Centralized sterilization and aseptic subassemblies for analyte monitoring systems

Abstract

To provide systems, devices, and methods for assembling an applicator and a sensor control device for use in an in vivo analyte monitoring system.SOLUTION: A system includes: a sensor applicator 102; a sensor control device 302 arranged within the sensor applicator and including an electronics housing and a sensor 316 extending from a bottom of the electronics housing; and a cap 210 coupled to one of the sensor applicator and the sensor control device, where the cap is removable prior to deploying the sensor control device from the sensor applicator.SELECTED DRAWING: Figure 6B

Description

[Background technology]

[0001] Diabetes is an incurable, chronic disease in which the body does not produce or properly use insulin, a hormone produced by the pancreas that regulates blood glucose. For example, when blood glucose levels increase after a meal, insulin reduces them by moving blood glucose from the blood into the body's cells. When the pancreas does not produce enough insulin (a condition known as Type I diabetes) or the body does not properly use insulin (a condition known as Type II diabetes), blood glucose remains in the blood, which is thought to potentially lead to hyperglycemia, or abnormally high blood sugar levels.

[0002] If the condition of diabetes is not carefully monitored and treated, many complications can occur, including diabetic ketoacidosis, nonketotic hyperosmolar coma, cardiovascular disease, stroke, renal failure, leg ulcers, eye injuries, and nerve damage. Traditionally, monitoring has involved an individual pricking a finger to draw blood and testing the blood for glucose levels. Recent advances have enabled continuous, long-term monitoring of blood glucose using biosensors that remain in contact with bodily fluids for periods of days, weeks, or longer.

[0003] For example, analyte monitoring systems have been developed to facilitate long-term monitoring of bodily fluid analytes, such as glucose. Analyte monitoring systems typically include a sensor applicator configured to place a biosensor in contact with the bodily fluid. More specifically, during delivery of the sensor to a user's skin, at least a portion of the sensor is positioned below the skin surface, for example, in the subcutaneous or dermal tissue.

[0004] It is important that devices implanted within the body or positioned under the skin be sterile upon insertion. Sterilization can include any number of processes that substantially remove or kill infectious agents, such as bacteria, fungi, and viruses, which, if not removed from the device, can be substantially harmful to the health and safety of the user.

[0005] Some, but not all, analyte monitoring systems may require separate sterilization processes to sterilize the sensor and electronic components. For example, electron beam sterilization is an example of radiation sterilization that can be used to extremely sterilize sensors. However, radiation sterilization can be harmful to the electronic components associated with the sensor. As a result, electronic components are typically sterilized through gaseous chemical sterilization, for example, using ethylene oxide. However, ethylene oxide can damage the chemical agent applied to the sensor. Therefore, integrating the electronics and sensor into one unit can complicate the sterilization process. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Patent No. 10,136,816 [Non-patent literature]

[0007] [Non-Patent Document 1] ISO / ASTM 51649:2005(E) "Standard Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies between 300 keV and 25 MeV" Summary of the Invention [Problem to be solved by the invention]

[0008] These problems can be avoided by separating the components into a sensor unit (e.g., a bioanalyte sensor) and an adapter unit (enclosing the data transmission electronics) so that each component can be packaged separately and sterilized using an appropriate sterilization method. However, this approach requires additional components, additional packaging, additional processing steps, and end-user assembly of the two components, introducing the possibility of user error. Thus, a need exists for an analyte monitoring system that can be sterilized without separating the components. [Brief explanation of the drawings]

[0009] The following figures are included to illustrate certain aspects of the present disclosure and should not be construed as limiting embodiments. The disclosed subject matter is capable of considerable modification, alteration, combination, and equivalents in form and function without departing from the scope of the present disclosure.

[0010] [Figure 1] FIG. 1 is a conceptual diagram depicting an exemplary analyte monitoring system that may incorporate one or more embodiments of the present disclosure. [Figure 2A] FIG. 2 is a stage diagram of assembly of the system of FIG. 1 incorporating a two-piece architecture. [Figure 2B] FIG. 2 is a stage diagram of assembly of the system of FIG. 1 incorporating a two-piece architecture. [Figure 2C] FIG. 2 is a stage diagram of assembly of the system of FIG. 1 incorporating a two-piece architecture. [Figure 2D] FIG. 2 is a stage diagram of assembly of the system of FIG. 1 incorporating a two-piece architecture. [Figure 2E] FIG. 2 is a stage diagram of assembly of the system of FIG. 1 incorporating a two-piece architecture. [Figure 2F] FIG. 2 illustrates an application of the system of FIG. 1 incorporating a two-piece architecture. [Figure 2G] FIG. 2 illustrates an application of the system of FIG. 1 incorporating a two-piece architecture. [Figure 3A] FIG. 1 is an isometric view of an exemplary sensor control device. [Figure 3B] FIG. 2 is a side view of an exemplary sensor control device. [Figure 4A] FIG. 3C is an isometric view of the plug assembly of FIGS. 3A-3B. [Figure 4B] FIG. 3C is an exploded view of the plug assembly of FIGS. 3A-3B. [Figure 5A] FIG. 3C is an exploded view of the electronic device housing of FIGS. 3A-3B. [Figure 5B] FIG. 4 is a bottom isometric view of the electronics housing of FIGS. 3A-3B. [Figure 6A] 2C is a side view of the sensor applicator of FIG. 1 coupled with the cap of FIG. 2B. [Figure 6B] 2C is a cross-sectional side view of the sensor applicator of FIG. 1 coupled with the cap of FIG. 2B. [Figure 7A] 6C is an enlarged cross-sectional side view of the sensor control device of FIG. 6B mounted within the cap of FIG. 6B. [Figure 7B] 6C is an enlarged cross-sectional side view of another embodiment of the sensor control device of FIG. 6B mounted within the sensor applicator of FIG. 6B. [Figure 8] FIG. 1 is a schematic diagram of an exemplary external sterilization assembly according to one or more embodiments of the present disclosure. [Figure 9] FIG. 1 is a schematic diagram of an exemplary external sterilization assembly according to one or more embodiments of the present disclosure. [Figure 10] FIG. 1 is a schematic diagram of an exemplary external sterilization assembly according to one or more embodiments of the present disclosure. [Figure 11] FIG. 1 is a schematic diagram of an exemplary external sterilization assembly according to one or more embodiments of the present disclosure. [Figure 12] FIG. 1 is a schematic diagram of an exemplary external sterilization assembly according to one or more embodiments of the present disclosure. [Figure 13]FIG. 1 is an isometric view of an exemplary sensor control device. [Figure 14A] FIG. 2 is a side view of the sensor applicator of FIG. 1. [Figure 14B] FIG. 14B is a cross-sectional side view of the sensor applicator of FIG. 14A. [Figure 15] 14B according to one or more additional embodiments. FIG. 14C is a cross-sectional side view of another exemplary embodiment of the sensor applicator of FIG. 14A and the external sterilization assembly of FIG. 14B according to one or more additional embodiments. [Figure 16] 14B in accordance with one or more additional embodiments. FIG. 14C is a cross-sectional side view of another exemplary embodiment of the sensor applicator of FIG. 14A and the external sterilization assembly of FIG. 14B in accordance with one or more additional embodiments. [Figure 17A] FIG. 14C is an isometric top view of an example external sterilization assembly of FIG. 14B according to one or more embodiments. [Figure 17B] FIG. 14C is an isometric bottom view of an example external sterilization assembly of FIG. 14B according to one or more embodiments. [Figure 18] FIG. 1 is an isometric view of an exemplary sensor control device. [Figure 19A] FIG. 2 is a side view of the sensor applicator of FIG. 1. [Figure 19B] FIG. 3B is a partial cross-sectional side view of the sensor applicator of FIG. 3A. [Figure 20A] 19C is a diagram of various views of the applicator insert of FIG. 19B in accordance with one or more embodiments of the present disclosure. [Figure 20B] 19C is a diagram of various views of the applicator insert of FIG. 19B in accordance with one or more embodiments of the present disclosure. [Figure 20C] 19C is a diagram of various views of the applicator insert of FIG. 19B in accordance with one or more embodiments of the present disclosure. [Figure 21] FIG. 19B is another cross-sectional side view of the sensor applicator of FIG. 19A illustrating a hybrid sterilization assembly according to one or more embodiments of the present disclosure. [Figure 22A] FIG. 26 is an isometric view of another embodiment of the applicator insert of FIGS. 20A-20C. [Figure 22B]FIG. 26 is a cross-sectional side view of another embodiment of the applicator insert of FIGS. 20A-20C. [Figure 23] FIG. 1 is a diagram of an exemplary analyte monitoring system that may incorporate one or more embodiments of the present disclosure. [Figure 24] FIG. 10 is a schematic diagram of an exemplary internal sterilization assembly according to one or more additional embodiments of the present disclosure. [Figure 25] FIG. 10 is a schematic diagram of another exemplary internal sterilization assembly according to one or more additional embodiments of the present disclosure. [Figure 26A] FIG. 1 is an isometric view of an exemplary sensor control device. [Figure 26B] FIG. 2 is a side view of an exemplary sensor control device. [Figure 27A] FIG. 26C is an isometric view of the plug assembly of FIGS. 26A-26B. [Figure 27B] FIG. 26C is an exploded view of the plug assembly of FIGS. 26A-26B. [Figure 27C] FIG. 16 is an exploded isometric bottom view of the plug and storage vial. [Figure 28A] FIG. 26C is an exploded view of the electronic device housing of FIGS. 26A-26B. [Figure 28B] FIG. 26C is a bottom isometric view of the electronics housing of FIGS. 26A-26B. [Figure 29A] 2C is a side view of the sensor applicator of FIG. 1 coupled with the cap of FIG. 2B. [Figure 29B] 2C is a cross-sectional side view of the sensor applicator of FIG. 1 coupled with the cap of FIG. 2B. [Figure 30] 29A-29B are perspective views of an exemplary embodiment of the cap of FIGS. 29A-29B. [Figure 31] FIG. 10 is a cross-sectional side view of a sensor control device positioned within a cap. [Figure 32A] FIG. 1 is an isometric view of an exemplary sensor control device. [Figure 32B] FIG. 2 is a side view of an exemplary sensor control device. [Figure 33A] FIG. 32C is an exploded perspective top view of the sensor control device of FIGS. 32A and 32B. [Figure 33B] FIG. 32C is an exploded perspective bottom view of the sensor control device of FIGS. 32A and 32B. [Figure 34A] 2C is a side view of the sensor applicator of FIG. 1 coupled with the cap of FIG. 2B. [Figure 34B] 2C is a cross-sectional side view of the sensor applicator of FIG. 1 coupled with the cap of FIG. 2B. [Figure 35] FIG. 10 is an enlarged cross-sectional side view of a sensor control device mounted within a sensor applicator. [Figure 36] FIG. 10 is an enlarged cross-sectional bottom view of a sensor control device mounted atop a cap post. [Figure 37A] FIG. 1 is an isometric view of an exemplary sensor control device. [Figure 37B] FIG. 2 is a side view of an exemplary sensor control device. [Figure 37C] FIG. 2 is a bottom view of an exemplary sensor control device. [Figure 38A] FIG. 37D is an isometric exploded top view of the sensor control device of FIGS. 37A-37C. [Figure 38B] FIG. 37D is an isometric exploded bottom view of the sensor control device of FIGS. 37A-37C. [Figure 39A] 37A-37C illustrate an exemplary assembly of the sensor control device. [Figure 39B] 37A-37C illustrate an exemplary assembly of the sensor control device. [Figure 39C] 37A-37C illustrate an exemplary assembly of the sensor control device. [Figure 39D] 37A-37C illustrate an exemplary assembly of the sensor control device. [Figure 40A] FIG. 37D is a side view of a sensor applicator with the pre-assembled sensor control device of FIGS. 37A-37C positioned thereon. [Figure 40B] FIG. 37D is a cross-sectional side view of a sensor applicator with the pre-assembled sensor control device of FIGS. 37A-37C disposed thereon. [Figure 41A]FIG. 10 is an enlarged cross-sectional view of a sensor control device during exemplary radiation sterilization. [Figure 41B] FIG. 10 is an enlarged cross-sectional view of a sensor control device during exemplary radiation sterilization. [Figure 42] FIG. 1 shows a plot graphically depicting approximate penetration depth for single-sided electron beam sterilization (or irradiation) treatment. [Figure 43] FIG. 37B is a cross-sectional side view of a sensor applicator having the pre-assembled sensor control device of FIGS. 37A-37C disposed thereon, according to one or more embodiments. [Figure 44] FIG. 2 is a side view of an exemplary sensor control device. [Figure 45] FIG. 45 is an exploded view of the sensor control device of FIG. 44. [Figure 46A] FIG. 46 is a cross-sectional side view of the assembled and sealed subassembly of FIG. 45 according to one or more embodiments. [Figure 46B] FIG. 45 is a cross-sectional side view of the fully assembled sensor control device of FIG. 44. [Figure 47A] 2C is a side view of the exemplary embodiment of the sensor applicator of FIG. 1 coupled with the cap of FIG. 2B. [Figure 47B] 2C is a cross-sectional side view of an exemplary embodiment of the sensor applicator of FIG. 1 coupled with the cap of FIG. 2B. [Figure 48] 47A-47B are perspective views of an exemplary embodiment of the cap of FIGS. 47A-47B. [Figure 49] FIG. 47C is a cross-sectional side view of a sensor control device positioned within the cap of FIGS. 47A-47B. [Figure 50A] FIG. 10 is an isometric view of another exemplary sensor control device. [Figure 50B] FIG. 10 is a side view of another exemplary sensor control device. [Figure 51A] FIG. 50C is an exploded isometric top view of the sensor control device of FIGS. 50A-B. [Figure 51B] FIG. 50C is an exploded isometric bottom view of the sensor control device of FIGS. 50A-50B. [Figure 52]FIG. 1 is a cross-sectional side view of an assembled and sealed subassembly according to one or more embodiments. [Figure 53A] 50A-50B. FIG. 50B is a cross-sectional side view illustrating the assembly of a sensor applicator with the sensor control device of FIGS. [Figure 53B] 50A-50B. FIG. 50B is a cross-sectional side view illustrating the assembly of a sensor applicator with the sensor control device of FIGS. [Figure 53C] 50A-50B. FIG. 50B is a cross-sectional side view illustrating the assembly of a sensor applicator with the sensor control device of FIGS. [Figure 54A] FIG. 53D is a perspective view of the cap post of FIG. 53C according to one or more additional embodiments. [Figure 54B] FIG. 53D is a top view of the cap post of FIG. 53C according to one or more additional embodiments. [Figure 55] FIG. 50C is a cross-sectional side view of the sensor control device of FIGS. 50A-50B positioned within the cap of FIGS. 12B-12C. [Figure 56A] FIG. 10 is a cross-sectional side view of a sensor applicator waiting to deploy a sensor control device at a target monitoring location. [Figure 56B] FIG. 10 is a cross-sectional side view of a sensor applicator waiting to deploy a sensor control device at a target monitoring location. [Figure 57A] 50A-50B are cross-sectional side views illustrating the assembly and disassembly of an exemplary embodiment of a sensor applicator having the sensor control device of FIGS. 50A-50B. [Figure 57B] 50A-50B are cross-sectional side views illustrating the assembly and disassembly of an exemplary embodiment of a sensor applicator having the sensor control device of FIGS. 50A-50B. [Figure 57C] 50A-50B are cross-sectional side views illustrating the assembly and disassembly of an exemplary embodiment of a sensor applicator having the sensor control device of FIGS. 50A-50B. [Figure 58A] FIG. 10 is an isometric bottom view of a housing according to one or more embodiments. [Figure 58B]FIG. 10 is an isometric bottom view of the housing with the sheath and other components at least partially positioned therein. [Figure 59] FIG. 2 is an enlarged cross-sectional side view of a sensor applicator having a sensor control device installed therein according to one or more embodiments. [Figure 60A] FIG. 1 is an isometric top view of a cap according to one or more embodiments. [Figure 60B] FIG. 10 is an enlarged cross-sectional view of the engagement between the cap and the housing according to one or more embodiments. [Figure 61A] FIG. 1 is an isometric view of a sensor cap according to one or more embodiments. [Figure 61B] FIG. 1 is an isometric view of a collar according to one or more embodiments. [Figure 62] FIG. 1 is an isometric top view of an exemplary sensor control device according to one or more embodiments of the present disclosure. [Figure 63] 1 is a schematic side view of an exemplary sensor applicator according to one or more embodiments of the present disclosure. [Figure 64A] FIG. 64 is an exploded isometric view of the sensor applicator and sensor control device of FIGS. 62 and 63. [Figure 64B] FIG. 64 is an exploded isometric view of the sensor applicator and sensor control device of FIGS. 62 and 63. [Figure 65A] 64A-64B depicting an exemplary deployment of a sensor control device according to one or more embodiments. [Figure 65B] 64A-64B depicting an exemplary deployment of a sensor control device according to one or more embodiments. [Figure 65C] 64A-64B depicting an exemplary deployment of a sensor control device according to one or more embodiments. [Figure 65D] 64A-64B depicting an exemplary deployment of a sensor control device according to one or more embodiments. [Figure 66] 65A-65D according to one or more embodiments. FIG. 65B is an enlarged cross-sectional side view of an engagement between the sensor holder and sensor control device of FIGS. 65A-65D according to one or more embodiments. [Figure 67] FIG. 63 is an exploded isometric view of another sensor applicator having the sensor control device of FIG. 62 in accordance with one or more additional embodiments. [Figure 68A] 68A-68C are staged cross-sectional side views of the sensor applicator of FIG. 67 depicting an exemplary deployment of a sensor control device according to one or more embodiments. [Figure 68B] 68A-68C are staged cross-sectional side views of the sensor applicator of FIG. 67 depicting an exemplary deployment of a sensor control device according to one or more embodiments. [Figure 68C] 68A-68C are staged cross-sectional side views of the sensor applicator of FIG. 67 depicting an exemplary deployment of a sensor control device according to one or more embodiments. [Figure 68D] 68A-68C are staged cross-sectional side views of the sensor applicator of FIG. 67 depicting an exemplary deployment of a sensor control device according to one or more embodiments. [Figure 69A] FIG. 10 is an enlarged schematic view of the sharp hub and fingers of the sensor holder. [Figure 69B] FIG. 10 is an enlarged schematic view of a finger interacting with an upper portion of a needle shroud. [Figure 69C] FIG. 10 is an enlarged schematic view of a finger interacting with an upper portion of a needle shroud. [Figure 70A] FIG. 10 is an enlarged cross-sectional side view of an exemplary engagement between a sensor holder and a sensor control device according to one or more embodiments. [Figure 70B] FIG. 10 is an enlarged cross-sectional side view of an exemplary engagement between a sensor holder and a sensor control device according to one or more embodiments. [Figure 71A] 1 is an isometric side view of an exemplary sensor holder according to one or more embodiments of the present disclosure. [Figure 71B] 1 is a cross-sectional side view of an exemplary sensor holder according to one or more embodiments of the present disclosure. [Figure 72A]FIG. 71C is an enlarged cross-sectional side view of the sensor holder of FIGS. 71A-71B holding a sensor control device according to one or more embodiments. [Figure 72B] FIG. 71C is an enlarged cross-sectional side view of the sensor holder of FIGS. 71A-71B holding a sensor control device according to one or more embodiments. [Figure 73A] FIG. 1 is a side view of an exemplary sensor applicator according to one or more embodiments. [Figure 73B] FIG. 1 is a cross-sectional side view of an exemplary sensor applicator according to one or more embodiments. [Figure 74A] FIG. 73C is an isometric top view of the inner applicator cover of FIG. 73B. [Figure 74B] FIG. 73C is an isometric bottom view of the inner applicator cover of FIG. 73B. [Figure 75] FIG. 73C is an isometric view of an exemplary embodiment of the sensor cap of FIG. 73B according to one or more embodiments. [Figure 76] FIG. 76 is an isometric cross-sectional side view of the sensor cap of FIG. 75 received by the inner applicator cover of FIGS. 74A-74B according to one or more embodiments. [Figure 77] 74A-74B illustrate the stepwise removal of the applicator cap of FIG. 73A and the inner applicator cover of FIGS. 74A-74B from the sensor applicator of FIGS. 73A-73B according to one or more embodiments. [Figure 78] 10 is a schematic diagram of an exemplary sensor applicator according to one or more additional embodiments of the present disclosure. [Figure 79] FIG. 10 is an exploded view of an exemplary sensor control device according to one or more additional embodiments. [Figure 80] FIG. 80 is a bottom view of one embodiment of the sensor control device of FIG. 79. [Figure 81A] FIG. 1 is an isometric view of a sensor control device in accordance with one or more embodiments of the present disclosure. [Figure 81B] FIG. 1 is a side view of a sensor control device in accordance with one or more embodiments of the present disclosure. [Figure 82]FIG. 82 is an exploded perspective top view of the sensor control device of FIG. 81. [Figure 83] FIG. 81B is a perspective cross-sectional side view of an exemplary sensor control device assembly including the sensor control device of FIG. 81A mounted within a sensor applicator compatible with the analyte monitoring system of FIG. 1. [Figure 84] FIG. 84 is an enlarged cross-sectional side view of the sensor control device assembly of FIG. 83. [Figure 85] FIG. 84 is a bottom view of some of the components of the sensor control device assembly of FIG. 83, including the sensor control device held in the sensor carrier of the sensor applicator. [Figure 86] FIG. 1 is a schematic diagram of an exemplary sterilization assembly according to one or more embodiments of the present disclosure. [Figure 87] FIG. 1 is a schematic diagram of another exemplary sterilization assembly according to one or more embodiments of the present disclosure. [Figure 88A] FIG. 1 is a schematic bottom view of another exemplary sterilization assembly according to one or more embodiments of the present disclosure. [Figure 88B] FIG. 88B is a schematic bottom view of an alternative embodiment of the sterilization assembly of FIG. 88A in accordance with one or more additional embodiments of the present disclosure. [Figure 88C] FIG. 88B is a schematic bottom view of an alternative embodiment of the sterilization assembly of FIG. 88A in accordance with one or more additional embodiments of the present disclosure. [Figure 89] 1 is a schematic isometric view of an exemplary sensor control device according to one or more embodiments. [Figure 90] FIG. 1 is a schematic diagram of another sterilization assembly according to one or more embodiments. [Figure 91A] FIG. 1 is a side view of an exemplary sensor control device in accordance with one or more embodiments of the present disclosure. [Figure 91B] FIG. 1 is an isometric view of an exemplary sensor control device in accordance with one or more embodiments of the present disclosure. [Figure 92A] FIG. 3 is an exploded isometric top view of the sensor control device of FIG. 2 according to one or more embodiments. [Figure 92B]FIG. 3 is an exploded isometric bottom view of the sensor control device of FIG. 2 according to one or more embodiments. [Figure 93] 91A-91B and 92A-92B according to one or more embodiments. FIG. [Figure 93A] FIG. 92C is an exploded isometric view of a portion of another embodiment of the sensor control device of FIGS. 91A-91B and 92A-92B. [Figure 94A] FIG. 1 is an isometric bottom view of the mount. [Figure 94B] FIG. 92C is an isometric top view of the sensor cap of FIGS. 91A-91B and 92A-92B. [Figure 95A] FIG. 1 is a side view of an exemplary sensor applicator according to one or more embodiments. [Figure 95B] FIG. 1 is a cross-sectional side view of an exemplary sensor applicator according to one or more embodiments. [Figure 96A] FIG. 95C is a perspective view of the cap post of FIG. 95B according to one or more embodiments. [Figure 96B] FIG. 95C is a top view of the cap post of FIG. 95B according to one or more embodiments. [Figure 97] FIG. 1 is a cross-sectional side view of a sensor control device positioned within an applicator cap according to one or more embodiments. [Figure 98] 1 is a cross-sectional view of a sensor control device illustrating an exemplary interaction between a sensor and a sharp body. [Figure 99] FIG. 10 is a cross-sectional side view of an exemplary analyte monitoring system enclosure used to house at least a portion of a sensor control device. [Figure 100A] FIG. 100 is an enlarged cross-sectional side view of the interface between the sensor applicator and the cap indicated by the dashed box in FIG. 99. [Figure 100B] FIG. 99 is an enlarged cross-sectional side view of the interface between the sensor applicator and the cap indicated by the dashed box in FIG. 99 during or after gaseous chemical sterilization. [Figure 101]FIG. 2 is a cross-sectional side view of another exemplary analyte monitoring system enclosure used to house at least a portion of the sensor control device of FIG. 1. [Figure 102A] 10A-10C provide finite element analysis results corresponding to the interface between the housing and the cap during an exemplary gaseous chemical sterilization. [Figure 102B] 10A-10C provide finite element analysis results corresponding to the interface between the housing and the cap during an exemplary gaseous chemical sterilization. [Figure 102C] 10A-10C provide finite element analysis results corresponding to the interface between the housing and the cap during an exemplary gaseous chemical sterilization. [Figure 103] FIG. 1 is an isometric view of an exemplary sensor control device. [Fig. 104A-B] FIG. 104 is an exploded isometric view of the sensor control device of FIG. 103 according to one or more embodiments. [Figure 105] FIG. 104C is a cross-sectional side view of the assembled sensor control device of FIGS. 104A-104B according to one or more embodiments. [Figure 106] FIG. 10 is an isometric view of another exemplary sensor control device. [Figure 107A-B] FIG. 107 is an exploded isometric view of the sensor control device of FIG. 106 according to one or more embodiments. [Figure 108] FIG. 107C is a cross-sectional side view of the assembled sensor control device of FIGS. 107A-107B according to one or more embodiments. [Figure 109] 1 is an isometric view of an exemplary conversion process for manufacturing a sensor control device according to the principles of the present disclosure. [Figure 110A] 109 according to one or more embodiments. FIG. [Figure 110B] 109 according to one or more embodiments. FIG. [Figure 110C] 109 according to one or more embodiments. FIG. [Figure 110D]109 according to one or more embodiments. FIG. [Figure 110E] 109 according to one or more embodiments. FIG. [Figure 111A] FIG. 109 is a top view of the sensor control device of FIG. 109 in preparation for pressure testing and / or vacuum sealing in accordance with one or more embodiments. [Figure 111B] FIG. 110 is a cross-sectional side view of the sensor control device of FIG. 109 having a compressor. [Figure 112] FIG. 1 is a partial cross-sectional side view of an exemplary sensor control device according to one or more embodiments. [Figure 113] FIG. 1 is a cross-sectional side view of an exemplary sensor applicator according to one or more embodiments. [Figure 114A] FIG. 27C is a top perspective view of an exemplary embodiment of the plug of FIGS. 27A-27B. [Figure 114B] FIG. 27C is a bottom perspective view of the exemplary embodiment of the plug of FIGS. 27A-27B. [Figure 115A] FIG. 27C is a perspective view depicting an exemplary embodiment of the connector of FIGS. 27A-27B in an open state. [Figure 115B] FIG. 27C is a perspective view depicting an exemplary embodiment of the connector of FIGS. 27A-27B in a closed state. [Figure 116] FIG. 27C is a perspective view of an exemplary embodiment of the sensor of FIGS. 27A-27B. [Figure 117A] FIG. 1 is a bottom perspective view illustrating an exemplary embodiment of a sensor module assembly. [Figure 117B] FIG. 1 is a top perspective view depicting an exemplary embodiment of a sensor module assembly. [Figure 118A] FIG. 114C is an enlarged partial view of an exemplary embodiment of the sensor plug of FIGS. 114A-B having an axial stiffening feature. [Figure 118B] FIG. 114C is an enlarged partial view of an exemplary embodiment of the sensor plug of FIGS. 114A-B having an axial stiffening feature. [Figure 119]FIG. 1 is a side view of an exemplary sensor according to one or more embodiments of the present disclosure. [Figure 120A] FIG. 1 is an isometric view of an exemplary connector assembly according to one or more embodiments. [Figure 120B] FIG. 1 is a partially exploded isometric view of an exemplary connector assembly according to one or more embodiments. [Figure 120C] FIG. 12C is an isometric bottom view of the connector of FIGS. 120A-120B. [Figure 121A] FIG. 10 is an isometric view of another exemplary connector assembly according to one or more embodiments. [Figure 121B] FIG. 10 is a partially exploded isometric view of another exemplary connector assembly according to one or more embodiments. [Figure 121C] FIG. 121C is an isometric bottom view of the connector of FIGS. 121A-121B. DETAILED DESCRIPTION OF THE INVENTION

[0011] FIELD OF THE INVENTION This application relates generally to systems, devices, and methods for assembling applicators and sensor control devices for use in in-vivo analyte monitoring systems.

[0012] 1 is a conceptual diagram depicting an exemplary analyte monitoring system 100 that can incorporate one or more embodiments of the present disclosure. System 100 (hereinafter "system 100") can be used to detect and quantify a variety of analytes, including, but not limited to, acetylcholine, amylase, bilirubin, cholesterol, human chorionic gonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA, fructosamine, glucose, glutamine, growth hormone, hormones, ketones (e.g., ketone bodies), lactate, oxygen, peroxide, prostate-specific antigen, prothrombin, RNA, thyroid-stimulating hormone, and troponin. Concentrations of drugs, such as, but not limited to, antibiotics (e.g., gentamicin and vancomycin), digitoxin, digoxin, drugs of abuse, theophylline, and warfarin, can be determined.

[0013] As shown, system 100 includes a sensor applicator 102 (alternatively referred to as an "inserter"), a sensor control device 104 (also referred to as an "in vivo analyte sensor control device"), and a reader device 106. The sensor applicator 102 is used to deliver the sensor control device 104 to a target monitoring location on a user's skin (e.g., the user's arm). Once delivered, the sensor control device 104 is maintained in place on the skin by an adhesive patch 108 coupled to its bottom. A portion of a sensor 110 extends from the sensor control device 104 and is positioned so that it can be transcutaneously positioned below the surface of the user's skin during a monitoring period and can be otherwise held.

[0014] An introducer can be included to facilitate the introduction of the sensor 110 into tissue. The introducer can include, for example, a needle, often referred to as a "point." Alternatively, the introducer can include other types of devices, such as a sheath or blade. The introducer can be temporarily present near the sensor 110 prior to tissue insertion and then withdrawn. While present, the introducer can facilitate the insertion of the sensor 110 into tissue by opening an access passage for the sensor 110 to follow. For example, the introducer can penetrate the epidermis to provide an access passage into the dermis to allow subcutaneous implantation of the sensor 110. After opening the access passage, the introducer can be withdrawn (retracted) so that it does not cause harm while the sensor 110 remains in place. In the illustrated embodiment, the introducer can be solid or hollow, beveled or not, and / or circular or non-circular in cross section. In more specific embodiments, a suitable introducer may be comparable in cross-sectional diameter and / or tip design to an acupuncture needle, which may have a cross-sectional diameter of about 250 microns, although a suitable introducer may have a larger or smaller cross-sectional diameter depending on the needs of a particular application.

[0015] In some embodiments, the tip of the introducer (while present) can be angled over the end of the sensor 110 so that the introducer penetrates the tissue first to open an access passage for the sensor 110. In other exemplary embodiments, the sensor 110 can reside within a lumen or channel in the introducer, which also opens an access passage for the sensor 110. In either case, the introducer is withdrawn after facilitating insertion of the sensor 110. Additionally, the introducer (sharp) can be made of a variety of materials, for example, various types of metals and plastics.

