On the other hand, in other embodiments, a material with a mass density of less than 0.9 g / cc may also be adequately used, as long as it does not deviate from the scope of this disclosure. Suitable materials for radiation shielding 816 include, but are not limited to, high-density polymers (e.g., polyethylene, polypropylene, polystyrene, polytetrafluoroethylene, etc.), metals (e.g., lead, stainless steel, aluminum, etc.), any combination thereof, or any material with a mass density exceeding 0.9 g / cc.

[0105] The collimator 818 can have any suitable cross-sectional shape necessary for properly focusing radiation onto the part 806 for sterilization. For example, in the illustrated embodiment, the collimator 818 is conical or frustoconical in shape. On the other hand, in other embodiments, without departing from the scope of the disclosure, the cross-sectional shape of the collimator 818 can be polygonal, such as a square (corresponding to a cubic structure), a rectangle (e.g., a parallelogram), or a pyramidal structure. In yet another embodiment, the collimator 818 may have a circular cross-sectional shape with parallel sides.

[0106] In the illustrated embodiment, the collimator 818 has a first opening 822a and a second opening 822b defined at both ends of the sterilization zone 820. The first opening 822a is configured to allow radiation 814 to enter the sterilization zone 820 and to allow the entered radiation 814 to collide with the part 806. On the other hand, the second opening 822b can be configured to allow the part 806 to be inserted into the sterilization zone 820. In embodiments in which the collimator 818 is conical or frustoconical in shape, the diameter of the second opening 822b can be smaller than the diameter of the first opening 822a. For example, in such an embodiment, the size (diameter) of the second opening 822b can be in the range of approximately 0.5 mm to approximately 3.0 mm, and the size (diameter) of the first opening 822a can be in the range of approximately 5.0 mm to approximately 16.0 mm. However, as will be understood by those skilled in the art, the diameters of the first aperture 822a and the second aperture 822b can be set to be larger or smaller than the above range, without departing from the scope of this disclosure. In practice, the diameters of the first aperture 822a and the second aperture 822b can be sized to match the size of the device, and it is sufficient that they are large enough to deliver a sufficient dose of radiation to component 806. Furthermore, in at least one embodiment, the collimator 818 can be cylindrical in shape, and the diameters of the first aperture 822a and the second aperture 822b can be the same.

[0107] In some embodiments, the assembly 800 may further include a shielding barrier 824. The shielding barrier 824 is located within the housing 804. The shielding barrier 824 may be configured to help block radiation 814 (e.g., electrons) that propagates within the housing 804 toward the radiation-sensitive component 808. The shielding barrier 824 may be made of any of the materials listed above as materials for the radiation shield 816. In the illustrated embodiments, the shielding barrier 824 is located vertically within the housing 804, but it may instead be located at any other angle suitable for protecting the radiation-sensitive component 808.

[0108] Figure 9 is a schematic diagram showing an external sterilization assembly 900 as another example according to one or more additional embodiments of the present disclosure. The external sterilization assembly 900 (hereinafter, "assembly 900") can be similar in several respects to assembly 800 shown in Figure 8, and is therefore best understood by referring to Figure 8. Accordingly, similar components are indicated by the same reference numerals and are not described herein. Like assembly 800, assembly 900 can also be designed or configured to assist in the sterilization process of medical device 902. In the illustrated embodiment, medical device 902 may include a two-piece sensor control device, but may instead include any of the medical devices listed in the description of medical device 802.

[0109] As shown in the figure, the medical device 902 may comprise a housing 904, a part requiring sterilization 906, and one or more radiation-sensitive components 908. The components 908 are located within the housing 904. The housing 904 may include a package (enclosure) that contains the part 906 and the radiation-sensitive components 908. The radiation-sensitive components 908 may comprise any of the electronic component modules listed in the description of the radiation-sensitive component 808 in Figure 8. The part 906 may comprise, for example, a needle / sensor subassembly, and the part 906 may be subjected to radiation sterilization 814 to properly sterilize it in preparation for use.

[0110] The assembly 900 may include a radiation shield 910. The radiation shield 910 is located outside the medical device 902 and is configured to contribute to the sterilization of the component 906 while preventing (blocking) radiation-sensitive components 908 from being affected or damaged by the propagation of radiation 814. In the illustrated embodiment, the radiation shield 910 may be configured to define or provide an internal cavity 912 in which the medical device 902 can be placed. Similar to the radiation shield 816 shown in Figure 8, the radiation shield 910 may also be provided with a collimator 914. The collimator 914 may be mainly composed of a hole (passage) extending through at least a portion of the body of the radiation shield 910, and may be configured to provide access to the cavity 912 through this passage. The collimator 914 defines a sterilization zone 916 configured to help focus the radiation 814 toward the component 906. The radiation shield 910 can be made of any of the materials listed in the above description of the radiation shield 816, thereby reducing or preventing radiation 814 from passing through parts of the radiation shield 816 other than the collimator 914 and damaging radiation-sensitive components 908 inside the housing 904.

[0111] During the sterilization process, when the component 906 is properly sterilized, radiation sterilization 814 can be directed toward the medical device 902. The collimator 914 and sterilization zone 916 are configured to concentrate and / or focus the radiation used in radiation sterilization 814 toward the component 906. Meanwhile, the rest of the radiation shield 910 is configured to prevent (block) radiation-sensitive components 908 within the housing 904 from being affected by the propagation of radiation 814. In the illustrated embodiment, the collimator 914 and sterilization zone 916 have a circular cross-sectional shape with parallel sides, but they may also have other cross-sectional shapes, such as shapes corresponding to conical, frustoconical, and pyramidal structures, polygons, or any combination thereof, but are not limited to these.

[0112] In some embodiments, the assembly 900 may further include a shielding barrier 824. The shielding barrier 824 may be positioned within the housing 904 in such a configuration that it helps block radiation 814 (e.g., electrons) that propagates within the housing 904 and is directed toward radiation-sensitive components 908.

[0113] Figure 10 is a schematic diagram showing an external sterilization assembly 1000 as another example according to one or more additional embodiments of the present disclosure. The external sterilization assembly 1000 (hereinafter, "assembly 1000") can be similar in several respects to assembly 900 shown in Figure 9, and is therefore best understood by referring to Figure 9. Accordingly, similar components are indicated by the same reference numerals and are not described herein. Similar to assembly 900, assembly 1000 can also be designed or configured to assist in the sterilization process of medical device 1002. In the illustrated embodiment, medical device 1002 may include a sensor control device similar to the sensor control device 104 shown in Figure 1, or it may instead include any of the medical devices listed in the description relating to medical device 802 shown in Figure 8.

[0114] As shown in the illustration, the medical device 1002 may comprise a housing 1004, a sterilizable component 1006, and one or more radiation-sensitive components 1008. Component 1008 is located within the housing 1004. In the illustrated embodiment, the housing 1004 may include an electronic component housing for a sensor control device (e.g., sensor control device 104 shown in Figure 1), and radiation-sensitive component 1008 may comprise any of the electronic component modules listed in the description of radiation-sensitive component 808 in Figure 8. In some embodiments, component 1006 may comprise a sensor (e.g., sensor 110 shown in Figure 1) extending from the housing 1004. Component 1006 may also further comprise a pointed body, which assists in the subcutaneous implantation of the sensor by the user and may be configured to require sterilization.

[0115] Assembly 1000 may include a radiation shield 1010. The radiation shield 1010 is located outside the medical device 1002 and is configured to contribute to the sterilization of the component 1006 while preventing (blocking) radiation-sensitive components 1008 from being affected or damaged by the propagation of radiation 814. The radiation shield 1010 may be made of any of the materials listed above in the description of the radiation shield 816 in Figure 8, thereby reducing or blocking radiation 814 from penetrating the radiation shield 1010 and damaging radiation-sensitive components 1008 within the housing 1004.

[0116] In the illustrated embodiment, the radiation shield 1010 may be configured to define or provide an internal cavity 1012 in which a medical device 1002 can be placed for sterilization. In some embodiments, the radiation shield 1010 may be configured in a box shape, and the internal cavity 1012 may be formed inside this box. The radiation shield 1010 may also be provided with a collimator 1014. The collimator 1014 may extend through at least a portion of the body of the radiation shield 1010 and be configured to provide access to the cavity 1012 through the collimator 1014. The collimator 1014 defines a sterilization zone 1016 configured to help focus radiation 814 toward the component 1006 for sterilization.

[0117] During sterilization, when part 1006 is properly sterilized, radiation sterilization 814 can be directed toward the medical device 1002. The collimator 1014 and sterilization zone 1016 are configured to concentrate and / or focus the radiation used for radiation sterilization 814 toward part 1006. Meanwhile, the rest of the radiation shield 1010 is configured to prevent (block) radiation-sensitive components 1008 within the housing 1004 from being affected by the propagation of radiation 814. In the illustrated embodiment, the collimator 1014 has a circular cross-section with parallel sides, but it may also have other cross-sectional shapes, including but not limited to conical, frustoconical, and pyramidal structures, polygons, or any combination thereof.

[0118] Figure 11 is a schematic diagram showing an external sterilization assembly 1100 as another example according to one or more additional embodiments of the present disclosure. The external sterilization assembly 1100 (hereinafter, "assembly 1100") can be similar in several respects to assembly 800 shown in Figure 8, assembly 900 shown in Figure 9, and assembly 1000 shown in Figure 10, and is therefore best understood by referring to Figures 8, 9, and 10. Like assemblies 800, 900, and 1000, assembly 1100 can also be designed or configured to assist in the sterilization process of a medical device 1102. In the illustrated embodiment, the medical device 1102 may include a two-piece sensor control device, but may instead include any of the medical devices listed in the description of medical device 802.

[0119] As shown in the figure, the medical device 1102 may comprise a housing 1104, a part requiring sterilization 1106, and one or more radiation-sensitive components 1108. The component 1108 is located within the housing 1104. The radiation-sensitive component 1108 may comprise any of the electronic component modules listed in the description of the radiation-sensitive component 808 in Figure 8. In the illustrated embodiment, the part 1106 may comprise, for example, a needle-sensor subassembly, and the part 1106 may be subjected to radiation sterilization 814 to properly sterilize it in preparation for use.

[0120] Assembly 1100 may include a radiation shield 1110. The radiation shield 1110 is positioned outside the medical device 1102 and is configured to contribute to the sterilization of the component 1106 while simultaneously preventing (blocking) radiation-sensitive components 1108 from being affected or damaged by the propagation of radiation 814. The radiation shield 1110 may be made of any of the materials listed above in the description of the radiation shield 816 in Figure 8, thereby reducing or blocking radiation 814 from penetrating the radiation shield 1110 and damaging radiation-sensitive components 1108.

[0121] In the illustrated embodiment, the radiation shield 1110 can be configured as a clamshell structure comprising a first portion 1112a and a second portion 1112b that can be fitted (or engaged) with the first portion 1112a. The radiation shield 1110 can also be configured to have or define an internal cavity 1114 in which a medical device 1102 can be placed for sterilization. In some embodiments, as shown in the illustration, the first portion 1112a and the second portion 1112b can cooperate to define a part of the internal cavity 1114, and the internal cavity 1114 can be formed when the two portions are properly fitted together. On the other hand, in other embodiments, the entire internal cavity 1114 can be defined within the first portion 1112a, or the entire internal cavity 1114 can be defined within the second portion 1112b.

[0122] In some embodiments, the assembly 1100 may further include an absorber 1116 configured to protect the medical device 1102. In at least one embodiment, as shown in the figure, a portion of the absorber 1116 may be provided or formed in each of the first portion 1112a and the second portion 1112b. In such embodiments, at least a portion of the internal cavity 1114 can be defined by the absorber 1116. The absorber 1116 may be made of a material capable of absorbing stray radiation without generating bremsstrahlung protons. Suitable materials for the absorber 1116 include, for example, any of the high-density polymers mentioned in the description of the radiation shield 816 shown in Figure 8.

[0123] Similar to the radiation shield 816 shown in Figure 8, a collimator can also be provided in the radiation shield 1110. In the illustrated embodiment, the radiation shield 1110 is provided or defined with a first collimator 1118a and a second collimator 1118b. However, without departing from the scope of this disclosure, the radiation shield 1110 may be configured to have only one of the collimators 1118a and 1118b. The first collimator 1118a is mainly composed of a hole (passage) extending through at least a portion of the first portion 1112a of the radiation shield 1110, and the second collimator 1118b is mainly composed of a hole (passage) extending through at least a portion of the second portion 1112b. These collimators 1118a and 1118b are configured to allow access to the internal cavity 1114, and the collimators 1118a and 1118b work together to define a sterilization zone 1120. This sterilization zone 1120 includes the internal cavity 1114 and supports the sterilization process by focusing radiation 814 toward the part 1106.

[0124] When properly sterilizing part 1106 during the sterilization process, the medical device 1102 can be placed inside the internal cavity 1114, and the opposing first part 1112a and second part 1112b can be fitted together to seal the medical device 1102. Once the medical device 1102 is properly placed inside the cavity 1114, the medical device 1102 can be configured to be placed in the sterilization zone 1120. Subsequently, when radiation sterilization 814 is irradiated onto the medical device 1102 from both sides of the radiation shield 1110, the radiation used for radiation sterilization 814 can be focused and / or concentrated towards part 1106 by collimators 1118a and 1118b, and the radiation can be irradiated onto part 1106 from both sides. In this case, the portion of the radiation shielding body 1110 other than the collimators 1118a and 1118b is configured to prevent (block) the radiation-sensitive component 1108 inside the housing 1104 from being affected by the propagation of radiation 814. In the illustrated embodiment, each collimator 1118a and 1118b is conical or frustoconical in shape, but they can also be other cross-sectional shapes, such as circular and pyramidal structures, polygons, or any combination thereof, although these are not limited to these.

[0125] In some embodiments, the assembly 1100 may further comprise one or more (two in the illustration) shielding barriers 824. The shielding barriers 824 may be positioned within the housing 1104 in such a configuration as to help block radiation 814 (e.g., electrons) that propagates within the housing 1104 and is directed toward radiation-sensitive components 1108.

[0126] Figure 12 is a schematic diagram showing an external sterilization assembly 1200 as another example according to one or more additional embodiments of the present disclosure. The external sterilization assembly 1200 (hereinafter, "assembly 1200") can be designed or configured to assist in the sterilization process of a medical device 1202. In the illustrated embodiment, the medical device 1202 is configured to include a subcutaneous injection needle or subcutaneous syringe. As shown, the medical device 1202 may comprise a housing 1204 (e.g., a barrel or vial), a part to be sterilized 1206, and one or more radiation-sensitive components 1208. Component 1208 is located within the housing 1204. In the illustrated embodiment, the radiation-sensitive component 1208 may comprise a radiation-sensitive chemical solution or test substance (e.g., an activator, drug, biomaterial, etc.). Meanwhile, part 1206 may comprise a needle designed to deliver the chemical solution.

[0127] In some embodiments, as shown in the figures, the component 1206 can be enclosed or surrounded by a cap 1210 (e.g., a needle cap), and the component 1206 can be sealed within this cap 1210. Furthermore, in at least one embodiment, the cap 1210 can be sealed to the housing 1204 by a sealing element 1212, such as an O-ring. The cap 1210 and the sealing element 1212 work together to form a sterile barrier system that surrounds and protects the exposed portion of the component 1206 until it is needed for use. To properly sterilize the component 1206 in preparation for use, the component 1206 can be subjected to radiation sterilization 814.

[0128] The assembly 1200 may include a radiation shield 1214. The radiation shield 1214 is located outside the medical device 1202 and is configured to contribute to the sterilization of the part 1206 while simultaneously preventing (blocking) radiation-sensitive components 1208 from being affected or damaged by the propagation of radiation 814. As shown in the figure, the radiation shield 1214 may be provided with a collimator 1216. The collimator 1216 is mainly composed of holes (passages) that extend through at least a portion of the body of the radiation shield 1214, and this collimator 1216 defines a sterilization zone 1218 configured to help focus the radiation 814 toward the part 1206 for sterilization. In the illustrated embodiment, the part 1206 is received within the sterilization zone 1218. The collimator 1216 allows the radiation 814 to reach and collide with the part 1206, thereby sterilizing it, while the rest of the radiation shield 1214 is configured to prevent (block) radiation-sensitive components 1208 within the housing 1204 from being affected by the propagation of the radiation 814. In the illustrated embodiment, the collimator 1216 is conical or frustoconical in shape, but it can also be other cross-sectional shapes such as polygonal, pyramidal, circular, or any combination thereof.

[0129] In embodiments where a cap 1210 is provided, the cap 1210 body can be made of a material through which radiation 814 can penetrate and propagate, thereby enabling radiation sterilization of the component 1206 via the cap. The material suitable for the cap 1210 can be the same as the material mentioned in the description of the cap 812 in Figure 8 above.

[0130] In some embodiments, the assembly 1200 may further include a shielding barrier 824. The arrangement of the shielding barrier 824 may help block radiation 814 (e.g., electrons) that propagates within the housing 1204 toward a radiation-sensitive component 1208 (e.g., a chemical solution). In the illustrated embodiment, a central opening 1220 may be defined or provided in the shielding barrier 824. This central opening 1220 may be configured to allow the radiation-sensitive component 1208 to be ejected out of the housing 1204 through a part 1206 (e.g., a needle). In other embodiments, the shielding barrier 824 may be provided with a meandering path through which the radiation-sensitive component 1208 can be ejected out of the housing 1204 through a part 1206.

[0131] Figure 13 is an isometric view showing an example of a sensor control device 1302 according to one or more additional embodiments of the present disclosure. The sensor control device 1302 may be identical or similar to the sensor control device 104 shown in Figure 1. Therefore, by using the sensor control device 1302 in combination with the sensor applicator 102 (Figure 1), the sensor control device 1302 can be delivered to a predetermined monitoring location on the user's skin. Furthermore, the sensor control device 1302 may be replaced with a medical device having similar characteristics to one or more of the medical devices 802, 902, 1002, 1102, and 1202 shown in Figures 8 to 12 of this specification. Therefore, the sensor control device 1302 may also need to be properly sterilized before use.

[0132] As shown in the figure, the sensor control device 1302 includes an electronic component housing 1304. The electronic component housing 1304 is substantially disc-shaped and may have a circular cross-sectional shape. On the other hand, in other embodiments, without departing from the scope of the present disclosure, the cross-sectional shape of the electronic component housing 1304 may be other shapes such as oval (e.g., tablet-shaped), squircle-shaped, or polygonal. The electronic component housing 1304 may be configured to house or enclose various electronic components for operating the sensor control device 1302.

[0133] The electronic component housing 1304 may comprise a shell 1306 and a mount 1308 configured to fit into the shell 1306. The shell 1306 can be secured to the mount 1308 by various means, such as snap-fit ​​engagement, interlocking fit, ultrasonic welding, one or more mechanical fasteners (e.g., screws), or any combination thereof. In some cases, securing the shell 1306 to the mount 1308 can form a sealing interface between them. In such embodiments, a sealing material of the type of gasket can be placed on or near the outer diameter (periphery) of the shell 1306 and the mount 1308. In this case, when the shell 1306 and the mount 1308 are secured to each other, the gasket is compressed, forming a sealing interface. In other embodiments, an adhesive can be applied to the outer diameter (periphery) of one or both of the shell 1306 and the mount 1308. The shell 1306 is fixed to the mount 1308 by adhesive, thereby providing structural integrity and sealing the interface between the two, which isolates the inside of the electronic component housing 1304 from external contamination.

