Focused sterilization and sterilized sub-assemblies for analyte monitoring systems

Abstract

A system includes: a sensor applicator; a sensor control device disposed within the sensor applicator and including an electronic device housing and a sensor extending from a bottom of the electronic device housing; and a cap coupled to one of the sensor applicator and the sensor control device, wherein the cap is removable prior to 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 improperly uses insulin, a hormone produced by the pancreas that regulates blood sugar. When blood sugar levels rise (for example, after a meal), insulin lowers them by moving sugar from the blood into the body's cells. When the pancreas does not produce enough insulin (a condition known as type 1 diabetes) or the body improperly uses insulin (a condition known as type 2 diabetes), sugar remains in the blood, which can lead to hyperglycemia, or abnormally high blood sugar levels.

[0002] If the symptoms of diabetes are not carefully monitored and treated, numerous complications can occur, including diabetic ketoacidosis, nonketotic hyperosmolar coma, cardiovascular disease, stroke, kidney failure, foot ulcers, eye damage, and nerve damage. Traditionally, monitoring has involved individuals pricking their fingers to draw blood and testing the blood for glucose levels. Recent advances have allowed for continuous and long-term monitoring of blood glucose using biosensors that remain in contact with body fluids for days, weeks, or longer periods of time.

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

[0004] It is important that devices implanted in the human body or positioned beneath the skin be sterile at the time of insertion. Sterilization can include any number of processes that effectively eliminate or kill transmissible agents, such as bacteria, fungi, and viruses. If these transmissible agents are not eliminated from the device, they can significantly compromise the health and safety of the user.

[0005] Some, but not all, analyte monitoring systems may require separate sterilization processes for the sensor and electronics. Electron beam sterilization, for example, is one example of radiation sterilization that can be used for terminal sensor sterilization. However, radiation sterilization can harm the electronics associated with the sensor. Therefore, electronics are often sterilized via gaseous chemical sterilization using, for example, ethylene oxide. However, ethylene oxide can damage the chemicals provided to the sensor. Therefore, integrating the electronics and sensor into a single unit can complicate the sterilization process.

[0006] These issues can be circumvented by separating the components into a sensor unit (e.g., a bioanalyte sensor) and an adapter unit (containing the data transmission electronics), allowing each component to be individually packaged and sterilized using appropriate sterilization methods. However, this approach requires additional components, additional packaging, additional process steps, and assembly of the two components by the end user, introducing the possibility of user error. Therefore, there is a need for an analyte monitoring system that can be sterilized without separating the components. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The following drawings are included to illustrate certain aspects of the present disclosure and should not be considered as exclusive embodiments. The disclosed subject matter is capable of numerous modifications, alterations, combinations, and equivalents in form and function without departing from the scope of the present disclosure.

[0008] Figure 1 is a conceptual diagram depicting an example analyte monitoring system that may incorporate one or more embodiments of the present disclosure.

[0009] Figures 2A-2G It consists of a two-piece structure Figure 1 A progressive view of the assembly and application of systems.

[0010] Figure 3A and Figure 3B An isometric view and a side view of an example sensor control device are shown, respectively.

[0011] Figure 4A and Figure 4B They are Figures 3A-3B Isometric and exploded views of the plug assembly.

[0012] Figure 5A and Figure 5B They are Figures 3A-3B Exploded view and bottom isometric view of the electronic device housing.

[0013] Figure 6A and Figure 6B They are Figure 1 A side view and a cross-sectional side view of a sensor applicator, wherein Figure 2B The cap is coupled to the sensor applicator.

[0014] Figure 7A yes Figure 6B An enlarged cross-sectional side view of a sensor control unit mounted on a Figure 6B inside the hat.

[0015] Figure 7B yes Figure 6B An enlarged cross-sectional side view of another embodiment of a sensor control device, the sensor control device being mounted on Figure 6B inside the sensor applicator.

[0016] Figures 8-12 is a schematic diagram of an example exterior sterilization assembly according to one or more embodiments of the present disclosure.

[0017] Figure 13 is an isometric view of an example sensor control device.

[0018] Figure 14A yes Figure 1 Side view of the sensor applicator.

[0019] Figure 14B yes Figure 14A Cross-sectional side view of a sensor applicator.

[0020] Figure 15 According to one or more of the following embodiments Figure 14A Sensor applicator and Figure 14B A cross-sectional side view of another example embodiment of an external sterilization assembly.

[0021] Figure 16 According to one or more additional embodiments Figure 14A Sensor applicator and Figure 14B A cross-sectional side view of another example embodiment of an external sterilization assembly.

[0022] Figure 17A and Figure 17B According to one or more embodiments Figure 14B Isometric top and bottom views of an example of an external sterilization assembly.

[0023] Figure 18 is an isometric view of an example sensor control device.

[0024] Figure 19A yes Figure 1 Side view of the sensor applicator.

[0025] Figure 19B yes Figure 3A Partial cross-sectional side view of a sensor applicator.

[0026] Figures 20A-20C According to one or more embodiments of the present disclosure Figure 19B Various views of the applicator insert.

[0027] Figure 21 According to one or more embodiments of the present disclosure Figure 19A Another cross-sectional side view of the sensor applicator showing the hybrid sterilization assembly.

[0028] Figure 22Aand Figure 22B They are Figures 20A-20C Isometric and cross-sectional side views of another embodiment of an applicator insert.

[0029] Figure 23 is a diagram of an example analyte monitoring system that may incorporate one or more embodiments of the present disclosure.

[0030] Figure 24 is a schematic diagram of an example internal sterilization assembly according to one or more additional embodiments of the present disclosure.

[0031] Figure 25 is a schematic diagram of another example interior sterilization assembly according to one or more additional embodiments of the present disclosure.

[0032] Figure 26A and Figure 26B An isometric view and a side view of an example sensor control device are shown, respectively.

[0033] Figure 27A and Figure 27B They are Figures 26A-26B Isometric and exploded views of the plug assembly.

[0034] Figure 27C is an exploded isometric bottom view of the stopper and preserving bottle.

[0035] Figure 28A and Figure 28B They are Figures 26A-26B Exploded view and bottom isometric view of the electronic device housing.

[0036] Figure 29A and Figure 29B They are Figure 1 A side view and a cross-sectional side view of a sensor applicator, wherein Figure 2B The cap is coupled to the sensor applicator.

[0037] Figure 30 yes Figure 29A-29B A perspective view of an example embodiment of a cap.

[0038] Figure 31 is a cross-sectional side view of the sensor control assembly positioned within the cap.

[0039] Figure 32A and Figure 32B An isometric view and a side view of an example sensor control device are shown, respectively.

[0040] Figure 33A and Figure 33B They are Figure 32A-Figure 32B Exploded perspective top and bottom views of the sensor control unit.

[0041] Figure 34A and Figure 34B They are Figure 1 A side view and a cross-sectional side view of a sensor applicator, wherein Figure 2B The cap is coupled to the sensor applicator.

[0042] Figure 35 is an enlarged cross-sectional side view of the sensor control assembly mounted within the sensor applicator.

[0043] Figure 36 An enlarged cross-sectional bottom view of the sensor control assembly mounted on top of the cap post.

[0044] Figures 37A-37C Isometric, side, and bottom views of an example sensor control unit.

[0045] Figure 38A and Figure 38B They are Figures 37A-37C Isometric exploded top and bottom views of a sensor control device.

[0046] Figures 39A-39D Shown Figures 37A-37C Example assembly of a sensor control device.

[0047] Figure 40A and Figure 40B are a side view and a cross-sectional side view of the sensor applicator, respectively, where Figures 37A-37C A preassembled sensor control unit is arranged in the sensor applicator.

[0048] Figure 41A and Figure 41B is an enlarged cross-sectional view of a sensor control device during an example radiation sterilization.

[0049] Figure 42 is a graph that graphically depicts the approximate penetration depth as a function of electron beam energy level for a single-sided electron beam sterilization (or irradiation) process.

[0050] Figure 43 is a cross-sectional side view of a sensor applicator according to one or more additional embodiments, wherein Figures 37A-37C A preassembled sensor control unit is arranged in the sensor applicator.

[0051] Figure 44 is a side view of an example sensor control device.

[0052] Figure 45 yes Figure 44 Exploded view of the sensor control unit.

[0053] Figure 46A According to one or more embodiments Figure 45 Cross-sectional side view of the assembled sealing subassembly.

[0054] Figure 46B yes Figure 44 Cross-sectional side view of the fully assembled sensor control unit.

[0055] Figure 47A and Figure 47B They are Figure 1 A side view and a cross-sectional side view of an example embodiment of a sensor applicator, wherein Figure 2B The cap is coupled to the sensor applicator.

[0056] Figure 48 yes Figures 47A-47B A perspective view of an example embodiment of a cap.

[0057] Figure 49 is located in Figures 47A-47B A cross-sectional side view of the sensor control unit inside the cap.

[0058] Figure 50A and Figure 50B An isometric view and a side view, respectively, of another example sensor control device.

[0059] Figure 51A and Figure 51B They are Figures 50A-50B Exploded isometric top and bottom views of the sensor control device.

[0060] Figure 52 is a cross-sectional side view of an assembled sealing subassembly according to one or more embodiments.

[0061] Figures 53A-53C The sensor applicator is shown with Figures 50A-50B Progressive cross-sectional side view of the assembly of the sensor control unit.

[0062] Figure 54A and Figure 54B According to one or more additional embodiments Figure 53C Perspective and top views of the cap column.

[0063] Figure 55 is located in Figure 12 B- Figure 12 C's cap Figures 50A-50B Cross-sectional side view of the sensor control unit.

[0064] Figure 56A and Figure 56B is a cross-sectional side view of a sensor applicator ready to deploy a sensor control device to a target monitoring location.

[0065] Figures 57A-57C is a diagram showing an example embodiment of a sensor applicator and Figures 50A-50B Progressive cross-sectional side view of the assembly and disassembly of the sensor control unit.

[0066] Figure 58A is an isometric bottom view of a housing according to one or more embodiments.

[0067] Figure 58B is an isometric bottom view of a housing in which a sheath and other components are at least partially positioned.

[0068] Figure 59 is an enlarged cross-sectional side view of a sensor applicator with a sensor control device installed in the sensor applicator according to one or more embodiments.

[0069] Figure 60A is an isometric top view of a cap according to one or more embodiments.

[0070] Figure 60B is an enlarged cross-sectional view of the joint between the cap and the housing according to one or more embodiments.

[0071] Figure 61A and Figure 61B isometric views of a sensor cap and collar, respectively, according to one or more embodiments.

[0072] Figure 62 is an isometric top view of an example sensor control device according to one or more embodiments of the present disclosure.

[0073] Figure 63 is a schematic side view of an example sensor applicator according to one or more embodiments of the present disclosure.

[0074] Figure 64A and Figure 64B yes Figure 62 and Figure 63 Exploded isometric view of the sensor applicator and sensor control unit.

[0075] Figures 65A-65D According to one or more embodiments Figure 63 and Figure 64A-Figure 64B A progressive cross-sectional side view of a sensor applicator depicting an example deployment of a sensor control device.

[0076] Figure 66 According to one or more embodiments Figures 65A-65D An enlarged cross-sectional side view of the engagement between the sensor holder and the sensor control device.

[0077] Figure 67 According to one or more additional embodiments, Figure 62 An exploded isometric view of another sensor applicator of the sensor control device.

[0078] Figures 68A-68D According to one or more embodiments Figure 67 A progressive cross-sectional side view of a sensor applicator depicting an example deployment of a sensor control device.

[0079] Figure 69A is an enlarged schematic diagram of the sensor holder's sharp hub and fingers.

[0080] Figure 69B and Figure 69C is an enlarged schematic view of the fingers interacting with the upper portion of the needle shield.

[0081] Figure 70A and Figure 70B is an enlarged cross-sectional side view of an example interface between a sensor holder and a sensor control device according to one or more embodiments.

[0082] Figure 71A and Figure 71B 1 and 2 are an isometric view and a cross-sectional side view, respectively, of an example sensor holder according to one or more embodiments of the present disclosure.

[0083] Figure 72A and Figure 72B A sensor control device according to one or more embodiments is provided. Figure 71A-71B An enlarged cross-sectional side view of the sensor holder.

[0084] Figure 73A and Figure 73B 2 are a side view and a cross-sectional side view, respectively, of an example sensor applicator according to one or more embodiments.

[0085] Figure 74A and Figure 74B They are Figure 73B Isometric top and bottom views of the inner applicator cover.

[0086] Figure 75 According to one or more embodiments Figure 73B An isometric view of an example embodiment of a sensor cap.

[0087] Figure 76 According to one or more embodiments Figure 75 An isometric cross-sectional side view of a sensor cap comprising Figures 74A-74B The inner applicator cap receives the

[0088] Figure 77 shows a method according to one or more embodiments Figure 73A Applicator cap and Figure 74A-74B The inner applicator cap from Figure 73A-73B Progressive removal of the sensor applicator.

[0089] Figure 78 is a schematic diagram of an example sensor applicator according to one or more additional embodiments of the present disclosure.

[0090] Figure 79 is an exploded view of an example sensor control device according to one or more additional embodiments.

[0091] Figure 80 yes Figure 79 A bottom view of an embodiment of a sensor control device.

[0092] Figure 81A and Figure 81B 1 and 2 are an isometric view and a side view, respectively, of a sensor control device according to one or more embodiments of the present disclosure.

[0093] Figure 82 yes Figure 81A Exploded perspective top view of the sensor control unit.

[0094] Figure 83 Included in the sensor applicator Figure 81A A perspective cross-sectional side view of an example sensor control device assembly of a sensor control device having a Figure 1 Compatible with analyte monitoring systems.

[0095] Figure 84 yes Figure 83 An enlarged cross-sectional side view of the sensor control assembly.

[0096] Figure 85 yes Figure 83 A bottom view of some components of a sensor control assembly including a sensor control held in a sensor carrier of a sensor applicator.

[0097] Figure 86 is a schematic diagram of an example sterilization assembly according to one or more embodiments of the present disclosure.

[0098] Figure 87 is a schematic diagram of another example sterilization assembly according to one or more embodiments of the present disclosure.

[0099] Figure 88A is a schematic bottom view of another example sterilization assembly according to one or more embodiments of the present disclosure.

[0100] Figure 88B and Figure 88C According to one or more additional embodiments of the present disclosure Figure 88A Schematic bottom view of an alternative embodiment of a sterilization assembly.

[0101] Figure 89 is an isometric schematic diagram of an example sensor control device according to one or more embodiments.

[0102] Figure 90 is a schematic diagram of another example sterilization assembly according to one or more embodiments.

[0103] Figure 91A and Figure 91B 1 and 2 are side and isometric views, respectively, of an example sensor control device according to one or more embodiments of the present disclosure.

[0104] Figure 92A and Figure 92B 2 are exploded isometric top and bottom views, respectively, of the sensor control device of FIG. 2 , according to one or more embodiments.

[0105] Figure 93 According to one or more embodiments Figures 91A-91B and Figures 92A-92B Cross-sectional side view of the sensor control unit.

[0106] Figure 93A yes Figures 91A-91B and Figures 92A-92B An exploded isometric view of a portion of another embodiment of a sensor control device.

[0107] Figure 94B yes Figures 91A-91B and Figures 92A-92B Isometric top view of a sensor cap.

[0108] Figure 95A and Figure 95B 2 are a side view and a cross-sectional side view, respectively, of an example sensor applicator according to one or more embodiments.

[0109] Figure 96A and Figure 96B According to one or more embodiments Figure 95B Perspective and top views of the cap column.

[0110] Figure 97 is a cross-sectional side view of a sensor control device positioned within an applicator cap according to one or more embodiments.

[0111] Figure 98 is a cross-sectional view of a sensor control device showing an example interaction between a sensor and a sharp object.

[0112] Figure 99is a cross-sectional side view of an example analyte monitoring system housing for housing at least a portion of a sensor control assembly.

[0113] Figure 100A It is as follows Figure 99 An enlarged cross-sectional side view of the interface between the sensor applicator and the cap indicated by the dashed box.

[0114] Figure 100B During or after gaseous chemical sterilization Figure 99 An enlarged cross-sectional side view of the interface between the sensor applicator and the cap indicated by the dashed box.

[0115] Figure 101 is used to accommodate Figure 1 Another example analyte monitoring system housing of at least a portion of a sensor control device is shown in a cross-sectional side view.

[0116] Figures 102A-102C Finite element analysis results corresponding to the interface between the housing and the cap during an example gaseous chemical sterilization are provided.

[0117] Figure 103 is an isometric view of an example sensor control device.

[0118] Figure 104A and Figure 104B According to one or more embodiments Figure 103 Exploded isometric view of the sensor control unit.

[0119] Figure 105 is a cross-sectional side view of the assembled sensor control device of Figures 104A-104B according to one or more embodiments.

[0120] Figure 106 is an isometric view of another example sensor control device.

[0121] Figure 107A and Figure 107B According to one or more embodiments Figure 106 Exploded isometric view of the sensor control unit.

[0122] Figure 108 is a cross-sectional side view of the assembled sensor control device of Figures 107A-107B according to one or more embodiments.

[0123] Figure 109 is an isometric view of an example converting process for manufacturing a sensor control device according to the principles of the present disclosure.

[0124] Figures 110A-110E Depicted according to one or more embodiments Figure 109Incremental manufacturing of sensor-controlled devices.

[0125] Figure 111A Prepared for pressure testing and / or vacuum sealing according to one or more embodiments Figure 109 Top view of the sensor control unit.

[0126] Figure 111B It has a compressor Figure 109 Cross-sectional side view of the sensor control unit.

[0127] Figure 112 is a partial cross-sectional side view of an example sensor control device according to one or more embodiments.

[0128] Figure 113 is a cross-sectional side view of an example sensor applicator according to one or more embodiments.

[0129] Figure 114A and Figure 114B They are Figures 27A-27B Top and bottom perspective views of an example embodiment of a plug.

[0130] Figure 115A and Figure 115B Depicts the open and closed states respectively Figures 27A-27B A perspective view of an example embodiment of a connector.

[0131] Figure 116 yes Figures 27A-27B A perspective view of an example embodiment of a sensor.

[0132] Figure 117A and Figure 117B Bottom and top perspective views, respectively, depict an example embodiment of a sensor module assembly.

[0133] Figure 118A and Figure 118B Has certain axial strengthening features Figures 114A-114B A close-up partial view of an example embodiment of a sensor plug.

[0134] Figure 119 is a side view of an example sensor according to one or more embodiments of the present disclosure.