[0016] Once the sensor control device 104 is properly assembled, the sensor 110 is placed in communication (e.g., electrical, mechanical, etc.) with one or more electronic components or sensor electronics contained within the sensor control device 104. In some applications, for example, the sensor control device 104 may include a printed circuit board (PCB) having a data processor (e.g., an application specific integrated circuit or ASIC) mounted thereon, and the sensor 110 may be operatively coupled to the data processor, which may further be coupled to an antenna and a power source.

[0017] The sensor control device 104 and the reader device 106 are configured to communicate with each other through a one-way or two-way encrypted or unencrypted local communication path or link 112. According to some embodiments, the reader device 106 provides an output medium for viewing analyte concentrations and alerts or notifications determined by the sensor 110 or its associated processor, and may also allow for one or more user inputs. The reader device 106 may be a general-purpose smart phone or a dedicated electronic reader instrument. Although only one reader device 106 is shown, in certain instances, multiple reader devices 106 may be present.

[0018] The reader device 106 may communicate with the remote terminal 114 and / or the trusted computer system 116 over communication paths / links 118 and / or 120, respectively, which may be wired or wireless, one-way or two-way, encrypted or unencrypted. Additionally or alternatively, the reader device 106 may communicate with a network 122 (e.g., a cellular network, the Internet, or a cloud server) over communication path / link 124. The network 122 may further be communicatively coupled to the remote terminal 114 over communication path / link 126 and / or to the trusted computer system 116 over communication path / link 128.

[0019] Alternatively, the sensor control device 104 may communicate directly with the remote terminal 114 and / or trusted computer system 116 without the presence of an involved reader device 106. For example, according to some embodiments, the sensor 110 may communicate with the remote terminal 114 and / or trusted computer system 116 through a direct communications link to the network 122 as described in U.S. Pat. No. 10,136,816, the entire contents of which are incorporated herein by reference.

[0020] Any suitable electronic communication protocol may be used for each communication path or link, such as near field communication (NFC), radio frequency identification (RFID), BLUETOOTH® protocol or BLUETOOTH® low energy protocol, WiFi, etc. According to some embodiments, the remote terminal 114 and / or trusted computer system 116 may be accessible by individuals other than the primary user who may have an interest in the user's analyte levels. The reader device 106 may include a display 130 and an optional input component 132. According to some embodiments, the display 130 may include a touch screen interface.

[0021] In some embodiments, the sensor control device 104 can automatically communicate data to the reader device 106. For example, analyte concentration data can be automatically and periodically communicated, such as when data is obtained or at a predetermined frequency after a predetermined period of time has passed, with the data stored in memory until transmission (e.g., every minute, every five minutes, or other predetermined period of time). In other embodiments, the sensor control device 104 can communicate with the reader device 106 in a non-automatic manner and not according to a set schedule. For example, data can be communicated from the sensor control device 104 using RFID technology when the sensor electronics are brought into communication range of the reader device 106. The data can remain stored in the memory of the sensor control device 104 until communicated to the reader device 106. Thus, the patient need not constantly maintain close proximity to the reader device 106 and can instead upload data at a convenient time. In still other embodiments, a combination of automatic and non-automatic data communication can be implemented. For example, data transmission may continue on an automatic basis until the reader device 106 is no longer within communication range of the sensor control device 104 .

[0022] The sensor control device 104 is often included with a sensor applicator in what is known as a "two-piece" architecture, which requires final assembly by the user before the sensor 110 can be properly delivered to a target monitoring location. More specifically, the sensor 110 and associated electronic components contained within the sensor control device 104 are provided to the user in multiple (two) packages, and the user must unpack the packages and manually assemble these components according to instructions before using the sensor applicator 102 to deliver the sensor 110 to a target monitoring location.

[0023] More recently, however, advanced designs of sensor control devices and sensor applicators have resulted in a one-piece architecture that allows the system to be shipped to the user in a single sealed package that does not require any end-user assembly steps. Instead of performing an end-user assembly step, the user simply unpacks the single package and then delivers the sensor control device to the target monitoring location. The one-piece system architecture has proven advantageous by eliminating component parts, various fabrication process steps, and user assembly steps. This results in reduced packaging and waste, and mitigates the possibility of user error or contamination of the system.

[0024] In the illustrated embodiment, system 100 may include what is known as a "two-piece" architecture, which requires final assembly by the user before sensor 110 can be properly delivered to the target monitoring location. More specifically, sensor 110 and associated electronic components contained within sensor control device 104 are provided to the user in multiple (two) packages, each of which may or may not be sealed with a sterile barrier, but which are at least closed upon packaging. The user must unpack the packages, manually assemble the components according to the instructions, and then deliver sensor 110 to the target monitoring location using sensor applicator 102.

[0025] 2A-2G illustrate the assembly and application of system 100 incorporating a two-piece architecture. FIGS. 2A and 2B show the first and second packages, respectively, provided to a user for final assembly. More specifically, FIG. 2A shows a sensor container or sensor tray 202 having a removable lid 204. A user prepares sensor tray 202 by removing lid 204, which acts as a sterile barrier to protect the contents of sensor tray 202 and otherwise maintains a sterile internal environment. Removal of lid 204 exposes platform 206 positioned within sensor tray 202, within which plug assembly 207 (partially visible) is positioned and strategically embedded. Plug assembly 207 includes a sensor module (not shown) and a tip module (not shown). The sensor module carries the sensor 110 (FIG. 1), and the tip module carries the associated tip that is used to assist in transcutaneously delivering the sensor 110 under the user's skin during application of the sensor control device 104 (FIG. 1).

[0026] 2B shows the sensor applicator 102 and where a user prepares the sensor applicator 102 for final assembly. The sensor applicator 102 includes a housing 208 sealed at one end with an applicator cap 210. In some embodiments, for example, an O-ring or another type of sealing gasket can seal the interface between the housing 208 and the applicator cap 210. In at least one embodiment, the O-ring or sealing gasket can be molded onto one of the housing 208 and the applicator cap 210. The applicator cap 210 provides a barrier to protect the contents of the sensor applicator 102. In particular, the sensor applicator 102 contains an electronics housing (not shown) that holds the electronic components for the sensor control device 104 (FIG. 1), and the applicator cap 210 may or may not maintain a sterile environment for these electronic components. Preparation of the sensor applicator 102 includes separating the housing 208 from the applicator cap 210, which can be accomplished by unscrewing the applicator cap 210 from the housing 208. The applicator cap 210 can then be disposed of or otherwise set aside.

[0027] 2C depicts a user inserting sensor applicator 102 into sensor tray 202. Sensor applicator 102 includes sheath 212 configured to be received by platform 206, with sheath 212 temporarily unlocked from housing 208, which in turn temporarily unlocks platform 206 from sensor tray 202. By advancing housing 208 into sensor tray 202, plug assembly 207 (FIG. 2A), which is positioned within sensor tray 202 and includes a sensor module and a tip module, is coupled to an electronics housing positioned within sensor applicator 102.

[0028] In FIG. 2D, the user removes sensor applicator 102 from sensor tray 202 by retracting housing 208 proximally relative to sensor tray 202 .

[0029] 2E shows the bottom or interior of sensor applicator 102 after removal from sensor tray 202 (FIG. 2). Sensor applicator 102 is removed from sensor tray 202 with sensor control device 104 fully assembled therein and positioned for delivery to a target monitoring location. As shown, a tip 220 extends from the bottom of sensor control device 104 and carries a portion of sensor 110 within its hollow or recessed portion. Tip 220 is configured to pierce a user's skin, thereby placing sensor 110 in contact with bodily fluids.

[0030] 2F and 2G illustrate an exemplary delivery of the sensor control device 104 to a target monitoring location 222, such as the back of a user's arm. FIG. 2F shows the user advancing the sensor applicator 102 toward the target monitoring location 222. After engaging the skin at the target monitoring location 222, the sheath 212 retracts into the housing 208, thereby allowing the sensor control device 104 (FIGS. 2E and 2G) to advance into engagement with the skin. With the assistance of the point 220 (FIG. 2E), the sensor 110 (FIG. 2E) is advanced percutaneously into the patient's skin at the target monitoring location 222.

[0031] 2G shows the user retracting the sensor applicator 102 from the target monitoring location, with the sensor control device 104 successfully adhered to the user's skin. An adhesive patch 108 (FIG. 1) affixed to the bottom of the sensor control device 104 adheres to the skin, securing the sensor control device 104 in place. When the housing 208 is fully advanced to the target monitoring location 222, the tip 220 (FIG. 2E) automatically retracts, while the sensor 110 (FIG. 2E) remains in place to measure the analyte level.

[0032] In a two-piece architecture system, the sensor tray 202 (FIG. 2A) and the sensor applicator 102 (FIG. 2B) are provided to the user in separate packages, thus requiring the user to unpack each package and ultimately assemble the system. In some applications, the separate sealed packages allow the sensor tray 202 and the sensor applicator 102 to be sterilized in separate sterilization processes that are unique to the contents of each package and are otherwise incompatible with the contents of the other.

[0033] More specifically, the sensor tray 202, which includes the plug assembly 207 (FIG. 2A), including the sensor 110 (FIGS. 1 and 2E) and the sharp 220 (FIG. 2E), can be sterilized using radiation sterilization, such as electron beam (or “e-beam”) irradiation. However, radiation sterilization may damage electronic components positioned within the electronics housing of the sensor control device 104. Therefore, depending on the need to sterilize the sensor applicator 102, which encloses the electronics housing of the sensor control device 104, the sensor applicator 102 can be sterilized by another method, such as gaseous chemical sterilization using, for example, ethylene oxide. However, gaseous chemical sterilization may damage enzymes or other chemicals and biologicals contained on the sensor 110. Due to this sterilization incompatibility, the sensor tray 202 and the sensor applicator 102 can be sterilized in separate sterilization processes and then packaged separately, thus requiring final assembly of the components by the user upon receipt.

[0034] In accordance with an embodiment of the present disclosure, system 100 (FIG. 1) can include a one-piece architecture that incorporates sterilization techniques specifically designed for the one-piece architecture. The one-piece architecture allows system 100 to be shipped to a user in a single, sealed package that does not require any end-user assembly steps. Instead of performing an end-user assembly step, the user need only unpack the single package and then deliver the sensor control device to the target monitoring location as generally described above with reference to FIGS. 2E-2G. The one-piece system architecture described herein has been found to be advantageous by eliminating component parts, various fabrication process steps, and user assembly steps. This results in reduced packaging and waste, and mitigates the possibility of user error or system contamination.

[0035] Collimated electron beam sterilization 3A and 3B are isometric and side views, respectively, of an exemplary sensor control device 302 in accordance with one or more embodiments of the present disclosure. The sensor control device 302 (alternatively referred to as a "puck") may be similar in some respects to the sensor control device 104 of FIG. 1 and, therefore, may be best understood with reference thereto. The sensor control device 302 may replace the sensor control device 104 of FIG. 1 and, therefore, may be used in conjunction with a sensor applicator 102 (FIG. 1) that delivers the sensor control device 302 to a target monitoring location on a user's skin.

[0036] However, the sensor control device 302 can be incorporated into a one-piece system architecture. Unlike a two-piece architecture system, for example, a user is not required to unpack multiple packages and finally assemble the sensor control device 302. Instead of requiring final assembly, the sensor control device 302 is already fully assembled and properly positioned within the sensor applicator 102 upon receipt by the user. To use the sensor control device 302, a user need only break a single barrier (e.g., applicator cap 210 in FIG. 2B ) before immediately dispatching the sensor control device 302 to a target monitoring location.

[0037] As shown, the sensor control device 302 includes an electronics housing 304 that may be generally disc-shaped and have a circular cross-section. However, in other embodiments, the electronics housing 304 may exhibit other cross-sectional shapes, such as an oval (e.g., pill-shaped), rounded square, or polygonal, without departing from the scope of the present disclosure. The electronics housing 304 may be configured to house or otherwise enclose various electrical components used to operate the sensor control device 302.

[0038] The electronics housing 304 may include a shell 306 and a mateable mount 308. The shell 306 may be secured to the mount 308 in various manners, such as by a snap-fit ​​engagement, an interference fit, sonic welding, or one or more mechanical fasteners (e.g., screws). In some cases, the shell 306 may be secured to the mount 308 such that a sealed interface occurs between the shell 306 and the mount 308. In such embodiments, a gasket or other type of sealing material may be disposed at or near the outer diameter (periphery) of the shell 306 and the mount 308, and the two components may be secured together to compress the gasket, thereby creating a sealed interface. In other embodiments, an adhesive may be applied to the outer diameter (periphery) of one or both of the shell 306 and the mount 308. The adhesive secures the shell 306 to the mount 308, providing structural integrity, but may also seal the interface between the two components, thereby isolating the interior of the electronics housing 304 from external contamination. If the sensor control device 302 is assembled in a controlled environment, it may not be necessary to terminally sterilize the internal electrical components. In lieu of sterilization, adhesive bonding can provide a sufficient sterile barrier to the assembled electronics housing 304.

[0039] The sensor control device 302 may further include a plug assembly 310 that can be coupled to the electronics housing 304. The plug assembly 310 may be similar in some respects to the plug assembly 207 of FIG. 2A . For example, the plug assembly 310 may include a sensor module 312 (partially visible) that is interconnectable with a tip module 314 (partially visible). The sensor module 312 may be configured to carry and include a sensor 316 (partially visible), and the tip module 314 may be configured to carry and include a tip 318 (partially visible) that is used to assist in transcutaneously delivering the sensor 316 beneath the user's skin during application of the sensor control device 302. As shown, corresponding portions of the sensor 316 and tip 318 extend from the electronics housing 304, and more specifically, from the bottom of the mount 308. An exposed portion of the sensor 316 may be received within a hollow or recessed portion of the tip 318. The remainder of the sensor 316 is positioned within the electronics housing 304 .

[0040] 4A and 4B are isometric and exploded views, respectively, of a plug assembly 310 according to one or more embodiments. The sensor module 312 can include a sensor 316, a plug 402, and a connector 404. The plug 402 can be designed to receive and support both the sensor 316 and the connector 404. As shown, a channel 406 can be defined through the plug 402 for receiving a portion of the sensor 316. Additionally, the plug 402 can provide one or more deflectable arms 407 configured to snap into corresponding features provided on the bottom of the electronics housing 304 (FIGS. 3A-3B).

[0041] The sensor 316 includes a tail 408, a flag 410, and a neck 412 interconnecting the tail 408 and the flag 410. The tail 408 can be configured to extend at least partially through the channel 406 and further extend distally from the plug 402. The tail 408 includes an enzyme or other chemical or biological agent, and in some embodiments, a membrane can cover the chemical agent. In use, the tail 408 is transdermally received under the user's skin, and the chemical agent contained on the tail 408 helps to facilitate analyte monitoring in the presence of bodily fluids.

[0042] The flag 410 may include a generally flat surface on which sensor contacts 414 (three are shown in FIG. 4B) are positioned. The sensor contacts 414 may be configured to align with a corresponding number of compliant carbon-impregnated polymer modules (not shown) enclosed within the connector 404.

[0043] The connector 404 includes one or more hinges 418 that allow it to move between an open and a closed state. While FIGS. 4A-4B show the connector 404 in a closed state, the connector 404 can pivot to the open state to receive the flag 410 and compliant carbon-impregnated polymer module therein. The compliant carbon-impregnated polymer module provides electrical contacts 420 (three shown) configured to provide conductive communication between the sensor 316 and corresponding circuit contacts provided within the electronics housing 304 ( FIGS. 3A-3B ). The connector 404 can be fabricated from silicone rubber and can act as a moisture barrier to the sensor 316 when assembled in a compressed state and after application to the user's skin.

[0044] The sharps module 314 includes a sharp 318 and a sharp hub 422 that carries the sharp 318. The sharp 318 includes an elongate shaft 424 and a sharp tip 426 at its distal end. The shaft 424 can be configured to extend through the channel 406 and further extend distally from the plug 402. Additionally, the shaft 424 can include a hollow or recessed portion 428 that at least partially surrounds the tail 408 of the sensor 316. The sharp tip 426 can be configured to pierce the skin while carrying the tail 408 to place the active chemical present on the tail 408 into contact with bodily fluids.

[0045] The sharp body hub 422 can include a hub mini-cylinder 430 and a hub snap pawl 432, each of which can be configured to assist in coupling the plug assembly 310 (and the overall sensor control device 302) to the sensor applicator 102 (FIG. 1).

[0046] 5A and 5B are exploded and bottom isometric views, respectively, of electronics housing 304 according to one or more embodiments. Shell 306 and mount 308 act as opposing clamshell halves that surround or otherwise substantially enclose the various electronic components of sensor control device 302 (FIGS. 3A-3B).

[0047] A printed circuit board (PCB) 502 may be disposed within the electronics housing 304. The PCB 502 may be populated with a plurality of electronic modules (not shown), including, but not limited to, a data processing unit, registers, transistors, capacitors, inductors, diodes, and switches. The data processing unit may include, for example, an application specific integrated circuit (ASIC) configured to perform one or more functions or routines associated with the operation of the sensor control device 302. More specifically, the data processing unit may be configured to perform data processing functions, where such functions may include, but are not limited to, filtering and encoding a plurality of data signals, each corresponding to a sampled analyte level of a user. The data processing unit may include an antenna for communicating with or otherwise in communication with the reader device 106 (FIG. 1).

[0048] As shown, shell 306, mount 308, and PCB 502 each define corresponding central openings 504, 506, and 508, respectively. When electronics housing 304 is assembled, central openings 504, 506, and 508 coaxially align to receive plug assembly 310 (FIGS. 4A-4B). Battery 510 can be housed within electronics housing 304 and configured to power sensor control device 302.

[0049] In FIG. 5B , a plug receptacle 512 can be defined within the bottom of the mount 308, providing a location where the plug assembly 310 ( FIGS. 4A-4B ) can be received and coupled to the electronics housing 304, thereby fully assembling the sensor control device 302 ( FIGS. 3A-3B ). The profile of the plug 402 ( FIGS. 4A-4B ) can be shaped to match or complement the plug receptacle 512, which can provide one or more snap-engagement ledges 514 (two shown) configured to interface with and receive the deflectable arm 407 ( FIGS. 4A-4B ) of the plug 402. The plug assembly 310 is coupled to the electronics housing 304 by advancing the plug 402 into the plug receptacle 512, allowing the deflectable arm 407 to lock into the corresponding snap-engagement ledge 514. With the plug assembly 310 (FIGS. 4A-4B) properly coupled to the electronics housing 304, one or more circuit contacts 516 (three shown) defined on the underside of the PCB 502 can be in conductive communication with electrical contacts 420 (FIGS. 4A-4B) of the connector 404 (FIGS. 4A-4B).

[0050] 6A and 6B are side and cross-sectional side views, respectively, of the sensor applicator 102 with the applicator cap 210 coupled thereto. More specifically, FIGS. 6A-6B illustrate how the sensor applicator 102, according to at least one embodiment, may be shipped to and received by a user. However, in some embodiments, the sensor applicator 102 may be further sealed in a bag (not shown) and delivered to a user in that state. The bag may be made of various materials that help prevent moisture migration into the sensor applicator 102, which may adversely affect the sensor 316. In at least one embodiment, for example, the sealed back may be made of foil. Any and all of the sensor applicators described or disclosed herein may be sealed in a bag and delivered to a user in that state.

[0051] In accordance with the present disclosure and as seen in FIG. 6B, the sensor control device 302 is already assembled and installed within the sensor applicator 102 before being delivered to a user. The applicator cap 210 can be threaded onto the housing 208 and can include a tamper-evident ring 602. When the applicator cap 210 is rotated (e.g., twisted off) relative to the housing 208, the tamper-evident ring 602 threads off, thereby freeing the applicator cap 210 from the sensor applicator 102. The user can then deliver the sensor control device 302 to a target monitoring location as generally described above with reference to FIGS. 2E-2G.

[0052] In some embodiments, as described above, the applicator cap 210 can be secured to the housing 208 by a sealing engagement to protect the internal components of the sensor applicator 102. In at least one embodiment, for example, an O-ring or another type of sealing gasket can seal the interface between the housing 208 and the applicator cap 210. The O-ring or sealing gasket can be a separate component part or alternatively can be cast onto one of the housing 208 and the applicator cap 210.

[0053] The housing 208 can be made of a variety of rigid materials. In some embodiments, for example, the housing 208 can be made of a thermoplastic polymer such as polyketone. In other embodiments, the housing 208 can be made of a cyclic olefin copolymer (COC), which can help prevent moisture migration into the interior of the sensor applicator 102. As will be appreciated, any and all of the housings described or discussed herein can be made of polyketone or COC.

[0054] 6B, the sensor control device 302 can be loaded into the sensor applicator 102 by mating the sharp body hub 422 with a sensor carrier 604 included in the sensor applicator 102. With the sensor control device 302 mated with the sensor carrier 604, the applicator cap 210 can then be secured to the sensor applicator 102.

[0055] In the illustrated embodiment, a collimator 606 is positioned within the applicator cap 210 and may generally serve to support the sensor control device 302 while it is enclosed within the sensor applicator 102. In some embodiments, the collimator 606 may form an integral part or extension of the applicator cap 210, such as by being cast with or overmolded onto the applicator cap 210. In other embodiments, the collimator 606 may comprise a separate structure fitted within or attached to the applicator cap 210 without departing from the scope of this disclosure. In still other embodiments, the collimator 606 may be omitted from the packaging received by the user, but may otherwise be used during sterilization and preparation of the sensor applicator 102 for delivery, as discussed below.

[0056] The collimator 606 can be designed to help receive and protect portions of the sensor control device 302 that need to be sterilized, and also to isolate the sterile components of the sensor applicator 102 from microbial contamination from elsewhere within the sensor control device 302. To achieve this design, the collimator 606 can define or otherwise provide a sterile zone 608 (alternatively referred to as a "sterile barrier enclosure" or "sterile sensor pathway") configured to receive the sensor 316 and sharps 318 extending from the bottom of the electronics housing 304. The sterile zone 608 can generally include a hole or passageway that extends at least partially through the body of the collimator 606. In the illustrated embodiment, the sterile zone 608 extends entirely through the collimator 606, although the sterile zone 608 could alternatively extend only partially through the collimator 606 without departing from the scope of the present disclosure.

[0057] With the sensor control device 302 loaded into the sensor applicator 102 and the applicator cap 210 having the collimator 606 secured thereto, the sensor 316 and sharps 318 can be positioned within a sealed area 610 defined at least in part by a sterile zone 608. The sealed area 610 is configured to isolate the sensor 316 and sharps 318 from external contamination and can include (encompass) selected portions within the electronics housing 304 and the sterile zone 608 of the collimator 606.

[0058] While positioned within the sensor applicator 102, the fully assembled sensor control device 302 can undergo radiation sterilization 612. Radiation sterilization 612 can include, for example, electron beam irradiation, although other sterilization methods can alternatively be used, including, but not limited to, low-energy x-ray irradiation. In some embodiments, radiation sterilization 612 can be delivered by either continuous-step irradiation or pulsed beam irradiation. In pulsed beam irradiation, the beam of radiation sterilization 612 is focused at a target location, the component part or device to be sterilized is moved thereto, and radiation sterilization 612 is activated to deliver a directional radiation pulse to this point. Radiation sterilization 612 is then stopped, another component part or device to be sterilized is moved to the target location, and the process is repeated.

[0059] Collimator 606 can be configured to focus radiation (e.g., beams, waves, energy) from radiation sterilization 612 toward components that need to be sterile, such as sensor 316 and sharpened tip 318. More specifically, the holes or passages in sterilization zone 608 allow transmission of radiation that is incident on and sterilizes sensor 316 and sharpened tip 318, while the remainder of collimator 606 prevents (blocks) the propagating radiation from destroying or damaging electronic components within electronics housing 304.

[0060] The sterilization zone 608 may exhibit any suitable cross-sectional shape necessary to properly focus radiation onto the sensor 316 and sharp point 318 for sterilization. In the illustrated embodiment, for example, the sterilization zone 608 is conical or frusto-conical in shape. However, in other embodiments, the sterilization zone 608 may exhibit a polygonal cross-sectional shape, such as a cubic, rectangular (including, for example, a parallelogram), or pyramidal shape, without departing from the scope of the present disclosure.

[0061] In the illustrated embodiment, the sterilization zone 608 provides a first opening 614a at a first end and a second opening 614b at a second end opposite the first end. The first opening 614a can be configured to admit the sensor 316 and sharpened point 318 into the sterilization zone 608, and the second opening 614b can allow radiation (e.g., a beam, wave, etc.) from the radiation sterilization 612 to enter the sterilization zone 608 and be incident on the sensor 316 and sharpened point 318.

[0062] In embodiments in which the sterilization zone 608 is conical or frusto-conical in shape, the first opening 614a can have a diameter smaller than the diameter of the second opening 614b. In such embodiments, for example, the size of the first opening 614a can range between about 0.5 mm and about 3.0 mm, and the size of the second opening 614b can range between about 5.0 mm and about 16.0 mm. However, as will be appreciated, the respective diameters of the first and second openings 614a, 614b can be larger or smaller than the ranges provided herein without departing from the scope of this disclosure and based on the application. Indeed, the diameters of the first and second openings 614a, 614b need only be large enough to allow a sufficient dose of radiation to be incident on the sensor 316 and the sharp point 318. Additionally, in at least one embodiment, the sterilization zone 608 may be cylindrical in shape, in which case the first opening 614a and the second opening 614b exhibit the same diameter.

[0063] The body of the collimator 606 reduces or eliminates radiation sterilization 612 from penetrating the body material and thereby damaging the electronic components within the electronics housing 304. To achieve this reduction or elimination, in some embodiments, the collimator 606 can be manufactured from a material having a mass density greater than 0.9 grams per cubic centimeter (g / cc). One exemplary material for the collimator 606 is polyethylene, but can alternatively include any material having a mass density similar to or greater than polyethylene. In some embodiments, for example, the material for the collimator 606 can include, but is not limited to, a metal (e.g., lead, stainless steel) or a high-density polymer.

[0064] In at least one embodiment, the collimator 606 can be fabricated from a material having a mass density lower than 0.9 grams per cubic centimeter (g / cc), yet the design of the collimator 606 can be modified so that the collimator 606 can operate to reduce or eliminate radiation sterilization 612 incident on electronic components still within the electronics housing 304. To accomplish this design modification, in some embodiments, the size (e.g., length) of the collimator 606 can be increased so that electrons propagating from the radiation sterilization 612 are required to pass through a larger amount of material before impinging on the sensitive electronics, as the case may be. The larger amount of material can help absorb or dissipate the radiation intensity of the radiation sterilization 612 so that the radiation sterilization 612 is harmless to the sensitive electronics. However, in other embodiments, the opposite may equally be true. More specifically, the size (e.g., length) of the collimator 606 can be reduced as long as the material for the collimator 606 provides a sufficiently high mass density.

[0065] In addition to the radiation blocking properties of the body of the collimator 606, in some embodiments, one or more shields 616 (not shown) may be disposed within the sensor housing 304 to protect sensitive electronic components from radiation while the sensor control device 302 undergoes radiation sterilization 612. The shields 616 may be positioned, for example, to be sandwiched between the data processing unit 618 and the radiation source (e.g., an electron beam electron accelerator). In such embodiments, the shields 616 may be positioned adjacent to and otherwise aligned with the data processing unit 618 and the radiation source to block or reduce radiation exposure (e.g., electron beam radiation or energy) that could otherwise damage the sensitive electronic circuitry of the data processing unit 618.

[0066] The shield 616 can be made of any material capable of blocking (or substantially blocking) the penetration of radiation. Suitable materials for the shield 616 include, but are not limited to, lead, tungsten, iron-based metals (e.g., stainless steel), copper, tantalum, tungsten, osmium, or any combination thereof. Suitable materials can be corrosion-resistant, austenitic, and any non-magnetic metal with a density ranging between about 5 grams per cubic centimeter (g / cc) and about 15 g / cc. The shield 616 can be fabricated by a variety of manufacturing techniques, including, but not limited to, stamping, casting, injection casting, sintering, two-shot casting, or any combination thereof.

[0067] However, in other embodiments, shield 616 may include a metal-filled thermoplastic polymer, such as, but not limited to, polyamide, polycarbonate, or polystyrene. In such embodiments, shield 616 may be fabricated by mixing the shielding material into an adhesive matrix and dripping this combination onto a molded component or otherwise directly onto data processing unit 618. Additionally, in such embodiments, shield 616 may include an enclosure that encapsulates (or substantially encapsulates) data processing unit 618.

[0068] In some embodiments, a collimator seal 620 can be added to the end of the collimator 606 to completely seal the sterilization zone 608 and therefore the sealed area 610. As shown, the collimator seal 620 can seal the second opening 614b. The collimator seal 620 can be added before or after radiation sterilization 612. In embodiments where the collimator seal 620 is added before radiation sterilization 612 begins, the collimator seal 620 can be made of a radio-transparent microbial barrier material that allows radiation to propagate therethrough. With the collimator seal 620 in place, the sealed area 610 can maintain a sterile environment for the assembled sensor control device 302 until the user removes (twists) the applicator cap 210.

[0069] In some embodiments, the collimator seal 620 can include two or more layers of different materials. The first layer can be made of a synthetic material (e.g., flash-spun high-density polyethylene fiber) such as Tyvek®, available from DuPont®. Tyvek® is very durable and puncture-resistant while allowing vapor transmission. The Tyvek® layer can be applied prior to or subsequently after radiation sterilization 612, and a foil or other vapor- and moisture-resistant material layer can be sealed (e.g., heat-sealed) over the Tyvek® layer to prevent migration of contaminants and moisture into the sterilization zone 608 and sealing area 610. In other embodiments, the collimator seal 620 can include only a single protective layer added to the end of the collimator 606. In such embodiments, this single layer is gas-permeable toward the sterilization process but also provides protection against moisture and other harmful elements after the sterilization process is complete. Thus, the collimator seal 620 can act as a moisture layer and a contaminant layer without departing from the scope of the present disclosure.

[0070] It should be noted that the sensor 316 and sharps 318 extend from the bottom of the electronics housing 304 into the sterilization zone 608 approximately concentric with the centerline of the sensor applicator 102 and applicator cap 210, although this is considered herein to have an off-center location. More specifically, in at least one embodiment, the sensor 316 and sharps 318 extend from the bottom of the electronics housing 304 off-center relative to the centerline of the sensor applicator 102 and applicator cap 210. In such embodiments, the collimator 606 may be redesigned or otherwise configured to accommodate the sensor 316 and sharps 318 with the sterilization zone 608 also off-centeredly located without departing from the scope of this disclosure.

[0071] In some embodiments, collimator 606 may include a first or "internal" collimator that may be housed within applicator cap 210 or otherwise within sensor applicator 102 as generally described above. A second or "external" collimator (not shown) may be included in the assembly (manufacturing) process or otherwise used to assist in sterilizing sensor applicator 102. In such embodiments, the external collimator may be located external to sensor applicator 102 and applicator cap 210 and used simultaneously with internal collimator 606 to assist in focusing sterilizing radiation 612 onto sensor 316 and sharps 318.