[0134] In the illustrated embodiment, the sensor control device 1302 can further include a plug assembly 1310 that can be coupled to the electronic component housing 1304. The plug assembly 1310 can include a sensor module 1312 (partially shown) that can be interconnected to a sharp body module 1314 (partially shown). The sensor module 1312 can be configured to carry or include a sensor 1316 (partially shown), and the sharp body module 1314 can be configured to carry or include a sharp body 1318 (partially shown). The sharp body 1318 can be configured to assist in the percutaneous delivery of the sensor 1316 into the user's subcutaneous tissue when the sensor control device 1302 is worn. The sharp body module 1314 can include a sharp body hub 1320 that carries the sharp body 1318.

[0135] As shown, a portion of the sensor 1316 and a corresponding portion of the sharp body 1318 extend from the electronic component housing 1304, more specifically from the bottom of the mount 1308. The exposed portion of the sensor 1316 (also referred to as the "tail") can be received within a hollow or recessed portion of the sharp body 1318. On the other hand, other portions of the sensor 1316 are disposed inside the electronic component housing 1304.

[0136] FIG. 14A is a side view of the sensor applicator 102 shown in FIG. 1. As shown, the sensor applicator 102 includes a housing 1402 and an applicator cap 1404 that can be detachably coupled to the housing 1402. In some embodiments, the applicator cap 1404 can be screwed onto the housing 1402 and include a tamper-evident ring 1406. Rotating (e.g., unscrewing) the applicator cap 1404 relative to the housing 1402 shears the tamper-evident ring 1406 and allows the applicator cap 1404 to be removed from the sensor applicator 102. After removing the applicator cap 1404, the user can use the sensor applicator 102 to place the sensor control device 1302 (FIGS. 13 and 14B) at a predetermined monitoring position on their body.

[0137] In some embodiments, to protect the internal components of the sensor applicator 102, the applicator cap 1404 can be configured to be sealed and engaged with the housing 1402 for attachment. In at least one embodiment, for example, the interface between the housing 1402 and the applicator cap 1404 can be sealed by a sealing gasket of a type such as an O-ring. The O-ring or sealing gasket may be provided as a separate component, or alternatively, may be molded onto either the housing 1402 or the applicator cap 1404.

[0138] Figure 14B is a side cross-sectional view of the sensor applicator 102. As shown, the sensor control device 1302 can be housed within the sensor applicator 102, and the sensor control device 1302 can be fixed within the applicator cap 1404 by coupling the applicator cap 1404 to the sensor applicator 102. The sensor control device 1302 may comprise one or more radiation-sensitive components 1408, which are housed within the electronic component housing 1304. The radiation-sensitive components 1408 may comprise electronic components or electronic component modules. Such electronic components or electronic component modules may include, but are not limited to, data processing units, resistors, transistors, capacitors, inductors, diodes, switches, or any combination thereof. The data processing unit may comprise, for example, an application-specific integrated circuit (ASIC) configured to implement one or more functions or routines associated with the operation of the sensor control device 1302. During operation, the data processing unit can perform data processing functions such as filtering and encoding each data signal corresponding to the values ​​of the test substance collected from the user. Furthermore, the data processing unit may be configured to include an antenna for communicating with the reading device 106 (Figure 1), or may be configured to be able to communicate with such an antenna.

[0139] In the illustrated embodiment, the cap filler 1410 is positioned inside the applicator cap 1404. Typically, the cap filler 1410 can be configured to assist in supporting the sensor control device 1302 within the sensor applicator 102. In one or more embodiments, the cap filler 1410 can be configured as an integral part (extension) with the applicator cap 1404, for example, by molding it integrally with the applicator cap 1404 or by overmolding it onto the applicator cap 1404. In other embodiments, without departing from the scope of this disclosure, the cap filler 1410 can be configured as a separate structure from the applicator cap 1404 and fitted or attached inside the applicator cap 1404.

[0140] More specifically, the distal end of the sensor 1316 and the distal end of the pointed body 1318 extending from the bottom of the electronic component housing 1304 of the sensor control device 1302 can be sterilized while they are positioned inside the sensor applicator 102. More specifically, the assembled sensor control device 1302 can be subjected to radiation sterilization 1412 similar to radiation sterilization 814 shown in Figures 8 to 12. Radiation sterilization 1412 can be performed by either continuous irradiation or pulsed beam irradiation. In pulsed beam irradiation, the beam for radiation sterilization 1412 is focused to a predetermined target position, and the component or device to be sterilized is moved to this target position. Then, radiation pulses are applied and irradiation is performed in this state. After that, radiation sterilization 1412 is stopped, and the next component or device to be sterilized is moved to the target position, and the same process is repeated.

[0141] According to this disclosure, by using the external sterilization assembly 1414, it is possible to assist in focusing the radiation 1412 when sterilizing the distal end of the sensor 1316 and the distal end of the sharp body 1318, while simultaneously preventing (blocking) radiation-sensitive components 1408 from being affected by the propagation of radiation 1412. As shown in the figure, the external sterilization assembly 1414 (hereinafter, "assembly 1414") may include a radiation shield 1416, and at least a portion of this radiation shield 1416 may be positioned outside the sensor applicator 102. The radiation shield 1416 may be provided with or defined an external collimator 1418. The external collimator 1418 may be configured to assist in focusing the radiation (e.g., beam, wave, energy, etc.) used for radiation sterilization 1412 toward the components to be sterilized. More specifically, the external collimator 1418 is configured to allow the radiation used for radiation sterilization 1412 to pass through it, reach and collide with the sensor 1316 and the sharp body 1318, and sterilize them, while preventing the radiation used for radiation sterilization 1412 from damaging radiation-sensitive components 1408 within the electronic component housing 1304.

[0142] In the illustrated embodiment, the external collimator 1418 is designed to align with the internal collimator 1420 defined by the cap filler 1410. Similar to the external collimator 1418, the internal collimator 1420 can also be configured to assist in focusing the radiation used for radiosterilization 1412 toward the component to be sterilized. As shown, the cap filler 1410 can define a radial shoulder 1422. The size of the radial shoulder 1422 is set to receive or fit the end of the radiation shield 1416, and at the position of this radial shoulder 1422, there is a transition from the external collimator 1418 to the internal collimator 1420. In some embodiments, the transition from the external collimator 1418 to the internal collimator 1420 can be continuous (smooth, without surface irregularities). In other embodiments, however, without departing from the scope of the present disclosure, this transition can be discontinuous (stepped).

[0143] The external collimator 1418 and the internal collimator 1420 work together to define a sterilization zone 1424 that focuses the radiation used for radiation sterilization 1412. The distal end of the sensor 1316 and the distal end of the sharp body 1318 can be placed within this sterilization zone 1424. The radiation used for radiation sterilization 1412 propagates through the sterilization zone 1424 and collides with the sensor 1316 and the sharp body 1318, sterilizing them. However, to prevent the radiation used for radiation sterilization 1412 from penetrating the inner wall of the sterilization zone 1424 and damaging radiation-sensitive components 1408 inside the housing 1304, both the cap filler 1410 and the radiation shield 1416 can be made of materials that substantially prevent the transmission of such radiation. In other words, both the cap filler 1410 and the radiation shield 1416 can be made of materials with sufficient density to absorb the dose of the delivered beam energy. In some embodiments, for example, one or both of the cap filler 1410 and the radiation shield 1416 may be made of a material with a mass density greater than 0.9 grams per cubic centimeter (g / cc). On the other hand, in other embodiments, materials with a mass density of less than 0.9 g / cc may also be used appropriately, without departing from the scope of the disclosure. Suitable materials for the cap filler 1410 and the radiation shield 1416 include, but are not limited to, high-density polymers (e.g., polyethylene, polypropylene, polystyrene, polytetrafluoroethylene, etc.), metals (e.g., lead, stainless steel, aluminum, etc.), any combination thereof, or any material with a mass density greater than 0.9 g / cc. In at least one embodiment, the cap filler 1410 may be made of a machined or 3D printed part of polypropylene, and the radiation shield 1416 may be made of stainless steel.

[0144] In some embodiments, the design of the sterilization zone 1424 can be modified so that, even if one or both of the cap filler 1410 and the radiation shield 1416 are constructed using materials with a mass density of less than 0.9 g / cc, the function of preventing radiation-sensitive components 1408 from being damaged by radiation sterilization 1412 can still be achieved. In such embodiments, the size (e.g., length) of the sterilization zone 1424 can be increased to increase the amount of material that electrons generated and propagated by radiation sterilization 1412 must pass through before colliding with radiation-sensitive components 1408. By increasing the amount of material that must pass through, the dose intensity of radiation sterilization 1412 is more easily absorbed or dissipated, so that delicate electronic components are not adversely affected by radiation sterilization 1412. On the other hand, in other embodiments, the opposite relationship may hold true. That is, if the mass density of the materials used in one or both of the cap filler 1410 and the radiation shield 1416 is sufficiently high, the size (e.g., length) of the sterilization zone 1424 can be reduced.

[0145] The sterilization zone 1424 defined by the external collimator 1418 and the internal collimator 1420 can have any suitable cross-sectional shape necessary to properly focus the radiation used for radiation sterilization 1412 onto the sensor 1316 and the sharp body 1318 for sterilization. For example, in the illustrated embodiment, both the external collimator 1418 and the internal collimator 1420 are conical or frustoconical in shape. On the other hand, in other embodiments, without departing from the scope of this disclosure, the cross-sectional shape of one or both of the external collimator 1418 and the internal collimator 1420 can be a polygon, such as a square (corresponding to a cubic structure), a rectangle (e.g., a parallelogram), or a pyramidal structure. In yet another embodiment, one or both of the external collimator 1418 and the internal collimator 1420 can have a circular cross-sectional shape with parallel sides.

[0146] In the illustrated embodiment, a first opening 1426a and a second opening 1426b are provided at both ends of the sterilization zone 1424. The first opening 1426a is defined by an external collimator 1418, while the second opening 1426b is defined by an internal collimator 1420. The first opening 1426a is configured to allow radiation used for radiation sterilization 1412 to enter the sterilization zone 1424, and the second opening 1426b is configured to provide a position where the entered radiation 1412 can collide with the sensor 1316 and the sharp body 1318. Furthermore, in the illustrated embodiment, the second opening 1426b is also configured to function as an insertion position for receiving the sensor 1316 and the sharp body 1318 into the sterilization zone 1424.

[0147] In embodiments where the sterilization zone 1424 is conical or frustoconical, the diameter of the first opening 1426a can be larger than the diameter of the second opening 1426b. For example, in such embodiments, the size (diameter) of the first opening 1426a can be in the range of approximately 5.0 mm to approximately 16.0 mm, and the size (diameter) of the second opening 1426b can be in the range of approximately 0.5 mm to approximately 3.0 mm. However, the diameters of the first opening 1426a and the second opening 1426b can be set to be larger or smaller than the above ranges depending on the application, as long as they do not deviate from the scope of this disclosure. In practice, the diameters of the first opening 1426a and the second opening 1426b only need to be large enough to allow a sufficient dose of radiation to hit the sensor 1316 and the sharp body 1318.

[0148] In the illustrated embodiment, the inner wall of the sterilization zone 1424 (e.g., the external collimator 1418 and the internal collimator 1420) extends from the first opening 1426a to the second opening 1426b at a substantially constant angle with respect to the centerline of the sensor applicator 102. This angle of the inner wall can be any angle in the range of 0° to 90° with respect to the centerline of the sensor applicator 102. However, it may be preferable for the angle of the inner wall to be in the range of 45° to 90° with respect to the centerline of the sensor applicator 102. On the other hand, in other embodiments, the angle of the inner wall can change from the first opening 1426a to the second opening 1426b, without departing from the scope of this disclosure. In such embodiments, several portions of the inner wall can be provided that extend for short distances at different angles from adjacent portions, or the inner wall can be smoothly undulated from the first opening 1426a to the second opening 1426b.

[0149] In some embodiments, the sterilization zone 1424 defined by the external collimator 1418 and the internal collimator 1420 may have a substantially cylindrical shape, with a circular or polygonal cross-section. In such embodiments, the diameters of the first opening 1426a and the second opening 1426b may be the same, and the walls of the sterilization zone 1424 may extend substantially parallel from the first end to the second end.

[0150] In some embodiments, a cap sealing portion 1428 (shown by a dashed line in the figure) can be provided at the interface between the cap filling 1410 and the radiation shield 1416. The cap sealing portion 1428 can be made of a radiation-permeable microbial barrier. In some embodiments, for example, the cap sealing portion 1428 can be made of a synthetic material such as "Tyvek" provided by DuPont (e.g., flash-spun high-density polyethylene fiber). The cap sealing portion 1428 seals a portion of the sterilization zone 1424, and this portion contributes to forming part of a sealed area 1430. This sealed area 1430 is configured to isolate the sensor 1316 and the sharp body 1318 from external contamination.

[0151] The sealed area 1430 may include (encompass) a selected portion of the interior of the electronic component housing 1304 and the sterilization zone 1424. In one or more embodiments, the sealed area 1430 may be defined or formed by at least a cap sealing portion 1428, a first sealing portion ("upper" sealing portion) 1432a, and a second sealing portion ("bottom" sealing portion) 1432b. The cap sealing portion 1428, the upper sealing portion 1432a, and the bottom sealing portion 1432b form barriers at their respective sealing positions, thereby enabling final sterilization of the sterilization zone 1424 containing the sensor 1316 and the sharp body 1318.

[0152] The upper sealing portion 1432a can be positioned to seal the interface between the pointed hub 1320 and the upper part of the electronic component housing 1304 (i.e., the shell 1306 shown in Figure 13), thereby preventing contaminants from entering the interior of the electronic component housing 1304. In some embodiments, the upper sealing portion 1432a can be formed as part of the pointed hub 1320, for example, by overmolding on the pointed hub 1320. On the other hand, in other embodiments, the upper sealing portion 1432a can be formed as part of the shell 1306 or by overmolding on the upper surface of the shell 1306. In yet another embodiment, without departing from the scope of this disclosure, the upper sealing portion 1432a can be made of a separate structure such as an O-ring, which can be interposed between the pointed hub 1320 and the upper surface of the shell 1306.

[0153] On the other hand, the bottom seal portion 1432b can be positioned to seal the interface between the cap filler 1410 and the bottom of the electronic component housing 1304 (i.e., the mount 1308 shown in Figure 13). This bottom seal portion 1432b prevents contaminants from entering the sterilization zone 1424 and the interior of the electronic component housing 1304. In some embodiments, the bottom seal portion 1432b can be formed as part of the cap filler 1410, for example, by overmolding onto the cap filler 1410. On the other hand, in other embodiments, the bottom seal portion 1432b can be formed as part of the mount 1308 or by overmolding onto the bottom of the mount 1308. In yet another embodiment, without departing from the scope of this disclosure, the bottom seal portion 1432b can be made of a separate structure such as an O-ring, which can be interposed between the cap filler 1410 and the bottom of the mount 1308.

[0154] When the sensor control device 1302 is loaded into the sensor applicator 102 and the applicator cap 1404 is attached to the sensor applicator 102, the upper sealing portion 1432a and the lower sealing portion 1432b are compressed, and the corresponding interfaces can be sealed. The upper sealing portion 1432a and the lower sealing portion 1432b can be made of various materials that have the function of sealing the interface between opposing structures with themselves in between. Suitable materials for the upper sealing portion 1432a and the lower sealing portion 1432b include, but are not limited to, silicone, thermoplastic elastomer (TPE), polytetrafluoroethylene (e.g., "TEFLON"), or any combination thereof.

[0155] It should be noted that while the sensor 1316 and the pointed body 1318 are configured to extend from the bottom of the electronic component housing 1304 and within a sterilization zone 1424 that extends substantially concentrically with the sensor applicator 102 and the applicator cap 1404, this specification also intends to include configurations with eccentric arrangements. More specifically, in at least one embodiment, the sensor 1316 and the pointed body 1318 can be configured to extend from the bottom of the electronic component housing 1304 in an eccentric arrangement from the centerline of the sensor applicator 102 and the applicator cap 1404. In such an embodiment, without departing from the scope of this disclosure, the sterilization zone 1424 can also be configured with an eccentric arrangement to accommodate the sensor 1316 and the pointed body 1318 by modifying the design of the external collimator 1418 and the internal collimator 1420, etc.

[0156] In some embodiments, the external sterilization assembly 1414 may further comprise a sterilization housing or sterilization "pod" 1434 coupled to or forming part of the radiation shield 1416. The sterilization pod 1434 is provided with or defined a chamber 1436. The size of this chamber 1436 is set to accommodate all or part of the sensor applicator 102. After the sensor applicator 102 is properly positioned (received) within the sterilization pod 1434, the sensor applicator 102 can be subjected to radiation sterilization 1412 to sterilize the sensor 1316 and the sharp body 1318. The sterilization pod 1434 may be constructed of any of the materials listed above as materials for the radiation shield 1416 to help prevent the radiation used in radiation sterilization 1412 from propagating through the walls of the sterilization pod 1434.

[0157] In some embodiments, the radiation shield 1416 can be detachably attached to the sterilization pod 1434 using one or more (one in the illustration) mechanical fasteners 1438, but instead, it can be detachably attached by a tight fit, snap-fit ​​engagement, or the like. By configuring the radiation shield 1416 to be detachably attached to the sterilization pod 1434, the radiation shield 1416 can be made replaceable, allowing it to be swapped with a shield of a different design (size) to suit specific sterilization applications depending on the type and design of the sensor applicator 102. Therefore, the sterilization pod 1434 may be equipped with a general-purpose mount configured to allow the radiation shield 1416 to be replaced with other shield designs with different parameters related to the external collimator 1418, as needed.

[0158] In some embodiments, the external sterilization assembly 1414 can further include a mounting tray 1440 that is coupled to or forms part of the sterilization pod 1434. The sterilization pod 1434 can be removably coupled to the mounting tray 1440 using one or more (one in the illustrated example) mechanical fasteners 1442. The mounting tray 1440 can be provided or defined with a central opening 1444. The central opening 1444 is sized to receive the sensor applicator 102 and is configured to be aligned with the chamber 1436. Such a configuration allows the sensor applicator 102 to be inserted from the central opening 1444 into the chamber 1436. Also, as will be described later, in some embodiments, by defining a plurality of central openings 1444 in the mounting tray 1440, a configuration can be provided that can receive a plurality of sensor applicators and perform sterilization processing on them.

[0159] FIG. 15 is a side cross-sectional view showing another exemplary embodiment of the sensor applicator 102 and the external sterilization assembly 1414 according to one or more additional embodiments. As illustrated, the sensor control device 1302 is also received within the sensor applicator 102 in this embodiment, and by coupling the applicator cap 1404 to the housing 1402, the sensor control device 1302 is fixed within the housing 1402.

