Centralized sterilization and sterile subassemblies for specimen monitoring systems

Abstract

A specimen monitoring system that can sterilize components without separating them. [Solution] The sample monitoring system includes a sensor applicator, a sensor control device disposed within the sensor applicator and including an electronic housing and a sensor extending from the bottom of the electronic housing, and a cap coupled to one of the sensor applicator and the sensor control device, which is removable before deploying the sensor control device from the sensor applicator.

Description

Background Art

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

[0002] When the symptoms of diabetes are not carefully monitored and treated, many complications can occur, including diabetic ketoacidosis, nonketotic hyperosmolar coma, cardiovascular disease, stroke, kidney failure, foot ulcers, eye damage, and nerve damage. Conventionally, monitoring has involved the steps of a person pricking a finger to draw blood and testing the blood for glucose levels. Recent advances have made continuous and long-term monitoring of blood glucose possible using biosensors that are maintained in contact with body fluids for days, weeks, or longer periods.

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

[0004] It is important that devices implanted in the body or positioned under the skin are sterile at the time of insertion. Sterilization may include any number of treatments that substantially remove or kill infectious agents such as bacteria, fungi, and viruses. These infectious agents may be substantially harmful to the user's health and safety if they are not removed from the device.

[0005] Some, though not all, sample monitoring systems may require separate sterilization processes for sensors and electronic components. For example, electron beam sterilization is an example of radiation sterilization that can be used to sterilize sensors to the extreme. However, radiation sterilization can damage electronic components associated with sensors. As a result, electronic components are generally sterilized through gaseous chemical sterilization, such as with ethylene oxide. However, ethylene oxide can damage chemical preparations applied to sensors. Therefore, integrating electronics and sensors into a single 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" [Overview of the project] [Problems that the invention aims to solve]

[0008] These problems can be avoided by separating the components into a sensor unit (e.g., a biological sample sensor) and an adapter unit (enclosing the data-transmitting electronic equipment), 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 final user assembly of the two components, which increases the possibility of user error. In other words, there is a need for a sample monitoring system that can be sterilized without separating the components. [Brief explanation of the drawing]

[0009] The following figures are included to illustrate certain aspects of the disclosure of the present invention and should not be considered as limiting embodiments. The subject matter disclosed can be modified, altered, combined, and equivalent in form and function without departing from the scope of the disclosure of the present invention.

[0010] [Figure 1] This is a conceptual diagram illustrating an exemplary sample monitoring system that may incorporate one or more embodiments of the disclosure of the present invention. [Figure 2A] This is a step-by-step assembly diagram of the system in Figure 1, which incorporates a two-piece architecture. [Figure 2B] This is a step-by-step assembly diagram of the system in Figure 1, which incorporates a two-piece architecture. [Figure 2C] This is a step-by-step assembly diagram of the system in Figure 1, which incorporates a two-piece architecture. [Figure 2D] This is a step-by-step assembly diagram of the system in Figure 1, which incorporates a two-piece architecture. [Figure 2E] This is a step-by-step assembly diagram of the system in Figure 1, which incorporates a two-piece architecture. [Figure 2F] This diagram shows an application of the system in Figure 1 that incorporates a two-piece architecture. [Figure 2G] FIG. 1 shows an application of the system incorporating a two-piece architecture. [Figure 3A] Isometric view of an exemplary sensor control device. [Figure 3B] Side view of an exemplary sensor control device. [[ID=[]] [Figure 4A] Isometric view of the plug assembly of FIGS. 3A - 3B. [Figure 4B] Exploded view of the plug assembly of FIGS. 3A - 3B. [Figure 5A] Exploded view of the electronic device housing of FIGS. 3A - 3B. [Figure 5B] Bottom isometric view of the electronic device housing of FIGS. 3A - 3B. [Figure 6A] Side view of the sensor applicator of FIG. 1 with the cap of FIG. 2B attached. [Figure 6B] Cross-sectional side view of the sensor applicator of FIG. 1 with the cap of FIG. 2B attached. [Figure 7A] Enlarged cross-sectional side view of the sensor control device of FIG. 6B mounted within the cap of FIG. 6B. [Figure 7B] 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] Schematic view of an exemplary external sterilization assembly according to one or more embodiments of the disclosure of the present invention. [Figure 9] Schematic view of an exemplary external sterilization assembly according to one or more embodiments of the disclosure of the present invention. [Figure 10] Schematic view of an exemplary external sterilization assembly according to one or more embodiments of the disclosure of the present invention. [Figure 11] Schematic view of an exemplary external sterilization assembly according to one or more embodiments of the disclosure of the present invention. [Figure 12] Schematic view of an exemplary external sterilization assembly according to one or more embodiments of the disclosure of the present invention. [Figure 13]This is an isometric view of an exemplary sensor control device. [Figure 14A] Figure 1 is a side view of the sensor applicator. [Figure 14B] Figure 14A is a cross-sectional side view of the sensor applicator. [Figure 15] Figure 14A shows a cross-sectional side view of another exemplary embodiment of the sensor applicator and Figure 14B shows the external sterilization assembly, according to one or two additional embodiments. [Figure 16] Figure 14A shows a cross-sectional side view of another exemplary embodiment of the sensor applicator and the external sterilization assembly shown in Figure 14B, according to one or more additional embodiments. [Figure 17A] This is an isometric top view of an example of the external sterilization assembly shown in Figure 14B, according to one or more embodiments. [Figure 17B] This is an isometric view of an example of the external sterilization assembly shown in Figure 14B according to one or more embodiments. [Figure 18] This is an isometric view of an exemplary sensor control device. [Figure 19A] Figure 1 is a side view of the sensor applicator. [Figure 19B] Figure 3A is a partial cross-sectional side view of the sensor applicator. [Figure 20A] This is one of various diagrams of the applicator insert shown in Figure 19B according to one or more embodiments of the disclosure of the present invention. [Figure 20B] This is one of various diagrams of the applicator insert shown in Figure 19B according to one or more embodiments of the disclosure of the present invention. [Figure 20C] This is one of various diagrams of the applicator insert shown in Figure 19B according to one or more embodiments of the disclosure of the present invention. [Figure 21] This is another cross-sectional side view of the sensor applicator in Figure 19A, showing a hybrid sterilization assembly according to one or more embodiments of the disclosure of the present invention. [Figure 22A] Figures 20A to 20C are isometric views of another embodiment of the applicator insert. [Figure 22B]Figures 20A to 20C are cross-sectional side views of another embodiment of the applicator insert. [Figure 23] This is a diagram illustrating an exemplary sample monitoring system that may incorporate one or more embodiments of the disclosure of the present invention. [Figure 24] This is a schematic diagram of an exemplary internal sterilization assembly according to one or more additional embodiments of the disclosure of the present invention. [Figure 25] This is a schematic diagram of another exemplary internal sterilization assembly according to one or more additional embodiments of the disclosure of the present invention. [Figure 26A] This is an isometric view of an exemplary sensor control device. [Figure 26B] This is a side view of an exemplary sensor control device. [Figure 27A] Figures 26A and 26B are isometric views of the plug assembly. [Figure 27B] Figures 26A and 26B are exploded views of the plug assembly. [Figure 27C] This is an isometric view of the disassembled plug and storage vial. [Figure 28A] Figures 26A and 26B are exploded views of the electronic equipment housing. [Figure 28B] Figures 26A and 26B are isometric views of the bottom of the electronic equipment housing. [Figure 29A] Figure 2B is a side view of the sensor applicator shown in Figure 1 with the cap attached. [Figure 29B] Figure 2B is a cross-sectional side view of the sensor applicator shown in Figure 1 with the cap attached. [Figure 30] Figures 29A and 29B are perspective views of exemplary embodiments of the cap. [Figure 31] This is a cross-sectional side view of a sensor control device positioned inside a cap. [Figure 32A] This is an isometric view of an exemplary sensor control device. [Figure 32B] This is a side view of an exemplary sensor control device. [Figure 33A] Figures 32A and 32B are exploded perspective top views of the sensor control device. [Figure 33B] Figures 32A and 32B are exploded perspective bottom views of the sensor control device. [Figure 34A] Figure 2B is a side view of the sensor applicator shown in Figure 1 with the cap attached. [Figure 34B] Figure 2B is a cross-sectional side view of the sensor applicator shown in Figure 1 with the cap attached. [Figure 35] This is an enlarged cross-sectional side view of the sensor control device mounted inside the sensor applicator. [Figure 36] This is an enlarged cross-sectional bottom view of the sensor control device mounted on top of the cap post. [Figure 37A] This is an isometric view of an exemplary sensor control device. [Figure 37B] This is a side view of an exemplary sensor control device. [Figure 37C] This is a bottom view of an exemplary sensor control device. [Figure 38A] Figures 37A to 37C are isometrically resolved top views of the sensor control device. [Figure 38B] Figures 37A to 37C are isometrically resolved bottom views of the sensor control device. [Figure 39A] Figures 37A to 37C show an exemplary assembly of a sensor control device. [Figure 39B] Figures 37A to 37C show an exemplary assembly of a sensor control device. [Figure 39C] Figures 37A to 37C show an exemplary assembly of a sensor control device. [Figure 39D] Figures 37A to 37C show an exemplary assembly of a sensor control device. [Figure 40A] Figures 37A to 37C are side views of the sensor applicator with the pre-assembled sensor control devices arranged on it. [Figure 40B] Figures 37A to 37C are cross-sectional side views of a sensor applicator in which the pre-assembled sensor control devices are arranged. [Figure 41A]This is an enlarged cross-sectional view of a sensor control device during exemplary radiation sterilization. [Figure 41B] This is an enlarged cross-sectional view of a sensor control device during exemplary radiation sterilization. [Figure 42] This figure shows a plot that graphically represents the approximate penetration depth for single-sided electron beam sterilization (or irradiation) treatment. [Figure 43] Figures 37A to 37C are cross-sectional side views of a sensor applicator on which one or more pre-assembled sensor control devices according to one or more embodiments are arranged. [Figure 44] This is a side view of an exemplary sensor control device. [Figure 45] Figure 44 is an exploded view of the sensor control device. [Figure 46A] Figure 45 is a cross-sectional side view of an assembled and sealed subassembly according to one or more embodiments. [Figure 46B] Figure 44 is a cross-sectional side view of the fully assembled sensor control device. [Figure 47A] Figure 2B is a side view of an exemplary embodiment of the sensor applicator shown in Figure 1 with the cap attached. [Figure 47B] Figure 2B is a cross-sectional side view of an exemplary embodiment of the sensor applicator shown in Figure 1 with the cap attached. [Figure 48] Figures 47A and 47B show perspective views of exemplary embodiments of the cap. [Figure 49] Figures 47A and 47B are cross-sectional side views of the sensor control device positioned within the cap. [Figure 50A] This is an isometric view of another exemplary sensor-controlled device. [Figure 50B] This is a side view of another exemplary sensor control device. [Figure 51A] Figures 50A and 50B are exploded isometric top views of the sensor control device. [Figure 51B] Figures 50A and 50B are exploded, isoangled base views of the sensor control device. [Figure 52]This is a cross-sectional side view of a subassembly assembled and sealed according to one or more embodiments. [Figure 53A] These are stepwise cross-sectional side views showing the assembly of the sensor applicator and the sensor control device shown in Figures 50A and 50B. [Figure 53B] These are stepwise cross-sectional side views showing the assembly of the sensor applicator and the sensor control device shown in Figures 50A and 50B. [Figure 53C] These are stepwise cross-sectional side views showing the assembly of the sensor applicator and the sensor control device shown in Figures 50A and 50B. [Figure 54A] A perspective view of the cap post of Figure 53C according to one or more additional embodiments. [Figure 54B] This is a top view of the cap post of Figure 53C according to one or more additional embodiments. [Figure 55] Figures 12B and 12C show cross-sectional side views of the sensor control device shown in Figures 50A and 50B, positioned within the cap. [Figure 56A] This is a cross-sectional side view of a sensor applicator waiting to deploy the sensor control device to the target monitoring location. [Figure 56B] This is a cross-sectional side view of a sensor applicator waiting to deploy the sensor control device to the target monitoring location. [Figure 57A] Figures 50A and 50B are stepwise cross-sectional side views showing the assembly and disassembly of an exemplary embodiment of a sensor applicator having a sensor control device. [Figure 57B] Figures 50A and 50B are stepwise cross-sectional side views showing the assembly and disassembly of an exemplary embodiment of a sensor applicator having a sensor control device. [Figure 57C] Figures 50A and 50B are stepwise cross-sectional side views showing the assembly and disassembly of an exemplary embodiment of a sensor applicator having a sensor control device. [Figure 58A] This is an isometric bottom view of a housing according to one or more embodiments. [Figure 58B]This is an isometric bottom view of the housing with the sheath and other components positioned at least partially. [Figure 59] This is an enlarged cross-sectional side view of a sensor applicator on which a sensor control device according to one or more embodiments is installed. [Figure 60A] This is an isometric top view of a cap according to one or more embodiments. [Figure 60B] This is an enlarged cross-sectional view of the engagement between the cap and the housing according to one or more embodiments. [Figure 61A] This is an isometric view of a sensor cap according to one or more embodiments. [Figure 61B] This is a color isometric drawing according to one or more embodiments. [Figure 62] This is an isometric top view of an exemplary sensor control device according to one or more embodiments of the disclosure of the present invention. [Figure 63] This is a schematic side view of an exemplary sensor applicator according to one or more embodiments of the disclosure of the present invention. [Figure 64A] Figures 62 and 63 are exploded isometric views of the sensor applicator and sensor control device. [Figure 64B] Figures 62 and 63 are exploded isometric views of the sensor applicator and sensor control device. [Figure 65A] Figures 63 and 64A to 64B are stepwise cross-sectional side views of a sensor applicator illustrating an exemplary deployment of a sensor control device according to one or more embodiments. [Figure 65B] Figures 63 and 64A to 64B are stepwise cross-sectional side views of a sensor applicator illustrating an exemplary deployment of a sensor control device according to one or more embodiments. [Figure 65C] Figures 63 and 64A to 64B are stepwise cross-sectional side views of a sensor applicator illustrating an exemplary deployment of a sensor control device according to one or more embodiments. [Figure 65D] Figures 63 and 64A to 64B are stepwise cross-sectional side views of a sensor applicator illustrating an exemplary deployment of a sensor control device according to one or more embodiments. [Figure 66] This is an enlarged cross-sectional side view of the engagement between the sensor holder and the sensor control device shown in Figures 65A to 65D according to one or more embodiments. [Figure 67] This is an exploded isometric view of another sensor applicator having the sensor control device of Figure 62 according to one or more additional embodiments. [Figure 68A] Figure 67 is a stepwise cross-sectional side view of a sensor applicator illustrating an exemplary deployment of a sensor control device according to one or more embodiments. [Figure 68B] Figure 67 is a stepwise cross-sectional side view of a sensor applicator illustrating an exemplary deployment of a sensor control device according to one or more embodiments. [Figure 68C] Figure 67 is a stepwise cross-sectional side view of a sensor applicator illustrating an exemplary deployment of a sensor control device according to one or more embodiments. [Figure 68D] Figure 67 is a stepwise cross-sectional side view of a sensor applicator illustrating an exemplary deployment of a sensor control device according to one or more embodiments. [Figure 69A] This is a schematic diagram of the pointed hub and fingers of the sensor holder. [Figure 69B] This is a magnified schematic diagram of the finger interacting with the upper part of the needle shroud. [Figure 69C] This is a magnified schematic diagram of the finger interacting with the upper part of the needle shroud. [Figure 70A] This 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] This 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] This is an isometric side view of an exemplary sensor holder according to one or more embodiments of the disclosure of the present invention. [Figure 71B] This is a cross-sectional side view of an exemplary sensor holder according to one or more embodiments of the disclosure of the present invention. [Figure 72A]These are enlarged cross-sectional side views of the sensor holder shown in Figures 71A and 71B, which holds a sensor control device according to one or more embodiments. [Figure 72B] These are enlarged cross-sectional side views of the sensor holder shown in Figures 71A and 71B, which holds a sensor control device according to one or more embodiments. [Figure 73A] This is a side view of an exemplary sensor applicator according to one or more embodiments. [Figure 73B] This is a cross-sectional side view of an exemplary sensor applicator according to one or more embodiments. [Figure 74A] Figure 73B is an isometric top view of the internal applicator cover. [Figure 74B] Figure 73B is an isometric view of the internal applicator cover. [Figure 75] This is an isometric view of an exemplary embodiment of the sensor cap shown in Figure 73B according to one or more embodiments. [Figure 76] This is an isometric cross-sectional side view of the sensor cap of Figure 75, received by the internal applicator cover of Figures 74A to 74B according to one or more embodiments. [Figure 77] This figure shows the stepwise removal of the applicator cap shown in Figure 73A and the internal applicator cover shown in Figures 74A to 74B from the sensor applicator shown in Figures 73A to 73B according to one or more embodiments. [Figure 78] This is a schematic diagram of an exemplary sensor applicator according to one or more additional embodiments of the disclosure of the present invention. [Figure 79] This is an exploded view of an exemplary sensor control device according to one or more additional embodiments. [Figure 80] Figure 79 is a bottom view of one embodiment of the sensor control device. [Figure 81A] This is an isometric view of a sensor control device according to one or more embodiments of the disclosure of the present invention. [Figure 81B] This is a side view of a sensor control device according to one or more embodiments of the disclosure of the present invention. [Figure 82]Figure 81 is an exploded perspective top view of the sensor control device. [Figure 83] This is a perspective cross-sectional side view of an exemplary sensor control device assembly, including the sensor control device shown in Figure 81A, mounted within a sensor applicator suitable for the sample monitoring system shown in Figure 1. [Figure 84] Figure 83 is an enlarged cross-sectional side view of the sensor control device assembly. [Figure 85] Figure 83 is a bottom view of several components of a sensor control device assembly, including a sensor control device held in a sensor carrier of a sensor applicator. [Figure 86] This is a schematic diagram of an exemplary sterilization assembly according to one or more embodiments of the disclosure of the present invention. [Figure 87] This is a schematic diagram of another exemplary sterilization assembly according to one or more embodiments of the disclosure of the present invention. [Figure 88A] This is a schematic bottom view of another exemplary sterilization assembly according to one or more embodiments of the disclosure of the present invention. [Figure 88B] This is a schematic bottom view of an alternative embodiment of the sterilization assembly shown in Figure 88A, according to one or more additional embodiments of the disclosure of the present invention. [Figure 88C] This is a schematic bottom view of an alternative embodiment of the sterilization assembly shown in Figure 88A, according to one or more additional embodiments of the disclosure of the present invention. [Figure 89] This is a schematic isometric view of an exemplary sensor control device according to one or more embodiments. [Figure 90] This is a schematic diagram of another sterilization assembly according to one or more embodiments. [Figure 91A] This is a side view of an exemplary sensor control device according to one or more embodiments of the disclosure of the present invention. [Figure 91B] This is an isometric view of an exemplary sensor control device according to one or more embodiments of the disclosure of the present invention. [Figure 92A] This is an exploded, isometric top view of the sensor control device shown in Figure 2 according to one or more embodiments. [Figure 92B]This is an exploded, isoangular bottom view of the sensor control device shown in Figure 2 according to one or more embodiments. [Figure 93] These are cross-sectional side views of the sensor control devices shown in Figures 91A to 91B and 92A to 92B according to one or more embodiments. [Figure 93A] Figures 91A-91B and 92A-92B are exploded isometric views of a portion of another embodiment of the sensor control device. [Figure 94A] This is an isometric view of the mount. [Figure 94B] Figures 91A-91B and 92A-92B are isometric top views of the sensor cap. [Figure 95A] This is a side view of an exemplary sensor applicator according to one or more embodiments. [Figure 95B] This is a cross-sectional side view of an exemplary sensor applicator according to one or more embodiments. [Figure 96A] This is a perspective view of the cap post of Figure 95B according to one or more embodiments. [Figure 96B] This is a top view of the cap post of Figure 95B according to one or more embodiments. [Figure 97] This is a cross-sectional side view of a sensor control device positioned within an applicator cap according to one or more embodiments. [Figure 98] This is a cross-sectional view of a sensor-controlled device illustrating an exemplary interaction between a sensor and a sharp object. [Figure 99] This is a cross-sectional side view of an exemplary specimen monitoring system enclosure used to house at least a portion of a sensor control device. [Figure 100A] Figure 99 is an enlarged cross-sectional side view of the interface between the sensor applicator and the cap, indicated by the dashed box. [Figure 100B] Figure 99 shows an enlarged cross-sectional side view of the interface between the sensor applicator and the cap, indicated by the dashed box, during or after gaseous chemical sterilization. [Figure 101]This is a cross-sectional side view of another exemplary specimen monitoring system enclosure used to house at least a portion of the sensor control device shown in Figure 1. [Figure 102A] This figure provides finite element analysis results corresponding to the interface between the housing and the cap during exemplary gaseous chemical sterilization. [Figure 102B] This figure provides finite element analysis results corresponding to the interface between the housing and the cap during exemplary gaseous chemical sterilization. [Figure 102C] This figure provides finite element analysis results corresponding to the interface between the housing and the cap during exemplary gaseous chemical sterilization. [Figure 103] This is an isometric view of an exemplary sensor control device. [Figure 104A-B] This is an exploded isometric view of the sensor control device of Figure 103 according to one or more embodiments. [Figure 105] Figures 104A to 104B are cross-sectional side views of the assembled sensor control device according to one or more embodiments. [Figure 106] This is an isometric view of another exemplary sensor-controlled device. [Figure 107A-B] This is an exploded isometric view of the sensor control device of Figure 106 according to one or more embodiments. [Figure 108] Figures 107A to 107B are cross-sectional side views of the assembled sensor control device according to one or more embodiments. [Figure 109] This is an isometric view of an exemplary conversion process for manufacturing a sensor control device according to the principles disclosed in the present invention. [Figure 110A] This diagram illustrates the stepwise fabrication of the sensor control device shown in Figure 109 according to one or more embodiments. [Figure 110B] This diagram illustrates the stepwise fabrication of the sensor control device shown in Figure 109 according to one or more embodiments. [Figure 110C] This diagram illustrates the stepwise fabrication of the sensor control device shown in Figure 109 according to one or more embodiments. [Figure 110D]This diagram illustrates the stepwise fabrication of the sensor control device shown in Figure 109 according to one or more embodiments. [Figure 110E] This diagram illustrates the stepwise fabrication of the sensor control device shown in Figure 109 according to one or more embodiments. [Figure 111A] Figure 109 is a top view of the sensor control device in preparation for pressure testing and / or vacuum sealing according to one or more embodiments. [Figure 111B] Figure 109 is a cross-sectional side view of a sensor control device having a compressor. [Figure 112] This is a partial cross-sectional side view of an exemplary sensor control device according to one or more embodiments. [Figure 113] This is a cross-sectional side view of an exemplary sensor applicator according to one or more embodiments. [Figure 114A] Figures 27A and 27B show a top perspective view of an exemplary embodiment of the plug. [Figure 114B] Figures 27A and 27B show bottom perspective views of exemplary embodiments of the plug. [Figure 115A] This is a perspective view illustrating an exemplary embodiment of the connector shown in Figures 27A and 27B in an open state. [Figure 115B] This is a perspective view illustrating an exemplary embodiment of the connector shown in Figures 27A and 27B in a closed state. [Figure 116] Figures 27A and 27B are perspective views of exemplary embodiments of the sensor. [Figure 117A] This is a bottom perspective view illustrating an exemplary embodiment of a sensor module assembly. [Figure 117B] This is a top perspective view illustrating an exemplary embodiment of a sensor module assembly. [Figure 118A] Figures 114A and 114B show enlarged sub-views of exemplary embodiments of a sensor plug having a certain axial stiffening feature. [Figure 118B] Figures 114A and 114B show enlarged sub-views of exemplary embodiments of a sensor plug having a certain axial stiffening feature. [Figure 119]This is a side view of an exemplary sensor according to one or more embodiments of the disclosure of the present invention. [Figure 120A] This is an isometric view of an exemplary connector assembly according to one or more embodiments. [Figure 120B] This is a partially exploded isometric view of an exemplary connector assembly according to one or more embodiments. [Figure 120C] Figures 120A and 120B are isometric bottom views of the connector. [Figure 121A] This is an isometric view of another exemplary connector assembly according to one or more embodiments. [Figure 121B] This is a partially exploded isometric view of another exemplary connector assembly according to one or more embodiments. [Figure 121C] Figures 121A and 121B are isometric bottom views of the connector. [Modes for carrying out the invention]

[0011] This application relates to a system, device, and method for assembling an applicator and sensor control device for use in a general in vivo sample monitoring system.