[0072] In one embodiment, for example, the external collimator can initially receive the radiation sterilization 612. Similar to the internal collimator 606, the external collimator can provide or define holes or passageways extending therethrough. The beam of radiation sterilization 612 passing through the passageways of the external collimator can be focused and received through the second opening 614b into the sterilization zone 608 of the internal collimator 606. Thus, the external collimator pre-focuses the radiation energy, and the internal collimator 606 can fully focus the radiation energy onto the sensor 316 and the sharp point 318.

[0073] In some embodiments, the internal collimator 606 can be eliminated if the external collimator functions to properly and completely focus the radiation sterilization 612 to properly sterilize the sensor 316 and sharps 318. In such embodiments, the sensor applicator can be positioned adjacent to the external collimator, after which the radiation sterilization 612 can be applied to the sensor applicator, and the external collimator can prevent the radiation energy from damaging the sensitive electronics within the electronics housing 304. Furthermore, in such embodiments, the sensor applicator 102 can be delivered to a user without the internal collimator 606 positioned within the applicator cap 210, thereby eliminating complications in manufacturing and use.

[0074] 7A is an enlarged cross-sectional side view of the sensor control device 302 mounted within the applicator cap 210 in accordance with one or more embodiments. As noted above, the sensor 316 and a portion of the sharps 318 may be disposed within the sealed area 610, thereby isolating them from external contamination. The sealed area 610 may include (encompass) selected portions within the electronics housing 304 and the sterile zone 608 of the collimator 606. In one or more embodiments, the sealed area 610 may be defined or otherwise formed by at least the first seal 702a, the second seal 702b, and the collimator seal 620.

[0075] The first seal 702a can be positioned to seal the interface between the sharp body hub 422 and the top of the electronics housing 304. More specifically, the first seal 702a can seal the interface between the sharp body hub 422 and the shell 306. Furthermore, the first seal 702a can surround the first central opening 504 defined in the shell 306 to prevent contaminants from migrating through the first central opening 504 into the electronics housing 304. In some embodiments, the first seal 702a can form a portion of the sharp body hub 422. For example, the first seal 702a can be overmolded onto the sharp body hub 422. In other embodiments, the first seal 702a can be overmolded onto the shell 306. In still other embodiments, the first seal 702a can include a separate structure, such as an O-ring, sandwiched between the sharp body hub 422 and the top surface of the shell 306 without departing from the scope of this disclosure.

[0076] The second seal 702b can be positioned to seal the interface between the collimator 606 and the bottom of the electronics housing 304. More specifically, the second seal 702b can be positioned to seal the interface between the mount 308 and the collimator 606, or alternatively, between the collimator 606 and the bottom of the plug 402 received in the bottom of the mount 308. In applications including the plug 402 as shown, the second seal 702b can be configured to seal around and otherwise surround the plug receptacle 512. In embodiments excluding the plug 402, the second seal 702b can instead surround the second central opening 506 ( FIG. 5A ) defined in the mount 308. As a result, the second seal 702b can prevent contaminants from migrating into the sterile zone 608 of the collimator 606 and further into the electronic device housing 304 through the plug receptacle 512 (or alternatively, the second central opening 506).

[0077] In some embodiments, the second seal 702b can form part of the collimator 606. For example, the second seal 702b can be overmolded onto the collimator 606. In other embodiments, the second seal 702b can be overmolded onto the plug 402 or onto the bottom of the mount 308. In still other embodiments, the second seal 702b can include a separate structure, such as an O-ring, that is sandwiched between the collimator 606 and the plug 402 or the bottom of the mount 308 without departing from the scope of this disclosure.

[0078] After the sensor control device 302 is loaded into the sensor applicator 102 (FIG. 6B) and the applicator cap 210 is secured to the sensor applicator 102, the first and second seals 702a, 702b are compressed, creating a corresponding sealed interface. The first and second seals 702a, 702b can be made of a variety of materials capable of creating a sealed interface between opposing structures. Suitable materials include, but are not limited to, silicone, thermoplastic elastomer (TPE), polytetrafluoroethylene (PTFE or Teflon®), or any combination thereof.

[0079] As discussed above, the collimator seal 620 can be configured to completely seal the bottom of the sterilization zone 608 and thus the bottom of the sealing area 610. Thus, the first and second seals 702a, 702b and the collimator seal 620 each create a barrier corresponding to their respective sealing location. The combination of these seals 702a, 702b and 620 allows for terminal sterilization of the sealing area 610 containing the sensor 316 and the sharp 318.

[0080] FIG. 7B is an enlarged cross-sectional side view of another embodiment of the sensor control device 302 mounted within the sensor applicator 102 in accordance with one or more embodiments. More specifically, FIG. 7B illustrates alternative embodiments of the first and second seals 702a, 702b. Again, the first seal 702a is positioned to seal the interface between the sharp body hub 422 and the top of the electronics housing 304, and more specifically, to completely seal the first central opening 504 defined within the shell 306. However, in the illustrated embodiment, the first seal 702a may be configured to seal both axially and radially. More specifically, when the sensor control device 302 is introduced into the sensor applicator 102, the sharp body hub 422 is received by the sensor carrier 604. The first seal 702a can be configured to simultaneously bias one or more axially extending members 704 of the sensor carrier 604 and one or more radially extending members 706 of the sensor carrier 604. Such dual biasing engagement compresses the first seal 702a both axially and radially, thereby enabling the first seal 702a to seal the top of the electronics housing 304 both radially and axially.

[0081] Again, the second seal 702b is positioned to seal the interface between the collimator 606 and the bottom of the electronics housing 304, more specifically between the mount 308 and the collimator 606, or alternatively between the collimator 606 and the bottom of the plug 402 received in the bottom of the mount 308. However, in the illustrated embodiment, the second seal 702b defines or otherwise provides a cylindrical longitudinal recess 708 that extends into the sterile zone 608 and is sized to receive the sensor 316 and sharp 1408 extending from the bottom of the mount 308. In some embodiments, a desiccant 710 can be positioned within the cylindrical longitudinal recess to help maintain a low humidity environment for moisture-sensitive biological components.

[0082] In some embodiments, the second seal 702b can be eliminated, and the collimator 606 can be directly coupled to the electronics housing 304. More specifically, in at least one embodiment, the collimator 606 can be threadably coupled to the underside of the mount 308. In such embodiments, the collimator 606 can be provided with or otherwise defined with a threaded extension configured to fit into a threaded opening defined in the bottom of the mount 308. Threadably coupling the collimator 606 to the mount 308 can serve to seal the interface between the collimator 606 and the bottom of the electronics housing 304, thus isolating the sealed area 610. Furthermore, in such embodiments, the pitch and gauge of the threads defined on the collimator 606 and the mount 308 can match that of the threaded engagement between the applicator cap 210 and the sensor applicator 102. As a result, when the applicator cap 210 is threaded onto or unthreaded from the sensor applicator 102, the collimator 606 can be correspondingly threaded onto or unscrewed from the electronics housing 404.

[0083] Embodiments disclosed herein include the following.

[0084] A. An analyte monitoring system including a sensor applicator, a sensor control device positioned within the sensor applicator and including an electronics housing, a sensor extending from a bottom of the electronics housing, a sharps hub positioned adjacent a top of the electronics housing, and a sharps carried by the sharps hub and extending through the electronics housing and further extending from the bottom of the electronics housing, The analyte monitoring system further includes a cap coupled to the sensor applicator, and a collimator positioned within the cap and defining a sterile zone to receive the sensor and the sharps extending from the bottom of the electronics housing.

[0085] B. A method of preparing an analyte monitoring system includes loading a sensor control device into a sensor applicator, the sensor control device including an electronics housing, a sensor extending from a bottom of the electronics housing, a sharps hub positioned adjacent a top of the electronics housing, and a sharps carried by the sharps hub and extending through the electronics housing and further extending from the bottom of the electronics housing. The method further includes securing a cap to the sensor applicator, wherein a collimator is positioned within the cap and defines a sterilization zone that receives the sensor and sharps extending from the bottom of the electronics housing, sterilizing the sensor and sharps with radiation sterilization while positioned within the sterilization zone, and preventing radiation from the radiation sterilization from damaging electronic components within the electronics housing with the collimator.

[0086] C. A method of preparing an analyte monitoring system includes loading a sensor control device into a sensor applicator, the sensor control device including an electronics housing, a sensor extending from a bottom of the electronics housing, a sharps hub positioned adjacent a top of the electronics housing, and a sharps carried by the sharps hub and extending through the electronics housing and further extending from the bottom of the electronics housing. The method further includes positioning the sensor applicator adjacent a collimator, subjecting the sensor and sharps to radiation sterilization, and preventing, with the collimator, radiation from the radiation sterilization from damaging electronic components within the electronics housing.

[0087] Each of embodiments A, B, and C may have one or more of the following additional elements in any combination: Element 1: the sterilization zone includes a passageway extending at least partially through the collimator. Element 2: the sterilization zone includes a cross-sectional shape selected from the group consisting of a cone, a frusto-cone, a cube, a rectangle, a pyramid, and any combination thereof. Element 3: the sterilization zone is frusto-cone shaped and defines a first opening at a first end and a second opening at a second end, the first opening receiving the sensor and sharps extending from the bottom of the electronics housing, and a seal positioned in the second opening. Element 4: further including a sealing region encompassing the sterilization zone and a portion of the interior of the electronics housing, the sealing region defined by a first seal sealing the interface between the sharps hub and the top of the electronics housing, a second seal sealing the interface between the collimator and the bottom of the electronics housing, and a third seal sealing the end of the sterilization zone. Element 5: The first seal surrounds a central opening defined in the top of the electronics housing to prevent contaminants from migrating through the central opening into a portion of the interior of the electronics housing, and the second seal surrounds an opening defined in the bottom of the electronics housing to prevent contaminants from migrating through the opening into a portion of the interior of the electronics housing. Element 6: The first seal provides one or both of an axial seal and a radial seal. Element 7: The second seal defines a cylindrical recess extending into the sterilization zone to receive the sensor and sharps. Element 8: Further including a printed circuit board positioned within the electronics housing, a data processing unit mounted on the printed circuit board, and a shield positioned within the electronics housing to protect the data processing unit from radiation from the radiation sterilization process. Element 9: The shield is fabricated from a non-magnetic metal selected from the group consisting of lead, tungsten, iron, stainless steel, copper, tantalum, osmium, a thermoplastic polymer mixed with a non-magnetic metal, and any combination thereof.

[0088] Element 10: Further including the step of creating a sealed area encompassing the sterile zone and a portion of the interior of the electronics housing when the cap is secured to the sensor applicator. Element 11: Creating a sealed area includes sealing the interface between the sharp body hub and the top of the electronics housing with a first seal, sealing the interface between the collimator and the bottom of the electronics housing with a second seal, and sealing an end of the sterile zone with a third seal. Element 12: Sealing the interface between the sharp body hub and the top of the electronics housing with the first seal includes providing one or both of an axial seal and a radial seal with the first seal. Element 13: The collimator includes an internal collimator, and sterilizing the sensor and sharps using radiation sterilization further includes positioning the sensor applicator adjacent to an external collimator positioned on its exterior, focusing radiation with the external collimator so that it is received by the internal collimator, and preventing the radiation from damaging electronic components within the electronics housing with the external and internal collimators. Element 14: The sterilization zone defines a first opening at a first end of the collimator and a second opening at a second end of the collimator, and sterilizing the sensor and sharps includes introducing radiation into the sterilization zone through the second opening. Element 15: Preventing radiation from the radiation sterilization from damaging the electronic components includes blocking the radiation with a material of the collimator. Element 16: A printed circuit board is positioned within the electronics housing and a data processing unit is mounted on the printed circuit board, and the method further includes protecting the data processing unit from radiation from the radiation sterilization process with a shield positioned within the electronics housing.

[0089] Element 17: Positioning the sensor applicator adjacent to the collimator includes positioning the collimator such that the collimator is external to the sensor applicator during radiation sterilization.

[0090] As non-limiting examples, exemplary combinations applicable to A, B, and C include combinations of elements 2 and 3, elements 4 and 5, elements 4 and 6, elements 4 and 7, elements 8 and 9, elements 10 and 11, and elements 11 and 12.

[0091] External Sterile Assembly Referring briefly again to FIG. 1 , the sensor control device 104 must be sterilized to render the product free of viable microorganisms before being delivered to an end user. Typically, the sensor 110 is sterilized using radiation sterilization, such as electron beam ("e-beam") irradiation. However, radiation sterilization can damage electronic components within the sensor control device 104, and the sensor control device 104 is typically sterilized by gaseous chemical sterilization (e.g., using ethylene oxide). However, gaseous chemical sterilization may damage enzymes or other chemicals and biologicals contained on the sensor 110.

[0092] In the past, this sterilization incompatibility has been avoided by separating the sensor 110 and the electronic components and sterilizing each individually. However, this approach requires additional parts, packaging, processing steps, and final assembly by the user, which introduces the possibility of user error. With the present disclosure, the sensor control device 104, or any device requiring terminal sterilization, can be properly sterilized using an external sterilization assembly designed to focus sterilizing radiation (e.g., beam, wave, energy) toward the component parts requiring sterilization while preventing the propagating radiation from destroying or damaging the sensitive electronic components.

[0093] 8 is a schematic diagram of an exemplary external sterilization assembly 800 according to one or more embodiments. External sterilization assembly 800 (hereinafter "assembly 800") is designed, and may be otherwise configured, to assist in sterilizing a medical device 802. Medical device 802 may include, for example, a sensor control device similar in some respects to sensor control device 104 of FIG. 1, but may alternatively include other types of medical devices, healthcare products, or systems requiring terminal sterilization of certain component parts. Exemplary medical devices or healthcare products that may incorporate the principles of the present disclosure include, but are not limited to, ingestible products, cardiac rhythm management (CRM) devices, subcutaneous sensing devices, externally worn medical devices, or any combination thereof.

[0094] The medical device 802 can include a housing 804, a sterilization-required part 806, and one or more radiation-sensitive components 808. In the illustrated embodiment, the radiation-sensitive components 808 can be mounted on a printed circuit board (PCB) 810 positioned within the housing 804, which can include an electronics housing for a sensor control device. The radiation-sensitive components 808 can include one or more electronic modules, such as, but not limited to, a data processing unit (e.g., an application-specific integrated circuit or ASIC), resistors, transistors, capacitors, inductors, diodes, and switches. However, in other embodiments, the radiation-sensitive components 808 can include a radiation-sensitive chemical solution or analyte, as described herein with reference to FIG. 12 .

[0095] In some embodiments, component 806 can include a sensor (e.g., sensor 110 of FIG. 1 ) extending from housing 804. As shown, component 806 can extend at an angle from the bottom of housing 804, or alternatively, can extend from another side of housing 804 perpendicular to the bottom of housing 804. In at least one embodiment, component 806 can also further include a sharp, which may require sterilization and can aid in implanting the sensor under the user's skin. In some embodiments, as shown, component 806 can be enclosed with cap 812 that forms a hermetic barrier that protects its exposed portions (e.g., the sensor and associated sharp) until it is needed for use.

[0096] To properly sterilize the component 806 for use, the medical device 802 can undergo radiation sterilization 814. Suitable radiation sterilization 814 processes include, but are not limited to, electron beam (e-beam) irradiation, gamma irradiation, x-ray irradiation, or any combination thereof. In embodiments that include a cap 812, the cap 812 can be fabricated from a material that allows transmission of radiation 814 therethrough to facilitate radiation sterilization of the component 806. Suitable materials for the cap 812 include, but are not limited to, non-magnetic metals (such as, for example, aluminum, copper, gold, or silver), thermoplastic ceramics, rubbers (such as, for example, ebonite), composite materials (such as, for example, fiberglass or carbon fiber reinforced polymers), epoxies, or any combination thereof. In some embodiments, the cap 812 can be transparent or translucent, although it can otherwise be opaque without departing from the scope of this disclosure.

[0097] Assembly 800 may include a radiation shield 816 configured to be positioned exterior to medical device 802 to assist in sterilizing component 806 while simultaneously preventing propagating radiation 814 from destroying or damaging radiation-sensitive component 808. To achieve this prevention, radiation shield 816 may be provided with a collimator 818 that generally includes holes or passageways extending at least partially through its body. Collimator 818 defines a sterilization zone 820 configured to focus radiation 814 toward component 806. In the illustrated embodiment, component 806 may be received within sterilization zone 820 for sterilization.

[0098] The radiation shield 816 can be made of a material that reduces or eliminates radiation 814 (e.g., beam, wave, energy, etc.) that penetrates the radiation shield 816 while focusing the radiation 814 toward the component 806, thereby damaging the radiation-sensitive components 808 within the housing 804. In other words, the radiation shield 816 can be made of a material that has a density sufficient to absorb the dose of the beam energy being transmitted therethrough. In some embodiments, for example, the radiation shield 816 can be made of any material that has a mass density greater than 0.9 grams per cubic centimeter (g / cc). However, in other embodiments, the mass density of a suitable material can be less than 0.9 g / cc without departing from the scope of the present disclosure. Suitable materials for the radiation shield 816 include, but are not limited to, high-density polymers (e.g., polyethylene, polypropylene, polystyrene, polytetrafluoroethylene), metals (e.g., lead, stainless steel, aluminum), any combination thereof, or any material that has a mass density greater than 0.9 g / cc.

[0099] Collimator 818 can exhibit any suitable cross-sectional shape necessary to focus radiation onto part 806 for sterilization. In the illustrated embodiment, for example, collimator 818 is conical or frusto-conical in shape. However, in other embodiments, collimator 818 can exhibit a polygonal cross-sectional shape, such as a cubic, rectangular (including, for example, a parallelogram), or pyramidal shape, without departing from the scope of the present disclosure. In still other embodiments, collimator 818 can exhibit a circular cross-sectional shape with parallel sides.

[0100] In the illustrated embodiment, the collimator 818 provides a first opening 822 a and a second opening 822 b, where the first opening 822 a and the second opening 822 b are defined at opposite ends of the sterilization zone 820. The first opening 822 a can be configured to allow radiation 814 to enter the sterilization zone 820 and be incident on the part 806, and the second opening 822 b can be configured to admit the part 806 into the sterilization zone 820. In embodiments in which the collimator 818 is conical or frusto-conical in shape, the second opening 822 b can have a diameter smaller than the diameter of the first opening 822 a. In such embodiments, for example, the size of the second opening 822 b can range between about 0.5 mm and about 3.0 mm, and the size of the first opening 822 a can range between about 5.0 mm and about 16.0 mm. However, as will be appreciated, the respective diameters of the first and second apertures 822 a, 822 b can be larger or smaller than those provided herein without departing from the scope of the present disclosure. Indeed, the diameters of the first and second apertures 822 a, 822 b can be scaled to device size and need only be large enough to allow a sufficient radiation dose to be incident on the component 806. Furthermore, in at least one embodiment, the collimator 818 can be cylindrical in shape, in which case the first aperture 822 a and the second aperture 822 b exhibit the same diameter.

[0101] In some embodiments, the assembly 800 may further include a barrier shield 824 positioned within the housing 804. The barrier shield 824 may be configured to assist in blocking radiation 814 (e.g., electrons) from propagating within the housing 804 toward the radiation-sensitive component 808. The barrier shield 824 may be fabricated from any of the materials described above with respect to the radiation shield 816. In the illustrated embodiment, the barrier shield 824 is positioned vertically within the housing 804, but may alternatively be positioned in any other angular configuration suitable for protecting the radiation-sensitive component 808.

[0102] Figure 9 is a schematic diagram of another exemplary external sterilization assembly 900 in accordance with one or more additional embodiments of the present disclosure. External sterilization assembly 900 (hereinafter "assembly 900") may be similar in some respects to assembly 800 of Figure 8 and, therefore, may be best understood by reference thereto, where like numbers will indicate like components that will not be described again. Like assembly 800, assembly 900 is designed, and may otherwise be configured, to assist in sterilizing a medical device 902. In the illustrated embodiment, medical device 902 may include a two-piece sensor control device, but may alternatively include any of the medical devices illustrated herein with respect to medical device 802.

[0103] As shown, medical device 902 can include a housing 904, a sterilization-requiring part 906, and one or more radiation-sensitive components 908 positioned within housing 904. Housing 904 can include a package or enclosure that encloses parts 906 and radiation-sensitive components 908. Radiation-sensitive components 908 can include any of the electronic modules described herein with respect to radiation-sensitive component 808 in FIG. 8. Part 906 can include, for example, a needle / sensor subassembly and can undergo radiation sterilization 814 to properly sterilize part 906 for use.

[0104] The assembly 900 may include a radiation shield 910 configured to be positioned exterior to the medical device 902 to assist in sterilizing the component 906 while preventing (blocking) the propagated radiation 814 from damaging the radiation-sensitive component 908. In the illustrated embodiment, the radiation shield 910 may define or otherwise provide an interior cavity 912 within which the medical device 902 may be positioned. Similar to the radiation shield 816 of FIG. 8 , the radiation shield 910 may be provided with a collimator 914 extending at least partially through its body and generally including holes or passageways providing access to the cavity 912. The collimator 914 may define a sterilization zone 916 that assists in focusing the radiation 814 toward the component 906. The radiation shield 910 may be fabricated from any of the materials described above for the radiation shield 816 to reduce or eliminate radiation 814 penetrating the radiation shield 910 except at the location of the collimator 914, thereby damaging the radiation-sensitive component 908 within the housing 904.

[0105] Sterilizing radiation 814 can be directed toward the medical device 902 to properly sterilize the part 906. The collimator 914 and sterilization zone 916 can be configured to concentrate and / or focus the sterilizing radiation 814 toward the part 906, while the remainder of the radiation shield 910 prevents (blocks) the propagating radiation 814 from damaging the radiation-sensitive components 908 within the housing 904. In the illustrated embodiment, the collimator 914 and sterilization zone 916 exhibit a circular cross-sectional shape with parallel sides, although it is contemplated that they may alternatively exhibit other cross-sectional shapes, including, but not limited to, a cone, a frusto-cone, a pyramid, a polygon, or any combination thereof.

[0106] In some embodiments, the assembly 900 may further include a barrier shield 824 positioned within the housing 904 to assist in blocking radiation 814 (e.g., electrons) from propagating within the housing 904 toward the radiation-sensitive component 908.

[0107] Figure 10 is a schematic diagram of another exemplary external sterilization assembly 1000 in accordance with one or more additional embodiments of the present disclosure. External sterilization assembly 1000 (hereinafter "assembly 1000") may be similar in some respects to assembly 900 of Figure 15 and, therefore, may be best understood by reference thereto, where like numbers will indicate like components that will not be described again. Like assembly 900, assembly 1000 is designed, and may otherwise be configured, to assist in sterilizing a medical device 1002. In the illustrated embodiment, medical device 1002 may include a sensor control device similar to sensor control device 104 of Figure 1, but may alternatively include any of the medical devices illustrated herein with respect to medical device 802 of Figure 8.

[0108] As shown, medical device 1002 can include a housing 1004, a sterilization-requiring part 1006, and one or more radiation-sensitive components 1008 positioned within housing 1004. In the illustrated embodiment, housing 1004 can include an electronics housing for a sensor control device (e.g., sensor control device 104 of FIG. 1), and radiation-sensitive component 1008 can include any of the electronic modules described herein for radiation-sensitive component 808 of FIG. 8. In some embodiments, component 1006 can include a sensor (e.g., sensor 110 of FIG. 1) extending from housing 1004, which also requires sterilization, and can further include a sharp to aid in implanting the sensor under the user's skin.

[0109] Assembly 1000 can include a radiation shield 1010 configured to be positioned on the exterior of medical device 1002 to assist in sterilizing parts 1006 while preventing (blocking) propagating radiation 814 from destroying or damaging radiation-sensitive components 1008. To reduce or eliminate radiation 814 penetrating radiation shield 1010 and thereby damaging radiation-sensitive components 1008 within housing 1004, radiation shield 1010 can be fabricated from any of the materials described above with respect to radiation shield 816 of FIG.

[0110] In the illustrated embodiment, the radiation shield 1010 can define or otherwise provide an internal cavity 1012 within which the medical device 1002 can be positioned for sterilization. In some embodiments, the radiation shield 1010 can include a box within which the internal cavity 1012 can be formed. The radiation shield 1010 can provide a collimator 1014 extending at least partially through its body and providing access into the cavity 1012. The collimator 1014 can define a sterilization zone 1016 that focuses radiation 814 toward the part 1006 for sterilization.

[0111] Sterilizing radiation 814 can be directed toward the medical device 1002 to properly sterilize the part 1006. The collimator 1014 and sterilization zone 1016 can concentrate and / or focus the sterilizing radiation 814 toward the part 1006, while the remainder of the radiation shield 1010 prevents (blocks) the propagating radiation 814 from damaging the radiation-sensitive components 1008 within the housing 1004. In the illustrated embodiment, the collimator 1014 exhibits a circular cross-sectional shape with parallel sides, although it is contemplated that the collimator 1014 could alternatively exhibit other cross-sectional shapes, including, but not limited to, a cone, a frusto-cone, a pyramid, a polygon, or any combination thereof.

[0112] Figure 11 is a schematic diagram of another exemplary external sterilization assembly 1100 in accordance with one or more additional embodiments of the present disclosure. External sterilization assembly 1100 (hereinafter "assembly 1100") may be similar in some respects to assemblies 800, 900, and 1000 of Figures 8, 9, and 10, respectively, and therefore may be best understood with reference to these figures. Like assemblies 800-1000, assembly 1100 is designed, and may be otherwise configured, to assist in sterilizing a medical device 1102. In the illustrated embodiment, medical device 1102 may include a two-piece sensor control device, but may alternatively include any of the medical devices illustrated herein with respect to medical device 802.

[0113] As shown, medical device 1102 can include a housing 1104, a sterilization-requiring part 1106, and one or more radiation-sensitive components 1108 positioned within housing 1104. Radiation-sensitive component 1108 can include any of the electronic modules described herein with respect to radiation-sensitive component 808 of Figure 8. In the illustrated embodiment, component 1106 can include, for example, a needle / sensor subassembly and can undergo radiation sterilization 814 to properly sterilize component 1106 for use.

[0114] Assembly 1100 can include a radiation shield 1110 configured to be positioned on the exterior of medical device 1102 to assist in sterilizing parts 1106 while preventing (blocking) propagating radiation 814 from damaging radiation-sensitive components 1108. To reduce or eliminate radiation 814 penetrating radiation shield 1110 and thereby damaging radiation-sensitive components 1108, radiation shield 1110 can be fabricated from any of the materials described above with respect to radiation shield 816 of FIG.

[0115] In the illustrated embodiment, the radiation shield 1110 may include a clamshell structure including a first portion 1112a and a matable (or engageable) second portion 1112b. The radiation shield 1110 may provide or otherwise define an internal cavity 1114 within which the medical device 1102 may be positioned for sterilization. In some embodiments, as shown, the first and second portions 1112a and 1112b may cooperate to define a portion of the internal cavity 1114 such that the internal cavity 1114 is formed when the first and second portions 1112a and 1112b are properly mated. However, in other embodiments, the internal cavity 1114 may be defined entirely within the first portion 1112a or entirely within the second portion 1112b.

[0116] In some embodiments, the assembly 1100 can further include an absorber 1116 configured to protect the medical device 1102. In at least one embodiment, a portion of the absorber 1116 can be provided by or otherwise form part of each of the first and second portions 1112a, 1112b, as shown. In such an embodiment, the interior cavity 1114 can be defined, at least in part, by the absorber 1116. The absorber 1116 can be made of a material that absorbs stray radiation without generating bremsstrahlung protons. Materials for the absorber 1116 can include, for example, any of the density polymers listed herein for the radiation shield 816 of FIG. 8.

[0117] 8, the radiation shield 1110 can provide one collimator. However, in the illustrated embodiment, the radiation shield 1110 provides a first collimator 1118a and a second collimator 1118b, and as otherwise defined, may alternatively include only one of the collimators 1118a, 1118b without departing from the scope of this disclosure. The first collimator 1118a generally includes a hole or passageway extending at least partially through the first portion 1112a of the radiation shield 1110, and the second collimator 1118b generally includes a hole or passageway extending at least partially through the second portion 1112b. Each collimator 1118a, 1118b provides access into the internal cavity 1114, and the collimators 1118a, 1118b cooperate to define a sterilization zone 1120 that includes the internal cavity 1114 and helps focus the radiation 814 toward the part 1106 for sterilization.

[0118] To properly sterilize the part 1106, the medical device 1102 can be positioned within the internal cavity 1114, and the opposing portions 1112 a, 1112 b can mate to enclose the medical device 1102. Once properly positioned within the cavity 1114, the medical device 1102 can be placed within the sterilization zone 1120. The radiation sterilization 814 can then be directed toward the medical device 1102 on the opposing side of the radiation shield 1110, and the collimators 1118 a, 1118 b can concentrate and / or focus the radiation sterilization 814 on either side of the part 1106. The remaining portions of the radiation shield 1110 prevent (block) the propagating radiation 814 from damaging the radiation-sensitive components 1108 within the housing 1104. In the illustrated embodiment, each collimator 1118a, 1118b exhibits a conical or frusto-conical cross-sectional shape, although it is contemplated that the collimators may alternatively exhibit other cross-sectional shapes, including, but not limited to, circular, pyramidal, polygonal, or any combination thereof.

[0119] In some embodiments, the assembly 1100 may further include one or more barrier shields 824 (two shown) positioned within the housing 1104 to assist in blocking radiation 814 (e.g., electrons) from propagating within the housing 1104 toward the radiation-sensitive component 1108.

[0120] 12 is a schematic diagram of another exemplary external sterilization assembly 1200 in accordance with one or more additional embodiments of the present disclosure. External sterilization assembly 1200 (hereinafter "assembly 1200") is designed, and may be otherwise configured, to assist in sterilizing a medical device 1202, which in the illustrated embodiment includes a hypodermic needle or hypodermic syringe. As shown, medical device 1202 may include a housing 1204 (e.g., a barrel or vial), a sterilization-requiring component 1206, and one or more radiation-sensitive components 1208 positioned within housing 1204. In the illustrated embodiment, radiation-sensitive component 1208 may include a chemical solution or analyte (such as, for example, an active agent, pharmaceutical, or biological agent) that may be sensitive to radiation, and component 1206 may include a needle designed to deliver the chemical solution.

[0121] In some embodiments, as shown, the part 1206 can be enveloped or otherwise surrounded by a cap 1210 (e.g., a needle cap) that encloses it. Additionally, in at least one embodiment, the cap 1210 can be sealed to the housing 1204 with a sealing element 1212, such as an O-ring. The cap 1210 and sealing element 1212 can cooperate to form a sterile barrier system that encloses and protects exposed portions of the part 1206 until required for use. To properly sterilize the part 1206 for use, the part 1206 can be subjected to radiation sterilization 814.