[0160] In the illustrated embodiment, the applicator cap 1404 can be positioned upside down, and a cap post 1502 can be provided by definition or other means. The size of this cap post 1502 is set to accommodate the distal end of the sensor 1316 and the distal end of the sharp body 1318 extending from the bottom of the electronic component housing 1304. The cap post 1502 contributes to the formation of a part of a sealed region 1430 configured to isolate the sensor 1316 and the sharp body 1318 from external contamination. In the illustrated embodiment, the sealed region 1430 can be defined or formed by the cap post 1502, an upper sealing portion 1432a, and a bottom sealing portion 1432b. The upper sealing portion 1432a and the bottom sealing portion 1432b can form a barrier at their respective sealing positions. In this embodiment as well, the upper sealing portion 1432a can be arranged to seal the interface between the pointed hub 1320 and the upper part of the electronic component housing 1304 (i.e., the shell 1306 shown in Figure 13), while the bottom sealing portion 1432b can be arranged to seal the interface between the applicator cap 1404 and the bottom of the electronic component housing 1304 (i.e., the mount 1308 shown in Figure 13). In some embodiments, the bottom sealing portion 1432b can be interposed between the cap post 1502 and the bottom of the electronic component housing 1304.

[0161] In the illustrated embodiment, the radiation shield 1416 can be positioned outside the sensor applicator 102 and extend into the portion (inverted shape) of the applicator cap 1404 that protrudes in the opposite direction. The radiation shield 1416 is provided with an external collimator 1418, which defines a sterilization zone 1504 configured to focus the radiation used for radiation sterilization 1412 toward the sensor 1316 and the sharp body 1318. In the illustrated embodiment, the cap post 1502 and the respective parts of the sensor 1316 and the sharp body 1318 positioned within the cap post 1502 extend into the sterilization zone 1504. The radiation used for radiation sterilization 1412 propagates through the sterilization zone 1504, sterilizing the sensor 1316 and the sharp body 1318 positioned within the cap post 1502. As mentioned above, the radiation shield 1416 can be made of a material that substantially prevents the transmission of radiation used in radiation sterilization 1412, so as not to penetrate the walls of the sterilization zone 1504 and damage radiation-sensitive components 1408 inside the housing 1304.

[0162] In the illustrated embodiment, the external collimator 1418 defines a first opening 1506a at the first end of the sterilization zone 1504 and a second opening 1506b at the second end of the sterilization zone 1504. The first opening 1506a is configured to allow radiation used for radiation sterilization 1412 to enter the sterilization zone 1504, and the second opening 1506b is configured to provide a position where the entered radiation 1412 is focused toward the sensor 1316 and the sharp body 1318. Furthermore, the second opening 1506b is configured to also function as an insertion position for receiving the sensor 1316 and the sharp body 1318, which are located within the cap post 1502, into the sterilization zone 1504.

[0163] As shown in the figure, the shape of the external collimator 1418 and the associated sterilization zone 1504 is conical or frustoconical, and the diameter of the first opening 1506a is larger than the diameter of the second opening 1506b. The size (diameter) of the first opening 1506a can be in the range of approximately 5.0 mm to approximately 16.0 mm, and the size (diameter) of the second opening 1506b can be in the range of approximately 0.5 mm to approximately 3.0 mm. Alternatively, the diameters of the first opening 1506a and the second opening 1506b can be set to be larger or smaller than the above ranges, as long as they do not deviate from the scope of this disclosure. In practice, the sizes of the openings 1506a and 1506b can be changed according to the scale of the device. On the other hand, in other embodiments, the external collimator 1418 and the associated sterilization zone 1504 may have a substantially cylindrical shape, with a circular or polygonal cross-sectional shape. In this case, the diameters of the first opening 1506a and the second opening 1506b are substantially the same, and the walls of the sterilization zone 1504 can be configured to extend substantially parallel to each other.

[0164] Figure 16 is a side cross-sectional view showing another exemplary embodiment of the sensor applicator 102 and the external sterilization assembly 1414 according to one or more additional embodiments. As shown, the sensor control device 1302 is also housed within the sensor applicator 102 in this embodiment, and the sensor control device 1302 is fixed within the housing 1402 by coupling the applicator cap 1404 to the housing 1402.

[0165] In this illustrated embodiment, the applicator cap 1404 can be positioned upside down, and the cap post 1602 can be provided by definition or the like. The size of the cap post 1602 is set to accommodate the distal end of the sensor 1316 and the distal end of the sharp body 1318 extending from the bottom of the electronic component housing 1304. Furthermore, the radiation shield 1416 can be positioned outside the sensor applicator 102 and extend into the portion (inverted shape) of the applicator cap 1404 that protrudes in the opposite direction. More specifically, the radiation shield 1416 can extend into the inverted shape of the applicator cap 1404 and extend to the bottom of the cap post 1602. However, unlike the cap post 1502 shown in Figure 15, the bottom of the cap post 1602 can be an open end. In some embodiments, a cap sealing portion 1604 can be provided at the interface between the cap post 1602 and the radiation shield 1416 to seal the open end of the cap post 1602. The cap sealing portion 1604 can be the same as the cap sealing portion 1428 shown in Figure 14B, and therefore its description is omitted here.

[0166] In some embodiments, the cap filler 1606 can be placed inside the applicator cap 1404. In one or more embodiments, the cap filler 1606 can be configured as an integral part (extension) with the applicator cap 1404, for example, by molding it integrally with the applicator cap 1404 or by overmolding it onto the applicator cap 1404. In other embodiments, without departing from the scope of this disclosure, the cap filler 1606 can be configured as a separate structure from the applicator cap 1404 and fitted or attached inside the applicator cap 1404. An internal collimator 1608 can be provided or defined in the cap filler 1606. The internal collimator 1608 is configured to contribute to focusing the radiation used for radiation sterilization 1412 toward the component to be sterilized. In at least one embodiment, as shown, the cap post 1602 can be received inside the internal collimator 1608.

[0167] The external collimator 1418 and the internal collimator 1608 work together to define a sterilization zone 1610 that focuses the radiation used for radiation sterilization 1412 toward the sensor 1316 and the sharp body 1318. The radiation used for radiation sterilization 1412 propagates through the sterilization zone 1610 and collides with the sensor 1316 and the sharp body 1318, thereby sterilizing them. However, to prevent the radiation used for radiation sterilization 1412 from penetrating the inner wall of the sterilization zone 1610 and damaging radiation-sensitive components 1408 inside the housing 1304, both the cap filler 1606 and the radiation shield 1416 can be made of any of the materials listed above as materials that substantially prevent the transmission of said radiation. In at least one embodiment, the cap filler 1606 can be made of a machined or 3D printed part of polypropylene, and the radiation shield 1416 can be made of stainless steel.

[0168] The external collimator 1418 and the internal collimator 1608 can have any appropriate cross-sectional shape necessary to properly focus the radiation used for radiation sterilization 1412 toward the sensor 1316 and the sharp body 1318 for sterilization. For example, in the illustrated embodiment, the external collimator 1418 is conical or frustoconical in shape, and the internal collimator 1608 is substantially cylindrical in shape with substantially parallel inner walls. On the other hand, in other embodiments, the cross-sectional shapes of the external collimator 1418 and the internal collimator 1608 can be configured to have other shapes, as long as they do not depart from the scope of this disclosure.

[0169] In the illustrated embodiment, an external collimator 1418 defines a first opening 1612a and a second opening 1612b. The first opening 1612a is configured to allow the radiation used for radiation sterilization 1412 to enter the sterilization zone 1610, while the second opening 1612b is located at or near the bottom opening of the cap post 1602 and is configured to focus the radiation used for radiation sterilization 1412 toward the sensor 1316 and the sharp body 1318 located inside the cap post 1602. The diameter of the first opening 1612a is larger than the diameter of the second opening 1612b, and, as in the embodiment described above, the size (diameter) of the first opening 1612a can be in the range of approximately 5.0 mm to approximately 16.0 mm, and the size (diameter) of the second opening 1612b can be in the range of approximately 0.5 mm to approximately 3.0 mm. In the illustrated embodiment, the external collimator 1418 is configured to guide electrons from radiation 1412 in a funnel shape to the bottom opening of the cap post 1602, thereby increasing the number of electrons that reach the sensor 1316 and the sharp body 1318.

[0170] The cap sealing portion 1604 can be positioned at the interface between the radiation shield 1416 and the cap post 1602, at the interface between the radiation shield 1416 and the cap filler 1606, or at both interfaces. The cap sealing portion 1604 seals a portion of the sterilization zone 1610, contributing to the formation of a sealed area 1430. This sealed area 1430 is configured to isolate the sensor 1316 and the sharp body 1318 from external contamination. The sealed area 1430 may include (contain) a selected portion of the interior of the electronic component housing 1304 and the sterilization zone 1610. In the illustrated embodiment, the sealed area 1430 can be defined or formed by the cap post 1602, an upper sealing portion 1432a, and a bottom sealing portion 1432b. The upper sealing portion 1432a and the bottom sealing portion 1432b can form barriers at their respective sealing positions. Furthermore, the bottom sealing portion 1432b can be arranged to seal the interface between the applicator cap 1404 and the bottom of the electronic component housing 1304 (i.e., the mount 1308 shown in Figure 13).

[0171] Figures 17A and 17B are partially exploded views showing an example of an external sterilization assembly 1414 according to one or more embodiments, where Figure 17A is an isometric top view and Figure 17B is an isometric bottom view. In at least one embodiment, the assembly 1414 can be designed or configured to accommodate a plurality of sensor applicators 102 (with sensor control devices arranged inside) and to support their sterilization process. In the illustrated embodiment, a plurality of central openings 1444 (Figure 17A) are defined in the mounting tray 1440, and a plurality of sterilization pods 1434 can be coupled to the mounting tray 1440 in alignment with these central openings 1444. The sensor applicators 102 can then be received into the sterilization pods 1434 through these central openings 1444. Each sterilization pod 1434 may be equipped with a shielding body 1416 (Figure 17B), and the shielding body 1416 can be configured as part of the corresponding sterilization pod 1434 by coupling or other means.

[0172] In some embodiments, the assembly 1414 may further include a cover 1702 configured to fit onto a mounting tray 1440. The cover 1702 may have or define a number of openings 1704 (Figure 17B). The size of these openings 1704 is set so that when the cover 1702 is placed on the mounting tray 1440, the top of each sensor applicator 102 is received within each opening 1704. In some embodiments, the cover 1702 may also be made of one of the materials listed above as materials for the radiation shield 1416 to help prevent radiation used for radiation sterilization from propagating through the walls of the assembly 1414. By fitting the cover 1702 onto the mounting tray 1440, the sensor applicators 102 can be sealed or enclosed within the assembly 1414.

[0173] Embodiments disclosed herein include the following:

[0174] Embodiment D An external sterilization assembly comprising a radiation shield and a collimator defined by the radiation shield. The radiation shield is configured to be positioned outside a medical device having sterilization parts and radiation-sensitive components, and the collimator is configured to be alignable with the sterilization parts, with the collimator focusing the radiation used in the radiation sterilization process toward the sterilization parts, while the radiation shield prevents radiation from damaging radiation-sensitive components.

[0175] Embodiment E An external sterilization assembly comprising a radiation shield configured to be positioned outside a sensor applicator. The sensor applicator comprises a housing, a cap coupled to the housing, and a sensor control device positioned within the housing. The sensor control device comprises an electronic component housing, radiation-sensitive components disposed within the electronic component housing, and a sensor and a sharp body extending from the electronic component housing. The external sterilization assembly further comprises an external collimator defined by the radiation shield. The external collimator is configured to be alignable with the sensor and the sharp body, and the external collimator focuses the radiation used for radiation sterilization toward the sensor and the sharp body, while the radiation shield prevents radiation from damaging the radiation-sensitive components.

[0176] Embodiment F A method comprising the step of arranging a radiation shield outside a sensor applicator. The sensor applicator comprises a housing, a cap coupled to the housing, and a sensor control device disposed within the housing. The sensor control device comprises an electronic component housing, radiation-sensitive components disposed within the electronic component housing, and a sensor and a sharp body extending from the electronic component housing. The method further comprises the steps of focusing radiation used for radiation sterilization toward the sensor and the sharp body using an external collimator defined by the radiation shield, and preventing radiation damage to the radiation-sensitive components by the radiation shield.

[0177] Furthermore, each embodiment of embodiments D, E, and F may include one or more of the following additional elements in any combination: [Element 1] The radiation shield is composed of a material selected from the group consisting of high-density polymers, metals, and any combination thereof. [Element 2] The radiation-sensitive components are selected from the group consisting of electronic component modules, chemical solutions, and any combination thereof. [Element 3] The cross-sectional shape of the collimator is selected from the group consisting of shapes corresponding to cones, frustums of cones, pyramids, and cubes, circles, rectangles, and any combination thereof. [Element 4] The medical device further includes a cap that encloses sterilizable components and acts as a sealing barrier. [Element 5] The radiation shield has an internal cavity for receiving a medical device, and the collimator focuses the radiation into the internal cavity.

[0178] [Element 6] The radiation shield is composed of a material selected from the group consisting of high-density polymers, metals, and any combination thereof. [Element 7] The cross-sectional shape of the external collimator is selected from the group consisting of shapes corresponding to cones, frustums of cones, pyramids, and cubes, circles, rectangles, and any combination thereof. [Element 8] The external sterilization assembly further comprises a sterilization pod defining a chamber for receiving at least a portion of the sensor applicator, and a radiation shield is detachably coupled to the sterilization pod. [Element 9] The external sterilization assembly further comprises a mounting tray defining a central opening and a cover configured to fit onto the mounting tray, wherein the central opening is sized to accommodate a sensor applicator and is configured to be alignable with the chamber, and the sensor applicator is sealed by fitting the cover onto the mounting tray. [Element 10] An external collimator is configured to be alignable with an internal collimator defined by a cap filler placed inside the cap, and the external and internal collimators cooperate to define a sterilization zone, into which a sensor and a sharp object are received. [Element 11] The cross-sectional shapes of the external and internal collimators are selected from the group consisting of shapes corresponding to cones, frustums of cones, pyramids, and cubes, circles, rectangles, and any combination thereof. [Element 12] The external sterilization assembly further comprises a cap sealing portion disposed at the interface between the external collimator and the internal collimator. [Element 13] The cap is installed in an inverted position, and a cap post for receiving the sensor and the sharp object is provided on the cap. [Element 14] The external collimator and the cap post work together to define the sterilization zone, and the sensor and sharpened body located inside the cap post extend into the sterilization zone.

[0179] [Element 15] The step of arranging a radiation shield outside the sensor applicator includes the step of arranging the sensor applicator in a chamber defined by a sterile pod, wherein the radiation shield is detachably coupled to the sterile pod. [Element 16] The step of placing a sensor applicator in a chamber defined by a sterilization pod further includes: passing the sensor applicator through a central opening defined by a mounting tray, which is configured to be alignable with the chamber; sealing the sensor applicator by placing a cover on the mounting tray; and performing radiation sterilization while the sensor applicator is sealed in the cover. [Element 17] The cross-sectional shape of the external collimator is selected from the group consisting of shapes corresponding to cones, frustums of cones, pyramids, and cubes, circles, rectangles, and any combination thereof.

[0180] Examples of exemplary combinations of elements applicable to embodiments D, E, and F include the combination of element 8 and element 9, the combination of element 10 and element 11, the combination of element 10 and element 12, the combination of element 13 and element 14, and the combination of element 15 and element 16.

[0181] Hybrid sterilization assembly Referring back to Figure 1, the sensor control device 104 needs to be sterilized to ensure that no living microorganisms are present before it is delivered to the end user. Generally, the sensor 110 is sterilized by radiation sterilization, such as electron beam irradiation. However, since radiation sterilization may damage the electronic components within the sensor control device 104, these electronic components are generally sterilized by chemical gas sterilization (for example, sterilization using ethylene oxide). However, chemical gas sterilization may damage enzymes and other chemical substances and biological materials contained on the sensor 110.

[0182] Thus, the problem of incompatibility in sterilization methods between the sensor 110 and the electronic components has conventionally been avoided by separating the sensor 110 and the electronic components and sterilizing each individually. However, this method increases the number of required parts, packages, and processes, and since the final assembly work must be performed by the user, there is a risk of human error by the user. According to this disclosure, any device requiring final sterilization, such as the sensor control device 104, can be properly sterilized by using an external sterilization assembly. This external sterilization assembly is designed to focus sterilization radiation (e.g., beam, wave, energy, etc.) toward the components that require sterilization, while simultaneously preventing delicate electronic components from being affected or damaged by the propagation of said radiation.

[0183] Figure 18 is an isometric view showing an example of a sensor control device 1802 according to one or more embodiments of the present disclosure. The sensor control device 1802 can be the same as or similar to the sensor control device 104 shown in Figure 1. Therefore, by using the sensor control device 1802 in combination with the sensor applicator 102 (Figure 1), the sensor control device 1802 can be delivered to a predetermined monitoring location on the user's skin. Therefore, the sensor control device 1802 may also need to be properly sterilized before use.

[0184] As shown in the figure, the sensor control device 1802 comprises an electronic component housing 1804. The electronic component housing 1804 is substantially disc-shaped and may have a circular cross-sectional shape. On the other hand, in other embodiments, without departing from the scope of the present disclosure, the cross-sectional shape of the electronic component housing 1804 may be other shapes such as oval (e.g., tablet-shaped or egg-shaped), squircle-shaped, polygonal, or any combination thereof. The electronic component housing 1804 may be configured to house or enclose various electronic components for operating the sensor control device 1802.

[0185] The electronic component housing 1804 may comprise a shell 1806 and a mount 1808 configured to fit into the shell 1806. The shell 1806 can be secured to the mount 1808 by various methods, such as snap-fit ​​engagement, interlocking fit, ultrasonic welding, laser welding, one or more mechanical fasteners (e.g., screws), or any combination thereof. In some cases, securing the shell 1806 to the mount 1808 can form a sealing interface between them. In such embodiments, a sealing material of the type of gasket can be placed on or near the outer diameter (periphery) of the shell 1806 and the mount 1808. In this case, when the shell 1806 and the mount 1808 are secured to each other, the gasket is compressed, forming a sealing interface. In other embodiments, an adhesive can be applied to the outer diameter (periphery) of one or both of the shell 1806 and the mount 1808. The shell 1806 is fixed to the mount 1808 by adhesive, thereby providing structural integrity and sealing the interface between the two, which isolates the inside of the electronic component housing 1804 from external contamination.

[0186] In the illustrated embodiment, the sensor control device 1802 may optionally include a plug assembly 1810 that can be coupled to an electronic component housing 1804. The plug assembly 1810 may include a sensor module 1812 (partially illustrated) that can be interconnected with a pointed body module 1814 (partially illustrated). The sensor module 1812 may be configured to carry or have a sensor 1816 (partially illustrated), and the pointed body module 1814 may be configured to carry or have a introducer or pointed body 1818 (partially illustrated). The pointed body 1818 may be configured to assist in the transcutaneous delivery of the sensor 1816 to the subcutaneous tissue of the user when the sensor control device 1802 is attached. In the illustrated embodiment, the pointed body module 1814 includes a pointed body hub 1820 that carries the pointed body 1818.

[0187] As shown in the figure, a portion of the sensor 1816 and a corresponding portion of the pointed body 1818 extend distally from the electronic component housing 1804, more specifically from the bottom of the mount 1808. In at least one embodiment, the exposed portion of the sensor 1816 (also called the "tail") can be housed within the hollow or recessed portion of the pointed body 1818. The other portion of the sensor 1816, on the other hand, is located inside the electronic component housing 1804.