[0135] Figure 120A and Figure 120B are isometric and partially exploded isometric views of an example connector assembly according to one or more embodiments.

[0136] Figure 120C yes Figures 120A-120B Isometric bottom view of the connector.

[0137] Figure 121A and Figure 121B is an isometric view and a partially exploded isometric view of another example connector assembly according to one or more embodiments.

[0138] Figure 121C yes Figure 121A-121B Isometric bottom view of the connector. DETAILED DESCRIPTION

[0139] The present application generally relates to systems, devices, and methods for assembling an applicator and sensor control device for use in an in vivo analyte monitoring system.

[0140] Figure 1 is a conceptual diagram depicting an example analyte monitoring system 100 that may incorporate one or more embodiments of the present disclosure. System 100 (hereinafter "system 100") can be used to detect and quantify a variety of analytes, including but not limited to acetylcholine, amylase, bilirubin, cholesterol, human chorionic gonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA, fructosamine, glucose, glutamine, growth hormone, hormones, ketones (e.g., ketone bodies), lactate, oxygen, peroxide, prostate-specific antigen, prothrombin, RNA, thyroid-stimulating hormone, and troponin. Concentrations of drugs such as, but not limited to, antibiotics (e.g., gentamicin, vancomycin, etc.), digitoxin, digoxin, drugs of abuse, theophylline, and warfarin can also be determined.

[0141] As illustrated, the system 100 includes a sensor applicator 102 (alternatively referred to as an "inserter"), a sensor control device 104 (also referred to as an "in vivo analyte sensor control device"), and a reader device 106. The sensor applicator 102 is used to deliver the sensor control device 104 to a target monitoring location on a user's skin (e.g., a user's arm). Once delivered, the sensor control device 104 is held in place on the skin using an adhesive patch 108 coupled to the bottom of the sensor control device 104. A portion of a sensor 110 extends from the sensor control device 104 and is positioned so that it can be transcutaneously positioned and otherwise maintained beneath the surface of the user's skin during a monitoring period.

[0142] An introducer may be included to facilitate the introduction of sensor 110 into tissue. The introducer may comprise, for example, a needle, often referred to as a "sharp." Alternatively, the introducer may comprise other types of devices, such as a sheath or a blade. The introducer may be temporarily positioned near sensor 110 prior to tissue insertion and then withdrawn thereafter. When present, the introducer facilitates insertion of sensor 110 into tissue by opening an access pathway for sensor 110 to follow. For example, the introducer may penetrate the epidermis to provide an access pathway to the dermis, allowing for subcutaneous implantation of sensor 110. After the access pathway is opened, the introducer may be withdrawn (retracted) so that it remains in place without causing harm while sensor 110 remains in place. In the illustrated embodiment, the introducer may be solid or hollow, beveled or non-beveled, and / or circular or non-circular in cross-section. In more specific embodiments, a suitable introducer may be comparable in cross-sectional diameter and / or tip design to an acupuncture needle, which may have a cross-sectional diameter of approximately 250 microns. However, it will be appreciated that suitable introducers may have a larger or smaller cross-sectional diameter if desired for a particular application.

[0143] In some embodiments, the tip of the introducer (when present) can be angled on the end of the sensor 110 so that the introducer first penetrates the tissue and opens an entry path for the sensor 110. In other illustrative embodiments, the sensor 110 can reside within a lumen or recess of the introducer, wherein the introducer similarly opens an entry path for the sensor 110. In either case, after facilitating insertion of the sensor 110, the introducer is subsequently withdrawn. Furthermore, the introducer (sharp) can be made of a variety of materials, such as various types of metals and plastics.

[0144] When the sensor control device 104 is properly assembled, the sensor 110 is placed in communication (e.g., electrically, mechanically, etc.) with one or more electrical components or sensor electronics included within the sensor control device 104. In some applications, for example, the sensor control device 104 may include a printed circuit board (PCB) having a data processor (e.g., an application specific integrated circuit or ASIC) mounted thereto, and the sensor 110 may be operatively coupled to the data processor, which in turn may be coupled to an antenna and a power source.

[0145] The sensor control device 104 and the reader device 106 are configured to communicate with each other via a local communication path or link 112, which can be wired or wireless, unidirectional or bidirectional, and encrypted or non-encrypted. According to some embodiments, the reader device 106 can constitute an output medium for observing analyte concentrations and alarms or notifications determined by the sensor 110 or a processor associated therewith and allowing one or more user inputs. The reader device 106 can be a multi-purpose smartphone or a dedicated electronic reader instrument. Although only one reader device 106 is shown, multiple reader devices 106 may be present in some cases.

[0146] The reader device 106 may also communicate with the remote terminal 114 and / or the trusted computer system 116 via communication paths / links 118 and / or 120, respectively, which may also be wired or wireless, unidirectional or bidirectional, and encrypted or unencrypted. The reader device 106 may also or alternatively communicate with a network 122 (e.g., a mobile phone network, the Internet, or a cloud server) via communication path / link 124. The network 122 may further be communicatively coupled to the remote terminal 114 via communication path / link 126 and / or to the trusted computer system 116 via communication path / link 128.

[0147] Alternatively, the sensor control device 104 may communicate directly with the remote terminal 114 and / or the trusted computer system 116 in the absence of the intermediate reader device 106. For example, according to some embodiments, the sensor 110 may communicate with the remote terminal 114 and / or the trusted computer system 116 via a direct communication link to the network 122 as described in U.S. Patent No. 10,136,816, which is incorporated herein by reference in its entirety.

[0148] Any suitable electronic communication protocol may be used in each of the communication paths or links, such as near field communication (NFC), radio frequency identification (RFID), BLUETOOTH® or BLUETOOTH® low energy protocol, WiFi, etc. According to some embodiments, individuals other than the primary user interested in the user's analyte level may access the remote terminal 114 and / or the trusted computer system 116. The reader device 106 may include a display 130 and an optional input component 132. According to some embodiments, the display 130 may include a touch screen interface.

[0149] In some embodiments, the sensor control device 104 can automatically forward data to the reader device 106. For example, analyte concentration data can be automatically and periodically transmitted, such as at a certain frequency as the data is acquired or after a certain period of time, with the data stored in memory until transmission (e.g., every minute, every five minutes, or other predetermined period of time). In other embodiments, the sensor control device 104 can communicate with the reader device 106 in a non-automatic manner rather than according to a set schedule. For example, when the sensor electronics are brought into communication range of the reader device 106, data can be transmitted from the sensor control device 104 using RFID technology. The data can remain stored in the memory of the sensor control device 104 until it is transmitted to the reader device 106. Thus, the patient does not have to remain in close proximity to the reader device 106 at all times, but can instead upload data at a convenient time. In still other embodiments, a combination of automatic and non-automatic data transmission can be implemented. For example, data transmission can continue on an automatic basis until the reader device 106 is no longer within communication range of the sensor control device 104.

[0150] The sensor control unit 104 is often included with the sensor applicator 104 in a so-called "two-piece" architecture that requires final assembly by the user before the sensor 110 can be properly delivered to the target monitoring site. More specifically, the sensor 110 and associated electrical components included in the sensor control unit 104 are provided to the user in multiple (two) packages, and the user must open the packages and follow instructions to manually assemble the components before delivering the sensor 110 to the target monitoring site using the sensor applicator 102.

[0151] However, recent advancements in the design of sensor control units and sensor applicators have resulted in a one-piece architecture that allows the system to be shipped to the user in a single, sealed package that does not require any final user assembly steps. Instead, the user only needs to open a single package and then deliver the sensor control unit to the intended monitoring location. This one-piece system architecture can prove advantageous in eliminating component parts, various manufacturing process steps, and user assembly steps. As a result, packaging and waste are reduced, and the potential for user error or contamination of the system is mitigated.

[0152] In the illustrated embodiment, the system 100 may include a so-called "two-piece" architecture that requires final assembly by the user before the sensor 110 can be properly delivered to the target monitoring site. More specifically, the sensor 110 and associated electrical components included in the sensor control device 104 are provided to the user in multiple (two) packages, each of which may or may not be sealed with a sterile barrier, but is at least enclosed in the package. The user must open the package and follow instructions to manually assemble these components, and then deliver the sensor 110 to the target monitoring site using the sensor applicator 102.

[0153] Figure 2A-2G is a progressive view of the assembly and application of system 100 comprising a two-piece architecture. Figure 2A and Figure 2B A first package and a second package are respectively depicted as being provided to a user for final assembly. More specifically, Figure 2A A sensor container or tray 202 is depicted having a removable lid 204. The user prepares the sensor tray 202 by removing the lid 204, which serves as a sterile barrier to protect the internal contents of the sensor tray 202 and otherwise maintain a sterile internal environment. Removal of the lid 204 exposes a platform 206 positioned within the sensor tray 202, and a plug assembly 207 (partially visible) disposed within and otherwise strategically embedded within the platform 206. The plug assembly 207 includes a sensor module (not shown) and a sharps module (not shown). The sensor module carries the sensor 110 ( Figure 1 ), and the sharp object module carries an associated sharp object for applying the sensor control device 104 ( Figure 1 ) during which the sensor 110 is delivered transcutaneously beneath the user's skin.

[0154] Figure 2B The sensor applicator 102 and the user preparing the sensor applicator 102 for final assembly are depicted. The sensor applicator 102 includes a housing 208 sealed at one end with an applicator cap 210. In some embodiments, for example, an O-ring or another type of sealing gasket can seal the interface between the housing 208 and the applicator cap 210. In at least one embodiment, the O-ring or sealing gasket can be molded onto one of the housing 208 and the applicator cap 210. The applicator cap 210 provides a barrier to protect the internal contents of the sensor applicator 102. In particular, the sensor applicator 102 includes an electronics housing (not shown) that holds the sensor control unit 104 ( Figure 1) and the applicator cap 210 may or may not maintain a sterile environment for the electrical components. Preparing the sensor applicator 102 includes decoupling the housing 208 from the applicator cap 210, which can be accomplished by unscrewing the applicator cap 210 from the housing 208. The applicator cap 210 can then be discarded or otherwise set aside.

[0155] Figure 2C The user is depicted inserting the sensor applicator 102 into the sensor tray 202. The sensor applicator 102 includes a sheath 212 that is configured to be received by the platform 206 to temporarily unlock the sheath 212 relative to the housing 208 and also temporarily unlock the platform 206 relative to the sensor tray 202. Advancing the housing 208 into the sensor tray 202 causes the plug assembly 207 ( Figure 2A ) is coupled to an electronics housing disposed within the sensor applicator 102, the plug assembly including a sensor module and a sharps module.

[0156] exist Figure 2D In FIG. 2 , the user removes the sensor applicator 102 from the sensor tray 202 by retracting the housing 208 proximally relative to the sensor tray 202 .

[0157] Figure 2E The bottom or interior of the sensor applicator 102 is depicted after being removed from the sensor tray 202 ( FIG. 2 ). The sensor applicator 102 is removed from the sensor tray 202 with the sensor control unit 104 fully assembled therein and positioned for delivery to a target monitoring site. As illustrated, a sharp object 220 extends from the bottom of the sensor control unit 104 and carries a portion of the sensor 110 within a hollow or recessed portion thereof. The sharp object 220 is configured to penetrate the user's skin and thereby place the sensor 110 in contact with bodily fluids.

[0158] Figure 2F and Figure 2G An example delivery of the sensor control device 104 to a target monitoring location 222 , such as the back of a user's arm, is depicted. Figure 2F The user is shown advancing the sensor applicator 102 toward the target monitoring location 222. Upon engaging the skin at the target monitoring location 222, the sheath 212 collapses into the housing 208, which allows the sensor control device 104 ( Figure 2E and Figure 2G ) is advanced to engage with the skin. With the aid of the sharp object 220 ( Figure 2E ), sensor 110 ( Figure 2E ) is advanced percutaneously into the patient's skin at the target monitoring location 222.

[0159] Figure 2G The user is shown retracting the sensor applicator 102 from the target monitoring location, with the sensor control device 104 successfully attached to the user's skin. The adhesive patch 108 ( Figure 1 ) adheres to the skin to secure the sensor control device 104 in place. When the housing 208 is fully advanced to the target monitoring position 222, the sharp object 220 ( Figure 2E ) automatically retracts, and the sensor 110 ( Figure 2E ) remains in place to measure analyte levels.

[0160] For a two-piece architecture system, the sensor tray 202 ( Figure 2A ) and sensor applicator 102 ( Figure 2B ) are provided to the user as separate packages, thus requiring the user to open each package and ultimately assemble the system. In some applications, the separate sealed packages allow the sensor tray 202 and sensor applicator 102 to be sterilized in separate sterilization processes that are unique to the contents of each package and are otherwise incompatible with the contents of the other package.

[0161] More specifically, radiation sterilization, such as electron beam (or "e-beam") radiation, may be used to sterilize the sensor tray 202, which includes the plug assembly 207 ( Figure 2A ), the plug assembly includes a sensor 110 ( Figure 1 and Figure 2E ) and sharp objects 220 ( Figure 2E ). However, radiation sterilization can damage electrical components disposed within the electronics housing of the sensor control unit 104. Therefore, if the sensor applicator 102, which contains the electronics housing of the sensor control unit 104, needs to be sterilized, it can be sterilized via another method, such as gaseous chemical sterilization using, for example, ethylene oxide. However, gaseous chemical sterilization can damage enzymes or other chemicals and biological agents included 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, thereby requiring the user to finally assemble these components upon receipt.

[0162] According to an embodiment of the present disclosure, the system 100 ( Figure 1 ) may include a one-piece architecture that incorporates sterilization technology specifically designed for the one-piece architecture. The one-piece architecture allows the system 100 to be shipped to the user in a single sealed package that does not require any final user assembly steps. Instead, the user only needs to open one package and then deliver the sensor control device to the target monitoring location, as described above with reference to Figures 2E-2G The one-piece system architecture described herein may prove advantageous in eliminating component parts, various manufacturing process 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.

[0163] Focused electron beam sterilization using a collimator

[0164] Figure 3A and Figure 3B 1 and 2 are isometric and side views, respectively, of an example sensor control device 302 according to one or more embodiments of the present disclosure. The sensor control device 302 (alternatively referred to as a "puck") may be similar in some aspects to a Figure 1 The sensor control device 302 is similar to and therefore best understood with reference to the sensor control device 104. Figure 1 The sensor control device 104 and thus can be used with the sensor applicator 102 ( Figure 1 ) in conjunction with a sensor applicator, the sensor applicator delivers the sensor control device 302 to a target monitoring location on the user's skin.

[0165] However, the sensor control device 302 can be incorporated into a one-piece system architecture. Unlike a two-piece architecture system, for example, the user is not required to open multiple packages and ultimately assemble the sensor control device 302. Instead, upon receipt by the user, the sensor control device 302 is already fully assembled and properly positioned within the sensor applicator 102. To use the sensor control device 302, the user only needs to break through one barrier (e.g., Figure 2B ), and then quickly delivering the sensor control device 302 to the target monitoring location.

[0166] As illustrated, sensor control device 302 includes an electronics housing 304 that is generally disc-shaped and may have a circular cross-section. However, in other embodiments, electronics housing 304 may exhibit other cross-sectional shapes, such as oval (e.g., pill-shaped), squarish, or polygonal, without departing from the scope of this disclosure. Electronics housing 304 may be configured to house or otherwise contain various electrical components used to operate sensor control device 302.

[0167] Electronics housing 304 may include a shell 306 and a base 308 that mates with shell 306. Shell 306 may be secured to base 308 via various means, such as a snap-fit, an interference fit, sonic welding, or one or more mechanical fasteners (e.g., screws). In some cases, shell 306 may be secured to base 308 to create a sealed interface therebetween. In such embodiments, a gasket or other type of sealing material may be positioned at or near the outer diameter (perimeter) of shell 306 and base 308, and securing the two components together compresses the gasket, thereby creating a sealed interface. In other embodiments, an adhesive may be applied to the outer diameter (perimeter) of one or both of shell 306 and base 308. The adhesive secures shell 306 to base 308 and provides structural integrity, but also seals the interface between the two components, thereby isolating the interior of electronic devices housing 304 from external contaminants. If sensor control unit 302 is assembled in a controlled environment, terminal sterilization of internal electrical components may not be required. In contrast, the adhesive coupling may provide an adequate sterile barrier for the assembled electronic device housing 304 .

[0168] Sensor control device 302 may also include a plug assembly 310 that can be coupled to electronic device housing 304. Plug assembly 310 may be similar in some aspects to Figure 2A Plug assembly 310 may be similar to plug assembly 207. For example, plug assembly 310 may include a sensor module 312 (partially visible) that may be interconnected with a sharps module 314 (partially visible). Sensor module 312 may be configured to carry and otherwise include a sensor 316 (partially visible), and sharps module 314 may be configured to carry and otherwise include a sharps 318 (partially visible) for facilitating transcutaneous delivery of sensor 316 beneath the user's skin during application of sensor control device 302. As illustrated, corresponding portions of sensor 316 and sharps 318 extend from electronic device housing 304, and more specifically, from the bottom of base 308. An exposed portion of sensor 316 may be received within a hollow or recessed portion of sharps 318. The remainder of sensor 316 is positioned within the interior of electronic device housing 304.

[0169] Figure 4A and Figure 4B 4 and 5. The figures are an isometric view and an exploded view, respectively, of the 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 receive and support both the sensor 316 and the connector 404. As illustrated, a channel 406 may be defined through the plug 402 to receive a portion of the sensor 316. In addition, the plug 402 may provide one or more deflectable arms 407 configured to snap onto a connector provided on the electronic device housing 304 ( Figures 3A-3B ) in the corresponding feature on the bottom of the ).

[0170] Sensor 316 includes a tail 408, a flag 410, and a neck 412 interconnecting tail 408 and flag 410. Tail 408 can be configured to extend at least partially through channel 406 and distally from plug 402. Tail 408 includes an enzyme or other chemical or biological agent, and in some embodiments, a membrane can cover the chemical. In use, tail 408 is transcutaneously received beneath the skin of a user, and the chemical included thereon helps facilitate analyte monitoring in the presence of bodily fluids.

[0171] Flag 410 may include a generally planar surface having one or more sensor contacts 414 ( Figure 4B The sensor contact(s) 414 may be configured to align with a corresponding number of compliant carbon-impregnated polymer modules (not shown) encapsulated within the connector 404 .

[0172] The connector 404 includes one or more hinges 418 that enable the connector 404 to move between an open state and a closed state. Figures 4A-4B 316 and is provided in the electronic device housing 304 ( Figures 3A-3B ) provides conductive communication between corresponding circuit contacts within the sensor 316. The connector 404 can be made of silicone rubber and can serve as a moisture barrier for the sensor 316 when assembled in a compressed state and after being applied to the user's skin.