[0122] The assembly 1200 can include a radiation shield 1214 configured to be positioned external to the medical device 1202 to assist in sterilizing the component 1206 while preventing (blocking) the propagated radiation 814 from damaging the radiation-sensitive components 1208. As shown, the radiation shield 1214 can provide a collimator 1216, which generally includes holes or passageways extending at least partially through the body of the radiation shield 1214 and defines a sterilization zone 1218 configured to focus the radiation 814 toward the component 1206 for sterilization. In the illustrated embodiment, the component 1206 can be received within the sterilization zone 1218. The collimator 1216 allows for the transmission of the radiation 814 incident on and sterilizing the component 1206, while the remainder of the radiation shield 1214 prevents (blocks) the propagated radiation 814 from damaging the radiation-sensitive components 1208 within the housing 1204. In the illustrated embodiment, the collimator 1216 is conical or frusto-conical in shape, but may alternatively exhibit other cross-sectional shapes such as polygonal, pyramidal, circular, or any combination thereof.

[0123] In embodiments that include a cap 1210, the body of the cap 1210 can include a material that allows propagation of radiation 814 therethrough to facilitate radiation sterilization of the part 1206. Suitable materials for the cap 1210 can be the same as those described herein with respect to the cap 812 of FIG.

[0124] In some embodiments, the assembly 1200 may further include a barrier shield 824 positioned to help block the radiation 814 (e.g., electrons) from propagating within the housing 1204 toward the radiation-sensitive component 1208 (e.g., a chemical solution). In the illustrated embodiment, the barrier shield 824 may define or otherwise provide a central opening 1220 configured to allow the radiation-sensitive component 1208 to pass through the part 1206 (e.g., a needle) and exit the housing 1204. In other embodiments, the barrier shield 824 may provide a tortuous path that allows the radiation-sensitive component 1208 to pass through the part 1206 and exit the housing 1204.

[0125] 13 is an isometric view of an exemplary sensor control device 1302 in accordance with one or more additional embodiments of the present disclosure. The sensor control device 1302 may be the same as or similar to the sensor control device 104 of FIG. 1 and, therefore, may be used in conjunction with a sensor applicator 102 (FIG. 1) that delivers the sensor control device 1302 to a target monitoring location on a user's skin. Additionally, the sensor control device 1302 may alternatively be characterized as a medical device similar to one or more of the medical devices 1402-1202 of FIGS. 8-12 described herein. Accordingly, the sensor control device 1302 may also require proper sterilization before use.

[0126] As shown, the sensor control device 1302 includes an electronics housing 1304 that may be generally disc-shaped and have a circular cross-section. However, in other embodiments, the electronics housing 1304 may exhibit other cross-sectional shapes, such as an oval (e.g., pill-shaped), a rounded square, or a polygon, without departing from the scope of this disclosure. The electronics housing 1304 may be configured to house or otherwise enclose various electronic components used to operate the sensor control device 1302.

[0127] The electronics housing 1304 can include a shell 1306 and a mateable mount 1308. The shell 1306 can be secured to the mount 1308 in a variety of ways, such as a snap-fit ​​engagement, an interference fit, sonic welding, one or more mechanical fasteners (e.g., screws), or any combination thereof. In some cases, the shell 1306 can be secured to the mount 1308 such that a sealed interface occurs between the shell 1306 and the mount 1308. In such embodiments, a gasket or other type of sealing material can be positioned at or near the outer diameter (periphery) of the shell 1306 and the mount 1308, and securing the two components together can compress the gasket, thereby creating a sealed 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 adhesive secures the shell 1306 to the mount 1308, providing structural integrity, but can also seal the interface between the two components, thereby isolating the interior of the electronics housing 1304 from external contamination.

[0128] In the illustrated embodiment, the sensor control device 1302 may further include a plug assembly 1310 that may be coupled to the electronics housing 1304. The plug assembly 1310 may include a sensor module 1312 (partially visible) that may be interconnected with a tip module 1314 (partially visible). The sensor module 1312 may be configured to carry, and otherwise include, a sensor 1316 (partially visible), and the tip module 1314 may be configured to carry, and otherwise include, a tip 1318 (partially visible) that is used to assist in transcutaneously delivering the sensor 1316 beneath the user's skin during application of the sensor control device 1302. The tip module 1314 may include a tip hub 1320 that carries the tip 1318.

[0129] As shown, the sensor 1316 and corresponding portions of the tip 1318 extend from the electronics housing 1304, and more specifically from the bottom of the mount 1308. The exposed portion of the sensor 1316 (alternatively referred to as the "tail") can be received within a hollow or recessed portion of the tip 1318. The remainder of the sensor 1316 is positioned within the electronics housing 1304.

[0130] FIG. 14A is a side view of the sensor applicator 102 of FIG. 1. As shown, the sensor applicator 102 includes a housing 1402 and an applicator cap 1404 removably coupled thereto. In some embodiments, the applicator cap 1404 can be threaded onto the housing 1402 and can include a tamper-evident ring 1406. Upon rotating (e.g., twisting) the applicator cap 1404 relative to the housing 1402, the tamper-evident ring 1406 can be threaded off, thereby freeing the applicator cap 1404 from the sensor applicator 102. With the applicator cap 1404 removed, a user can use the sensor applicator 102 to position the sensor control device 1302 (FIGS. 13 and 14B) at a target monitoring location on the user's body.

[0131] In some embodiments, the applicator cap 1404 can be secured to the housing 1402 by a sealing engagement to protect the internal components of the sensor applicator 102. In at least one embodiment, for example, an O-ring or another type of sealing gasket can seal the interface between the housing 1402 and the applicator cap 1404. The O-ring or sealing gasket can be a separate component part or alternatively can be cast onto one of the housing 1402 and the applicator cap 1404.

[0132] 14B is a cross-sectional side view of the sensor applicator 102. As shown, the sensor control device 1302 can be received within the sensor applicator 102, and an applicator cap 1404 can be coupled to the sensor applicator 102 to secure the sensor control device 1302 within the applicator cap 1404. The sensor control device 1302 can include one or more radiation-sensitive components 1408 positioned within the electronics housing 1304. The radiation-sensitive components 1408 can include electronic components or modules such as, but not limited to, a data processing unit, a register, a transistor, a capacitor, an inductor, a diode, a switch, or any combination thereof. The data processing unit can include, for example, an application-specific integrated circuit (ASIC) configured to perform one or more functions or routines associated with the operation of the sensor control device 1302. In operation, the data processing unit can perform data processing functions such as filtering and encoding a data signal corresponding to a sampled analyte level of a user. The data processing unit may include or otherwise be in communication with an antenna for communicating with the reader device 106 (FIG. 1).

[0133] In the illustrated embodiment, a cap filler 1410 may be positioned within the applicator cap 1404 and may generally serve to support the sensor control device 1302 within the sensor applicator 102. In one or more embodiments, the cap filler 1410 may comprise an integral portion or extension of the applicator cap 1404, such as being cast with or overmolded onto the applicator cap 1404. In other embodiments, the cap filler 1410 may comprise a separate structure fitted within or otherwise attached to the applicator cap 1404 without departing from the scope of this disclosure.

[0134] The sensor control device 1302, and more specifically the distal end of the sensor 1316 and tip 1318 extending from the bottom of the electronics housing 1304, can be sterilized while positioned within the sensor applicator 102. More specifically, the fully assembled sensor control device 1302 can be subjected to radiation sterilization 1412, which can be similar to radiation sterilization 814 of FIGS. 8-12. The radiation sterilization 1412 can be delivered by either continuous step irradiation or pulsed beam irradiation. In pulsed beam irradiation, the beam of radiation sterilization 1412 is focused at a target location, the component part or device to be sterilized is moved thereto, and the irradiation is activated to deliver a directional pulse of radiation to this point. The radiation sterilization 1412 is then stopped, another component part or device to be sterilized is moved to the target location, and the process is repeated.

[0135] In accordance with the present disclosure, sterilizing the distal end of the sensor 1316 and sharpened tip 1318 can utilize an external sterilization assembly 1414 to assist in focusing the radiation 1412 while simultaneously preventing (blocking) the propagating radiation 1412 from damaging the radiation-sensitive components 1408. As shown, the external sterilization assembly 1414 (hereinafter "assembly 1414") can include a radiation shield 1416 positioned at least partially external to the sensor applicator 102. The radiation shield 1416 can provide or define an external collimator 1418 configured to assist in focusing the radiation 1412 (e.g., beam, wave, energy, etc.) toward the components to be sterilized. More specifically, the external collimator 1418 allows transmission of the radiation 1412 that is incident on and sterilizes the sensor 1316 and sharpened tip 1318, but prevents the radiation 1412 from damaging the radiation-sensitive components 1408 within the electronics housing 1304.

[0136] In the illustrated embodiment, the outer collimator 1418 is designed to align with the inner collimator 1420 defined by the cap filler 1410. Similar to the outer collimator 1418, the inner collimator 1420 can help focus the radiation 1412 toward the components being sterilized. As shown, the cap filler 1410 can define a radial shoulder 1422 sized to receive and otherwise fit the end of the radiation shield 1416, with the outer collimator 1418 transitioning into the inner collimator 1420 at the radial shoulder 1422. In some embodiments, the transition between the outer collimator 1418 and the inner collimator 1420 can be continuous, flush, or smooth. However, in other embodiments, the transition can be intermittent or gradual without departing from the scope of this disclosure.

[0137] The outer collimator 1418 and inner collimator 1420 cooperate to focus the radiation 1412 and define a sterilization zone 1424 within which the distal ends of the sensor 1316 and sharpened tip 1318 can be positioned. The propagated radiation 1412 passes through the sterilization zone 1424 and can be incident on and sterilize the sensor 1316 and sharpened tip 1318. However, the cap filler 1410 and the radiation shield 1416 can each be made of a material that substantially prevents the radiation 1412 from penetrating the inner walls of the sterilization zone 1424 and thereby damaging the radiation-sensitive components 1408 within the housing 1304. In other words, the cap filler 1410 and the radiation shield 1416 can each be made of a material that is dense enough to absorb the beam energy being transmitted therethrough. In some embodiments, for example, one or both of the cap filler 1410 and the radiation shield 1416 can be made of a material having a mass density greater than 0.9 grams per cubic centimeter (g / cc). However, in other embodiments, the mass density of suitable materials can be less than 0.9 g / cc without departing from the scope of this disclosure. Suitable materials for the cap filler 1410 and the radiation shield 1416 include, but are not limited to, high density polymers (such as, for example, polyethylene, polypropylene, polystyrene, polytetrafluoroethylene), metals (such as, for example, lead, stainless steel, aluminum), any combination thereof, or any material having a mass density greater than 0.9 g / cc. In at least one embodiment, the cap filler 1410 can be made of machined or 3D printed polypropylene, and the radiation shield 1416 can be made of stainless steel.

[0138] In some embodiments, one or both of the cap fill 1410 and the radiation shield 1416 can be made of a material having a mass density lower than 0.9 g / cc, but the sterilization zone 1424 can be designed to still operate to prevent the radiation sterilization 1412 from damaging the radiation-sensitive components 1408. In such embodiments, the size (e.g., length) of the sterilization zone 1424 can be increased, possibly requiring electrons propagating from the radiation sterilization 1412 to pass through a larger amount of material before impinging on the radiation-sensitive components 1408. The larger amount of material can help absorb or dissipate the radiation intensity of the radiation sterilization 1412 so that the radiation sterilization 1412 is harmless to sensitive electronics. However, in other embodiments, the opposite may equally be true. More specifically, the size (e.g., length) of the sterilization zone 1424 can be reduced as long as the material for the cap fill 1410 and / or the radiation shield 1416 provides a sufficiently large mass density.

[0139] The sterilization zone 1424 defined by the outer and inner collimators 1418, 1420 can exhibit any suitable cross-sectional shape necessary to properly focus the radiation 1412 onto the sensor 1316 and sharp point 1318 for sterilization. In the illustrated embodiment, for example, each of the outer and inner collimators 1418, 1420 is conical or frusto-conical in shape. However, in other embodiments, one or both of the outer and inner collimators 1418, 1420 can exhibit a polygonal cross-sectional shape, such as a cubic, rectangular (including, for example, a parallelogram), or pyramidal shape, without departing from the scope of this disclosure. In still other embodiments, one or both of the outer and inner collimators 1418, 1420 can exhibit a circular cross-section and parallel sides.

[0140] In the illustrated embodiment, the sterilization zone 1424 provides a first opening 1426a defined by the outer collimator 1418 and a second opening 1426b defined by the inner collimator 1420, where the first opening 1426a and the second opening 1426b are positioned at opposite ends of the sterilization zone 1424. The first opening 1426a allows the radiation 1412 to enter the sterilization zone 1424, and the second opening 1426b provides a location where the radiation 1412 can strike the sensor 1316 and the sharpened tip 1318. In the illustrated embodiment, the second opening 1426b also provides a location where the sensor 1316 and the sharpened tip 1318 can be received within the sterilization zone 1424.

[0141] In embodiments in which the sterilization zone 1424 is conical or frusto-conical in shape, the diameter of the first opening 1426a can be larger than the diameter of the second opening 1426b. In such embodiments, for example, the size of the first opening 1426a can range between about 5.0 mm and about 16.0 mm, and the size of the second opening 1426b can range between about 0.5 mm and about 3.0 mm. However, the respective diameters of the first and second openings 1426a, 1426b can be larger or smaller than those provided herein without departing from the scope of this disclosure and based on the application. In fact, the diameters of the first and second openings 1426a, 1426b need only be large enough to allow a sufficient radiation dose to be incident on the sensor 1316 and the sharp point 1318.

[0142] In the illustrated embodiment, the interior walls of the sterilization zone 1424 (e.g., the outer and inner collimators 1418, 1420) extend at a substantially constant angle relative to the centerline of the sensor applicator 102 between the first opening 1426a and the second opening 1426b. The wall angle can be anywhere between 0° and 90° relative to the centerline of the sensor applicator 102. However, the wall angle is preferably between 45° and 90° relative to the centerline of the sensor applicator 102. However, in other embodiments, the wall angle can vary between the first opening 1426a and the second opening 1426b without departing from the scope of this disclosure. In such embodiments, a portion of the wall can extend only a short distance at a different angle than an adjacent portion, or the wall can otherwise undulate between the first opening 1426a and the second opening 1426b.

[0143] In some embodiments, the sterilization zone 1424 defined by the outer and inner collimators 1418 may be substantially cylindrical, or may exhibit a circular or polygonal cross-section. In such embodiments, the first opening 1426a and the second opening 1426b may exhibit the same diameter, and the walls of the sterilization zone 1424 may be substantially parallel between the first and second ends of the sterilization zone 1424.

[0144] In some embodiments, a cap seal 1428 (shown in dashed lines) can be positioned at the interface between the cap fill 1410 and the radiation shield 1416. The cap seal 1428 can include a radio-permeable microbial barrier. In some embodiments, for example, the cap seal 1428 can be made of a synthetic material (e.g., flash-spun high-density polyethylene fibers) such as TYVEK® available from DuPont®. The cap seal 1428 can completely seal a portion of the sterile zone 1424 to help form part of a sealed region 1430 configured to isolate the sensor 1316 and sharps 1318 from external contamination.

[0145] The sealed area 1430 can include (encompass) selected portions within the electronics housing 1304 and the sterilization zone 1424. In one or more embodiments, the sealed area 1430 can be defined or otherwise formed by at least the cap seal 1428, a first or "top" seal 1432a, and a second or "bottom" seal 1432b. The cap seal 1428 and the top and bottom seals 1432a, 1432b each create a barrier corresponding to its respective sealing location, thereby enabling terminal sterilization of the sterilization zone 1424 that confines the sensor 1316 and sharp 1318.

[0146] The top seal 1432a can be positioned to seal the interface between the sharp body hub 1320 and the top of the electronics housing 1304 (i.e., the shell 1306 in FIG. 13), thereby preventing contaminants from migrating into the electronics housing 1304. In some embodiments, the top seal 1432a can form part of the sharp body hub 1320, such as by being overmolded onto the sharp body hub 1320. However, in other embodiments, the top seal 1432a can form part of or be overmolded onto the top surface of the shell 1306. In still other embodiments, the top seal 1432a can include a separate structure, such as an O-ring, sandwiched between the sharp body hub 1320 and the top surface of the shell 1306 without departing from the scope of this disclosure.

[0147] The bottom seal 1432b can be positioned to seal the interface between the cap fill 1410 and the bottom of the electronics housing 1304 (i.e., the mount 1308 in FIG. 13 ). The bottom seal 1432b can prevent contaminants from migrating into the sterilization zone 1424 and into the electronics housing 1304. In some embodiments, the bottom seal 1432b can form part of the cap fill 1410, such as by being overmolded onto the cap fill 1410. In other embodiments, the bottom seal 1432b can form part of or be overmolded onto the bottom of the mount 1308. In still other embodiments, the bottom seal 1432b can include a separate structure, such as an O-ring, sandwiched between the cap fill 1410 and the mount 1308 without departing from the scope of this disclosure.

[0148] After the sensor control device 1302 is loaded into the sensor applicator 102 and the applicator cap 1404 is secured to the sensor applicator 102, the top and bottom seals 1432 a, 1432 b can compress to create a corresponding sealed interface. The top and bottom seals 1432 a, 1432 b can be made of a variety of materials capable of creating a sealed interface between opposing structures. Suitable materials include, but are not limited to, silicone, thermoplastic elastomer (TPE), polytetrafluoroethylene (e.g., TEFLON®), or any combination thereof.

[0149] It should be noted that the sensor 1316 and sharps 1318 extend from the bottom of the electronics housing 1304 into the sterilization zone 1424 approximately concentric with the centerline of the sensor applicator 102 and applicator cap 1404, although this is considered herein to have an off-center location. More specifically, in at least one embodiment, the sensor 1316 and sharps 1318 extend from the bottom of the electronics housing 1304 off-center relative to the centerline of the sensor applicator 102 and applicator cap 1404. In such embodiments, the outer and inner collimators 1418, 1420 can be redesigned or otherwise configured to accommodate the sensor 1316 and sharps 1318 with the sterilization zone 1424 also off-centeredly located without departing from the scope of this disclosure.

[0150] In some embodiments, the external sterilization assembly 1414 may further include a sterilization housing or "pod" 1434 coupled to or forming part of the radiation shield 1416. The sterilization pod 1434 provides or otherwise defines a chamber 1436 sized to receive all or a portion of the sensor applicator 102. Once properly seated (received) within the sterilization pod 1434, the sensor applicator 102 may undergo radiation sterilization 1412 to sterilize the sensor 1316 and sharp 1318. To help prevent the radiation 1412 from propagating through the walls of the sterilization pod 1434, the sterilization pod 1434 may be fabricated from any of the materials listed herein for the radiation shield 1416.

[0151] In some embodiments, the radiation shield 1416 may be removably coupled to the sterilization pod 1434 using one or more mechanical fasteners 1438 (one shown), although alternatively, the radiation shield 1416 may be removably coupled by an interference fit, snap fit engagement, etc. Removably coupling the radiation shield 1416 to the sterilization pod 1434 allows the radiation shield 1416 to be interchangeable with shields for various types and designs of sensor applicators 102 that are differently designed (sized) to suit particular sterilization applications. Thus, the sterilization pod 1434 may include a universal mount that allows the radiation shield 1416 to be interchangeable with other shield designs having different parameters for the external collimator 1418 as needed.

[0152] In some embodiments, the external sterilization assembly 1414 can further include a mounting tray 1440 coupled to or forming part of the sterilization pod 1434. The sterilization pod 1434 can be removably coupled to the mounting tray 1440 using, for example, one or more mechanical fasteners 1442 (one shown). The mounting tray 1440 can provide or define a central opening 1444 sized to receive the sensor applicator 102 and alignable with the chamber 1436 to allow the sensor applicator 102 to enter the chamber 1436. As described below, in some embodiments, the mounting tray 1440 can define a corresponding plurality of central openings 1444 for receiving a plurality of sensor applicators for sterilization.

[0153] 15 is a cross-sectional side view of another exemplary embodiment of a sensor applicator 102 and an external sterilization assembly 1414 in accordance with one or more additional embodiments. As shown, the sensor control device 1302 is again received within the sensor applicator 102, and an applicator cap 1404 is coupled to the housing 1402 within which the sensor control device 1302 is secured.

[0154] In the illustrated embodiment, the applicator cap 1404 can be inverted and can define or otherwise provide a cap post 1502 sized to receive the distal ends of the sensor 1316 and sharp 1318 extending from the bottom of the electronics housing 1304. The cap post 1502 helps form part of a sealing area 1430 configured to isolate the sensor 1316 and sharp 1318 from external contamination. In the illustrated embodiment, the sealing area 1430 can be defined or otherwise formed by the cap post 1502 and top and bottom seals 1432 a, 1432 b that create corresponding barriers at the respective sealing locations. Again, the top seal 1432a can be positioned to seal the interface between the sharp body hub 1320 and the top of the electronics housing 1304 (i.e., shell 1306 in FIG. 13), and the bottom seal 1432b can be positioned to seal the interface between the applicator cap 1404 and the bottom of the electronics housing 1304 (i.e., mount 1308 in FIG. 13). In some embodiments, the bottom seal 1432b can be sandwiched between the cap post 1502 and the bottom of the electronics housing 1304.

[0155] In the illustrated embodiment, the radiation shield 1416 may be positioned external to the sensor applicator 102 and may extend into the inverted portion of the applicator cap 1404. An external collimator 1418 provided by the radiation shield 1416 defines a sterilization zone 1504 configured to focus the radiation 1412 toward the sensor 1316 and the sharpened tip 1318. In the illustrated embodiment, the cap post 1502 and the portions of the sensor 1316 and sharpened tip 1318 positioned within the cap post 1502 extend into the sterilization zone 1504. The propagated radiation 1412 may pass through the sterilization zone 1504 and sterilize the sensor 1316 and sharpened tip 1318 positioned within the cap post 1502. However, as noted above, the radiation shield 1416 may be fabricated from a material that substantially prevents the radiation 1412 from penetrating the walls of the sterilization zone 1504 and thereby damaging the radiation-sensitive components 1408 within the housing 1304.

[0156] In the illustrated embodiment, the external collimator 1418 defines a first opening 1506a at a first end of the sterilization zone 1504 and a second opening 1506b at a second end of the sterilization zone 1504. The first opening 1506a allows the radiation 1412 to enter the sterilization zone 1504, and the second opening 1506b provides a location where the radiation 1412 can be focused toward the sensor 1316 and the sharpened tip 1318. The second opening 1506b can provide a location where the sensor 1316 and the sharpened tip 1318 positioned within the cap post 1502 can be received within the sterilization zone 1504.

[0157] As shown, the outer collimator 1418 and associated sterilization zone 1504 are conical or frusto-conical in shape, with the diameter of the first opening 1506a being larger than the diameter of the second opening 1506b. The size of the first opening 1506a can range between about 5.0 mm and about 16.0 mm, and the size of the second opening 1506b can range between about 0.5 mm and about 3.0 mm, although these sizes can alternatively be larger or smaller than the provided ranges without departing from the scope of this disclosure. Indeed, the size of the openings 1506a, 1506b can vary depending on the size of the device. However, in other embodiments, the external collimator 1418 and associated sterilization zone 1504 may be substantially cylindrical, or may have a circular or polygonal cross-section, in which case the first opening 1506a and the second opening 1506b have substantially the same diameter and the walls of the sterilization zone 1504 are substantially parallel.

[0158] 16 is a cross-sectional side view of another exemplary embodiment of a sensor applicator 102 and an external sterilization assembly 1414 in accordance with one or more additional embodiments. As shown, again, the sensor control device 1302 is received within the sensor applicator 102, and an applicator cap 1404 is coupled to the housing 1402, within which the sensor control device 1302 is secured.

[0159] In the illustrated embodiment, the applicator cap 1404 may again be inverted and may define or otherwise be provided with a cap post 1602 sized to receive the distal ends of the sensor 1316 and tip 1318 extending from the bottom of the electronics housing 1304. Additionally, a radiation shield 1416 may be positioned on the exterior of the sensor applicator 102 and may extend into the inverted portion of the applicator cap 1404. More specifically, the radiation shield 1416 may extend into the inverted portion of the applicator cap 1404 and further extend to the bottom of the cap post 1602. However, unlike the cap post 1502 of FIG. 15 , the bottom of the cap post 1602 may be open-ended. In some embodiments, a cap seal 1604 may be positioned at the interface between the cap post 1602 and the radiation shield 1416 to completely seal the open end of the cap post 1602. Cap seal 1604 can be similar to cap seal 1428 of FIG. 14B and therefore will not be described again.

[0160] In some embodiments, a cap filler 1606 can be positioned within the applicator cap 1404. In one or more embodiments, the cap filler 1606 can comprise an integral portion or extension of the applicator cap 1404, such as being cast with or overmolded onto the applicator cap 1404. In other embodiments, the cap filler 1606 can comprise a separate structure fitted within or otherwise attached to the applicator cap 1404 without departing from the scope of this disclosure. The cap filler 1606 can provide or otherwise define an internal collimator 1608 that can help focus the radiation 1412 toward the components being sterilized. In at least one embodiment, the cap post 1602 can be received within the internal collimator 1608, as shown.

[0161] The external collimator 1418 and the internal collimator 1608 may cooperate to define a sterilization zone 1610 that focuses the radiation 1412 toward the sensor 1316 and the sharpened tip 1318. The propagating radiation 1412 may pass through the sterilization zone 1610 and impinge on and sterilize the sensor 1316 and the sharpened tip 1318. However, the cap filler 1606 and the radiation shield 1416 may each be fabricated from any of the materials described herein that substantially prevent the radiation 1412 from penetrating the inner walls of the sterilization zone 1610 and thereby damaging the radiation-sensitive components 1408 within the housing 1304. In at least one embodiment, the cap filler 1606 may be fabricated from machined or 3D printed polypropylene, and the radiation shield 1416 may be fabricated from stainless steel.

[0162] The outer and inner collimators 1418, 1608 can exhibit any suitable cross-sectional shape necessary to properly focus the radiation 1412 toward the sensor 1316 and sharpened tip 1318 for sterilization. In the illustrated embodiment, for example, the outer collimator 1418 is conical or frusto-conical in shape, and the inner collimator 1608 is substantially cylindrical with substantially parallel inner walls. However, in other embodiments, the outer and inner collimators 1418, 1608 can exhibit other cross-sectional shapes without departing from the scope of this disclosure.

[0163] In the illustrated embodiment, the external collimator 1418 defines a first opening 1612a that allows the radiation 1412 to enter the sterilization zone 1610 and a second opening 1612b positioned at or near the bottom opening to the cap post 1602 to focus the radiation 1412 onto the sensor 1316 and sharp point 1318 positioned within the cap post 1602. As in the prior embodiment, the diameter of the first opening 1612a is larger than the diameter of the second opening 1612b, and the size of the first opening 1612a can range between about 5.0 mm and about 16.0 mm, and the size of the second opening 1612b can range between about 0.5 mm and about 3.0 mm. In the illustrated embodiment, the external collimator 1418 passes the electrons of the radiation 1412 toward the bottom opening to the cap post 1602 , increasing the electrons at the sensor 1316 and tip 1318 .

[0164] The cap seal 1604 can be positioned at the interface between the radiation shield 1416 and the cap post 1602 and / or cap filler 1606. The cap seal 1604 can completely seal a portion of the sterilization zone 1610 to help form part of a sealed area 1430 configured to isolate the sensor 1316 and sharps 1318 from external contamination. The sealed area 1430 can include (encompass) selected portions within the electronics housing 1304 and the sterilization zone 1610. In the illustrated embodiment, the sealed area 1430 can be defined or otherwise formed by the cap post 1602 and top and bottom seals 1432 a, 1432 b that create a corresponding barrier at each sealing location. The bottom seal 1432 b can be positioned to seal the interface between the applicator cap 1404 and the bottom of the electronics housing 1304 (i.e., the mount 1308 in FIG. 13 ).

[0165] 17A and 17B are isometric top and bottom views, respectively, of an example external sterilization assembly 1414 according to one or more embodiments. In at least one embodiment, the assembly 1414 is designed and may be otherwise configured to assist in containing and sterilizing multiple sensor applicators 102 (i.e., having sensor control devices installed therein). In the illustrated embodiment, the mounting tray 1440 defines multiple central openings 1444 (FIG. 17A), and multiple sterilization pods 1434 may be aligned with and coupled to the mounting tray 1440. The sensor applicators 102 may be received within the sterilization pods 1434 through the central openings 1444, and each sterilization pod 1434 may have a corresponding shield 1416 (FIG. 17B) coupled to or otherwise forming part of it.

[0166] In some embodiments, the assembly 1414 can further include a cover 1702 that is matable with the mounting tray 1440. The cover 1702 can include or define a plurality of openings 1106 that are sized to receive the top of the sensor applicator 102 when it is placed on the mounting tray 1440. In some embodiments, the cover 1702 can be made of any of the materials listed herein for the radiation shield 1416 to help prevent radiation sterilization from propagating through the walls of the assembly 1414. With the cover 1702 mated with the mounting tray 1414, the sensor applicator 102 can be enclosed or otherwise encased within the assembly 1414.

[0167] Embodiments disclosed herein include the following.

[0168] D. An external sterilization assembly comprising: a radiation shield positionable on the exterior of a medical device having a sterilization-requiring portion and a radiation-sensitive component; and a collimator defined by the radiation shield and alignable with the sterilization-requiring portion, wherein the collimator focuses radiation from a radiation sterilization process toward the sterilization-requiring portion and the radiation shield prevents the radiation from damaging the radiation-sensitive component.

[0169] E. An external sterilization assembly including a radiation shield positionable externally to a sensor applicator including a housing, a cap coupled to the housing, and a sensor control device positioned within the housing, the sensor control device including an electronics housing, a radiation-sensitive component positioned within the electronics housing, and a sensor and a sharps extending from the electronics housing. The external sterilization assembly further includes an external collimator defined by the radiation shield and alignable with the sensor and the sharps, the external collimator focusing radiation from the radiation sterilization process toward the sensor and the sharps, and the radiation shield preventing the radiation from damaging the radiation-sensitive component.

[0170] F. A method comprising: disposing a radiation shield external to a sensor applicator having a housing, a cap coupled to the housing, and a sensor control device positioned within the housing, the sensor control device including an electronics housing, a radiation-sensitive component positioned within the electronics housing, and a sensor and a sharp point extending from the electronics housing, the method further comprising focusing radiation from a radiation sterilization process toward the sensor and sharp point with an external collimator defined by the radiation shield, and preventing the radiation from damaging the radiation-sensitive component with the radiation shield.

[0171] Each of embodiments D, E, and F can have one or more of the following additional elements in any combination: Element 1: The radiation shield is made of a material selected from the group consisting of a high density polymer, a metal, and any combination thereof. Element 2: The radiation-sensitive component is selected from the group consisting of an electronic module, a chemical solution, and any combination thereof. Element 3: The collimator includes a cross-sectional shape selected from the group consisting of a cone, a frusto-cone, a pyramid, a circle, a cube, a rectangle, and any combination thereof. Element 4: The collimator further includes a cap that encloses the sterilization-requiring portion and provides a hermetic barrier. Element 5: The radiation shield defines an internal cavity that receives the medical device, and the collimator focuses radiation into the internal cavity.