[0188] Figure 19A is a side view of the sensor applicator 102 shown in Figure 1. As shown, the sensor applicator 102 comprises a housing 1902 and an applicator cap 1904 detachably coupled to the housing 1902. In some embodiments, the applicator cap 1904 is screwed onto the housing 1902 and may include a tamper-evident ring 1906. When the applicator cap 1904 is rotated relative to the housing 1902 (for example, by twisting it off), the tamper-evident ring 1906 is sheared, and the applicator cap 1904 can be removed from the sensor applicator 102. After removing the applicator cap 1904, the user can use the sensor applicator 102 to position the sensor control device 1802 (Figure 18) at a predetermined monitoring position on their body.

[0189] Figure 19B is a partial side cross-sectional view showing a portion of the sensor applicator 102. As shown, the sensor control device 1802 can be housed within the sensor applicator 102, and the sensor control device 1802 can be fixed within the applicator cap 1904 by coupling the applicator cap 1904 to the housing 1902. The sensor control device 1802 may comprise one or more radiation-sensitive components 1908, which are housed within the electronic component housing 1804. The radiation-sensitive components 1908 may comprise electronic components or electronic component modules. Such electronic components or electronic component modules may include, but are not limited to, data processing units, resistors, transistors, capacitors, inductors, diodes, switches, or any combination thereof. The data processing unit may comprise, for example, an application-specific integrated circuit (ASIC) configured to implement one or more functions or routines associated with the operation of the sensor control device 1802. During operation, the data processing unit can perform data processing functions such as filtering and encoding each data signal corresponding to the values ​​of the test substance collected from the user. Furthermore, the data processing unit may be configured to include an antenna for communicating with the reading device 106 (Figure 1), or may be configured to be able to communicate with such an antenna.

[0190] In the illustrated embodiment, the applicator insert 1910 is positioned within the applicator cap 1904. Typically, the applicator insert 1910 can be configured to assist in supporting the sensor control device 1802 within the sensor applicator 102. In one embodiment, the applicator insert 1910 can be configured as an integral part (extension) with the applicator cap 1904, for example, by molding it integrally with the applicator cap 1904 or by overmolding it onto the applicator cap 1904. In other embodiments, without departing from the scope of this disclosure, the applicator insert 1910 can be configured as a separate structure from the applicator cap 1904 and fitted or attached within the applicator cap 1904. In this embodiment, for example, by screwing the applicator cap 1904 into the housing 1902, the inner surface 1912 of the applicator insert 1910 gradually advances and engages with the bottom edge, bottom surface, or bottom of the applicator insert 1910 in the axial and / or radial directions. This makes it possible to fix the applicator insert 1910 in the axial direction within the applicator cap 1904.

[0191] The sensor applicator 102 may further include a sheath 1914. In some embodiments, the applicator insert 1910 can be fixed in place within the applicator cap 1904 by engaging it with the sheath 1914, preventing rotation. More specifically, the applicator insert 1910 may have or define one or more (one in the illustration) radial alignment shapes 1916. These radial alignment shapes 1916 are configured to fit into corresponding grooves (slots) 1918 defined in the sheath 1914. The radial alignment shapes 1916 may consist of, for example, rails, flag-shaped parts, tabs, or projections extending from the body of the applicator insert 1910, and can be fitted into the slot 1918 by, for example, sliding the radial alignment shapes 1916 longitudinally into the slot 1918. Furthermore, the mating engagement between the radial alignment shape portion 1916 and the slot 1918 makes it possible to align the angular position (direction of rotation) of the applicator insert 1910 with the correct position relative to the sensor control device 1802. However, as will be understood by those skilled in the art, it is also possible to configure the mating structure in the opposite way to the above, with the radial alignment shape portion 1916 provided on the sheath 1914 side and the slot 1918 on the applicator insert 1910 side.

[0192] The applicator insert 1910 may be provided with or defined an internal collimator 1920a, which constitutes part of the hybrid sterilization assembly. Details of the hybrid sterilization assembly will be described later. The internal collimator 1920a can contribute to defining part of the sterilization zone 1922, more specifically, the upper portion 1924 of the sterilization zone 1922. When the sensor control device 1802 is mounted inside the sensor applicator 102, the distal end of the sensor 1816 and the distal end of the pointed body 1818 can be configured to extend from the bottom of the electronic component housing 1804 and fit within the upper portion 1924.

[0193] In some embodiments, a microbial barrier 1926a can be placed in an opening leading to the upper portion 1924 of the sterilization zone 1922. The microbial barrier 1926a contributes to sealing at least a portion of the upper portion 1924 of the sterilization zone 1922, thereby isolating the distal end of the sensor 1816 and the distal end of the sharp body 1818 from external contamination. The microbial barrier 1926a can be made of a radiation-permeable material, such as a synthetic material (e.g., flash-spun high-density polyethylene fiber). An example of such a synthetic material is "Tyvek" provided by DuPont. In other embodiments, the microbial barrier 1926a may be made of tape, paper, film, foil, or any combination thereof, but is not limited thereto. In at least one embodiment, without departing from the scope of this disclosure, the microbial barrier 1926a may be made of or formed by a thin portion of the applicator insert 1910.

[0194] In some embodiments, a moisture barrier 1926b may be provided at the opening 1928 leading to the applicator cap 1904. Similar to the microbial barrier 1926a, the moisture barrier 1926b may also be configured to help isolate a portion of the sensor applicator 102 from external contamination. The moisture barrier 1926b may be made of any of the materials listed in the description of the microbial barrier 1926a above. However, in at least one embodiment, the moisture barrier 1926b may also be made of a thin portion of the applicator cap 1904, without departing the scope of this disclosure. In such an embodiment, it is not necessary to provide the opening 1928.

[0195] Figures 20A to 20C show an applicator insert 1910 from different directions according to one or more embodiments of the present disclosure. More specifically, Figure 20A is an isometric top view of the applicator insert 1910, Figure 20B is an isometric bottom view thereof, and Figure 20C is an isometric cross-sectional view thereof. As shown, the applicator insert 1910 comprises a substantially cylindrical body 2002, the body 2002 having a first end (upper end) 2004a and a second end (lower end) 2004b located opposite the upper end 2004a. The upper end 2004a is configured to be generally closed except for an opening 2005, and the lower end 2004b is configured to be generally open. The size of the opening 2005 is set so that a sensor 1816 (Figure 19B) and a sharp body 1818 (Figure 19B) can pass through it.

[0196] The radial alignment shape 1916 described above is provided on the side wall of the main body 2002. In some embodiments, additional radial alignment shapes 2006 (three in the illustration) may be provided or defined on the side wall of the main body 2002. In the illustrated embodiments, each of these additional radial alignment shapes 2006 comprises a pair of longitudinally extending tabs (projections) 2008. This pair of projections 2008 is provided on the side wall at mutually offset angular positions and is configured to define a slot 2010 between these projections 2008. The size of the slot 2010 is set to accommodate the projections (tabs) provided on the sheath 1914 (Figure 19B), thereby contributing to aligning the angular position (orientation in the rotational direction) of the applicator insert 1910 with the correct position relative to the sensor control device 1802 (Figure 19B). Furthermore, similar to the arrangement configuration of the radial alignment shape portion 1916 described above, it is also possible to configure the matable structure of these additional radial alignment shape portions 2006 in the opposite configuration to that described above, with the additional radial alignment shape portion 2006 provided on the sheath 1914 side and the corresponding projection (tab) provided on the applicator insert 1910 side.

[0197] As most clearly shown in Figures 20A and 20C, the applicator insert 1910 may further comprise one or more sensor positioning shapes 2012. The sensor positioning shapes 2012 can also be used to align the orientation of the applicator insert 1910 with respect to the sensor control device 1802 (Figure 19B) within the sensor applicator 102 (Figure 19B). As shown, the sensor positioning shape 2012 can be defined on the upper end portion 2004a of the main body 2002 and extend axially from there. The size of the sensor positioning shape 2012 can be set to fit into a corresponding opening provided at the bottom of the sensor control device 1802. In the illustrated embodiment, the sensor positioning shape 2012 is composed of a cylindrical projection, but it can also be composed of other types of structural shapes suitable for mating with the corresponding shape provided at the bottom of the sensor control device 1802. In an embodiment in which the sensor control device 1802 has an eccentric configuration, and the sensor 1816 and the pointed body 1818 are provided in an eccentric arrangement from the center line of the sensor control device 1802, a configuration using the sensor positioning shape portion 2012 in conjunction with the radial alignment shape portion 1916 and the additional radial alignment shape portion 2006 is particularly advantageous.

[0198] The internal collimator 1920a can be formed or provided on the upper end 2004a of the applicator insert 1910. As most clearly shown in Figure 20C, the internal collimator 1920a can be defined by the applicator insert 1910 and comprise a collimating insert 2014 and a gasket 2016. The fabrication of the internal collimator 1920a can begin with the fabrication or manufacture of the collimating insert 2014. Next, the applicator insert 1910 can be overmolded onto this collimating insert 2014. Alternatively, the collimating insert 2014 may be insert-molded inside the applicator insert 1910. Therefore, the applicator insert 1910 can be made of rigid plastic. Next, in a second injection molding (overmolding) step, the gasket 2016 can be molded onto the applicator insert 1910.

[0199] The collimating insert 2014 can be made of a material that reduces or prevents the transmission of sterilization radiation. Suitable materials for the collimating insert 2014 include, but are not limited to, high-density polymers (e.g., polyethylene, polypropylene, polystyrene, polytetrafluoroethylene, polyamide, etc.), metals (e.g., lead, tungsten, stainless steel, aluminum, etc.), composite materials, or any combination thereof. In some embodiments, the collimating insert 2014 can be made of any material with a mass density greater than 0.9 grams per cubic centimeter (g / cc).

[0200] The gasket 2016 can be made of any material that contributes to forming a sealing interface between the gasket 2016 and the bottom of the electronic component housing 1804 (Figure 19B) when the applicator insert 1910 is installed in the sensor applicator 102 (Figure 19B). Suitable materials for the gasket 2016 include, but are not limited to, silicone, thermoplastic elastomer (TPE), polytetrafluoroethylene (e.g., "TEFLON"), or any combination thereof. As shown in the figure, the gasket 2016 can fill the void 2018 defined by the applicator insert 1910 and provide an annular projection 2020. The annular projection 2020 can be configured to protrude above the upper surface of the upper end portion 2004a of the main body 2002, and / or to protrude from the upper surface of the upper end portion 2004a. The annular projection 2020 not only contributes to the formation of a sealing interface, but also has the advantage of contributing to the absorption of gaps caused by tolerances when the applicator insert 1910 is installed inside the sensor applicator 102. Furthermore, since the mass of the gasket 2016 also contributes to the absorption of radiation used in the sterilization process described later, it can also function as an additional protective layer to suppress the propagation of radiation. In at least one embodiment, the collimating insert 2014 can be omitted from the internal collimator 1920a if the gasket 2016 is made of a size or material that provides sufficient radiation absorption.

[0201] Figure 21 is another side cross-sectional view of the sensor applicator 102 shown in Figure 19A, according to one or more embodiments of the present disclosure, and shows a hybrid sterilization assembly 2102. The hybrid sterilization assembly 2102 (also called a “separable collimated assembly” or “collaborative collimated assembly”) can be used to assist in the sterilization of the sensor control device 1802, which is located within the sensor applicator 102, and more specifically, the distal end of the sensor 1816 and the distal end of the sharp body 1818 extending from the bottom of the electronic component housing 1804. More specifically, the exposed parts of the sensor 1816 and the sharp body 1818 can be sterilized by radiation sterilization 2104 of the assembled sensor control device 1802. Suitable radiation sterilization 2104 treatments include, but are not limited to, electron beam irradiation, gamma ray irradiation, X-ray irradiation, or any combination thereof.

[0202] Radiation sterilization 2104 can be performed by either continuous irradiation or pulsed beam irradiation. In pulsed beam irradiation, the beam for radiation sterilization 2104 is focused to a predetermined target position, and the component or device to be sterilized is moved to this target position. Then, radiation pulses are applied and irradiation is performed in this state. After that, radiation sterilization 2104 is stopped, and the next component or device to be sterilized is moved to the target position, and the same process is repeated.

[0203] According to this disclosure, the hybrid sterilization assembly 2102 helps to focus the radiation 2104 when sterilizing the distal end of the sensor 1816 and the distal end of the sharp body 1818, while simultaneously preventing (blocking) radiation-sensitive components 1908 from being affected by the propagation of radiation 2104. As shown in the figure, the hybrid sterilization assembly 2102 (hereinafter, "assembly 2102") may include the internal collimator 1920a and the external collimator 1920b described above. As shown in the figure, the internal collimator 1920a may be disposed within the sensor applicator 102, while the external collimator 1920b may extend into the sensor applicator 102 (i.e., the applicator cap 1904) through an opening 1928 leading to the applicator cap 1904. These internal collimators 1920a and external collimators 1920b can work together to define a sterilization zone 1922, and the radiation 2104 (e.g., beam, wave, energy, etc.) focused by the sterilization zone 1922 can collide with the sensor 1816 and the sharp body 1818 to sterilize them.

[0204] In the illustrated embodiment, the external collimator 1920b is designed to align with the internal collimator 1920a, more specifically, with the collimating insert 2014. In at least one embodiment, for example, the collimating insert 2014 can define a radial shoulder 2106. The size of the radial shoulder 2106 is set to receive or fit with the end of the external collimator 1920b extending into the applicator cap 1904. At the position of this radial shoulder 2106, a transition from the external collimator 1920b to the internal collimator 1920a is possible. In some embodiments, the transition from the internal collimator 1920a to the external collimator 1920b can be continuous (smooth, without surface irregularities). On the other hand, in other embodiments, without departing from the scope of the present disclosure, this transition can be discontinuous (stepped).

[0205] Similar to the collimating insert 2014 of the internal collimator 1920a, the external collimator 1920b can also be constructed of a material that substantially prevents the transmission of radiation used in radiation sterilization 2104, so as not to penetrate the inner wall of the sterilization zone 1922 and damage radiation-sensitive components 1908 within the electronic component housing 1804. Therefore, the external collimator 1920b can be constructed of any of the materials listed herein as suitable for the collimating insert 2014. In at least one embodiment, both the collimating insert 2014 and the external collimator 1920b can be constructed of stainless steel. As mentioned above, shielding or protection to suppress radiation damage to radiation-sensitive components 1908 can also be obtained to some extent by the gasket 2016.

[0206] The sterilization zone 1922 defined by the internal collimator 1920a and the external collimator 1920b can have any suitable cross-sectional shape necessary to properly focus the radiation used for radiation sterilization 2104 onto the sensor 1816 and the sharp body 1818 for sterilization. For example, in the illustrated embodiment, both the internal collimator 1920a and the external collimator 1920b are conical or frustoconical in shape. On the other hand, in other embodiments, without departing from the scope of this disclosure, the cross-sectional shape of one or both of the internal collimator 1920a and the external collimator 1920b can be a polygon, such as a square (corresponding to a cubic structure), a rectangle (e.g., a parallelogram), or a pyramidal structure. In yet another embodiment, one or both of the internal collimator 1920a and the external collimator 1920b can have a circular cross-sectional shape with parallel sides.

[0207] In the illustrated embodiment, a first opening 2108a and a second opening 2108b are provided at both ends of the sterilization zone 1922. The first opening 2108a is defined by an external collimator 1920b, while the second opening 2108b is defined by an internal collimator 1920a. The first opening 2108a is configured to allow radiation used for radiation sterilization 2104 to enter the sterilization zone 1922, and the second opening 2108b is configured to function as an insertion position for receiving the sensor 1816 and the sharp body 1818 into the sterilization zone 1922.

[0208] In embodiments where the sterilization zone 1922 is conical or frustoconical, the diameter of the first opening 2108a can be larger than the diameter of the second opening 2108b. For example, in such embodiments, the size (diameter) of the first opening 2108a can be in the range of approximately 5.0 mm to approximately 16.0 mm, and the size (diameter) of the second opening 2108b can be in the range of approximately 0.5 mm to approximately 5.0 mm. However, the diameters of the first opening 2108a and the second opening 2108b can be set to be larger or smaller than the above ranges depending on the application, as long as they do not deviate from the scope of this disclosure. In practice, the diameters of the first opening 2108a and the second opening 2108b only need to be large enough to allow a sufficient dose of radiation to hit the sensor 1816 and the sharp body 1818.

[0209] In an embodiment in which the sterilization zone 1922 has a substantially cylindrical shape and a circular or polygonal cross-sectional shape, the diameters of the first opening 2108a and the second opening 2108b can be the same. In such an embodiment, the walls of the sterilization zone 1922 may extend substantially parallel from the first end to the second end, or they may extend substantially non-parallel.

[0210] In the illustrated embodiment, the inner wall of the sterilization zone 1922 (e.g., the internal collimator 1920a and the external collimator 1920b) extends from the first opening 2108a to the second opening 2108b at a substantially constant angle with respect to the centerline of the sensor applicator 102. This angle of the inner wall can be any angle in the range of 0° to 90° with respect to the centerline of the sensor applicator 102. However, it may be preferable for the angle of the inner wall to be in the range of 45° to 90° with respect to the centerline. On the other hand, in other embodiments, the angle of the inner wall can change from the first opening 2108a to the second opening 2108b, without departing from the scope of this disclosure. In such embodiments, several portions of the inner wall can be provided that extend for short distances at different angles from adjacent portions, or the inner wall can be smoothly undulated from the first opening 2108a to the second opening 2108b.

[0211] The microbial barrier 1926a may be installed at the interface between the internal collimator 1920a and the external collimator 1920b, or positioned on or near the radial shoulder 2106. The microbial barrier 1926a is configured to be present during radiation sterilization. As described above, the microbial barrier 1926a can contribute to sealing at least a portion of the sterilization zone 1922. More specifically, the microbial barrier 1926a contributes to sealing a portion of the sterilization zone 1922 so that the portion constitutes part of a sealed area 2110. This sealed area 2110 is configured to isolate the sensor 1816 and the sharp body 1818 from external contamination. The sealed area 2110 may include (encompass) a selected portion of the interior of the electronic component housing 1804 and the sterilization zone 1922. In one or more embodiments, the sealed region 2110 can be defined or formed by at least a microbial barrier 1926a, a first sealing portion ("upper" sealing portion) 2112a, and a second sealing portion ("bottom" sealing portion) 2112b. The microbial barrier 1926a, the upper sealing portion 2112a, and the bottom sealing portion 2112b form barriers at their respective sealing positions, thereby enabling final sterilization of the sterilization zone 1922 containing the sensor 1816 and the sharp body 1818.

[0212] The upper sealing portion 2112a can be positioned to seal the interface between the pointed hub 1820 and the upper part of the electronic component housing 1804 (i.e., the shell 1806 shown in Figure 18), thereby preventing contaminants from entering the interior of the electronic component housing 1804. In some embodiments, the upper sealing portion 2112a can be formed as part of the pointed hub 1820, for example, by overmolding on the pointed hub 1820. On the other hand, in other embodiments, the upper sealing portion 2112a can be formed as part of the shell 1806 or by overmolding on the upper surface of the shell 1806. In yet another embodiment, without departing from the scope of this disclosure, the upper sealing portion 2112a can be made of a separate structure such as an O-ring, which can be interposed between the pointed hub 1820 and the upper surface of the shell 1806.

[0213] On the other hand, the bottom seal portion 2112b can be composed of a gasket 2016 (Figure 20C) overmolded onto the applicator insert 1910, or more specifically, an annular projection 2020 (Figures 20A and 20C). During sterilization, the bottom seal portion 2112b can be positioned to seal the interface between the applicator insert 1910 and the bottom of the electronic component housing 1804 (i.e., the mount 1808 shown in Figure 18). This bottom seal portion 2112b prevents contaminants from entering the sterilization zone 1922 and the interior of the electronic component housing 1804.