[0173] Sharps module 314 includes a sharp 318 and a sharps hub 422 that carries sharps 318. Sharps 318 include an elongated shaft 424 and a sharps tip 426 at the distal end of shaft 424. Shaft 424 can be configured to extend through passage 406 and distally from plug 402. Furthermore, shaft 424 can include a hollow or recessed portion 428 that at least partially circumscribes tail 408 of sensor 316. Sharps tip 426 can be configured to penetrate the skin while carrying tail 408 to allow active chemicals present on tail 408 to contact bodily fluids.

[0174] The sharps hub 422 may include a hub cylinder 430 and a hub snap detent 432, each of which may be configured to help couple the plug assembly 310 (and the entire sensor control device 302) to the sensor applicator 102 ( Figure 1 ).

[0175] Figure 5A and Figure 5B 304, according to one or more embodiments. The housing 306 and base 308 operate as opposing clamshell halves that enclose or otherwise substantially enclose the sensor control device 302 ( Figures 3A-3B ) various electronic components.

[0176] A printed circuit board (PCB) 502 may be positioned within the electronic device housing 304. A plurality of electronic modules (not shown) may be mounted to the PCB 502, including, but not limited to, a data processing unit, resistors, transistors, capacitors, inductors, diodes, and switches. The data processing unit may include, for example, an application specific integrated circuit (ASIC) configured to implement one or more functions or routines associated with the operation of the sensor control device 302. More specifically, the data processing unit may be configured to perform data processing functions, where such functions may include, but are not limited to, filtering and encoding of data signals, each of which corresponds to a sampled analyte level of a user. The data processing unit may also include, or otherwise be in communication with, an antenna for communicating with the reader device 106 ( Figure 1 ) communication.

[0177] As shown, the shell 306, the base 308, and the PCB 502 each define corresponding central apertures 504, 506, and 508, respectively. When the electronic device housing 304 is assembled, the central apertures 504, 506, and 508 are coaxially aligned to receive the plug assembly 310 therethrough ( Figures 4A-4B A battery 510 may also be housed within the electronics housing 304 and configured to power the sensor control unit 302 .

[0178] exist Figure 5B In the embodiment, a plug receptacle 512 may be defined in the bottom of the base 308 and provide a plug assembly 310 ( Figures 4A-4B ) can be received and coupled to the electronic device housing 304, thereby fully assembling the sensor control device 302 ( Figures 3A-3B Plug 402 ( Figures 4A-4B) may be contoured to match or be shaped in a complementary manner to the plug receptacle 512, and the plug receptacle 512 may provide one or more snap ledges 514 (two shown) configured to engage the deflectable arms 407 ( Figures 4A-4B ) interface connects and receives the deflectable arm. The plug assembly 310 is coupled to the electronic device housing 304 by advancing the plug 402 into the plug receptacle 512 and allowing the deflectable arm 407 to lock into the corresponding snap tab 514. When the plug assembly 310 ( Figures 4A-4B ) is properly coupled to the electronic device housing 304, one or more circuit contacts 516 (three shown) defined on the underside of the PCB 502 can mate with the connector 404 ( Figures 4A-4B ) of the electrical contacts 420 ( Figures 4A-4B ) for conductive connectivity.

[0179] Figure 6A and Figure 6B 1 and 2 are side views and cross-sectional side views, respectively, of the sensor applicator 102 with the applicator cap 210 coupled thereto. More specifically, Figures 6A-6B This depicts how the sensor applicator 102, according to at least one embodiment, may be shipped to and received by a user. However, in some embodiments, the sensor applicator 102 may be further sealed within a bag (not shown) and delivered to the user within the bag. The bag may be made of a variety of materials that help prevent moisture from entering the sensor applicator 102, which could adversely affect the sensor 316. In at least one embodiment, for example, the sealed backing may be made of foil. Any and all sensor applicators described or discussed herein may be sealed within a bag and delivered to the user within the bag.

[0180] According to this disclosure, and as Figure 6B As seen in FIG, the sensor control device 302 has been assembled and installed within the sensor applicator 102 prior to being delivered to the user. The applicator cap 210 may be threaded onto the housing 208 and include a tamper-evident ring 602. When the applicator cap 210 is rotated (e.g., unscrewed) relative to the housing 208, the tamper-evident ring 602 may shear and thereby release the applicator cap 210 from the sensor applicator 102. Thereafter, the user may deliver the sensor control device 302 to the target monitoring location, as described above with reference to FIG. Figures 2E-2G Generally described.

[0181] In some embodiments, as mentioned above, the applicator cap 210 can be secured to the housing 208 via a sealing engagement to protect the internal components of the sensor applicator 102. In at least one embodiment, for example, an O-ring or another type of sealing gasket can seal the interface between the housing 208 and the applicator cap 210. The O-ring or sealing gasket can be a separate component part or, alternatively, molded onto one of the housing 208 and the applicator cap 210.

[0182] The housing 208 can be made from a variety of rigid materials. In some embodiments, for example, the housing 208 can be made from a thermoplastic polymer such as polyketone. In other embodiments, the housing 208 can be made from cyclic olefin copolymer (COC), which can help prevent moisture from entering the interior of the sensor applicator 102. As will be appreciated, any and all housings described or discussed herein can be made from polyketone or COC.

[0183] Specific references Figure 6B , the sensor control assembly 302 may be loaded into the sensor applicator 102 by mating the sharps hub 422 with the sensor carrier 604 included within the sensor applicator 102. Once the sensor control assembly 302 is mated with the sensor carrier 604, the applicator cap 210 may then be secured to the sensor applicator 102.

[0184] In the illustrated embodiment, the collimator 606 is positioned within the applicator cap 210 and generally helps support the sensor control assembly 302 when contained within the sensor applicator 102. In some embodiments, the collimator 606 may form an integral part or extension of the applicator cap 210, such as being molded with or overmolded onto the applicator cap 210. In other embodiments, the collimator 606 may comprise a separate structure that fits within or is attached to the applicator cap 210 without departing from the scope of the present disclosure. In still other embodiments, as discussed below, the collimator 606 may be omitted from the packaging received by the user, but may be otherwise used when sterilizing the sensor applicator 102 and preparing it for delivery.

[0185] The collimator 606 can be designed to receive and help protect parts of the sensor control unit 302 that need to be sterile and to isolate the sterile components of the sensor applicator 102 from microbial contamination from other locations within the sensor control unit 302. To achieve this, the collimator 606 can define or otherwise provide a sterile zone 608 (alternatively referred to as a "sterile barrier enclosure" or "sterile sensor path") that is configured to receive the sensor 316 and sharps 318, such as extending from the bottom of the electronics housing 304. The sterile zone 608 can generally include a hole or passageway that extends at least partially through the body of the collimator 606. In the illustrated embodiment, the sterile zone 608 extends through the entire body of the collimator 606, but may alternatively extend only partially through the body without departing from the scope of this disclosure.

[0186] When the sensor control unit 302 is loaded into the sensor applicator 102 and the applicator cap 210 with the collimator 606 is secured to the sensor applicator, the sensor 316 and the sharps 318 can be positioned within a sealed area 610 that is at least partially defined by the sterile zone 608. The sealed area 610 is configured to isolate the sensor 316 and the sharps 318 from external contamination and can include (surround) selected portions of the interior of the electronics housing 304 and the sterile zone 608 of the collimator 606.

[0187] When positioned within the sensor applicator 102, the fully assembled sensor control device 302 can be subjected to radiation sterilization 612. Radiation sterilization 612 can include, for example, electron beam radiation, but other sterilization methods can alternatively be used, including but not limited to low-energy X-ray radiation. In some embodiments, radiation sterilization 612 can be delivered by continuous process radiation or by pulsed beam radiation. In pulsed beam radiation, the beam of radiation sterilization 612 is focused at a target location, and the component part or device to be sterilized is moved to the target location, at which point the radiation sterilization 612 is activated to provide a targeted pulse of radiation. The radiation sterilization 612 is then turned off, and another component part or device to be sterilized is moved to the target location and the process is repeated.

[0188] The collimator 606 can be configured to focus radiation (e.g., beam, wave, energy, etc.) from the radiation sterilization 612 toward components that need to be sterile, such as the sensor 316 and the sharps 318. More specifically, the aperture or passageway of the sterilization zone 608 allows the radiation to be transmitted to impinge on the sensor 316 and the sharps 318 and sterilize them, while the remainder of the collimator 606 prevents (blocks) the propagating radiation from damaging or otherwise destroying the electronic components within the electronics housing 304.

[0189] The sterilization zone 608 can exhibit any suitable cross-sectional shape necessary to properly focus radiation on the sensor 316 and the sharp object 318 for sterilization. In the illustrated embodiment, for example, the sterilization zone 608 is conical or frusto-conical in shape. However, in other embodiments, the sterilization zone 608 can exhibit a polygonal cross-sectional shape, such as a cubic, rectangular (e.g., including a parallelogram), or pyramidal, without departing from the scope of the present disclosure.

[0190] In the illustrated embodiment, the sterilization zone 608 provides a first opening 614a at a first end and a second opening 614b at a second end opposite the first end. The first opening 614a can be configured to receive the sensor 316 and the sharp object 318 into the sterilization zone 608, and the second opening 614b can allow radiation (e.g., beam, wave, etc.) from the radiation sterilization 612 to enter the sterilization zone 608 and impinge on the sensor 316 and the sharp object 318.

[0191] In the embodiment that the sterilization zone 608 is conical or truncated conical in shape, the first orifice 614a may have a diameter smaller than the diameter of the second orifice 614b. In such an embodiment, for example, the size of the first orifice 614a may be in the range of about 0.5mm and about 3.0mm, and the size of the second orifice 614b may be in the range of about 5.0mm and about 16.0mm. However, as will be understood, without departing from the scope of this disclosure and depending on the application, the corresponding diameters of the first orifice 614a and the second orifice 614b may be greater than or less than the range provided herein. In fact, the diameters of the first orifice 614a and the second orifice 614b only need to be large enough to allow sufficient doses of radiation to irradiate the sensor 316 and the sharp object 318. In addition, in at least one embodiment, the sterilization zone 608 may be cylindrical in shape, with the first orifice 614a and the second orifice 614b exhibiting the same diameter.

[0192] The body of the collimator 606 reduces or eliminates the risk of radiation sterilization 612 penetrating through the body material and thereby damaging electronic components within the electronic device housing 304. To achieve this, in some embodiments, the collimator 606 can be made of a material having a mass density greater than 0.9 grams per cubic centimeter (g / cc). One example material for the collimator 606 is polyethylene, but alternatively, any material having a mass density similar to or greater than polyethylene can be included. In some embodiments, for example, the material for the collimator 606 can include, but is not limited to, metals (e.g., lead, stainless steel) or high-density polymers.

[0193] In at least one embodiment, the design of collimator 606 can be modified so that it can be made of a material with a mass density less than 0.9 grams per cubic centimeter (g / cc), while still operating to reduce or eliminate radiation sterilization 612 exposure to electronic components within electronic device housing 304. To achieve this, in some embodiments, the size (e.g., length) of collimator 606 can be increased so that propagating electrons from radiation sterilization 612 need to pass through a greater amount of material before potentially impacting sensitive electronic devices. This greater amount of material can help absorb or dissipate the dose intensity of radiation sterilization 612, rendering it harmless to sensitive electronic devices. However, in other embodiments, the opposite may also be true. More specifically, the size (e.g., length) of collimator 606 can be reduced, as long as the material used for collimator 606 exhibits a sufficiently high mass density.

[0194] In addition to the radiation blocking properties of the body of the collimator 606, in some embodiments, one or more shields 616 (one shown) may also be positioned within the sensor housing 304 to protect sensitive electronic components from radiation exposure when the sensor control unit 302 undergoes radiation sterilization 612. The shield 616 may, for example, be positioned to be interposed between a data processing unit 618 and a radiation source (e.g., an electron beam electron accelerator). In such embodiments, the shield 616 may be positioned adjacent to and otherwise aligned with 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 sensitive electronic circuitry of the data processing unit 618.

[0195] Shield 616 can be made of any material capable of blocking (or substantially blocking) the transmission of radiation. Suitable materials for shield 616 include, but are not limited to, lead, tungsten, iron-based metals (e.g., stainless steel), copper, tantalum, tungsten, osmium, or any combination thereof. Suitable metals can be corrosion-resistant, austenitic, and any non-magnetic metal with a density ranging from about 5 grams per cubic centimeter (g / cc) to about 15 g / cc. Shield 616 can be manufactured using a variety of manufacturing techniques, including, but not limited to, stamping, casting, injection molding, sintering, two-shot molding, or any combination thereof.

[0196] However, in other embodiments, shield 616 may comprise a metal-filled thermoplastic polymer such as, but not limited to, polyamide, polycarbonate, or polystyrene. In such embodiments, shield 616 may be manufactured by mixing the shielding material in an adhesive matrix and dispensing the combination onto a formed part or otherwise directly onto data processing unit 618. Furthermore, in such embodiments, shield 616 may comprise a housing that encapsulates (or substantially encapsulates) data processing unit 618.

[0197] In some embodiments, a collimator seal 620 can be applied to the end of the collimator 606 to seal the sterilization zone 608 and, therefore, the sealing area 610. As shown, the collimator seal 620 can seal the second aperture 614b. The collimator seal 620 can be applied before or after the radiation sterilization 612. In embodiments where the collimator seal 620 is applied before the radiation sterilization 612, the collimator seal 620 can be made of a radiation-transparent microbial barrier material that allows radiation to propagate therethrough. With the collimator seal 620 in place, the sealing area 610 can maintain a sterile environment for the assembled sensor control device 302 until the user removes (unscrews) the applicator cap 210.

[0198] In some embodiments, the collimator seal 620 may comprise two or more layers of different materials. The first layer may be made of a synthetic material (e.g., flash-spun high-density polyethylene fiber), such as Tyvek® available from DuPont®. Tyvek® is highly durable and puncture-resistant, yet vapor-permeable. The Tyvek® layer may be applied before or after radiation sterilization 612, and after radiation sterilization 612, a layer of foil or other vapor- and moisture-resistant material may be sealed (e.g., heat-sealed) over the Tyvek® layer to prevent contaminants and moisture from entering the sterilization zone 608 and the sealing area 610. In other embodiments, the collimator seal 620 may comprise only a single protective layer applied to the ends of the collimator 606. In such embodiments, this single layer is gas-permeable during the sterilization process, but also provides protection from moisture and other harmful elements once the sterilization process is complete. Thus, the collimator seal 620 can function as a moisture and contaminant barrier without departing from the scope of this disclosure.

[0199] Note that while the sensor 316 and sharps 318 extend from the bottom of the electronics housing 304 and into the sterilization zone 608 generally concentric with the centerline of the sensor applicator 102 and the applicator cap 210, an off-center arrangement is contemplated herein. More specifically, in at least one embodiment, the sensor 316 and sharps 318 may extend from the bottom of the electronics housing 304 off-center from the centerline of the sensor applicator 102 and the applicator cap 210. In such an embodiment, the collimator 606 may be redesigned and otherwise configured such that the sterilization zone 608 is also positioned off-center to receive the sensor 316 and sharps 318 without departing from the scope of this disclosure.

[0200] In some embodiments, the collimator 606 may include a first or "inner" collimator that can be housed within the applicator cap 210 or otherwise housed within the sensor applicator 102, as generally described above. A second or "outer" collimator (not shown) may also be included or otherwise used during the assembly (manufacturing) process to assist in sterilizing the sensor applicator 102. In such embodiments, the outer collimator may be positioned outside the sensor applicator 102 and applicator cap 210 and used simultaneously with the inner collimator 606 to assist in focusing the sterilizing radiation 612 on the sensor 316 and sharps 318.

[0201] In one embodiment, for example, the external collimator can initially receive the sterilization radiation 612. Similar to the internal collimator 606, the external collimator can provide or define an aperture or passage extending through the external collimator. The beam of sterilization radiation 612 passing through the passage of the external collimator can be focused via the second aperture 614b and received into the sterilization zone 608 of the internal collimator 606. Thus, the external collimator can be operated to pre-focus the radiation energy, and the internal collimator 606 can fully focus the radiation energy on the sensor 316 and the sharp object 318.

[0202] In some embodiments, the internal collimator 606 can be omitted if the external collimator is capable of properly and fully focusing the radiation sterilization 612 to properly sterilize the sensor 316 and the sharps 318. In such embodiments, the sensor applicator can be positioned adjacent to the external collimator and then subjected to the radiation sterilization 612, and the external collimator can prevent the radiation energy from damaging sensitive electronics within the electronics housing 304. Furthermore, in such embodiments, the sensor applicator 102 can be delivered to the user without the internal collimator 606 being positioned within the applicator cap 210, thereby eliminating manufacturing and usage complexities.

[0203] Figure 7Ais an enlarged cross-sectional side view of the sensor control assembly 302 mounted within the applicator cap 210, according to one or more embodiments. As indicated above, portions of the sensor 316 and sharps 318 can be disposed within a sealed region 610 and thereby isolated from external contamination. The sealed region 610 can include (surround) selected portions of: the interior of the electronics housing 304 and the sterilization zone 608 of the collimator 606. In one or more embodiments, the sealed region 610 can be defined by and otherwise formed from at least the first seal 702a, the second seal 702b, and the collimator seal 620.

[0204] The first seal 702a can be arranged to seal the interface between the sharps hub 422 and the top of the electronic device housing 304. More specifically, the first seal 702a can seal the interface between the sharps hub 422 and the shell 306. Furthermore, the first seal 702a can circumscribe the first central aperture 504 defined in the shell 306, thereby preventing contaminants from migrating into the interior of the electronic device housing 304 via the first central aperture 504. In some embodiments, the first seal 702a can form a portion of the sharps hub 422. For example, the first seal 702a can be overmolded onto the sharps hub 422. In other embodiments, the first seal 702a can be overmolded onto the top surface of the shell 306. In still other embodiments, without departing from the scope of this disclosure, the first seal 702a can comprise a separate structure, such as an O-ring, interposed between the sharps hub 422 and the top surface of the shell 306.