[0172] Element 6: The radiation shield is fabricated from a material selected from the group consisting of a high density polymer, a metal, and any combination thereof. Element 7: The external collimator includes a cross-sectional shape selected from the group consisting of a cone, a frustocone, a pyramid, a circle, a cube, a rectangle, and any combination thereof. Element 8: Further including a sterilization pod defining a chamber that receives at least a portion of the sensor applicator, the radiation shield being removably coupled to the sterilization pod. Element 9: Further including a mounting tray alignable with the chamber and defining a central opening sized to receive the sensor applicator, and a cover mateable with the mounting tray to encase the sensor applicator. Element 10: The external collimator is alignable with an internal collimator defined by a cap filler positioned within the cap, the external collimator and the internal collimator cooperating to define a sterilization zone that receives the sensor and sharps therein. Element 11: The external and internal collimators include a cross-sectional shape selected from the group consisting of a cone, a frusto-cone, a pyramid, a circle, a cube, a rectangle, and any combination thereof. Element 12: The cap further includes a cap seal positioned at the interface between the external collimator and the internal collimator. Element 13: The cap is inverted to provide a cap post that receives the sensor and the sharps. Element 14: The external collimator and the cap post cooperate to define a sterile zone, and the sensor and sharps positioned within the cap post extend into the sterile zone.

[0173] Element 15: The step of disposing the radiation shield external to the sensor applicator includes disposing the sensor applicator in a chamber defined by a sterilization pod, wherein the radiation shield is removably coupled to the sterilization pod. Element 16: The step of disposing the sensor applicator in the chamber defined by the sterilization pod further includes extending the sensor applicator through a central opening defined by a mounting tray and aligned with the chamber, disposing a cover on the mounting tray thereby encasing the sensor applicator, and effecting radiation sterilization while the sensor applicator is encased by the cover. Element 17: The external collimator includes a cross-sectional shape selected from the group consisting of a cone, a frusto-cone, a pyramid, a circle, a cube, a rectangle, and any combination thereof.

[0174] As non-limiting examples, exemplary combinations applicable to D, E, and F include combinations of elements 8 and 9, elements 10 and 11, elements 10 and 12, elements 13 and 14, and elements 15 and 16.

[0175] Hybrid Sterile Assembly Referring briefly again to FIG. 1 , the sensor control device 104 must be a sterilized product to render it free of viable microorganisms before it is delivered to an end user. Typically, the sensor 110 is sterilized using radiation sterilization, such as electron beam ("e-beam") irradiation. However, radiation sterilization can damage electronic components within the sensor control device 104, and the sensor control device 104 is typically sterilized by gaseous chemical sterilization (e.g., using ethylene oxide). However, gaseous chemical sterilization may damage enzymes or other chemicals and biologicals contained on the sensor 110.

[0176] In the past, this sterilization incompatibility has been avoided by separating the sensor 110 and electronic components and sterilizing each individually. However, this approach requires additional parts, packaging, processing steps, and final assembly by the user, which introduces the possibility of user error. With the present disclosure, the sensor control device 104, or any device requiring terminal sterilization, can be properly sterilized using multiple external sterilization assemblies designed to focus sterilizing radiation (e.g., beams, waves, energy) toward the component parts requiring sterilization while simultaneously preventing the propagating radiation from destroying or damaging sensitive electronic components.

[0177] 18 is an isometric view of an exemplary sensor control device 1802 in accordance with one or more embodiments of the present disclosure. Sensor control device 1802 can be the same as or similar to sensor control device 104 of FIG. 1 and, therefore, can be used in conjunction with sensor applicator 102 (FIG. 1) that delivers sensor control device 1802 to a target monitoring location on a user's skin. Therefore, sensor control device 1802 also requires proper sterilization before use.

[0178] As shown, the sensor control device 1802 includes an electronics housing 1804 that may be generally disc-shaped and have a circular cross-section. However, in other embodiments, the electronics housing 1804 may exhibit other cross-sectional shapes, such as an oval (e.g., pill-shaped or oval), a rounded square, a polygon, or any combination thereof, without departing from the scope of this disclosure. The electronics housing 1804 may be configured to house or otherwise enclose various electronic components used to operate the sensor control device 1802.

[0179] The electronics housing 1804 can include a shell 1806 and a mateable mount 1808. The shell 1806 can be secured to the mount 1808 in a variety of ways, such as a snap-fit ​​engagement, an interference fit, sonic or laser welding, one or more mechanical fasteners (e.g., screws), or any combination thereof. In some cases, the shell 1806 can be secured to the mount 1808 such that a sealed interface occurs between the shell 1806 and the mount 1808. In such embodiments, a gasket or other type of sealing material can be positioned at or near the outer diameter (periphery) of the shell 1806 and the mount 1808, and securing the two components together can compress the gasket, thereby creating a sealed 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 adhesive secures shell 1806 to mount 1808, providing structural integrity, but also seals the interface between these two components, thereby isolating the interior of electronics housing 1804 from outside contamination.

[0180] In the illustrated embodiment, the sensor control device 1802 may optionally include a plug assembly 1810 that may be coupled to the electronics housing 1804. The plug assembly 1810 may include a sensor module 1812 (partially visible) that may be interconnected with a tip module 1814 (partially visible). The sensor module 1812 may be configured to carry, and otherwise include, a sensor 1816 (partially visible), and the tip module 1814 may be configured to carry, and otherwise include, an introducer or tip 1818 (partially visible) that is used to assist in percutaneously delivering the sensor 1816 beneath the user's skin during application of the sensor control device 1802. In the illustrated embodiment, the tip module 1814 includes a tip hub 1820 that carries the tip 1818.

[0181] As shown, the sensor 1816 and corresponding portions of the tip 1818 extend distally from the electronics housing 1804, and more specifically from the bottom of the mount 1808. In at least one embodiment, the exposed portion of the sensor 1816 (alternatively referred to as the "tail") can be received within a hollow or recessed portion of the tip 1818. The remainder of the sensor 1816 is positioned within the electronics housing 1804.

[0182] FIG. 19A is a side view of the sensor applicator 102 of FIG. 1. As shown, the sensor applicator 102 includes a housing 1902 and an applicator cap 1904 removably coupled thereto. In some embodiments, the applicator cap 1904 can be threaded onto the housing 1902 and can include a tamper-evident ring 1906. Upon rotating (e.g., twisting off) the applicator cap 1904 relative to the housing 1902, the tamper-evident ring 1906 can be threaded off, thereby freeing the applicator cap 1904 from the sensor applicator 102. With the applicator cap 1904 removed, a user can use the sensor applicator 102 to position the sensor control device 1802 ( FIG. 18 ) at a target monitoring location on the user's body.

[0183] 19B is a partial cross-sectional side view of the sensor applicator 102. As shown, the sensor control device 1802 can be received within the sensor applicator 102, and an applicator cap 1904 can be coupled to the housing 1902 to secure the sensor control device 1802 within the housing 1902. The sensor control device 1802 can include one or more radiation-sensitive components 1908 positioned within the electronics housing 1804. The radiation-sensitive components 1908 can include electronic components or modules such as, but not limited to, a data processing unit, a register, a transistor, a capacitor, an inductor, a diode, a switch, or any combination thereof. The data processing unit can include, for example, an application-specific integrated circuit (ASIC) configured to perform one or more functions or routines associated with the operation of the sensor control device 1802. In operation, the data processing unit can perform data processing functions such as filtering and encoding a data signal corresponding to a user's sampled analyte level. The data processing unit can include an antenna for communicating with or otherwise communicate with the reader device 106 (FIG. 1).

[0184] In the illustrated embodiment, an applicator insert 1910 may be positioned within the applicator cap 1904 and may generally serve to support the sensor control device 1802 within the sensor applicator 102. In one embodiment, the applicator insert 1910 may comprise an integral portion or extension of the applicator cap 1904, such as being cast with or overmolded onto the applicator cap 1904. In other embodiments, the applicator insert 1910 may comprise a separate structure fitted within or otherwise attached to the applicator cap 1904 without departing from the scope of this disclosure. In such an embodiment, for example, by threading applicator cap 1904 onto housing 1908, inner surface 1912 of applicator insert 1910 can be gradually advanced into axial and / or radial engagement with the bottom edge, bottom surface, or bottom portion of applicator insert 1910, thereby axially securing applicator insert 1910 within applicator cap 1904.

[0185] The sensor applicator 102 may further include a sheath 1914, and in some embodiments, the applicator insert 1910 may engage the sheath 1914 to prevent the applicator insert 1910 from rotating within the applicator cap 1904. More specifically, the applicator insert 1910 may provide or otherwise define one or more radial alignment features 1916 (one shown) that may mate with corresponding grooves or slots 1918 defined in the sheath 1914. The radial alignment features 1916 may include, for example, rails, flags, tabs, protrusions, or the like, extending from the body of the applicator insert 1910 and may mate with the slots 1918, for example, by sliding the radial alignment features 1916 longitudinally into the slots 1918. The mating engagement between the radial alignment feature 1916 and the slot 1918 can serve to angularly (rotationally) orient the applicator insert 1910 relative to the sensor control device 1802. However, as will be appreciated, the matable structures can alternatively be reversed, with the radial alignment feature 1916 instead being provided on the sheath 1914 and the slot 1918 being provided on the applicator insert 1910.

[0186] The applicator insert 1910 provides, and can otherwise define, an internal collimator 1920a that forms part of a hybrid sterilization assembly, described in more detail below. The internal collimator 1920a can help define a portion of a sterilization zone 1922, more specifically an upper portion 1924 of the sterilization zone 1922. When the sensor control device 1802 is installed in the sensor applicator 102, the sensor 1816 and the distal end of the sharp 1818 can extend from the bottom of the electronics housing 1804 and reside within the upper portion 1924.

[0187] In some embodiments, a microbial barrier 1926a can be positioned at the opening to the upper portion 1924 of the sterilization zone 1922. The microbial barrier 1926a can help seal at least a portion of the upper portion 1924 of the sterilization zone 1922, thereby isolating the sensor 1816 and the distal end of the sharp 1818 from external contamination. The microbial barrier 1926a can be fabricated from a radiolucent material such as a synthetic material (e.g., flash-spun high-density polyethylene fiber). One exemplary synthetic material includes TYVEK®, available from DuPont®. However, in other embodiments, the microbial barrier 1926a can include, but is not limited to, tape, paper, film, foil, or any combination thereof. In at least one embodiment, the microbial barrier 1926a can include or otherwise be formed by a thin-walled portion of the applicator insert 1910 without departing from the scope of this disclosure.

[0188] In some embodiments, moisture barrier 1926b can be disposed or otherwise positioned at opening 1928 to applicator cap 1904. Similar to microbial barrier 1926a, moisture barrier 1926b can be configured to help isolate a portion of sensor applicator 102 from external contamination. Moisture barrier 1926b can be fabricated from any of the materials described above for microbial barrier 1926a. However, in at least one embodiment, moisture barrier 1926b can include a thinned portion of applicator cap 1904 without departing from the scope of the present disclosure. In such an embodiment, opening 1928 would not be necessary.

[0189] 20A-20C illustrate various views of an applicator insert 1910 in accordance with one or more embodiments of the present disclosure. More specifically, FIG. 20A is an isometric top view, FIG. 20B is an isometric bottom view, and FIG. 20C is an isometric cross-sectional view of applicator insert 1910. As shown, applicator insert 1910 includes a generally cylindrical body 2002 having a first or upper end 2004a and an opposing second or lower end 2004b. Upper end 2004a is generally closed except for an opening 2005 sized to receive sensor 1816 (FIG. 19B) and tip 1918 (FIG. 19B) therethrough, and lower end 2004b is generally open.

[0190] The radial alignment features 1916 described above are provided on the sidewall of the body 2002. In some embodiments, additional radial alignment features 2006 (three shown) may be provided or otherwise defined on the sidewall of the body 2002. In the illustrated embodiment, the additional radial alignment features 2006 each include a pair of longitudinally extending tabs or protrusions 2008 that are angularly offset from one another on the sidewall and cooperate to define a slot 2010 therebetween. The slot 2010 may be sized to receive a protrusion or tab provided on the sheath 1914 ( FIG. 19B ) to assist in angularly (rotationally) orienting the applicator insert 1910 relative to the sensor control device 1802 ( FIG. 19B ). Furthermore, similar to the arrangement of the radial alignment feature 1916, the matable structures of the additional radial alignment feature 2006 can alternatively be reversed, in which case the additional radial alignment feature 2006 is instead provided on the sheath 1914 and a corresponding protrusion or tab is provided on the applicator insert 1910.

[0191] 20A and 20C , the applicator insert 1910 may further include one or more sensor positioning features 2012 that may also be used to help properly orient the applicator insert 1910 relative to the sensor control device 1802 ( FIG. 19B ) within the sensor applicator 102 ( FIG. 19B ). As shown, the sensor positioning feature 2012 may be defined on the top end 2004 a of the body 2002 and extend axially therefrom. The sensor positioning feature 2012 may be sized to be received within a corresponding opening defined in the bottom of the sensor control device 1802. In the illustrated embodiment, the sensor positioning feature 2012 includes a cylindrical protrusion, but may alternatively include other types of structural features suitable for mating with corresponding features on the bottom of the sensor control device 1802. In embodiments in which the sensor control device 1802 includes an eccentric orientation and the sensor 1916 and the sharp body 1918 are not concentric with the centerline of the sensor control device, the sensor positioning feature 2012 has been found to be particularly advantageous in conjunction with the radial alignment feature 1916 and the additional radial alignment feature 2006.

[0192] Internal collimator 1920a can be formed or otherwise provided in top end 2004a of applicator insert 1910. As best seen in FIG. 20C , internal collimator 1920a can be defined by applicator insert 1910 and can include collimating insert 2014 and gasket 2016. Internal collimator 1920a can be fabricated by first fabricating or otherwise creating collimating insert 2014. Applicator insert 1910 can then be overmolded onto collimating insert 2014. Similarly, collimating insert 2014 can be insert molded into applicator insert 1910. Thus, applicator insert 1910 can be manufactured from a hard plastic. Gasket 2016 can then be cast onto applicator insert 1910 in a second-shot casting (overmolding) process.

[0193] The collimating insert 2014 can be made of a material that reduces or prevents the penetration of sterilizing radiation therethrough. Suitable materials for the collimating insert 2014 include, but are not limited to, high density polymers (such as, for example, polyethylene, polypropylene, polystyrene, polytetrafluoroethylene, polyamide), metals (such as, for example, lead, tungsten, stainless steel, aluminum), composite materials, or any combination thereof. In some embodiments, the collimating insert 2014 can be made of any material that has a mass density greater than 0.9 grams per cubic centimeter (g / cc).

[0194] The gasket 2016 can be made of any material that helps form a sealed interface with the bottom of the electronics housing 1804 (FIG. 19B) when the applicator insert 1910 is installed within the sensor applicator 102 (FIG. 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, the gasket 2016 can fill the gap 2018 defined by the applicator insert 1910 and can provide an annular protrusion 2020 that passes over and / or protrudes from an upper surface of the upper end 2004 a of the body 2002. The annular protrusion 2020 has been found to be advantageous not only in facilitating a sealed interface but also in helping to bridge tolerances when the applicator insert 1910 is installed within the sensor applicator 102. Additionally, the mass of the gasket 2016 can help to absorb radiation during the sterilization process described below, thereby providing another layer of protection against radiation propagation. In at least one embodiment, the gasket 2016 can be large enough or of a material that absorbs enough radiation to be able to exclude the collimating insert 2014 from the inner collimator 1920 a.

[0195] 21 is another cross-sectional side view of the sensor applicator 102 of FIG. 19A illustrating a hybrid sterilization assembly 2102 in accordance with one or more embodiments of the present disclosure. Alternatively, the hybrid sterilization assembly 2102, referred to as a "split collimation assembly" or "cooperative collimation assembly," can be used to assist in sterilizing the sensor control device 1802, and more specifically, the distal ends of the sensor 1816 and sharpened tip 1818 extending from the bottom of the electronics housing 1804, while positioned within the sensor applicator 102. More specifically, the fully assembled sensor control device 1802 can be subjected to radiation sterilization 2104 to sterilize exposed portions of the sensor 1816 and sharpened tip 1818. Suitable radiation sterilization 2104 processes include, but are not limited to, electron beam (e-beam) irradiation, gamma irradiation, x-ray irradiation, or any combination thereof.

[0196] Radiation sterilization 2104 can be delivered by either continuous step irradiation or pulsed beam irradiation. In pulsed beam irradiation, the beam of radiation sterilization 2104 is focused at a target location, the component part or device to be sterilized is moved thereto, and the irradiation is activated to deliver a directional pulse of radiation to this point. The radiation sterilization 2104 is then stopped, another component part or device to be sterilized is moved to the target location, and the process is repeated.

[0197] In accordance with the present disclosure, a hybrid sterilization assembly 2102 can be used to assist in focusing the radiation 2104 during sterilization of the distal end of the sensor 1816 and sharp tip 1818, while simultaneously preventing (blocking) the propagating radiation 2104 from damaging the radiation-sensitive component 1908. As shown, the hybrid sterilization assembly 2102 (hereinafter "assembly 2102") can include the inner collimator 1920a and outer collimator 1920b described above. As shown, the inner collimator 1920a can be positioned within the sensor applicator 102, and the outer collimator 1920b can extend into the sensor applicator 102 (i.e., applicator cap 1904) by passing through an opening 1928 into the applicator cap 1904. The inner collimator 1920a and outer collimator 1920b can cooperate to define a sterilization zone 1922 that focuses radiation 2104 (e.g., beam, wave, energy, etc.) onto the sensor 1816 and the sharp body 1818 to sterilize them.

[0198] In the illustrated embodiment, the outer collimator 1920b is designed to align with the inner collimator 1920a, and more specifically, the collimating insert 2014. In at least one embodiment, for example, the collimating insert 2014 can define a radial shoulder 2106 sized to receive and fit over the end of the outer collimator 1920b that extends into the applicator cap 1904. The outer collimator 1920b can transition to the inner collimator 1920a at the radial shoulder 2106. In some embodiments, the transition between the outer collimator 1920a and the inner collimator 1920b can be continuous, flush, or smooth. However, in other embodiments, the transition can be intermittent or gradual without departing from the scope of this disclosure.

[0199] Like the collimating insert 2014 of the inner collimator 1920a, the outer collimator 1920b can be made of a material that substantially prevents the radiation 2104 from penetrating the interior walls of the sterile zone 1922 and thereby damaging the radiation-sensitive components 1908 within the electronics housing 1804. Accordingly, the outer collimator 1920b can be made of any of the materials listed herein as suitable for the collimating insert 2014. In at least one embodiment, the collimating insert 2014 and the outer collimator 1920b can each be made of stainless steel. However, in addition, as described above, the gasket 2016 can provide some degree of shielding or protection against radiation damaging the radiation-sensitive components 1908.

[0200] The sterilization zone 1922 defined by the inner and outer collimators 1920a, 1920b can exhibit any suitable cross-sectional shape necessary to properly focus the radiation 2104 onto the sensor 1816 and the sharp point 1818 for sterilization. In the illustrated embodiment, for example, each of the outer and inner collimators 1920a, 1920b is conical or frusto-conical in shape. However, in other embodiments, one or both of the inner and outer collimators 1920a, 1920b can exhibit a polygonal cross-sectional shape, such as a cube, a rectangle (including, for example, a parallelogram), or a pyramid, without departing from the scope of this disclosure. In still other embodiments, one or both of the inner and outer collimators 1920a, 1920b can exhibit a circular cross-sectional shape with parallel sides.

[0201] In the illustrated embodiment, the sterilization zone 1922 provides a first opening 2108a defined by an outer collimator 1920b and a second opening 2108b defined by an inner collimator 1920a, where the first opening 2108a and the second opening 2108b are positioned at opposite ends of the sterilization zone 1922. The first opening 2108a allows radiation 2104 to enter the sterilization zone 1922, and the second opening 2108b provides a location where the sensor 1816 and sharp object 1818 can be received within the sterilization zone 1922.

[0202] In embodiments in which the sterilization zone 1922 is conical or frusto-conical in shape, the diameter of the first opening 2108a can be larger than the diameter of the second opening 2108b. In such embodiments, for example, the size of the first opening 2108a can range between about 5.0 mm and about 16.0 mm, and the size of the second opening 2108b can range between about 0.5 mm and about 5.0 mm. However, the respective diameters of the first and second openings 2108a, 2108b can be larger or smaller than the ranges provided herein without departing from the scope of this disclosure and based on the application. In fact, the diameters of the first and second openings 2108a, 2108b need only be large enough to allow a sufficient radiation dose to be incident on the sensor 1816 and the tip 1818.

[0203] In embodiments where the sterilization zone 1922 is substantially cylindrical or otherwise exhibits a circular or polygonal cross-section, the first opening 2108a and the second opening 2108b may exhibit the same diameter. In such embodiments, the walls of the sterilization zone 1922 may or may not be substantially parallel between the first and second ends of the sterilization zone 1922.

[0204] In the illustrated embodiment, the interior walls of the sterilization zone 1922 (e.g., the inner and outer collimators 1920a, 1920b) extend at a substantially constant angle relative to the centerline of the sensor applicator 102 between the first opening 2108a and the second opening 2108b. The wall angle can be anywhere between 0° and 90° relative to the centerline of the sensor applicator 102. However, the wall angle is preferably between 45° and 90° relative to the centerline. However, in other embodiments, the wall angle can vary between the first opening 2108a and the second opening 2108b without departing from the scope of this disclosure. In such embodiments, a portion of the wall can extend only a short distance at a different angle than an adjacent portion, or the wall can otherwise undulate between the first opening 2108a and the second opening 2108b.

[0205] The microbial barrier 1926a is located at the interface between the inner collimator 1920a and the outer collimator 1920b and may otherwise be positioned at or near the radial shoulder 2106. The microbial barrier 1926a may be present during a radiation sterilization process. As described above, the microbial barrier 1926a may help seal at least a portion of the sterilization zone 1922. More specifically, the microbial barrier 1926a may completely seal a portion of the sterilization zone 1922 to help form part of a sealed region 2110 configured to isolate the sensor 1816 and the sharps 1818 from external contamination. The sealed region 2110 may include (encompass) selected portions within the electronics housing 1804 and the sterilization zone 1922. In one or more embodiments, the sealed area 2110 may be defined or otherwise formed by at least the microbial barrier 1926a, the first or "top" seal 2112a, and the second or "bottom" seal 2112b. The microbial barrier 1926a and each of the top and bottom seals 2112a, 2112b create a corresponding barrier at its respective sealed location, thereby enabling terminal sterilization of the sterilization zone 1922 that confines the sensor 1816 and sharp 1818.

[0206] The top seal 2112a can be positioned to seal the interface between the sharp body hub 1820 and the top of the electronics housing 1804 (i.e., the shell 1806 in FIG. 18 ), thereby preventing contaminants from migrating into the electronics housing 1804. In some embodiments, the top seal 2112a can form part of the sharp body hub 1820, such as by being overmolded onto the sharp body hub 1820. However, in other embodiments, the top seal 2112a can form part of or be overmolded onto the top surface of the shell 1806. In still other embodiments, the top seal 2112a can include a separate structure, such as an O-ring, sandwiched between the sharp body hub 1820 and the top surface of the shell 1806 without departing from the scope of this disclosure.

[0207] Bottom seal 2112b may include a gasket 2016 (FIG. 20C), more specifically an annular protrusion 2020 (FIGS. 20A and 20C) overmolded onto applicator insert 1910. When activated, bottom seal 2112b may be positioned to seal the interface between applicator insert 1910 and the bottom of electronics housing 1804 (i.e., mount 1808 in FIG. 18). Bottom seal 2112b may prevent contaminants from migrating into sterile zone 1922 and into electronics housing 1804.

[0208] After the sensor control device 1802 is loaded into the sensor applicator 102 and the applicator cap 1904 is secured to the sensor applicator 102, the top and bottom seals 2112a, 2112b may be gradually compressed to create a corresponding sealed interface. The top and bottom seals 2112a, 2112b may be made of a variety of materials capable of creating a sealed interface between opposing structures. Suitable materials include, but are not limited to, silicone, thermoplastic elastomer (TPE), polytetrafluoroethylene (e.g., TEFLON®), or any combination thereof.

[0209] Once the radiation sterilization process is complete, the external collimator 1920b can be removed from the applicator cap 1904, and a moisture barrier 1926b can be positioned to block an opening 1928 in the applicator cap 1904. During delivery, a user can simply remove the applicator cap 1904 in preparation for sending out the sensor control device 1802. In at least one embodiment, removing the applicator cap 1904 also removes the applicator insert 1910, which can be received therein in a manner that allows the applicator insert 1910 to be secured to the applicator cap 1904 for disassembly. In such an embodiment, for example, the applicator insert 1910 can be coupled to the applicator cap 1904 using a snap-fit ​​engagement or the like.

[0210] In some embodiments, the electronics housing 1804 can be filled with a potting material 2114 that fills voids within the sensor control device 1802. The potting material 2114 can include a biocompatible material that meets the requirements of ISO 10993. In some embodiments, for example, the potting material 2114 can include a urethane material such as Resinaid® 3672 available from Henkel® or a silicone material such as SI5055 or SI5240. In other embodiments, the potting material 2114 can include an acrylate adhesive material such as GE4949 available from Delo®.

[0211] The potting material 2114 can act as an additional safety barrier to absorb or deflect the propagating radiation 2104. In at least one embodiment, for example, the potting material 2114 can provide an electron beam resistance of at least 85 kGy. Thus, the radiation 2104 can be forced to pass through the potting material 2114 instead of through the air typically present in the electronics housing 1804 before impinging on the radiation-sensitive component 1908. While the potting material 2114 may not include a dense material, it can nevertheless act as another level of radiation shielding. Furthermore, the potting material 2114 can increase the robustness of the sensor control device 1802 and the electronics housing 1804. Thus, the use of the potting material 2114 can allow the electronics housing 1804 to be manufactured from thinner material, if desired.

[0212] It should be noted that the sensor 1816 and sharps 1818 extend from the bottom of the electronics housing 1804 into the sterilization zone 1922 generally concentric with the centerline of the sensor applicator 102 and applicator cap 1904, although this is considered herein to have an off-center arrangement. More specifically, in at least one embodiment, the sensor 1816 and sharps 1818 extend from the bottom of the electronics housing 1804 eccentrically relative to the centerline of the sensor applicator 102 and applicator cap 1904. In such embodiments, the inner and outer collimators 1920a, 1920b can be redesigned or otherwise configured to accommodate the sensor 1816 and sharps 1818 with the sterilization zone 1922 also eccentrically positioned without departing from the scope of this disclosure.

[0213] Figures 22A and 22B are isometric and cross-sectional side views of another embodiment of an applicator insert 1910. Applicator insert 1910 shown in Figures 22A-22B can be similar in most respects to applicator insert 1910 of Figures 20A-20C. However, unlike applicator insert 1910 of Figures 20A-20C, applicator insert 1910 of Figures 22A-22B provides an eccentric orientation in which internal collimator 1920a is positioned eccentrically relative to centerline 2202 (Figure 22B) of body 2002. In such embodiments, the sensor control device 1802 (FIGS. 19B and 21) can be provided with an eccentric orientation to allow the sensor 1816 (FIGS. 19B and 21) and the point 1818 (FIGS. 19B and 21) to extend into the opening 2005 defined in the top end 2004a of the applicator insert 1910. Furthermore, in such embodiments, the radial alignment feature 1916, the additional radial alignment feature 2006, and the sensor positioning feature 2012 have been found to be particularly advantageous in assisting in properly orienting the applicator insert 1910 relative to the sensor control device 1802 within the sensor applicator 102 (FIGS. 19B and 21).

[0214] Embodiments disclosed herein include the following.

[0215] H. A sensor applicator comprising: a housing in which a sensor control device including a sensor, a sharp point, and a radiation-sensitive component is mounted; an applicator cap removably coupled to the housing; an applicator insert positionable within the applicator cap, the applicator insert defining an internal collimator that receives the sensor and the distal end of the sharp point; and an external collimator extendable within the applicator cap, the internal collimator and external collimator cooperating to focus radiation from a radiation sterilization process toward the sensor and the sharp point while preventing the radiation from damaging the radiation-sensitive component.

[0216] I. A method of sterilizing a sensor control device, comprising: placing a sensor control device including a sensor, a sharp, and radiation-sensitive components into a sensor applicator housing; receiving the distal end of the sensor and sharp within an internal collimator defined by an applicator insert; removably coupling an applicator cap to the housing, thereby securing the applicator insert within the applicator cap; extending an external collimator into the applicator cap and aligning the external collimator with the internal collimator; and cooperatively focusing radiation from a radiation sterilization process toward the sensor and sharp, while preventing the radiation from damaging the radiation-sensitive components, using the internal collimator and the external collimator.

[0217] J. A hybrid sterilization assembly comprising: an applicator insert positionable within an applicator cap of a sensor applicator; an internal collimator defined by the applicator insert and adapted to receive the distal end of a sensor and a sharpened tip of a sensor control device positioned within a housing of the sensor applicator; and an external collimator extendable within the applicator cap and alignable with the internal collimator, the internal collimator and external collimator cooperating to focus radiation from a radiation sterilization process toward the sensor and the sharpened tip while preventing the radiation from damaging radiation-sensitive components.

[0218] Each of embodiments H, I, and J may have one or more of the following additional elements in any combination: Element 1: The applicator insert engages an inner surface of the applicator cap to axially secure the applicator insert within the applicator cap. Element 2: Further including a sheath extending from the housing into the applicator cap when the applicator cap is coupled to the housing, and one or more radial alignment features on the applicator insert that are mateable with one or more corresponding features on the sheath, thereby rotationally orienting the applicator insert relative to the sensor control device. Element 3: Further including one or more sensor positioning features on the applicator insert that are mateable with one or more corresponding features on the sensor control device to rotationally orient the applicator insert relative to the sensor control device. Element 4: The internal collimator includes a collimating insert, and the external collimator is alignable with the collimating insert. Element 5: The collimating insert and the external collimator are each fabricated from a material selected from the group consisting of a high density polymer, a metal, a composite material, and any combination thereof. Element 6: The internal collimator further includes a gasket engageable with a bottom of the sensor control device to create a sealed interface. Element 7: The internal collimator and the external collimator cooperate to define a sterilization zone exhibiting a cross-sectional shape selected from the group consisting of a cone, a frusto-cone, a pyramid, a circle, a cube, a rectangle, and any combination thereof. Element 8: Further including an embedding material positioned within the sensor control device.

[0219] Element 9: further comprising engaging an inner surface of the applicator cap against the applicator insert, thereby axially securing the applicator insert within the applicator cap. Element 10: the inner collimator includes a gasket, and the method further includes engaging the gasket against a bottom of the sensor control device when the applicator insert is axially secured within the applicator cap, and generating a sealed interface between the gasket and the bottom of the sensor control device. Element 11: the inner collimator and the outer collimator cooperate to define a sterile zone that receives the sensor and sharps, and the method further includes sealing at least a portion of the sterile zone with a microbial barrier positioned at the interface between the inner collimator and the outer collimator. Element 12: the inner collimator includes a collimating insert, and the step of aligning the external collimator with the inner collimator includes aligning the external collimator with the collimating insert. Element 13: The inner collimator and the outer collimator cooperate to define a sterilization zone exhibiting a cross-sectional shape selected from the group consisting of a cone, a truncated cone, a pyramid, a circle, a cube, a rectangle, and any combination thereof.