[0214] When the sensor control device 1802 is loaded into the sensor applicator 102 and the applicator cap 1904 is attached to the sensor applicator 102, the upper sealing portion 2112a and the lower sealing portion 2112b are gradually compressed, and the corresponding interfaces can be sealed. The upper sealing portion 2112a and the lower sealing portion 2112b can be made of various materials that have the function of sealing the interface between opposing structures with themselves in between. Suitable materials for the upper sealing portion 2112a and the lower sealing portion 2112b include, but are not limited to, silicone, thermoplastic elastomer (TPE), polytetrafluoroethylene (e.g., "TEFLON"), or any combination thereof.

[0215] Once radiation sterilization is complete, the external collimator 1920b can be removed from the applicator cap 1904, and then the moisture barrier 1926b can be attached to close the opening 1928 inside the applicator cap 1904. After delivery to the user, the only preparation the user needs to perform when delivering the sensor control device 1802 is to remove the applicator cap 1904. In at least one embodiment, the applicator insert 1910 can be removed simultaneously with the removal of the applicator cap 1904. In this case, the applicator insert 1910 can be received inside the applicator cap 1904 so that it is removed integrally while remaining fixed to the applicator cap 1904 during disassembly. In such an embodiment, the applicator insert 1910 can be coupled to the applicator cap 1904 using, for example, a snap-fit ​​engagement.

[0216] In some embodiments, the potting material 2114 can be filled into the electronic component housing 1804 to fill the voids in the sensor control device 1802. The potting material 2114 can be made of a biocompatible material that meets the requirements of ISO 10993. In some embodiments, for example, the potting material 2114 can be made of a urethane material such as Resinaid® 3672, both provided by Henkel®, or a silicone material such as SI5055 or SI5240. In other embodiments, the potting material 2114 can also be made of an acrylate adhesive such as GE4949, provided by Delo®.

[0217] The potting material 2114 can function as an additional protective barrier to absorb or deflect the incoming radiation 2104. In at least one embodiment, for example, the potting material 2114 can be configured to have radiation resistance to withstand an electron beam of at least 85 kGy. Thus, it is possible to configure the system so that the radiation 2104 is required to pass through the potting material 2114 rather than the air normally present in the electronic component housing 1804 before impacting the radiation-sensitive component 1908. The potting material 2114 may not be made of a high-density material, but it can still function as an additional radiation shielding layer. Furthermore, the potting material 2114 can also improve the robustness of the sensor control device 1802 and the electronic component housing 1804. Thus, by using the potting material 2114, the electronic component housing 1804 can be constructed of thinner material as needed.

[0218] It should be noted that while the sensor 1816 and the pointed body 1818 are configured to extend from the bottom of the electronic component housing 1804 and within a sterilization zone 1922 that extends substantially concentrically with the sensor applicator 102 and the applicator cap 1904, this specification also intends to include configurations with eccentric arrangements. More specifically, in at least one embodiment, the sensor 1816 and the pointed body 1818 can be configured to extend from the bottom of the electronic component housing 1804 in an eccentric arrangement from the centerline of the sensor applicator 102 and the applicator cap 1904. In such an embodiment, without departing from the scope of this disclosure, the sterilization zone 1922 can also be configured with an eccentric arrangement to accommodate the sensor 1816 and the pointed body 1818 by modifying the design of the internal collimator 1920a and the external collimator 1920b, etc.

[0219] Figures 22A and 22B illustrate other embodiments of the applicator insert 1910, with Figure 22A being an isometric view and Figure 22B being a side cross-sectional view. The applicator insert 1910 shown in Figures 22A and 22B can be similar in many respects to the applicator insert 1910 shown in Figures 20A to 20C. However, unlike the applicator insert 1910 shown in Figures 20A to 20C, the applicator insert 1910 shown in Figures 22A and 22B has an eccentric configuration in which the internal collimator 1920a is positioned eccentrically from the center line 2202 (Figure 22B) of the main body 2002. In such embodiments, the sensor control device 1802 (Figures 19B and 21) also has an eccentric configuration, and the sensor 1816 (Figures 19B and 21) and the pointed body 1818 (Figures 19B and 21) can be configured to extend into an opening 2005 defined at the upper end 2004a of the applicator insert 1910. Furthermore, in such embodiments, a configuration using a radial alignment shape portion 1916, an additional radial alignment shape portion 2006, and a sensor positioning shape portion 2012 is particularly advantageous in that it contributes to aligning the orientation of the applicator insert 1910 with respect to the sensor control device 1802 in the appropriate direction within the sensor applicator 102 (Figures 19B and 21).

[0220] Embodiments disclosed herein include the following:

[0221] Embodiment H A sensor applicator comprising a housing, an applicator cap, an applicator insert, and an external collimator. A sensor control device is disposed within the housing, and the sensor control device comprises a sensor, a sharp body, and radiation-sensitive components. The applicator cap is detachably coupled to the housing. The applicator insert is configured to be positioned within the applicator cap, and this applicator insert defines an internal collimator that receives the distal end of the sensor and the distal end of the sharp body. The external collimator is configured to extend into the applicator cap. The internal and external collimators work together to focus the radiation used for radiation sterilization toward the sensor and the sharp body, while simultaneously preventing radiation damage to radiation-sensitive components.

[0222] Embodiment I A method for sterilizing a sensor control device. The method includes the steps of: placing a sensor control device, comprising a sensor, a sharp body, and radiation-sensitive components, within a housing of a sensor applicator; and receiving the distal end of the sensor and the distal end of the sharp body within an internal collimator defined by an applicator insert. Furthermore, the method includes the steps of: fixing the applicator insert within the applicator cap by detachably coupling the applicator cap to the housing; and extending an external collimator into the applicator cap to align the external collimator with the internal collimator. Furthermore, the method includes the steps of using the internal and external collimators, in cooperation with each other, to focus the radiation used for radiation sterilization toward the sensor and the sharp body, while simultaneously preventing radiation damage to the radiation-sensitive components.

[0223] Embodiment J A hybrid sterilization assembly comprising an applicator insert, an internal collimator, and an external collimator. The applicator insert is configured to be repositionable within the applicator cap of a sensor applicator. The internal collimator is defined by the applicator insert and receives the distal end of the sensor and the distal end of the sharp object of the sensor control device when it is housed within the sensor applicator housing. The external collimator is configured to extend within the applicator cap and to be alignable with the internal collimator. The internal and external collimators work together to focus the radiation used for radiation sterilization toward the sensor and sharp object, while simultaneously preventing radiation damage to radiation-sensitive components.

[0224] Furthermore, each embodiment of Embodiments H, I, and J may include one or more of the following additional elements in any combination: [Element 1] The applicator insert engages with the inner surface of the applicator cap, thereby fixing the applicator insert axially within the applicator cap. [Element 2] The sensor applicator further comprises a sheath extending from the housing and one or more radial alignment shapes provided on the applicator insert, wherein the sheath is configured to extend into the applicator cap when the applicator cap is coupled to the housing, and the one or more radial alignment shapes are configured to fit with one or more corresponding shapes provided on the sheath, thereby aligning the rotational direction of the applicator insert with the correct direction relative to the sensor control device. [Element 3] The sensor applicator further comprises one or more sensor positioning shapes provided on the applicator insert, and one or more sensor positioning shapes are configured to be mates with one or more corresponding shapes provided on the sensor control device, and this mating is configured to align the rotational direction of the applicator insert with the correct direction relative to the sensor control device. [Element 4] The internal collimator is equipped with a collimating insert, and the external collimator is configured to be alignable with the collimating insert. [Element 5] Both the collimating insert and the external collimator are made of a material selected from the group consisting of high-density polymers, metals, composite materials, and any combination thereof. [Element 6] The internal collimator further comprises a gasket configured to engage with the bottom of the sensor control device and form a sealing interface with the bottom. [Element 7] The internal and external collimators are configured to work together to define the sterilization zone, and the cross-sectional shape of the sterilization zone is selected from the group consisting of shapes corresponding to cones, frustums of cones, pyramids, and cubes, circles, rectangles, and any combination thereof. [Element 8] The sensor applicator further comprises a potting material disposed within the sensor control device.

[0225] [Element 9] The method further includes the step of fixing the applicator insert axially within the applicator cap by engaging the inner surface of the applicator cap with the applicator insert. [Element 10] The internal collimator is equipped with a gasket, and the method further includes the steps of engaging the gasket with the bottom of a sensor control device when fixing the applicator insert axially within the applicator cap, and forming a sealing interface between the gasket and the bottom of the sensor control device pressed against it. [Element 11] The internal collimator and the external collimator are configured to cooperate in defining a sterile zone for receiving a sensor and a sharp object, and the method further includes the step of sealing at least a portion of the sterile zone by placing a microbial barrier at the interface between the internal collimator and the external collimator. [Element 12] The internal collimator includes a collimating insert, and the step of aligning the external collimator with the internal collimator includes the step of aligning the external collimator with the collimating insert. [Element 13] An internal collimator and an external collimator are configured to work together to define a sterilization zone, wherein the cross-sectional shape of the sterilization zone is selected from the group consisting of shapes corresponding to cones, frustums of cones, pyramids, and cubes, circles, rectangles, and any combination thereof.

[0226] [Element 14] The hybrid sterilization assembly further comprises a microbial barrier positioned at the interface between the internal collimator and the external collimator. [Element 15] The internal collimator is equipped with a collimating insert, and both the collimating insert and the external collimator are made of a material selected from the group consisting of high-density polymers, metals, composite materials, and any combination thereof. [Element 16] The internal collimator further comprises a gasket configured to engage with the bottom of the sensor control device and form a sealing interface with the bottom. [Element 17] An internal collimator and an external collimator are configured to work together to define a sterilization zone, wherein the cross-sectional shape of the sterilization zone is selected from the group consisting of shapes corresponding to cones, frustums of cones, pyramids, and cubes, circles, rectangles, and any combination thereof.

[0227] Examples of exemplary combinations of elements applicable to embodiments H, I, and J include the combination of element 4 and element 5, the combination of element 4 and element 6, the combination of element 9 and element 10, and the combination of element 15 and element 16.

[0228] Internally Sterilized Assembly Some medical devices require sterilization to ensure they are free of viable microorganisms before being delivered to end users. Some medical devices are equipped with subcutaneous sensing devices (subcutaneous sensors), which must be sterilized by radiation sterilization, such as electron beam irradiation. However, radiation sterilization can damage the electronic components of medical devices, so these electronic components are generally sterilized by chemical gas sterilization (for example, sterilization using ethylene oxide). However, chemical gas sterilization can damage enzymes and other chemical substances and biological materials contained on the subcutaneous sensing device.

[0229] Thus, the problem of incompatibility in sterilization methods between subcutaneous sensing devices and electronic components has conventionally been avoided by separating the subcutaneous sensing devices and electronic components and sterilizing each individually. However, this method increases the number of required parts, packages, and processes, and since the final assembly must be performed by the user, there is a risk of human error by the user. According to this disclosure, any device requiring final sterilization can be properly sterilized by using an internal sterilization assembly. This internal sterilization assembly is designed to focus sterilization radiation (e.g., beam, wave, energy, etc.) towards the components requiring sterilization, while simultaneously preventing delicate electronic components from being affected or damaged by the propagation of said radiation.

[0230] Figure 23 is a schematic diagram showing an example internal sterilization assembly 2300 according to one or more embodiments of the present disclosure. The internal sterilization assembly 2300 (hereinafter, "assembly 2300") may be designed or configured to assist in the sterilization process of a medical device 2302. The medical device 2302 may include a type of healthcare product having one or more components that require final sterilization, such as any healthcare device, mechanism, assembly, or system of such type. Good examples of the medical device 2302 include, but are not limited to, oral ingestion products, cardiac rhythm management (CRM) devices, subcutaneous sensing devices, externally attached medical devices, drug delivery devices, or any combination thereof.

[0231] In the illustrated embodiment, the medical device 2302 comprises a subcutaneous sensing device or a "sensor control device" (also called an "in vivo test substance sensor control device"). As shown, the medical device 2302 can be housed in a sensor applicator 2304 (also called an "insertor"), to which a cap 2306 can be detachably coupled. The medical device 2302 may comprise a housing 2308, a sterilizable component 2310, and one or more radiation-sensitive components 2312. In some embodiments, the component 2310 may comprise a sensor extending from the housing 2308. In at least one embodiment, the component 2310 may further comprise a pointed body, which assists in the subcutaneous implantation of the sensor by the user and may be configured to require sterilization. As shown in the figure, part 2310 can extend inclined from the bottom of the housing 2308, but it may also be configured to extend vertically from the bottom of the housing 2308, or to extend from a surface of the housing 2308 other than the bottom. Furthermore, part 2310 can be configured to extend eccentrically from the centerline of the housing 2308, such as extending from one end of the housing 2308 as shown in the figure, but it may also be configured to extend concentrically with the housing 2308, as long as it does not deviate from the scope of this disclosure.

[0232] The sensor applicator 2304 is used to deliver the medical device 2302 to a predetermined monitoring location on the user's skin (e.g., the user's upper arm). In some embodiments, the cap 2306 is screwed onto the sensor applicator 2304 and can be removed from the sensor applicator 2304 by twisting it to release its engagement. After removing the cap 2306, the user can then use the sensor applicator 2304 to position the medical device 2302 at the predetermined monitoring location on their body. Component 2310 is positioned transcutaneously beneath the user's skin surface and is provided to be held in place by some means, including such transcutaneous placement. In some embodiments, the medical device 2302 can be spring-frigidified so that it can be pushed out from the sensor applicator 2304. Once the medical device 2302 is delivered, it can be held in place on the skin by an adhesive patch (not shown) attached to the bottom of the medical device 2302.

[0233] In the illustrated embodiment, the radiation-sensitive component 2312 can be mounted on a printed circuit board (PCB) 2314 located within the housing 2308. The radiation-sensitive component 2312 may include one or more electronic component modules. Such electronic component modules include, but are not limited to, data processing units (e.g., application-specific integrated circuits ("ASICs")), resistors, transistors, capacitors, inductors, diodes, switches, or any combination thereof. In other embodiments, the radiation-sensitive component 2312 may include a radiation-sensitive chemical solution or test substance (e.g., an activator, drug, biomaterial, etc.). In such embodiments, the medical device 2302 is configured to include a subcutaneous injection needle or subcutaneous syringe, and the chemical solution or test substance can be placed in an ampoule of the medical device 2302.

[0234] To properly sterilize the component 2310 in preparation for use, the medical device 2302 can be subjected to radiation sterilization 2316. Suitable radiation sterilization 2316 treatments include, but are not limited to, electron beam irradiation, gamma ray irradiation, X-ray irradiation, or any combination thereof. A collimator 2318 can be defined in the cap 2306, allowing radiation 2316 to reach and collide with the component 2310 through this collimator 2318, thereby sterilizing it. On the other hand, the cap 2306 also functions as a radiation shield, configured to prevent (block) radiation-sensitive components 2312 from being affected or damaged by the propagation of radiation 2316. To achieve such a configuration, the cap 2306 can be made of a material that reduces or prevents the transmission of radiation 2316.

[0235] More specifically, the cap 2306 can be made of a material having sufficient density to absorb the energy dose of the delivered radiation beam 2316. In some embodiments, for example, the cap 2306 can be made of a material with a mass density greater than 0.9 grams per cubic centimeter (g / cc). On the other hand, in other embodiments, materials with a mass density of less than 0.9 g / cc may also be used appropriately, as long as they do not deviate from the scope of this disclosure. Suitable materials for the cap 2306 include, but are not limited to, high-density polymers (e.g., polyethylene, polypropylene, polystyrene, polytetrafluoroethylene, etc.), metals (e.g., lead, stainless steel, aluminum, etc.), any combination thereof, or any material with a mass density greater than 0.9 g / cc.

[0236] As shown in the figure, the collimator 2318 can be mainly composed of a hole (passage) extending through at least a portion of the cap 2306. This collimator 2318 defines a sterilization zone 2320 configured to assist in focusing the radiation 2316 toward the part 2310. In the illustrated embodiment, the part 2310 is received within the sterilization zone 2320 for sterilization. The collimator 2318 can have any appropriate cross-sectional shape necessary to properly focus the radiation 2316 onto the part 2310 for sterilization. For example, in the illustrated embodiment, the collimator 2318 is conical or frustoconical in shape. On the other hand, in other embodiments, without departing from the scope of this disclosure, the cross-sectional shape of the collimator 2318 can be polygonal, such as a square (corresponding to a cubic structure), a rectangle (e.g., a parallelogram), or a pyramidal structure. In yet another embodiment, the collimator 2318 may have a circular cross-sectional shape and parallel sides.

[0237] In the illustrated embodiment, the collimator 2318 has a first opening 2322a and a second opening 2322b defined at both ends of the sterilization zone 2320. The first opening 2322a is configured to allow radiation 2316 to enter the sterilization zone 2320 and to allow the entered radiation 2316 to collide with the part 2310. On the other hand, the second opening 2322b can be configured to allow the part 2310 to be inserted into the sterilization zone 2320. In embodiments where the collimator 2318 is conical or frustoconical, the diameter of the second opening 2322b can be smaller than the diameter of the first opening 2322a. For example, in such embodiments, the size (diameter) of the second opening 2322b can be in the range of about 0.5 mm to about 3.0 mm, and the size (diameter) of the first opening 2322a can be in the range of about 5.0 mm to about 16.0 mm. However, as those skilled in the art will understand, the diameters of the first aperture 2322a and the second aperture 2322b can be set to be larger or smaller than the above range, without departing from the scope of this disclosure. In practice, the diameters of the first aperture 2322a and the second aperture 2322b can be sized to match the size of the device, as long as they are large enough to allow a sufficient dose of radiation to hit the component 2310. Furthermore, in at least one embodiment, the collimator 2318 can be cylindrical in shape, and the diameters of the first aperture 2322a and the second aperture 2322b can be the same.

[0238] In some embodiments, a cap seal portion 2324 (shown as a dashed line in the figure) can be positioned in the opening of the collimator 2318 or the first opening 2322a. The cap seal portion 2324 can be made of a radiation-permeable microbial barrier. In some embodiments, for example, the cap seal portion 2324 can be made of a synthetic material such as "Tyvek" provided by DuPont (e.g., flash-spun high-density polyethylene fiber). On the other hand, in other embodiments, the cap seal portion 2324 can be made of tape, paper, foil, or any combination thereof, but is not limited thereto. In yet other embodiments, without departing from the scope of this disclosure, the cap seal portion 2324 can be made of a thin-walled portion of the cap 2306. In such embodiments, the first opening 2322a can be omitted.

[0239] The cap sealing portion 2324 can be configured to seal a portion of the sterilization zone 2320, isolating the component 2310 from external contamination, while simultaneously allowing radiation 2316 to penetrate the cap sealing portion 2324 and sterilize the component 2310. In some embodiments, a desiccant (not shown) can be placed within the sterilization zone 2320.

[0240] In some embodiments, the assembly 2300 may further include a shielding barrier 2326. The shielding barrier 2326 is located within the housing 2308. The shielding barrier 2326 may be configured to help block radiation 2316 (e.g., electrons) that propagates within the housing 2308 toward the radiation-sensitive component 2312. The shielding barrier 2326 may be made of any of the materials listed above as materials for the cap 2306. In the illustrated embodiments, the shielding barrier 2326 is located vertically within the housing 2308, but it may instead be located at any other angle suitable for protecting the radiation-sensitive component 2312.