[0205] The second seal 702b can be arranged to seal the interface between the collimator 606 and the bottom of the electronic device housing 304. More specifically, the second seal 702b can be arranged to seal the interface between the base 308 and the collimator 606, or alternatively, the interface between the collimator 606 and the bottom of the plug 402 as received within the bottom of the base 308. In applications that include the plug 402, as illustrated, the second seal 702b can be configured to seal around and otherwise circumscribe the plug receptacle 512. In embodiments where the plug 402 is omitted, the second seal 702b can alternatively circumscribe the second central aperture 506 ( Figure 5A Thus, the second seal 702b can prevent contaminants from migrating into the sterile zone 608 of the collimator 606 and also prevent contaminants from migrating into the interior of the electronics housing 304 via the plug receptacle 512 (or alternatively, the second central aperture 506 ).

[0206] 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 top of the collimator 606. In other embodiments, the second seal 702b can be overmolded onto the plug 402 or onto the bottom of the base 308. In still other embodiments, the second seal 702b can comprise a separate structure, such as an O-ring, interposed between the collimator 606 and the bottom of the plug 402 or base 308 without departing from the scope of the present disclosure.

[0207] Before loading the sensor control device 302 onto the sensor applicator 102 ( Figure 6B ) and secure the applicator cap 210 to the sensor applicator 102, the first seal 702a and the second seal 702b become compressed and form corresponding sealing interfaces. The first seal 702a and the second seal 702b can be made of a variety of materials capable of forming 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.

[0208] As discussed above, the collimator seal 620 can be configured to seal the bottom of the sterilization zone 608 and, therefore, the bottom of the sealed area 610. Thus, the first and second seals 702a, 702b, and the collimator seal 620 each form a corresponding barrier at their respective sealing locations. The combination of these seals 702a, 702b, and 620 allows the sealed area 610, which contains the sensor 316 and the sharp object 318, to be terminally sterilized.

[0209] Figure 7B is an enlarged cross-sectional side view of another embodiment of a sensor control device 302 installed within a sensor applicator 102 according to one or more embodiments. More specifically, Figure 7BAn alternative embodiment of a first seal 702a and a second seal 702b is depicted. The first seal 702a is again arranged to seal the interface between the sharps hub 422 and the top of the electronic device housing 304, and more specifically, to seal the first central aperture 504 defined in 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 unit 302 is introduced into the sensor applicator 102, the sharps hub 422 is received by the sensor carrier 604. The first seal 702a can be configured to simultaneously bias against 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. This dual biasing engagement compresses the first seal 702a both axially and radially, thereby allowing the first seal 702a to seal against the top of the electronic device housing 304 in both radial and axial directions.

[0210] The second seal 702b is again arranged to seal the interface between the collimator 606 and the bottom of the electronics housing 304, and more particularly, the interface between the base 308 and the collimator 606, or alternatively, the interface between the collimator 606 and the bottom of the plug 402, as received within the bottom of the base 308. However, in the illustrated embodiment, the second seal 702b can extend into the sterilization zone 608 and define or otherwise provide a cylindrical well 708 that is sized to receive the sensor 316 and sharps 1408, as extending from the bottom of the base 308. In some embodiments, a desiccant 710 can be positioned within the cylindrical well to help maintain a low humidity environment for moisture-sensitive biological components.

[0211] In some embodiments, the second seal 702b can be omitted, and the collimator 606 can be directly coupled to the electronics housing 304. More specifically, in at least one embodiment, the collimator 606 can be threadedly coupled to the underside of the base 308. In such an embodiment, the collimator 606 can provide or otherwise define a threaded extension that is configured to mate with a threaded aperture defined in the bottom of the base 308. Threading the collimator 606 to the base 308 can seal the interface between the collimator 606 and the bottom of the electronics housing 304 and, thereby, operate to isolate the seal area 610. Furthermore, in such an embodiment, the pitch and specifications of the threads defined on the collimator 606 and the base 308 can match those of the threaded interface between the applicator cap 210 and the sensor applicator 102. As a result, when the applicator cap 210 is threaded onto or unscrewed from the sensor applicator 102, the collimator 606 can be correspondingly threaded onto or unscrewed from the electronics housing 404.

[0212] Embodiments disclosed herein include:

[0213] A. An analyte monitoring system comprising: a sensor applicator; a sensor control device positioned within the sensor applicator and comprising: an electronics housing; a sensor extending from a bottom of the electronics housing; a sharps hub positioned adjacent to a top of the electronics housing; and a sharp carried by the sharps hub and extending through and from the bottom of the electronics housing. The analyte monitoring system further comprises: a cap coupled to the sensor applicator; and a collimator positioned within the cap and defining a sterile zone that receives the sensor and sharps extending from the bottom of the electronics housing.

[0214] B. A method of preparing an analyte monitoring system, the method comprising loading a sensor control assembly into a sensor applicator, the sensor control assembly comprising: an electronics housing; a sensor extending from a bottom of the electronics housing; a sharps hub positioned adjacent to a top of the electronics housing; and a sharp carried by the sharps hub and extending through the electronics housing and from the bottom of the electronics housing. The method further comprises: securing a cap to the sensor applicator, wherein a collimator is disposed within the cap and defines a sterilization zone that receives the sensor and sharp extending from the bottom of the electronics housing; sterilizing the sensor and sharp using radiation sterilization while they are positioned within the sterilization zone; and utilizing the collimator to prevent radiation from the radiation sterilization from damaging electronic components within the electronics housing.

[0215] C. A method of preparing an analyte monitoring system, the method comprising loading a sensor control assembly into a sensor applicator, the sensor control assembly comprising: an electronics housing; a sensor extending from a bottom of the electronics housing; a sharps hub positioned adjacent to a top of the electronics housing; and a sharp carried by the sharps hub and extending through and from the bottom of the electronics housing. The method further comprises positioning the sensor applicator adjacent to a collimator; subjecting the sensor and sharps to radiation sterilization; and utilizing the collimator to prevent radiation from the radiation sterilization from damaging electronic components within the electronics housing.

[0216] Each of embodiments A, B, and C may have one or more of the following additional elements in any combination: Element 1: wherein the sterilization zone includes a passage extending at least partially through the collimator. Element 2: wherein the sterilization zone includes a cross-sectional shape selected from the group consisting of: conical, frustoconical, cubic, rectangular, pyramidal, and any combination thereof. Element 3: wherein the sterilization zone is frustoconical and defines a first orifice at a first end and a second orifice at a second end, and wherein the first orifice receives a sensor and a sharp extending from a bottom of the electronic device housing, and a seal is disposed at the second orifice. Element 4: further comprising a sealing area surrounding the sterilization zone and a portion of the interior of the electronic device housing, wherein the sealing area is defined by: a first seal that seals an interface between the sharp hub and the top of the electronic device housing; a second seal that seals an interface between the collimator and the bottom of the electronic device housing; and a third seal that seals an end of the sterilization zone. Element 5: Wherein, the first seal circumscribes a central aperture defined in the top portion of the electronic device housing and prevents contaminants from migrating through the central aperture into the portion of the interior of the electronic device housing, and wherein the second seal circumscribes an aperture defined in the bottom portion of the electronic device housing and prevents contaminants from migrating through the aperture into the portion of the interior of the electronic device housing. Element 6: Wherein, the first seal provides one or both of an axial seal and a radial seal. Element 7: Wherein, the second seal extends into the sterilization zone and defines a cylindrical well for receiving a sensor and a sharp object. Element 8: Also included: a printed circuit board disposed within the electronic device housing; a data processing unit mounted to the printed circuit board; and a shield positioned within the electronic device housing to protect the data processing unit from radiation from the radiation sterilization process. Element 9: Wherein, the shield is made of a non-magnetic metal selected from the group consisting of lead, tungsten, iron, stainless steel, copper, tantalum, osmium, a thermoplastic polymer blended with a non-magnetic metal, and any combination thereof.

[0217] Element 10: Also included is forming a sealing area when the cap is secured to the sensor applicator, the sealing area surrounding the sterilization zone and a portion of the interior of the electronic device housing. Element 11: Wherein, forming the sealing area includes sealing an interface between the sharps hub and the top of the electronic device housing with a first seal, sealing an interface between the collimator and the bottom of the electronic device housing with a second seal, and sealing an end of the sterilization zone with a third seal. Element 12: Wherein, sealing the interface between the sharps hub and the top of the electronic device housing with the first seal includes providing one or both of an axial seal and a radial seal with the first seal. Element 13: Wherein, the collimator includes an internal collimator, and sterilizing the sensor and sharps using radiation sterilization further includes: positioning the sensor applicator adjacent to an external collimator disposed externally of the sensor applicator; focusing radiation using the external collimator for receipt by the internal collimator; and preventing radiation from damaging electronic components within the electronic device housing using the external collimator and the internal collimator. Element 14: wherein the sterilization zone defines a first aperture at a first end of the collimator and a second aperture at a second end of the collimator, and wherein sterilizing the sensor and the sharps comprises introducing radiation into the sterilization zone through the second aperture. Element 15: wherein preventing radiation from the radiation sterilization from damaging the electronic components comprises utilizing a material of the collimator to block the radiation. Element 16: wherein the printed circuit board is disposed within the electronic equipment housing and the data processing unit is mounted to the printed circuit board, the method further comprising utilizing a shield positioned within the electronic equipment housing to protect the data processing unit from radiation from the radiation sterilization process.

[0218] Element 17: wherein positioning the sensor applicator adjacent to the collimator includes arranging the collimator such that it resides external to the sensor applicator during radiation sterilization.

[0219] As non-limiting examples, exemplary combinations suitable for A, B, and C include: 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.

[0220] External sterilization components

[0221] Again briefly refer to Figure 1Before the sensor control unit 104 is delivered to the end user, it must be sterilized to render the product free of viable microorganisms. Radiation sterilization, such as electron beam (e-beam) radiation, is typically used to sterilize the sensor 110. However, radiation sterilization can damage electronic components within the sensor control unit 104, which are typically sterilized via gaseous chemical sterilization (e.g., using ethylene oxide). However, gaseous chemical sterilization can damage enzymes or other chemicals and biological agents included on the sensor 110.

[0222] In the past, this sterilization incompatibility has been circumvented by separating the sensor 110 and the electronic components and sterilizing each separately. However, this approach requires additional parts, packaging, process steps, and final assembly by the user, which introduces the possibility of user error. According to the present disclosure, the sensor control unit 104, or any device requiring terminal sterilization, can be properly sterilized using an external sterilization assembly designed to focus sterilizing radiation (e.g., beam, wave, energy, etc.) toward the component parts requiring sterilization while preventing the transmitted radiation from damaging or destroying sensitive electronic components.

[0223] Figure 8 is a schematic diagram of an example external sterilization assembly 800 according to one or more embodiments of the present disclosure. External sterilization assembly 800 (hereinafter "assembly 800") can be designed and otherwise configured to assist in sterilizing a medical device 802. Medical device 802 can include, for example, Figure 1 The sensor control device 104 is similar to the sensor control device of the present invention, but may alternatively include other types of medical devices, healthcare products, or systems that require terminal sterilization of specific components. Example medical devices or healthcare products that may incorporate the principles of the present disclosure include, but are not limited to, ingestible products, cardiac rhythm management (CRM) devices, subcutaneous sensing devices, externally mounted medical devices, or any combination thereof.

[0224] The medical device 802 may include a housing 804, a part to be sterilized 806, and one or more radiation-sensitive components 808. In the illustrated embodiment, the radiation-sensitive component 808 may be mounted to a printed circuit board (PCB) 810 positioned within the housing 804, and the housing 804 may include an electronics housing for a sensor control device. The radiation-sensitive component 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), resistors, transistors, capacitors, inductors, diodes, and switches. However, in other embodiments, the radiation-sensitive component 808 may include a radiation-sensitive chemical solution or analyte, as described herein with reference to Figure 12 described.

[0225] In some embodiments, part 806 may include a sensor (e.g., Figure 1 110). As shown, part 806 may extend from the bottom of housing 804 at an angle, but may alternatively extend perpendicular to the bottom of housing 804 or from another surface of housing 804. In at least one embodiment, part 806 may also include a sharp tip, which may also require sterilization and may aid in implanting the sensor beneath the user's skin. In some embodiments, as shown, part 806 may be enclosed in a cap 812 that provides a sealing barrier that protects exposed portions of part 806 (e.g., the sensor and associated sharp tip) until part 806 is needed.

[0226] Medical device 802 can undergo radiation sterilization 814 to properly sterilize component 806 for use. Suitable radiation sterilization 814 processes include, but are not limited to, electron beam (e-beam) radiation, gamma ray radiation, X-ray radiation, or any combination thereof. In embodiments including cap 812, cap 812 can be made of a material that allows radiation 814 to propagate through it, facilitating radiation sterilization of component 806. Suitable materials for cap 812 include, but are not limited to, non-magnetic metals (e.g., aluminum, copper, gold, silver, etc.), thermoplastics, ceramics, rubbers (e.g., hard rubber), composite materials (e.g., fiberglass, carbon fiber reinforced polymer, etc.), epoxies, or any combination thereof. In some embodiments, cap 812 can be transparent or translucent, but can otherwise be opaque without departing from the scope of this disclosure.

[0227] The assembly 800 may include a radiation shield 816 positioned external to the medical device 802 and configured to assist in sterilizing the part 806 while preventing (blocking) the transmitted radiation 814 from damaging or otherwise harming the radiation-sensitive component 808. To accomplish this, the radiation shield 816 may include a collimator 818, which generally includes a hole or passage extending at least partially through the body of the radiation shield 816. The collimator 818 defines a sterilization zone 820 configured to focus the radiation 814 toward the part 806. In the illustrated embodiment, the part 806 may also be received within the sterilization zone 820 for sterilization.

[0228] When radiation 814 (e.g., beam, wave, energy, etc.) is focused toward part 806, radiation shield 816 can be made of a material that reduces or eliminates the risk of radiation 814 penetrating therethrough and thereby damaging radiation-sensitive components 808 within housing 804. In other words, radiation shield 816 can be made of a material dense enough to absorb a dose of the delivered beam energy. In some embodiments, for example, radiation shield 816 can be made of any material having a mass density greater than 0.9 grams per cubic centimeter (g / cc). However, in other embodiments, suitable materials can have a mass density less than 0.9 g / cc without departing from the scope of this disclosure. Suitable materials for radiation shield 816 include, but are not limited to, high-density polymers (e.g., polyethylene, polypropylene, polystyrene, polytetrafluoroethylene, etc.), metals (e.g., lead, stainless steel, aluminum, etc.), any combination thereof, or any material having a mass density greater than 0.9 g / cc.

[0229] The collimator 818 can exhibit any suitable cross-sectional shape necessary to focus radiation on the part 806 for sterilization. In the illustrated embodiment, for example, the collimator 818 is conical or frustoconical in shape. However, in other embodiments, the collimator 818 can exhibit a polygonal cross-sectional shape, such as a cube, a rectangle (e.g., including a parallelogram), or a pyramid, without departing from the scope of the present disclosure. In still other embodiments, the collimator 818 can exhibit a circular cross-sectional shape with parallel sides.

[0230] In the illustrated embodiment, the collimator 818 provides a first aperture 822a and a second aperture 822b, wherein the first aperture 822a and the second aperture 822b are defined at opposite ends of the sterilization zone 820. The first aperture 822a can allow radiation 814 to enter the sterilization zone 820 and impinge 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 collimator 818 is conical or frustoconical in shape, the second aperture 822b can have a smaller diameter than the first aperture 822a. In such embodiments, for example, the size of the second aperture 822b can range from about 0.5 mm to about 3.0 mm, and the size of the first aperture 822a can range from about 5.0 mm to about 16.0 mm. However, as will be appreciated, the respective diameters of the first aperture 822a and the second aperture 822b can be larger or smaller than the ranges provided herein without departing from the scope of the present disclosure. In fact, the diameters of the first aperture 822a and the second aperture 822b can be scaled to the size of the device and need only be large enough to allow a sufficient dose of radiation to be impinged on the part 806. Furthermore, in at least one embodiment, the collimator 818 can be cylindrical in shape, with the first aperture 822a and the second aperture 822b exhibiting the same diameter.

[0231] In some embodiments, the assembly 800 can also include a barrier shield 824 positioned within the housing 804. The barrier shield 824 can 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 can be made of any of the materials mentioned above for the radiation shield 816. In the illustrated embodiment, the barrier shield 824 is positioned vertically within the housing 804, but can alternatively be positioned at any other angle configuration suitable for protecting the radiation-sensitive component 808.

[0232] Figure 9 is a schematic diagram of another example exterior sterilization assembly 900 according to one or more additional embodiments of the present disclosure. The exterior sterilization assembly 900 (hereinafter "assembly 900") can be similar in some aspects to Figure 8 800, and thus may be best understood with reference thereto, wherein like reference numerals will refer to like components that are not described again. Similar to assembly 800, assembly 900 may be designed and otherwise configured to facilitate sterilization of medical device 902. In the illustrated embodiment, medical device 902 may include a two-piece sensor-control device, but may alternatively include any of the medical devices mentioned herein with respect to medical device 802.

[0233] As illustrated, medical device 902 includes a housing 904, a part 906 to be sterilized, and one or more radiation-sensitive components 908 positioned within housing 904. Housing 904 may include packaging or a housing containing part 906 and radiation-sensitive component(s) 908. Radiation-sensitive component(s) 908 may include the components described herein. Figure 8 Any of the electronic modules mentioned above may include radiation-sensitive component(s) 808. Part 906 may include, for example, a needle / sensor subassembly and may be subjected to radiation sterilization 814 to properly sterilize part 906 for use.

[0234] The assembly 900 may include a radiation shield 910 positioned external to the medical device 902 and configured to assist in sterilizing the parts 906 while preventing (blocking) the propagating radiation 814 from damaging the radiation sensitive component(s) 908. In the illustrated embodiment, the radiation shield 910 may define or otherwise provide an interior cavity 912 into which the medical device 902 may be positioned. Figure 8Similar to the radiation shield 816 of FIG. 910 , the radiation shield 910 may provide a collimator 914, which generally includes a hole or passageway that extends at least partially through the body of the radiation shield 910 and provides access to the cavity 912. The collimator 914 may define a sterile zone 916 that helps focus the radiation 814 toward the part 906. The radiation shield 910 may be made of any of the materials mentioned above with respect to the radiation shield 816 to reduce or eliminate the radiation 814 from penetrating therethrough (except at the collimator 914) and thereby damaging the radiation-sensitive component(s) 908 within the housing 904.

[0235] To properly sterilize the part 906, the sterilizing radiation 814 can be directed toward the medical device 902. The collimator 914 and the sterilizing zone 916 can be configured to concentrate and / or focus the sterilizing radiation 814 toward the part 906, while the remainder of the radiation shield 910 prevents (blocks) the propagating radiation 814 from damaging the radiation-sensitive component(s) 908 within the housing 904. In the illustrated embodiment, the collimator 914 and the sterilizing zone 916 exhibit a circular cross-sectional shape with parallel sides, but may alternatively exhibit other cross-sectional shapes, including, but not limited to, conical, frustoconical, pyramidal, polygonal, or any combination thereof.