[0220] Element 14: Further including a microbial barrier positioned at the interface between the inner collimator and the outer collimator. Element 15: The inner collimator includes a collimating insert, wherein the collimating insert and the outer collimator are each fabricated from a material selected from the group consisting of a high density polymer, a metal, a composite material, and any combination thereof. Element 16: The inner collimator further includes a gasket engageable with a bottom of the sensor control device to create a sealed interface. Element 17: The inner collimator and the outer collimator cooperate to define a sterile zone exhibiting a cross-sectional shape selected from the group consisting of a cone, a frustum cone, a pyramid, a circle, a cube, a rectangle, and any combination thereof.

[0221] By way of non-limiting example, exemplary combinations applicable to H, I, and J include combinations of elements 4 and 5, elements 4 and 6, elements 9 and 10, and elements 15 and 16.

[0222] Internal Sterile Assembly Before delivery to an end user, some medical devices must be sterilized to render the product free of viable microorganisms. However, some medical devices include subcutaneous sensing devices or subcutaneous sensors that must be sterilized using radiation sterilization, such as electron beam ("e-beam") irradiation. However, radiation sterilization can damage electronic components associated with the medical device, which are typically sterilized by gaseous chemical sterilization (e.g., using ethylene oxide). However, gaseous chemical sterilization may damage enzymes or other chemicals and biological agents contained on the subcutaneous sensing device.

[0223] In the past, this sterilization incompatibility has been avoided by separating the subcutaneous sensing device and the electronic components and sterilizing each individually. However, this approach requires additional parts, packaging, processing steps, and final assembly by the user, which introduces the possibility of user error. With the present disclosure, any device requiring terminal sterilization can be properly sterilized using an external sterilization assembly designed to focus sterilizing radiation (e.g., beam, wave, energy) toward the component parts requiring sterilization while simultaneously preventing the propagating radiation from destroying or damaging the sensitive electronic components.

[0224] 23 is a schematic diagram of an exemplary internal sterilization assembly 2300 in accordance with one or more embodiments of the present disclosure. The internal sterilization assembly 2300 (hereinafter "assembly 2300") is designed, and may be otherwise configured, to assist in sterilizing a medical device 2302. The medical device 2302 may include any type of healthcare product including any device, mechanism, assembly, or system that requires terminal sterilization of one or more component parts. Suitable examples of medical devices 2302 include, but are not limited to, an ingestible product, a cardiac rhythm management (CRM) device, a subcutaneous sensing device, an externally worn medical device, a drug delivery device, or any combination thereof.

[0225] In the illustrated embodiment, the medical device 2302 includes a subcutaneous sensing device or "sensor control device," also referred to as an "in vivo analyte sensor control device." As shown, the medical device 2302 can be housed within a sensor applicator 2304 (alternatively referred to as an "inserter"), to which a cap 2306 can be removably coupled. The medical device 2302 can include a housing 2308, a sterilization-requiring part 2310, and one or more radiation-sensitive components 2312. In some embodiments, the part 2310 can include a sensor extending from the housing 2308. In at least one embodiment, the part 2310 can also include a sharp, which may require sterilization and can aid in implanting the sensor under the user's skin. As shown, the part 2310 can extend at an angle from the bottom surface of the housing 2308, but alternatively, the part 2310 can extend perpendicularly from the bottom surface or another surface of the housing 2308. Additionally, as shown, component 2310 may extend from one end of housing 2308 or otherwise offset from the centerline of housing 2308, or alternatively, may extend concentrically with the housing without departing from the scope of this disclosure.

[0226] The sensor applicator 2304 is used to deliver the medical device 2302 to a target monitoring location on the user's skin (e.g., the user's arm). In some embodiments, the cap 2306 is threaded onto the sensor applicator 2304 and can be removed from the sensor applicator 2304 by twisting the cap 2306 out of engagement with the sensor applicator 2304. With the cap 2306 removed, the user can use the sensor applicator 2304 to position the sensor control device 2302 at a target monitoring location on the user's body. The component 2310 is positioned such that it can be transcutaneously positioned below the surface of the user's skin and otherwise held there. In some embodiments, the medical device 2302 can be spring-loaded for ejection from the sensor applicator 2304. Once delivered, the medical device 2302 can be maintained in place on the skin by an adhesive patch (not shown) coupled to its bottom.

[0227] In the illustrated embodiment, the radiation-sensitive component 2312 may be mounted on a printed circuit board (PCB) 2314 positioned within the housing 2308. The radiation-sensitive component 2312 may include one or more electronic modules, such as, but not limited to, a data processing unit (e.g., an application-specific integrated circuit or "ASIC"), a resistor, a transistor, a capacitor, an inductor, a diode, a switch, or any combination thereof. However, in other embodiments, the radiation-sensitive component 2312 may include a radiation-sensitive chemical solution or analyte (e.g., an active agent, a pharmaceutical, a biologic, etc.). In such embodiments, the medical device 2302 may alternatively include a hypodermic needle or syringe, and the chemical solution or analyte may be positioned within an ampoule of the medical device 2302.

[0228] The medical device 2302 can be subjected to radiation sterilization 2316 to properly sterilize the part 2310 for use. Suitable radiation sterilization 2316 processes include, but are not limited to, electron beam (e-beam) irradiation, gamma irradiation, x-ray irradiation, or any combination thereof. The cap 2306 can define a collimator 2318 that allows the radiation 2316 to be incident on the part 2310 and sterilize it. However, the cap 2306 can act as a radiation shield that helps prevent (block) the propagating radiation 2316 from destroying or damaging the radiation-sensitive component 2312. To accomplish this, the cap 2306 can be fabricated from a material that reduces or prevents the radiation 2316 from penetrating it.

[0229] More specifically, cap 2306 can be made of a material having a density sufficient to absorb the dose of the beam energy of radiation 2316 being transmitted. In some embodiments, for example, cap 2306 can be made of any material having a mass density greater than 0.9 grams per cubic centimeter (g / cc). However, in other embodiments, the mass density of suitable materials can be less than 0.9 g / cc without departing from the scope of the present disclosure. Suitable materials for cap 2306 include, but are not limited to, high density polymers (such as, for example, polyethylene, polypropylene, polystyrene, polytetrafluoroethylene), metals (such as, for example, lead, stainless steel, aluminum), any combination thereof, or any material having a mass density greater than 0.9 g / cc.

[0230] As shown, collimator 2318 generally includes holes or passages extending at least partially through cap 2306. Collimator 2318 defines a sterilization zone 2320 configured to focus radiation 2316 toward part 2310. In the illustrated embodiment, part 2310 can be received within sterilization zone 2320 for sterilization. Collimator 2318 can exhibit any suitable cross-sectional shape necessary to focus radiation 2316 onto part 2310 for sterilization. In the illustrated embodiment, for example, collimator 2318 is conical or frusto-conical in shape. However, in other embodiments, collimator 2318 can exhibit a polygonal cross-sectional shape, such as a cube, rectangle (including, for example, a parallelogram), or pyramid, without departing from the scope of this disclosure. In still other embodiments, collimator 2318 can exhibit a circular cross-sectional shape with parallel sides.

[0231] In the illustrated embodiment, the collimator 2318 provides a first opening 2322a and a second opening 2322b, where the first opening 2322a and the second opening 2322b are defined on opposite ends of the sterilization zone 2320. The first opening 2322a allows the radiation 2316 to enter the sterilization zone 2320 and be incident on the part 2310, and the second opening 2322b can be configured to admit the part 2310 into the sterilization zone 2320. In embodiments where the collimator 2318 is conical or frusto-conical in shape, the second opening 2322b can have a diameter smaller than the diameter of the first opening 2322a. In such embodiments, for example, the size of the second opening 2322b can range between about 0.5 mm and about 3.0 mm, and the size of the first opening 2322a can range between about 5.0 mm and about 16.0 mm. However, as will be appreciated, the respective diameters of the first and second openings 2322a, 2322b can be larger or smaller than the ranges provided herein without departing from the scope of the present disclosure. Indeed, the diameters of the first and second openings 2322a, 2322b can be scaled relative to the device size and need only be large enough to allow a sufficient radiation dose to be incident on the component 2310. Furthermore, in at least one embodiment, the collimator 2318 can be cylindrical in shape, in which case the first opening 2322a and the second opening 2322b exhibit the same diameter.

[0232] In some embodiments, a cap seal 2324 (shown in dashed lines) can be positioned over the opening of the collimator 2318 and elsewhere over the first opening 2322a. The cap seal 2324 can include a radio-transparent microbial barrier. In some embodiments, for example, the cap seal 2324 can be made of a synthetic material (e.g., flash-spun high-density polyethylene fibers) such as Tyvek® available from DuPont®. However, in other embodiments, the cap seal 2324 can include, but is not limited to, tape, paper, foil, or any combination thereof. In still other embodiments, the cap seal 2324 can include a thinned portion of the cap 2306 without departing from the scope of this disclosure. In such embodiments, the first opening 2322a can be eliminated.

[0233] The cap seal 2324 can completely seal off a portion of the sterilization zone 2320 to isolate the part 2310 from outside contamination while allowing the radiation 2316 to pass through the cap seal 2324 to sterilize the part 2310. In some embodiments, a desiccant (not shown) can be placed within the sterilization zone 2320.

[0234] In some embodiments, the assembly 2300 may further include a barrier shield 2326 positioned within the housing 2308. The barrier shield 2326 may be configured to assist in blocking radiation 2316 (e.g., electrons) from propagating within the housing 2308 toward the radiation-sensitive component 2312. The barrier shield 2326 may be fabricated from any of the materials described above with respect to the cap 2306. In the illustrated embodiment, the barrier shield 2326 is positioned vertically within the housing 2308, but may alternatively be positioned in any other angular configuration suitable for protecting the radiation-sensitive component 2312.

[0235] Figure 24 is a schematic diagram of another exemplary internal sterilization assembly 2400 in accordance with one or more additional embodiments of the present disclosure. Internal sterilization assembly 2400 (hereinafter "assembly 2400") may be similar in some respects to assembly 2300 of Figure 23 and, therefore, may be best understood by reference thereto, where like numbers represent like components that will not be described in detail again. Like assembly 2300 of Figure 23, for example, assembly 2400 may be designed and otherwise configured to assist in sterilizing a medical device 2402, which may be similar to medical device 2302 of Figure 23. Medical device 2402 may include a sensor control device similar to medical device 2302 of Figure 23, but may alternatively include any of the health care products described herein.

[0236] As shown, the medical device 2402 can be housed within the sensor applicator 2404, and more specifically, within a pocket 2406 defined within the sensor applicator 2404. In some embodiments, a desiccant (not shown) can be disposed within the pocket 2406. Similar to the medical device 2302 of FIG. 23 , the medical device 2402 can include a housing 2308, a sterilization-requiring component 2310, and a radiation-sensitive component 2312. In some embodiments, the assembly 2400 can further include a barrier shield 2326, as generally described above. As shown, the component 2310 can extend vertically from the bottom surface of the housing 2308, although it can alternatively extend at an angle or from another surface. Furthermore, as shown, the component 2310 can extend along the centerline of the housing 2308, although it can alternatively extend eccentrically relative to the centerline without departing from the scope of this disclosure.

[0237] The sensor applicator 2404 is used to deliver the medical device 2402 to a target monitoring location on the user's skin (e.g., the user's arm). As shown, the sensor applicator 2404 can include a spring-loaded button 2408 at least partially received therein. The button 2408 extends through a channel 2409 defined in the sensor applicator 2404 and is engageable with the top of the housing 2308 at a lower end of the channel 2409. In at least one embodiment, a sealing interface is provided where the bottom of the button 2408 engages the housing 2308. The medical device 2402 can be deployed from the pocket 2406 for use by depressing the button 2408, which acts against the housing 2308, thereby pushing the medical device 2402 out of the pocket 2406 and distally away from the sensor applicator 2404. The component 2310 is positioned such that it can be transcutaneously positioned below the surface of the user's skin and otherwise retained therein. Once delivered, the medical device 2402 can be kept in place on the skin by an adhesive patch (not shown) coupled to its bottom.

[0238] To properly sterilize the component 2310 prior to use, the medical device 2402 can be subjected to radiation sterilization 2316. In the illustrated embodiment, the radiation sterilization 2316 is directed toward the top of the sensor applicator 2404, and the button 2408 defines a collimator 2410 that allows the radiation 2316 to be incident on and sterilize the component 2310. As shown, the collimator 2410 generally includes holes or passageways that extend at least partially through the button 2408. The collimator 2410 focuses the radiation 2316 toward the component 2310 and can exhibit any suitable cross-sectional shape necessary to focus the radiation 2316 onto the component 2310 for sterilization. In the illustrated embodiment, for example, the collimator 2410 is at least partially conical or frusto-conical in shape. However, in other embodiments, collimator 2410 can exhibit a polygonal cross-sectional shape, such as a cube, rectangle (including, for example, a parallelogram), or pyramid, without departing from the scope of the present disclosure. In still other embodiments, collimator 2410 can exhibit a circular cross-sectional shape with parallel sides.

[0239] However, portions of the sensor applicator 2404 and the button 2408 can also act as a radiation shield to help prevent (block) propagated radiation 2316, other than that passing through the collimator 2410, from destroying or damaging the radiation-sensitive component 2312. To accomplish this, the sensor applicator 2404 and the button 2408 can be made of a material similar to that of the cap 2306 in FIG. 23. In at least one embodiment, the radiation sterilization 2316 can be emitted from a device or machine configured to focus and / or target it directly into the collimator 2410, thereby reducing exposure of the radiation 2316 to adjacent portions of the sensor applicator 2404.

[0240] In some embodiments, a first seal 2412a (shown in dashed lines) can be positioned over the opening to the pocket 2406, and a second seal 2412b can be placed over the opening to the collimator 2410 on top of the button 2406. The seals 2412a, 2412b can include a radio-permeable microbial barrier similar to the cap seal 2324 of FIG. 23. The first seal 2412a can completely seal the pocket 2406 on the bottom of the sensor applicator 2404 to isolate the component 2310 from external contamination, and the second seal 2412b can completely seal the collimator 2410 while allowing radiation 2316 to pass through the first seal 2412a to sterilize the component 2310.

[0241] FIG. 25 is a schematic diagram of another exemplary internal sterilization assembly 2500 according to one or more additional embodiments of the present disclosure. Internal sterilization assembly 2500 (hereinafter "assembly 2500") may be similar in some respects to assemblies 2300 and 2400 of FIGS. 23 and 24 and, therefore, may be best understood by reference thereto, where like numbers represent like components that will not be described in detail again. Like assemblies 2300 and 2400 of FIGS. 23 and 24, for example, assembly 2500 may be designed and otherwise configured to assist in sterilizing medical device 2502, which may be similar to medical devices 2302 and 2402 of FIGS. 23 and 24. Medical device 2502 may include a sensor control device similar to medical devices 2302 and 2402 of FIGS. 23 and 24, but may alternatively include any of the health care products described herein.

[0242] As shown, the medical device 2502 can be housed within a sensor applicator 2504, which can include a spring-loaded sheath 2506. The medical device 2502 can be positioned within a pocket 2508 defined at least in part by the sheath 2506. In some embodiments, a desiccant (not shown) can be disposed within the pocket 2508. Similar to the medical devices 2302 and 2402 of FIGS. 23 and 24, the medical device 2502 can include a housing 2308, a sterilization-requiring part 2310, and a radiation-sensitive component 2312. In some embodiments, the assembly 2500 can further include a barrier shield 2326, as generally described above.

[0243] As shown, the part 2310 can extend perpendicularly from the bottom surface of the housing 2308, but can alternatively extend at an angle or from another surface. Further, as shown, the part 2310 can extend along the centerline of the housing 2308, but can alternatively extend eccentrically relative to the centerline without departing from the scope of this disclosure.

[0244] The sensor applicator 2504 is used to deliver the medical device 2502 to a target monitoring location on the user's skin (e.g., the user's arm). The medical device 2502 can be deployed from the pocket 2508 for use by pressing the sheath 2506 against the user's skin, thereby causing the sheath 2506 to collapse into the body of the sensor applicator 2504. The medical device 2502 can be released from the sensor applicator 2504 when the sheath 2506 collapses past the housing 2308. The component 2310 is positioned such that it can be percutaneously positioned below the surface of the user's skin and otherwise held there. Once delivered, the medical device 2502 can be maintained in place on the skin by an adhesive patch (not shown) coupled to its bottom.

[0245] To properly sterilize the part 2310 prior to use, the medical device 2502 can be subjected to radiation sterilization 2316. In the illustrated embodiment, the radiation sterilizer 2316 is directed toward the top of the sensor applicator 2504, which defines a collimator 2510 that allows it to impinge on and sterilize the part 2310. As shown, the collimator 2510 generally comprises holes or passages that extend through the body of the sensor applicator 2504. The collimator 2510 can exhibit any suitable cross-sectional shape necessary to focus the radiation 2316 toward the part 2310 and to focus the radiation 2316 on the part 2310 for sterilization. In the illustrated embodiment, for example, the collimator 2510 is conical or frusto-conical in shape. However, in other embodiments, the collimator 2510 can exhibit a polygonal cross-sectional shape, such as a cube, a rectangle (including, for example, a parallelogram), or a pyramid, without departing from the scope of the present disclosure. In yet other embodiments, the collimator 2510 can exhibit a circular cross-sectional shape with parallel sides.

[0246] However, the sensor applicator 2504 can also act as a radiation shield to help prevent (block) propagating radiation 2316, other than that passing through the collimator 2510, from destroying or damaging the radiation-sensitive component 2312. To accomplish this, the sensor applicator 2504 can be made of a material similar to that of the cap 2306 of FIG. 23. In at least one embodiment, the radiation sterilization 2316 can be emitted from a device or machine configured to focus and / or target it directly into the collimator 2510, thereby reducing exposure of the radiation 2316 to adjacent portions of the sensor applicator 2504.

[0247] In some embodiments, a first seal 2512a (shown in dashed lines) can be positioned over the opening to the pocket 2508, and a second seal 2512b can be placed over the opening to the collimator 2510 at the top of the sensor applicator 2504. The seals 2512a, 2512b can include a radio-permeable microbial barrier similar to the cap seal 2324 of FIG. 23. The first seal 2512a can completely seal the pocket 2508 at the bottom of the sensor applicator 2504 to isolate the part 2310 from outside contamination, and the second seal 2512b can completely seal the collimator 2510 while allowing radiation 2316 to pass through them to sterilize the part 2310.

[0248] Embodiments disclosed herein include the following.

[0249] K. An internal sterilization assembly including a sensor applicator, a medical device at least partially contained within the sensor applicator and having a sterilization-requiring portion and a radiation-sensitive component, and a cap removably coupled to the sensor applicator and providing a collimator alignable with the sterilization-requiring portion, wherein the collimator focuses radiation from a radiation sterilization process toward the sterilization-requiring portion and prevents the radiation from damaging the radiation-sensitive component.

[0250] Embodiment K may have one or more of the following additional elements in any combination: Element 1: the radiation-sensitive component is selected from the group consisting of an electronic module, a chemical solution, and any combination thereof. Element 2: the collimator includes a cross-sectional shape selected from the group consisting of a cone, a frusto-cone, a pyramid, a circle, a cube, a rectangle, and any combination thereof. Element 3: the medical device includes an in-vivo analyte sensor control device, and the sterilization-requiring portion includes at least one of a sensor and a sharp point extending from a housing of the in-vivo analyte sensor control device. Element 4: at least one of the sensor and a sharp point extends at an angle from the bottom of the housing. Element 5: at least one of the sensor and a sharp point extends perpendicularly from the bottom of the housing. Element 6: at least one of the sensor and a sharp point extends from the bottom of the housing along the centerline of the housing. Element 7: at least one of the sensor and a sharp point extends from the bottom of the housing offset relative to the centerline of the housing. Element 8: The cap is fabricated from a material having a mass density greater than 0.9 g / cc. Element 9: The cap is fabricated from a material selected from the group consisting of a dense polymer, a metal, and any combination thereof. Element 10: The medical device includes an in-vivo analyte sensor control device having a housing that houses a radiation-sensitive component, the internal sterilization assembly further including a barrier shield positioned within the housing to block radiation from propagating within the housing toward the radiation-sensitive component. Element 11: The sensor applicator further includes a spring-loaded button at least partially received within the sensor applicator and engageable with a top of the medical device, the collimator being defined therethrough. Element 12: The sensor applicator further includes a sealing interface at an intersection of the button and the medical device. Element 13: At least one of the button and the sensor applicator is fabricated from a material selected from the group consisting of a dense polymer, a metal, and any combination thereof. Element 14: The sensor applicator includes a spring-loaded sheath, the medical device being received within a pocket defined at least in part by the sheath.Element 15: A collimator is defined that passes through the sensor applicator.

[0251] As non-limiting examples, exemplary combinations applicable to A, B, and C include combinations of elements 3 and 4, elements 3 and 5, elements 3 and 6, elements 3 and 7, elements 8 and 9, elements 11 and 12, elements 11 and 13, and elements 14 and 15.

[0252] One-piece biosensor design with sensor storage vial 26A and 26B are isometric and side views, respectively, of an exemplary sensor control device 2602 in accordance with one or more embodiments of the present disclosure. The sensor control device 2602 (alternatively referred to as a "puck") may be similar in some respects to the sensor control device 104 of FIG. 1 and, therefore, may be best understood with reference thereto. The sensor control device 2602 may replace the sensor control device 104 of FIG. 1 and, therefore, may be used in conjunction with a sensor applicator 102 (FIG. 1) that delivers the sensor control device 2602 to a target monitoring location on a user's skin.

[0253] However, the sensor control device 2602 can be incorporated into a one-piece system architecture in contrast to the sensor control device 104 of FIG. 1. Unlike a two-piece architecture, for example, a user is not required to unpack multiple packages and finally assemble the sensor control device 2602. Instead of requiring final assembly, upon receipt by the user, the sensor control device 2602 is already fully assembled and properly positioned within the sensor applicator 102 (FIG. 1). To use the sensor control device 2602, the user need only open a single barrier (e.g., applicator cap 210 of FIG. 2B) before immediately delivering the sensor control device 2602 to a target monitoring location.

[0254] As shown, the sensor control device 2602 includes an electronics housing 2604 that may be generally disc-shaped and have a circular cross-section. However, in other embodiments, the electronics housing 2604 may exhibit other cross-sectional shapes, such as oval or polygonal, without departing from the scope of the present disclosure. The electronics housing 2604 may be configured to house or otherwise enclose various electrical components used to operate the sensor control device 2602.

[0255] The electronics housing 2604 can include a shell 2606 and a mateable mount 2608. The shell 2606 can be secured to the mount 2608 in a variety of ways, such as a snap-fit ​​engagement, an interference fit, sonic welding, or one or more mechanical fasteners (e.g., screws). In some cases, the shell 2606 can be secured to the mount 2608 such that a sealed interface occurs between the shell 2606 and the mount 2608. In such embodiments, a gasket or other type of sealing material can be positioned at or near the outer diameter (periphery) of the shell 2606 and the mount 2608, and securing the two components together can compress the gasket, thereby creating a sealed 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 adhesive secures the shell 2606 to the mount 2608 to provide structural integrity, but can also seal the interface between the two components, thereby isolating the interior of the electronics housing 2604 from external contamination. Terminal sterilization of the internal electrical components may not be necessary if the sensor control device 2602 is assembled in a controlled environment. In lieu of sterilization, adhesive bonding may provide a sufficient sterile barrier to the assembled electronics housing 2604.

[0256] The sensor control device 2602 may further include a plug assembly 2610 that can be coupled to the electronics housing 2604. The plug assembly 2610 may be similar in some respects to the plug assembly 207 of FIG. 2A . For example, the plug assembly 2610 may include a sensor module 2612 (partially visible) that is interconnectable with a tip module 2614 (partially visible). The sensor module 2612 may be configured to carry, and otherwise include, a sensor 2616 (partially visible), and the tip module 2614 may be configured to carry, and otherwise include, a tip 2618 (partially visible) that is used to assist in transcutaneously delivering the sensor 2616 beneath the user's skin during application of the sensor control device 2602. As shown, corresponding portions of the sensor 2616 and tip 2618 extend from the electronics housing 2604, and more specifically, from the bottom of the mount 2608. The exposed portion of the sensor 2616 can be received within a hollow or recessed portion of the point 2618. The remainder of the sensor 2616 is positioned within the electronics housing 2604.

[0257] As discussed in more detail below, the sensor control device 2602 may further include a sensor storage vial 2620 that surrounds the exposed portions of the sensor 2616 and sharps 2618 to provide a storage barrier that protects them from gaseous chemical sterilization.

[0258] 27A and 27B are isometric and exploded views, respectively, of a plug assembly 2610 according to one or more embodiments. The sensor module 2612 can include a sensor 2616, a plug 2702, and a connector 2704. The plug 2702 can be designed to receive and support both the sensor 2616 and the connector 2704. As shown, a channel 2706 can be defined through the plug 2702 for receiving a portion of the sensor 2616. Additionally, the plug 2702 can provide one or more deflectable arms 2707 configured to snap into corresponding features on the bottom of the electronics housing 2604 (FIGS. 26A-26B).

[0259] Sensor 2616 includes a tail 2708, a flag 2710, and a neck 2712 interconnecting tail 2708 and flag 2710. Tail 2708 can be configured to extend at least partially through channel 2706 and further extend distally from plug 2702. Tail 2708 includes an enzyme or other chemical or biological agent, and in some embodiments, a membrane can cover the chemical agent. In use, tail 2708 is transdermally received under a user's skin, and the chemical agent contained on tail 2708 helps to facilitate analyte monitoring in the presence of bodily fluids.

[0260] Flag 2710 can include a generally flat surface with sensor contacts 2714 (three shown in FIG. 27B) positioned thereon. The sensor contacts 2714 can be configured to align with a corresponding number of compliant carbon-impregnated polymer modules (tops of which are shown at 2720) enclosed within connector 2704.

[0261] The connector 2704 includes one or more hinges 2718 that allow it to move between an open and a closed state. In FIGS. 27A-27B, the connector 2704 is shown in a closed state, but can pivot to the open state to receive the flag 2710 and compliant carbon-impregnated polymer module therein. The compliant carbon-impregnated polymer module provides electrical contacts 2720 (three shown) configured to provide conductive communication between the sensor 2616 and corresponding circuit contacts provided in the electrical housing 2604 ( FIGS. 26A-26B ). The connector 2704 can be fabricated from silicone rubber and can act as a moisture barrier to the sensor 2616 when assembled in a compressed state and after application to the user's skin.

[0262] The tip module 2614 includes a tip 2618 and a tip hub 2722 that carries the tip. The tip 2618 includes an elongate shaft 2724 and a tip tip 2726 at its distal end. The shaft 2724 can be configured to extend through the channel 2706 and further extend distally from the plug 2702. Additionally, the shaft 2724 can include a hollow or recessed portion 2728 that at least partially surrounds the tail 2708 of the sensor 2616. The tip tip 2726 can be configured to pierce the skin while carrying the tail 2708 to place the active chemical agent present on the tail 2708 into contact with bodily fluids.

[0263] The sharp body hub 2722 can include a hub mini-cylinder 2730 and a hub snap pawl 2732, each of which can be configured to assist in coupling the plug assembly 2610 (and the entire sensor control device 2602) to the sensor applicator 102 (FIG. 1).

[0264] 27B , the storage vial 2620 may include a generally cylindrical, elongated body 2734 having a first end 2736a and an opposite second end 2736b. The first end 2736a may be open to provide access to an interior chamber 2738 defined within the body 2734. In contrast, the second end 2736b may be closed and may be provided with or otherwise define an enlarged head 2740. The enlarged head 2740 exhibits an outer diameter that is larger than the outer diameter of the remainder of the body 2734. However, in other embodiments, the enlarged head 2740 may be positioned at an intermediate location between the first end 2736a and the second end 2736b.

[0265] 27C is an exploded isometric bottom view of plug 2702 and storage vial 2620. As shown, plug 2702 can define an opening 2742 configured to receive storage vial 2620, and more specifically, first end 2736a of body 2734. Channel 2706 can terminate at opening 2742 such that components extending distally from channel 2706 will be received within inner chamber 2738 when storage vial 2620 is coupled to plug 2702.

[0266] The storage vial 2620 can be removably coupled to the plug 2702 at the opening 2742. In some embodiments, for example, the storage vial 2620 can be received in the opening 2742 by an interference fit or a friction fit. In other embodiments, the storage vial 2620 can be secured in the opening 2742 using a frangible member (e.g., a shear ring) or frangible material that can be broken by a small separation force. In such embodiments, for example, the storage vial 2620 can be secured in the opening 2742 using a small amount of glue or a light coat of wax, or can include a peelable glue. As described below, the storage vial 2620 can be separated from the plug 2702 before delivering the sensor control device 2602 ( FIGS. 26A-26B ) to a target monitoring location on the user's skin.

[0267] 27A and 27B , the inner chamber 2738 may be sized and otherwise configured to receive the tail 2708, the distal section of the shaft 2724, and the tip 2726, collectively referred to as the "distal portion of the sensor 2616 and the tip 2618." The inner chamber 2738 may be sealed or otherwise isolated to prevent migration of substances into the inner chamber 2738 that may adversely interact with the chemical formulation of the sensor 2616. More specifically, because gases used during gaseous chemical sterilization may adversely affect the enzymes provided on the tail 2708 (and other sensor components such as membrane coatings that regulate the influx of analytes), the inner chamber 2728 may be sealed to protect or isolate the distal portion of the sensor 2616 and the tip 2618 during the gaseous chemical sterilization process.

[0268] In some embodiments, the seal 2744 ( FIG. 27B ) can provide a sealing barrier between the inner chamber 2738 and the external environment. In at least one embodiment, the seal 2744 can be positioned within the inner chamber 2738, although it can alternatively be positioned external to the body 2734 without departing from the scope of this disclosure. The sensor 2616 and a distal portion of the tip 2618 can extend through the seal 2744 into the inner chamber 2738, while the seal 2744 can maintain a sealed interface around the sensor 2616 and the distal portion of the tip 2618 to prevent migration of contaminants into the inner chamber 2738. The seal 2744 can be made of, for example, a flexible elastomer or wax.

[0269] In other embodiments (or in addition to seal 2744), a sensor storage fluid 2746 (FIG. 27B) can be present within inner chamber 2738, and sensor 2616 and a distal portion of tip 2618 can be immersed in or otherwise encapsulated by storage fluid 2746. Storage fluid 2746 can create a sealed interface that prevents sterilizing gas from interacting with enzymes disposed on tail 2708.

[0270] To properly sterilize the sensor 2616 and sharp 2618, the plug assembly 2610 can undergo radiation sterilization. Suitable radiation sterilization processes include, but are not limited to, electron beam (e-beam) irradiation, gamma irradiation, x-ray irradiation, or any combination thereof. In some embodiments, the plug assembly 2610 can undergo radiation sterilization before coupling the storage vial 2620 to the plug 2702. However, in other embodiments, the plug assembly 2610 can be sterilized after the storage vial 2620 is coupled to the plug 2702. In such embodiments, the body 2734 and storage fluid 2746 of the storage vial 2620 can include materials and / or substances that allow the propagation of radiation therethrough to facilitate radiation sterilization of the sensor 2616 and the distal portion of the sharp 2618.