[0241] Figure 24 is a schematic diagram showing an internal sterilization assembly 2400 as another example according to one or more additional embodiments of the present disclosure. The internal sterilization assembly 2400 (hereinafter, "assembly 2400") can be similar in several respects to assembly 2300 shown in Figure 23, and is therefore best understood by referring to Figure 23. Accordingly, similar components are indicated by the same reference numerals and their detailed description is omitted here. Similar to assembly 2300 shown in Figure 23, assembly 2400 can also be designed or configured to assist in the sterilization of, for example, a medical device 2402. This medical device 2402 can be similar to the medical device 2302 shown in Figure 23. In the illustrated embodiment, the medical device 2402 may include a sensor control device similar to the medical device 2302 shown in Figure 23, but may instead include any of the healthcare products listed herein.

[0242] As shown in the figure, the medical device 2402 can be housed in a sensor applicator 2404, more specifically in a pocket 2406 defined in the sensor applicator 2404. In some embodiments, a desiccant (not shown) can be placed in the pocket 2406. Similar to the medical device 2302 shown in Figure 23, the medical device 2402 may also comprise a housing 2308, a sterilizable component 2310, and one or more radiation-sensitive components 2312. In some embodiments, as generally described above, the assembly 2400 may further comprise a shielding barrier 2326. The component 2310 may extend vertically from the bottom of the housing 2308 as shown, but may instead extend at an angle, or from a surface other than the bottom. Furthermore, while component 2310 may be configured to extend along the centerline of housing 2308 as shown in the figure, it may also be configured to extend eccentrically from the centerline, without departing from the scope of this disclosure.

[0243] The sensor applicator 2404 is used to deliver the medical device 2402 to a predetermined monitoring location on the user's skin (e.g., the user's upper arm). As shown in the figure, the sensor applicator 2404 may include a spring-loaded button 2408, at least a portion of which may be received within the sensor applicator 2404. The button 2408 extends into a groove 2409 defined in the sensor applicator 2404 and is configured to engage with the upper part of the housing 2308 at the lower end of the groove 2409. In at least one embodiment, a sealing interface is formed where the bottom of the button 2408 engages with the housing 2308. By pressing the button 2408, the medical device 2402 can be delivered from the pocket 2406 to the use position. Upon pressing, button 2408 acts on housing 2308, resulting in the medical device 2402 being pushed distally, ejected from pocket 2406, and separated from sensor applicator 2404. Component 2310 is positioned percutaneously beneath the user's skin surface and is configured to be held in place by some means, including such percutaneous placement. Once medical device 2402 is delivered, an adhesive patch (not shown) attached to the bottom of medical device 2402 can hold it in place on the skin.

[0244] To properly sterilize the component 2310 before use, the medical device 2402 can be subjected to radiation sterilization 2316. In the illustrated embodiment, the radiation sterilization 2316 is configured to irradiate the upper part of the sensor applicator 2404. A collimator 2410 can also be defined on the button 2408, allowing the radiation 2316 to pass through the collimator 2410, reach and collide with the component 2310, and sterilize it. As shown in the figure, the collimator 2410 can mainly consist of a hole (passage) extending through at least a portion of the button 2408. This collimator 2410 focuses the radiation 2316 toward the component 2310. The collimator 2410 can have any appropriate cross-sectional shape necessary to focus the radiation 2316 onto the component 2310 for sterilization. For example, in the illustrated embodiment, at least a portion of the collimator 2410 is conical or frustoconical in shape. On the other hand, in other embodiments, without departing from the scope of the present disclosure, the cross-sectional shape of the collimator 2410 may be a polygon, such as a square (corresponding to a cubic structure), a rectangle (e.g., a parallelogram), or a pyramidal structure. In yet another embodiment, the collimator 2410 may have a circular cross-sectional shape with parallel sides.

[0245] On the other hand, the rest of the sensor applicator 2404 and the button 2408 can also function as radiation shields, and can be configured so that radiation 2316 propagates only through the collimator 2410, preventing (blocking) propagation through other paths, so that radiation-sensitive components 2312 are not affected or damaged. To achieve such a configuration, the sensor applicator 2404 and the button 2408 can be made of the same material as the cap 2306 shown in Figure 23. In addition, in at least one embodiment, the radiation 2316 can be emitted from a device or machine configured to focus and / or irradiate radiation for radiation sterilization 2316 precisely within the collimator 2410, thereby suppressing exposure of the portion of the sensor applicator 2404 adjacent to the collimator 2410 to radiation 2316.

[0246] In some embodiments, a first sealing portion 2412a (shown by a dashed line in the figure) can be positioned at the opening of the pocket 2406, and a second sealing portion 2412b can be positioned at the opening above the button 2408 leading to the collimator 2410. Similar to the cap sealing portion 2324 shown in Figure 23, the sealing portions 2412a and 2412b can also be constructed of a radiation-penetrating microbial barrier. The first sealing portion 2412a can be configured to seal the pocket 2406 from the bottom side of the sensor applicator 2404, isolating the component 2310 from external contamination. The second sealing portion 2412b, on the other hand, can be configured to seal the collimator 2410 while simultaneously allowing radiation 2316 to penetrate the second sealing portion 2412b and sterilize the component 2310.

[0247] Figure 25 is a schematic diagram showing an internal sterilization assembly 2500 as another example according to one or more additional embodiments of the present disclosure. The internal sterilization assembly 2500 (hereinafter, "assembly 2500") can be similar in several respects to assembly 2300 shown in Figure 23 and assembly 2400 shown in Figure 24, and is therefore best understood by referring to Figures 23 and 24. Accordingly, similar components are indicated by the same reference numerals and their detailed description is omitted here. Similar to assembly 2300 shown in Figure 23 and assembly 2400 shown in Figure 24, assembly 2500 can also be designed or configured, for example, to assist in the sterilization of a medical device 2502. This medical device 2502 can be similar to medical device 2302 shown in Figure 23 and medical device 2402 shown in Figure 24. The medical device 2502 may include a sensor control device similar to medical device 2302 shown in Figure 23 and medical device 2402 shown in Figure 24, but may instead include any of the healthcare products listed herein.

[0248] As shown in the figure, the medical device 2502 can be housed in a sensor applicator 2504. This sensor applicator 2504 may include a spring-biased sheath 2506. The medical device 2502 can be placed in a pocket 2508, at least in part, defined by the sheath 2506. In some embodiments, a desiccant (not shown) may be placed in the pocket 2508. Similar to the medical device 2302 shown in Figure 23 and the medical device 2402 shown in Figure 24, the medical device 2502 may also include a housing 2308, a sterilizable component 2310, and one or more radiation-sensitive components 2312. In some embodiments, as generally described above, the assembly 2500 may further include a shielding barrier 2326.

[0249] Component 2310 may extend vertically from the bottom of the housing 2308 as shown in the figure, but it may also extend at an angle or from a surface other than the bottom. Furthermore, component 2310 may extend along the centerline of the housing 2308 as shown in the figure, but it may also extend eccentrically from the centerline, as long as it does not deviate from the scope of this disclosure.

[0250] The sensor applicator 2504 is used to deliver the medical device 2502 to a predetermined monitoring location on the user's skin (e.g., the user's upper arm). When the sheath 2506 is pressed against the user's skin, the sheath 2506 contracts toward the body of the sensor applicator 2504, allowing the medical device 2502 to be delivered from the pocket 2508 to the use location. Then, when the sheath 2506 is contracted toward the housing 2308, the medical device 2502 can be delivered from the sensor applicator 2504. Component 2310 is positioned percutaneously beneath the surface of the user's skin and is provided to be held in place by some means, including such percutaneous placement. Once the medical device 2502 is delivered, an adhesive patch (not shown) attached to the bottom of the medical device 2502 can hold it in place on the skin.

[0251] To properly sterilize the component 2310 before use, the medical device 2502 can be subjected to radiation sterilization 2316. In the illustrated embodiment, the radiation sterilization 2316 is configured to irradiate the upper part of the sensor applicator 2504. A collimator 2510 can also be defined on the sensor applicator 2504, allowing the radiation 2316 to pass through the collimator 2510, reach and collide with the component 2310, and sterilize it. As shown in the figure, the collimator 2510 can mainly consist of a hole (passage) extending through the body of the sensor applicator 2504. This collimator 2510 focuses the radiation 2316 toward the component 2310. The collimator 2510 can have any appropriate cross-sectional shape necessary to focus the radiation 2316 onto the component 2310 for sterilization. For example, in the illustrated embodiment, the collimator 2510 is conical or frustoconical in shape. On the other hand, in other embodiments, without departing from the scope of the present disclosure, the cross-sectional shape of the collimator 2510 may be a polygon, such as a square (corresponding to a cubic structure), a rectangle (e.g., a parallelogram), or a pyramidal structure. In yet another embodiment, the collimator 2510 may have a circular cross-sectional shape with parallel sides.

[0252] On the other hand, the sensor applicator 2504 can also function as a radiation shield, and can be configured so that radiation 2316 propagates only through the collimator 2510, preventing (blocking) propagation through other paths, so that radiation-sensitive components 2312 are not affected or damaged. To achieve such a configuration, the sensor applicator 2504 can be made of the same material as the cap 2306 shown in Figure 23. In addition, in at least one embodiment, the radiation 2316 can be emitted from a device or machine configured to precisely focus and / or irradiate radiation for radiation sterilization 2316 within the collimator 2510, thereby suppressing exposure of the portion of the sensor applicator 2504 adjacent to the collimator 2510 to radiation 2316.

[0253] In some embodiments, a first sealing portion 2512a (shown as a dashed line in the figure) can be positioned at the opening of the pocket 2508, and a second sealing portion 2512b can be positioned at the opening leading to the collimator 2510 on the top of the sensor applicator 2504. Similar to the cap sealing portion 2324 shown in Figure 23, the sealing portions 2512a and 2512b can also be made of a radiation-penetrating microbial barrier. The first sealing portion 2512a can be configured to seal the pocket 2508 from the bottom side of the sensor applicator 2504, isolating the component 2310 from external contamination. On the other hand, the second sealing portion 2512b can be configured to seal the collimator 2510 while simultaneously allowing radiation 2316 to penetrate the second sealing portion 2512b and sterilize the component 2310.

[0254] Embodiments disclosed herein include the following:

[0255] Embodiment K An internal sterilization assembly comprising a sensor applicator, a medical device, and a cap. The medical device comprises sterilizable parts and radiation-sensitive components, with at least a portion of the medical device housed within the sensor applicator. The cap is detachably coupled to the sensor applicator and is equipped with a collimator configured to align with the sterilizable parts. The collimator focuses the radiation used for radiation sterilization toward the sterilizable parts, while the cap's configuration prevents radiation-sensitive components from being damaged by radiation.

[0256] Furthermore, Embodiment K may include one or more of the following additional elements in any combination: [Element 1] The radiation-sensitive component is selected from the group consisting of electronic component modules, chemical solutions, and any combination thereof. [Element 2] The cross-sectional shape of the collimator is selected from the group consisting of shapes corresponding to cones, frustums of cones, pyramids, and cubes, circles, rectangles, and any combination thereof. [Element 3] The medical device comprises an in vivo test substance sensor control device, the sterile component comprises at least one of a sensor and a sharp body, and the sensor and sharp body extend from the housing of the in vivo test substance sensor control device. [Element 4] At least one of the sensor and the pointed body extends inclined from the bottom of the housing. [Element 5] At least one of the sensor and the pointed body extends vertically from the bottom of the housing. [Element 6] At least one of the sensor and the pointed body extends from the bottom of the housing along the centerline of the housing. [Element 7] At least one of the sensor and the pointed body extends from the bottom of the housing in an eccentric position from the centerline of the housing. [Element 8] The cap is made of a material having a mass density of more than 0.9 g / cc. [Element 9] The cap is made of a material selected from the group consisting of high-density polymers, metals, and any combination thereof. [Element 10] The medical device comprises an in vivo test substance sensor control device having a housing containing radiation-sensitive components, wherein an internal sterile assembly further includes a shielding barrier, the shielding barrier being located within the housing and configured to block radiation from propagating within the housing towards the radiation-sensitive components. [Element 11] The internal sterilization assembly further includes a spring-loaded button, at least a portion of which is received within a sensor applicator, and the spring-loaded button is configured to be engageable with the top of a medical device, and the collimator is defined through this button. [Element 12] The internal sterilization assembly further includes a sealing interface at the contact point between the spring-biased button and the medical device. [Element 13] At least one of the spring-biased button and the sensor applicator is made of a material selected from the group consisting of high-density polymer, metal, and any combination thereof. [Element 14] The sensor applicator includes a spring-biased sheath, the medical device is housed in a pocket, and at least a portion of this pocket is defined by this sheath. [Element 15] The collimator described above is defined by passing through the sensor applicator.

[0257] Examples of exemplary combinations of elements applicable to Embodiment K include, but are not limited to, the combination of element 3 and element 4, the combination of element 3 and element 5, the combination of element 3 and element 6, the combination of element 3 and element 7, the combination of element 8 and element 9, the combination of element 11 and element 12, the combination of element 11 and element 13, and the combination of element 14 and element 15.

[0258] One-piece biosensor design using a sensor protection vial Figures 26A and 26B illustrate an example sensor control device 2602 according to one or more embodiments of the present disclosure, where Figure 26A is an isometric view and Figure 26B is a side view. The sensor control device 2602 (also called the “pack”) can be similar in some respects to the sensor control device 104 shown in Figure 1, and therefore it is most appropriate to understand it by referring to Figure 1. The sensor control device 2602 can be used in place of the sensor control device 104 shown in Figure 1. Therefore, by using the sensor control device 2602 in combination with the sensor applicator 102 (Figure 1), the sensor control device 2602 can be delivered to a predetermined monitoring location on the user’s skin.

[0259] However, unlike the sensor control device 104 shown in Figure 1, the sensor control device 2602 can be incorporated into a one-piece system. This configuration differs from the two-piece configuration in that, for example, the user does not need to open multiple packages and perform the final assembly of the sensor control device 2602. That is, upon receiving the device, the sensor control device 2602 is already assembled and set in the correct position within the sensor applicator 102 (Figure 1). When using the sensor control device 2602, the user only needs to open one barrier (for example, the applicator cap 210 shown in Figure 2B), and the sensor control device 2602 can be quickly delivered to the designated monitoring location.

[0260] As shown in the figure, the sensor control device 2602 includes an electronic component housing 2604. The electronic component housing 2604 is substantially disc-shaped and may have a circular cross-sectional shape. On the other hand, in other embodiments, without departing from the scope of the present disclosure, the cross-sectional shape of the electronic component housing 2604 may be other shapes such as oval or polygonal. The electronic component housing 2604 may be configured to house or enclose various electrical components for operating the sensor control device 2602.

[0261] The electronic component housing 2604 may comprise a shell 2606 and a mount 2608 configured to fit into the shell 2606. The shell 2606 can be secured to the mount 2608 by various means, such as snap-fit ​​engagement, interlocking, ultrasonic welding, or one or more mechanical fasteners (e.g., screws). In some cases, securing the shell 2606 to the mount 2608 can form a sealing interface between them. In such embodiments, a sealing material of the type of gasket can be placed on or near the outer diameter (periphery) of the shell 2606 and the mount 2608. In this case, when the shell 2606 and the mount 2608 are secured to each other, the gasket is compressed, forming a sealing interface. In other embodiments, an adhesive can be applied to the outer diameter (periphery) of one or both of the shell 2606 and the mount 2608. The shell 2606 is fixed to the mount 2608 by adhesive, thereby achieving structural integrity and sealing the interface between the two, which isolates the inside of the electronic component housing 2604 from external contamination. Furthermore, when the sensor control device 2602 is assembled in a controlled environment, there is no need to perform final sterilization on the internal electrical components. In other words, by bonding with adhesive, a sufficient sterile barrier can be formed for the electronic component housing 2604 once the assembly is complete.

[0262] The sensor control device 2602 may further comprise a plug assembly 2610 that can be coupled to the electronic component housing 2604. The plug assembly 2610 may be similar in some respects to the plug assembly 207 shown in Figure 2A. For example, the plug assembly 2610 may comprise a sensor module 2612 (partially illustrated) that can be interconnected with a pointed body module 2614 (partially illustrated). The sensor module 2612 may be configured to carry or have a sensor 2616 (partially illustrated), and the pointed body module 2614 may be configured to carry or have a pointed body 2618 (partially illustrated). The pointed body 2618 may be configured to assist in the transcutaneous delivery of the sensor 2616 to the user's subcutaneous tissue when the sensor control device 2602 is mounted. As shown, a portion of the sensor 2616 and a corresponding portion of the pointed body 2618 extend from the electronic component housing 2604, more specifically from the bottom of the mount 2608. The exposed portion of the sensor 2616 can be housed within the hollow or recessed portion of the pointed body 2618. Meanwhile, the rest of the sensor 2616 is located inside the electronic component housing 2604.

[0263] Furthermore, as will be described in more detail later, the sensor control device 2602 may also be equipped with a sensor protection vial 2620. The sensor protection vial 2620 surrounds the exposed parts of the sensor 2616 and the sharp body 2618, and functions as a protective barrier to protect these exposed parts from chemical gas sterilization.

[0264] Figures 27A and 27B illustrate a plug assembly 2610 according to one or more embodiments, where Figure 27A is an isometric view and Figure 27B is an exploded view. The sensor module 2612 may comprise a sensor 2616, a plug 2702, and a connector 2704. The plug 2702 may be designed to receive and support both the sensor 2616 and the connector 2704. As shown, a groove (sharp slot) 2706 for receiving a portion of the sensor 2616 may be defined to penetrate the plug 2702. Furthermore, the plug 2702 may be provided with one or more flexible arms 2707. These flexible arms 2707 are configured to snap-engage with corresponding shapes provided at the bottom of the electronic component housing 2604 (Figures 26A and 26B).

[0265] The sensor 2616 comprises a tail portion 2708, a flag-shaped portion 2710, and a neck portion 2712 connecting the tail portion 2708 and the flag-shaped portion 2710. The tail portion 2708 can be configured so that at least a portion of it extends distally from the plug 2702 through a groove 2706. The tail portion 2708 contains a chemical substance or biomaterial such as an enzyme, and in some embodiments, this chemical substance can be coated with a membrane. When in use, the tail portion 2708 is inserted percutaneously under the user's skin, and the chemical substance contained in the tail portion 2708 facilitates the monitoring of the test substance in the presence of body fluids.

[0266] The flag-shaped portion 2710 has a substantially flat surface, and one or more (three in Figure 27B) sensor contacts 2714 can be arranged on this substantially flat surface. Each sensor contact 2714 can be configured to be aligned with a flexible carbon-impregnated polymer module (the upper part of which is shown as reference number 2720 in the figure) sealed within the connector 2704. The number of carbon-impregnated polymer modules is provided to correspond to the number of sensor contacts 2714.