[0012] Figure 1 is a conceptual diagram illustrating an exemplary sample monitoring system 100 that may incorporate one or more embodiments of the disclosure of the present invention. Using System 100 (hereinafter referred to as "System 100"), a variety of samples can be detected and quantified, 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), lactic acid, oxygen, peroxides, prostate-specific antigen, prothrombin, RNA, thyroid-stimulating hormone, and troponin. The concentrations of drugs such as antibiotics (e.g., gentamicin and vancomycin), digitoxin, digoxin, addiction drugs, theophylline, and warfarin can be determined.

[0013] As shown in the figure, system 100 includes a sensor applicator 102 (also referred to as the "insertor"), a sensor control device 104 (also referred to as the "in vivo sample 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 the user's skin (e.g., the user's arm). Once delivered, the sensor control device 104 is held in place on the skin by an adhesive patch 108 attached to its base. A portion of the sensor 110 extends from the sensor control device 104 and is positioned to be percutaneously positioned beneath the surface of the user's skin during the monitoring period and to be held elsewhere.

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

[0015] In some embodiments, the tip of the introducer can be inclined over the end of the sensor 110 so that the introducer first penetrates the tissue and opens an access passage to the sensor 110. In other exemplary embodiments, the sensor 110 may be located within the lumen or groove of the introducer, and the introducer also opens an access passage to the sensor 110. In either case, the introducer is withdrawn after facilitating the insertion of the sensor 110. Furthermore, the introducer (sharp body) can be manufactured from a variety of materials, such as various types of metals and plastics.

[0016] With the sensor control device 104 properly assembled, the sensor 110 is brought into communication (e.g., electrically, mechanically, etc.) with one or more electronic components or sensor electronic equipment contained within the sensor control device 104. In some applications, for example, the sensor control device 104 may include a printed circuit board (PCB) on which a data processor (e.g., an application-specific integrated circuit or ASIC) is mounted, and the sensor 110 can be operationally coupled to this data processor, which can further be coupled to an antenna and a power supply.

[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 local communication link 112. In some embodiments, the reader device 106 constitutes an output medium for viewing sample concentrations and alarms or notifications determined by the sensor 110 or its associated processor, and can further allow one or more user inputs. The reader device 106 can be a multipurpose smart phone or a dedicated electronic reader device. Although only one reader device 106 is shown, in certain cases, multiple reader devices 106 may exist.

[0018] The reader device 106 can communicate with the remote terminal 114 and / or the highly reliable computer system 116 via wired or wireless one-way or two-way encrypted or unencrypted communication paths / links 118 and / or 120, respectively. In addition to or instead of this, the reader device 106 can communicate with a network 122 (e.g., a mobile phone network, the Internet, or a cloud server) via a communication path / link 124. The network 122 can further communicate with the remote terminal 114 via a communication path / link 126 and / or with the highly reliable computer system 116 via a communication path / link 128.

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

[0020] Any suitable electronic communication protocol, such as Near Field Communication (NFC), Radio Frequency Identification (RFID), Bluetooth® protocol or Bluetooth® Low Energy protocol, or Wi-Fi, can be used for each communication path or link. In some embodiments, the remote terminal 114 and / or the highly reliable computer system 116 can be made accessible to individuals other than the primary user who are interested in the user's sample level. The reader device 106 may include a display 130 and an optional input component 132. In some embodiments, the display 130 may include a touch screen interface.

[0021] In some embodiments, the sensor control device 104 can automatically transmit data to the reader device 106. For example, sample concentration data can be automatically and periodically communicated when data is available or at a predetermined frequency after a predetermined period has elapsed, and the data is stored in memory until transmission (e.g., every minute, every five minutes, or at other predetermined intervals). In other embodiments, the sensor control device 104 can communicate with the reader device 106 in a non-automatic manner without following a set schedule. For example, data can be communicated from the sensor control device 104 using RFID technology when the sensor electronic device is within the communication range of the reader device 106. The data can remain stored in the memory of the sensor control device 104 until it is communicated to the reader device 106. Therefore, the patient does not need to constantly maintain proximity to the reader device 106, but can instead upload data at a convenient time. In yet another embodiment, a combination of automatic and non-automatic data transmission can be implemented. For example, data transmission can continue automatically until the reader device 106 is no longer within the communication range of the sensor control device 104.

[0022] In a “two-piece” architecture known to require final assembly by the user before the sensor 110 can be properly delivered to the target monitoring location, the sensor control device 104 is often included together with the sensor applicator. More specifically, the sensor 110 and the 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 the instructions before delivering the sensor 110 to the target monitoring location using the sensor applicator 102.

[0023] However, very recently, advanced designs in sensor control devices and sensor applicators have led to a one-piece architecture that allows systems to be shipped to users in a single sealed package, eliminating the need for any final user assembly stages. Instead of performing a final user assembly, the user simply unpacks a single package and then sends the sensor control device to the target monitoring location. The one-piece system architecture has proven advantageous by eliminating component parts, various manufacturing stages, and user assembly stages. As a result, packaging and waste are reduced, and the possibility of user error or system contamination is mitigated.

[0024] In the illustrated embodiment, the system 100 may include a “two-piece” architecture known to require final assembly by the user before the sensor 110 can be properly delivered to the 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 a plurality (two) packages, each of which may or may not be sealed with a sterile barrier, but is at least closed during packaging. The user must unpack the packages, manually assemble the components according to the instructions, and then deliver the sensor 110 to the target monitoring location using the sensor applicator 102.

[0025] Figures 2A to 2G illustrate the assembly and application of system 100 incorporating a two-piece architecture. Figures 2A and 2B show the first and second packages provided to the user for final assembly, respectively. More specifically, Figure 2A shows a sensor container or sensor tray 202 with a removable lid 204. The user prepares the sensor tray 202 by removing the lid 204, which acts as a sterile barrier to protect the contents of the sensor tray 202 and otherwise maintains a sterile internal environment. Removing the lid 204 exposes a platform 206 positioned within the sensor tray 202, where a plug assembly 207 (partially visible) is positioned and otherwise planned and embedded. The plug assembly 207 includes a sensor module (not shown) and a sharp body module (not shown). The sensor module carries the sensor 110 (Figure 1), and the acupuncture module carries an associated acupuncture body used to assist in the transcutaneous delivery of the sensor 110 beneath the user's skin during the application of the sensor control device 104 (Figure 1).

[0026] Figure 2B shows the sensor applicator 102 and where the user is preparing 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 may seal the interface between the housing 208 and the applicator cap 210. In at least one embodiment, the O-ring or sealing gasket may be cast on either the housing 208 or 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 includes an electronic housing (not shown) that holds electronic components for a sensor control device 104 (Figure 1), and the applicator cap 210 may or may not maintain a sterile environment for these electronic components. The preparation step for the sensor applicator 102 includes the step of separating the housing 208 from the applicator cap 210, which can be achieved by twisting the applicator cap 210 off the housing 208. The applicator cap 210 can then be disposed of or set aside.

[0027] Figure 2C illustrates the user inserting the sensor applicator 102 into the sensor tray 202. The sensor applicator 102 includes a sheath 212 configured to be accepted by the platform 206, the sheath 212 being temporarily unlocked from the housing 208, and the platform 206 being temporarily unlocked from the sensor tray 202. By advancing the housing 208 into the sensor tray 202, the plug assembly 207 (Figure 2A), which is positioned within the sensor tray 202 and includes the sensor module and the pointed body module, is coupled to the electronic housing positioned within the sensor applicator 102.

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

[0029] Figure 2E shows the bottom or interior of the sensor applicator 102 after removal from the sensor tray 202 (Figure 2). The sensor applicator 102 has been removed from the sensor tray 202 with the sensor control device 104 fully assembled inside and positioned for delivery to the target monitoring location. As shown, a pointed body 220 extends from the bottom of the sensor control device 104, and the pointed body 220 carries a portion of the sensor 110 in its hollow or recessed portion. The pointed body 220 is configured to penetrate the user's skin, thereby bringing the sensor 110 into contact with bodily fluids.

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

[0031] Figure 2G shows the sensor control device 104 successfully adhered to the user's skin, with the user retracting the sensor applicator 102 from the target monitoring location. The adhesive patch 108 (Figure 1) attached to the bottom of the sensor control device 104 adheres to the skin, fixing the sensor control device 104 in place. When the housing 208 has fully advanced to the target monitoring location 222, the pointed body 220 (Figure 2E) automatically retracts, while the sensor 110 (Figure 2E) remains in place to measure the sample level.

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

[0033] More specifically, the sensor tray 202, which includes a plug assembly 207 (Figure 2A) containing the sensor 110 (Figures 1 and 2E) and the sharp body 220 (Figure 2E), can be sterilized using radiation sterilization such as electron beam (or "electron beam") irradiation. However, radiation sterilization may damage electronic components positioned within the electronic housing of the sensor control device 104. Therefore, depending on the need to sterilize the sensor applicator 102 that encloses the electronic housing of the sensor control device 104, the sensor applicator 102 can be sterilized by another method, such as gaseous chemical sterilization using ethylene oxide. However, gaseous chemical sterilization may damage enzymes or other chemical and biological agents 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, so that the user can finally assemble the components upon acceptance.

[0034] In embodiments of the disclosure of the present invention, System 100 (Figure 1) may include a one-piece architecture that incorporates a sterilization technique specifically designed for a one-piece architecture. The one-piece architecture allows System 100 to be shipped to the user in a single sealed package that does not require any final user assembly steps. Instead of performing a final user assembly step, the user only needs to unpack one package and then deliver the sensor control device to the target monitoring location as generally described above with reference to Figures 2E-2G. The one-piece system architecture described herein has proven advantageous in that it eliminates component parts, various manufacturing steps, and user assembly steps. As a result, packaging and waste are reduced, and the possibility of user error or contamination of the system is mitigated.

[0035] Focused electron beam sterilization using a collimator Figures 3A and 3B are isometric and side views, respectively, of an exemplary sensor control device 302 according to one or more embodiments of the disclosure of the present invention. The sensor control device 302 (also referred to as the "pack") can be similar in several respects to the sensor control device 104 of Figure 1, and is therefore best understood by referring to it. The sensor control device 302 can replace the sensor control device 104 of Figure 1, and can therefore be used in conjunction with the sensor applicator 102 (Figure 1) that delivers the sensor control device 302 to a target monitoring location on the user's skin.

[0036] However, the sensor control device 302 can be integrated into a one-piece system architecture. Unlike a two-piece architecture system, for example, the 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 user acceptance. To use the sensor control device 302, the user only needs to overcome one barrier (e.g., the applicator cap 210 in Figure 2B) before immediately sending the sensor control device 302 to the target monitoring location.

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

[0038] The electronic equipment housing 304 may include a shell 306 and a mount 308 to which it can be mated. The shell 306 can be fastened to the mount 308 by various means such as snap-fit ​​engagement, interlocking fit, ultrasonic welding, or one or more mechanical fasteners (e.g., screws). In some cases, the shell 306 can be fastened to the mount 308 such that a sealed interface is created between it and the mount 308. In such embodiments, a gasket or other type of sealing material can be placed around or near the outer diameter (circumference) of the shell 306 and the mount 308, and the gasket can be compressed by fastening these two components together, thereby creating a sealed interface. In other embodiments, an adhesive can be applied to the outer diameter (circumference) of one or both of the shell 306 and the mount 308. The adhesive fastens the shell 306 to the mount 308, giving it structural integrity, but it can also seal the interface between these two components, thereby isolating the interior of the electronic equipment housing 304 from external contamination. When the sensor control device 302 is assembled in a controlled environment, it may not be necessary to ultimately sterilize the internal electrical components. Instead of sterilization, adhesive bonding can provide a sufficient sterile barrier to the assembled electronic equipment housing 304.

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

[0040] Figures 4A and 4B are isometric and exploded views, respectively, of a plug assembly 310 according to one or more embodiments. The sensor module 312 may include a sensor 316, a plug 402, and a connector 404. The plug 402 may be designed to accept and support both the sensor 316 and the connector 404. As shown, a channel 406 can be defined through the plug 402 to accept a portion of the sensor 316. Furthermore, the plug 402 may provide one or more deflectable arms 407 configured to snap into corresponding feature portions provided on the bottom of the electronic equipment housing 304 (Figures 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 distally from the plug 402. The tail 408 contains an enzyme or other chemical or biological agent, and in some embodiments, a membrane can cover the chemical agent. During use, the tail 408 is received percutaneously under the user's skin, and the chemical agent contained on the tail 408 helps facilitate specimen monitoring in the presence of body fluids.

[0042] The flag 410 may include a substantially flat surface on which sensor contacts 414 (three shown in Figure 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. Figures 4A and 4B show the connector 404 in the closed state, but the connector 404 can pivot and rotate to the open state to receive the flag 410 and the compliant carbon-impregnated polymer module inside. The compliant carbon-impregnated polymer module provides electrical contacts 420 (three shown) configured to give conductive communication between the sensor 316 and the corresponding circuit contacts provided in the electronic housing 304 (Figures 3A and 3B). The connector 404 can be manufactured 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 sharp body module 314 includes a sharp body 318 and a sharp body hub 422 that supports it. The sharp body 318 includes an elongated shaft 424 and a sharp body tip 426 at its distal end. The shaft 424 may extend through the channel 406 and further extend distally from the plug 402. Furthermore, the shaft 424 may include a hollow portion or recessed portion 428 that at least partially surrounds the tail 408 of the sensor 316. The sharp body tip 426 may be configured to penetrate the skin while supporting the tail 408 in order to bring the activating agent present on the tail 408 into contact with body fluids.

[0045] The pointed hub 422 may include a hub miniature cylinder 430 and a hub snap clasp 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 (Figure 1).

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

[0047] A printed circuit board (PCB) 502 can be placed inside the electronic equipment housing 304. The PCB 502 can be fitted with several electronic modules (not shown), including but not limited to data processing units, 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, in which case such functions may include, but are not limited to, filtering and encoding of several data signals, each corresponding to a user's sampled specimen level. The data processing unit may include or otherwise communicate with the reader device 106 (Figure 1), including an antenna for communication with it.

[0048] As shown in the diagram, the shell 306, mount 308, and PCB 502 each define corresponding central openings 504, 506, and 508, respectively. When the electronic housing 304 is assembled, the central openings 504, 506, and 508 are coaxially aligned to receive the plug assembly 310 (Figures 4A to 4B). The battery 510 can be housed within the electronic housing 304 and configured to power the sensor control device 302.

[0049] In Figure 5B, a plug receptacle 512 can be positioned within the bottom of the mount 308, providing a place for the plug assembly 310 (Figures 4A-4B) to be received and coupled into the electronics housing 304, thereby allowing the sensor control device 302 (Figures 3A-3B) to be fully assembled. The profile of the plug 402 (Figures 4A-4B) can be molded to fit or complement the plug receptacle 512, and the plug receptacle 512 can provide one or more snap engagement ledges 514 (two shown) configured to interface with and receive the deflectable arm 407 (Figures 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 (Figures 4A to 4B) properly coupled to the electronic equipment housing 304, one or more circuit contacts 516 (three shown) located on the underside of the PCB 502 can be electrically connected to the electrical contacts 420 (Figures 4A to 4B) of the connector 404 (Figures 4A to 4B).

[0050] Figures 6A and 6B are a side view and a cross-sectional side view, respectively, of the sensor applicator 102 with the applicator cap 210 attached. More specifically, Figures 6A and 6B show how the sensor applicator 102 according to at least one embodiment may be shipped to the user and how the user may receive it. However, in some embodiments, the sensor applicator 102 may be further sealed in a bag (not shown) and delivered to the user in that state. The bag may be manufactured from a variety of materials that help prevent moisture from moving into the sensor applicator 102, which could adversely affect the sensor 316. In at least one embodiment, for example, the sealing back may be manufactured from foil. Any and all of the sensor applicators described or disclosed herein may be sealed in a bag and delivered to the user in that state.

[0051] As disclosed in the present invention and as shown in Figure 6B, the sensor control device 302 is already assembled and installed in the sensor applicator 102 before being delivered to the user. The applicator cap 210 can be screwed onto the housing 208 and may 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 is unscrewed, thereby freeing the applicator cap 210 from the sensor applicator 102. Subsequently, the user can deliver the sensor control device 302 to the target monitoring location as generally described above with reference to Figures 2E to 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 may be a separate component or, instead, may be cast onto one of the housing 208 or the applicator cap 210.

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

[0054] Referring particularly to Figure 6B, the sensor control device 302 can be loaded into the sensor applicator 102 by fitting the pointed hub 422 with the sensor carrier 604 contained within the sensor applicator 102. With the sensor control device 302 fitted with the sensor carrier 604, the applicator cap 210 can then be fixed to the sensor applicator 102.

[0055] In the illustrated embodiment, the collimator 606 is positioned within the applicator cap 210, and the collimator 606 can generally be used to support the sensor control device 302 while it is enclosed within the sensor applicator 102. In some embodiments, the collimator 606 can form an integral or extension portion of the applicator cap 210 by casting it together with the applicator cap 210 or by overmolding it onto the applicator cap 210. In other embodiments, the collimator 606 may include a separate structure fitted into or attached to the applicator cap 210, without departing from the scope of the disclosure of the present invention. In yet another embodiment, as discussed below, the collimator 606 may be removed from the package to be accepted by the user but otherwise used while the sensor applicator 102 is being sterilized and prepared for delivery.

[0056] The collimator 606 can be designed to help receive and protect portions of the sensor control device 302 that require sterility, and further to isolate sterile components of the sensor applicator 102 from microbial contamination from other parts of the sensor control device 302. To achieve this design, the collimator 606 can define or otherwise provide a sterile zone 608 (also referred to as a “sterile barrier enclosure space” or “sterile sensor pathway”) configured to receive the sensor 316 and the sharp body 318 extending from the bottom of the electronic equipment housing 304. The sterile zone 608 may generally include a hole or passage extending at least partially through the body of the collimator 606. In the illustrated embodiment, the sterile zone 608 extends through the entire collimator 606, but alternatively, it may extend only partially through the collimator 606 without departing from the scope of the disclosure of the present invention.

[0057] With the sensor control device 302 loaded into the sensor applicator 102 and the applicator cap 210 having a collimator 606 fixed thereto, the sensor 316 and the sharp body 318 can be placed within a sealed area 610, at least partially defined by a sterilization zone 608. The sealed area 610 is configured to isolate the sensor 316 and the sharp body 318 from external contamination and may include (contain) a selected portion within the electronic equipment housing 304 and the sterilization 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 may include, for example, electron beam irradiation, but other sterilization methods, including but not limited to low-energy X-ray irradiation, can be used instead. In some embodiments, radiation sterilization 612 can be delivered by either continuous-process irradiation or pulsed-beam irradiation. In pulsed-beam irradiation, the beam of radiation sterilization 612 is focused to a target location, the component or device to be sterilized is moved there, and radiation sterilization 612 is operated to supply directional radiation pulses to this point. Then radiation sterilization 612 is stopped, another component or device to be sterilized is moved to the target location, and this process is repeated.

[0059] The collimator 606 can be configured to focus radiation (e.g., beam, wave, or energy) from the radiation sterilization 612 toward components that need to be sterile, such as the sensor 316 and the sharpened body 318. More specifically, the holes or passages in the sterilization zone 608 allow the transmission of radiation that enters onto the sensor 316 and the sharpened body 318 to sterilize them, while the remaining portion of the collimator 606 prevents (blocks) the propagating radiation from destroying or damaging electronic components within the electronic equipment housing 304.

[0060] The sterilization zone 608 can exhibit any suitable cross-sectional shape necessary to properly focus the radiation onto the sensor 316 and the pointed body 318 for sterilization. In the illustrated embodiment, for example, the sterilization zone 608 is conical or truncated cone in shape. However, in other embodiments, the sterilization zone 608 can exhibit a polygonal cross-sectional shape such as a cube, rectangle (including, for example, a parallelogram), or pyramidal shape without departing from the scope of the disclosure of the present invention.

[0061] In the illustrated embodiment, the sterilization zone 608 has a first opening 614a at a first end and a second opening 614b at a second end opposite the first end. The first opening 614a can be configured to receive the sensor 316 and the sharp body 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 the sharp body 318.

[0062] In embodiments where the shape of the sterilization zone 608 is conical or truncated cone, the first opening 614a may have a smaller diameter than the second opening 614b. In such embodiments, for example, the size of the first opening 614a may range between about 0.5 mm and about 3.0 mm, and the size of the second opening 614b may range between about 5.0 mm and about 16.0 mm. However, as can be seen, the respective diameters of the first and second openings 614a, 614b may be larger or smaller than those provided herein, without departing from the scope of the disclosure of the present invention and on an application basis. In fact, the diameters of the first and second openings 614a, 614b only need to be large enough to allow a sufficient dose of radiation to enter onto the sensor 316 and the pointed body 318. Furthermore, 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 have the same diameter.

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

[0064] In at least one embodiment, the collimator 606 can be manufactured from a material having a mass density lower than 0.9 grams per cubic centimeter (g / cc), but the design of the collimator 606 can still be modified so that it can operate to reduce or eliminate the radiation sterilization 612 incident on the electronic components within the electronic equipment housing 304. To achieve this design modification, in some embodiments, the size (e.g., length) of the collimator 606 can be increased so that a large amount of material is required to pass through due to electrons propagating from the radiation sterilization 612 before it incident on the sensitive electronic equipment. The larger amount of material can help absorb or dissipate the irradiation intensity of the radiation sterilization 612 so that it is harmless to the sensitive electronic equipment. However, in other embodiments, the reverse may be equivalent. 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 large mass density.

[0065] In addition to the radiation shielding properties of the collimator 606 body, in some embodiments, one or more shields 616 (not shown) may be placed inside 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, 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 the data processing unit 618 and aligned with both the data processing unit 618 and the radiation source to block or mitigate radiation exposure (e.g., electron beam radiation or energy) that could otherwise damage the sensitive electronic circuits of the data processing unit 618.

[0066] Shield 616 can be manufactured from any material having the function of blocking (or substantially blocking) the transmission of radiation. Suitable materials for Shield 616 include, but are not limited to, lead, tungsten, ferrous 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 densities ranging from about 5 grams per cubic centimeter (g / cc) to about 15 g / cc. Shield 616 can be manufactured by a variety of manufacturing techniques, including, but not limited to, press working, casting, injection casting, sintering, two-shot casting, or any combination thereof.

[0067] However, in other embodiments, the shield 616 may include a metal-filled thermoplastic polymer such as, but not limited to, polyamide, polycarbonate, or polystyrene. In such embodiments, the shield 616 can be fabricated by mixing the shielding material into an adhesive matrix and dropping this combination onto the molded component or otherwise directly onto the data processing unit 618. Furthermore, in such embodiments, the shield 616 may include an enclosure that encapsulates (or substantially encapsulates) the 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 starting radiation sterilization 612, the collimator seal 620 can be manufactured from a radiopermeable microbial barrier material that allows radiation to propagate through it. Having the collimator seal 620 in place allows the sealed area 610 to maintain a sterile environment for the assembled sensor control device 302 until the user removes (twists off) the applicator cap 210.

[0069] In some embodiments, the collimator seal 620 may include two or more layers of different materials. The first layer may be made of a synthetic material such as Tyvek®, available from DuPont® (e.g., flash-spun density polyethylene fiber). Tyvek® is highly durable and puncture-resistant and allows vapor permeability. The Tyvek® layer may be applied before or immediately after radiation sterilization 612, and a foil or other vapor-resistant and moisture-resistant material layer may be sealed (e.g., heat-sealed) on top of the Tyvek® layer to prevent the movement of contaminants and moisture into the sterilization zone 608 and the sealed area 610. In other embodiments, the collimator seal 620 may consist of only a single protective layer added to the end of the collimator 606. 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. Accordingly, the collimator seal 620 can function as a moisture layer and a contaminant layer without departing from the scope of the disclosure of the present invention.