[0236] In some embodiments, assembly 900 may also include a barrier shield 824 positioned within housing 904 to help block radiation 814 (eg, electrons) from propagating within housing 904 toward radiation-sensitive component(s) 908 .

[0237] Figure 10 is a schematic diagram of another example exterior sterilization assembly 1000 according to one or more additional embodiments of the present disclosure. The exterior sterilization assembly 1000 (hereinafter "assembly 1000") can be used in some aspects with Figure 15 The assembly 1000 is similar to the assembly 900 of FIG. 1 and thus may be best understood with reference thereto, wherein like reference numerals will refer to like parts that are not described again. Similar to the assembly 900, the assembly 1000 may be designed and otherwise configured to facilitate sterilization of the medical device 1002. In the illustrated embodiment, the medical device 1002 may include a sterilization apparatus that is similar to the assembly 900. Figure 1 The sensor control device 104 is similar to the sensor control device, but may alternatively include the sensor control device described herein Figure 8 The medical device 802 refers to any medical device.

[0238] As shown, the medical device 1002 includes a housing 1004, a part 1006 to be sterilized, and one or more radiation-sensitive components 1008 positioned within the housing 1004. In the illustrated embodiment, the housing 1004 may include a sensor control device (e.g., Figure 1 The electronic device housing of the sensor control device 104) and the radiation sensitive component(s) 1008 may include the Figure 8 Any of the electronic modules mentioned above may include the radiation sensitive component(s) 808. In some embodiments, part 1006 may include a sensor extending from housing 1004 (e.g., Figure 1 sensor 110) and may also include a sharp object that also needs to be sterilized and is used to help implant the sensor under the user's skin.

[0239] Assembly 1000 may include a radiation shield 1010 positioned external to medical device 1002 and configured to assist in sterilizing part 1006 while preventing (blocking) propagating radiation 814 from damaging or destroying radiation sensitive component(s) 1008. Radiation shield 1010 may be a radiation shield as described above with respect to Figure 8 The radiation shield 816 is made of any material mentioned to reduce or eliminate radiation 814 from penetrating therethrough and thereby damaging the radiation-sensitive component(s) 1008 within the housing 1004 .

[0240] In the illustrated embodiment, the radiation shield 1010 can define or otherwise provide an interior cavity 1012 into which the medical device 1002 can be positioned for sterilization. In some embodiments, the radiation shield 1010 can include a box, and the interior cavity 1012 can be formed within the interior of the box. The radiation shield 1010 can also provide a collimator 1014 that extends at least partially through the body of the radiation shield 1010 and provides access to the cavity 1012. The collimator 1014 can define a sterilization zone 1016 that focuses the radiation 814 toward the part 1006 for sterilization.

[0241] To properly sterilize the part 1006, the sterilizing radiation 814 can be directed toward the medical device 1002. The collimator 1014 and the sterilizing zone 1016 can concentrate and / or focus the sterilizing radiation 814 toward the part 1006, while the remainder of the radiation shield 1010 prevents (blocks) the propagating radiation 814 from damaging the radiation-sensitive component(s) 1008 within the housing 1004. In the illustrated embodiment, the collimator 1014 exhibits a circular cross-sectional shape with parallel sides, but may alternatively exhibit other cross-sectional shapes, including, but not limited to, conical, frustoconical, pyramidal, polygonal, or any combination thereof.

[0242] Figure 11 is a schematic diagram of another example exterior sterilization assembly 1100 according to one or more additional embodiments of the present disclosure. The exterior sterilization assembly 1100 (hereinafter "assembly 1100") can be respectively Figure 8 、 Figure 9 and Figure 10 100 are similar to, and therefore are best understood with reference to, assemblies 800, 900, and 1000 of the present invention. Assembly 1100, similar to assemblies 800-1000, can be designed and otherwise configured to facilitate sterilization of a medical device 1102. In the illustrated embodiment, medical device 1102 can include a two-piece sensor-control assembly, but can alternatively include any of the medical devices mentioned herein with respect to medical device 802.

[0243] As illustrated, medical device 1102 includes a housing 1104, a part to be sterilized 1106, and one or more radiation-sensitive components 1108 positioned within housing 1104. Radiation-sensitive component(s) 1108 may include the components described herein. Figure 8 Any of the electronic modules mentioned for the radiation-sensitive component(s) 808. In the illustrated embodiment, the part 1106 may include, for example, a needle / sensor subassembly and may be subjected to radiation sterilization 814 to properly sterilize the part 1106 for use.

[0244] Assembly 1100 may include a radiation shield 1110 positioned external to medical device 1102 and configured to assist in sterilizing part 1106 while preventing (blocking) propagating radiation 814 from damaging radiation sensitive component(s) 1108. Radiation shield 1110 may be configured as described above with respect to Figure 8 The radiation shield 816 is made of any material mentioned to reduce or eliminate radiation 814 from penetrating therefrom and thereby damaging the radiation sensitive component(s) 1108 .

[0245] In the illustrated embodiment, radiation shield 1110 may include a clamshell structure comprising a first portion 1112a and a second portion 1112b that mates with (or is engageable with) first portion 1112a. Radiation shield 1110 may also provide or otherwise define an interior cavity 1114 within which medical device 1102 may be positioned for sterilization. In some embodiments, as illustrated, first portion 1112a and second portion 1112b may cooperatively define a portion of interior cavity 1114, such that when first portion 1112a and second portion 1112b are properly mated, interior cavity 1114 is formed. However, in other embodiments, interior cavity 1114 may be completely defined within first portion 1112a or completely defined within second portion 1112b.

[0246] 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 illustrated, a portion of the absorber 1116 may be provided by or otherwise form a portion of each of the first portion 1112a and the second portion 1112b. In such an embodiment, the inner cavity 1114 may be at least partially defined by the absorber 1116. The absorber 1116 may be made of a material that absorbs stray radiation without causing the generation of bremsstrahlung protons. Materials for the absorber 1116 may include, for example, those described herein for Figure 8 The radiation shield 816 may be any of the high density polymers mentioned.

[0247] and Figure 8 Similar to the radiation shield 816 of FIG. 1 , the radiation shield 1110 may provide a collimator. However, in the illustrated embodiment, the radiation shield 1110 provides or otherwise defines a first collimator 1118a and a second collimator 1118b, but may alternatively include only one of the collimators 1118a, 1118b without departing from the scope of the present disclosure. The first collimator 1118a generally includes an aperture or passage extending at least partially through the first portion 1112a of the radiation shield 1110, and the second collimator 1118b generally includes an aperture or passage extending at least partially through the second portion 1112b. Each collimator 1118a, 1118b provides access to the interior cavity 1114, and the collimators 1118a, 1118b cooperatively define a sterilization zone 1120 that includes the interior cavity 1114 and helps focus the radiation 814 toward the part 1106 for sterilization.

[0248] To properly sterilize part 1106, medical device 1102 can be positioned within interior cavity 1114, and opposing portions 1112a, 1112b can be mated to encapsulate medical device 1102. Once properly positioned within cavity 1114, medical device 1102 can be positioned within sterilization zone 1120. Sterilizing radiation 814 can then be directed toward medical device 1102 on opposing sides of radiation shield 1110, and collimators 1118a, 1118b can concentrate and / or focus sterilizing radiation 814 on opposing sides of part 1106 toward part 1106. The remaining portions of radiation shield 1110 prevent (block) the propagating radiation 814 from damaging radiation-sensitive component(s) 1108 within housing 1104. In the illustrated embodiment, each collimator 1118a, 1118b exhibits a conical or frusto-conical cross-sectional shape, but may alternatively exhibit other cross-sectional shapes including, but not limited to, circular, pyramidal, polygonal, or any combination thereof.

[0249] In some embodiments, assembly 1100 may also include one or more barrier shields 824 (two shown) positioned within housing 1104 to help block radiation 814 (eg, electrons) from propagating within housing 1104 toward radiation-sensitive component(s) 1108 .

[0250] Figure 12 is a schematic diagram of another example external sterilization assembly 1200 according to one or more additional embodiments of the present disclosure. External sterilization assembly 1200 (hereinafter "assembly 1200") can be designed and otherwise configured to facilitate sterilization of a medical device 1202, which, in the illustrated embodiment, comprises a hypodermic needle or syringe. As illustrated, medical device 1202 comprises a housing 1204 (e.g., a barrel or bottle), a part 1206 to be sterilized, and one or more radiation-sensitive components 1208 positioned within housing 1204. In the illustrated embodiment, radiation-sensitive component 1208 can comprise a chemical solution or analyte (e.g., an active agent, a drug, a biologic, etc.) that can be sensitive to radiation, and component 1206 can comprise a needle designed to deliver the chemical solution.

[0251] In some embodiments, as shown, part 1206 can be enclosed or otherwise surrounded by a cap 1210 (e.g., a needle cap) that encapsulates part 1206. Furthermore, in at least one embodiment, cap 1210 can be sealed against housing 1204 using a sealing element 1212 (such as an O-ring, etc.). Cap 1210 and sealing element 1212 can cooperate to provide a sterile barrier system that surrounds and protects exposed portions of part 1206 until it is needed for use. Part 1206 can be subjected to radiation sterilization 814 to properly sterilize part 1206 for use.

[0252] Assembly 1200 may include a radiation shield 1214 positioned external to medical device 1202 and configured to facilitate sterilization of part 1206 while preventing (blocking) propagating radiation 814 from damaging radiation-sensitive components 1208. As illustrated, radiation shield 1214 may include a collimator 1216, which generally includes a hole or passage extending at least partially through the body of radiation shield 1214 and defines a sterilization zone 1218 configured to focus radiation 814 toward part 1206 for sterilization. In the illustrated embodiment, part 1206 may also be received within sterilization zone 1218. Collimator 1216 allows transmission of radiation 814 to impinge on and sterilize part 1206, while the remainder of radiation shield 1214 prevents (blocks) propagating radiation 814 from damaging radiation-sensitive component(s) 1208 within housing 1204. In the illustrated embodiment, the collimator 1216 is conical or frusto-conical in shape, but may alternatively exhibit other cross-sectional shapes, such as polygonal, pyramidal, circular, or any combination thereof.

[0253] In embodiments including cap 1210, the body of cap 1210 may include a material that allows radiation 814 to propagate therethrough to facilitate radiation sterilization of part 1206. Suitable materials for cap 1210 may be similar to those described herein for Figure 8 The material of the cap 812 is the same as mentioned.

[0254] 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 the radiation-sensitive component 1208 (e.g., a chemical solution). In the illustrated embodiment, the barrier shield 824 may define or otherwise provide a central aperture 1220 configured to allow the radiation-sensitive component 1208 to exit the housing 1204 via the feature 1206 (e.g., a needle). In other embodiments, the barrier shield 824 may provide a tortuous path that allows the radiation-sensitive component 1208 to exit the housing 1204 via the feature 1206.

[0255] Figure 13 is an isometric view of an example sensor control device 1302 according to one or more additional embodiments of the present disclosure. The sensor control device 1302 may be used with Figure 1 The sensor control device 104 is the same as or similar to the sensor applicator 102 ( Figure 1 ) is used in conjunction with the sensor applicator to deliver the sensor control device 1302 to the target monitoring location on the user's skin. In addition, the sensor control device 1302 can alternatively be characterized as a medical device that is similar to the medical device described herein. Figures 8-12 Thus, the sensor control device 1302 may also require proper sterilization before use.

[0256] As illustrated, sensor control device 1302 includes an electronics housing 1304 that is generally disc-shaped and may have a circular cross-section. However, in other embodiments, electronics housing 1304 may exhibit other cross-sectional shapes, such as oval (e.g., pill-shaped), squarish, or polygonal, without departing from the scope of this disclosure. Electronics housing 1304 may be configured to house or otherwise contain various electronic components used to operate sensor control device 1302.

[0257] Electronic device housing 1304 may include a shell 1306 and a base 1308 that mates with shell 1306. Shell 1306 may be secured to base 1308 via a variety of methods, such as a snap-fit, an interference fit, sonic welding, one or more mechanical fasteners (e.g., screws), or any combination thereof. In some cases, shell 1306 may be secured to base 1308 to create a sealed interface therebetween. In such embodiments, a gasket or other type of sealing material may be positioned at or near the outer diameter (perimeter) of shell 1306 and base 1308, and securing the two components together compresses the gasket, thereby creating a sealed interface. In other embodiments, an adhesive may be applied to the outer diameter (perimeter) of one or both of shell 1306 and base 1308. The adhesive secures shell 1306 to base 1308 and provides structural integrity, but also seals the interface between the two components, thereby isolating the interior of electronic device housing 1304 from external contaminants.

[0258] In the illustrated embodiment, sensor control device 1302 may also include a plug assembly 1310 that may be coupled to electronics housing 1304. Plug assembly 1310 may include a sensor module 1312 (partially visible) that may be interconnected with a sharps module 1314 (partially visible). Sensor module 1312 may be configured to carry and otherwise include a sensor 1316 (partially visible), and sharps module 1314 may be configured to carry and otherwise include a sharp 1318 (partially visible) for facilitating transcutaneous delivery of sensor 1316 beneath a user's skin during application of sensor control device 1302. Sharps module 1314 may include a sharps hub 1320 that carries sharps 1318.

[0259] As illustrated, corresponding portions of sensor 1316 and spike 1318 extend from electronic device housing 1304, and more particularly, from the bottom of base 1308. An exposed portion of sensor 1316 (alternatively referred to as a "tail") may be received within a hollow or recessed portion of spike 1318. The remainder of sensor 1316 is positioned within the interior of electronic device housing 1304.

[0260] Figure 14A yes Figure 1 1404. As shown, the sensor applicator 102 includes a housing 1402 and an applicator cap 1404 that can be removably coupled to the housing 1402. In some embodiments, the applicator cap 1404 can be threaded onto the housing 1402 and include a tamper-evident ring 1406. When the applicator cap 1404 is rotated (e.g., unscrewed) relative to the housing 1402, the tamper-evident ring 1406 can shear and thereby release the applicator cap 1404 from the sensor applicator 102. Once the applicator cap 1404 is removed, the user can then use the sensor applicator 102 to remove the sensor control device 1302 ( Figure 13 and Figure 14B ) is positioned at the target monitoring location on the user's body.

[0261] In some embodiments, the applicator cap 1404 can be secured to the housing 1402 via a sealing engagement to protect the internal components of the sensor applicator 102. In at least one embodiment, for example, an O-ring or another type of sealing gasket can seal the interface between the housing 1402 and the applicator cap 1404. The O-ring or sealing gasket can be a separate component part or alternatively molded onto one of the housing 1402 and the applicator cap 1404.

[0262] Figure 14Bis a cross-sectional side view of the sensor applicator 102. As illustrated, the sensor control device 1302 can be received within the sensor applicator 102, and the applicator cap 1404 can be coupled to the sensor applicator 102 to secure the sensor control device 1302 therein. The sensor control device 1302 can include one or more radiation-sensitive components 1408 disposed within the electronics housing 1304. The radiation-sensitive components 1408 can include electronic components or modules, such as, but not limited to, a data processing unit, a resistor, a transistor, a capacitor, an inductor, a diode, a switch, or any combination thereof. The data processing unit can include, for example, an application specific integrated circuit (ASIC) configured to implement one or more functions or routines associated with the operation of the sensor control device 1302. In operation, the data processing unit can perform data processing functions, such as filtering and encoding of data signals corresponding to the sampled analyte level of the user. The data processing unit can also include an antenna or otherwise be in communication with an antenna for communicating with the reader device 106 ( Figure 1 ) communication.

[0263] In the illustrated embodiment, a cap filler 1410 can be positioned within the applicator cap 1404 and can generally help support the sensor control device 1302 within the sensor applicator 102. In one or more embodiments, the cap filler 1410 can comprise an integral part or extension of the applicator cap 1404, such as molded with or overmolded onto the applicator cap 1404. In other embodiments, the cap filler 1410 can comprise a separate structure that fits within or is otherwise attached to the applicator cap 1404 without departing from the scope of this disclosure.

[0264] The sensor control assembly 1302, and more particularly the distal end of the sensor 1316 and sharps 1318 extending from the bottom of the electronics housing 1304, can be sterilized while positioned within the sensor applicator 102. More specifically, the fully assembled sensor control assembly 1302 can be subjected to radiation sterilization 1412, which can be combined with Figures 8-12 The radiation sterilization 1412 is similar to the radiation sterilization 814 described above. The radiation sterilization 1412 can be delivered by continuous process radiation or by pulsed beam radiation. In pulsed beam radiation, the beam of the radiation sterilization 1412 is focused at a target location, and the component part or device to be sterilized is moved to the target location, at which point the radiation is activated to provide a targeted pulse of radiation. The radiation sterilization 1412 is then turned off, and another component part or device to be sterilized is moved to the target location and the process is repeated.

[0265] According to the present disclosure, an external sterilization assembly 1414 can be used to help focus radiation 1412 when sterilizing the distal ends of the sensor 1316 and sharps 1318, while simultaneously preventing (blocking) the propagating radiation 1412 from damaging the radiation-sensitive components 1408. As illustrated, the external sterilization assembly 1414 (hereinafter "assembly 1414") can include a radiation shield 1416 positioned at least partially outside the sensor applicator 102. The radiation shield 1416 can provide or define an external collimator 1418 configured to help focus the radiation 1412 (e.g., beam, wave, energy, etc.) toward the component to be sterilized. More specifically, the external collimator 1418 allows for the transmission of radiation 1412 to impinge on and sterilize the sensor 1316 and sharps 1318, but prevents the radiation 1412 from damaging the radiation-sensitive components 1408 within the electronic device housing 1304.

[0266] In the illustrated embodiment, the external collimator 1418 is designed to align with the internal collimator 1420 defined by the cap filler 1410. Similar to the external collimator 1418, the internal collimator 1420 can help focus the radiation 1412 toward the component to be sterilized. As illustrated, the cap filler 1410 can define a radial shoulder 1422 that is sized to receive and otherwise mate with the end of the radiation shield 1416, 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, the transition can be discontinuous or stepped without departing from the scope of this disclosure.