[0267] The connector 2704 is equipped with one or more hinges 2718, which allow the connector 2704 to transition between an open state and a closed state. Figures 27A and 27B show the connector 2704 in a closed state, but the connector 2704 can be opened by pivoting, thereby allowing the flag-shaped portion 2710 and the flexible carbon-impregnated polymer module to be received inside the connector 2704. The flexible carbon-impregnated polymer module provides electrical contacts 2720 (three are shown in the figures). The electronic component housing 2604 (Figures 26A and 26B) is provided with corresponding circuit contacts, and the electrical contacts 2720 are configured to ensure conductive connections between the sensor 2616 and the circuit contacts. The connector 2704 can be made of silicone rubber and can function as a moisture barrier for the sensor 2616 while assembled in a compressed state and after being attached to the user's skin.

[0268] The pointed body module 2614 comprises a pointed body 2618 and a pointed body hub 2722 that supports the pointed body 2618. The pointed body 2618 has an elongated shaft 2724 and a pointed end 2726 provided at the distal end of the shaft 2724. The shaft 2724 can be configured to extend distally from the plug 2702 through a groove 2706. Furthermore, the shaft 2724 can have a hollow portion or recess 2728 that surrounds at least a portion of the tail portion 2708 of the sensor 2616. The pointed end 2726 can be configured to penetrate the skin while supporting the tail portion 2708, thereby bringing the active chemical substance present on the tail portion 2708 into contact with body fluids.

[0269] The pointed hub 2722 may include a small-diameter cylindrical hub portion 2730 and a hub snap claw 2732. Both of these can be configured to contribute to the coupling of the plug assembly 2610 (and by extension, the entire sensor control device 2602) to the sensor applicator 102 (Figure 1).

[0270] Referring in detail to Figure 27B, the protective vial 2620 may comprise a substantially cylindrical, elongated body 2734. The body 2734 has a first end 2736a and a second end 2736b located opposite the first end 2736a. The first end 2736a has an open end that provides access to an internal chamber 2738 defined within the body 2734. The second end 2736b, on the other hand, has a closed end, and an enlarged head 2740 may be provided or defined at this second end 2736b. The outer diameter of the enlarged head 2740 is configured to be larger than the outer diameter of the rest of the body 2734. In other embodiments, the enlarged head 2740 may also be positioned at an intermediate location between the first end 2736a and the second end 2736b.

[0271] Figure 27C is an exploded isometric view showing the plug 2702 and the protective vial 2620. As shown, the plug 2702 can be defined with an opening 2742. The opening 2742 is configured to receive the protective vial 2620, more specifically, the first end 2736a of the body 2734. The groove 2706 can be configured to terminate at the opening 2742, so that when the protective vial 2620 is coupled to the plug 2702, the components extending outward (distal) from the groove 2706 are received into the internal chamber 2738.

[0272] The protective vial 2620 can be detachably coupled to the opening 2742 of the plug 2702. For example, in some embodiments, the protective vial 2620 can be received into the opening 2742 by an interlocking or friction fit. On the other hand, in other embodiments, the protective vial 2620 can also be fixed into the opening 2742 using a fragile member (e.g., a shear ring) or a fragile material. This fragile member or material is configured to break with a small force applied to detach the protective vial 2620. In such embodiments, the protective vial 2620 may also be fixed into the opening 2742 with a small amount of (dot-applied) adhesive or a lightly applied wax, or the protective vial 2620 itself may contain an easily removable adhesive. As will be described later, the protective vial 2620 can be removed from the plug 2702 before delivering the sensor control device 2602 (Figures 26A and 26B) to a predetermined monitoring location on the user's skin.

[0273] Referring again to Figures 27A and 27B, the size and configuration of the internal chamber 2738 are set to accommodate the tail portion 2708, the distal section of the shaft 2724, and the sharp end portion 2726. These tail portion 2708, the distal section of the shaft 2724, and the sharp end portion 2726 are sometimes collectively referred to as the "distal portion of the sensor 2616 and the distal portion of the sharp body 2618." The internal chamber 2738 can be sealed or isolated to prevent substances that may adversely affect the chemical structure of the sensor 2616 from entering the interior. More specifically, since the gas used in chemical gas sterilization may adversely affect the enzyme (and other sensor components, such as membrane coatings that regulate the inflow of the test substance) located on the tail 2708, the internal chamber 2738 can be sealed to protect or isolate the distal portion of the sensor 2616 and the distal portion of the sharp body 2618 during chemical gas sterilization.

[0274] In some embodiments, the sealing portion 2744 (Figure 27B) can form a sealing barrier between the internal chamber 2738 and the external environment. In at least one embodiment, the sealing portion 2744 can be located inside the internal chamber 2738, but alternatively, the sealing portion 2744 may be located outside the main body 2734, as long as it does not deviate from the scope of this disclosure. The distal portion of the sensor 2616 and the distal portion of the sharp body 2618 can be configured to extend into the internal chamber 2738 through the sealing portion 2744. Even in this case, the sealing portion 2744 maintains a sealing interface around the distal portion of the sensor 2616 and the distal portion of the sharp body 2618, preventing contaminants from entering the internal chamber 2738. The sealing portion 2744 can be made of, for example, a flexible elastomer or wax.

[0275] In other embodiments (or in addition to the sealing portion 2744), a sensor preservation fluid 2746 (Figure 27B) can be present in the internal chamber 2738. The distal portion of the sensor 2616 and the distal portion of the pointed body 2618 can be immersed in the preservation fluid 2746 or sealed by the preservation fluid 2746. The preservation fluid 2746 can form a sealing interface that prevents sterilization gas from reacting with the enzyme provided on the tail portion 2708.

[0276] The sensor 2616 and the sharpened body 2618 can be properly sterilized by radiation sterilization of the plug assembly 2610. Suitable radiation sterilization methods include, but are not limited to, electron beam irradiation, gamma ray irradiation, X-ray irradiation, or any combination thereof. In some embodiments, radiation sterilization of the plug assembly 2610 can be performed before coupling the protective vial 2620 to the plug 2702. On the other hand, in other embodiments, radiation sterilization of the plug assembly 2610 can be performed after coupling the protective vial 2620 to the plug 2702. In such embodiments, the body 2734 and the storage fluid 2746 of the protective vial 2620 can be made of a material and / or substance through which radiation can propagate, so that radiation sterilization of the distal portion of the sensor 2616 and the distal portion of the sharpened body 2618 can be easily performed.

[0277] Suitable materials for the body 2734 include, but are not limited to, non-magnetic metals (e.g., aluminum, copper, gold, silver, etc.), thermoplastics, ceramics, rubber (e.g., ebonite), composite materials (e.g., fiberglass, carbon fiber reinforced polymers, etc.), epoxy, or any combination thereof. In some embodiments, the material used for the body 2734 may be transparent or translucent, but may also be opaque, as long as it does not deviate from the scope of this disclosure.

[0278] The preservation fluid 2746 can consist of any fluid (i.e., liquid, gas, gel, wax, or any combination thereof) that is inert and biocompatible and can enclose the distal portion of the sensor 2616 and the distal portion of the sharp body 2618. In some embodiments, the preservation fluid 2746 can be configured to allow radiation to pass through and propagate. The preservation fluid 2746 can consist of a fluid that is insoluble in the chemicals used in chemical gas sterilization. Suitable examples of the preservation fluid 2746 include, but are not limited to, silicone oil, mineral oil, gel (e.g., petrolatum), wax, fresh water, brine, synthetic fluid, glycerol, sorbitan ester, or any combination thereof. As will be understood by those skilled in the art, it may be preferable to use a more viscous gel or fluid so that the preservation fluid 2746 does not flow easily.

[0279] In some embodiments, the storage fluid 2746 may be configured to include an anti-inflammatory agent, such as a known anti-inflammatory agent like nitric oxide. The configuration including an anti-inflammatory agent has the advantage of minimizing the localized inflammatory response that occurs when the sharp body 2618 and sensor 2616 penetrate the user's skin. Observations have confirmed that inflammation can impair the accuracy of glucose readings, but by configuring the storage fluid 2746 to include an anti-inflammatory agent, the healing process is accelerated, and it becomes possible to reach a state where accurate readings can be obtained more quickly.

[0280] Figures 28A and 28B show an electronic component housing 2604 according to one or more embodiments, with Figure 28A being an exploded view and Figure 28B being an isometric view. The shell 2606 and mount 2608 are configured like a pair of opposing bivalve shells and function to surround or substantially enclose the various electronic components contained in the sensor control device 2602 (Figures 26A and 26B).

[0281] The printed circuit board (PCB) 2802 can be placed inside the electronic component housing 2604. Multiple electronic component modules (not shown) can be mounted on the printed circuit board 2802. Mountable electronic component modules include, but are not limited to, data processing units, resistors, transistors, capacitors, inductors, diodes, and switches. The data processing unit may include, for example, an application-specific integrated circuit (ASIC) configured to implement one or more functions or routines related to the operation of the sensor control device 2602. More specifically, the data processing unit may be configured to perform data processing functions. Data processing functions include, but are not limited to, filtering and encoding of data signals corresponding to the values ​​of the test substance collected by the user. Furthermore, the data processing unit may be configured to include an antenna for communicating with the reading device 106 (Figure 1), or may be configured to communicate with such an antenna.

[0282] As shown in the figures, the shell 2606, mount 2608, and printed circuit board 2802 have corresponding central openings 2804, 2806, and 2808 defined in them, respectively. When the electronic component housing 2604 is assembled, the central openings 2804, 2806, and 2808 are coaxially aligned, and the plug assembly 2610 (Figures 27A and 27B) can be inserted into these coaxially aligned central openings. The electronic component housing 2604 can also house a battery 2810, which can be configured to supply power to the sensor control device 2602.

[0283] As shown in Figure 28B, a plug receptacle 2812 can be defined at the bottom of the mount 2608. The plug receptacle 2812 can function as a mounting point for receiving the plug assembly 2610 (Figures 27A and 27B) and connecting it to the electronic component housing 2604. By housing the plug assembly 2610 in the plug receptacle 2812, the assembly of the sensor control device 2602 (Figures 26A and 26B) can be completed. The external shape of the plug 2702 (Figures 27A to 27C) can be made to fit (be complementary to) the plug receptacle 2812. In addition, the plug receptacle 2812 may be provided with one or more (two in the illustration) snap engagement ledges 2814. The snap engagement ledge portion 2814 is configured to engage with and receive the flexible arms 2707 (Figures 27A and 27B) of the plug 2702. The plug assembly 2610 can be coupled to the electronic component housing 2604 by inserting the plug 2702 into the plug receptacle 2812, thereby locking each flexible arm 2707 to the corresponding snap engagement ledge portion 2814. Once the plug assembly 2610 (Figures 27A and 27B) is properly coupled to the electronic component housing 2604, one or more (three in the illustration) circuit contacts 2816 defined on the underside of the printed circuit board 2802 can be electrically connected to the electrical contacts 2720 (Figures 27A and 27B) of the connector 2704 (Figures 27A and 27B).

[0284] Figures 29A and 29B illustrate exemplary embodiments of the sensor applicator 102 with the applicator cap 210 attached, with Figure 29A being a side view and Figure 29B being a side cross-sectional view. More specifically, Figures 29A and 29B show the state of the sensor applicator 102 at the time of shipment to the user and at the time of receipt by the user. As shown in Figure 29B, according to this disclosure, the sensor control device 2602 is already assembled and installed in the sensor applicator 102 before being delivered to the user.

[0285] As described above, the distal end of the sensor 2616 and the distal end of the sharp body 2618 can be sterilized by radiation sterilization of the plug assembly 2610 before coupling it to the electronic component housing 2604. After the plug assembly 2610 has been properly sterilized, the sensor control device 2602 can be assembled by coupling the plug assembly 2610 to the electronic component housing 2604, as described above. Next, the sensor control device 2602 can be loaded into the sensor applicator 102, and the applicator cap 210 can be coupled to the sensor applicator 102. The applicator cap 210 is screwed onto the housing 208 and may be equipped with a tamper-evident ring 2902. When the applicator cap 210 is rotated relative to the housing 208 (for example, by twisting it off), the tamper-evident ring 2902 is sheared, and the applicator cap 210 can be removed from the sensor applicator 102.

[0286] According to this disclosure, the sensor control device 2602 can be subjected to chemical gas sterilization 2904 while it is loaded into the sensor applicator 102. This chemical gas sterilization 2904 is configured to sterilize exposed parts of the sensor control device 2602, such as the electronic component housing 2604. To realize this configuration, a chemical substance can be injected into a sterilization chamber 2906, which is collaboratively defined by the sensor applicator 102 and the cap 210 interconnected thereto. In some applications, the chemical substance can be injected into the sterilization chamber 2906 through one or more vents 2908 defined at the proximal end 2910 of the applicator cap 210. Examples of chemical substances that may be used for chemical gas sterilization 2904 include, but are not limited to, ethylene oxide, hydrogen peroxide vapor, and nitrogen oxides (e.g., nitrous oxide, nitrogen dioxide, etc.).

[0287] Since the distal portion of the sensor 2616 and the distal portion of the sharpened body 2618 are sealed within the protective vial 2620, the chemicals used during chemical gas sterilization do not react with the enzymes, chemicals, or biological substances located on the tail portion 2708.

[0288] Once the inside of the sterilization chamber 2906 reaches the desired level of sterility assurance, the gaseous solution used in the chemical gas sterilization process is removed, and the sterilization chamber 2906 is aerated. Aeration can be performed by circulating nitrogen gas or filtered air into the sterilization chamber 2906 after a series of depressurization operations. After the sterilization chamber 2906 has been properly aerated, the vent 2908 can be closed by the sealing part 2912 (shown by a dashed line in the figure).

[0289] In some embodiments, the sealing portion 2912 can be configured to include two or more layers made of different materials. The first layer can be made of a synthetic material such as "Tyvek" provided by DuPont (e.g., flash-spun high-density polyethylene fiber). "Tyvek" has excellent durability and puncture resistance and is also permeable to vapor. This "Tyvek" layer can be attached before chemical gas sterilization. After chemical gas sterilization, a layer of vapor-resistant and moisture-resistant material such as foil can be sealed (e.g., heat-sealed) on top of the "Tyvek" layer to prevent contaminants and moisture from entering the sterilization chamber 2906. On the other hand, in other embodiments, the sealing portion 2912 can be configured as a single protective layer, and this single protective layer can be attached to the applicator cap 210. In such embodiments, the single protective layer can permeate gas during sterilization, while providing protection against harmful elements such as moisture after sterilization is complete.

[0290] The sealing portion 2912 is positioned in place, allowing the applicator cap 210 to function as a barrier against external contamination and maintain a sterile environment for the assembled sensor control device 2602 until the user removes (twists off) the applicator cap 210. The applicator cap 210 can also create a dust-free environment. Maintaining such a dust-free environment during delivery and storage prevents contamination of the adhesive patch 2914 used to secure the sensor control device 2602 to the user's skin.

[0291] Figure 30 is a perspective view showing an exemplary embodiment of the applicator cap 210 according to the present disclosure. As shown, the applicator cap 210 has a substantially circular cross-sectional shape and is defined by a screw thread 3002 for connecting the applicator cap 210 to the sensor applicator 102 (Figures 29A and 29B). A vent 2908 provided at the bottom of the applicator cap 210 can also be seen in Figure 30.

[0292] The applicator cap 210 may be further provided with or defined a cap post 3004. The cap post 3004 is located in the center of the inside of the applicator cap 210 and extends proximally from the bottom of the applicator cap 210. The cap post 3004 may be configured to assist in supporting the sensor control device 2602 while it is enclosed within the sensor applicator 102 (Figures 29A and 29B). Furthermore, an opening 3006 may be defined in the cap post 3004. The opening 3006 is configured so that a protective vial 2620 can be inserted by coupling the applicator cap 210 to the sensor applicator 102.

[0293] In some embodiments, the opening 3006 of the cap post 3004 may comprise one or more flexible portions 3008. The flexible portions 3008 are configured to be stretchable (flexible) so that a protective vial 2620 can pass through them. For example, in some embodiments, the flexible portions 3008 may be made of a collet-type device having a plurality of flexible fingers configured to bend radially outward to receive the protective vial 2620. On the other hand, in other embodiments, the flexible portions 3008 may be made of a flexible material such as an elastomer, configured to receive the protective vial 2620 by stretching radially.

[0294] Figure 31 is a side cross-sectional view showing a sensor control device 2602 arranged inside an applicator cap 210 according to one or more embodiments. As shown, the cap post 3004 is defined with a post chamber 3102 configured to receive a protective vial 2620. The opening 3006 of the cap post 3004 has a first diameter D1 and is configured to allow access to the post chamber 3102 through this opening 3006. On the other hand, the enlarged head 2740 of the protective vial 2620 has a second diameter D2, which is larger than the first diameter D1 and also larger than the outer diameter of the rest of the protective vial 2620. Therefore, when extending the protective vial 2620 into the post chamber 3102, the flexible portion 3008 of the opening 3006 bends (extends) radially outward, thereby accommodating the enlarged head 2740.

[0295] In some embodiments, the enlarged head 2740 may be provided with or defined an inclined outer surface that contributes to biasing the flexible shaped portion 3008 radially outward. Alternatively, the enlarged head 2740 may be further defined with an upper shoulder portion 3104 to prevent the protective vial 2620 from moving in the reverse direction and coming out of the post chamber 3102. More specifically, the shoulder portion 3104 may have an acute angle at a position where the diameter is a second diameter D2, which engages with the flexible shaped portion 3008 when the protective vial 2620 moves in the reverse direction, but does not provide a bias that causes the flexible shaped portion 3008 to bend radially outward.

[0296] As the enlarged head 2740 passes through the opening 3006, the flexible shaped portion 3008 returns to its natural state (or a state close to it). In some embodiments, the flexible shaped portion 3008 can be configured to allow the applicator cap 210 to rotate relative to the protective vial 2620, even if it is engaged with the outer surface of the protective vial 2620. Thus, when the user removes the applicator cap 210 by rotating it relative to the sensor applicator 102 (Figures 29A and 29B), the protective vial 2620 can remain stationary relative to the cap post 3004.

[0297] When the applicator cap 210 is removed from the sensor applicator 102, thereby detaching the sensor control device 2602 from the applicator cap 210, the shoulder portion 3104 defined on the enlarged head 2740 engages with the flexible shaped portion 3008 of the opening 3006. At this time, since the diameter of the shoulder portion 3104 is larger than the diameter of the opening 3006, the shoulder portion 3104 abuts against the flexible shaped portion 3008, restricting its movement. As a result, the protective vial 2620 is detached from the sensor control device 2602, exposing the distal portion of the sensor 2616 and the distal portion of the sharp body 2618. Therefore, when the applicator cap 210 is detached from the sensor applicator 102 and the sensor control device 2602, the flexible shaped portion 3008 prevents the enlarged head 2740 from coming out of the post chamber 3102 through the opening 3006. Meanwhile, the detached protective vial 2620 falls into the post chamber 3102 and remains there.

[0298] In some embodiments, instead of providing a flexible shaped portion 3008 in the opening 3006 as generally described above, the opening 3006 may be threaded. In such embodiments, the small diameter portion near the distal end of the protective vial 2620 can also be threaded, so that this small diameter portion engages with the threads of the opening 3006. The protective vial 2620 can be received into the post chamber 3102 by screw rotation. On the other hand, when removing the applicator cap 210 from the sensor applicator 102, the threads of the opening 3006 and the threads of the protective vial 2620 interlock and restrain each other, and as a result, the protective vial 2620 can be separated from the sensor control device 2602.