[0070] The sensor 316 and the pointed body 318 extend from the bottom of the electronic equipment housing 304 into the sterilization zone 608 which is substantially concentric with the centerlines of the sensor applicator 102 and applicator cap 210, but it should be noted that this specification considers them to have an eccentric arrangement. More specifically, in at least one embodiment, the sensor 316 and the pointed body 318 extend eccentrically with respect to the centerlines of the sensor applicator 102 and applicator cap 210 from the bottom of the electronic equipment housing 304. In such an embodiment, without departing from the scope of the disclosure of the present invention, the collimator 606 may be redesigned or otherwise configured so that the sterilization zone 608 is also eccentrically arranged to receive the sensor 316 and the pointed body 318.

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

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

[0073] In some embodiments, the internal collimator 606 can be eliminated if the external collimator has the function of properly and completely focusing the radiation sterilization 612 to properly sterilize the sensor 316 and the sharp body 318. In such embodiments, the sensor applicator can be positioned adjacent to the external collimator, and then the radiation sterilization 612 can be applied to the sensor applicator, and the external collimator can prevent the radiation energy from damaging the highly sensitive electronic equipment inside the electronic equipment housing 304. Furthermore, in such embodiments, the sensor applicator 102 can be delivered to the user without the internal collimator 606 positioned within the applicator cap 210, thereby eliminating complexity in manufacturing and use.

[0074] Figure 7A is an enlarged cross-sectional side view of a sensor control device 302 mounted within an applicator cap 210 according to one or more embodiments. As shown above, a portion of the sensor 316 and the pointed body 318 can be placed within a sealed area 610, thereby isolating them from external contamination. The sealed area 610 may include (contain) a selected portion within the electronic equipment housing 304 and the sterilization zone 608 of the collimator 606. In one or more embodiments, the sealed area 610 may be defined or otherwise formed by at least a first seal 702a, a second seal 702b, and a collimator seal 620.

[0075] The first seal 702a can be positioned to seal the interface between the pointed body hub 422 and the upper part of the electronic equipment housing 304. More specifically, the first seal 702a can seal the interface between the pointed body hub 422 and the shell 306. Furthermore, the first seal 702a can surround a first central opening 504 defined within the shell 306 to prevent contaminants from moving through the first central opening 504 into the electronic equipment housing 304. In some embodiments, the first seal 702a can form part of the pointed body hub 422. For example, the first seal 702a can be overmolded onto the pointed body hub 422. In other embodiments, the first seal 702a can be overmolded onto the shell 306. In yet another embodiment, the first seal 702a may include a separate structure, such as an O-ring, sandwiched between the pointed body hub 422 and the upper surface of the shell 306, without departing from the scope of the disclosure of the present invention.

[0076] The second seal 702b can be positioned to seal the interface between the collimator 606 and the bottom of the electronic equipment 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 a plug 402 received within the bottom of the mount 308. In applications including a plug 402 as shown, the second seal 702b can be configured to seal around and surround the plug receptacle 512. In embodiments that exclude the plug 402, the second seal 702b can instead surround a second central opening 506 (Figure 5A) defined within the mount 308. As a result, the second seal 702b can prevent contaminants from moving into the sterile zone 608 of the collimator 606 and further prevent them from moving into the electronic equipment 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 the bottom of the mount 308. In yet another embodiment, the second seal 702b may include a separate structure, such as an O-ring, that is sandwiched between the collimator 606 and the bottom of the plug 402 or the mount 308, without departing from the scope of the disclosure of the present invention.

[0078] After loading the sensor control device 302 into the sensor applicator 102 (Figure 6B) and securing the applicator cap 210 to the sensor applicator 102, the first and second seals 702a and 702b are compressed, generating corresponding sealing interfaces. The first and second seals 702a and 702b can be manufactured from a variety of materials that have the function of generating a sealing 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 therefore the bottom of the sealed area 610. Thus, each of the first and second seals 702a, 702b and the collimator seal 620 creates a barrier corresponding to its respective sealing location. The combination of these seals 702a, 702b and 620 allows for the final sterilization of the sealed area 610, which includes the sensor 316 and the sharp body 318.

[0080] Figure 7B is an enlarged cross-sectional side view of another embodiment of a sensor control device 302 mounted within a sensor applicator 102 according to one or more embodiments. More specifically, Figure 7B shows alternative embodiments of the first and second seals 702a, 702b. Here again, the first seal 702a is positioned to seal the interface between the pointed body hub 422 and the upper part of the electronic equipment housing 304, more specifically, to completely seal the first central opening 504 defined within the shell 306. However, in the illustrated embodiment, the first seal 702a can be configured to seal both axially and radially. More specifically, when the sensor control device 302 is introduced into the sensor applicator 102, the pointed 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 a double biasing engagement compresses the first seal 702a in both the axial and radial directions, thereby enabling the first seal 702a to seal the upper part of the electronic equipment housing 304 in both the radial and axial directions.

[0081] Here again, the second seal 702b is positioned to seal the interface between the collimator 606 and the bottom of the electronic equipment 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 within 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 the pointed body 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 electronic equipment housing 304. More specifically, in at least one embodiment, the collimator 606 can be screw-connected to the underside of the mount 308. In such embodiments, the collimator 606 may provide or otherwise provide a threaded extension configured to fit into a threaded opening defined within the bottom of the mount 308. Screw-connecting the collimator 606 to the mount 308 can seal the interface between the collimator 606 and the bottom of the electronic equipment housing 304, and thus isolate 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 be adapted to those of the threaded engagement between the applicator cap 210 and the sensor applicator 102. As a result, when the applicator cap 210 is screwed onto or removed from the sensor applicator 102, the collimator 606 can be appropriately screwed onto or twisted off the electronic equipment housing 404.

[0083] Embodiments disclosed herein include the following:

[0084] A. A sample monitoring system comprising a sensor applicator, a sensor control device positioned within the sensor applicator and including an electronic housing, a sensor extending from the bottom of the electronic housing, a pointed body hub positioned adjacent to the top of the electronic housing, and a pointed body supported by the pointed body hub, extending through the electronic housing and further extending from the bottom of the electronic housing. The sample monitoring system further comprises a cap coupled to the sensor applicator and a collimator positioned within the cap and defining a sterile zone for receiving the sensor and pointed body extending from the bottom of the electronic housing.

[0085] B. A method for preparing a sample monitoring system includes the step of loading a sensor control device into a sensor applicator, the sensor control device including an electronic housing, a sensor extending from the bottom of the electronic housing, a pointed body hub positioned adjacent to the top of the electronic housing, and a pointed body supported by the pointed body hub, extending through the electronic housing and further extending from the bottom of the electronic housing. The method further includes the step of fixing a cap to the sensor applicator, the fixing step of positioning a collimator within the cap and defining a sterilization zone to receive the sensor and pointed body extending from the bottom of the electronic housing, the step of sterilizing the sensor and pointed body by radiation sterilization while they are positioned within the sterilization zone, and the step of using the collimator to prevent radiation from the radiation sterilization from damaging the electronic components in the electronic housing.

[0086] C. A method for preparing a sample monitoring system includes the step of loading a sensor control device into a sensor applicator, the sensor control device including an electronic housing, a sensor extending from the bottom of the electronic housing, a pointed body hub positioned adjacent to the top of the electronic housing, and a pointed body supported by the pointed body hub, extending through the electronic housing and further extending from the bottom of the electronic housing. The method further includes the steps of positioning the sensor applicator adjacent to a collimator, subjecting the sensor and the pointed body to radiation sterilization, and using the collimator to prevent radiation from radiation sterilization from damaging electronic components within the electronic 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 passage extending at least partially through the collimator. Element 2: The sterilization zone includes a cross-sectional shape selected from the group consisting of conical, truncated conical, cubic, rectangular, pyramidal, and any combination thereof. Element 3: The sterilization zone is truncated conical, with a first opening at a first end and a second opening at a second end, the first opening receiving a sensor and a pointed body extending from the bottom of the electronic housing, and a seal positioned at the second opening. Element 4: Further includes a sealed area encompassing the sterilization zone and a portion of the interior of the electronic housing, the sealed area being defined by a first seal sealing the interface between the pointed body hub and the top of the electronic housing, a second seal sealing the interface between the collimator and the bottom of the electronic housing, and a third seal sealing the end of the sterilization zone. Element 5: A first seal surrounds a central opening defined within the upper part of the electronic equipment housing to prevent contaminants from moving through the central opening into a portion of the interior of the electronic equipment housing, and a second seal surrounds an opening defined within the bottom part of the electronic equipment housing to prevent contaminants from moving through this opening into a portion of the interior of the electronic equipment housing. Element 6: The first seal provides either or both an axial seal and a radial seal. Element 7: The second seal defines a cylindrical longitudinal recess extending into the sterilization zone to receive sensors and sharp objects. Element 8: Further comprising a printed circuit board positioned within the electronic equipment housing, a data processing unit mounted on the printed circuit board, and a shield positioned within the electronic equipment housing to protect the data processing unit from radiation from radiation sterilization. Element 9: The shield is made of a non-magnetic metal selected from the group consisting of lead, tungsten, iron, stainless steel, copper, tantalum, osmium, thermoplastic polymers mixed with non-magnetic metals, and any combination thereof.

[0088] Element 10: The step of creating a sealed area encompassing the sterilization zone and a portion of the interior of the electronic equipment housing when the cap is secured to the sensor applicator. Element 11: The step of creating the sealed area includes sealing the interface between the pointed body hub and the top of the electronic equipment housing with a first seal, sealing the interface between the collimator and the bottom of the electronic equipment housing with a second seal, and sealing the end of the sterilization zone with a third seal. Element 12: The step of sealing the interface between the pointed body hub and the top of the electronic equipment housing with a first seal includes providing either or both of an axial seal and a radial seal with the first seal. Element 13: The collimator includes an internal collimator, and the step of sterilizing the sensor and sharp object using radiation sterilization further includes the steps of positioning the sensor applicator adjacent to an external collimator positioned outside it, focusing the radiation by the external collimator so that the internal collimator receives the light, and preventing the radiation from damaging electronic components within the electronic equipment housing by the external and internal collimators. Element 14: The sterilization zone has a first opening at the first end of the collimator and a second opening at the second end of the collimator, and the step of sterilizing the sensor and sharp object includes introducing radiation into the sterilization zone through the second opening. Element 15: The step of preventing radiation from radiation sterilization from damaging electronic components includes blocking the radiation with the collimator material. Element 16: A printed circuit board is positioned within the electronic equipment housing, 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 by a shield positioned within the electronic equipment housing.

[0089] Element 17: The step of positioning the sensor applicator adjacent to the collimator includes the step of positioning the collimator such that it is outside the sensor applicator during radiation sterilization.

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

[0091] External sterilization assembly Referring again briefly to Figure 1, the sensor control device 104 must be sterilized to ensure that no viable microorganisms are present before it is delivered to the end user. Generally, the sensor 110 is sterilized using radiation sterilization, such as electron beam irradiation ("electron beam"). However, radiation sterilization can damage the electronic components within the sensor control device 104, which is generally sterilized by gaseous chemical sterilization (e.g., using ethylene oxide). However, gaseous chemical sterilization can damage enzymes or other chemical and biological agents contained on the sensor 110.

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

[0093] Figure 8 is a schematic diagram of an exemplary external sterilization assembly 800 according to one or more embodiments. The external sterilization assembly 800 (hereinafter referred to as "assembly 800") is designed and can otherwise be configured to assist in the sterilization of a medical device 802. The medical device 802 may include, for example, a sensor control device similar in some respects to the sensor control device 104 of Figure 1, but may instead include other types of medical devices, healthcare products, or systems that require final sterilization of specific component parts. Exemplary medical devices or healthcare products that can incorporate the principles of the disclosure of the present invention include, but are not limited to, ingestible products, cardiac rhythm management (CRM) devices, subcutaneous sensing devices, externally attached medical devices, or any combination thereof.

[0094] The medical device 802 may include a housing 804, a sterilization-required component 806, and one or more radiation-sensitive components 808. In the illustrated embodiment, the radiation-sensitive components 808 may be mounted on a printed circuit board (PCB) 810 positioned within the housing 804, and the housing 804 may include an electronic housing for a sensor control device. The radiation-sensitive components 808 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 register, a transistor, a capacitor, an inductor, a diode, and a switch. However, in other embodiments, the radiation-sensitive components 808 may include a radiation-sensitive chemical solution or specimen, as described herein with reference to Figure 12.

[0095] In some embodiments, component 806 may include a sensor (e.g., sensor 110 in Figure 1) extending from the housing 804. As shown, component 806 may extend inclined from the bottom of the housing 804, or alternatively, it may extend perpendicularly from another face of the housing 804. In at least one embodiment, component 806 may also further include a pointed body that may require sterilization and can be used to help implant the sensor under the user's skin. In some embodiments, as shown, component 806 may be enclosed in a cap 812 that forms a sealing barrier protecting its exposed portion (e.g., the sensor and associated pointed body) until it is needed for use.

[0096] To properly sterilize the component 806 for use, the medical device 802 may undergo radiation sterilization 814. Appropriate radiation sterilization 814 treatment includes, but is not limited to, electron beam (e-beam) irradiation, gamma ray irradiation, X-ray irradiation, or any combination thereof. In embodiments including a cap 812, the cap 812 may be manufactured from a material that allows the radiation 814 to propagate through the cap 812 to facilitate radiation sterilization of the component 806. Suitable materials for the cap 812 include, but are not limited to, non-magnetic metals (e.g., aluminum, copper, gold, silver), thermoplastic ceramics, rubber (e.g., ebonite), composite materials (e.g., fiberglass, carbon fiber reinforced polymers), epoxy, or any combination thereof. In some embodiments, the cap 812 may be transparent or translucent, but may otherwise be opaque without departing from the scope of the disclosure of the present invention.

[0097] The assembly 800 may include a radiation shield 816 positioned outside the medical device 802 to assist in sterilizing the component 806, while simultaneously preventing (blocking) propagating radiation 814 from destroying or damaging the radiation-sensitive component 808. To achieve this prevention (blocking), the radiation shield 816 may provide a collimator 818 which typically includes holes or passages extending at least partially through its body. The collimator 818 defines a sterilization zone 820 configured to focus the radiation 814 toward the component 806. In the illustrated embodiment, the component 806 can be received into the sterilization zone 820 for sterilization.

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

[0099] The collimator 818 can exhibit any suitable cross-sectional shape necessary to focus radiation onto the part 806 for sterilization. In the illustrated embodiment, for example, the collimator 818 has a conical or truncated cone shape. However, in other embodiments, the collimator 818 can exhibit a polygonal cross-sectional shape such as a cube, rectangle (including, for example, a parallelogram), or pyramidal shape without departing from the scope of the disclosure of the present invention. In yet another embodiment, the collimator 818 can exhibit a circular cross-sectional shape with parallel sides.

[0100] In the illustrated embodiment, the collimator 818 provides a first aperture 822a and a second aperture 822b, in which case the first aperture 822a and the second aperture 822b are located at opposite ends of the sterilization zone 820. The first aperture 822a allows radiation 814 to enter the sterilization zone 820 and be incident on the part 806, and the second aperture 822b can be configured to receive the part 806 into the sterilization zone 820. In embodiments where the shape of the collimator 818 is conical or truncated cone, the second aperture 822b may have a smaller diameter than the diameter of the first aperture 822a. In such embodiments, for example, the size of the second aperture 822b may range between about 0.5 mm and about 3.0 mm, and the size of the first aperture 822a may range between about 5.0 mm and about 16.0 mm. However, as can be acknowledged, the respective diameters of the first and second apertures 822a and 822b can be larger or smaller than those provided herein without departing from the scope of the disclosure of the present invention. In fact, the diameters of the first and second apertures 822a and 822b can be scaled relative to the device size and only need to be large enough to allow a sufficient dose of radiation to enter the component 806. Furthermore, in at least one embodiment, the collimator 818 can be cylindrical in shape, in which case the first aperture 822a and the second aperture 822b have 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 help block radiation 814 (e.g., electrons) from propagating within the housing 804 toward the radiation-sensitive component 808. The barrier shield 824 may be manufactured 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 it may instead 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 according to one or more additional embodiments of the disclosure of the present invention. The external sterilization assembly 900 (hereinafter "assembly 900") can be similar in several respects to assembly 800 of Figure 8, and is therefore best understood by referring to it, in which similar numbers indicate similar components that will not be described again. Like assembly 800, assembly 900 is designed and can otherwise be configured to assist in sterilizing a medical device 902. In the illustrated embodiment, the medical device 902 may include a two-piece sensor control device, but instead may include any of the medical devices shown herein with respect to medical device 802.

[0103] As shown in the figures, the medical device 902 may include a housing 904, a sterilization-required component 906, and one or more radiation-sensitive components 908 positioned within the housing 904. The housing 904 may include a package or enclosure that confines the component 906 and the radiation-sensitive components 908. The radiation-sensitive components 908 may include any of the electronic modules shown herein with respect to the radiation-sensitive component 808 in Figure 8. The component 906 may include, for example, a needle / sensor subassembly and may undergo radiation sterilization 814 to properly sterilize the component 906 for use.

[0104] The assembly 900 may include a radiation shield 910 configured to be positioned outside the medical device 902 to assist in sterilizing component 906 while simultaneously preventing (blocking) propagating radiation 814 from damaging the radiation-sensitive component 908. In the illustrated embodiment, the radiation shield 910 may define or otherwise provide an internal cavity 912 into which the medical device 902 can be positioned. Similar to the radiation shield 816 in Figure 8, the radiation shield 910 may provide a collimator 914 that extends at least partially through its body and generally includes a hole or passage providing access to the cavity 912. The collimator 914 may define a sterilization zone 916 that assists in focusing the radiation 814 toward component 906. To reduce or eliminate radiation 814 that penetrates the radiation shield 910 except at the location of the collimator 914 and thereby damage the radiation-sensitive component 908 located inside the housing 904, the radiation shield 910 may be manufactured from any of the materials described above with respect to the radiation shield 816.

[0105] To properly sterilize component 906, the radiation sterilization 814 can be directed towards the medical device 902. The collimator 914 and sterilization zone 916 can be configured to concentrate and / or focus the radiation sterilization 814 toward component 906, while the remainder of the radiation shield 910 prevents (blocks) the propagating radiation 814 from damaging the radiation-sensitive components 908 located within the housing 904. In the illustrated embodiment, the collimator 914 and sterilization zone 916 exhibit a circular cross-sectional shape with parallel sides, but other cross-sectional shapes, including but not limited to conical, truncated conical, pyramidal, polygonal, or any combination thereof, may be shown instead.

[0106] In some embodiments, the assembly 900 may further include a barrier shield 824 positioned within the housing 904 to help block 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 according to one or more additional embodiments of the disclosure of the present invention. The external sterilization assembly 1000 (hereinafter "assembly 1000") can be similar in several respects to assembly 900 of Figure 15, and is therefore best understood by referring to it, in which similar numbers indicate similar components that will not be described again. Like assembly 900, assembly 1000 is designed and can otherwise be configured to assist in sterilizing a medical device 1002. In the illustrated embodiment, the medical device 1002 may include a sensor control device similar to the sensor control device 104 of Figure 1, but instead may include any of the medical devices shown herein with respect to the medical device 802 of Figure 8.

[0108] As shown in the illustration, the medical device 1002 may include a housing 1004, a sterilization-required component 1006, and one or more radiation-sensitive components 1008 positioned within the housing 1004. In the illustrated embodiment, the housing 1004 may include an electronic housing for a sensor control device (e.g., sensor control device 104 in Figure 1), and the radiation-sensitive component 1008 may include any of the electronic modules shown herein with respect to the radiation-sensitive component 808 in Figure 8. In some embodiments, component 1006 may include a sensor (e.g., sensor 110 in Figure 1) extending from the housing 1004, which also requires sterilization and may further include a pointed body to assist in implanting the sensor under the user's skin.

[0109] Assembly 1000 may include a radiation shield 1010 positioned outside the medical device 1002 to assist in sterilizing component 1006 and simultaneously prevent (block) propagating radiation 814 from destroying or damaging the radiation-sensitive component 1008. To reduce or eliminate radiation 814 that penetrates the radiation shield 1010 and thereby damage the radiation-sensitive component 1008 located inside the housing 1004, the radiation shield 1010 may be manufactured from any of the materials described above with respect to the radiation shield 816 in Figure 8.

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

[0111] To properly sterilize component 1006, the radiation sterilizer 814 can be directed towards the medical device 1002. The collimator 1014 and sterilization zone 1016 can concentrate and / or focus the radiation sterilizer 814 toward component 1006, while the remainder of the radiation shield 1010 prevents (blocks) the propagating radiation 814 from damaging the radiation-sensitive components 1008 located within the housing 1004. In the illustrated embodiment, the collimator 1014 exhibits a circular cross-sectional shape with parallel sides, but it is conceivable that it could instead exhibit other cross-sectional shapes, including but not limited to conical, truncated conical, pyramidal, polygonal, or any combination thereof.

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

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

[0114] The assembly 1100 may include a radiation shield 1110 positioned outside the medical device 1102 to assist in sterilizing the component 1106, while simultaneously preventing (blocking) propagating radiation 814 from damaging the radiation-sensitive component 1108. To reduce or eliminate radiation 814 that penetrates the radiation shield 1110 and thereby damage the radiation-sensitive component 1108, the radiation shield 1110 may be made of any of the materials described above with respect to the radiation shield 816 in Figure 8.

[0115] In the illustrated embodiment, the radiation shield 1110 may include a clamshell structure comprising a first portion 1112a and a second portion 1112b that is matable (or engageable) with it. The radiation shield 1110 may provide or otherwise define an internal cavity 1114 into which a medical device 1102 can be positioned for sterilization. In some embodiments, as illustrated, the first portion 1112a and the second portion 1112b may cooperate to define a portion of the internal cavity 1114 so that the internal cavity 1114 is formed when the first portion 1112a and the second portion 1112b are properly mated together. 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 may further include an absorber 1116 configured to protect the medical device 1102. In at least one embodiment, as shown, a portion of the absorber 1116 may be provided by or otherwise form part of first and second portions 1112a, 1112b, respectively. In such embodiments, an internal cavity 1114 may be defined at least partially by the absorber 1116. The absorber 1116 may be manufactured from a material that absorbs stray radiation without generating bremsstrahlung protons. The material for the absorber 1116 may include, for example, any of the density polymers shown herein with respect to the radiation shield 816 in Figure 8.

[0117] Similar to the radiation shield 816 in Figure 8, the radiation shield 1110 may 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 specified, may instead include only one of the collimators 1118a or 1118b without departing from the scope of the disclosure of the present invention. The first collimator 1118a generally includes a hole or passage extending at least partially through the first portion 1112a of the radiation shield 1110, and the second collimator 1118b generally includes a hole or passage extending at least partially through the second portion 1112b. Each collimator 1118a, 1118b provides access to the internal cavity 1114, and the collimators 1118a, 1118b work together to define a sterilization zone 1120 that includes the internal cavity 1114 and helps focus the radiation 814 toward the part 1106 toward sterilization.

[0118] To properly sterilize component 1106, the medical device 1102 can be positioned within the internal cavity 1114, and the opposing portions 1112a and 1112b can be fitted together to enclose the medical device 1102. Once the medical device 1102 is properly positioned within the cavity 1114, it can be placed in the sterilization zone 1120. The radiation sterilizer 814 can then be directed toward the medical device 1102 and toward the opposing side of the radiation shield 1110, and the collimators 1118a and 1118b can concentrate and / or focus the radiation sterilizer 814 toward component 1106 on both sides. The remaining portion of the radiation shield 1110 prevents (blocks) the propagating radiation 814 from damaging the radiation-sensitive components 1108 located within the housing 1104. In the illustrated embodiment, each collimator 1118a, 1118b exhibits a conical or truncated conical cross-sectional shape, but it is conceivable that other cross-sectional shapes, including but not limited to circular, pyramidal, polygonal, or any combination thereof, may be exhibited instead.