[0267] The outer collimator 1418 and the inner collimator 1420 can cooperate to define a sterile zone 1424 that focuses the radiation 1412 and into which the distal ends of the sensor 1316 and the sharp object 1318 can be positioned. The propagating radiation 1412 can traverse the sterile zone 1424 to impinge on and sterilize the sensor 1316 and the sharp object 1318. However, the cap filler 1410 and the radiation shield 1416 can each be made of a material that substantially prevents the radiation 1412 from penetrating the inner wall(s) of the sterile zone 1424 and thereby damaging the radiation-sensitive components 1408 within the housing 1304. In other words, the cap filler 1410 and the radiation shield 1416 can each be made of a material that is dense enough to absorb a dose of the delivered beam energy. In some embodiments, for example, one or both of the cap filler 1410 and the radiation shield 1416 may be made of a material having a mass density greater than 0.9 grams per cubic centimeter (g / cc). However, in other embodiments, the mass density of suitable materials may be less than 0.9 g / cc without departing from the scope of the present disclosure. Suitable materials for the cap filler 1410 and the radiation shield 1416 include, but are not limited to, high-density polymers (e.g., polyethylene, polypropylene, polystyrene, polytetrafluoroethylene, etc.), metals (e.g., lead, stainless steel, aluminum, etc.), any combination thereof, or any material having a mass density greater than 0.9 g / cc. In at least one embodiment, the cap filler 1410 may be made of machined or 3D-printed polypropylene, and the radiation shield 1416 may be made of stainless steel.

[0268] In some embodiments, the design of sterilization zone 1424 can be modified so that one or both of cap filler 1410 and radiation shield 1416 can be made of a material having a mass density less than 0.9 g / cc, yet still operable to prevent radiation sterilization 1412 from damaging radiation-sensitive components 1408. In such embodiments, the size (e.g., length) of sterilization zone 1424 can be increased so that propagating electrons from radiation sterilization 1412 are required to pass through a greater amount of material before potentially impinging on radiation-sensitive components 1408. This greater amount of material can help absorb or dissipate the dose intensity of radiation 1412, rendering it harmless to sensitive electronic devices. However, in other embodiments, the opposite may also be true. More specifically, the size (e.g., length) of sterilization zone 1424 can be reduced, as long as the materials used for cap filler 1410 and / or radiation shield 1416 exhibit a sufficiently high mass density.

[0269] The sterilization zone 1424 defined by the external collimator 1418 and the internal collimator 1420 can exhibit any suitable cross-sectional shape necessary to properly focus the radiation 1412 on the sensor 1316 and the sharp object 1318 for sterilization. In the illustrated embodiment, for example, the external collimator 1418 and the internal collimator 1420 are both conical or frusto-conical in shape. However, in other embodiments, one or both of the external collimator 1418 and the internal collimator 1420 can exhibit a polygonal cross-sectional shape, such as a cube, a rectangle (e.g., including a parallelogram), or a pyramid, without departing from the scope of the present disclosure. In still other embodiments, one or both of the external collimator 1418 and the internal collimator 1420 can exhibit a circular cross-sectional shape with parallel sides.

[0270] In the illustrated embodiment, the sterile zone 1424 provides a first aperture 1426a defined by the outer collimator 1418 and a second aperture 1426b defined by the inner collimator 1420, wherein the first aperture 1426a and the second aperture 1426b are located at opposite ends of the sterile zone 1424. The first aperture 1426a allows the radiation 1412 to enter the sterile zone 1424, and the second aperture 1426b provides a location where the radiation 1412 can impinge on the sensor 1316 and the sharp 1318. In the illustrated embodiment, the second aperture 1426b also provides a location where the sensor 1316 and the sharp 1318 can be received into the sterile zone 1424.

[0271] In embodiments where the sterilization zone 1424 is conical or frustoconical in shape, the diameter of the first orifice 1426a can be greater than the diameter of the second orifice 1426b. In such embodiments, for example, the size of the first orifice 1426a can be within a range between about 5.0 mm and about 16.0 mm, and the size of the second orifice 1426b can be within a range between about 0.5 mm and about 3.0 mm. However, the respective diameters of the first orifice 1426a and the second orifice 1426b can be greater or less than the ranges provided herein without departing from the scope of this disclosure and depending on the application. In practice, the diameters of the first orifice 1426a and the second orifice 1426b only need to be large enough to allow a sufficient dose of radiation to be irradiated on the sensor 1316 and the sharp object 1318.

[0272] In the illustrated embodiment, the inner wall of the sterilization zone 1424 (e.g., the outer collimator 1418 and the inner collimator 1420) extends between the first orifice 1426a and the second orifice 1426b at a substantially constant angle relative to the centerline of the sensor applicator 102. The angle of the wall can be any angle between 0° and 90° relative to the centerline of the sensor applicator 102. However, the angle of the wall can preferably be between 45° and 90° relative to the centerline of the sensor applicator 102. However, in other embodiments, the angle of the wall can vary between the first orifice 1426a and the second orifice 1426b without departing from the scope of the present disclosure. In such embodiments, portions of the wall can extend at a different angle than adjacent portions for a short distance, or the wall can otherwise undulate between the first orifice 1426a and the second orifice 1426b.

[0273] In some embodiments, the sterilization zone 1424 defined by the outer collimator 1418 and the inner collimator can be substantially cylindrical, and in other cases exhibit a circular or polygonal cross-section. In such embodiments, the first orifice 1426a and the second orifice 1426b can exhibit the same diameter, and the walls of the sterilization zone 1424 can be substantially parallel between the first end and the second end of the sterilization zone 1424.

[0274] In some embodiments, a cap seal 1428 (shown in phantom) can be disposed at the interface between the cap filler 1410 and the radiation shield 1416. The cap seal 1428 can include a radiolucent microbial barrier. In some embodiments, for example, the cap seal 1428 can be made of a synthetic material (e.g., flash-spun high-density polyethylene fiber), such as TYVEK® available from DuPont®. The cap seal 1428 can seal a portion of the sterilization zone 1424 to help form a portion of a sealed area 1430 configured to isolate the sensor 1316 and sharps 1318 from external contamination.

[0275] The sealing area 1430 can include (surround) selected portions of the interior of the electronic device housing 1304 and the sterilization zone 1424. In one or more embodiments, the sealing area 1430 can be defined by and otherwise formed of at least a cap seal 1428, a first or "top" seal 1432a, and a second or "bottom" seal 1432b. The cap seal 1428 and the top and bottom seals 1432a, 1432b can each form a corresponding barrier at their respective sealing locations, thereby allowing the sterilization zone 1424 containing the sensor 1316 and the sharps 1318 to be terminally sterilized.

[0276] The top seal 1432a can be arranged to seal the sharps hub 1320 with the top of the electronic device housing 1304 (ie, Figure 131306) and thereby prevent contaminants from migrating into the interior of the electronic device housing 1304. In some embodiments, the top seal 1432a can form a portion of the sharps hub 1320, such as being overmolded onto the sharps hub 1320. However, in other embodiments, the top seal 1432a can form a portion of the top surface of the shell 1306 or be overmolded onto the top surface of the shell 1306. In still other embodiments, the top seal 1432a can include a separate structure, such as an O-ring, interposed between the sharps hub 1320 and the top surface of the shell 1306 without departing from the scope of this disclosure.

[0277] The bottom seal 1432b can be arranged to seal the cap filler 1410 to the bottom of the electronic device housing 1304 (ie, Figure 13 The bottom seal 1432b can prevent contaminants from migrating into the sterilization zone 1424 and into the interior of the electronic device housing 1304. In some embodiments, the bottom seal 1432b can form a portion of the cap filler 1410, such as being overmolded onto the top of the cap filler 1410. In other embodiments, the bottom seal 1432b can form a portion of the bottom of the base 1308 or be overmolded onto the bottom of the base 1308. In still other embodiments, the bottom seal 1432b can comprise a separate structure, such as an O-ring, inserted between the cap filler 1410 and the bottom of the base 1308 without departing from the scope of this disclosure.

[0278] When the sensor control unit 1302 is loaded into the sensor applicator 102 and the applicator cap 1404 is secured to the sensor applicator 102, the top seal 1432a and the bottom seal 1432b can be compressed and form corresponding sealing interfaces. The top seal 1432a and the bottom seal 1432b can be made of a variety of materials that can form 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.

[0279] Note that while the sensor 1316 and sharp object 1318 extend from the bottom of the electronics housing 1304 and into the sterilization zone 1424, which is generally concentric with the centerline of the sensor applicator 102 and the applicator cap 1404, an eccentric arrangement is contemplated herein. More specifically, in at least one embodiment, the sensor 1316 and sharp object 1318 may extend from the bottom of the electronics housing 1304 eccentrically with respect to the centerline of the sensor applicator 102 and the applicator cap 1404. In such an embodiment, the external collimator 1418 and the internal collimator 1420 may be redesigned and otherwise configured such that the sterilization zone 1424 is also positioned eccentrically to receive the sensor 1316 and sharp object 1318 without departing from the scope of this disclosure.

[0280] In some embodiments, the external sterilization assembly 1414 may further include a sterilization housing or "pod" 1434 coupled to or forming part of the radiation shield 1416. The sterilization pod 1434 provides and otherwise defines a chamber 1436 sized to receive all or a portion of the sensor applicator 102. Once properly seated (received) within the sterilization pod 1434, the sensor applicator 102 may be subjected to radiation sterilization 1412 to sterilize the sensor 1316 and sharps 1318. The sterilization pod 1434 may be made of any of the materials mentioned herein for the radiation shield 1416 to help prevent radiation 1412 from propagating through the walls of the sterilization pod 1434.

[0281] In some embodiments, the radiation shield 1416 can be removably coupled to the sterilization chamber 1434 using one or more mechanical fasteners 1438 (one shown), but can alternatively be removably coupled via an interference fit, a snap-fit ​​engagement, etc. Removably coupling the radiation shield 1416 to the sterilization chamber 1434 enables the radiation shield 1416 to be interchangeable with differently designed (sized) shields to accommodate specific sterilization applications for different types and designs of sensor applicators 102. Thus, the sterilization chamber 1434 can include a universal base that allows the radiation shield 1416 to be interchanged with other shield designs having different parameters for the external collimator 1418, as needed.

[0282] In some embodiments, the external sterilization assembly 1414 may further include a mounting tray 1440 that is coupled to or forms a portion of the sterilization pod 1434. The sterilization pod 1434 may be removably coupled to the mounting tray 1440 using, for example, one or more mechanical fasteners 1442 (one shown). The mounting tray 1440 may provide or define a central aperture 1444 that is sized to receive the sensor applicator 102 and that may be aligned with the cavity 1436 to enable the sensor applicator 102 to enter the cavity 1436. As described below, in some embodiments, the mounting tray 1440 may define a plurality of central apertures 1444 for receiving a corresponding plurality of sensor applicators for sterilization.

[0283] Figure 15 is a cross-sectional side view of another example embodiment of a sensor applicator 102 and an external sterilization assembly 1414 according to one or more additional embodiments. As illustrated, the sensor control assembly 1302 is again received within the sensor applicator 102, and the applicator cap 1404 is coupled to the housing 1402 to secure the sensor control assembly 1302 therein.

[0284] In the illustrated embodiment, the applicator cap 1404 can be inverted and can define or otherwise provide a cap post 1502 that is sized to receive distal ends of the sensor 1316 and sharps 1318 extending from the bottom of the electronic device housing 1304. The cap post 1502 helps provide a portion of a sealing area 1430 that is configured to isolate the sensor 1316 and sharps 1318 from external contaminants. In the illustrated embodiment, the sealing area 1430 can be defined by and otherwise formed by the cap post 1502 and top and bottom seals 1432a, 1432b that form corresponding barriers at their respective sealing locations. The top seal 1432a can again be arranged to seal the sharps hub 1320 from the top (i.e., Figure 13 1306 ), and the bottom seal 1432b can be arranged to seal the applicator cap 1404 with the bottom of the electronic device housing 1304 (ie, Figure 13 In some embodiments, bottom seal 1432b can be inserted between cap post 1502 and the bottom of electronic device housing 1304.

[0285] In the illustrated embodiment, the radiation shield 1416 can be positioned external to the sensor applicator 102 and can extend into an inverted portion of the applicator cap 1404. An external collimator 1418 provided by the radiation shield 1416 defines a sterilization zone 1504 that is configured to focus radiation 1412 toward the sensor 1316 and sharps 1318. In the illustrated embodiment, the cap post 1502 and portions of the sensor 1316 and sharps 1318 positioned within the cap post 1502 extend into the sterilization zone 1504. The propagated radiation 1412 can traverse the sterilization zone 1504 to sterilize the sensor 1316 and sharps 1318 positioned within the cap post 1502. However, as indicated above, the radiation shield 1416 may be made of a material that substantially prevents the radiation 1412 from penetrating the wall(s) of the sterile field 1504 and thereby damaging the radiation-sensitive components 1408 within the housing 1304 .

[0286] In the illustrated embodiment, the external collimator 1418 defines a first aperture 1506a at a first end of the sterile region 1504 and a second aperture 1506b at a second end of the sterile region 1504. The first aperture 1506a permits radiation 1412 to enter the sterile region 1504, and the second aperture 1506b provides a location at which the radiation 1412 is focused toward the sensor 1316 and the sharp 1318. The second aperture 1506b also provides a location at which the sensor 1316 and the sharp 1318, positioned within the cap post 1502, can be received into the sterile region 1504.

[0287] As illustrated, the external collimator 1418 and the associated sterilization zone 1504 are conical or frustoconical in shape, and the diameter of the first orifice 1506a is greater than the diameter of the second orifice 1506b. The size of the first orifice 1506a can be in the range of between about 5.0 mm and about 16.0 mm, and the size of the second orifice 1506b can be in the range of between about 0.5 mm and about 3.0 mm, but can alternatively be greater than or less than the provided range without departing from the scope of this disclosure. In practice, the size of the orifices 1506a, 1506b can vary depending on the scale of the device. However, in other embodiments, the external collimator 1418 and the associated sterilization zone 1504 can be substantially cylindrical and, in other cases, exhibit a circular or polygonal cross-section, wherein the first orifice 1506a and the second orifice 1506b exhibit substantially the same diameter, and the walls of the sterilization zone 1504 are substantially parallel.

[0288] Figure 16is a cross-sectional side view of another example embodiment of a sensor applicator 102 and an external sterilization assembly 1414 according to one or more additional embodiments. As illustrated, the sensor control assembly 1302 is again received within the sensor applicator 102, and the applicator cap 1404 is coupled to the housing 1402 to secure the sensor control assembly 1302 therein.

[0289] In the illustrated embodiment, the applicator cap 1404 may again be inverted and may define or otherwise provide a cap post 1602 that is sized to receive the distal ends of the sensor 1316 and sharps 1318 extending from the bottom of the electronics housing 1304. Additionally, the radiation shield 1416 may be positioned external to the sensor applicator 102 and may extend into the inverted portion of the applicator cap 1404. More specifically, the radiation shield 1416 may extend into the inverted portion of the applicator cap 1404 and to the bottom of the cap post 1602. However, unlike Figure 15 Unlike the cap column 1502 of the embodiment, the bottom of the cap column 1602 can be open. In some embodiments, the cap seal 1604 can be arranged at the interface between the cap column 1602 and the radiation shield 1416 to seal the open end of the cap column 1602. The cap seal 1604 can be arranged at the interface between the cap column 1602 and the radiation shield 1416 to seal the open end of the cap column 1602. Figure 14B The cap seal 1428 is similar and therefore will not be described again.

[0290] In some embodiments, the cap filler 1606 can be positioned within the applicator cap 1404. In one or more embodiments, the cap filler 1606 can comprise an integral portion or extension of the applicator cap 1404, such as being molded with or overmolded onto the applicator cap 1404. In other embodiments, the cap filler 1606 can comprise a separate structure that fits within or is otherwise attached to the applicator cap 1404 without departing from the scope of this disclosure. The cap filler 1606 can also provide or otherwise define an internal collimator 1608 that can help focus the radiation 1412 toward the component to be sterilized. In at least one embodiment, as illustrated, the cap post 1602 can be received within the internal collimator 1608.

[0291] The outer collimator 1418 and the inner collimator 1608 can cooperate to define a sterilization zone 1610 that focuses radiation 1412 toward the sensor 1316 and the sharp object 1318. The propagating radiation 1412 can traverse the sterilization zone 1610 to impinge on the sensor 1316 and the sharp object 1318 and sterilize them. However, the cap filler 1606 and the radiation shield 1416 can each be made of any material mentioned herein that substantially prevents the radiation 1412 from penetrating the inner wall(s) of the sterilization zone 1610 and thereby damaging the radiation-sensitive components 1408 within the housing 1304. In at least one embodiment, the cap filler 1606 can be made of machined or 3D-printed polypropylene, and the radiation shield 1416 can be made of stainless steel.

[0292] The external collimator 1418 and the internal collimator 1608 can exhibit any suitable cross-sectional shape necessary to properly focus the radiation 1412 toward the sensor 1316 and the sharp object 1318 for sterilization. In the illustrated embodiment, for example, the external collimator 1418 is conical or frusto-conical in shape, and the internal collimator 1608 is substantially cylindrical with substantially parallel interior walls. However, in other embodiments, the external collimator 1418 and the internal collimator 1608 can exhibit other cross-sectional shapes without departing from the scope of the present disclosure.

[0293] In the illustrated embodiment, the external collimator 1418 defines a first aperture 1612a that allows radiation 1412 to enter the sterilization zone 1610, and a second aperture 1612b positioned at or near the bottom opening to the post 1602 to focus the radiation 1412 at the sensor 1316 and sharp object 1318 positioned within the post 1602. The diameter of the first aperture 1612a is larger than the diameter of the second aperture 1612b, and as in the previous embodiment, the size of the first aperture 1612a can range from about 5.0 mm to about 16.0 mm, and the size of the second aperture 1612b can range from about 0.5 mm to about 3.0 mm. In the illustrated embodiment, the external collimator 1418 focuses electrons of the radiation 1412 toward the bottom opening of the post 1602 and amplifies the electrons at the sensor 1316 and sharp object 1318.

[0294] The cap seal 1604 may be disposed at an interface between the radiation shield 1416 and the cap post 1602 and / or the cap filler 1606. The cap seal 1604 may seal against a portion of the sterilization zone 1610 to help form a portion of a sealing area 1430 that is configured to isolate the sensor 1316 and the sharps 1318 from external contamination. The sealing area 1430 may include (surround) selected portions of: the interior of the electronic device housing 1304 and the sterilization zone 1610. In the illustrated embodiment, the sealing area 1430 may be defined and otherwise formed by the cap post 1602 and the top seal 1432a and the bottom seal 1432b that form corresponding barriers at their respective sealing locations. The bottom seal 1432b may be arranged to seal the applicator cap 1404 from the bottom (i.e., Figure 13 The interface between the base 1308).