[0299] Therefore, several advantages can be obtained by incorporating the sensor control device 2602 into a substance monitoring system (for example, the substance monitoring system 100 shown in Figure 1). First, since the final assembly of the sensor control device 2602 can be performed in a controlled environment, tolerances can be reduced or eliminated, which enables the sensor control device 2602 to be made smaller and thinner. Furthermore, by performing the final assembly of the sensor control device 2602 in a controlled environment, thorough pre-inspection of the sensor control device 2602 can be performed in the factory, making it possible to thoroughly inspect the sensor unit before packaging it for final delivery.

[0300] Embodiments disclosed herein include the following:

[0301] Embodiment L A sensor control device comprising an electronic component housing, a plug assembly, and a protective vial. The plug assembly comprises a sensor module having a sensor and a sharp body module having a sharp body, and is configured to be mated with the electronic component housing. The protective vial defines an internal chamber and is coupled to the plug assembly. The distal end of the sensor and the distal end of the sharp body are configured to be receivable within the internal chamber and are isolated from chemical gas sterilization within the internal chamber.

[0302] Embodiment M A substance monitoring system comprising a sensor applicator and a sensor control device. The sensor control device comprises an electronic component housing, a plug assembly, and a protective vial, and is located within the sensor applicator. The plug assembly comprises a sensor module having a sensor and a sharp body module having a sharp body, and is coupled to the electronic component housing. The protective vial defines an internal chamber and is coupled to the plug assembly. The substance monitoring system also further comprises a cap coupled to the sensor applicator, which functions as a barrier to seal the sensor control device within the sensor applicator. The distal end of the sensor and the distal end of the sharp body are received within the internal chamber and isolated from chemical gas sterilization within the internal chamber.

[0303] Embodiment N A method for preparing a system for monitoring a substance under test. The method includes loading a sensor control device into a sensor applicator. The sensor control device comprises an electronic component housing, a plug assembly, and a protective vial. The plug assembly comprises a sensor module having a sensor and a sharp body module having a sharp body, and is configured to be matable with the electronic component housing. The protective vial defines an internal chamber and is coupled to the plug assembly. The method further includes attaching a cap to the sensor applicator to provide a barrier that seals the sensor control device within the sensor applicator, sterilizing the sensor control device by chemical gas sterilization with the sensor control device placed inside the sensor applicator, and isolating the distal part of the sensor and the distal part of the sharp body received in the internal chamber from chemical gas sterilization.

[0304] Furthermore, each embodiment of embodiments L, M, and N may include one or more of the following additional elements in any combination: [Element 1] The sensor module further includes a plug, and a protective vial is detachably coupled to the plug. [Element 2] The protective vial is provided with an enlarged head, and the diameter of the enlarged head is larger than the diameter of the rest of the protective vial. [Element 3] The protective vial further comprises a sealing portion that functions as a sealing barrier between the internal chamber and the outside of the internal chamber, wherein the distal portion of the sensor and the distal portion of the sharp body extend through the sealing portion into the internal chamber. [Element 4] The protective vial further comprises a preservation fluid in an internal chamber that isolates the distal end of the sensor and the distal end of the sharp body from chemical gas sterilization. [Element 5] At least a portion of the distal end of the sensor and the distal end of the pointed body are immersed in the storage fluid. [Element 6] The storage fluid is composed of an inert and biocompatible fluid selected from the group consisting of silicone oil, mineral oil, gel, wax, fresh water, brine, synthetic fluid, glycerol, sorbitan ester, or any combination thereof. [Element 7] The storage fluid contains an anti-inflammatory agent.

[0305] [Element 8] The cap is provided with a cap post that defines a post chamber and an opening, and is configured so that the enlarged head of the protective vial is received into the post chamber through this opening. [Element 9] The opening is provided with one or more flexible shaped parts, and these one or more flexible shaped parts are configured to receive the enlarged head by bending radially outward. [Element 10] One or more flexible parts are provided with multiple flexible fingers. [Element 11] When removing the cap from the sensor applicator and sensor control device, one or more flexible parts prevent the enlarged head from coming out of the post chamber through the opening. [Element 12] The cap is configured to rotate relative to the protective vial when the protective vial is received in the post chamber. [Element 13] The protective vial further comprises a preservation fluid in an internal chamber that isolates the distal end of the sensor and the distal end of the sharp body from chemical gas sterilization.

[0306] [Element 14] The method includes, before the step of loading the sensor control device into the sensor applicator, the steps of assembling a plug assembly, coupling a protective vial to the plug assembly to receive the distal portion of the sensor and the distal portion of the sharp body into the internal chamber, and providing the sensor control device by coupling the plug assembly to an electronic component housing. [Element 15] The method includes a step of sterilizing the plug assembly by radiation before the step of joining the protective vial to the plug assembly. [Element 16] The step of isolating the distal portion of the sensor and the distal portion of the sharp body from chemical gas sterilization includes immersing at least a portion of the distal portion of the sensor and the distal portion of the sharp body in a storage fluid present in an internal chamber. [Element 17] The cap is provided with a cap post having a defined post chamber, and one or more flexible shaped parts are provided at the opening of the post chamber, and the step of attaching the cap to a sensor applicator includes inserting the enlarged head of a protective vial through the opening and receiving it in the post chamber, and receiving the enlarged head by one or more flexible shaped parts bending radially outward.

[0307] Examples of exemplary combinations of elements applicable to embodiments L, M, and N include, but are not limited to, the combination of element 4 and element 5, element 4 and element 6, element 4 and element 7, element 8 and element 9, element 9 and element 10, element 9 and element 17, element 8 and element 12, element 8 and element 13, and element 14 and element 15.

[0308] Focused electron beam sterilization and isolation structure in a one-piece sensor design Figures 32A and 32B illustrate an example of a sensor control device 3202 according to one or more embodiments of the present disclosure, where Figure 32A is an isometric view and Figure 32B is a side view. The sensor control device 3202 (also called the “pack”) can be similar in some respects to the sensor control device 104 shown in Figure 1, and therefore it is most appropriate to understand it by referring to Figure 1. In some applications, the sensor control device 3202 can be used in place of the sensor control device 104 shown in Figure 1. Therefore, by using the sensor control device 3202 in combination with the sensor applicator 102 (Figure 1), the sensor control device 3202 can be delivered to a predetermined monitoring location on the user’s skin.

[0309] However, unlike the sensor control device 104 shown in Figure 1, the sensor control device 3202 can be incorporated into a one-piece system. This configuration differs from the two-piece configuration in that, for example, the user does not need to open multiple packages and perform the final assembly of the sensor control device 3202 before use. That is, when the user receives it, the sensor control device 3202 is already assembled and set in the correct position within the sensor applicator 102 (Figure 1). When using the sensor control device 3202, the user only needs to open one barrier (for example, remove the applicator cap 210 shown in Figure 2B), and the sensor control device 3202 can be quickly delivered to the designated monitoring location.

[0310] As shown in the figure, the sensor control device 3202 includes an electronic component housing 3204. The electronic component housing 3204 is substantially disc-shaped and may have a circular cross-sectional shape. On the other hand, in other embodiments, without departing from the scope of the present disclosure, the cross-sectional shape of the electronic component housing 3204 may be other shapes such as oval or polygonal. The electronic component housing 3204 may be configured to house or enclose various electrical components for operating the sensor control device 3202.

[0311] The electronic component housing 3204 may comprise a shell 3206 and a mount 3208 configured to be mated to the shell 3206. The shell 3206 can be fixed to the mount 3208 by various means, such as snap-fit ​​engagement, interlocking, sonic welding (or ultrasonic welding), fastening by one or more mechanical fasteners (e.g., screws), or any combination thereof. In some embodiments, the interface between the shell 3206 and the mount 3208 can be sealed. In such embodiments, a sealant of the type of gasket can be placed or attached to or near the outer diameter (periphery) of the shell 3206 and the mount 3208. In this case, when the shell 3206 is fixed to the mount 3208, this sealant is compressed, forming a sealed interface. In at least one embodiment, an adhesive can also be applied to the outer diameter (periphery) of one or both of the shell 3206 and the mount 3208. This adhesive can not only fix the shell 3206 to the mount 3208 but also seal these interfaces.

[0312] In embodiments where a sealing interface is formed between the shell 3206 and the mount 3208, the inside of the electronic component housing 3204 can be effectively isolated from external contamination between the two. Furthermore, in such embodiments, if the assembly of the sensor control device 3202 is performed in a controlled sterile environment, there is no need to perform a final sterilization treatment (e.g., chemical gas sterilization) on the internal electrical components. In other words, such a sealing engagement can form a sufficient sterile barrier for the electronic component housing 3204 once the assembly is complete.

[0313] The sensor control device 3202 may further comprise a sensor module 3210 (partially shown in Figure 32B) and a sharp body module 3212 (partially shown). The sensor module 3210 and the sharp body module 3212 are configured to be interconnectable and coupled to the electronic component housing 3204. The sensor module 3210 may be configured to c...

Claims

1. An assembly for delivering a substance to a sensor, comprising a sensor control device and an applicator for delivering the substance to a sensor, The sensor control device comprises an electronic component housing, a circuit board, and a sensor for the substance to be tested. The aforementioned electronic component housing is A shell having a first opening and a first interface surrounding the first opening, A mount fixed to the shell to define an internal space, having a second opening aligned with the first opening, and a second interface surrounding the second opening, wherein the first interface fits into the second interface to define a first sterile barrier. A first fitting member extending into at least one of the first opening and the second opening, The circuit board is placed inside the electronic component housing. The substance sensor has a proximal portion that is coupled to the circuit board and a distal portion that extends below the surface of the user's skin and is configured to measure the level of the substance in body fluids. The applicator comprises an applicator housing, an applicator cap, a pointed body hub, a collimator, and a sterilization zone. The applicator housing comprises a sensor carrier configured to fix the sensor control device inside the applicator housing, The applicator cap is detachably coupled to the applicator housing, thereby sealing the inside of the applicator. The pointed hub comprises a pointed body and a second fitting member, and is detachably connected to the shell. The second fitting member extends into at least one of the first opening and the second opening and is configured to fit into the first fitting member of the electronic component housing to define a second sterile barrier. The collimator is located inside the applicator cap. The sterilization zone is configured to receive the distal portion of the substance sensor to be tested. The aforementioned applicator is A third sterile barrier that seals the interface between the collimator and the bottom of the mount, The system further comprises a fourth sterile barrier that seals the end of the sterilization zone, An assembly in which the sterilization zone is defined by the collimator, the second sterile barrier, the third sterile barrier, and the fourth sterile barrier.

2. The assembly according to claim 1, wherein the first fitting member extends from the shell into at least one of the first opening and the second opening.

3. The assembly according to claim 2, wherein the first fitting member is the concave surface of the shell.

4. The assembly according to claim 1, wherein the first fitting member extends from the mount into at least one of the first opening and the second opening.

5. The assembly according to claim 1, wherein the applicator cap is detachably coupled to the applicator housing via a threaded surface, thereby defining a microbial barrier.

6. The assembly according to claim 1, wherein the fourth sterile barrier prevents moisture from penetrating the fourth sterile barrier and entering the collimator without preventing electron beam radiation from penetrating the fourth sterile barrier and reaching the collimator.

7. The assembly according to claim 1, wherein the sterilization zone is configured to isolate the substance sensor and perform low-energy electron beam sterilization.

8. The assembly according to claim 1, wherein the sterilization zone comprises a first sterilization zone and a second sterilization zone.

9. The circuit board further comprises a plurality of electronic component modules, The assembly according to claim 1, wherein the circuit board is positioned offset from the central axis of the collimator in order to prevent the electronic component module from being exposed to electron beam radiation.

10. The assembly according to claim 1, wherein the collimator has a shape selected from the group consisting of a cone shape, a frustocone shape, a pyramidal shape, and any combination thereof.

11. The assembly according to claim 1, wherein the collimator has a cross-sectional shape selected from the group consisting of a circle, a shape corresponding to a cube, a rectangle, and any combination thereof.

12. The assembly further comprises a desiccant placed inside the applicator cap, The cross-section of the desiccant is aligned axially with the cross-section of the collimator. The assembly according to claim 11, wherein the cross-section of the desiccant has a cross-sectional shape substantially similar to the cross-sectional shape of the collimator.

13. The assembly according to claim 1, wherein the collimator has a generally semi-conical or semi-cylindrical shape.

14. The assembly further comprises a desiccant placed inside the applicator cap, The cross-section of the desiccant is aligned axially with the cross-section of the collimator. The assembly according to claim 13, wherein the cross-section of the desiccant has a cross-sectional shape substantially similar to the cross-sectional shape of the collimator.

15. The assembly according to claim 1, wherein the central axis of the circuit board is positioned to be approximately offset from the distal portion of the substance sensor.

16. The assembly according to claim 1, wherein the approximate center point of the circuit board is positioned so as not to be aligned with the collimator in the axial direction.

17. The assembly according to claim 1, further comprising a microbial barrier disposed at the interface between the applicator housing and the applicator cap.

18. The assembly according to claim 1, wherein the first end of the sterilization zone is demarcated by a sealing portion, and the second end of the sterilization zone is demarcated by the pointed body hub.

19. The assembly according to claim 1, further comprising a sterilization zone having a first end demarcated by the mount and a second end demarcated by the pointed body hub.

20. The shell further comprises a third interface adjacent to the first outer edge, The mount further comprises a fourth interface adjacent to the second outer edge, The assembly according to claim 1, wherein the third interface and the fourth interface are configured to be fit together so as to form a sealing portion.

21. The aforementioned electronic component module includes one or more ASICs, The assembly according to claim 9, wherein the pointed body has a U-shaped cross-sectional shape facing the side opposite to the one or more ASICs.

22. The assembly according to claim 1, wherein one of the first interface and the second interface is composed of an annular projection, and the other of the first interface and the second interface is composed of a groove configured to receive the annular projection.

23. The assembly according to claim 1, wherein the first sterile barrier is defined between the sterilization zone and the natural microbial load in the internal space of the electronic component housing.

24. The assembly according to claim 1, wherein the second sterile barrier is a meandering pathway.

25. The assembly according to claim 1, wherein the second sterile barrier is defined between the natural microbial load of the applicator and the sterile zone.

26. The assembly according to claim 1, wherein the first sterile barrier is sealed with an adhesive.

27. The assembly according to claim 1, wherein the third sterile barrier is in proximity to the proximal portion of the collimator.

28. The assembly according to claim 1, wherein the fourth sterile barrier is in close proximity to the distal portion of the collimator.

29. A method for assembling an assembly for delivering a test substance sensor, The method includes the step of providing a sensor control device comprising an electronic component housing, The aforementioned electronic component housing is A shell having a first opening and a first interface surrounding the first opening, A mount fixed to the shell to define an internal space, having a second opening aligned with the first opening, and a second interface surrounding the second opening, wherein the first interface fits into the second interface to define a first sterile barrier. A first fitting member extending into at least one of the first opening and the second opening, The method further includes the step of coupling the sensor control device to the applicator for delivering the substance to be tested, The applicator comprises an applicator housing, a pointed body hub, a collimator, and a sterilization zone. The applicator housing comprises a sensor carrier configured to fix the sensor control device inside the applicator housing, The pointed hub comprises a pointed body and a second fitting member, and is detachably connected to the shell. The second fitting member extends into at least one of the first opening and the second opening and is configured to fit into the first fitting member of the electronic component housing to define a second sterile barrier. The collimator is located inside the applicator cap. The sterilization zone is configured to receive the distal portion of the substance sensor to be tested. The aforementioned applicator is A third sterile barrier that seals the interface between the collimator and the bottom of the mount, The system further comprises a fourth sterile barrier that seals the end of the sterilization zone, The sterilization zone is defined by the collimator, the second sterile barrier, the third sterile barrier, and the fourth sterile barrier. The method is, To seal the inside of the applicator, the applicator cap is coupled to the applicator housing. A step of sterilizing the sensor control device, the applicator, and the applicator cap, Methods that further include this.

30. The method according to claim 29, wherein the first fitting member extends from the shell into at least one of the first opening and the second opening.

31. The method according to claim 30, wherein the first fitting member is the concave surface of the shell.

32. The method according to claim 29, wherein the first fitting member extends from the mount into at least one of the first opening and the second opening.

33. The method according to claim 29, wherein the applicator cap is coupled to the applicator housing via a threaded surface.

34. The applicator further comprises a sealing portion located near the distal end of the collimator, The method according to claim 29, wherein the sealing portion prevents moisture from penetrating the sealing portion and entering the collimator without preventing electron beam radiation from penetrating the sealing portion and reaching the collimator.

35. The method according to claim 34, wherein the sealing portion includes a microbial barrier.

36. The method according to claim 29, wherein the collimator has a shape selected from the group consisting of a cone shape, a frustocone shape, a pyramidal shape, and any combination thereof.

37. The method according to claim 29, wherein the collimator has a cross-sectional shape selected from the group consisting of a circle, a shape corresponding to a cube, a rectangle, and any combination thereof.

38. The method according to claim 29, wherein the collimator has a generally semi-conical or semi-cylindrical shape.

39. The applicator cap further comprises a desiccant placed inside the applicator cap, The cross-section of the desiccant is aligned axially with the cross-section of the collimator. The method according to claim 38, wherein the cross-section of the desiccant has a cross-sectional shape substantially similar to the cross-sectional shape of the collimator.

40. The aforementioned sensor control device further comprises a circuit board and a sensor for the substance to be tested. The circuit board comprises a plurality of electronic component modules and is arranged in the internal space of the electronic component housing. The aforementioned sensor for the substance to be tested, A tail portion extends through the second opening and is configured to measure the level of a test substance in body fluids, It comprises a plurality of electrical contacts connected to the circuit board, and a flag-shaped portion disposed within the internal space of the electronic component housing, A neck portion that connects the tail portion and the flag-shaped portion, The method according to claim 29, comprising:

41. The method according to claim 40, wherein the circuit board is positioned in the internal space of the electronic component housing such that the central axis of the circuit board is positioned approximately offset from the tail portion of the substance sensor.

42. The method according to claim 40, wherein the circuit board is arranged in the internal space of the electronic component housing such that the approximate center point of the circuit board is not aligned with the collimator in the axial direction.

43. The method according to claim 29, wherein a first end of the further sterilization zone is demarcated by a sealing portion, and a second end of the further sterilization zone is demarcated by the pointed body hub.

44. The method according to claim 29, wherein in the sterilization step, the sensor control device is positioned at an angle to the axis of the electron beam path, which is the path through which high-energy electrons travel when the sensor control device is sterilized.

45. The method according to claim 44, wherein the angle is in the range of approximately 0 to 40 degrees.

46. The method according to claim 29, wherein the first sterile barrier is sealed with an adhesive.

47. The method according to claim 29, wherein the third sterile barrier is close to the proximal portion of the collimator.

48. The method according to claim 29, wherein the fourth sterile barrier is in close proximity to the distal portion of the collimator.

49. The method according to claim 40, wherein the sensor for the substance to be tested is isolated in the sterilization step.

50. The method according to claim 49, wherein the sensor for the substance to be tested is sterilized using low-energy electron beam sterilization.

51. The method according to claim 29, wherein in the sterilization step, the sensor control device, the applicator, and the applicator cap are exposed to an electron beam in the range of about 80 keV to about 700 keV.

52. The method according to claim 29, wherein in the sterilization step, the sensor control device, the applicator, and the applicator cap are exposed to an electron beam in the range of about 80 keV to about 300 keV.

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