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

[0120] Figure 12 is a schematic diagram of another exemplary external sterilization assembly 1200 according to one or more additional embodiments of the disclosure of the present invention. The external sterilization assembly 1200 (hereinafter "assembly 1200") is designed and, in the illustrated embodiment, to assist in sterilizing a medical device 1202 including a subcutaneous needle or subcutaneous syringe, and can otherwise be configured so. As illustrated, the medical device 1202 may include a housing 1204 (e.g., a barrel or vial), a sterilization-to-sterilize component 1206, and one or more radiation-sensitive components 1208 positioned within the housing 1204. In the illustrated embodiment, the radiation-sensitive component 1208 may contain a chemical solution or specimen that may be sensitive to irradiation (e.g., an active drug, pharmaceutical, or biologic), and component 1206 may include a needle designed to deliver the chemical solution.

[0121] In some embodiments, as shown, the part 1206 may be enclosed or surrounded by a cap 1210 (e.g., a needle cap) that seals it. Furthermore, in at least one embodiment, the cap 1210 may be sealed to the housing 1204 with a sealing element 1212 such as an O-ring. The cap 1210 and the sealing element 1212 can work together to form a sterile barrier system that surrounds and protects the exposed portion of the part 1206 until it is needed for use. To properly sterilize the part 1206 for use, the part 1206 may undergo radiation sterilization 814.

[0122] The assembly 1200 may include a radiation shield 1214 positioned outside the medical device 1202 to assist in sterilizing a component 1206, while simultaneously preventing (blocking) the propagating radiation 814 from damaging a radiation-sensitive component 1208. As shown, the radiation shield 1214 may provide a collimator 1216, which generally includes a hole or passage extending at least partially through the body of the radiation shield 1214, defining 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 into the sterilization zone 1218. The collimator 1216 allows the transmission of radiation 814 that enters the component 1206 and sterilizes it, while the remainder of the radiation shield 1214 prevents (blocks) the propagating radiation 814 from damaging a radiation-sensitive component 1208 located inside the housing 1204. In the illustrated embodiment, the collimator 1216 has a conical or truncated cone shape, but it can instead have other cross-sectional shapes such as polygonal, pyramidal, circular, or any combination thereof.

[0123] In embodiments including the cap 1210, the body of the cap 1210 may include a material that allows radiation 814 to propagate through it, in order to facilitate radiation sterilization of the part 1206. Suitable materials for the cap 1210 may be the same as those shown herein with respect to the cap 812 in Figure 8.

[0124] In some embodiments, the assembly 1200 may further include a barrier shield 824 positioned to help block radiation 814 (e.g., electrons) from propagating within the housing 1204 toward a 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 exit the housing 1204 through a component 1206 (e.g., a needle). In other embodiments, the barrier shield 824 may provide a meandering passage that allows the radiation-sensitive component 1208 to exit the housing 1204 through the component 1206.

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

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

[0127] The electronic equipment housing 1304 may include a shell 1306 and a mount 1308 to which it can be mated. The shell 1306 can be fastened to the mount 1308 by a variety of means, such as snap-fit ​​engagement, interlocking fit, ultrasonic welding, or one or more mechanical fasteners (e.g., screws), or any combination thereof. In some cases, the shell 1306 can be fastened to the mount 1308 such that a sealed interface is created between it and the mount 1308. In such embodiments, a gasket or other type of sealing material can be positioned on or near the outer diameter (circumference) of the shell 1306 and the mount 1308, and the gasket can be compressed by fastening these two components together, thereby creating a sealed interface. In other embodiments, an adhesive can be applied to the outer diameter (circumference) of one or both of the shell 1306 and the mount 1308. The adhesive fastens the shell 1306 to the mount 1308, providing structural integrity, but can also seal the interface between these two components, thereby isolating the interior of the electronic equipment housing 1304 from external contamination.

[0128] In the illustrated embodiment, the sensor control device 1302 may further include a plug assembly 1310 that can be coupled to an electronic housing 1304. The plug assembly 1310 may include a sensor module 1312 (partially visible) that is interconnectable with a sharp body module 1314 (partially visible). The sensor module 1312 may be configured to carry and include a sensor 1316 (partially visible), and the sharp body module 1314 may be configured to carry and include a sharp body 1318 (partially visible) used to assist in the transcutaneous delivery of the sensor 1316 under the user's skin during application of the sensor control device 1302. The sharp body module 1314 may include a sharp body hub 1320 that carries the sharp body 1318.

[0129] As shown in the figure, the corresponding portions of the sensor 1316 and the pointed body 1318 extend from the electronic housing 1304, more specifically from the bottom of the mount 1308. The exposed portion of the sensor 1316 (also referred to as the "tail") can be received in the hollow or recessed portion of the pointed body 1318. The remaining portion of the sensor 1316 is positioned within the electronic housing 1304.

[0130] Figure 14A is a side view of the sensor applicator 102 of Figure 1. As shown, the sensor applicator 102 includes a housing 1402 and an applicator cap 1404 detachably coupled thereto. In some embodiments, the applicator cap 1404 can be screwed onto the housing 1402 and may include a tamper-evident ring 1406. When the applicator cap 1404 is rotated (e.g., twisted off) relative to the housing 1402, the tamper-evident ring 1406 is unscrewed, thereby freeing the applicator cap 1404 from the sensor applicator 102. With the applicator cap 1404 removed, the user can use the sensor applicator 102 to position the sensor control device 1302 (Figures 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 may be a separate component or, instead, may be cast onto either the housing 1402 or the applicator cap 1404.

[0132] Figure 14B is a cross-sectional side view of the sensor applicator 102. As shown, the sensor control device 1302 can be housed in the sensor applicator 102, and the 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 may include one or more radiation-sensitive components 1408 positioned within the electronic equipment housing 1304. The radiation-sensitive components 1408 may include, but are not limited to, electronic components or electronic modules such as data processing units, registers, transistors, capacitors, inductors, diodes, switches, or any combination thereof. 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 1302. When in operation, the data processing unit may perform data processing functions such as filtering and encoding data signals corresponding to the user's sampled sample level. The data processing unit includes an antenna for communicating with the reader device 106 (Figure 1), or is otherwise capable of communicating with it.

[0133] In the illustrated embodiment, the cap filler 1410 can be positioned within the applicator cap 1404, and the cap filler 1410 can generally serve to support the sensor control device 1302 within the sensor applicator 102. In one or more embodiments, the cap filler 1410 may include an integral portion or extension of the applicator cap 1404, which may be cast together with the applicator cap 1404 or overmolded thereon. In other embodiments, the cap filler 1410 may include separate structures fitted into or otherwise attached to the applicator cap 1404, without departing from the scope of the disclosure of the present invention.

[0134] The sensor control device 1302, more specifically the distal ends of the sensor 1316 and the pointed body 1318 extending from the bottom of the electronic equipment housing 1304, can be sterilized while positioned within the sensor applicator 102. More specifically, a fully assembled sensor control device 1302 can undergo radiation sterilization 1412, which can be similar to radiation sterilization 814 shown in Figures 8-12. Radiation sterilization 1412 can be delivered by either continuous-process irradiation or pulsed-beam irradiation. In pulsed-beam irradiation, the beam of radiation sterilization 1412 is focused to a target location, the component or device to be sterilized is moved there, and the irradiation is operated to supply directional radiation pulses to this point. Then, radiation sterilization 1412 is stopped, another component or device to be sterilized is moved to the target location, and this process is repeated.

[0135] With the disclosure of the present invention, an external sterilization assembly 1414 can be used to assist in focusing radiation 1412 and simultaneously prevent (block) the propagating radiation 1412 from damaging the radiation-sensitive components 1408 during the sterilization of the distal ends of the sensor 1316 and the sharp body 1318. As shown in the figures, the external sterilization assembly 1414 (hereinafter referred to as "assembly 1414") may include a radiation shield 1416 positioned at least partially outside the sensor applicator 102. The radiation shield 1416 may provide or define an external collimator 1418 configured to assist in focusing radiation 1412 (e.g., beam, wave, energy) toward the components to be sterilized. More specifically, the external collimator 1418 allows the transmission of radiation 1412 that enters onto the sensor 1316 and the sharp body 1318 to sterilize them, but prevents the radiation 1412 from damaging the radiation-sensitive components 1408 located inside the electronic equipment housing 1304.

[0136] In the illustrated embodiment, the external collimator 1418 is designed to align with the internal collimator 1420, which is determined by the cap filler 1410. Similar to the external collimator 1418, the internal collimator 1420 can be used to focus radiation 1412 toward the component to be sterilized. As shown, the cap filler 1410 can receive the end of the radiation shield 1416 and otherwise define a radial shoulder 1422 sized to fit therein, and the external collimator 1418 transitions to the internal collimator 1420 at the radial shoulder 1422. In some embodiments, the transition between the external collimator 1418 and the internal collimator 1420 can be continuous, flush, or smooth. However, in other embodiments, this transition can be discontinuous or stepwise without departing from the scope of the disclosure of the present invention.

[0137] The external collimator 1418 and the internal collimator 1420 work together to focus the radiation 1412 and define a sterilization zone 1424 in which the distal ends of the sensor 1316 and the sharp body 1318 can be positioned. The propagating radiation 1412 can pass through the sterilization zone 1424 and be incident on the sensor 1316 and the sharp body 1318 to sterilize them. However, each of the cap filler 1410 and the radiation shield 1416 can be manufactured from a material that substantially prevents the radiation 1412 from penetrating the inner wall of the sterilization zone 1424 and thereby damaging the radiation-sensitive components 1408 located inside the housing 1304. In other words, each of the cap filler 1410 and the radiation shield 1416 can be manufactured from a material that has sufficient density to absorb the emitted beam energy. In some embodiments, for example, one or both of the cap filler 1410 and the radiation shield 1416 can be manufactured from a material having a mass density higher than 0.9 grams per cubic centimeter (g / cc). However, in other embodiments, the mass density of a suitable material can be lower than 0.9 g / cc without departing from the scope of the disclosure of the present invention. Suitable materials for the cap filler 1410 and the radiation shield 1416 include, but are not limited to, density polymers (e.g., polyethylene, polypropylene, polystyrene, polytetrafluoroethylene), metals (e.g., lead, stainless steel, aluminum), any combination thereof, or any material having a mass density higher than 0.9 g / cc. In at least one embodiment, the cap filler 1410 can be manufactured from machined or 3D printed polypropylene, and the radiation shield 1416 can be manufactured from stainless steel.

[0138] In some embodiments, one or both of the cap filler 1410 and / or radiation shield 1416 can be manufactured from a material having a mass density lower than 0.9 g / cc, but the design of the sterilization zone 1424 can be modified so that they can still function to prevent radiation sterilization 1412 from damaging the radiation-sensitive component 1408. In such embodiments, the size (e.g., length) of the sterilization zone 1424 can be increased so that a large amount of material is required to pass through due to electrons propagating from radiation sterilization 1412 before incident on the radiation-sensitive component 1408. The larger amount of material can help absorb or dissipate the irradiation intensity of radiation sterilization 1412 so that radiation sterilization 1412 is harmless to highly sensitive electronic equipment. However, in other embodiments, the reverse may be equivalent. More specifically, the size (e.g., length) of the sterilization zone 1424 can be reduced as long as the material for the cap filler 1410 and / or radiation shield 1416 provides a sufficiently large mass density.

[0139] The sterilization zone 1424, defined by the external and internal collimators 1418 and 1420, can exhibit any suitable cross-sectional shape necessary to properly focus the radiation 1412 onto the sensor 1316 and the pointed body 1318 for sterilization. In the illustrated embodiment, for example, each of the external and internal collimators 1418 and 1420 is conical or truncated cone in shape. However, in other embodiments, one or both of the external and internal collimators 1418 and 1420 can exhibit a polygonal cross-sectional shape such as cubic, rectangular (including, for example, parallelogram), or pyramidal without departing from the scope of the disclosure of the present invention. In yet another embodiment, one or both of the external and internal collimators 1418 and 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 an external collimator 1418 and a second opening 1426b defined by an internal collimator 1420, in which case the first opening 1426a and the second opening 1426b are located at opposite ends of the sterilization zone 1424. The first opening 1426a allows radiation 1412 to enter the sterilization zone 1424, and the second opening 1426b provides a location where radiation 1412 can strike the sensor 1316 and the sharp body 1318. In the illustrated embodiment, the second opening 1426b also provides a location where the sensor 1316 and the sharp body 1318 can be received into the sterilization zone 1424.

[0141] In embodiments where the sterilization zone 1424 is conical or truncated cone-shaped, 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 and 1426b can be larger or smaller than those provided herein, without departing from the scope of the disclosure of the present invention and on an application basis. In fact, the diameters of the first and second openings 1426a and 1426b only need to be large enough to allow a sufficient dose of radiation to enter the sensor 1316 and the sharpened body 1318.

[0142] In the illustrated embodiment, the inner wall of the sterilization zone 1424 (e.g., external and internal collimators 1418, 1420) extends at a substantially constant angle with respect to the centerline of the sensor applicator 102 between the first opening 1426a and the second opening 1426b. The angle of the wall can be any angle between 0° and 90° with respect to the centerline of the sensor applicator 102. However, the angle of the wall can preferably be between 45° and 90° with respect to the centerline of the sensor applicator 102. However, in other embodiments, the angle of the wall can vary between the first opening 1426a and the second opening 1426b without departing from the scope of the disclosure of the present invention. In such embodiments, a portion of the wall may extend for a short distance at a different angle from the adjacent portion, or the wall may undulate between the first opening 1426a and the second opening 1426b.

[0143] In some embodiments, the sterilization zone 1424, defined by the external and internal collimators 1418, may be substantially cylindrical, and may otherwise exhibit a circular or polygonal cross-section. In such embodiments, the first opening 1426a and the second opening 1426b may have 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 by the dashed line) can be positioned at the interface between the cap filling 1410 and the radiation shield 1416. The cap seal 1428 may include a radiopermeable microbial barrier. In some embodiments, for example, the cap seal 1428 may be manufactured from a synthetic material such as TYVEK®, available from DuPont® (e.g., flash-spun density polyethylene fiber). The cap seal 1428 can completely seal a portion of the sterile zone 1424 to help form a portion of a sealed area 1430 configured to isolate the sensor 1316 and the sharp body 1318 from external contamination.

[0145] The sealed area 1430 may include (encompass) a selected portion within the electronic equipment housing 1304 and the sterilization zone 1424. In one or more embodiments, the sealed area 1430 may be defined by or otherwise formed by at least a cap seal 1428, a first seal or "top" seal 1432a, and a second seal or "bottom" seal 1432b. Each of the cap seal 1428, as well as the top and bottom seals 1432a, 1432b, generates a barrier corresponding to its respective sealed location, thereby enabling the sterilization of the sterilization zone 1424 that confines the sensor 1316 and the sharp body 1318.

[0146] The upper seal 1432a can be positioned to seal the interface between the pointed body hub 1320 and the upper part of the electronic equipment housing 1304 (i.e., the shell 1306 in Figure 13), thereby preventing contaminants from moving into the electronic equipment housing 1304. In some embodiments, the upper seal 1432a can form part of the pointed body hub 1320, such as by overmolding it onto the pointed body hub 1320. However, in other embodiments, the upper seal 1432a can form part of the upper surface of the shell 1306 or be overmolded thereon. In yet another embodiment, the upper seal 1432a may include a separate structure, such as an O-ring, that is sandwiched between the pointed body hub 1320 and the upper surface of the shell 1306, without departing from the scope of the disclosure of the present invention.

[0147] The bottom seal 1432b can be positioned to seal the interface between the cap filler 1410 and the bottom of the electronic equipment housing 1304 (i.e., the mount 1308 in Figure 13). The bottom seal 1432b can prevent contaminants from moving into the sterilization zone 1424 and into the electronic equipment housing 1304. In some embodiments, the bottom seal 1432b can form part of the cap filler 1410 by overmolding it or the like. In other embodiments, the bottom seal 1432b can form part of the bottom of the mount 1308 or overmolde it. In yet another embodiment, the bottom seal 1432b may include a separate structure, such as an O-ring, that is sandwiched between the cap filler 1410 and the mount 1308, without departing from the scope of the disclosure of the present invention.

[0148] After loading the sensor control device 1302 into the sensor applicator 102 and securing the applicator cap 1404 to the sensor applicator 102, the top and bottom seals 1432a and 1432b can be compressed to create the corresponding sealing interface. The top and bottom seals 1432a and 1432b can be manufactured from a variety of materials that have the function of creating a sealing 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] The sensor 1316 and the pointed body 1318 extend from the bottom of the electronic equipment housing 1304 into the sterilization zone 1424 which is substantially concentric with the centerlines of the sensor applicator 102 and applicator cap 1404, but it should be noted that this specification considers them to have an eccentric arrangement. More specifically, in at least one embodiment, the sensor 1316 and the pointed body 1318 extend eccentrically with respect to the centerlines of the sensor applicator 102 and applicator cap 1404 from the bottom of the electronic equipment housing 1304. In such embodiments, without departing from the scope of the disclosure of the present invention, the external and internal collimators 1418, 1420 may be redesigned or otherwise configured so that the sterilization zone 1424 is also eccentrically arranged to receive the sensor 1316 and the pointed body 1318.

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

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

[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, for example, using one or more mechanical fasteners 1442 (one shown). The mounting tray 1440 can be sized to receive the sensor applicator 102 and can provide or define a central opening 1444 that can be aligned with the chamber 1436 to allow the sensor applicator 102 to enter the chamber 1436. In some embodiments, as described below, the mounting tray 1440 can define a corresponding plurality of central openings 1444 for receiving a plurality of sensor applicators for sterilization.

[0153] FIG. 15 is a cross-sectional side view of another exemplary embodiment of a sensor applicator 102 and an external sterilization assembly 1414 according to one or more additional embodiments. As shown, the sensor control device 1302 is also here received within the sensor applicator 102, and the applicator cap 140,4 is coupled to the housing 1402 and the sensor control device 1302 is secured therein.

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

[0155] In the illustrated embodiment, the radiation shield 1416 can be positioned outside the sensor applicator 102 and can extend into the inverted portion of the applicator cap 1404. The external collimator 1418 provided by the radiation shield 1416 defines a sterilization zone 1504 configured to focus the radiation 1412 towards the sensor 1316 and the stylet 1318. In the illustrated embodiment, the cap post 1502 and the portions of the sensor 1316 and the stylet 1318 positioned within the cap post 1502 extend into the sterilization zone 1504. The transmitted radiation 1412 can pass through the sterilization zone 1504 and sterilize the sensor 1316 and the stylet 1318 positioned within the cap post 1502. However, as shown above, the radiation shield 1416 can be made of 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 for focusing the radiation 1412 towards the sensor 1316 and the stylet 1318. The second opening 1506b can provide a location for receiving the sensor 1316 and the stylet 1318 positioned within the cap post 1502 into the sterilization zone 1504.

[0157] As shown in the figure, the external collimator 1418 and associated sterilization zone 1504 are conical or truncated cone 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 approximately 5.0 mm and approximately 16.0 mm, and the size of the second opening 1506b can range between approximately 0.5 mm and approximately 3.0 mm; however, these sizes can be larger or smaller than the provided range without departing from the scope of the disclosure of the present invention. In fact, the sizes of the openings 1506a and 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, with other circular or polygonal cross-sections, 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] Figure 16 is a cross-sectional side view of another exemplary embodiment of the sensor applicator 102 and external sterilization assembly 1414 according to one or more additional embodiments. As shown, here again the sensor control device 1302 is received within the sensor applicator 102, and the applicator cap 1404 is coupled to the housing 1402, in which the sensor control device 1302 is fixed.

[0159] In the illustrated embodiment, the applicator cap 1404 can also be inverted to define or otherwise provide a cap post 1602 sized to receive the distal ends of the sensor 1316 and the pointed body 1318 extending from the bottom of the electronic equipment housing 1304. Furthermore, the radiation shield 1416 can be positioned outside the sensor applicator 102 and can extend into the inverted portion of the applicator cap 1404. More specifically, the radiation shield 1416 can 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 in Figure 15, the bottom of the cap post 1602 can be an open end. In some embodiments, a cap seal 1604 can 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. The cap seal 1604 can be the same as the cap seal 1428 in Figure 14B, and therefore will not be described again.

[0160] In some embodiments, the cap filler 1606 can be positioned within the applicator cap 1404. In one or more embodiments, the cap filler 1606 may include an integral portion or extension of the applicator cap 1404, which may be cast together with the applicator cap 1404 or overmolded thereon. In other embodiments, the cap filler 1606 may include separate structures fitted into or otherwise attached to the applicator cap 1404, without departing from the scope of the disclosure of the present invention. The cap filler 1606 may provide or otherwise define an internal collimator 1608 which can help focus radiation 1412 toward the component to be sterilized. In at least one embodiment, as shown, the cap post 1602 may be received within the internal collimator 1608.

[0161] The external collimator 1418 and the internal collimator 1608 can work together to define a sterilization zone 1610 that focuses radiation 1412 toward the sensor 1316 and the sharp body 1318. The propagating radiation 1412 can pass through the sterilization zone 1610 and enter onto the sensor 1316 and the sharp body 1318 to sterilize them. However, the cap filler 1606 and the radiation shield 1416 can each be manufactured from one of the materials described herein that substantially prevents radiation 1412 from penetrating the inner wall of the sterilization zone 1610 and thereby damaging the radiation-sensitive components 1408 located within the housing 1304. In at least one embodiment, the cap filler 1606 can be manufactured from machined or 3D printed polypropylene, and the radiation shield 1416 can be manufactured from stainless steel.

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

[0163] In the illustrated embodiment, the external collimator 1418 defines a first opening 1612a that allows radiation 1412 to enter the sterilization zone 1610, and a second opening 1612b located at or near the bottom of the cap post 1602 to focus the radiation 1412 onto the sensor 1316 and the sharp body 1318 positioned within the cap post 1602. As in the conventional 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 from about 5.0 mm to about 16.0 mm, while the size of the second opening 1612b can range from about 0.5 mm to about 3.0 mm. In the illustrated embodiment, the external collimator 1418 directs electrons of radiation 1412 toward the bottom opening to the cap post 1602, increasing the electrons at the locations of the sensor 1316 and the sharp body 1318.

[0164] The cap seal 1604 can be positioned at the interface between the radiation shield 1416 and the cap post 1602 and / or the cap filling 1606. The cap seal 1604 can completely seal a portion of the sterilization zone 1610 to help form a portion of a sealed area 1430 configured to isolate the sensor 1316 and the sharp body 1318 from external contamination. The sealed area 1430 can include (encompass) a selected portion within the electronic equipment 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 upper and bottom seals 1432a, 1432b that generate barriers corresponding to their respective sealed locations. The bottom seal 1432b can be positioned to seal the interface between the applicator cap 1404 and the bottom of the electronic equipment housing 1304 (i.e., the mount 1308 in Figure 13).

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

[0166] In some embodiments, the assembly 1414 may further include a cover 1702 that is matable with a mounting tray 1440. The cover 1702 may include or be defined to include a plurality of openings 1106 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 may be manufactured from one of the materials shown herein with respect to the radiation shield 1416, so as 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 may be enclosed within the assembly 1414 or otherwise wrapped.

[0167] Embodiments disclosed herein include the following:

[0168] D. An external sterilization assembly comprising a radiation shield that can be positioned outside a medical device having a part to be sterilized and a radiation-sensitive component, and a collimator that is positioned by the radiation shield and can be aligned with the part to be sterilized, wherein the collimator focuses radiation from the radiation sterilization process toward the part to be sterilized, and the radiation shield prevents the radiation from damaging the radiation-sensitive component.

[0169] E. A sensor applicator including a housing, a cap coupled to the housing, and a sensor control device positioned within the housing, with a positionable radiation shield outside the sensor applicator, wherein the sensor control device includes an electronic housing, radiation-sensitive components positioned within the electronic housing, and a sensor and sharp body extending from the electronic housing, the internal sterilization assembly further includes an external collimator positioned by the radiation shield and aligned with the sensor and sharp body, the external collimator focusing radiation from the radiation sterilization process toward the sensor and sharp body, and the radiation shield preventing radiation from damaging the radiation-sensitive components.

[0170] F. A method comprising placing a radiation shield outside a sensor applicator having a housing, a cap coupled to the housing, and a sensor control device positioned within the housing, wherein the sensor control device includes an electronic equipment housing, a radiation-sensitive component positioned within the electronic equipment housing, and a sensor and a sharp body extending from the electronic equipment housing. The method further comprises focusing radiation from a radiation sterilization process toward the sensor and the sharp body using 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 may 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 density polymers, metals, and any combination thereof. Element 2: The radiation-sensitive component is selected from the group consisting of electronic modules, chemical solutions, and any combination thereof. Element 3: The collimator includes a cross-sectional shape selected from the group consisting of conical, truncated conical, pyramidal, circular, cubic, rectangular, and any combination thereof. Element 4: Further includes a cap that encloses the part to be sterilized and provides a sealing barrier. Element 5: The radiation shield defines an internal cavity into which a medical device is received, and the collimator focuses radiation into the internal cavity.