[0295] Figure 17A and Figure 17B 14 and 15. The figures are partially exploded isometric top and bottom views, respectively, of one example of an external sterilization assembly 1414 according to one or more embodiments. In at least one embodiment, the assembly 1414 can be designed and otherwise configured to accommodate and facilitate sterilization of multiple sensor applicators 102 (i.e., having sensor controls positioned therein). In the illustrated embodiment, the mounting tray 1440 defines a plurality of central apertures 1444 ( Figure 17A ), and a plurality of sterilization pods 1434 may be aligned with the central aperture 1444 and coupled to the mounting tray 1440. The sensor applicator 102 may be received within the sterilization pod 1434 via the central aperture 1444, and each sterilization pod 1434 may have a corresponding shield 1416 ( Figure 17B ).

[0296] In some embodiments, assembly 1414 may further include a cover 1702 that may mate with mounting tray 1440. Cover 1702 may include or define a plurality of apertures 1106 ( Figure 17B ), the plurality of apertures being sized to receive the top of the sensor applicator 102 when the cover 1702 is placed on top of the mounting tray 1440. In some embodiments, the cover 1702 can be made of any of the materials mentioned herein for the radiation shield 1416 to help prevent radiation sterilization from propagating through the walls of the assembly 1414. With the cover 1702 mated with the mounting tray 1414, the sensor applicator 102 can be potted or otherwise enclosed within the assembly 1414.

[0297] Embodiments disclosed herein include:

[0298] D. An external sterilization assembly comprising: a radiation shield positionable on an exterior of a medical device having a part to be sterilized and a radiation-sensitive component; and a collimator defined by the radiation shield and alignable with the part to be sterilized, wherein the collimator focuses radiation from a radiation sterilization process toward the part to be sterilized and the radiation shield prevents the radiation from damaging the radiation-sensitive component.

[0299] E. An external sterilization assembly comprising a radiation shield positionable external to a sensor applicator, the sensor applicator comprising a housing, a cap coupled to the housing, and a sensor control positioned within the housing, wherein the sensor control comprises an electronics housing, a radiation-sensitive component disposed within the electronics housing, and a sensor and a sharp extending from the electronics housing. The external sterilization assembly further comprises an external collimator defined by the radiation shield and alignable with the sensor and the sharp, wherein the external collimator focuses radiation from a radiation sterilization process toward the sensor and the sharp, and the radiation shield prevents the radiation from damaging the radiation-sensitive component.

[0300] F. A method comprising disposing a radiation shield external to a sensor applicator having a housing, a cap coupled to the housing, and a sensor control positioned within the housing, wherein the sensor control comprises an electronics housing, a radiation-sensitive component disposed within the electronics housing, and a sensor and a sharp extending from the electronics housing. The method further comprises: utilizing an external collimator defined by the radiation shield to focus radiation from a radiation sterilization process toward the sensor and the sharp; and utilizing the radiation shield to prevent the radiation from damaging the radiation-sensitive component.

[0301] Each of embodiments D, E, and F may have one or more of the following additional elements in any combination: Element 1: wherein the radiation shield is made of a material selected from the group consisting of: a high-density polymer, a metal, and any combination thereof. Element 2: wherein the radiation-sensitive component is selected from the group consisting of: an electronic module, a chemical solution, and any combination thereof. Element 3: wherein the collimator comprises a cross-sectional shape selected from the group consisting of: a cone, a frustoconical, a pyramid, a circle, a cube, a rectangle, and any combination thereof. Element 4: further comprising a cap that encapsulates the parts to be sterilized and provides a sealing barrier. Element 5: wherein the radiation shield defines an interior cavity that receives the medical device, and the collimator focuses radiation into the interior cavity.

[0302] Element 6: wherein the radiation shield is made of a material selected from the group consisting of: a high-density polymer, a metal, and any combination thereof. Element 7: wherein the external collimator comprises a cross-sectional shape selected from the group consisting of: a cone, a frustoconical, a pyramid, a circle, a cube, a rectangle, and any combination thereof. Element 8: further comprising a sterilization chamber defining a chamber for receiving at least a portion of a sensor applicator, wherein the radiation shield is removably coupled to the sterilization chamber. Element 9: further comprising: a mounting tray defining a central aperture alignable with the chamber and sized to receive the sensor applicator; and a cover mateable with the mounting tray to enclose the sensor applicator. Element 10: wherein the external collimator is alignable with an internal collimator defined by a cap filler positioned within the cap, and wherein the external collimator and the internal collimator cooperatively define a sterilization zone into which the sensor and sharp are received. Element 11: wherein the outer collimator and the inner collimator each comprise a cross-sectional shape selected from the group consisting of: conical, frustoconical, pyramidal, circular, cubic, rectangular, and any combination thereof. Element 12: further comprising a cap seal disposed at an interface between the outer collimator and the inner collimator. Element 13: wherein the cap is inverted and a cap post is provided for receiving a sensor and a sharp. Element 14: wherein the outer collimator and the cap post cooperatively define a sterile zone, and the sensor and sharp positioned within the cap post extend into the sterile zone.

[0303] Element 15: wherein arranging the radiation shield external to the sensor applicator comprises positioning the sensor applicator within a chamber defined by a sterilization chamber to which the radiation shield is removably coupled. Element 16: wherein positioning the sensor applicator within the chamber defined by the sterilization chamber further comprises: extending the sensor applicator through a central aperture defined by a mounting tray and aligned with the chamber; positioning a cover on the mounting tray and thereby enclosing the sensor applicator; and performing a radiation sterilization process while the sensor applicator is enclosed by the cover. Element 17: wherein the external collimator comprises a cross-sectional shape selected from the group consisting of: conical, frustoconical, pyramidal, circular, cubic, rectangular, and any combination thereof.

[0304] As non-limiting examples, exemplary combinations suitable for D, E, and F include: 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.

[0305] Mixed sterilization components

[0306] Again briefly refer to Figure 1Before the sensor control unit 104 is delivered to the end user, it must be sterilized to render the product free of viable microorganisms. Radiation sterilization, such as electron beam (e-beam) radiation, is typically used to sterilize the sensor 110. However, radiation sterilization can damage electronic components within the sensor control unit 104, which are typically sterilized via gaseous chemical sterilization (e.g., using ethylene oxide). However, gaseous chemical sterilization can damage enzymes or other chemicals and biological agents included on the sensor 110.

[0307] In the past, this sterilization incompatibility has been circumvented by separating the sensor 110 and the electronic components and sterilizing each separately. However, this approach requires additional parts, packaging, process steps, and final assembly by the user, which introduces the possibility of user error. According to the present disclosure, the sensor control unit 104, or any device requiring terminal sterilization, can be properly sterilized using an external sterilization assembly designed to focus sterilizing radiation (e.g., beam, wave, energy, etc.) toward the component parts requiring sterilization while preventing the transmitted radiation from damaging or destroying sensitive electronic components.

[0308] Figure 18 is an isometric view of an example sensor control device 1802 according to one or more embodiments of the present disclosure. The sensor control device 1802 may be used with Figure 1 The sensor control device 104 is the same as or similar to the sensor applicator 102 ( Figure 1 ) is used in conjunction with the sensor applicator to deliver the sensor control device 1802 to the target monitoring location on the user's skin. Therefore, the sensor control device 1802 also needs to be properly sterilized before use.

[0309] As illustrated, sensor control device 1802 includes an electronics housing 1804 that is generally disc-shaped and may have a circular cross-section. However, in other embodiments, electronics housing 1804 may exhibit other cross-sectional shapes, such as oval (e.g., pill-shaped or egg-shaped), squarish, polygonal, or any combination thereof, without departing from the scope of this disclosure. Electronics housing 1804 may be configured to house or otherwise contain various electronic components used to operate sensor control device 1802.

[0310] Electronic device housing 1804 may include a shell 1806 and a base 1808 that mates with shell 1806. Shell 1806 may be secured to base 1808 via a variety of methods, such as a snap-fit, an interference fit, sonic or laser welding, one or more mechanical fasteners (e.g., screws), or any combination thereof. In some cases, shell 1806 may be secured to base 1808 to create a sealed interface therebetween. In such embodiments, a gasket or other type of sealing material may be positioned at or near the outer diameter (perimeter) of shell 1806 and base 1808, and securing the two components together compresses the gasket, thereby creating a sealed interface. In other embodiments, an adhesive may be applied to the outer diameter (perimeter) of one or both of shell 1806 and base 1808. The adhesive secures shell 1806 to base 1808 and provides structural integrity, but also seals the interface between the two components, thereby isolating the interior of electronic device housing 1804 from external contaminants.

[0311] In the illustrated embodiment, sensor control device 1802 can optionally include a plug assembly 1810 that can be coupled to electronics housing 1804. Plug assembly 1810 can include a sensor module 1812 (partially visible) that can be interconnected with a sharps module 1814 (partially visible). Sensor module 1812 can be configured to carry and otherwise include a sensor 1816 (partially visible), and sharps module 1814 can be configured to carry and otherwise include an introducer or sharp 1818 (partially visible) for facilitating transcutaneous delivery of sensor 1816 beneath a user's skin during application of sensor control device 1802. In the illustrated embodiment, sharps module 1814 includes a sharps hub 1820 that carries sharps 1818.

[0312] As illustrated, sensor 1816 and corresponding portions of spike 1818 extend distally from electronic device housing 1804, and more particularly, from the bottom of base 1808. In at least one embodiment, an exposed portion of sensor 1816 (alternatively referred to as a "tail") can be received within a hollow or recessed portion of spike 1818. The remainder of sensor 1816 is positioned within the interior of electronic device housing 1804.

[0313] Figure 19A yes Figure 11902 and a side view of the sensor applicator 102. As illustrated, the sensor applicator 102 includes a housing 1902 and an applicator cap 1904 that can be removably coupled to the housing 1902. In some embodiments, the applicator cap 1904 can be threaded onto the housing 1902 and include a tamper-evident ring 1906. When the applicator cap 1904 is rotated (e.g., unscrewed) relative to the housing 1902, the tamper-evident ring 1906 can shear and thereby release the applicator cap 1904 from the sensor applicator 102. Once the applicator cap 1904 is removed, the user can then use the sensor applicator 102 to remove the sensor control device 1802 ( Figure 18 ) is positioned at the target monitoring location on the user's body.

[0314] Figure 19B is a partial cross-sectional side view of the sensor applicator 102. As illustrated, the sensor control device 1802 can be received within the sensor applicator 102, and the applicator cap 1904 can be coupled to the housing 1902 to secure the sensor control device 1802 therein. The sensor control device 1802 can include one or more radiation-sensitive components 1908 disposed within the electronics housing 1804. The radiation-sensitive components 1908 can include electronic components or modules, such as, but not limited to, a data processing unit, a resistor, a transistor, a capacitor, an inductor, a diode, a switch, or any combination thereof. The data processing unit can include, for example, an application specific integrated circuit (ASIC) configured to implement one or more functions or routines associated with the operation of the sensor control device 1802. In operation, the data processing unit can perform data processing functions, such as filtering and encoding of data signals corresponding to the sampled analyte level of the user. The data processing unit can also include an antenna or otherwise communicate with an antenna for communicating with the reader device 106 ( Figure 1 ) communication.

[0315] In the illustrated embodiment, an applicator insert 1910 can be positioned within the applicator cap 1904 and can generally help support the sensor control device 1802 within the sensor applicator 102. In one embodiment, the applicator insert 1910 can comprise an integral portion or extension of the applicator cap 1904, such as being molded with or overmolded onto the applicator cap 1904. In other embodiments, the applicator insert 1910 can comprise a separate structure that fits within or is otherwise attached to the applicator cap 1904 without departing from the scope of the present disclosure. In such an embodiment, for example, tightening the applicator cap 1904 onto the housing 1908 can progressively advance the inner surface 1912 of the applicator insert 1910 into axial and / or radial engagement with a bottom edge, surface, or portion of the applicator insert 1910, thereby securing the applicator insert 1910 axially within the applicator cap 1904.

[0316] The sensor applicator 102 may also include a sheath 1914, and in some embodiments, the applicator insert 1910 may engage the sheath 1914 to rotationally secure the applicator insert 1910 within the applicator cap 1904. More specifically, the applicator insert 1910 may provide or otherwise define one or more radial alignment features 1916 (one shown) that may mate with corresponding recesses or slots 1918 defined in the sheath 1914. For example, the radial alignment features 1916 may include, for example, tracks, flags, tabs, protrusions, etc., extending from the body of the applicator insert 1910 and may mate with the slots 1918 by longitudinally sliding the radial alignment features 1916 into the slots 1918. The mating engagement between the radial alignment features 1916 and the slots 1918 may also help angularly (rotationally) orient the applicator insert 1910 relative to the sensor control 1802. However, as will be appreciated, the mateable configuration may alternatively be reversed, with the radial alignment feature 1916 instead being provided on the sheath 1914 and the slot 1918 being provided on the applicator insert 1910 .

[0317] The applicator insert 1910 can provide and otherwise define an internal collimator 1920a that forms part of a hybrid sterilization assembly described in detail below. The internal collimator 1920a can help define a portion of a sterilization zone 1922, and more particularly, an upper portion 1924 of the sterilization zone 1922. When the sensor control unit 1802 is installed in the sensor applicator 102, the distal ends of the sensor 1816 and the sharps 1818 can extend from the bottom of the electronics housing 1804 and reside within the upper portion 1924.

[0318] In some embodiments, microbial barrier 1926a can be positioned at the opening to upper portion 1924 of sterile zone 1922. Microbial barrier 1926a can help seal at least some of upper portion 1924 of sterile zone 1922, thereby isolating sensor 1816 and the distal end of sharp object 1818 from external contamination. Microbial barrier 1926a can be made of a radiolucent material, such as a synthetic material (e.g., flash-spun high-density polyethylene fiber). An example synthetic material includes TYVEK® available from DuPont®. However, in other embodiments, microbial barrier 1926a can include, but is not limited to, tape, paper, film, foil, or any combination thereof. In at least one embodiment, microbial barrier 1926a can include or otherwise be formed from a thinned portion of applicator insert 1910 without departing from the scope of this disclosure.

[0319] In some embodiments, moisture barrier 1926b can be positioned or otherwise arranged at opening 1928 to applicator cap 1904. Similar to microbial barrier 1926a, moisture barrier 1926b can be configured to help isolate portions of sensor applicator 102 from external contamination. Moisture barrier 1926b can be made of any of the materials mentioned above with reference to microbial barrier 1926a. However, in at least one embodiment, moisture barrier 1926b can comprise a thinned portion of applicator cap 1904 without departing from the scope of this disclosure. In such an embodiment, opening 1928 would not be necessary.

[0320] Figures 20A-20C are various views of an applicator insert 1910 according to one or more embodiments of the present disclosure. More specifically, Figure 20A is an isometric top view of the applicator insert 1910, Figure 20B is an isometric bottom view of the applicator insert 1910, and Figure 20C is an isometric cross-sectional view of an applicator insert 1910. As illustrated, the applicator insert 1910 includes a generally cylindrical body 2002 having a first or top end 2004a and a second or bottom end 2004b opposite the top end 2004a. Figure 19B ) and Sharp Objects 1918 ( Figure 19B ), the top end 2004a is typically closed and the bottom end 2004b is typically open.

[0321] The radial alignment features 1916 described above are provided on the sidewalls of the body 2002. In some embodiments, additional radial alignment features 2006 (three shown) may be provided or otherwise defined on the sidewalls of the body 2002. In the illustrated embodiment, the additional radial alignment features 2006 each include a pair of longitudinally extending tabs or protrusions 2008 angularly offset from one another on the sidewalls to cooperatively define a slot 2010 therebetween. The slots 2010 may be sized to receive a plurality of radial alignment features 2006 provided on the sheath 1914 ( Figure 19B ) to assist in positioning the sensor control device 1802 ( Figure 19B ) to angularly (rotationally) orient the applicator insert 1910. Furthermore, similar to the arrangement of the radial alignment features 1916, the matable configuration of the additional radial alignment features 2006 may alternatively be reversed, wherein the additional radial alignment features 2006 are instead provided on the sheath 1914 and corresponding protrusions or tabs are provided on the applicator insert 1910.

[0322] As in Figure 20A and Figure 20C As best seen in FIG. 1 , the applicator insert 1910 may also include one or more sensor locating features 2012 that may be used to also assist in positioning the sensor applicator 102 ( Figure 19B ) relative to the sensor control device 1802 ( Figure 19B ) to properly orient the applicator insert 1910. As illustrated, a sensor locating feature 2012 can be defined on the top end 2004a of the body 2002 and extend axially therefrom. The sensor locating feature 2012 can be sized to be received within a corresponding aperture defined in the bottom of the sensor control device 1802. In the illustrated embodiment, the sensor locating feature 2012 comprises a cylindrical protrusion, but may alternatively comprise other types of structural features suitable for mating with corresponding features on the bottom of the sensor control device 1802. The sensor locating feature 2012, in combination with the radial alignment feature 1916 and the additional radial alignment feature 2006, can prove particularly advantageous in embodiments in which the sensor control device 1802 includes an off-center orientation in which the sensor 1916 and the sharp object 1918 are not concentric with the centerline of the sensor control device.

[0323] An internal collimator 1920a may be formed or otherwise provided at the top end 2004a of the applicator insert 1910. Figure 20CAs best seen in FIG, internal collimator 1920a can be defined by applicator insert 1910 and can include collimation insert 2014 and gasket 2016. Internal collimator 1920a can be manufactured by first manufacturing or otherwise producing collimation insert 2014. Applicator insert 1910 can then be overmolded onto collimation insert 2014. Furthermore, collimation insert 2014 can be insert molded into applicator insert 1910. Thus, applicator insert 1910 can be made of a hard plastic. Gasket 2016 can then be molded onto applicator insert 1910 in a second shot molding (overmolding) process.

[0324] The collimation insert 2014 can be made of a material that reduces or prevents the sterilizing radiation from penetrating therethrough. Suitable materials for the collimation insert 2014 include, but are not limited to, high-density polymers (e.g., polyethylene, polypropylene, polystyrene, polytetrafluoroethylene, polyamide, etc.), metals (e.g., lead, tungsten, stainless steel, aluminum, etc.), composite materials, or any combination thereof. In some embodiments, the collimation insert 2014 can be made of any material having a mass density greater than 0.9 grams per cubic centimeter (g / cc).