[0271] Suitable materials for body 2734 include, but are not limited to, non-magnetic metals (such as, for example, aluminum, copper, gold, silver), thermoplastic ceramics, rubbers (such as, for example, ebonite), composite materials (such as, for example, fiberglass, carbon fiber reinforced polymers), epoxies, or any combination thereof. In some embodiments, the material for body 2734 can be transparent or translucent, while in others it can be opaque without departing from the scope of this disclosure.

[0272] The preservation fluid 2746 can include any inert, biocompatible fluid (i.e., liquid, gas, gel, wax, or any combination thereof) that functions to encapsulate the sensor 2616 and the distal portion of the sharp body 2618. In some embodiments, the preservation fluid 2746 can allow the propagation of radiation therethrough. The preservation fluid 2746 can include a fluid that is insoluble in the chemicals involved in gaseous chemical sterilization. Suitable examples of preservation fluids 2746 include, but are not limited to, silicone oil, mineral oil, gel (e.g., petrolatum), wax, fresh water, saline, synthetic fluids, glycerin, sorbitan esters, or any combination thereof. As will be appreciated, more viscous gels and fluids may be preferred so that the preservation fluid 2746 does not flow easily.

[0273] In some embodiments, the preservation fluid 2746 may include an anti-inflammatory agent such as nitric oxide or another known anti-inflammatory agent. Anti-inflammatory agents have been found to be advantageous by minimizing the local inflammatory response caused by the penetration of the sharps 2618 and sensor 2616 into the user's skin. It has been recognized that inflammation can affect the accuracy of glucose readings, and that the inclusion of an anti-inflammatory agent can speed up the healing process, resulting in more rapid acquisition of accurate readings.

[0274] 28A and 28B are exploded and isometric views, respectively, of an electronics housing 2604 according to one or more embodiments. The shell 2606 and mount 2608 act as opposing clamshell halves that surround or otherwise substantially enclose the various electronic components of the sensor and control device 2602 (FIGS. 26A-26B).

[0275] A printed circuit board (PCB) 2802 may be positioned within the electronics housing 2604. The PCB 2802 may be populated with a plurality of electronic modules (not shown), including, but not limited to, a data processing unit, registers, transistors, capacitors, inductors, diodes, and switches. The data processing unit may include, for example, an application specific integrated circuit (ASIC) configured to perform one or more functions or routines associated with the operation of the sensor control device 2602. More specifically, the data processing unit may be configured to perform data processing functions, where such functions may include, but are not limited to, filtering and encoding a plurality of data signals, each corresponding to a sampled analyte level of a user. The data processing unit may include an antenna for communicating with or otherwise communicate with the reader device 106 (FIG. 1).

[0276] As shown, shell 2606, mount 2608, and PCB 2802 each define corresponding central openings 2804, 2806, and 2808, respectively. When electronics housing 2604 is assembled, central openings 2804, 2806, and 2808 coaxially align to receive plug assembly 2610 (FIGS. 27A-27B). A battery 2810 can be housed within electronics housing 2604 and configured to power sensor control device 2602.

[0277] 28B, a plug receptacle 2812 can be defined within the bottom of the mount 2808 and can provide a location where the plug assembly 2610 ( FIGS. 27A-27B ) can be received to couple to the electronics housing 2604, thereby fully assembling the sensor control device 2602 ( FIGS. 26A-3B ). The profile of the plug 2702 ( FIGS. 27A-27C ) can be shaped to match or complement the plug receptacle 2812, which can provide one or more snap-engagement ledges 2814 (two shown) configured to interface with and receive the deflectable arm 2707 ( FIGS. 27A-27B ) of the plug 2702. The plug assembly 2610 is coupled to the electronics housing 2604 by advancing the plug 2702 into the plug receptacle 2812, allowing the deflectable arm 2707 to engage in a corresponding snap-engagement ledge 2814. With the plug assembly 2610 ( FIGS. 27A-27B ) properly coupled to the electronics housing 2604, one or more circuit contacts 2816 (three shown) defined on the underside of the PCB 2802 can be in conductive communication with electrical contacts 2720 ( FIGS. 27A-27B ) of the connector 2704 ( FIGS. 27A-27B ).

[0278] 29A and 29B are a side view and a cross-sectional side view, respectively, of an exemplary embodiment of the sensor applicator 102 coupled with the applicator cap 210. More specifically, FIGS. 29A-29B illustrate how the sensor applicator 102 may be shipped to a user and how it may be received by the user. In accordance with this disclosure and as seen in FIG. 29B, the sensor control device 2602 is already assembled and installed in the sensor applicator 102 before delivery to the user.

[0279] As noted above, the plug assembly 2610 can be subjected to radiation sterilization to sterilize the sensor 2616 and the distal portion of the sharp 2618 prior to coupling the plug assembly 2610 to the electronics housing 2604. Once properly sterilized, the plug assembly 2610 can then be coupled to the electronics housing 2604, as generally described above, thereby forming the fully assembled sensor control device 2602. The sensor control device 2602 can then be loaded into the sensor applicator 102, and the applicator cap 210 can be coupled to the sensor applicator 102. The applicator cap 210 can be threaded onto the housing 208 and can include a tamper-evident ring 2902. When the applicator cap 210 is rotated (e.g., twisted off) relative to the housing 208, the tamper-evident ring 2902 threads off, thereby allowing the applicator cap 210 to be freed from the sensor applicator 102.

[0280] In accordance with the present disclosure, while loaded into the sensor applicator 102, the sensor control device 2602 can be subjected to gaseous chemical sterilization 2904 configured to sterilize the electronics housing 2604 and any other exposed portions of the sensor control device 2602. To achieve gaseous chemical sterilization 2904, chemicals can be injected into a sterilization chamber 2906 cooperatively defined by the sensor applicator 102 and the interconnected cap 210. In some applications, chemicals can be injected into the sterilization chamber 2906 through one or more vent holes 2908 defined in the applicator cap 210 at its proximal end 2910. Exemplary chemicals that can be used for gaseous chemical sterilization 2904 include, but are not limited to, ethylene oxide, hydrogen peroxide vapor, and nitrogen oxides (such as, for example, nitrous oxide and nitrogen dioxide).

[0281] The sensor 2616 and the distal portion of the tip 2618 are sealed in a storage vial 2620 so that the chemicals used during the gaseous chemical sterilization process do not interact with the enzymes, chemicals, or biological agents provided on the tail 2708.

[0282] Once the desired level of sterility assurance has been achieved within the sterilization chamber 2906, the gas solution is removed and the sterilization chamber 2906 is aerated. Aeration can be achieved by a series of vacuum reductions followed by circulation of nitrogen gas or sterile air through the sterilization chamber 2906. Once the sterilization chamber 2906 is properly aerated, the vent hole 2908 can be blocked with a seal 2912 (shown in dashed lines).

[0283] In some embodiments, the seal 2912 may include two or more layers of different materials. The first layer may be made of a synthetic material (e.g., flash-spun high-density polyethylene fiber) such as Tyvek®, available from DuPont®. Tyvek® is highly durable and puncture-resistant while allowing vapor transmission. The Tyvek® layer may be applied prior to or following the gaseous chemical sterilization process, and a foil or other vapor- and moisture-resistant material layer may be sealed (e.g., heat-sealed) over the Tyvek® layer to prevent migration of contaminants and moisture into the sterilization chamber 2906. In other embodiments, the seal 2912 may include only a single protective layer applied to the applicator cap 210. In such embodiments, this single layer is gas-permeable for the sterilization process but also provides protection against moisture and other harmful elements after the sterilization process is complete.

[0284] With the seal 2912 in place, the applicator cap 210 provides a barrier to external contamination, thereby maintaining a sterile environment for the assembled sensor control device 2602 until the user removes (twists) the applicator cap 210. The applicator cap 210 can create a dust-free environment that prevents the adhesive patch 2914 used to secure the sensor control device 2602 to the user's skin from becoming contaminated during shipping and storage.

[0285] 30 is a perspective view of an exemplary embodiment of an applicator cap 210 in accordance with the present disclosure. As shown, the applicator cap 210 has a generally circular cross-section and defines a series of threads 7302 that are used to couple the applicator cap 210 to the sensor applicator 102 (FIGS. 29A and 29B). A vent hole 2908 is also visible in the bottom of the applicator cap 210.

[0286] The applicator cap 210 may further provide, and may otherwise define, a cap post 3004 centrally positioned within the interior of the applicator cap 210 and extending proximally from the bottom of the applicator cap 210. The cap post 3004 may be configured to help support the sensor control device 2602 while the sensor control device 2602 is confined within the sensor applicator 102 ( FIGS. 29A-29B ). Additionally, the cap post 3004 may define an opening 3006 configured to receive the storage vial 2620 when the applicator cap 210 is coupled to the sensor applicator 102.

[0287] In some embodiments, the opening 3006 to the cap post 3004 can include one or more compliant features 3008 that are stretchable or flexible to allow the storage vial 2620 to pass through. In some embodiments, for example, the compliant feature 3008 can include a collet-type device including a plurality of compliant fingers configured to flex radially outward to accept the storage vial 2620. However, in other embodiments, the compliant feature 3008 can include an elastomer or another type of compliant material configured to expand radially to accept the storage vial 2620.

[0288] 31 is a cross-sectional side view of a sensor control device 2602 positioned within an applicator cap 210 in accordance with one or more embodiments. As shown, a cap post 3004 defines a post chamber 3102 configured to receive a storage vial 2620. An opening 3006 into the cap post 3004 provides access into the post chamber 3102 and provides a first diameter D1. In contrast, an enlarged head 2740 of the storage vial 2620 provides a second diameter D2 that is larger than the first diameter D1 and is also larger than the outer diameter of the remainder of the storage vial 2620. Thus, as the storage vial 2620 extends into the post chamber 3102, a compliant feature 3008 of the opening 3006 can flex (expand) radially outward to accommodate the enlarged head 2740.

[0289] In some embodiments, the enlarged head 2740 can provide or otherwise define a sloped outer surface that assists in biasing the compliant feature 3008 radially outward. However, the enlarged head 2740 can define an upper shoulder 3104 that prevents the storage vial 2620 from backing out of the post chamber 3102. More specifically, the shoulder 3104 can include a sharp surface at the second diameter D2 that engages the compliant feature 3008 but does not bias the compliant feature 3008 to deflect radially outward in the backing direction.

[0290] With the enlarged head 2740 bypassing the opening 3006, the compliant feature 3008 flexes back to (or toward) its natural state. In some embodiments, the compliant feature 3008 can engage the outer surface of the storage vial 2620, yet still allow the applicator cap 210 to rotate relative to the storage vial 2620. Thus, when a user removes the applicator cap 210 by rotating the applicator cap 210 relative to the sensor applicator 102 ( FIGS. 29A-29B ), the storage vial 2620 can remain stationary relative to the cap post 3004.

[0291] When the applicator cap 210 is removed from the sensor applicator 102, thereby also separating the sensor control device 2602 from the applicator cap 210, a shoulder 3104 defined on the enlarged head 2740 will engage the compliant feature 3008 at the opening 3006. Because the diameter of the shoulder 3104 is larger than the diameter of the opening 3006, the shoulder 3104 will bond to the compliant feature 3008, thereby separating the storage vial 2620 from the sensor control device 2602, thereby exposing the sensor 2616 and a distal portion of the sharp point 2618. Thus, the compliant feature 3008 can prevent the enlarged head 2740 from exiting the post chamber 3102 through the opening 3006 when the applicator cap 210 is separated from the sensor applicator 102 and the sensor control device 2602. The separated storage vial 2620 will drop into the post chamber 3102 and remain therein.

[0292] In some embodiments, instead of the opening 3006 including the compliant feature 3008 as generally described above, the opening 3006 can be threaded. In such embodiments, a small portion near the distal end of the storage vial 2620 can also be threaded and threadably engage with the threads of the opening 3006. The storage vial 2620 can be received within the post chamber 3102 by threaded rotation. However, when the applicator cap 210 is removed from the sensor applicator 102, opposing threads on the opening 3006 and threads on the storage vial 2620 mate, allowing the storage vial 2620 to be separated from the sensor control device 2602.

[0293] Thus, there are several advantages to incorporating the sensor control device 2602 into an analyte monitoring system (e.g., the analyte monitoring system 100 of FIG. 1 ). Because the sensor control device 2602 is ultimately assembled in a controlled environment, tolerances can be reduced or eliminated entirely, allowing the sensor control device 2602 to be thin and small. Furthermore, because the sensor control device 2602 is ultimately assembled in a controlled environment, thorough pre-testing of the sensor control device 2602 can be performed at the factory, allowing the sensor unit to be fully tested before being packaged for final delivery.

[0294] Embodiments disclosed herein include the following.

[0295] L. A sensor control device comprising: an electronics housing; a plug assembly mateable with the electronics housing, the plug assembly including a sensor module having a sensor and a sharps module having a sharps; and a storage vial coupled to the plug assembly and defining an internal chamber, wherein the sensor and a distal portion of the sharps are receivable within the internal chamber and are isolated from gaseous chemical sterilization within the internal chamber.

[0296] M. An analyte monitoring system comprising: a sensor applicator; a sensor control device positioned within the sensor applicator and including an electronics housing; a plug assembly coupled to the electronics housing, the plug assembly including a sensor module having a sensor and a sharps module having a sharps; and a storage vial coupled to the plug assembly and defining an interior chamber, the analyte monitoring system further comprising a cap coupled to the sensor applicator and providing a barrier sealing the sensor control device within the sensor applicator, the sensor and a distal portion of the sharps being received within the interior chamber and isolated from gaseous chemical sterilization within the interior chamber.

[0297] N. A method of preparing an analyte monitoring system comprising loading into a sensor applicator a sensor control device comprising an electronics housing, a plug assembly mateable with the electronics housing, the plug assembly comprising a sensor module having a sensor and a sharps module having a sharps, and a storage vial coupled to the plug assembly and defining an internal chamber, the method further comprising securing a cap to the sensor applicator thereby providing a barrier sealing the sensor control device within the sensor applicator, sterilizing the sensor control device with gaseous chemical sterilization while the sensor control device is positioned within the sensor applicator, and isolating the sensor received in the internal chamber and a distal portion of the sharps from the gaseous chemical sterilization.

[0298] Each of embodiments L, M, and N can have one or more of the following additional elements in any combination: Element 1: the sensor module further includes a plug, and the storage vial is removably coupled to the plug. Element 2: the storage vial provides an enlarged head, and the diameter of the enlarged head is larger than the diameter of the remainder of the storage vial. Element 3: the sensor module further includes a seal providing a hermetic barrier between the inner chamber and its exterior, and the sensor and distal portion of the sharp extend through the seal into the inner chamber. Element 4: the sensor module further includes a storage fluid in the inner chamber that isolates the sensor and distal portion of the sharp from gaseous chemical sterilization. Element 5: the sensor and distal portion of the sharp are at least partially immersed in the storage fluid. Element 6: the storage fluid includes an inert biocompatible fluid selected from the group consisting of silicone oil, mineral oil, gel, wax, fresh water, saline, synthetic fluid, glycerin, sorbitan ester, and any combination thereof. Element 7: the storage fluid includes an anti-inflammatory agent.

[0299] Element 8: The cap provides a cap post that defines a post chamber and an opening that receives the enlarged head of the storage vial into the post chamber. Element 9: The opening includes one or more compliant features that flex radially outward to receive the enlarged head. Element 10: The one or more compliant features include a plurality of compliant fingers. Element 11: The one or more compliant features prevent the enlarged head from escaping the post chamber through the opening when the cap is separated from the sensor applicator and sensor control device. Element 12: The cap is rotatable relative to the storage vial when the storage vial is received in the post chamber. Element 13: The cap further includes a storage fluid in the inner chamber that isolates the sensor and distal portion of the sharp from gaseous chemical sterilization.

[0300] Element 14: The step of loading the sensor control device into the sensor applicator is preceded by the steps of assembling a plug assembly, coupling a storage vial to the plug assembly such that the sensor and the distal portion of the sharp are received in the inner chamber, and coupling the plug assembly to the electronics housing, thereby providing a sensor control device. Element 15: The step of coupling the storage vial to the plug assembly is preceded by the step of sterilizing the plug assembly by radiation sterilization. Element 16: The step of isolating the sensor and the distal portion of the sharp from gaseous chemical sterilization includes at least partially immersing the sensor and the distal portion of the sharp in a storage fluid present in the inner chamber. Element 17: The cap provides a cap post defining a post chamber with one or more compliant features disposed in the opening, and the step of securing the cap to the sensor applicator includes receiving an enlarged head of the storage vial into the post chamber through the opening and deflecting the one or more compliant features radially outward to receive the enlarged head.

[0301] As non-limiting examples, exemplary combinations applicable to L, M, and N include combinations of elements 4 and 5, elements 4 and 6, elements 4 and 7, elements 8 and 9, elements 9 and 10, elements 9 and 17, elements 8 and 12, elements 8 and 13, and elements 14 and 15.

[0302] Isolation of one-piece sensor designs using focused electron beam sterilization 32A and 32B are isometric and side views, respectively, of an exemplary sensor control device 3202 in accordance with one or more embodiments of the present disclosure. The sensor control device 3202 (alternatively referred to as a "puck") may be similar in some respects to the sensor control device 104 of FIG. 1 and, therefore, may be best understood with reference thereto. In some applications, the sensor control device 3202 may replace the sensor control device 104 of FIG. 1 and, therefore, may be used in conjunction with a sensor applicator 102 (FIG. 1) that delivers the sensor control device 3202 to a target monitoring location on a user's skin.

[0303] However, the sensor control device 3202 can be incorporated into a one-piece system architecture in contrast to the sensor control device 104 of FIG. 1. Unlike a two-piece architecture, for example, a user is not required to unpack multiple packages and perform final assembly of the sensor control device 3202 prior to use. Instead of requiring final assembly, the sensor control device 3202 is already fully assembled and properly positioned within the sensor applicator 102 (FIG. 1) upon receipt by the user. To use the sensor control device 3202, the user need only open one barrier (e.g., remove the applicator cap 210 of FIG. 2B) before immediately delivering the sensor control device 3202 to the target monitoring location.

[0304] As shown, the sensor control device 3202 includes an electronics housing 3204 that may be generally disc-shaped and have a circular cross-section. However, in other embodiments, the electronics housing 3204 may exhibit other cross-sectional shapes, such as oval or polygonal, without departing from the scope of the present disclosure. The electronics housing 3204 may be configured to house or otherwise enclose various electrical components used to operate the sensor control device 3202.

[0305] The electronics housing 3204 can include a shell 3206 and a mateable mount 3208. The shell 3206 can be secured to the mount 3208 in a variety of ways, such as a snap-fit ​​engagement, an interference fit, sonic (or ultrasonic) welding, or using 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 gasket or other type of sealing material can be positioned or applied at or near the outer diameter (periphery) of the shell 3206 and the mount 3208. Securing the shell 3206 to the mount 3208 can compress the sealing material, thereby creating a sealed interface. In at least one embodiment, an adhesive can be applied to the outer diameter (periphery) of one or both of the shell 3206 and the mount 3208, and the adhesive can seal the interface in addition to securing the shell 3206 to the mount 3208.

[0306] In embodiments in which a sealed interface is provided between the shell 3206 and the mount 3208, the interior of the electronics housing 3204 can be substantially isolated from external contamination between these two components. In such embodiments, when the sensor control device 3202 is assembled in a controlled, sterile environment, it may not be necessary to sterilize the internal electrical components (e.g., by gaseous chemical sterilization). Instead of requiring sterilization of the internal electrical components, the sealed engagement can provide a sufficient sterility barrier for the assembled electronics housing 3204.

[0307] The sensor control device 3202 may further include a sensor module 3210 (partially visible in FIG. 32B ) and a tip module 3212 (partially visible). The sensor module 3210 and tip module 3212 may be interconnectable and coupled to the electronics housing 3204. The sensor module 3210 may be configured to carry, and otherwise include, a sensor 3214 ( FIG. 32B ), and the tip module 3212 may be configured to carry, and otherwise include, a tip 3216 ( FIG. 32B ) used to assist in transcutaneously delivering the sensor 3214 under the user's skin during application of the sensor control device 3202.

[0308] 32B, the sensor 3214 and corresponding portions of the tip 3216 extend from the electronics housing 3204, and more specifically from the bottom of the mount 3208. The exposed portion of the sensor 3214 can be received within a hollow or recessed portion of the tip 3216. The remainder of the sensor 3214 is positioned within the electronics housing 3204.

[0309] An adhesive patch 3218 can be positioned on and attached to the underside of the mount 3208. Similar to the adhesive patch 108 of FIG. 1 , the adhesive patch 3218 can be configured to securely hold the sensor control device 3202 in place on the user's skin during operation. In some embodiments, a transfer adhesive 3220 can be sandwiched between the adhesive patch 3218 and the bottom of the mount 3208. The transfer adhesive 3220 can help facilitate the assembly process of the sensor control device 3202.

[0310] 33A and 33B are exploded perspective top and bottom views, respectively, of a sensor control device 3202 according to one or more embodiments. As shown, the shell 3206 and mount 3208 of the electronics housing 3204 act as opposing clamshell halves that surround or otherwise substantially enclose the various electronic components of the sensor control device 3202.

[0311] A printed circuit board (PCB) 3302 can be positioned within the electronics housing 3204. As shown in FIG. 33B, a plurality of electronic modules 3304 can be mounted on the underside of the PCB 3302. Exemplary electronic modules 3304 include, but are not limited to, resistors, transistors, capacitors, inductors, diodes, and switches. A data processing unit 3306 ( FIG. 33B ) can be mounted on the PCB 3302 and can include, for example, an application specific integrated circuit (ASIC) configured to perform one or more functions or routines associated with the operation of the sensor control device 3202. More specifically, the data processing unit 3306 can be configured to perform data processing functions such as filtering and encoding a plurality of data signals, each corresponding to a sampled analyte level of the user. The data processing unit 3306 can include an antenna for communicating with or otherwise communicate with the reader device 106 ( FIG. 1 ).

[0312] As shown, the shell 3206, mount 3208, and PCB 3302 each define a corresponding central opening 3308a, 3308b, 3308c, respectively. When the sensor control device 3202 is assembled, the central openings 3308a-3308c are coaxially aligned to receive portions of the sensor module and tip modules 3210, 3212 therethrough.

[0313] A battery 3310 and a corresponding battery mount 3312 may be housed within the electronics housing 3204. The battery 3310 may be configured to power the sensor control device 3202.

[0314] The sensor module 3210 can include a sensor 3214 and a connector 3314. The sensor 3214 can include a tail 3316, a flag 3318, and a neck 3320 interconnecting the same. The tail 3316 can be configured to extend through a central opening 3308b defined in the mount 3208 and further extend distally from an underside of the mount 3208. The tail 3316 can include an enzyme or other chemical or biological agent, and in some embodiments, a membrane can cover the chemical agent. In use, the tail 3316 is transdermally received under the user's skin, and the chemical agent contained on the tail 3316 helps to facilitate analyte monitoring in the presence of bodily fluids.

[0315] The flag 3318 may include a generally flat surface with one or more sensor contacts 3322 (three are shown in FIG. 33A ) positioned thereon. The flag 3318 may be configured to be received within the connector 3314, where the sensor contacts 3322 align with a corresponding number of compliant carbon-impregnated polymer modules (not shown) enclosed within the connector 3314.

[0316] The connector 3314 includes one or more hinges 3324 that allow it to pivot between an open and a closed state. While FIGS. 33A-33B show the connector 3314 in a closed state, the connector 3314 can be moved to the open state to receive the flag 3318 and compliant carbon-impregnated polymer module therein. The compliant carbon-impregnated polymer module provides electrical contacts 3326 (three shown in FIG. 33A ) configured to provide conductive communication between the sensor 3214 and corresponding circuit contacts 3328 provided on the PCB 3302. When the sensor module 3210 is properly coupled to the electronics housing 3204, the circuit contacts 3328 are in conductive communication with the electrical contacts 3326 of the connector 3314. The connector 3314 can be fabricated from silicone rubber and can act as a moisture barrier to the sensor 3214.

[0317] The tip module 3212 includes a tip 3216 and a tip hub 3330 that carries the tip. The tip 3216 includes an elongate shaft 3332 and a tip tip 3334 at its distal end. The shaft 3332 can be configured to extend through each of the coaxially aligned central openings 3308a-3308c and further extend distally from the bottom of the mount 3208. Further, the shaft 3332 can include a hollow or recessed portion 3336 that at least partially surrounds the tail 3316 of the sensor 3214. The tip 3334 can be configured to pierce the skin while carrying the tail 3316 to place the active chemical agent of the tail 3316 into contact with bodily fluids.

[0318] The point hub 3330 can include a hub mini-cylinder 3338 and a hub snap pawl 3340, each of which can be configured to assist in coupling the sensor control device 3202 to the sensor applicator 102 (FIG. 1).

[0319] 33A , in some embodiments, the sensor module 3210 can be at least partially received within a sensor mount pocket 3342 included within the electronics housing 3204. In some embodiments, the sensor mount pocket 3342 can comprise a separate structure, or alternatively, can form an integral part or extension of the mount 3208. The sensor mount pocket 3342 can be shaped and otherwise configured to receive and seat the sensor 3214 and connector 3314. As shown, the sensor mount pocket 3342 defines a perimeter 3344 that generally surrounds the area for receiving the sensor 3214 and connector 3314. In at least one embodiment, the perimeter 3344 can be sealed to the underside of the PCB 3302 when the electronics housing 3204 is fully assembled. In some embodiments, a gasket (e.g., an O-ring, etc.), adhesive, or another type of sealing material can be applied (placed) on the perimeter 3344, which can act to seal the interface between the sensor mount pocket 3342 and the PCB 3302.

[0320] Sealing the interface between the sensor mount pocket 3342 and the underside of the PCB 3302 can help to create or define a sealed zone or area within the electronics housing 3204. The sealed area has been found to be advantageous in helping to isolate (protect) the tail 3316 of the sensor 3214 from potentially harmful sterilizing gases used during gaseous chemical sterilization.

[0321] 33B , a plurality of channels or grooves 3346 can be provided on the bottom of the mount 3208. As shown, the grooves 3346 can form a plurality of concentric rings in combination with the radially extending channels. An adhesive patch 3218 ( FIGS. 32A-32B ) can be attached to the underside of the mount 3208, and in some embodiments, a transfer adhesive 3220 ( FIGS. 32A-32B ) can be sandwiched between the adhesive patch 3218 and the bottom of the mount 3208. The grooves 3346 have been found to be advantageous by facilitating the egress of moisture beneath the adhesive patch 3218 and away from the center of the electronics housing 3204.

[0322] In some embodiments, a cap post seal interface 3348 can be defined at the center of the mount 3208 on the bottom of the mount 3208. As shown, the cap post seal interface 3348 can include a substantially flat portion of the bottom of the mount 3208. A second central opening 3308b can be defined at the center of the cap post seal interface 3348, and the groove 3346 can surround the cap post seal interface 3348. The cap post seal interface 3348 can provide a sealing surface that can help isolate (protect) the tail 3316 of the sensor 3214 from potentially harmful sterilization gases used during gaseous chemical sterilization.

[0323] FIGS. 34A and 34B are side and cross-sectional side views, respectively, of the sensor applicator 102 coupled with the applicator cap 210. More specifically, FIGS. 34A-34B illustrate how the sensor applicator 102 may be shipped to a user and how it may be received by the user. In accordance with the present disclosure and as seen in FIG. 34B, the sensor control device 3202 is already assembled and installed within the sensor applicator 102 before delivery to the user. The applicator cap 210 may be threaded onto the housing 208 and may include a tamper-evident ring 3402. When the applicator cap 210 is rotated (e.g., twisted off) relative to the housing 208, the tamper-evident ring 3402 threads off, thereby freeing the applicator cap 210 from the sensor applicator 102. The user may then deliver the sensor control device 3202 to a target monitoring location as generally described above with reference to FIGS. 2E-2G.

[0324] 34B , the sensor control device 3202 can be loaded into the sensor applicator 102 by mating the point hub 3330 with a sensor carrier 3404 included in the sensor applicator 102. More specifically, the hub mini-cylinder 3338 and the hub snap pawl 3340 can be received by corresponding mating features on the sensor carrier 3404.

[0325] With the sensor control device 3202 mated with the sensor carrier 3404, the applicator cap 210 can then be secured to the sensor applicator 102. As shown, the applicator cap 210 provides, and can otherwise define, a cap post 3406 centrally positioned within the interior of the applicator cap 210 and extending proximally from a bottom thereof. The cap post 3406 can be configured to help support the sensor control device 3202 while it is enclosed within the sensor applicator 102. Additionally, the cap post 3406 can define a post chamber 3408 configured to receive the sensor 3214 and the point 3216 extending from the bottom of the electronics housing 3204. With the sensor control device 3202 loaded into the sensor applicator 102, the sensor 3214 and sharp 3216 can be positioned within a sealed area 3410 defined at least in part by the post chamber 3408 and configured to isolate the sensor 3214 and sharp 3216 during gaseous chemical sterilization.

[0326] In some embodiments, the sensor module and sharps modules 3210, 3212 may be subjected to radiation sterilization to sterilize the sensor 3214 and the distal portion of the sharps 3216 prior to assembling and loading the sensor control device 3202 into the sensor applicator 102. Once properly sterilized, the sensor module and sharps modules 3210, 3212 may then be coupled to the electronics housing 3204, and the fully assembled sensor control device 3202 may be loaded into the sensor applicator 102 as described above.

[0327] However, in other embodiments, the fully assembled sensor control device 3202 may be loaded into the sensor applicator 102 first, and then the sensor module and sharps modules 3210, 3212 may undergo radiation sterilization 3412 while they are positioned within the sensor applicator 102. Radiation sterilization 3412 may include, for example, electron beam irradiation, although other sterilization methods may alternatively be used, including, but not limited to, gamma irradiation, x-ray irradiation, or any combination thereof.

[0328] In some embodiments, as shown, the sensor control device 3202 can be subjected to "focused" radiation sterilization 3412, in which radiation (e.g., beams, waves, etc.) from the radiation sterilization 3412 is applied to the sensor module and tip module 3210, 3212 (e.g., sensor 3214 and tip 3216) and directed at others. In such embodiments, electrical components 3304 (FIG. 33B) coupled to the PCB 3302 (FIGS. 33A-33B) including the data processing unit 3306 (FIG. 33B) can be positioned outside the range of the propagating radiation, such that these electrical components are not affected by the radiation. The electrical components 3304 and data processing unit 3306 can be positioned near the periphery of the PCB 3302, for example, so as not to fall within the range (extent) of the focused radiation sterilization 3412. In other embodiments, the radiation immunity of the electrical components can be achieved by shielding the sensitive electrical components 3304 with appropriate electromagnetic shielding.