[0172] Element 6: The radiation shield is made of a material selected from the group consisting of density polymer, metal, and any combination thereof. Element 7: The external collimator includes a cross-sectional shape selected from the group consisting of cone, truncated cone, pyramidal, circular, cubic, rectangular, and any combination thereof. Element 8: Further includes a sterile pod that defines a chamber for receiving at least a portion of a sensor applicator, the radiation shield being removably coupled to the sterile pod. Element 9: Further includes a mounting tray that is alignable to the chamber and defines a central opening sized to receive a sensor applicator, and a cover that is matable with the mounting tray to enclose the sensor applicator. Element 10: The external collimator is alignable to an internal collimator defined by a cap filler positioned within the cap, and the external and internal collimators cooperate to define a sterile zone for receiving the sensor and sharp objects. Element 11: The external and internal collimators include a cross-sectional shape selected from the group consisting of conical, truncated conical, pyramidal, circular, cubic, rectangular, and any combination thereof. Element 12: Further includes a cap seal positioned at the interface between the external and internal collimators. Element 13: The cap provides a cap post that inverts to receive the sensor and the sharp body. Element 14: The external collimator and the cap post cooperate to define a sterilization zone, and the sensor and sharp body positioned within the cap post extend into the sterilization zone.

[0173] Element 15: The step of disposing the radiation shield outside the sensor applicator includes the step of disposing the sensor applicator in a chamber defined by a sterilization pod, and the radiation shield is removably coupled to the sterilization pod. Element 16: The step of disposing the sensor applicator in a chamber defined by a sterilization pod is defined by a mounting tray, and further includes the steps of extending the sensor applicator through a central aperture aligned with the chamber, disposing a cover on the mounting tray to thereby enclose the sensor applicator, and effecting a radiation sterilization process while the sensor applicator is enclosed by the cover. Element 17: The external collimator includes a cross-sectional shape selected from the group consisting of conical, frustoconical, pyramidal, circular, cubic, rectangular, and any combination thereof.

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

[0175] Mixed sterilization assembly Referring briefly again to FIG. 1, the sensor control device 104 must be sterilized to render it free of viable microorganisms before being delivered to an end user. Generally, the sensor 110 is sterilized using radiation sterilization such as electron beam (''electron beam'') irradiation. However, radiation sterilization can damage the electronic components within the sensor control device 104, and the sensor control device 104 is generally sterilized by gaseous chemical sterilization (e.g., using ethylene oxide). However, gaseous chemical sterilization can damage enzymes or other chemical and biological agents included on the sensor 110.

[0176] In the past, this sterilization incompatibility has been avoided by separating the sensor 110 from the electronic components and sterilizing each individually. However, this method requires additional parts, packaging, processing steps, and final assembly by the user, which can lead to user error. With the disclosure of the present invention, the sensor control device 104 or any device requiring final sterilization can be properly sterilized using a plurality of external sterilization assemblies designed to focus radiation sterilization (e.g., beam, wave, or energy) onto the components requiring sterilization, while simultaneously preventing the propagating radiation from destroying or damaging the highly sensitive electronic components.

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

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

[0179] The electronic equipment housing 1804 may include a shell 1806 and a mount 1808 to which it can be mated. The shell 1806 can be fastened to the mount 1808 by a variety of means, such as snap-fit ​​engagement, interlocking fit, ultrasonic welding or laser welding, or one or more mechanical fasteners (e.g., screws), or any combination thereof. In some cases, the shell 1806 can be fastened to the mount 1808 such that a sealed interface is created between it and the mount 1808. In such embodiments, a gasket or other type of sealing material can be positioned on or near the outer diameter (circumference) of the shell 1806 and the mount 1808, and the gasket can be compressed by fastening these two components to each other, thereby creating a sealed interface. In other embodiments, an adhesive can be applied to the outer diameter (circumference) of one or both of the shell 1806 and the mount 1808. The adhesive secures the shell 1806 to the mount 1808, providing structural integrity, but it also seals the interface between these two components, thereby isolating the interior of the electronic housing 1804 from external contamination.

[0180] In the illustrated embodiment, the sensor control device 1802 may optionally include a plug assembly 1810 that can be coupled to the electronic housing 1804. The plug assembly 1810 may include a sensor module 1812 (partially visible) that is interconnectable with a sharp body module 1814 (partially visible). The sensor module 1812 may be configured to carry and include a sensor 1816 (partially visible), and the sharp body module 1814 may be configured to carry and include an introducer or sharp body 1818 (partially visible) used to assist in percutaneous delivery of the sensor 1816 under the user's skin during application of the sensor control device 1802. In the illustrated embodiment, the sharp body module 1814 includes a sharp body hub 1820 that carries the sharp body 1818.

[0181] As shown in the figure, the corresponding portions of the sensor 1816 and the pointed body 1818 extend distally from the electronic equipment housing 1804, more specifically from the bottom of the mount 1808. In at least one embodiment, the exposed portion of the sensor 1816 (also referred to as the "tail") can be received within the hollow or recessed portion of the pointed body 1818. The remaining portion of the sensor 1816 is positioned within the electronic equipment housing 1804.

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

[0183] Figure 19B is a partial cross-sectional side view of the sensor applicator 102. As shown, the sensor control device 1802 can be housed in the sensor applicator 102, and the 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 may include one or more radiation-sensitive components 1908 positioned within the electronic housing 1804. The radiation-sensitive components 1908 may include, but are not limited to, electronic components or electronic modules such as data processing units, registers, transistors, capacitors, inductors, diodes, switches, or any combination thereof. 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 1802. When in operation, the data processing unit may perform data processing functions such as filtering and encoding data signals corresponding to the user's sampled sample level. The data processing unit may include or otherwise communicate with the reader device 106 (Figure 1) by including an antenna.

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

[0185] The sensor applicator 102 may further include a sheath 1914, and in some embodiments, the applicator insert 1910 may engage with 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 provide one or more radial alignment features 1916 (shown as one) that can be fitted into corresponding grooves or slots 1918 defined within the sheath 1914. The radial alignment features 1916 may include, for example, rails, flags, tabs, or projections extending from the body of the applicator insert 1910, and can be fitted into the slot 1918 by sliding the radial alignment features 1916 longitudinally into the slot 1918. The mating engagement between the radial alignment feature 1916 and the slot 1918 can be used to orient the applicator insert 1910 angularly (rotationally) relative to the sensor control device 1802. However, as can be acknowledged, the mating structures can be reversed instead, in which case the radial alignment feature 1916 is instead located on the sheath 1914 and the slot 1918 is located on the applicator insert 1910.

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

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

[0188] In some embodiments, the moisture barrier 1926b can be positioned at or elsewhere over the opening 1928 to the applicator cap 1904. Similar to the microbial barrier 1926a, the moisture barrier 1926b can be configured to help isolate a portion of the sensor applicator 102 from external contamination. The moisture barrier 1926b can be manufactured from any of the materials described above with respect to the microbial barrier 1926a. However, in at least one embodiment, the moisture barrier 1926b can include a thin-walled portion of the applicator cap 1904 without departing from the scope of the disclosure of the present invention. In such embodiments, the opening 1928 becomes unnecessary.

[0189] Figures 20A to 20C are various illustrations of the applicator insert 1910 according to one or more embodiments of the disclosure of the present invention. More specifically, Figure 20A is an isometric top view of the applicator insert 1910, Figure 20B is an isometric bottom view, and Figure 20C is an isometric cross-sectional view. As shown, the applicator insert 1910 includes a substantially cylindrical body 2002 having a first end or upper end 2004a and a second end or lower end 2004b opposite to it. The upper end 2004a is substantially closed except for an opening 2005 sized to receive the sensor 1816 (Figure 19B) and the pointed body 1918 (Figure 19B), while the lower end 2004b is substantially open.

[0190] The radial alignment feature 1916 described above is provided on the side wall of the main body 2002. In some embodiments, additional radial alignment feature 2006 (three shown) may be provided on the side wall of the main body 2002 or otherwise specified. In the illustrated embodiments, each of the additional radial alignment feature 2006 includes a pair of longitudinally extending tabs or projections 2008 that are angularly offset from each other on the side wall and cooperate to define the slot 2010 between them. The slot 2010 may be sized to receive projections or tabs provided on the sheath 1914 (Figure 19B) to assist in angularly (rotationally) orienting the applicator insert 1910 with respect to the sensor control device 1802 (Figure 19B). Furthermore, similar to the arrangement of the radial alignment feature 1916, the mating structures of the additional radial alignment feature 2006 can be reversed instead, in which case the additional radial alignment feature 2006 is instead provided on the sheath 1914 and the corresponding projection or tab is provided on the applicator insert 1910.

[0191] As best seen in Figures 20A and 20C, the applicator insert 1910 may further include one or more sensor positioning features 2012 that can also be used to properly orient the applicator insert 1910 relative to the sensor control device 1802 (Figure 19B) within the sensor applicator 102 (Figure 19B). As shown, the sensor positioning features 2012 may be defined on the upper end 2004a of the body 2002 and extend axially from there. The sensor positioning features 2012 may be sized to be received in a corresponding opening defined within the bottom of the sensor control device 1802. In the illustrated embodiment, the sensor positioning features 2012 include a cylindrical projection, but instead may include other types of structural features suitable for mating into a corresponding feature on the bottom of the sensor control device 1802. In embodiments where the sensor control device 1802 has an eccentric orientation and the sensor 1916 and the pointed body 1918 are not concentric with the centerline of the sensor control device, the sensor positioning feature 2012 has proven particularly advantageous together with the radial alignment feature 1916 and the additional radial alignment feature 2006.

[0192] The internal collimator 1920a can be formed on the upper end 2004a of the applicator insert 1910 or provided elsewhere. As best seen in Figure 20C, the internal collimator 1920a can be defined by the applicator insert 1910 and may include the sighting insert 2014 and the gasket 2016. The internal collimator 1920a can be manufactured by first fabricating or otherwise generating the sighting insert 2014. The applicator insert 1910 can then be overmolded onto the sighting insert 2014. Similarly, the sighting insert 2014 can be insert-cast into the applicator insert 1910. Thus, the applicator insert 1910 can be manufactured from rigid plastic. The gasket 2016 can then be cast onto the applicator insert 1910 in a second-shot casting (overmolding) step.

[0193] The sighting insert 2014 can be manufactured from a material that reduces or prevents sterilization radiation from penetrating it. Suitable materials for the sighting insert 2014 include, but are not limited to, density polymers (e.g., polyethylene, polypropylene, polystyrene, polytetrafluoroethylene, polyamide), metals (e.g., lead, tungsten, stainless steel, aluminum), composite materials, or any combination thereof. In some embodiments, the sighting insert 2014 can be manufactured from any material having a mass density higher than 0.9 grams per cubic centimeter (g / cc).

[0194] The gasket 2016 can be manufactured from any material that helps form a sealing interface with the bottom of the electronic equipment housing 1804 (Figure 19B) when the applicator insert 1910 is installed inside the sensor applicator 102 (Figure 19B). Suitable materials for gasket 2016 include, but are not limited to, silicone, thermoplastic elastomer (TPE), polytetrafluoroethylene (e.g., TEFLON®), or any combination thereof. As shown in the figure, gasket 2016 can fill the void 2018 defined by applicator insert 1910 and can provide an annular projection 2020 that passes over and / or protrudes from the upper surface of the upper end 2004a of the body 2002. The annular projection 2020 has proven advantageous not only in facilitating a sealing interface but also in helping to fill tolerances when the applicator insert 1910 is mounted within the sensor applicator 102. Furthermore, the mass of gasket 2016 can be used to absorb radiation during the sterilization process described below, thereby providing another protective layer to counteract radiation propagation. In at least one embodiment, gasket 2016 can be made of a material that is large enough to exclude the sighting insert 2014 from the internal collimator 1920a or that absorbs radiation sufficiently.

[0195] Figure 21 is another cross-sectional side view of the sensor applicator 102 of Figure 19A, showing a hybrid sterilization assembly 2102 according to one or more embodiments of the disclosure of the present invention. Alternatively, the hybrid sterilization assembly 2102, referred to as a “split-sight assembly” or “collaborative-sight assembly,” can be used to assist in sterilizing the distal ends of the sensor control device 1802, more specifically the sensor 1816 and the pointed body 1818, which extend from the bottom of the electronic equipment housing 1804, while it is positioned within the sensor applicator 102. More specifically, to sterilize the exposed portions of the sensor 1816 and the pointed body 1818, the fully assembled sensor control device 1802 can undergo radiation sterilization 2104. Appropriate radiation sterilization 2104 treatment includes, but is not limited to, electron beam (e-beam) irradiation, gamma ray irradiation, X-ray irradiation, or any combination thereof.

[0196] The radiation sterilizer 2104 can be delivered by either continuous process irradiation or pulsed beam irradiation. In pulsed beam irradiation, the beam of the radiation sterilizer 2104 is focused to a target location, the component or device to be sterilized is moved there, and the irradiation is operated to supply directional radiation pulses to this point. Then the radiation sterilizer 2104 is stopped, another component or device to be sterilized is moved to the target location, and this process is repeated.

[0197] With the disclosure of the present invention, a hybrid sterilization assembly 2102 can be used to assist in focusing the radiation 2104 during the sterilization of the distal ends of the sensor 1816 and the sharp body 1818, while simultaneously preventing (blocking) the propagating radiation 2104 from damaging the radiation-sensitive component 1908. As shown in the figures, the hybrid sterilization assembly 2102 (hereinafter referred to as "assembly 2102") may include the internal collimator 1920a and the external collimator 1920b described above. As shown in the figures, the internal collimator 1920a may be positioned within the sensor applicator 102, and the external collimator 1920b may extend into the sensor applicator 102 (i.e., the applicator cap 1904) by passing through an opening 1928 to the applicator cap 1904. The internal collimator 1920a and the external collimator 1920b can work together to define a sterilization zone 1922 in which radiation 2104 (e.g., a beam, wave, or energy) is focused onto the sensor 1816 and the sharp body 1818 to sterilize them.

[0198] In the illustrated embodiment, the external collimator 1920b is designed to align with the internal collimator 1920a, more specifically, the sighting insert 2014. In at least one embodiment, for example, the sighting insert 2014 may define a radial shoulder 2106 sized to receive the end of the external collimator 1920b extending into the applicator cap 1904 and to mate with the other. The external collimator 1920b can transition to the internal collimator 1920a at the radial shoulder 2106. In some embodiments, the transition between the external collimator 1920a and the internal collimator 1920b may be continuous, flush, or smooth. However, in other embodiments, this transition may be discontinuous or stepwise without departing from the scope of the disclosure of the present invention.

[0199] Similar to the sighting insert 2014 of the internal collimator 1920a, the external collimator 1920b can be manufactured from a material that substantially prevents radiation 2104 from penetrating the inner wall of the sterilization zone 1922 and thereby damaging the radiation-sensitive components 1908 located within the electronic equipment housing 1804. Thus, the external collimator 1920b can be manufactured from any of the materials shown herein as suitable for the sighting insert 2014. In at least one embodiment, each of the sighting insert 2014 and the external collimator 1920b can be manufactured from stainless steel. However, furthermore, as described above, the gasket 2016 may provide some degree of shielding or protection against radiation damaging the radiation-sensitive components 1908.

[0200] The sterilization zone 1922, defined by the internal and external collimators 1920a and 1920b, can exhibit any suitable cross-sectional shape necessary to properly focus the radiation 2104 onto the sensor 1816 and the pointed body 1818 for sterilization. In the illustrated embodiment, for example, each of the external and internal collimators 1920a and 1920b has a conical or truncated conical shape. However, in other embodiments, one or both of the internal and external collimators 1920a and 1920b can exhibit a polygonal cross-sectional shape such as a cube, rectangle (including, for example, a parallelogram), or pyramidal shape without departing from the scope of the disclosure of the present invention. In yet another embodiment, one or both of the internal and external collimators 1920a and 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 external collimator 1920b and a second opening 2108b defined by an internal collimator 1920a, in which case the first opening 2108a and the second opening 2108b are located 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 place where the sensor 1816 and the sharp body 1818 can be received into the sterilization zone 1922.

[0202] In embodiments where the shape of the sterilization zone 1922 is conical or truncated cone, 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 and 2108b can be larger or smaller than the range provided herein, without departing from the scope of the disclosure of the present invention and on an application basis. In fact, the diameters of the first and second openings 2108a and 2108b only need to be large enough to allow a sufficient dose of radiation to enter the sensor 1816 and the sharpened body 1818.

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

[0204] In the illustrated embodiment, the inner wall of the sterilization zone 1922 (e.g., internal and external collimators 1920a, 1920b) extends at a substantially constant angle with respect to the centerline of the sensor applicator 102 between the first opening 2108a and the second opening 2108b. The angle of the wall can be any angle between 0° and 90° with respect to the centerline of the sensor applicator 102. However, the angle of the wall can preferably be between 45° and 90° with respect to the centerline. However, in other embodiments, the angle of the wall can vary between the first opening 2108a and the second opening 2108b without departing from the scope of the disclosure of the present invention. In such embodiments, a portion of the wall may extend for a short distance at a different angle from the adjacent portion, or the wall may undulate between the first opening 2108a and the second opening 2108b.

[0205] The microbial barrier 1926a is installed at the interface between the internal collimator 1920a and the external collimator 1920b, and can otherwise be positioned on or near the radial shoulder 2106. The microbial barrier 1926a can be present during radiation sterilization. As described above, the microbial barrier 1926a can be used to help seal at least a portion of the sterilization zone 1922. More specifically, the microbial barrier 1926a can completely seal a portion of the sterilization zone 1922 to help form a sealed area 2110 configured to isolate the sensor 1816 and the sharp body 1818 from external contamination. The sealed area 2110 may include (encompass) a selected portion within the electronic equipment 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 a microbial barrier 1926a, a first seal or "top" seal 2112a, and a second seal or "bottom" seal 2112b. Each of the microbial barrier 1926a, as well as the top and bottom seals 2112a, 2112b, generates a barrier corresponding to its respective sealed location, thereby enabling the final sterilization of the sterilization zone 1922 that confines the sensor 1816 and the sharp body 1818.

[0206] The upper seal 2112a can be positioned to seal the interface between the pointed body hub 1820 and the upper part of the electronic equipment housing 1804 (i.e., the shell 1806 in Figure 18), thereby preventing contaminants from moving into the electronic equipment housing 1804. In some embodiments, the upper seal 2112a can form part of the pointed body hub 1820 by overmolding it or the like. However, in other embodiments, the upper seal 2112a can form part of the upper surface of the shell 1806 or be overmolded on the upper surface. In yet another embodiment, the upper seal 2112a may include a separate structure, such as an O-ring, that is sandwiched between the pointed body hub 1820 and the upper surface of the shell 1806, without departing from the scope of the disclosure of the present invention.

[0207] The bottom seal 2112b may include a gasket 2016 (Figure 20C), more specifically an annular projection 2020 (Figures 20A and 20C) overmolded onto the applicator insert 1910. When in operation, the bottom seal 2112b may be positioned to seal the interface between the applicator insert 1910 and the bottom of the electronic equipment housing 1804 (i.e., mount 1808 in Figure 18). The bottom seal 2112b can prevent contaminants from moving into the sterile zone 1922 and into the electronic equipment housing 1804.

[0208] After loading the sensor control device 1802 into the sensor applicator 102 and securing the applicator cap 1904 to the sensor applicator 102, the upper and lower seals 2112a and 2112b can gradually compress, generating the corresponding sealing interface. The upper and lower seals 2112a and 2112b can be manufactured from a variety of materials that have the function of generating a sealing 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] After radiation sterilization is complete, the external collimator 1920b can be removed from the applicator cap 1904, and the moisture barrier 1926b can be positioned to close the opening 1928 within the applicator cap 1904. During delivery, the user can easily remove the applicator cap 1904 in preparation for delivering 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 inside the applicator cap 1904 in a manner that allows the applicator insert 1910 to be fixed 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, an embedding material 2114 can be filled into the electronic equipment housing 1804 to fill the voids within the sensor control device 1802. The embedding material 2114 may include biocompatible materials that meet the requirements of ISO 10993. In some embodiments, for example, the embedding material 2114 may include a urethane material such as Resinaid® 3672 available from Henkel® or a silicone material such as SI5055 or SI5240. In other embodiments, the embedding material 2114 may include an acrylate adhesive material such as GE4949 available from Delo®.

[0211] The embedding material 2114 can act as an additional safety barrier to absorb or deflect propagating radiation 2104. In at least one embodiment, for example, the embedding material 2114 can provide electron beam resistance of at least 85 kGy. Thus, the radiation 2104 can be forced to pass through the embedding material 2114 instead of passing through the air commonly present inside the electronic equipment housing 1804 before being incident on the radiation-sensitive component 1908. The embedding material 2114 may not contain density material, but nevertheless can act as another level of radiation shielding. Furthermore, the embedding material 2114 can enhance the robustness of the sensor control device 1802 and the electronic equipment housing 1804. Thus, by using the embedding material 2114, it is possible to manufacture the electronic equipment housing 1804 from thinner material as needed.

[0212] The sensor 1816 and the pointed body 1818 extend substantially concentrically with the centerlines of the sensor applicator 102 and applicator cap 1904 into the sterilization zone 1922 from the bottom of the electronic equipment housing 1804, but it should be noted that this specification considers them to have an eccentric arrangement. More specifically, in at least one embodiment, the sensor 1816 and the pointed body 1818 extend eccentrically with respect to the centerlines of the sensor applicator 102 and applicator cap 1904 from the bottom of the electronic equipment housing 1804. In such embodiments, without departing from the scope of the disclosure of the present invention, the internal and external collimators 1920a, 1920b may also be redesigned or otherwise configured to accommodate the sensor 1816 and the pointed body 1818 by eccentrically arranging the sterilization zone 1922.

[0213] Figures 22A and 22B are isometric and cross-sectional side views of another embodiment of the applicator insert 1910. The applicator insert 1910 shown in Figures 22A to 22B can be similar in most respects to the applicator insert 1910 shown in Figures 20A to 20C. However, unlike the applicator insert 1910 of Figures 20A to 20C, the applicator insert 1910 of Figures 22A to 22B provides an eccentric orientation in which the internal collimator 1920a is positioned eccentrically with respect to the center line 2202 of the main body 2002 (Figure 22B). In such embodiments, the sensor control device 1802 (Figures 19B and 21) can provide an eccentric orientation so that the sensor 1816 (Figures 19B and 21) and the pointed body 1818 (Figures 19B and 21) can extend into an opening 2005 defined within the upper 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 proven particularly advantageous in assisting in properly aligning the applicator insert 1910 with respect to the sensor control device 1802 located within the sensor applicator 102 (Figures 19B and 21).

[0214] Embodiments disclosed herein include the following:

[0215] A sensor applicator comprising a housing on which a sensor control device including a sensor, a sharp body, and radiation-sensitive components is installed; 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 distal ends of the sensor and the sharp body; and an external collimator extendable within the applicator cap, wherein the internal and external collimators cooperate to focus radiation from a radiation sterilization process toward the sensor and the sharp body, while simultaneously preventing the radiation from damaging the radiation-sensitive components.

[0216] I. A method for sterilizing a sensor control device, comprising the steps of: placing the sensor control device, which includes a sensor, a sharp body, and a radiation-sensitive component, into a housing of a sensor applicator; receiving the distal ends of the sensor and the sharp body into an internal collimator defined by an applicator insert; removably coupling an applicator cap to the housing so as to fix the applicator insert into the applicator cap; extending an external collimator into the applicator cap and aligning the external collimator with the internal collimator; and cooperating with the internal and external collimators to focus radiation from a radiation sterilization process toward the sensor and the sharp body, while simultaneously preventing the radiation from damaging the radiation-sensitive component.

[0217] A hybrid sterilization assembly comprising: an applicator insert that can be positioned within the applicator cap of a sensor applicator; an internal collimator that receives the distal end of the sensor and sharp body of a sensor control device positioned within the housing of the sensor applicator as determined by the applicator insert; and an external collimator that is extendable within the applicator cap and alignable with the internal collimator, wherein the internal and external collimators cooperate to focus radiation from the radiation sterilization process toward the sensor and sharp body, while simultaneously preventing the radiation from damaging the 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 with the inner surface of the applicator cap to axially secure the applicator insert within the applicator cap. Element 2: Further includes 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 provided on the applicator insert and matable with one or more corresponding features provided on the sheath, thereby rotatably orienting the applicator insert with respect to a sensor control device. Element 3: Further includes one or more sensor positioning features provided on the applicator insert and matable with one or more corresponding features provided on the sensor control device, for rotatably orienting the applicator insert with respect to a sensor control device. Element 4: The internal collimator includes a sighting insert, and the external collimator is alignable with the sighting insert. Element 5: Each of the sighting insert and the external collimator is manufactured from a material selected from the group consisting of density polymers, metals, composite materials, and any combination thereof. Element 6: The internal collimator further includes a gasket that can engage with the bottom of the sensor control device to create a sealed interface. Element 7: The internal and external collimators cooperate to define a sterile zone exhibiting a cross-sectional shape selected from the group consisting of conical, truncated conical, pyramidal, circular, cubic, rectangular, and any combination thereof. Element 8: Further includes an embedding material positioned within the sensor control device.

[0219] Element 9: The method further includes the step of engaging the inner surface of the applicator cap with the applicator insert, thereby axially fixing the applicator insert within the applicator cap. Element 10: The internal collimator includes a gasket, and the method further includes the steps of engaging the gasket with the bottom of the sensor control device when the applicator insert is axially fixed within the applicator cap, and creating a sealed interface between the gasket and the bottom of the sensor control device. Element 11: The internal and external collimators cooperate to define a sterile zone for receiving the sensor and sharp objects, and the method further includes the step of sealing at least a portion of the sterile zone with a microbial barrier positioned at the interface between the internal and external collimators. Element 12: The internal collimator includes a sighting insert, and the step of aligning the external collimator with the internal collimator includes the step of aligning the external collimator with the sighting insert. Element 13: The internal and external collimators work together to define a sterilization zone exhibiting a cross-sectional shape selected from the group consisting of conical, truncated conical, pyramidal, circular, cubic, rectangular, and any combination thereof.

[0220] Element 14: Further includes a microbial barrier positioned at the interface between the internal collimator and the external collimator. Element 15: The internal collimator includes a sighting insert, and each of the sighting insert and the external collimator is manufactured from a material selected from the group consisting of density polymers, metals, composite materials, and any combination thereof. Element 16: The internal collimator further includes a gasket that can engage with the bottom of the sensor control device to create a sealed interface. Element 17: The internal and external collimators cooperate to define a sterilization zone exhibiting a cross-sectional shape selected from the group consisting of conical, truncated cone, pyramidal, circular, cubic, rectangular, and any combination thereof.

[0221] As a non-limiting example, exemplary combinations applicable to H, I, and J include the combinations of element 4 and element 5, element 4 and element 6, element 9 and element 10, and element 15 and element 16.

[0222] Internally Sterilized Assembly Before being delivered to the end user, some medical devices must be sterilized to ensure the absence of viable microorganisms. However, some medical devices, including subcutaneous sensing devices or sensors, must be sterilized using radiation sterilization, such as electron 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 can damage enzymes or other chemical and biological agents contained on subcutaneous sensing devices.

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

[0224] Figure 23 is a schematic diagram of an exemplary internal sterilization assembly 2300 according to one or more embodiments of the disclosure of the present invention. The internal sterilization assembly 2300 (hereinafter, "assembly 2300") is designed and can otherwise be configured to assist in the sterilization of a medical device 2302. The medical device 2302 may include a type of healthcare product that includes any device, mechanism, assembly, or system that requires final sterilization of one or more component parts. Suitable examples of the medical device 2302 include, but are not limited to, ingestible products, cardiac rhythm management (CRM) devices, subcutaneous sensing devices, externally attached medical devices, drug delivery devices, 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 specimen sensor control device." As shown, the medical device 2302 can be housed in a sensor applicator 2304 (alternatively referred to as an "insertor"), to which a cap 2306 can be removably coupled. The medical device 2302 may include a housing 2308, a sterilization-required component 2310, and one or more radiation-sensitive components 2312. In some embodiments, component 2310 may include a sensor extending from the housing 2308. In at least one embodiment, component 2310 may further include a pointed body that may require sterilization and can help implant the sensor under the user's skin. As shown, component 2310 may extend inclined from the bottom surface of the housing 2308, or alternatively, it may extend vertically from the bottom surface or another surface of the housing 2308. Furthermore, as shown in the figures, the component 2310 may extend from one end of the housing 2308 or offset from the centerline of the housing 2308, but alternatively, it may extend concentrically with the housing without departing from the scope of the disclosure of the present invention.

[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, a cap 2306 can be screwed onto the sensor applicator 2304 and 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 the target monitoring location on the user's body. Component 2310 is positioned so that it can be percutaneously positioned beneath the surface of the user's skin and otherwise held there. In some embodiments, the medical device 2302 can be spring-suspended toward ejection from the sensor applicator 2304. Once ejected, the medical device 2302 can be maintained in place on the skin by an adhesive patch (not shown) bonded to its base.

[0227] In the illustrated embodiment, the radiation-sensitive component 2312 can 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 sample (e.g., an active drug, pharmaceutical, or biologic). In such embodiments, the medical device 2302 may instead include a subcutaneous needle or a subcutaneous syringe, which can position the chemical solution or sample within the ampoule of the medical device 2302.

[0228] The medical device 2302 may undergo radiation sterilization 2316 to properly sterilize the component 2310 for use. Appropriate radiation sterilization 2316 treatment includes, but is not limited to, electron beam (e-beam) irradiation, gamma ray irradiation, X-ray irradiation, or any combination thereof. The cap 2306 may define a collimator 2318 that allows radiation 2316 to enter onto the component 2310 and sterilize it. However, the cap 2306 may also act as a radiation shield to help prevent (block) the propagating radiation 2316 from destroying or damaging the radiation-sensitive component 2312. To achieve this, the cap 2306 may be manufactured from a material that reduces or prevents radiation 2316 from penetrating it.

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

[0230] As shown in the illustration, the collimator 2318 generally includes a hole or passage extending at least partially through the cap 2306. The collimator 2318 defines a sterilization zone 2320 configured to focus radiation 2316 toward part 2310. In the illustrated embodiment, part 2310 can be received into the sterilization zone 2320 toward sterilization. The collimator 2318 can exhibit any suitable cross-sectional shape necessary to focus radiation 2316 toward part 2310 toward sterilization. In the illustrated embodiment, for example, the collimator 2318 is conical or truncated cone. However, in other embodiments, the collimator 2318 can exhibit a polygonal cross-sectional shape such as cubic, rectangular (including, for example, parallelogram), or pyramidal without departing from the scope of the disclosure of the present invention. In yet another embodiment, the 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, in which case the first opening 2322a and the second opening 2322b are located at opposite ends of the sterilization zone 2320. The first opening 2322a allows radiation 2316 to enter the sterilization zone 2320 and be incident on the part 2310, and the second opening 2322b can be configured to receive the part 2310 into the sterilization zone 2320. In embodiments where the shape of the collimator 2318 is conical or truncated cone, the second opening 2322b may have a smaller diameter than the diameter of the first opening 2322a. In such embodiments, for example, the size of the second aperture 2322b can range between approximately 0.5 mm and approximately 3.0 mm, and the size of the first aperture 2322a can range between approximately 5.0 mm and approximately 16.0 mm. However, as can be seen, the respective diameters of the first and second apertures 2322a and 2322b can be larger or smaller than the range provided herein without departing from the scope of the disclosure of the present invention. In fact, the diameters of the first and second apertures 2322a and 2322b can be scaled relative to the device size and only need to be large enough to allow a sufficient dose of radiation to enter the component 2310. Furthermore, in at least one embodiment, the collimator 2318 can have a cylindrical shape, in which case the first aperture 2322a and the second aperture 2322b have the same diameter.

[0232] In some embodiments, the cap seal 2324 (shown by the dashed line) can be positioned in the opening of the collimator 2318 and in the first opening 2322a. The cap seal 2324 may include a radiopaque microbial barrier. In some embodiments, for example, the cap seal 2324 may be made of a synthetic material such as Tyvek®, available from DuPont® (e.g., flash-spun density polyethylene fiber). However, in other embodiments, the cap seal 2324 may include, but is not limited to, tape, paper, foil, or any combination thereof. In yet another embodiment, the cap seal 2324 may include a thin-walled portion of the cap 2306 without departing from the scope of the disclosure of the present invention. In such embodiments, the first opening 2322a may be eliminated.

[0233] The cap seal 2324 completely seals a portion of the sterilization zone 2320, isolating the part 2310 from external contamination, while simultaneously allowing radiation 2316 to sterilize the part 2310 through the cap seal 2324. In some embodiments, a desiccant (not shown) can be placed inside 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 help block radiation 2316 (e.g., electrons) from propagating within the housing 2308 toward the radiation-sensitive component 2312. The barrier shield 2326 may be manufactured 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 it may instead 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 according to one or more additional embodiments of the disclosure of the present invention. The internal sterilization assembly 2400 (hereinafter "assembly 2400") can be similar in several respects to assembly 2300 of Figure 23, and is therefore best understood by referring to it, in which similar numbers represent similar components that will not be described in detail again. Similar to assembly 2300 of Figure 23, for example, assembly 2400 is designed and can be otherwise configured to assist in sterilizing a medical device 2402, which can be similar to medical device 2302 of Figure 23. The medical device 2402 may include a sensor control device similar to medical device 2302 of Figure 23, but may instead include any of the healthcare products described herein.

[0236] As shown in the figures, the medical device 2402 can be housed within a sensor applicator 2404, more specifically in a pocket 2406 defined within the sensor applicator 2404. In some embodiments, a desiccant (not shown) can be placed in the pocket 2406. Similar to the medical device 2302 in Figure 23, the medical device 2402 may include a housing 2308, a sterilization-required component 2310, and a radiation-sensitive component 2312. In some embodiments, the assembly 2400 may further include a barrier shield 2326, as generally described above. As shown in the figures, the component 2310 may extend vertically from the bottom surface of the housing 2308, but instead may extend inclined or from another surface. Furthermore, as shown in the figures, the component 2310 may extend along the centerline of the housing 2308, but instead may extend eccentrically with respect to the centerline without departing from the scope of the disclosure of the present invention.

[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 in the figure, the sensor applicator 2404 may include a spring-loaded button 2408 that is at least partially received therein. The button 2408 extends through a channel 2409 defined within the sensor applicator 2404 and is engageable at the lower end of the channel 2409 with the upper part of the housing 2308. In at least one embodiment, the bottom of the button 2406 provides a sealing interface where it engages with the housing 2308. The medical device 2402 can be deployed from the pocket 2406 for use by pressing the button 2408, which acts against the housing 2308, thereby pushing the medical device 2402 distally away from the sensor applicator 2404. Component 2310 is positioned so that it can be percutaneously positioned beneath the surface of the user's skin and otherwise held there. Once deployed, the medical device 2402 can be maintained in place on the skin by an adhesive patch (not shown) attached to its base.

[0238] To properly sterilize the component 2310 before use, the medical device 2402 can undergo radiation sterilization 2316. In the illustrated embodiment, the radiation sterilization 2316 is directed towards the top of the sensor applicator 2404, and the button 2408 defines a collimator 2410 that allows the radiation 2316 to enter onto the component 2310 and sterilize it. As shown, the collimator 2410 generally includes a hole or passage that extends at least partially through the button 2408. The collimator 2410 can have any suitable cross-sectional shape necessary to focus the radiation 2316 toward the component 2310 and 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 truncated cone in shape. However, in other embodiments, the collimator 2410 may have a polygonal cross-sectional shape such as a cube, rectangle (including, for example, a parallelogram), or pyramidal shape without departing from the scope of the disclosure of the present invention. In yet another embodiment, the collimator 2410 may have a circular cross-sectional shape with parallel sides.

[0239] However, each part of the sensor applicator 2404 and the button 2408 can also act as a radiation shield to help prevent (block) propagating radiation 2316, except that which passes through the collimator 2410, from destroying or damaging the radiation-sensitive components 2312. To achieve this, the sensor applicator 2404 and the button 2408 can be manufactured from a material similar to the material of the cap 2306 in Figure 23. In at least one embodiment, the radiation-sterilized 2316 can be emitted from a device or machine configured to focus and / or target it directly into the collimator 2410, thereby reducing the exposure of the radiation 2316 to adjacent parts of the sensor applicator 2404.

[0240] In some embodiments, a first seal 2412a (shown by the dashed line) can be positioned at the opening of the pocket 2406, and a second seal 2412b can be positioned at the opening to the collimator 2410 above the button 2406. The seals 2412a and 2412b may include a radiopaque microbial barrier similar to the cap seal 2324 in Figure 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, while the second seal 2412b can completely seal the collimator 2410, while simultaneously allowing radiation 2316 to sterilize the component 2310 through the first seal 2412a.

[0241] Figure 25 is a schematic diagram of another exemplary internal sterilization assembly 2500 according to one or more additional embodiments of the disclosure of the present invention. The internal sterilization assembly 2500 (hereinafter "assembly 2500") can be similar in several respects to the assemblies 2300 and 2400 of Figures 23 and 24, and can therefore be best understood by referring to them, in which case similar numbers represent similar components that will not be described in detail again. Similar to the assemblies 2300 and 2400 of Figures 23 and 24, for example, assembly 2500 can be designed and otherwise configured to assist in sterilizing a medical device 2502, which can be similar to the medical devices 2302 and 2402 of Figures 23 and 24. The medical device 2502 may include a sensor control device similar to the medical devices 2302 and 2402 of Figures 23 and 24, but may instead include any of the healthcare products described herein.

[0242] As shown in the figures, the medical device 2502 can be housed in a sensor applicator 2504 which may include a spring-suspended sheath 2506. The medical device 2502 can be positioned in a pocket 2508 which is at least partially defined by the sheath 2506. In some embodiments, a desiccant (not shown) may be placed in the pocket 2508. Similar to the medical devices 2302 and 2402 in Figures 23 and 24, the medical device 2502 may include a housing 2308, a sterilization-required component 2310, and a radiation-sensitive component 2312. In some embodiments, the assembly 2500 may further include a barrier shield 2326 which has been generally described above.

[0243] As shown in the figures, part 2310 may extend vertically from the bottom surface of the housing 2308, but alternatively, it may extend at an angle or from another surface. Furthermore, as shown in the figures, part 2310 may extend along the centerline of the housing 2308, but alternatively, it may extend eccentrically with respect to the centerline without departing from the scope of the disclosure of the present invention.

[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 retract into the body of the sensor applicator 2504. Once the sheath 2506 has collapsed to the point where it passes through the housing 2308, the medical device 2502 can be released from the sensor applicator 2504. Component 2310 is positioned to percutaneously position it beneath the surface of the user's skin and to hold it there. In the deployed state, the medical device 2502 can be maintained in place on the skin by an adhesive patch (not shown) bonded to its base.

[0245] To properly sterilize the component 2310 before use, the medical device 2502 can undergo radiation sterilization 2316. In the illustrated embodiment, the radiation sterilization 2316 is directed towards the top of the sensor applicator 2504, which defines a collimator 2510 that allows it to be incident on the component 2310 and sterilize it. As shown, the collimator 2510 generally includes a hole or passage extending 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 component 2310 and to focus the radiation 2316 onto the component 2310 toward sterilization. In the illustrated embodiment, for example, the collimator 2510 is conical or truncated cone in shape. However, in other embodiments, the collimator 2510 can exhibit a polygonal cross-sectional shape such as cubic, rectangular (including, for example, parallelogram), or pyramidal without departing from the scope of the disclosure of the present invention. In yet another embodiment, the collimator 2510 may have 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, except that which passes through the collimator 2510, from destroying or damaging the radiation-sensitive components 2312. To achieve this, the sensor applicator 2504 can be manufactured from a material similar to the material of the cap 2306 in Figure 23. In at least one embodiment, the radiation-sterilized 2316 can be emitted from a device or machine configured to focus and / or target it directly into the collimator 2510, thereby reducing the exposure of the radiation 2316 to adjacent portions of the sensor applicator 2504.

[0247] In some embodiments, a first seal 2512a (shown by the dashed line) can be positioned at the opening of the pocket 2508, and a second seal 2512b can be positioned at the opening to the collimator 2510 at the top of the sensor applicator 2504. The seals 2512a and 2512b may include a radiopaque microbial barrier similar to the cap seal 2324 in Figure 23. The first seal 2512a can completely seal the pocket 2508 at the bottom of the sensor applicator 2504 to isolate the component 2310 from external contamination, and the second seal 2512b can completely seal the collimator 2510, while simultaneously allowing radiation 2316 to sterilize the component 2310 through these seals.

[0248] Embodiments disclosed herein include the following:

[0249] K. An internal sterilization assembly comprising a sensor applicator, a medical device at least partially housed within the sensor applicator and having a part to be sterilized and a radiation-sensitive component, and a cap detachably coupled to the sensor applicator and providing a collimator that can be aligned with the part to be sterilized, wherein the collimator focuses radiation from a radiation sterilization process toward the part to be sterilized 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, truncated cone, pyramidal, circular, cubic, rectangular, and any combination thereof. Element 3: The medical device includes an in vivo specimen sensor control device, and the part to be sterilized includes at least one of a sensor and a sharp body extending from the housing of the in vivo specimen sensor control device. Element 4: At least one of the sensor and the sharp body extends inclined from the bottom of the housing. Element 5: At least one of the sensor and the sharp body extends vertically from the bottom of the housing. Element 6: At least one of the sensor and the sharp body extends from the bottom of the housing along the centerline of the housing. Element 7: At least one of the sensor and the sharp body extends from the bottom of the housing offset from the centerline of the housing. Element 8: The cap is manufactured from a material having a mass density greater than 0.9 g / cc. Element 9: The cap is manufactured from a material selected from the group consisting of density polymers, metals, and any combination thereof. Element 10: The medical device includes an in vivo specimen sensor control device having a housing for containing a radiation-sensitive component, and the internal sterile assembly further includes a barrier shield positioned within the housing to block radiation from propagating within the housing toward the radiation-sensitive component. Element 11: Further includes a spring-suspended button at least partially received within the sensor applicator and engageable with the top of the medical device, with a collimator defined passing through the button. Element 12: Further includes a sealed interface at the intersection of the button and the medical device. Element 13: At least one of the button and the sensor applicator is manufactured from a material selected from the group consisting of density polymers, metals, and any combination thereof. Element 14: The sensor applicator includes a spring-suspended sheath, and the medical device is housed within a pocket at least partially defined by the sheath.Element 15: The collimator through which the sensor applicator passes is defined.

[0251] As an unrestricted example, exemplary combinations applicable to A, B, and C include the combinations of element 3 and element 4, element 3 and element 5, element 3 and element 6, element 3 and element 7, element 8 and element 9, element 11 and element 12, element 11 and element 13, and element 14 and element 15.

[0252] One-piece biosensor design with sensor storage vial Figures 26A and 26B are isometric and side views, respectively, of an exemplary sensor control device 2602 according to one or more embodiments of the disclosure of the present invention. The sensor control device 2602 (also referred to as the "pack") can be similar in several respects to the sensor control device 104 of Figure 1, and is therefore best understood by referring to it. The sensor control device 2602 can replace the sensor control device 104 of Figure 1, and can therefore be used in conjunction with the sensor applicator 102 (Figure 1) that delivers the sensor control device 2602 to a target monitoring location on the user's skin.

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

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

[0255] The electronic equipment housing 2604 may include a shell 2606 and a mount 2608 to which it can be mated. The shell 2606 can be secured to the mount 2608 by various means such as snap-fit ​​engagement, interlocking fit, ultrasonic 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 is created between it and the mount 2608. In such embodiments, a gasket or other type of sealing material can be positioned on or near the outer diameter (circumference) of the shell 2606 and the mount 2608, and the gasket can be compressed by securing these two components to each other, thereby creating a sealed interface. In other embodiments, an adhesive can be applied to the outer diameter (circumference) of one or both of the shell 2606 and the mount 2608. The adhesive secures the shell 2606 to the mount 2608, providing structural integrity, but can also seal the interface between these two components, thereby isolating the interior of the electronic equipment housing 2604 from external contamination. When the sensor control device 2602 is assembled in a controlled environment, it may not be necessary to ultimately sterilize the internal electrical components. Instead of sterilization, adhesive bonding can provide a sufficient sterile barrier to the assembled electronic equipment housing 2604.

[0256] The sensor control device 2602 may further include a plug assembly 2610 that can be coupled to the electronic housing 2604. The plug assembly 2610 may be similar in some respects to the plug assembly 207 in Figure 2A. For example, the plug assembly 2610 may include a sensor module 2612 (partially visible) that is interconnectable with a pointed body module 2614 (partially visible). The sensor module 2612 may be configured to carry and include a sensor 2616 (partially visible), and the pointed body module 2614 may be configured to carry and include a pointed body 2618 (partially visible) used to assist in the transcutaneous delivery of the sensor 2616 under the user's skin during application of the sensor control device 2602. As shown, the corresponding parts of the sensor 2616 and the pointed body 2618 extend from the electronic housing 2604, more specifically from the bottom of the mount 2608. The exposed portion of the sensor 2616 can be accommodated within the hollow or recessed portion of the pointed body 2618. The remaining portion of the sensor 2616 is positioned within the electronic equipment housing 2604.

[0257] As will be discussed in more detail below, the sensor control device 2602 may further include a sensor storage vial 2620 that provides a storage barrier surrounding the exposed portions of the sensor 2616 and the sharp body 2618 to protect them from gaseous chemical sterilization.

[0258] Figures 27A and 27B are isometric and exploded views, respectively, of a plug assembly 2610 according to one or more embodiments. The sensor module 2612 may include a sensor 2616, a plug 2702, and a connector 2704. The plug 2702 may be designed to accept and support both the sensor 2616 and the connector 2704. As shown, a channel 2706 can be defined through the plug 2702 to accept a portion of the sensor 2616. Furthermore, the plug 2702 may provide one or more deflectable arms 2707 configured to snap into corresponding feature portions provided on the bottom of the electronic equipment housing 2604 (Figures 26A-26B).

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

[0260] Flag 2710 may include a nearly flat surface on which sensor contacts 2714 (three shown in Figure 27B) are positioned. Sensor contacts 2714 may be configured to align with a corresponding number of compliant carbon-impregnated polymer modules (with their tops shown at location 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. Figures 27A–27B show the connector 2704 in the closed state, but it can pivot and rotate to the open state to receive the flag 2710 and the compliant carbon-impregnated polymer module inside. The compliant carbon-impregnated polymer module provides electrical contacts 2720 (three shown) configured to give conductive communication between the sensor 2616 and the corresponding circuit contacts provided within the electrical housing 2604 (Figures 26A–26B). The connector 2704 can be manufactured 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 sharp body module 2614 includes a sharp body 2618 and a sharp body hub 2722 that supports it. The sharp body 2618 includes an elongated shaft 2724 and a sharp body tip 2726 at its distal end. The shaft 2724 may be configured to extend through the channel 2706 and further distally from the plug 2702. Furthermore, the shaft 2724 may include a hollow portion or recessed portion 2728 that at least partially surrounds the tail 2708 of the sensor 2616. The sharp body tip 2726 may be configured to penetrate the skin while supporting the tail 2708 in order to bring the activating agent present on the tail 2708 into contact with body fluids.

[0263] The pointed hub 2722 may include a hub miniature cylinder 2730 and a hub snap clasp 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 (Figure 1).

[0264] Referring particularly to Figure 27B, the storage vial 2620 may include a substantially cylindrical, elongated body 2734 having a first end 2736a and a second end 2736b opposite to it. The first end 2736a may be open to provide access to an inner chamber 2738 defined within the body 2734. In contrast, the second end 2736b may be closed and provide or otherwise define an expanding head 2740. The expanding head 2740 has an outer diameter larger than the remaining outer diameter of the body 2734. However, in other embodiments, the expanding head 2740 may be positioned at an intermediate location between the first end 2736a and the second end 2736b.