[0329] In accordance with the present disclosure, while loaded into the sensor applicator 102, the sensor control device 3202 can be subjected to gaseous chemical sterilization 3414 to sterilize the electronics housing 3204 and any other exposed portions of the sensor control device 3202. To achieve the gaseous chemical sterilization 3414, chemicals can be injected into a sterilization chamber 3416 defined by the sensor applicator 102 and the interconnected cap 210 in cooperation. In some applications, the chemicals can be injected through one or more vent holes 3418 defined in the applicator cap 210 at its proximal end 3420. Exemplary chemicals that can be used for the gaseous chemical sterilization 3414 include, but are not limited to, ethylene oxide, hydrogen peroxide vapor, and nitrogen oxides (such as, for example, nitrous oxide and nitrogen dioxide).

[0330] The sensor 3214 and tip 3216 are sealed within the sealed area 3410 so that the chemicals used during the gaseous chemical sterilization process do not interact with the enzymes, chemicals, or biologicals disposed on the tail 3316.

[0331] Once the desired level of sterility assurance has been achieved within the sterilization chamber 3416, the gas solution is removed and the sterilization chamber 3416 is aerated. Aeration can be achieved by a series of vacuums followed by nitrogen or sterile air circulation through the sterilization chamber 3416. Once the sterilization chamber 3416 is properly aerated, the vent hole 3418 can be blocked with a seal 3422 (shown in dashed lines) added to the proximal end 3420 of the applicator cap 210.

[0332] In some embodiments, the seal 3422 may include two or more layers of different materials. A first layer may be made of a synthetic material (e.g., flash-spun high-density polyethylene fiber) such as Tyvek®, available from DuPont®. Tyvek® is very durable and puncture-resistant while allowing vapor transmission. The Tyvek® layer may be applied prior to or subsequent to gaseous chemical sterilization 3414, and a foil or other vapor- and moisture-resistant material layer may be sealed (e.g., heat-sealed) over the Tyvek® layer to prevent migration of contaminants and moisture into the sterilization chamber 3416. In other embodiments, the seal 3422 may include only a single protective layer applied to the applicator cap 210. In such embodiments, this single layer is gas-permeable for the sterilization process but also provides protection against moisture and other harmful elements after the sterilization process is complete.

[0333] With the seal 3422 in place, the applicator cap 210 provides a barrier to external contamination, thereby maintaining a sterile environment for the assembled sensor control device 3202 until the user removes (twists) the applicator cap 210. The applicator cap 210 can create a dust-free environment that prevents the adhesive patch 3218 used to secure the sensor control device 3202 to the user's skin from becoming contaminated during shipping and storage.

[0334] 35 is an enlarged cross-sectional side view of a sensor control device 3202 mounted within a sensor applicator 102 having an applicator cap 210 secured thereto in accordance with one or more embodiments. As discussed above, the sensor 3214 and sharpened tip 3216 are disposed within a sealed region 3410, thereby protecting them from substances that may adversely interact with the chemical formulation of the sensor 3214. More specifically, gases used during gaseous chemical sterilization 3414 (FIG. 34B) may adversely affect enzymes disposed on the tail 3316 of the sensor 3214, and the sealed region 3410 protects the tail 3316 from migration of such chemicals.

[0335] As shown, the sealed region 3410 can include (encompass) a selected portion within the electronics housing 3204 and the post chamber 3408 of the cap post 3406. In one or more embodiments, the sealed region 3410 can be defined or otherwise formed by at least a first seal 3502a, a second seal 3502b, and a third seal 3502c. The first seal 3502a can be positioned to seal the interface between the sharp body hub 3330 and the shell 3206. Furthermore, the first seal 3502a can surround a first central opening 3308a defined in the shell 3206 such that fluid (e.g., a gaseous chemical) is prevented from migrating into the electronics housing 3204 through the first central opening 3308a.

[0336] In some embodiments, the first seal 3502a can form part of the sharp body hub 3330. For example, the first seal 3502a can be overmolded onto the sharp body hub 3330. In other embodiments, the first seal 3502a can be overmolded onto the top surface of the shell 3206. In still other embodiments, the first seal 3502a can include a separate structure, such as an O-ring, sandwiched between the sharp body hub 3330 and the top surface of the shell 3206 without departing from the scope of this disclosure.

[0337] The second seal 3502b can be positioned to seal the interface between the cap post 3406 and the bottom of the mount 3208 and can surround a second central opening 3308b defined in the mount 3208. As a result, the second seal 3502b can prevent fluid (e.g., a gaseous chemical) from migrating into the post chamber 3408 of the cap post 3406 and also through the second central opening 3308b into the electronics housing 3204.

[0338] In some embodiments, the second seal 3502b can form part of the cap post 3406. For example, the second seal 3502b can be overmolded onto the top of the cap post 3406. In other embodiments, the second seal 3502b can be overmolded onto the cap post seal interface 3348 at the bottom of the mount 3208. In still other embodiments, the second seal 3502b can include a separate structure, such as an O-ring, sandwiched between the cap post 3406 and the bottom of the mount 3208 without departing from the scope of this disclosure.

[0339] After the sensor control device 3202 is loaded into the sensor applicator 102 and the applicator cap 210 is secured to the sensor applicator 102, the first and second seals 3502a, 3502b are compressed, creating a corresponding sealed interface. The first and second seals 3502a, 3502b can be made of a variety of materials capable of creating a sealed interface between opposing structures. Suitable materials include, but are not limited to, silicone, thermoplastic elastomer (TPE), polytetrafluoroethylene (Teflon®), rubber, elastomer, or any combination thereof.

[0340] The third seal 3502c can be positioned to seal the interface between the sensor mount pocket 3342 and the PCB 3302, more specifically between the perimeter 3344 of the sensor mount pocket 3342 and the underside of the PCB 3302. The third seal 3502c can include a gasket (e.g., an O-ring, etc.), adhesive, or another type of sealing material applied to the perimeter 3344. When actuated, the third seal 3502c can prevent fluids (e.g., gaseous chemicals, liquids, etc.) from migrating into the sensor mount pocket 3342 and thus into the post chamber 3408 from adversely reacting with the enzyme on the tail 3316.

[0341] The applicator cap 210 can be secured to the sensor applicator 102 by threading it onto the sensor applicator 102 through relative rotation. As the applicator cap 210 rotates relative to the sensor applicator 102, the cap post 3406 advances until the second seal 3502b engages the cap post seal interface 3348 at the bottom of the mount 3208. After engaging the cap post seal interface 3348, the second seal 3502b frictionally engages the mount 3208, thereby biasing a corresponding rotation of the entire electronics housing 3204 in the same angular direction.

[0342] 1, prior art sensor control devices typically define conical carrier gripping features on the exterior of the electronics housing that are configured to mate with corresponding conical features provided on the radially biased arms of the sensor mount pocket 3342. The mating engagement between these corresponding conical features helps prevent the electronics housing from rotating within the sensor applicator 102.

[0343] In contrast, the electronics housing 3204 of the sensor control device 3202 of the present disclosure provides or otherwise defines a sloped and otherwise continuously smooth outer surface 3504 around its outer diameter (perimeter). In some embodiments, the smooth outer surface 3504 may be provided on the mount 3208 as shown, but may alternatively be provided on the shell 3206 without departing from the scope of the present disclosure. One or more radially biased arms of the sensor mount pocket 3342 may be positioned to engage the outer surface 3504 to assist in centering the sensor control device 3202 within the sensor applicator 102. Because the electronics housing 3204 is biased to rotate by the frictional engagement between the second seal 3502b and the bottom of the mount 3208, the outer surface 3504 slidingly engages the radially biased arms, thereby unrestraining their rotation.

[0344] 36 is an enlarged cross-sectional bottom view of the sensor control device 3202 positioned on a cap post 3406 according to one or more embodiments. As shown, an adhesive patch 3218 is positioned on the underside of the mount 3208, with a transfer adhesive 3220 sandwiched between the adhesive patch 3218 and the mount 3208.

[0345] The adhesive patch 3218 can block or otherwise cover most of the groove 3346 defined on the bottom of the mount 3208. Additionally, as shown, the adhesive patch 3218 can extend only a short distance into the cap post seal interface 3348. To enable the groove 3346 to properly direct moisture away from the center of the electronics housing 3204 and away from the cap post seal interface 3348, the adhesive patch 3218 (and transfer adhesive 3220, if included) can provide or otherwise define one or more channels 3602 aligned with and positioned in fluid communication with the groove 3346. In the illustrated embodiment, the channels 3602 extend radially outward from the center of the electronics housing 3204, but can alternatively be defined in other configurations and still interconnect with the groove 3346 to facilitate fluid communication therebetween.

[0346] In operation, with moisture accumulating around the center of the electronics housing 3204 and at the cap post seal interface 3348, moisture can flow through the channel 3602 and into the groove 3346. Once in the groove 3346, the moisture can flow radially outward under the adhesive patch 3218 toward the outer periphery of the sensor control device 3202.

[0347] Embodiments disclosed herein include the following.

[0348] O. An analyte monitoring system including a sensor applicator, a sensor control device positioned within the sensor applicator, the sensor control device including an electronics housing having a shell and a mount mateable with the shell, a printed circuit board positioned within the electronics housing, a sensor extending from a bottom of the mount, a sharps hub positioned adjacent a top of the shell, and a sharps carried by the sharps hub and extending through the electronics housing and further extending from the bottom of the mount, the analyte monitoring system further including a cap coupled to the sensor applicator, the cap providing a cap post defining a post chamber that receives the sensor and sharps extending from the bottom of the mount, and a sealed region encompassing the post chamber and a portion of the interior of the electronics housing, the sealed region being defined by a first seal that seals the interface between the sharps hub and the shell, a second seal that seals the interface between the cap post and the bottom of the mount, and a third seal that seals the interface between the mount and the printed circuit board, wherein a portion of the sensor and sharps reside within the sealed region and are thereby isolated from gaseous chemical sterilization.

[0349] P. A method of preparing an analyte monitoring system comprising loading into a sensor applicator a sensor control device including an electronics housing having a shell and a mount mateable with the shell, a printed circuit board positioned within the electronics housing, a sensor module having a sensor extending from a bottom of the mount, and a sharps module having a sharps hub and a sharps carried by the sharps hub, extending through the electronics housing, and further extending from the bottom of the mount, The method further comprises securing a cap to the sensor applicator providing a cap post defining a post chamber that receives the sensor and sharps extending from the bottom of the mount, creating a sealed region containing the post chamber and a portion of the interior of the electronics housing when the cap is secured to the sensor applicator, and within which resides a portion of the sensor and sharps, sterilizing the sensor control device with gaseous chemical sterilization while the sensor control device is positioned within the sensor applicator, and isolating the portion of the sensor and sharps that reside within the sealed region from the gaseous chemical sterilization.

[0350] Each of embodiments O and P can have one or more of the following additional elements in any combination: Element 1: A first seal surrounds a central opening defined in the shell and prevents fluid from migrating through the central opening into the portion of the electronics housing. Element 2: A second seal surrounds a central opening defined in the mount and prevents fluid from migrating through the central opening into this portion of the electronics housing and also prevents fluid from migrating into the post chamber. Element 3: The first seal is overmolded onto the sharp hub. Element 4: The first seal is sandwiched between the sharp hub and the top surface of the shell. Element 5: The second seal is overmolded onto the cap post. Element 6: The second seal is sandwiched between the cap post and the bottom surface of the mount. Element 7: The first and second seals are fabricated from a material selected from the group consisting of silicone, thermoplastic elastomer, polytetrafluoroethylene, and any combination thereof. Element 8: The mount provides a sensor mount pocket that at least partially receives the sensor module within the electronics housing, and the third seal is positioned on the periphery of the sensor mount pocket. Element 9: The third seal includes one of a gasket and an adhesive. Element 10: Further including a plurality of grooves defined on a bottom of the mount and a cap post seal interface defined on the bottom of the mount at a center of the mount, and the second seal seals to the cap post seal interface. Element 11: Further including an adhesive patch coupled to the bottom of the mount and extending radially into the cap post seal interface, and one or more channels defined in the adhesive patch that interconnect with the plurality of grooves and facilitate fluid communication between the cap post seal interface and the plurality of grooves. Element 12: The electronics housing defines a sloped, smooth outer surface that allows the sensor control device to rotate unhindered relative to the sensor applicator when the cap is coupled to the sensor applicator.

[0351] Element 13: Creating a sealed region when the cap is secured to the sensor applicator includes sealing the interface between the sharps hub and the shell with a first seal, sealing the interface between the cap post and the bottom of the mount with a second seal, and sealing the interface between the mount and the printed circuit board with a third seal. Element 14: Sterilizing the sensor and sharps with radiation sterilization and assembling the sensor module and sharps module into the electronics housing precedes loading the sensor control device into the sensor applicator. Element 15: Sterilizing the sensor and sharps with radiation sterilization while the sensor control device is positioned in the sensor applicator precedes sterilizing the sensor control device with gaseous chemical sterilization. Element 16: The radiation sterilization is at least one of focused radiation sterilization and low-energy radiation sterilization. Element 17: The electronics housing defines a sloped, smooth outer surface, and the method further includes the step of allowing the sensor control device to rotate relative to the sensor applicator when securing the cap to the sensor applicator.

[0352] As non-limiting examples, exemplary combinations applicable to O and P include combinations of elements 1 and 2, elements 1 and 3, elements 1 and 4, elements 1 and 5, elements 1 and 6, elements 1 and 7, elements 1 and 8, elements 3 and 4, elements 3 and 5, elements 3 and 6, elements 10 and 11, and elements 15 and 16.

[0353] One-piece pack architecture with ASIC shielding, use of low and medium energy radiation sterilization, and magnetic deflection 37A-37C are isometric, side, and bottom views, respectively, of an exemplary sensor control device 3702 in accordance with one or more embodiments of the present disclosure. The sensor control device 3702 (also referred to as an on-body patch or on-body unit) may be similar in some respects to the sensor control device 104 of FIG. 1 and, therefore, may be most clearly understood with reference thereto. The sensor control device 3702 may replace the sensor control device 104 of FIG. 1 and, therefore, may be used in conjunction with a sensor applicator 102 (FIG. 1) that delivers the sensor control device 3702 to a target monitoring location on a user's skin. However, in contrast to the sensor control device 104 of FIG. 1, various structural advantages and improvements allow the sensor control device 3702 to be incorporated into a one-piece system architecture.

[0354] 1, for example, a user is not required to unpack multiple packages and finally assemble the sensor control device 3702 prior to delivery to a target monitoring location. Instead of requiring final assembly, the sensor control device 3702 may already be fully assembled and properly positioned within the sensor applicator 102 upon receipt by the user. To use the sensor control device 3702, a user need only break a single barrier (e.g., the applicator cap 210 of FIG. 2B) before immediately delivering the sensor control device 3702 to a target monitoring location.

[0355] Referring initially to FIG. 37A , the sensor control device 3702 includes an electronics housing 3704 that is generally disc-shaped and can have a generally circular cross-section. However, in other embodiments, the electronics housing 3704 can exhibit other cross-sectional shapes, such as oval or polygonal, without departing from the scope of this disclosure. The electronics housing 3704 can include a shell 3706 and a mateable mount 3708. An adhesive patch 3710 can be positioned on the underside of the mount 3708 and attached thereto. Similar to the adhesive patch 108 of FIG. 1 , the adhesive patch 3710 can be configured to securely maintain the sensor control device 3702 in place on the user's skin during operation.

[0356] In some embodiments, the shell 3706 can define a datum feature 3712. As shown, the datum feature 3712 can include a recess or light-blocking pocket defined in the shell 3706 and extending a short distance into the electronics housing 3704. The datum feature 3712 can serve as a “datum c” feature configured to help facilitate control of at least one degree of freedom of the sensor control device 3702 during factory assembly. In contrast, conventional sensor control devices (e.g., the sensor control device 104 of FIG. 1 ) typically include a tab extending radially from the side of the shell. The tab is used as a manufacturing clocking datum but must be removed at the end of fabrication; this removal step is followed by inspection of the shell where the tab once resided, thereby adding additional complexity to the conventional fabrication process.

[0357] The shell 3706 can define a central opening 3714 sized to receive a point (not shown) extendable through the center of the electronics housing 3704 .

[0358] 37B shows a portion of the sensor 3716 extending from the electronics housing 3704. The remainder of the sensor 3716 is positioned within the electronics housing 3704. Similar to the sensor 110 of FIG. 1, the exposed portion of the sensor 3716 is configured to be positioned transcutaneously beneath a user's skin during use. The exposed portion of the sensor 3716 may include an enzyme or other chemical or biological agent, and in some embodiments, a membrane may cover the chemical agent.

[0359] Sensor control device 3702 offers structural improvements that result in a height H and diameter D that can be smaller than conventional sensor control devices (e.g., sensor control device 104 of FIG. 1). In at least one embodiment, for example, height H can be about 1 mm or less than the height of conventional sensor control devices, and diameter D can be about 2 mm or less than the diameter of conventional sensor control devices.

[0360] Additionally, structural improvements to the sensor control device 3702 enable the shell 3706 to provide or otherwise define a chamfered or angled perimeter 3718. In contrast, conventional sensor control devices typically require a rounded or outwardly arcuate perimeter to contain internal components. The reduced height H, reduced diameter D, and angled perimeter 3718 have each been found to be advantageous by resulting in a sensor control device 3702 that is thinner, smaller, and less prone to premature delamination due to catching on sharp corners while attached to a user's skin.

[0361] 37C shows a central opening 3720 defined on the underside of the mount 3708. The central opening 3720 can be sized to receive the combination of a tip (not shown) and a sensor 3716, where the sensor 3716 is received in a hollow or recessed portion of the tip. When the electronics housing 3704 is assembled, the central opening 3720 is coaxially aligned with the central opening 3714 of the shell 3706 (FIG. 37A), and the tip penetrates the electronics housing by extending through each central opening 3714, 3720 simultaneously.

[0362] 38A and 38B are exploded top and bottom views, respectively, of a sensor control device 3702 in accordance with one or more embodiments. A shell 3706 and a mount 3708 act as opposing clamshell halves that surround or otherwise substantially enclose various electronic components of the sensor control device 3702. As shown, the sensor control device 3702 may include a printed circuit board assembly (PCBA) 3802 that includes a printed circuit board (PCB) 3804 having a plurality of electronic modules 3806 coupled thereto. Exemplary electronic modules 3806 include, but are not limited to, resistors, transistors, capacitors, inductors, diodes, and switches. Conventional sensor control devices typically stack PCB components on only one side of the PCB. In contrast, the PCB components 3806 in the sensor control device 3702 may be distributed across the surface area of ​​both sides (i.e., the top and bottom) of the PCB 3804.

[0363] Separate from the electronics module 3806, the PCBA 3802 may further include a data processing unit 3808 mounted on the PCB 3804. The data processing unit 3808 may include, for example, an application specific integrated circuit (ASIC) configured to perform one or more functions or routines associated with the operation of the sensor control device 3702. More specifically, the data processing unit 3808 may be configured to perform data processing functions, where such functions may include, but are not limited to, filtering and encoding multiple data signals each corresponding to a sampled analyte level of a user. The data processing unit 3808 may include an antenna for communicating with or otherwise communicate with the reader device 106 (FIG. 1).

[0364] A battery opening 3810 may be defined within the PCB 3804 and sized to receive and seat a battery 3812 configured to power the sensor control device 3702. An axial battery contact 3814a and a radial battery contact 3814b may be coupled to the PCB 3804 and may extend into the battery opening 3810 to facilitate the transfer of power from the battery 3812 to the PCB 3804. As the names suggest, the axial battery contact 3814a may be configured to provide axial contact to the battery 3812, whereas the radial battery contact 3814b may provide radial contact to the battery 3812. Positioning the battery 3812 in the battery opening 3810 using the battery contacts 3814a, 3814b helps reduce the height H (FIG. 37B) of the sensor control device 3702 while allowing the PCB 3804 to be centered and its components to be distributed on both sides (i.e., top and bottom), which helps facilitate providing a chamfer 3718 (FIG. 37B) on the electronics housing 3704.

[0365] The sensor 3716 may be centrally positioned relative to the PCB 3804 and may include a tail 3816, a flag 3818, and an interconnecting neck 3820. The tail 3816 extends through the central opening 3720 of the mount 3708 and may be configured to be transcutaneously received under the skin of a user. Additionally, the tail 3816 may have an enzyme or other chemical agent included thereon to help facilitate analyte monitoring.

[0366] The flag 3818 may include a generally flat surface on which one or more sensor contacts 3822 (three shown in FIG. 38B ) are positioned. The sensor contacts 3822 may be configured to align with and engage one or more circuit contacts 3824 (three shown in FIG. 38A ) provided on the PCB 3804. In some embodiments, the sensor contacts 3822 may include carbon-impregnated polymer printed or otherwise applied to the flag 3818 in the form of fingers. Conventional sensor control devices typically include connectors made of silicone rubber that encapsulate one or more compliant carbon-impregnated polymer modules that function as conductive contacts between the sensor and the PCB. In contrast, the sensor contacts 3822 of the present disclosure provide a direct connection between the sensor 3716 and the PCB 3804, thereby eliminating the need for prior art connectors and advantageously reducing the height H ( FIG. 37B ). Furthermore, the elimination of the compliant carbon-impregnated polymer modules eliminates significant circuit resistance, thus improving circuit conductivity.

[0367] The sensor control device 3702 may further include a compliant member 3826 that may be positioned to be sandwiched between the flag 3818 and the inner surface of the shell 3706. More specifically, when the shell 3706 and the mount 3708 are assembled together, the compliant member 3826 may be configured to provide a passive biasing load against the flag 3818 that urges the sensor contacts 3822 into continuous engagement with corresponding circuit contacts 3824. In the illustrated embodiment, the compliant member 3826 is a resilient O-ring, but may alternatively include any other type of biasing device or mechanism, such as a compression spring, or the like, without departing from the scope of the present disclosure.

[0368] The sensor control device 3702 can further include one or more electromagnetic shields, shown as a first shield 3828a and a second shield 3828b. The shields 3828a, 3828b can be positioned between the shell 3706 and the mount 3708, i.e., within the electronics housing 3704 (FIGS. 37A-37B). In the illustrated embodiment, the first shield 3828a is positioned above the PCB 3804 so as to face the top surface of the PCB 3804, and the second shield 3828b is positioned below the PCB 3804 so as to face the bottom surface of the PCB 3804.

[0369] The shields 3828a, 3828b can be configured to protect sensitive electronic components from radiation while the sensor control device 3702 undergoes radiation sterilization. More specifically, at least one of the shields 3828a, 3828b can be positioned to be sandwiched between the data processing unit 3808 and a radiation source, such as an electron beam electron accelerator. In some embodiments, for example, at least one of the shields 3828a, 3828b can be positioned adjacent to and aligned with the data processing unit 3808 and the radiation source to block or reduce an absorbed dose of radiation that could otherwise damage the sensitive electronic circuitry of the data processing unit 3808.

[0370] In the illustrated embodiment, the data processing unit 3808 is sandwiched between the first shield 3828a and the second shield 3828b such that the first shield 3828a and the second shield 3828b substantially axially sandwich the data processing unit 3808. However, in at least one embodiment, only one of the shields 3828a, 3828b may be required to adequately protect the data processing unit 3808 during radiation sterilization. For example, if the sensor control device 3702 is to undergo radiation sterilization directed toward the bottom of the mount 3708, only the second shield 3828b may be required to be sandwiched between the data processing unit 3808 and the radiation source, and the first shield 3828a may be eliminated. Alternatively, if the sensor control device 3702 is to undergo radiation sterilization directed toward the top of the shell 3706, only the first shield 3828a may be required to be sandwiched between the data processing unit 3808 and the radiation source, and the second shield 3828b may be eliminated. However, in other embodiments, both shields 3828a, 3828b may be used without departing from the scope of the present disclosure.

[0371] The shields 3828a, 3828b can be made of any material capable of attenuating (or substantially attenuating) the transmission of radiation. Suitable materials for the shields 3828a, 3828b include, but are not limited to, lead, tungsten, iron-based metals (e.g., stainless steel), copper, tantalum, tungsten, osmium, aluminum, carbon, or any combination thereof. Suitable materials for the shields 3828a, 3828b can be corrosion-resistant, austenitic, and any non-magnetic metal with a density ranging between about 2 grams per cubic centimeter (g / cc) and about 23 g / cc. The shields 3828a, 3828b can be fabricated by a variety of manufacturing techniques, including, but not limited to, stamping, casting, injection casting, sintering, two-shot casting, or any combination thereof.

[0372] However, in other embodiments, the shields 3828a, 3828b may comprise a metal-filled thermoplastic polymer such as, but not limited to, polyamide, polycarbonate, or polystyrene. In such embodiments, the shields 3828a, 3828b may be fabricated by mixing the shielding material into an adhesive matrix and dripping this combination onto a molded component or otherwise directly onto the data processing unit 3808. Further, in such embodiments, the shields 3828a, 3828b may comprise an enclosure that encapsulates (or substantially encapsulates) the data processing unit 3808. In such embodiments, the shields 3828a, 3828b may comprise a metal-filled thermoplastic polymer as described above, or alternatively may be made of any of the materials described herein that have the ability to attenuate (or substantially attenuate) the transmission of radiation.

[0373] The shell 3706 can provide or otherwise define a first clocking receptacle 3830a (FIG. 38B) and a second clocking receptacle 3830b (FIG. 38B), and the mount 3708 can provide or otherwise define a first clocking post 3832a (FIG. 38A) and a second clocking post 3832b (FIG. 38A). Mating of the first and second clocking receptacles 3830a, 3830b with the first and second clocking posts 3832a, 3832b, respectively, results in proper alignment of the shell 3706 with the mount 3708.

[0374] 38A , the inner surface of the mount 3708 can provide or otherwise define a plurality of pockets or recesses configured to contain various component parts of the sensor control device 3702 when the shell 3706 is mated to the mount 3708. For example, the inner surface of the mount 3708 can define a battery locator 3834 configured to receive a portion of the battery 3812 when the sensor control device 3702 is assembled. An adjacent contact pocket 3836 can be configured to receive a portion of the axial contact 3814a.

[0375] Additionally, a plurality of module pockets 3838 may be defined within the interior surface of the mount 3708 that contain various electronic modules 3806 positioned on the bottom of the PCB 3804. Additionally, a shield locator 3840 may be defined within the interior surface of the mount 3708 that receiv...

Claims

1. 1. An assembly for analyte sensor delivery, comprising: a sensor control device, 1. An electronic device housing, comprising: a shell having a first opening defined therein; a mount secured to the shell and having a second opening aligned with the first opening; an electronics housing including: a collar positioned within the electronic device housing and axially aligned with the first opening in the shell and the second opening in the mount; a first sealing element positioned on the collar; a circuit board positioned within the electronics housing; an analyte sensor having a proximal portion and a distal portion, the proximal portion electrically coupled to the circuit board, the distal portion extending from an underside of the electronics housing and configured to extend beneath the skin of a user to sense an analyte level in a bodily fluid; an adhesive patch attached to the underside of the electronics housing and configured to secure the sensor control device to the user's skin; a sharp hub configured to sealingly engage the first seal element, the sharp hub including a sharp and a mating member, the sharp and the mating member extending through the first opening and the second opening and extending distally from the underside of the electronics housing, the sharp configured to pierce the user's skin to position the distal portion of the analyte sensor in contact with the user's bodily fluid; a sensor cap having an inner chamber, a first end, and a second end; Including, the inner chamber of the sensor cap receives the distal portion of the analyte sensor; the first end of the sensor cap is removably coupled to the fitting and configured to sealingly engage a second seal element positioned between the mount and the first end of the sensor cap to seal the inner chamber; the second end includes an engagement feature; Assembly characterized by:

2. and an applicator for delivery of the analyte sensor, the applicator comprising: an applicator housing; a sheath coupled to the applicator housing for engaging the user's skin; a sharps carrier coupled to the sharps hub; a sensor carrier that removably secures the sensor control device within the applicator; a spring biasing the point carrier to move upward within the applicator; an applicator cap coupled to the applicator housing to seal the applicator; 2. The assembly of claim 1.

3. 3. The assembly of claim 2, wherein the sensor carrier includes one or more carrier arms that engage the tip carrier to maintain the tip carrier in place, and the spring is configured to bias the tip carrier to move upwardly within the applicator when the one or more carrier arms disengage from the tip carrier.

4. 3. The assembly of claim 2, wherein the sheath is telescopically received within the applicator housing to allow the sensor control device to advance into engagement with the user's skin.

5. 3. The assembly of claim 2, wherein the spring is configured to automatically retract the sharps carrier and the sharps hub into the applicator when the sensor control device is positioned at a target monitoring location.

6. 10. The assembly of claim 1, further comprising a connector that electrically couples a plurality of electrical contacts on the proximal portion of the analyte sensor to the circuit board.

7. 3. The assembly of claim 2, wherein the sensor carrier includes one or more flexible arms configured to removably secure the sensor control device within the applicator.

8. 8. The assembly of claim 7, wherein the one or more flexible arms are configured to engage a plurality of carrier gripping features along the periphery of the electronics housing to removably secure the sensor control device within the applicator.

9. The assembly of claim 8 , wherein the plurality of carrier gripping features are configured to prevent the sensor control device from rotating within the applicator.

10. 10. The assembly of claim 1, wherein the periphery of the mount is secured to the periphery of the shell using an adhesive.

11. The assembly of claim 10 , wherein the outer periphery of the mount is secured to the outer periphery of the shell through a tongue-and-groove engagement.

12. 10. The assembly of claim 1, wherein the mount further comprises a plurality of module pockets defined on an interior surface of the mount for receiving a plurality of electronic components disposed on the circuit board.

13. 2. The assembly of claim 1, further comprising: one or more pockets defined on an underside of the mount at the location of the second opening; and one or more protrusions defined on an end of the sensor cap that are receivable in the one or more pockets when the sensor cap is coupled to the fitting member.

14. 2. The assembly of claim 1, further comprising: a channel defined on an inner surface of the mount near the second opening; an annular lip defined on an underside of the collar that is mateable with the channel; and an adhesive disposed within the channel to secure and seal the collar to the mount at the location of the channel.

15. 15. The assembly of claim 14, further comprising a groove defined through the annular lip to accommodate a portion of the analyte sensor that extends laterally within the electronics housing, the adhesive sealing around the analyte sensor at the location of the groove.

16. 15. The assembly of claim 14, further comprising: a collar channel defined on a top surface of the collar; an annular ridge defined on an inner surface of the shell that is mateable with the collar channel; and an adhesive disposed within the collar channel to secure and seal the shell to the collar.

17. 2. The assembly of claim 1, wherein the first end of the sensor cap includes one or more square internal threads, the mating member includes one or more square external threads corresponding to the one or more square internal threads, and the sensor cap is removably coupled to the mating member by engagement of the one or more square external threads with the one or more square internal threads.

18. 10. The assembly of claim 1, wherein the sensor cap is configured to isolate the analyte sensor and the sharps within the inner chamber for sterilization.

19. 3. The assembly of claim 2, wherein the applicator cap seals within the applicator when the applicator cap is coupled to the applicator housing.

20. The assembly of claim 2 , wherein the applicator cap further comprises a cap post configured to receive the engagement feature of the sensor cap.

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