[0265] Figure 27C is an exploded isoangular bottom view of the plug 2702 and the storage vial 2620. As shown, the plug 2702 can have an opening 2742 configured to receive the storage vial 2620, more specifically the first end 2736a of the body 2734. The channel 2706 can be terminated at the opening 2742 such that components extending distally from the channel 2706 are received into the inner chamber 2738 when the storage vial 2620 is coupled to the 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 into the opening 2742 by a crimp fit or friction fit. In other embodiments, the storage vial 2620 can be secured into the opening 2742 using a fragile member (e.g., a shear ring) or fragile material that can be broken by a small separation force. In such embodiments, for example, the storage vial 2620 can be secured into the opening 2742 using a small amount of surface-coated (dot-coated) adhesive or light-coated wax, or may include an easily peelable adhesive. As described below, the storage vial 2620 may be separated from the plug 2702 before the sensor control device 2602 (Figures 26A-26B) is delivered to the target monitoring location on the user's skin.

[0267] Referring again to Figures 27A and 27B, the inner chamber 2738 is sized to accommodate the tail 2708, the distal section of the shaft 2724, and the tip 2726 of the sharp body, collectively referred to as the "distal portion of the sensor 2616 and sharp body 2618," and can be otherwise configured. The inner chamber 2738 can be sealed or otherwise isolated to prevent substances that may cause adverse interactions with the chemical formulation of the sensor 2616 from moving into the inner chamber 2738. More specifically, since the gas used during gaseous sterilization may adversely affect the enzymes (and other sensor components such as membrane coatings that regulate sample inflow) provided on the tail 2708, the inner chamber 2728 can be sealed to protect or isolate the distal portion of the sensor 2616 and sharp body 2618 during gaseous sterilization.

[0268] In some embodiments, the seal 2744 (Figure 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 inside the inner chamber 2738, but alternatively, it can be positioned outside the body 2734 without departing from the scope of the disclosure of the present invention. The distal portions of the sensor 2616 and the pointed body 2618 can extend through the seal 2744 into the inner chamber 2738, but the seal 2744 can maintain a sealing interface around the distal portions of the sensor 2616 and the pointed body 2618 to prevent the movement of contaminants into the inner chamber 2738. The seal 2744 can be manufactured, for example, from a flexible elastomer or wax.

[0269] In other embodiments (or in addition to seal 2744), a sensor preservation fluid 2746 (Figure 27B) may be present in the inner chamber 2738, and the distal portions of the sensor 2616 and the pointed body 2618 may be immersed in or otherwise sealed by the preservation fluid 2746. The preservation fluid 2746 can create a sealed interface that prevents sterilization gases from interacting with enzymes provided on the tail 2708.

[0270] To properly sterilize the sensor 2616 and the sharpened body 2618, the plug assembly 2610 can be subjected to radiation sterilization. Appropriate radiation sterilization includes, but is not limited to, electron beam (e-beam) irradiation, gamma ray irradiation, X-ray irradiation, or any combination thereof. In some embodiments, the plug assembly 2610 can be subjected to radiation sterilization before the storage vial 2620 is coupled to the plug 2702. However, in other embodiments, the plug assembly 2610 can be sterilized after the storage vial 2620 has been coupled to the plug 2702. In such embodiments, the body 2734 and storage fluid 2746 of the storage vial 2620 may contain materials and / or substances that allow radiation to propagate through them to facilitate radiation sterilization of the distal portions of the sensor 2616 and the sharpened body 2618.

[0271] Suitable materials for the body 2734 include, but are not limited to, non-magnetic metals (e.g., aluminum, copper, gold, silver), thermoplastic ceramics, rubber (e.g., ebonite), composite materials (e.g., fiberglass, carbon fiber reinforced polymers), epoxy, or any combination thereof. In some embodiments, the material for the body 2734 may be transparent or translucent, but may otherwise be opaque without departing from the scope of the disclosure of the present invention.

[0272] The preservation fluid 2746 may include any inert, biocompatible fluid (i.e., liquid, gas, gel, wax, or any combination thereof) that serves to enclose the distal portions of the sensor 2616 and the sharp body 2618. In some embodiments, the preservation fluid 2746 may allow radiation to propagate through it. The preservation fluid 2746 may include fluids insoluble in the chemicals contained in gaseous chemical sterilization. Suitable examples of the preservation fluid 2746 include, but are not limited to, silicone oils, mineral oils, gels (e.g., petrolatum), waxes, fresh water, brine, synthetic fluids, glycerin, sorbitan esters, or any combination thereof. As can be seen, more viscous gels and fluids may be preferred so that the preservation fluid 2746 does not flow easily.

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

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

[0275] A printed circuit board (PCB) 2802 can be positioned within the electronic equipment housing 2604. The PCB 2802 can be fitted with several electronic modules (not shown), including but not limited to data processing units, 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, in which case such functions may include, but are not limited to, filtering and encoding of several data signals, each corresponding to a user's sampled specimen level. The data processing unit may include or otherwise communicate with the reader device 106 (Figure 1), including an antenna for communication with it.

[0276] As shown in the figures, the shell 2606, mount 2608, and PCB 2802 each define corresponding central openings 2804, 2806, and 2808, respectively. When the electronic equipment housing 2604 is assembled, the central openings 2804, 2806, and 2808 are coaxially aligned to receive the plug assembly 2610 (Figures 27A to 27B). The electronic equipment housing 2604 can be configured to house the battery 2810 and supply power to the sensor control device 2602.

[0277] In Figure 28B, a plug receptacle 2812 can be positioned within the bottom of the mount 2808, and the plug receptacle 2812 can provide a place to receive the plug assembly 2610 (Figures 27A-27B) and couple it to the electronic equipment housing 2604, thereby providing a place to fully assemble the sensor control device 2602 (Figures 26A-3B). The profile of the plug 2702 (Figures 27A-27C) can be molded to fit or complement the plug receptacle 2812, and the plug receptacle 2812 can provide one or more snap engagement ledges 2814 (two shown) configured to interface with and receive the deflectable arm 2707 (Figures 27A-27B) of the plug 2702. The plug assembly 2610 is coupled to the electronic equipment housing 2604 by advancing the plug 2702 into the plug receptacle 2812, allowing the deflectable arm 2707 to engage in the corresponding snap engagement ledge 2814. With the plug assembly 2610 (Figures 27A-27B) properly coupled to the electronic equipment housing 2604, one or more circuit contacts 2816 (three shown) located on the underside of the PCB 2802 can make conductive communication with the electrical contacts 2720 (Figures 27A-27B) of the connector 2704 (Figures 27A-27B).

[0278] Figures 29A and 29B are a side view and a cross-sectional side view, respectively, of an exemplary embodiment of the sensor applicator 102 with the applicator cap 210 attached. More specifically, Figures 29A and 29B show the state in which the sensor applicator 102 is shipped to the user and the state in which the user can receive it. As disclosed in the present invention and as seen in Figure 29B, the sensor control device 2602 is already assembled and installed inside the sensor applicator 102 before being delivered to the user.

[0279] As described above, before coupling the plug assembly 2610 to the electronic circuit housing 2604, the plug assembly 2610 can undergo radiation sterilization to sterilize the distal portions of the sensor 2616 and the sharp body 2618. In a properly sterilized state, the plug assembly 2610 can then be coupled to the electronic circuit housing 2604, as generally described above, thereby forming a 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 screwed onto the housing 208 and may 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 will break, thereby freeing the applicator cap 210 from the sensor applicator 102.

[0280] The disclosure of the present invention allows the sensor control device 2602 to undergo gaseous chemi-sterilization 2904 while loaded in the sensor applicator 102, configured to sterilize the electronic housing 2604 and any exposed portions of the sensor control device 2602. To achieve gaseous chemi-sterilization 2904, a chemical can be injected into a sterilization chamber 2906, which is determined in cooperation with the sensor applicator 102 and the interconnected cap 210. In some applications, the chemical can be injected into the sterilization chamber 2906 through one or more vents 2908 located at the proximal end 2910 of the applicator cap 210. Exemplary chemicals that can be used for gaseous chemi-sterilization 2904 include, but are not limited to, ethylene oxide, hydrogen peroxide vapor, and nitrogen oxides (e.g., nitrous oxide, nitrogen dioxide).

[0281] Since the distal portions of the sensor 2616 and the sharpened body 2618 are sealed inside the storage vial 2620, the chemicals used during gaseous chemical sterilization do not interact with the enzymes, chemical agents, or biological agents provided on the tail 2708.

[0282] Once the desired level of sterility assurance is achieved within the sterilization chamber 2906, the gaseous solution is removed and the sterilization chamber 2906 is aerated. Aeration can be achieved by a series of depressurizations followed by nitrogen gas circulation or germicidal air circulation through the sterilization chamber 2906. With the sterilization chamber 2906 properly aerated, the vent 2908 can be sealed with seal 2912 (shown by the dashed line).

[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 such as Tyvek®, available from DuPont® (e.g., flash-spun density polyethylene fiber). Tyvek® is highly durable and puncture-resistant and allows vapor permeability. The Tyvek® layer may be added before or after gaseous chemical sterilization, and a foil or other vapor-resistant and moisture-resistant material layer may be sealed (e.g., heat-sealed) on top of the Tyvek® layer to prevent the movement of contaminants and moisture into the sterilization chamber 2906. In other embodiments, the seal 2912 may consist of only a single protective layer added to the applicator cap 210. 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.

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

[0285] Figure 30 is a perspective view of an exemplary embodiment of the applicator cap 210 according to the disclosure of the present invention. As shown, the applicator cap 210 has a substantially circular cross-section and defines a series of screw threads 7302 used to connect the applicator cap 210 to the sensor applicator 102 (Figures 29A and 29B). A ventilation hole 2908 is also visible inside the bottom of the applicator cap 210.

[0286] The applicator cap 210 may further provide and otherwise provide a cap post 3004 that is centrally located within the applicator cap 210 and extends proximal to the bottom of the applicator cap 210. The cap post 3004 may be configured to assist in supporting the sensor control device 2602 while it is confined within the sensor applicator 102 (Figures 29A-29B). Furthermore, the cap post 3004 may provide 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 may include one or more compliant feature portions 3008 that are stretchable or flexible to allow the storage vial 2620 to pass through. In some embodiments, for example, the compliant feature portion 3008 may include a collet-type device that includes a plurality of compliant fingers configured to flex radially outward to receive the storage vial 2620. However, in other embodiments, the compliant feature portion 3008 may include an elastomer or another type of compliant material configured to expand radially to receive the storage vial 2620.

[0288] Figure 31 is a cross-sectional side view of a sensor control device 2602 positioned within an applicator cap 210 according to one or more embodiments. As shown, the cap post 3004 defines a post chamber 3102 configured to receive a storage vial 2620. The opening 3006 to the cap post 3004 provides access to the post chamber 3102 and provides a first diameter D1. In contrast, the expanding head 2740 of the storage vial 2620 provides a second diameter D2 which is larger than the first diameter D1 and further larger than the remaining outer diameter of the storage vial 2620. Thus, as the storage vial 2620 extends into the post chamber 3102, the compliant feature portion 3008 of the opening 3006 can bend (expand) radially outward to receive the expanding head 2740.

[0289] In some embodiments, the magnifying head 2740 may provide or otherwise define an inclined outer surface that helps bias the compliant feature portion 3008 radially outward. However, the magnifying head 2740 may define an upper shoulder 3104 that prevents the storage vial 2620 from returning to the post chamber 3102. More specifically, the shoulder 3104 may include an acute-angled surface at a location of a second diameter D2 that engages with the compliant feature portion 3008 but does not bias the compliant feature portion 3008 to deflect radially outward in the return direction.

[0290] With the expanding head 2740 bypassing the opening 3006, the compliant feature portion 3008 flexes back to (or toward) its natural position. In some embodiments, the compliant feature portion 3008 can engage with the outer surface of the storage vial 2620, but nevertheless it is possible to allow the applicator cap 210 to rotate relative to the storage vial 2620. Thus, when the user removes the applicator cap 210 by rotating it relative to the sensor applicator 102 (Figures 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 separating the sensor control device 2602 from the applicator cap 210, the shoulder 3104 defined on the magnifying head 2740 engages with the compliant feature 3008 at the opening 3006. Since the diameter of the shoulder 3104 is larger than the diameter of the opening 3006, the shoulder 3104 engages with the compliant feature 3008, thereby separating the storage vial 2620 from the sensor control device 2602, thereby exposing the distal portions of the sensor 2616 and the pointed body 2618. Thus, the compliant feature 3008 can prevent the magnifying head 2740 from coming out of 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 fall into the post chamber 3102 and remain there.

[0292] In some embodiments, instead of including the compliant feature portion 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 screwably engaged with the threads of the opening 3006. The storage vial 2620 can be received into the post chamber 3102 by screwing and rotating. However, when the applicator cap 210 is removed from the sensor applicator 102, the opposing threads on the opening 3006 and the threads on the storage vial 2620 can be engaged, allowing the storage vial 2620 to be separated from the sensor control device 2602.

[0293] Therefore, there are several advantages to integrating the sensor control device 2602 into a sample monitoring system (e.g., the sample monitoring system 100 in Figure 1). Since the sensor control device 2602 is ultimately assembled in a controlled environment, tolerances can be reduced or completely eliminated, thereby making the sensor control device 2602 thinner and smaller. Furthermore, since 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, thereby allowing the sensor unit to be fully tested before packaging for final delivery.

[0294] Embodiments disclosed herein include the following:

[0295] L. A sensor control device comprising an electronic equipment housing, a plug assembly matable with the electronic equipment housing, the plug assembly including a sensor module having a sensor and a sharp body module having a sharp body, and a storage vial coupled to the plug assembly and defining an inner chamber, wherein the distal portions of the sensor and sharp body are receivable into the inner chamber and isolated from gaseous chemical sterilization within the inner chamber.

[0296] A sample monitoring system comprising: a sensor applicator; a sensor control device positioned within the sensor applicator and including an electronic housing; a plug assembly coupled to the electronic housing, the plug assembly comprising a sensor module having a sensor and a sharp body module having a sharp body; and a storage vial coupled to the plug assembly and defining an inner chamber. The sample monitoring system further comprises a cap coupled to the sensor applicator and providing a barrier to seal the sensor control device within the sensor applicator, the distal portions of the sensor and sharp body being received into the inner chamber and isolated from gaseous chemical sterilization within the inner chamber.

[0297] N. A method for preparing a specimen monitoring system, comprising loading a sensor control device into a sensor applicator, the sensor control device comprising an electronic equipment housing, a plug assembly matable with the electronic equipment housing, the plug assembly comprising a sensor module having a sensor and a sharp body module having a sharp body, and a storage vial coupled to the plug assembly and defining an inner chamber. The method further comprises the steps of securing a cap to the sensor applicator, thereby providing a barrier to seal the sensor control device inside the sensor applicator, sterilizing the sensor control device by gaseous chemical sterilization while the sensor control device is positioned inside the sensor applicator, and isolating the distal portions of the sensor and sharp body received in the inner chamber from gaseous chemical sterilization.

[0298] Each of embodiments L, M, and N may have one or more of the following additional elements in any combination: Element 1: The sensor module further includes a plug, and a storage vial is removably coupled to the plug. Element 2: The storage vial provides an expanding head, the diameter of which is greater than the remaining diameter of the storage vial. Element 3: The inner chamber further includes a seal providing a sealing barrier between the inner chamber and its exterior, the distal portion of the sensor and sharp body extending through the seal into the inner chamber. Element 4: The inner chamber further includes a storage fluid that isolates the distal portion of the sensor and sharp body from gaseous chemical sterilization. Element 5: The distal portion of the sensor and sharp body is 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, brine, 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 for receiving the magnifying 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 magnifying head. Element 10: One or more compliant features include a plurality of compliant fingers. Element 11: One or more compliant features prevent the magnifying head from passing through the opening and out of the post chamber 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 into the post chamber. Element 13: The inner chamber further contains a storage fluid that isolates the distal portion of the sensor and sharp body from gaseous chemical sterilization.

[0300] Element 14: The steps of assembling the plug assembly, connecting the storage vial to the plug assembly so that the distal portions of the sensor and sharp body are received into the inner chamber, and connecting the plug assembly to the electronic housing so as to provide the sensor control device, precede the step of loading the sensor control device into the sensor applicator. Element 15: The step of sterilizing the plug assembly by radiation sterilization precedes the step of connecting the storage vial to the plug assembly. Element 16: The step of isolating the distal portions of the sensor and sharp body from gaseous chemical sterilization includes at least partially immersing the distal portions of the sensor and sharp body in the storage fluid present in the inner chamber. Element 17: The step of fixing the cap to the sensor applicator, wherein the cap provides a cap post defining a post chamber in which one or more compliant features are positioned at the opening, includes receiving the magnification head of the storage vial into the post chamber through the opening, and flexing one or more compliant features radially outward to receive the magnification head.

[0301] As an unrestricted example, exemplary combinations applicable to L, M, and N include the combinations of element 4 and element 5, element 4 and element 6, element 4 and element 7, element 8 and element 9, element 9 and element 10, element 9 and element 17, element 8 and element 12, element 8 and element 13, and element 14 and element 15.

[0302] Isolation of one-piece sensor design using focused electron beam sterilization Figures 32A and 32B are isometric and side views, respectively, of an exemplary sensor control device 3202 according to one or more embodiments of the disclosure of the present invention. The sensor control device 3202 (also referred to as the “pack”) can be similar in some respects to the sensor control device 104 of Figure 1, and is therefore best understood by referring to it. In some applications, the sensor control device 3202 can replace the sensor control device 104 of Figure 1, and can therefore be used in conjunction with the sensor applicator 102 (Figure 1) that delivers the sensor control device 3202 to a target monitoring location on the user’s skin.

[0303] However, the sensor control device 3202 can be integrated into a one-piece system architecture, in contrast to the sensor control device 104 in Figure 1. Unlike a two-piece architecture, for example, the user is not required to unpack multiple packages and finally assemble the sensor control device 3202 before use. Instead of requiring final assembly, the sensor control device 3202 is already fully assembled and properly positioned within the sensor applicator 102 (Figure 1) upon user acceptance. To use the sensor control device 3202, the user only needs to clear one barrier (for example, remove the applicator cap 210 in Figure 2B) before immediately sending the sensor control device 3202 to the target monitoring location.

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

[0305] The electronic equipment housing 3204 may include a shell 3206 and a mount 3208 to which it can be mated. The shell 3206 can be secured to the mount 3208 by a variety of means, such as snap-fit ​​engagement, interlocking fit, ultrasonic (or sotopulsive) welding, or by 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 added to or near the outer diameter (circumference) of the shell 3206 and the mount 3208. The sealing material can be compressed by securing the shell 3206 to the mount 3208, thereby creating a sealed interface. In at least one embodiment, an adhesive can be added to the outer diameter (circumference) of one or both of the shell 3206 and the mount 3208, so that the adhesive can not only secure the shell 3206 to the mount 3208 but also seal the interface.

[0306] In embodiments where a sealed interface is provided between the shell 3206 and the mount 3208, the interior of the electronic equipment 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 the sterilization of the internal electrical components, the sealed engagement can provide a sufficient sterile barrier to the assembled electronic equipment housing 3204.

[0307] The sensor control device 3202 may further include a sensor module 3210 (partially visible in Figure 32B) and a pointed body module 3212 (partially visible). The sensor module 3210 and the pointed body module 3212 are interconnectable and can be coupled to the electronic housing 3204. The sensor module 3210 may be configured to carry and include a sensor 3214 (Figure 32B), and the pointed body module 3212 may be configured to carry and include a pointed body 3216 (Figure 32B) used to assist in the transcutaneous delivery of the sensor 3214 under the user's skin during application of the sensor control device 3202.

[0308] As shown in Figure 32B, the corresponding portions of the sensor 3214 and the pointed body 3216 extend from the electronic equipment housing 3204, more specifically from the bottom of the mount 3208. The exposed portion of the sensor 3214 can be accommodated in the hollow or recessed portion of the pointed body 3216. The remaining portion of the sensor 3214 is positioned within the electronic equipment housing 3204.

[0309] The adhesive patch 3218 can be positioned and attached to the underside of the mount 3208. Similar to the adhesive patch 108 in Figure 1, the adhesive patch 3218 can be configured to fix and maintain the sensor control device 3202 in place on the user's skin while it is operating. 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] Figures 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 electronic equipment housing 3204 act as opposing clamshell halves that surround or substantially enclose various electronic components of the sensor control device 3202.

[0311] A printed circuit board (PCB) 3302 can be positioned within the electronic equipment housing 3204. As shown in Figure 33B, multiple 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 (Figure 33B) can be mounted on the PCB 3302, and the data processing unit 3306 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 3202. More specifically, the data processing unit 3306 may be configured to perform data processing functions such as filtering and encoding multiple data signals, each corresponding to a user's sampled sample level. The data processing unit 3306 may include or otherwise communicate with the reader device 106 (Figure 1), including an antenna for communication with it.

[0312] As shown in the figure, the shell 3206, mount 3208, and PCB 3302 each define corresponding central openings 3308a, 3308b, and 3308c, respectively. When the sensor control device 3202 is assembled, the central openings 3308a to 3308c are coaxially aligned to receive the sensor module and portions of the pointed body modules 3210 and 3212 passing through them.

[0313] The electronic equipment housing 3204 can house a battery 3310 and a corresponding battery mount 3312. The battery 3310 can be configured to supply power to the sensor control device 3202.

[0314] The sensor module 3210 may include a sensor 3214 and a connector 3314. The sensor 3214 includes a tail 3316, a flag 3318, and a neck 3320 interconnecting them. The tail 3316 may extend through a central opening 3308b defined within the mount 3208 and further extend distally from the underside of the mount 3208. The tail 3316 contains an enzyme or other chemical or biological agent, and in some embodiments, a membrane may cover the chemical agent. During use, the tail 3316 is received percutaneously under the user's skin, and the chemical agent contained on the tail 3316 helps facilitate specimen monitoring in the presence of body fluids.

[0315] The flag 3318 may include a substantially flat surface on which one or more sensor contacts 3322 (three are shown in Figure 33A) are positioned. The flag 3318 may be configured to be received within a connector 3314, in which case 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 and rotate between an open and a closed state. Figures 33A and 33B show the connector 3314 in the closed state, but the connector 3314 can transition to an open state to accept a flag 3318 and a compliant carbon-impregnated polymer module contained therein. The compliant carbon-impregnated polymer module provides electrical contacts 3326 (three shown in Figure 33A) configured to provide conductive communication between the sensor 3214 and the corresponding circuit contacts 3328 provided on the PCB 3302. With the sensor module 3210 properly coupled to the electronic housing 3204, the circuit contacts 3328 are in conductive communication with the electrical contacts 3326 of the connector 3314. The connector 3314 can be manufactured from silicone rubber and can act as a moisture barrier to the sensor 3214.

[0317] The sharp body module 3212 includes a sharp body 3216 and a sharp body hub 3330 that supports it. The sharp body 3216 includes an elongated shaft 3332 and a sharp body tip 3334 at its distal end. The shaft 3332 may be configured to extend through each of the coaxially aligned central openings 3308a to 3308c and further to extend distally from the bottom of the mount 3208. Furthermore, the shaft 3332 may include a hollow portion or recessed portion 3336 that at least partially surrounds the tail 3316 of the sensor 3214. The sharp body tip 3334 may be configured to penetrate the skin while supporting the tail 3316 in order to bring the activating agent of the tail 3316 into contact with body fluids.

[0318] The pointed hub 3330 may include a hub miniature cylinder 3338 and a hub snap clasp 3340, each of which can be configured to assist in coupling the sensor control device 3202 to the sensor applicator 102 (Figure 1).

[0319] Referring particularly to Figure 33A, in some embodiments, the sensor module 3210 can be at least partially received in a sensor mount pocket 3342 contained within the electronic housing 3204. In some embodiments, the sensor mount pocket 3342 may include a separate structure, or it may instead form an integral part or extension of the mount 3208. The sensor mount pocket 3342 is molded to receive and seat the sensor 3214 and connector 3314, and may be otherwise configured. As shown, the sensor mount pocket 3342 defines a perimeter 3344 that substantially encloses 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 electronic housing 3204 is fully assembled. In some embodiments, a gasket (e.g., an O-ring), adhesive, or another type of sealing material may be added (placed) on the perimeter 3344, which can work 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 PCB 3302 can help create or define a sealed zone or sealed area within the electronics housing 3204. A sealed area has proven advantageous in that it helps isolate (protect) the tail 3316 of the sensor 3214 from potentially harmful sterilization gases used during gaseous chemical sterilization.

[0321] Referring particularly to Figure 33B, multiple channels or grooves 3346 can be provided on the bottom of the mount 3208. As shown, the grooves 3346 can form multiple concentric rings in combination with multiple radially extending channels. An adhesive patch 3218 (Figures 32A-32B) can be attached to the underside of the mount 3208, and in some embodiments, a transfer adhesive 3220 (Figures 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 in that they facilitate the release of moisture away from the center of the electronic equipment housing 3204 beneath the adhesive patch 3218.

[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 may include a substantially flat portion of the bottom of the mount 3208. A second central opening 3308b may be defined at the center of the cap post seal interface 3348, and a groove 3346 may 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] Figures 34A and 34B are a side view and a cross-sectional side view, respectively, of the sensor applicator 102 with the applicator cap 210 attached. More specifically, Figures 34A to 34B show the state in which the sensor applicator 102 is shipped to the user and the state in which the user can receive it. As disclosed in the present invention and as seen in Figure 34B, the sensor control device 3202 is already assembled and installed inside the sensor applicator 102 before being delivered to the user. The applicator cap 210 can be screwed 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 is unscrewed, thereby freeing the applicator cap 210 from the sensor applicator 102. Subsequently, the user can deliver the sensor control device 3202 to the target monitoring location as generally described above with reference to Figures 2E to 2G.

[0324] Referring particularly to Figure 34B, the sensor control device 3202 can be loaded into the sensor applicator 102 by mating the pointed hub 3330 with the sensor carrier 3404 contained within the sensor applicator 102. More specifically, the hub miniature cylinder 3338 and the hub snap stopper 3340 can be received by the corresponding mating features of 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 in the figure, the applicator cap 210 provides, or may otherwise define, a cap post 3406 centrally located within the applicator cap 210 and extending proximal to its bottom. The cap post 3406 can be configured to assist in supporting the sensor control device 3202 while it is confined within the sensor applicator 102. Furthermore, the cap post 3406 can define a post chamber 3408 configured to receive the sensor 3214 and the pointed body 3216 extending from the bottom of the electronic housing 3204. With the sensor control device 3202 loaded into the sensor applicator 102, the sensor 3214 and the sharp body 3216 can be positioned within a sealed region 3410, which is at least partially defined by the post chamber 3408 and configured to isolate the sensor 3214 and the sharp body 3216 during gaseous chemical sterilization.

[0326] In some embodiments, before assembling the sensor control device 3202 and loading it into the sensor applicator 102, the sensor module and the pointed body modules 3210, 3212 can be radiation-sterilized to sterilize the distal portions of the sensor 3214 and the pointed body 3216. After proper sterilization, the sensor module and the pointed body modules 3210, 3212 can then be coupled to the electronic equipment housing 3204, and the fully assembled sensor control device 3202 can then be loaded into the sensor applicator 102 as described above.

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

[0328] In some embodiments, as shown, the sensor control device 3202 can undergo "focused" radiation sterilization 3412, in which case radiation (e.g., a beam, wave) from the radiation sterilization 3412 is applied to the sensor module and the sharp body modules 3210, 3212 (e.g., sensor 3214 and sharp body 3216) and directed toward them. In such embodiments, electrical components 3304 (Figure 33B) coupled to the PCB 3302 (Figures 33A-33B), including the data processing unit 3306 (Figure 33B), can be positioned outside the range of the propagating radiation, thereby preventing these electrical components from being affected by the radiation. The electrical components 3304 and the data processing unit 3306 can be positioned, for example, near their outer periphery on the PCB 3302 so as not to fall within the range (spread) of the focused radiation sterilization 3412. In other embodiments, protection of electrical components from radiation can be achieved by shielding the highly sensitive electrical components 3304 with appropriate electromagnetic shielding.

[0329] By disclosing the present invention, the sensor control device 3202 can undergo gaseous chemi-sterilization 3414 to sterilize the electronic housing 3204 and any exposed portions of the sensor control device 3202 while loaded in the sensor applicator 102. To achieve gaseous chemi-sterilization 3414, a chemical can be injected into a sterilization chamber 3416, which is determined in cooperation with the sensor applicator 102 and the interconnected cap 210. In some applications, the chemical can be injected through one or more vents 3418 located at the proximal end 3420 of the applicator cap 210. Exemplary chemicals that can be used for gaseous chemi-sterilization 3414 include, but are not limited to, ethylene oxide, hydrogen peroxide vapor, and nitrogen oxides (e.g., nitrous oxide, nitrogen dioxide).

[0330] Since the sensor 3214 and the pointed body 3216 are sealed within the sealed area 3410, the chemicals used during gaseous chemical sterilization do not interact with the enzymes, chemical agents, or biological agents provided on the tail 3316.

[0331] Once the desired level of sterility assurance is achieved within the sterilization chamber 3416, the gaseous solution is removed and the sterilization chamber 3416 is aerated. Aeration can be achieved by a series of depressurizations followed by nitrogen or germicidal air circulation through the sterilization chamber 3416. With the sterilization chamber 3416 properly aerated, the vent 3418 can be sealed with a seal 3422 (shown by the dashed line) attached 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. The first layer may be made of a synthetic material such as Tyvek®, available from DuPont® (e.g., flash-spun density polyethylene fiber). Tyvek® is highly durable and puncture-resistant and allows vapor permeability. The Tyvek® layer may be added before or after gaseous chemical sterilization 3414, and a foil or other vapor-resistant and moisture-resistant material layer may be sealed (e.g., heat-sealed) on top of the Tyvek® layer to prevent the movement of contaminants and moisture into the sterilization chamber 3416. In other embodiments, the seal 3422 may consist of only a single protective layer added 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 against external contamination, thereby maintaining a sterile environment for the assembled sensor control device 3202 until the user removes (twists off) the applicator cap 210. The applicator cap 210 can also create a dust-free environment, preventing the adhesive patch 3218 used to secure the sensor control device 3202 to the user's skin from becoming contaminated during transport and storage.

[0334] Figure 35 is an enlarged cross-sectional side view of a sensor control device 3202 mounted within a sensor applicator 102 to which an applicator cap 210 according to one or more embodiments is fixed. As described above, the sensor 3214 and the sharp body 3216 are located within a sealed region 3410, thereby protecting the sensor 3214 from substances that may cause adverse interactions with the chemical formulation. More specifically, the gas used in gaseous chemical sterilization 3414 (Figure 34B) may adversely affect enzymes provided on the tail 3316 of the sensor 3214, and the sealed region 3410 protects the tail 3316 from the movement of such chemicals.

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

[0336] In some embodiments, the first seal 3502a can form part of the pointed body hub 3330. For example, the first seal 3502a can be overmolded onto the pointed body hub 3330. In other embodiments, the first seal 3502a can be overmolded onto the upper surface of the shell 3206. In yet another embodiment, the first seal 3502a may include a separate structure, such as an O-ring, sandwiched between the pointed body hub 3330 and the upper surface of the shell 3206, without departing from the scope of the disclosure of the present invention.

[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 the second central opening 3308b defined within the mount 3208. As a result, the second seal 3502b can prevent fluids (e.g., gaseous chemicals) from moving into the post chamber 3408 of the cap post 3406, and further prevent them from moving into the electronic equipment housing 3204 through the second central opening 3308b.

[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 on top of the cap post 3406. In other embodiments, the second seal 3502b can be overmolded on the cap post seal interface 3348 at the bottom of the mount 3208. In yet another embodiment, the second seal 3502b may include a separate structure, such as an O-ring, that is sandwiched between the cap post 3406 and the bottom of the mount 3208, without departing from the scope of the disclosure of the present invention.

[0339] After loading the sensor control device 3202 into the sensor applicator 102 and securing the applicator cap 210 to the sensor applicator 102, the first and second seals 3502a and 3502b become compressed, generating corresponding sealing interfaces. The first and second seals 3502a and 3502b can be manufactured from a variety of materials that have the function of generating a sealing 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 outer periphery 3344 of the sensor mount pocket 3342 and the underside of the PCB 3302. The third seal 3502c may include a gasket (e.g., an O-ring), adhesive, or another type of sealing material attached (positioned) to the outer periphery 3344. When in operation, the third seal 3502c can prevent fluids (e.g., gaseous chemicals, liquids, etc.) from entering the sensor mount pocket 3342 and thus moving into the post chamber 3408 to cause adverse reactions with the enzyme on the tail 3316.

[0341] The applicator cap 210 can be secured to the sensor applicator 102 by screwing it onto the sensor applicator 102 by 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 with the cap post seal interface 3348 located at the bottom of the mount 3208. After engaging with the cap post seal interface 3348, the second seal 3502b frictionally engages with the mount 3208, thereby biasing the entire electronic housing 3204 to rotate in the same angular direction.

[0342] In conventional sensor control devices, such as the sensor control device 104 in Figure 1, a conical carrier gripping feature is typically defined on the outside of the electronic device housing and configured to fit into a corresponding conical feature provided on a radially biased arm of the sensor mount pocket 3342. The mating engagement between these corresponding conical features helps prevent the electronic device housing from rotating within the sensor applicator 102.

[0343] In contrast, the electronic housing 3204 of the sensor control device 3202 disclosed in the present invention provides or otherwise provides a continuously smooth outer surface 3504 that slopes around its outer diameter (periphery). In some embodiments, as shown, the smooth outer surface 3504 may be provided on the mount 3208, but instead, it may be provided on the shell 3206 without departing from the scope of the disclosure of the present invention. One or more radially biased arms of the sensor mount pocket 3342 can be positioned to engage with the outer surface 3504 in order to assist in centering the sensor control device 3202 in the sensor applicator 102. Since the electronic housing 3204 is biased to rotate by frictional engagement between the second seal 3502b and the bottom of the mount 3208, the outer surface 3504 slides into the radially biased arms, thereby not restricting the rotation of the arms.

[0344] Figure 36 is an enlarged cross-sectional bottom view of a sensor control device 3202 positioned on a cap post 3406 according to one or more embodiments. As shown, an adhesive patch 3218 is positioned below the mount 3208, and a transfer adhesive 3220 is 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. Furthermore, as shown in the figure, the adhesive patch 3218 can extend only a short distance into the cap post seal interface 3348. In order to enable the groove 3346 to properly direct moisture away from the center of the electronic equipment housing 3204 and further away from the cap post seal interface 3348, the adhesive patch 3218 (and the transfer adhesive 3220, if included) may provide or otherwise define one or more channels 3602 aligned with the groove 3346 and positioned to communicate with other fluids. In the illustrated embodiment, the channels 3602 extend radially outward from the center of the electronic equipment housing 3204, but they may be defined in other configurations, and nevertheless be interconnected with the groove 3346 to facilitate fluid communication between the channels 3602 and the groove 3346.

[0346] During operation, with moisture accumulating around the center of the electronic equipment housing 3204 and at the cap post seal interface 3348, the moisture can flow through the channel 3602 into the groove 3346. Once inside the groove 3346, the moisture can flow radially outward beneath the adhesive patch 3218 toward the outer circumference of the sensor control device 3202.

[0347] Embodiments disclosed herein include the following:

[0348] O. A sample monitoring system comprising a sensor applicator, a sensor control device positioned within the sensor applicator, the sensor control device including an electronic housing having a shell and a mount matable to the shell, a printed circuit board positioned within the electronic housing, a sensor extending from the bottom of the mount, a sharp body hub positioned adjacent to the top of the shell, and a sharp body supported by the sharp body hub, extending through the electronic housing and further extending from the bottom of the mount. The sample monitoring system further comprises a cap coupled to the sensor applicator, the cap providing a cap post defining a post chamber for receiving the sensor and sharp body extending from the bottom of the mount, and a sealed region encompassing the post chamber and a portion of the interior of the electronic housing, wherein the sealed region is defined by a first seal sealing the interface between the sharp body hub and the shell, a second seal sealing the interface between the cap post and the bottom of the mount, and a third seal sealing the interface between the mount and the printed circuit board, and the sensor and a portion of the sharp body are located within the sealed region, thereby isolating them from gaseous chemical sterilization.

[0349] A method for preparing a specimen monitoring system, comprising loading a sensor control device into a sensor applicator, the sensor control device comprising an electronic equipment housing having a shell and a mount matable to the shell; a printed circuit board positioned within the electronic equipment housing; a sensor module having a sensor extending from the bottom of the mount; and a sharp body module having a sharp body hub and a sharp body supported by the sharp body hub, extending through the electronic equipment housing and further extending from the bottom of the mount. The method further comprises the steps of: fixing a cap to the sensor applicator that provides a cap post defining a post chamber for receiving the sensor and sharp body extending from the bottom of the mount; creating a sealed region containing the post chamber and a portion of the interior of the electronic equipment housing, with a portion of the sensor and sharp body present therein, when the cap is fixed to the sensor applicator; sterilizing the sensor control device by gaseous chemical sterilization while the sensor control device is positioned within the sensor applicator; and isolating the portions of the sensor and sharp body present within the sealed region from gaseous chemical sterilization.

[0350] Each of embodiments O and P may have one or more of the following additional elements in any combination: Element 1: A first seal surrounding a central opening defined in the shell, preventing fluid from moving through the central opening into the aforementioned portion of the electronic housing. Element 2: A second seal surrounding a central opening defined in the mount, preventing fluid from moving through the central opening into this portion of the electronic housing, and further preventing fluid from moving into the post chamber. Element 3: The first seal being overmolded onto a pointed hub. Element 4: The first seal being sandwiched between the pointed hub and the upper surface of the shell. Element 5: The second seal being overmolded onto a cap post. Element 6: The second seal being sandwiched between the cap post and the bottom surface of the mount. Element 7: The first and second seals being manufactured 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 a sensor module within the electronic housing, and a third seal is positioned on the outer periphery of the sensor mount pocket. Element 9: The third seal includes either a gasket or an adhesive. Element 10: Further includes a plurality of grooves defined on the bottom of the mount and a cap post seal interface defined at the center of the mount on the bottom of the mount, with a second seal sealing the cap post seal interface. Element 11: Further includes 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 within the adhesive patch that interconnect with the plurality of grooves to facilitate fluid communication between the cap post seal interface and the plurality of grooves. Element 12: The electronic housing has a sloped, smooth outer surface that allows the sensor control device to rotate unimpeded relative to the sensor applicator when the cap is coupled to the sensor applicator.

[0351] Element 13: The step of creating a sealed area when the cap is fixed to the sensor applicator includes the steps of sealing the interface between the sharp body 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: The steps of sterilizing the sensor and sharp body by radiation sterilization and assembling the sensor module and sharp body module into the electronic housing precede the step of loading the sensor control device into the sensor applicator. Element 15: The step of sterilizing the sensor and sharp body by radiation sterilization while the sensor control device is positioned within the sensor applicator precedes the step of sterilizing the sensor control device by gaseous chemical sterilization. Element 16: The radiation sterilization is at least one of focused radiation sterilization and low-energy radiation sterilization. Element 17: The electronic device housing has a sloping smooth outer surface, and the method further includes the step of enabling the sensor control device to rotate relative to the sensor applicator when the cap is secured to the sensor applicator.

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

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

[0354] Unlike the sensor control device 104 in Figure 1, for example, the user is not required to unpack multiple packages and finally assemble the sensor control device 3702 before delivery to the target monitoring location. Instead of requiring final assembly, the sensor control device 3702 can be fully assembled and properly positioned within the sensor applicator 102 upon user acceptance. To use the sensor control device 3702, the user only needs to break one barrier (e.g., the applicator cap 210 in Figure 2B) before immediately delivering the sensor control device 3702 to the target monitoring location.

[0355] Referring first to Figure 37A, the sensor control device 3702 includes an electronic housing 3704 which is substantially disc-shaped and may have a substantially circular cross-section. However, in other embodiments, the electronic housing 3704 may exhibit other cross-sectional shapes, such as oval or polygonal, without departing from the scope of the disclosure of the present invention. The electronic housing 3704 may include a shell 3706 and a mount 3708 that can be mated thereto. An adhesive patch 3710 may be positioned and attached to the underside of the mount 3708. Similar to the adhesive patch 108 in Figure 1, the adhesive patch 3710 may be configured to fix and 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 reference feature 3712. As shown, the reference feature 3712 may include a recess or light-shielding pocket defined within the shell 3706 and extending a short distance into the electronic housing 3704. The reference feature 3712 can function as a “datum c” feature configured to 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., sensor control device 104 in Figure 1) typically include a tab extending radially from the side of the shell. The tab is used as a clocking datum during the manufacturing process but must be removed at the end of manufacturing, and this removal step is followed by an inspection of the shell where the tab once existed, thereby adding an additional complexity to the conventional manufacturing process.

[0357] The shell 3706 may have a central opening 3714 sized to receive a pointed body (not shown) that can extend through the center of the electronic equipment housing 3704.

[0358] Figure 37B shows the portion of the sensor 3716 extending from the electronic equipment housing 3704. The remaining portion of the sensor 3716 is positioned within the electronic equipment housing 3704. Similar to the sensor 110 in Figure 1, the exposed portion of the sensor 3716 is configured to be positioned transcutaneously beneath the user's skin during use. The exposed portion of the sensor 3716 may contain enzymes or other chemical or biological agents, and in some embodiments, a film may cover the chemical agent.

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

[0360] Furthermore, structural improvements to the sensor control device 3702 allow the shell 3706 to provide or otherwise define a chamfered or beveled perimeter 3718. In contrast, conventional sensor control devices generally require a rounded or outwardly arc-shaped perimeter to accommodate internal components. Each of the low height H, small diameter D, and beveled perimeter 3718 has proven advantageous in that it results in a sensor control device 3702 that is thinner, smaller, and less prone to premature detachment due to catching on sharp corners while attached to the user's skin.

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

[0362] Figures 38A and 38B are exploded top and bottom views, respectively, of a sensor control device 3702 according to one or more embodiments. The shell 3706 and mount 3708 act as opposing clamshell halves that surround or substantially enclose the 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, which includes a printed circuit board (PCB) 3804 to which a plurality of electronic modules 3806 are coupled. 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 can be distributed across both sides (i.e., the top and bottom) of the PCB 3804.

[0363] Apart from the electronic 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 applic...

Claims

1. A sample automation system, Sensor applicator, A cap coupled to the sensor applicator, A sensor control device, which is positioned within the aforementioned sensor applicator and includes an electronic equipment housing, A sensor having a proximal portion and a distal portion, wherein the proximal portion is received within the electronic device housing and the distal portion extends from the bottom of the electronic device housing, A pointed hub positioned adjacent to the upper part of the aforementioned electronic device housing, Supported by the pointed body hub, extending through the electronic device housing, and further extending from the bottom of the electronic device housing, A collimator positioned within the cap, comprising a collimator that defines a sterilization zone configured to receive the sensor and the pointed body extending from the bottom of the electronic device housing, A specimen monitoring system characterized by including the following:

2. The aforementioned sterilization zone is A passage extending at least partially through the collimator, and A cross-sectional shape selected from a group consisting of cubes, rectangles, pyramidal shapes, and any combination thereof. The specimen monitoring system according to claim 1, characterized by including one of the following.

3. The specimen monitoring system according to claim 1, wherein the sterilization zone has a first opening at a first end and a second opening at a second end, the first opening receiving the sensor and the sharp body extending from the bottom of the electronic device housing, and a seal is provided at the second opening.

4. The specimen monitoring system according to claim 1, further comprising a sealed region encompassing the sterilization zone and a portion of the interior of the electronic equipment housing, wherein the sealed region is defined by a first seal sealing the interface between the pointed hub and the upper part of the electronic equipment housing, a second seal sealing the interface between the collimator and the bottom of the electronic equipment housing, and a third seal sealing the end of the sterilization zone.

5. The first seal surrounds a central opening located in the upper part of the electronic equipment housing to prevent contaminants from moving through the central opening into a portion of the interior of the electronic equipment housing, and the second seal surrounds an opening located in the lower part of the electronic equipment housing to prevent contaminants from moving through the opening into a portion of the interior of the electronic equipment housing. The first seal provides either or both axial sealing and radial sealing. The specimen monitoring system according to claim 4, characterized in that the second seal extends into the sterilization zone and defines a cylindrical vertical recess for receiving the sensor and the sharp body.

6. The specimen monitoring system according to claim 1, further comprising a printed circuit board disposed within the electronic equipment housing, a data processing unit mounted on the printed circuit board, and a shield positioned within the electronic equipment housing to protect the data processing unit from radiation from radiation sterilization.

7. The specimen monitoring system according to claim 6, characterized in that the shield is made of a non-magnetic metal selected from the group consisting of lead, tungsten, iron, stainless steel, copper, tantalum, osmium, thermoplastic polymers mixed with non-magnetic metals, and any combination thereof.

8. A step of loading a sensor control device into a sensor applicator, wherein the sensor control device includes an electronic housing and a sensor having a proximal portion and a distal portion, the proximal portion being received within the electronic housing and the distal portion extending from the bottom of the electronic housing, and the sensor control device includes a pointed body hub positioned adjacent to the top of the electronic housing and a pointed body supported by the pointed body hub, extending through the electronic housing and further extending from the bottom of the electronic housing, The step of securing the cap to the sensor applicator is to define a sterilization zone in which a collimator is positioned inside the cap and configured to receive the sensor and the pointed body extending from the bottom of the electronic device housing, The steps include: sterilizing the sensor and the pointed body by radiation sterilization while they are positioned within the sterilization zone, The steps include: preventing the radiation from the radiation sterilization from damaging the electronic components within the electronic equipment housing using the collimator; A method for preparing a specimen monitoring system, characterized by including the following:

9. The method according to 8, further comprising the step of generating a sealed area encompassing the sterilization zone and a portion of the interior of the electronic equipment housing when the cap is fixed to the sensor applicator, wherein the step of generating the sealed area optionally includes the steps of sealing the interface between the pointed body hub and the top of the electronic equipment housing with a first seal, sealing the interface between the collimator and the bottom of the electronic equipment housing with a second seal, and sealing the end of the sterilization zone with a third seal, wherein optionally the step of sealing the interface between the pointed body hub and the top of the electronic equipment housing with the first seal includes the step of providing one or both of axial and radial sealing with the first seal.

10. The collimator includes an internal collimator, and the step of sterilizing the sensor and the sharpened body using radiation sterilization is, The steps include positioning the sensor applicator adjacent to an external collimator located outside the sensor applicator, The steps include focusing the radiation using the external collimator so that it can be received by the internal collimator, The method according to 8, further comprising the step of preventing radiation from damaging the electronic components within the electronic equipment housing using the external collimator and the internal collimator.

11. The method according to 8, wherein the sterilization zone has a first opening at the first end of the collimator and a second opening at the second end of the collimator, and the step of sterilizing the sensor and the sharp body includes the step of introducing radiation into the sterilization zone through the second opening.

12. The method according to 8, characterized in that the step of preventing radiation from the radiation sterilization from damaging the electronic components includes the step of blocking the radiation with the collimator material.

13. The method according to the 8th method, wherein a printed circuit board is placed inside the electronic device housing, a data processing unit is mounted on the printed circuit board, and the method further comprises the step of protecting the data processing unit from radiation from the radiation sterilization process by a shield positioned inside the electronic device housing.

14. A step of loading a sensor control device into a sensor applicator, wherein the sensor control device includes an electronic housing and a sensor having a proximal portion and a distal portion, the proximal portion being received within the electronic housing and the distal portion extending from the bottom of the electronic housing, and the sensor control device includes a pointed body hub positioned adjacent to the top of the electronic housing and a pointed body supported by the pointed body hub, extending through the electronic housing and further extending from the bottom of the electronic housing, The step of positioning the sensor applicator adjacent to the collimator, wherein the sensor and the sharpened body are subjected to radiation sterilization. The steps include preventing the radiation from the radiation sterilization from damaging the electronic components within the electronic equipment housing using the collimator, A method for preparing a specimen monitoring system, characterized by including the following:

15. The method according to 14, characterized in that the step of positioning the sensor applicator adjacent to the collimator includes the step of positioning the collimator such that it is outside the sensor applicator during radiation sterilization.

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