[0325] The gasket 2016 may be provided when the applicator insert 1910 is installed on the sensor applicator 102 ( Figure 19B ) when helping with electronic device housing 1804 ( Figure 19B ) and the bottom of the body 2002. Suitable materials for gasket 2016 include, but are not limited to, silicone, thermoplastic elastomer (TPE), polytetrafluoroethylene (e.g., TEFLON®), or any combination thereof. As illustrated, gasket 2016 can fill void 2018 defined by applicator insert 1910 and can provide an annular protrusion 2020 that projects beyond and / or from the upper surface of top end 2004a of body 2002. Annular protrusion 2020 can prove advantageous not only in promoting a sealing interface but also in helping to absorb tolerances when applicator insert 1910 is installed in sensor applicator 102. Furthermore, the mass of gasket 2016 can also help absorb radiation during the sterilization process described below, thereby providing another layer of protection against radiation transmission. In at least one embodiment, the gasket 2016 can be large enough or of a material that absorbs enough radiation that the collimating insert 2014 can be omitted from the internal collimator 1920a.

[0326] Figure 21 According to one or more embodiments of the present disclosure Figure 19AFIG2 is another cross-sectional side view of the sensor applicator 102 illustrating a hybrid sterilization assembly 2102. The hybrid sterilization assembly 2102 (alternatively referred to as a "split collimation assembly" or a "cooperative collimation assembly") can be used to facilitate sterilization of the sensor control unit 1802, and more particularly, the distal ends of the sensor 1816 and sharps 1818 extending from the bottom of the electronics housing 1804, while positioned within the sensor applicator 102. More specifically, the fully assembled sensor control unit 1802 can be subjected to radiation sterilization 2104 to sterilize the exposed portions of the sensor 1816 and sharps 1818. Suitable radiation sterilization 2104 processes include, but are not limited to, electron beam (e-beam) radiation, gamma ray radiation, X-ray radiation, or any combination thereof.

[0327] Radiation sterilization 2104 can be delivered via either continuous process radiation or pulsed beam radiation. In pulsed beam radiation, the beam of radiation sterilization 2104 is focused at a target location, and the component part or device to be sterilized is moved to the target location, at which point the radiation is activated to provide a targeted pulse of radiation. The radiation sterilization 2104 is then turned off, and another component part or device to be sterilized is moved to the target location and the process is repeated.

[0328] According to the present disclosure, a hybrid sterilization assembly 2102 can be used to help focus radiation 2104 when sterilizing the distal end of the sensor 1816 and sharp object 1818, while simultaneously preventing (blocking) the propagating radiation 2104 from damaging the radiation-sensitive component 1908. As illustrated, the hybrid sterilization assembly 2102 (hereinafter "assembly 2102") can include the internal collimator 1920a and the external collimator 1920b previously described above. As illustrated, the internal collimator 1920a can be disposed within the sensor applicator 102, and the external collimator 1920b can extend into the sensor applicator 102 (i.e., the applicator cap 1904) by penetrating an opening 1928 leading to the applicator cap 1904. The inner collimator 1920a and the outer collimator 1920b can cooperatively define a sterilization zone 1922 that focuses the radiation 2104 (eg, beam, wave, energy, etc.) so that it impinges on the sensor 1816 and the sharps 1818 and sterilizes them.

[0329] In the illustrated embodiment, the outer collimator 1920b is designed to align with the inner collimator 1920a, and more particularly, with the collimation insert 2014. In at least one embodiment, for example, the collimation insert 2014 may define a radial shoulder 2106 that is sized to receive and otherwise mate with the end of the outer collimator 1920b extending into the applicator cap 1904. The outer collimator 1920b may transition to the inner collimator 1920a at the radial shoulder 2106. In some embodiments, the transition between the inner collimator 1920a and the outer collimator 1920b may be continuous, flush, or smooth. However, in other embodiments, the transition may be discontinuous or stepped without departing from the scope of this disclosure.

[0330] Similar to the collimation insert 2014 of the internal collimator 1920a, the external collimator 1920b can be made of a material that substantially prevents radiation 2104 from penetrating the inner wall(s) of the sterilization zone 1922 and thereby damaging the radiation-sensitive components 1908 within the electronics housing 1804. Thus, the external collimator 1920b can be made of any material mentioned herein as suitable for the collimation insert 2014. In at least one embodiment, the collimation insert 2014 and the external collimator 1920b can each be made of stainless steel. Furthermore, as mentioned above, the gasket 2016 can also provide a degree of shielding or protection from radiation damage to the radiation-sensitive components 1908.

[0331] The sterilization zone 1922 defined by the inner collimator 1920a and the outer collimator 1920b can exhibit any suitable cross-sectional shape necessary to properly focus the radiation 2104 on the sensor 1816 and the sharp object 1818 for sterilization. In the illustrated embodiment, for example, the inner collimator 1920a and the outer collimator 1920b are both conical or frusto-conical in shape. However, in other embodiments, one or both of the inner collimator 1920a and the outer collimator 1920b can exhibit a polygonal cross-sectional shape, such as a cube, a rectangle (e.g., including a parallelogram), or a pyramid, without departing from the scope of this disclosure. In still other embodiments, one or both of the inner collimator 1920a and the outer collimator 1920b can exhibit a circular cross-sectional shape with parallel sides.

[0332] In the illustrated embodiment, the sterile zone 1922 provides a first aperture 2108a defined by an outer collimator 1920b and a second aperture 2108b defined by an inner collimator 1920a, wherein the first aperture 2108a and the second aperture 2108b are located at opposite ends of the sterile zone 1922. The first aperture 2108a permits radiation 2104 to enter the sterile zone 1922, and the second aperture 2108b provides a location at which the sensor 1816 and the sharp 1818 can be received into the sterile zone 1922.

[0333] In embodiments where the sterilization zone 1922 is conical or frustoconical in shape, the diameter of the first orifice 2108a can be greater than the diameter of the second orifice 2108b. In such embodiments, for example, the size of the first orifice 2108a can be within a range between about 5.0 mm and about 16.0 mm, and the size of the second orifice 2108b can be within a range between about 0.5 mm and about 5.0 mm. However, the respective diameters of the first orifice 2108a and the second orifice 2108b can be greater or less than the ranges provided herein without departing from the scope of this disclosure and depending on the application. In practice, the diameters of the first orifice 2108a and the second orifice 2108b only need to be large enough to allow a sufficient dose of radiation to be irradiated on the sensor 1816 and the sharp object 1818.

[0334] In embodiments where the sterilization zone 1922 is substantially cylindrical and otherwise exhibits a circular or polygonal cross-section, the first orifice 2108a and the second orifice 2108b can exhibit the same diameter. In such embodiments, the walls of the sterilization zone 1922 may or may not be substantially parallel between the first and second ends of the sterilization zone 1922.

[0335] In the illustrated embodiment, the inner wall of the sterilization zone 1922 (e.g., the inner collimator 1920a and the outer collimator 1920b) extends between the first orifice 2108a and the second orifice 2108b at a substantially constant angle relative to the centerline of the sensor applicator 102. The angle of the wall can be any angle between 0° and 90° relative to the centerline of the sensor applicator 102. However, the angle of the wall can preferably be between 45° and 90° relative to the centerline. However, in other embodiments, the angle of the wall can vary between the first orifice 2108a and the second orifice 2108b without departing from the scope of the present disclosure. In such embodiments, portions of the wall can extend for a short distance at a different angle than adjacent portions, or the wall can undulate between the first orifice 2108a and the second orifice 2108b.

[0336] Microbial barrier 1926a may be mounted at the interface between inner collimator 1920a and outer collimator 1920b and otherwise positioned at or near radial shoulder 2106. Microbial barrier 1926a may be present during the radiation sterilization process. As indicated above, microbial barrier 1926a may help seal at least a portion of sterile zone 1922. More specifically, microbial barrier 1926a may seal a portion of sterile zone 1922 to help form a portion of sealed area 2110, which is configured to isolate sensor 1816 and sharps 1818 from external contamination. Sealed area 2110 may include (surround) selected portions of the interior of electronics housing 1804 and sterile zone 1922. In one or more embodiments, sealed area 2110 may be defined by and otherwise formed by at least microbial barrier 1926a, a first or "top" seal 2112a, and a second or "bottom" seal 2112b. The microbial barrier 1926a and the top and bottom seals 2112a, 2112b can each form corresponding barriers at their respective sealing locations, thereby allowing the sterilization zone 1922 containing the sensor 1816 and the sharps 1818 to be terminally sterilized.

[0337] The top seal 2112a can be arranged to seal the sharps hub 1820 with the top of the electronic device housing 1804 (ie, Figure 18 1806) and thereby prevent contaminants from migrating into the interior of the electronic device housing 1804. In some embodiments, the top seal 2112a can form a portion of the sharps hub 1820, such as being overmolded onto the sharps hub 1820. However, in other embodiments, the top seal 2112a can form a portion of the top surface of the shell 1806 or be overmolded onto the top surface of the shell 1806. In still other embodiments, the top seal 2112a can include a separate structure, such as an O-ring, interposed between the sharps hub 1820 and the top surface of the shell 1806 without departing from the scope of this disclosure.

[0338] The bottom seal 2112b may include a gasket 2016 ( Figure 20C ), and more particularly includes an annular protrusion 2020 ( Figure 20A and Figure 20C In operation, bottom seal 2112b may be arranged to seal applicator insert 1910 against the bottom of electronic device housing 1804 (ie, Figure 18 The bottom seal 2112b can prevent contaminants from migrating into the sterilization zone 1922 and into the interior of the electronic device housing 1804.

[0339] When the sensor control unit 1802 is loaded into the sensor applicator 102 and the applicator cap 1904 is secured to the sensor applicator 102, the top seal 2112a and the bottom seal 2112b can become progressively compressed and thereby create corresponding sealing interfaces. The top seal 2112a and the bottom seal 2112b can be made of a variety of materials capable 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.

[0340] Once the radiation sterilization process is complete, the external collimator 1920b can be removed from the applicator cap 1904, and the moisture barrier 1926b can be placed to block the opening 1928 in the applicator cap 1904. At the time of delivery, the user can simply remove the applicator cap 1904 to prepare for delivery of the sensor control device 1802. In at least one embodiment, removing the applicator cap 1904 will simultaneously remove the applicator insert 1910, which can be received in the applicator cap 1904, allowing the applicator insert 1910 to be secured to the applicator cap 1904 for removal. 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.

[0341] In some embodiments, electronic device housing 1804 may be filled with a potting material 2114 that fills the void within sensor control unit 1802. Potting material 2114 may comprise a biocompatible material that meets the requirements of ISO 10993. In some embodiments, for example, potting material 2114 may comprise a urethane (such as Resinaid® 3672) or a silicone material (such as SI 5055 or SI 5240 available from Henkel®). In other embodiments, potting material 2114 may comprise an acrylate adhesive material, such as GE 4949 available from Delo®.

[0342] Potting material 2114 can also serve as an additional safety barrier to absorb or deflect propagating radiation 2104. In at least one embodiment, for example, potting material 2114 can exhibit an electron beam resistance of at least 85 kGy. Thus, instead of passing through the air typically present within electronics housing 1804, radiation 2104 can be required to pass through potting material 2114 before impinging on radiation-sensitive component(s) 1908. While potting material 2114 may not include high-density materials, it can still serve as another level of radiation shielding. Furthermore, potting material 2114 can also increase the robustness of sensor control unit 1802 and electronics housing 1804. Thus, using potting material 2114 can allow electronics housing 1804 to be constructed from thinner materials, if desired.

[0343] Note that while the sensor 1816 and sharps 1818 extend from the bottom of the electronics housing 1804 and into the sterilization zone 1922, which is generally concentric with the centerline of the sensor applicator 102 and applicator cap 1904, an off-center arrangement is contemplated herein. More specifically, in at least one embodiment, the sensor 1816 and sharps 1818 may extend from the bottom of the electronics housing 1804 off-center from the centerline of the sensor applicator 102 and applicator cap 1904. In such an embodiment, the inner collimator 1920a and the outer collimator 1920b may be redesigned and otherwise configured such that the sterilization zone 1922 is also positioned off-center to receive the sensor 1816 and sharps 1818 without departing from the scope of this disclosure.

[0344] Figure 22A and Figure 22B are isometric and cross-sectional side views of another embodiment of an applicator insert 1910 . Figures 22A-22B The applicator insert 1910 depicted in FIG. 1 is similar in most respects to the Figures 20A-20C Similar to the applicator insert 1910 of . However, Figures 20A-20C The applicator insert 1910 is different, Figures 22A-22B The applicator insert 1910 exhibits an off-center orientation, wherein the internal collimator 1920a is positioned off-center with respect to the centerline 2202 of the body 2002 ( Figure 22B In such an embodiment, the sensor control device 1802 ( Figure 19B and Figure 21 ) may also exhibit an off-center orientation such that sensor 1816 ( Figure 19B and Figure 21 ) and sharp objects 1818 ( Figure 19B and Figure 21) can extend into the aperture 2005 defined in the tip 2004a of the applicator insert 1910. Furthermore, in such an embodiment, the radial alignment feature 1916, the additional radial alignment feature 2006, and the sensor locating feature 2012 can be used to assist in positioning the sensor applicator 102 ( Figure 19B and Figure 21 ) has proven to be particularly advantageous in properly orienting the applicator insert 1910 relative to the sensor control unit 1802.

[0345] Embodiments disclosed herein include:

[0346] H. A sensor applicator comprising: a housing having a sensor control disposed therein, the sensor control including a sensor, a sharp, and a radiation-sensitive component; an applicator cap removably coupled to the housing; an applicator insert positionable within the applicator cap and defining an internal collimator at a distal end that receives the sensor and the sharp; and an external collimator extending into the applicator cap, wherein the internal collimator and the external collimator cooperatively focus radiation from a radiation sterilization process toward the sensor and the sharp while preventing the radiation from damaging the radiation-sensitive component.

[0347] I. A method of sterilizing a sensor control assembly, the method comprising: positioning a sensor control assembly within a housing of a sensor applicator, the sensor control assembly including a sensor, a sharp, and a radiation-sensitive component; receiving distal ends of the sensor and sharp within an internal collimator defined by an applicator insert; removably coupling an applicator cap to the housing and thereby securing the applicator insert within the applicator cap; extending an external collimator into the applicator cap and aligning the external collimator with the internal collimator; and utilizing the internal and external collimators to cooperatively focus radiation from a radiation sterilization process toward the sensor and sharp while preventing the radiation from damaging the radiation-sensitive component.

[0348] J. A hybrid sterilization assembly comprising: an applicator insert positionable within an applicator cap of a sensor applicator; an internal collimator defined by the applicator insert to receive a distal end of a sensor and a sharp of a sensor control device disposed within a housing of the sensor applicator; and an external collimator extendable into the applicator cap and alignable with the internal collimator, wherein the internal collimator and the external collimator cooperatively focus radiation from a radiation sterilization process toward the sensor and the sharp while preventing the radiation from damaging radiation-sensitive components.

[0349] Each of embodiments H, I, and J may have one or more of the following additional elements in any combination: Element 1: wherein the applicator insert engages an inner surface of the applicator cap to axially secure the applicator insert within the applicator cap. Element 2: further comprising: a sheath extending from the housing and 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 cooperable with one or more corresponding features provided on the sheath to rotationally orient the applicator insert relative to the sensor control. Element 3: further comprising one or more sensor positioning features provided on the applicator insert and cooperable with one or more corresponding features on the sensor control to rotationally orient the applicator insert relative to the sensor control. Element 4: wherein the internal collimator comprises a collimation insert, and the external collimator is alignable with the collimation insert. Element 5: wherein the collimation insert and the external collimator are each made of a material selected from the group consisting of: a high-density polymer, a metal, a composite material, and any combination thereof. Element 6: wherein the internal collimator further comprises a gasket engageable with a bottom portion of the sensor control unit to create a sealed interface. Element 7: wherein the internal collimator and the external collimator cooperatively define a sterilization zone, the sterilization zone exhibiting a cross-sectional shape selected from the group consisting of: conical, frustoconical, pyramidal, circular, cubic, rectangular, and any combination thereof. Element 8: further comprising a potting material disposed within the sensor control unit.

[0350] Element 9: Also included is engaging an inner surface of the applicator cap against the applicator insert and thereby axially securing the applicator insert within the applicator cap. Element 10: Wherein, the internal collimator includes a gasket, the method further comprising: engaging the gasket against the bottom of the sensor control when the applicator insert is axially secured within the applicator cap; and generating a sealed interface with the gasket against the bottom of the sensor control. Element 11: Wherein, the internal collimator and the external collimator cooperatively define a sterilization zone for receiving sensors and sharps, the method further comprising sealing at least a portion of the sterilization zone with a microbial barrier positioned at an interface between the internal collimator and the external collimator. Element 12: Wherein, the internal collimator includes an alignment insert, and wherein aligning the external collimator with the internal collimator comprises aligning the external collimator with the alignment insert. Element 13: wherein the inner collimator and the outer collimator cooperatively define a sterilization zone, the sterilization zone exhibiting a cross-sectional shape selected from the group consisting of: conical, frustoconical, pyramidal, circular, cubic, rectangular, and any combination thereof.

[0351] Element 14: Also included is a microbial barrier positioned at an interface between the inner collimator and the outer collimator. Element 15: Wherein, the inner collimator includes a collimation insert, and wherein the collimation insert and the outer collimator are each made of a material selected from the group consisting of: a high-density polymer, a metal, a composite material, and any combination thereof. Element 16: Wherein, the inner collimator further includes a gasket engageable with the bottom of the sensor control device to create a sealed interface. Element 17: Wherein, the inner collimator and the outer collimator cooperatively define a sterilization zone, the sterilization zone exhibiting a cross-sectional shape selected from the group consisting of: conical, frustoconical, pyramidal, circular, cubic, rectangular, and any combination thereof.

[0352] As non-limiting examples, exemplary combinations suitable for H, I, and J include: element 4 and element 5; element 4 and element 6; element 9 and element 10; and element 15 and element 16.

[0353] Internal sterilization components

[0354] Before delivery to an end user, some medical devices must be sterilized to render the product free of viable microorganisms. However, some medical devices include subcutaneous sensing devices or sensors that must be sterilized using radiation sterilization, such as electron beam (e-beam) radiation. However, radiation sterilization can damage electronic components associated with the medical device, which are typically sterilized via gaseous chemical sterilization (e.g., using ethylene oxide). However, gaseous chemical sterilization can damage enzymes or other chemicals and biological agents included in the subcutaneous sensing device.

[0355] In the past, this sterilization incompatibility has been circumvented by separating the subcutaneous sensing device and the electronic components and sterilizing each separately. However, this approach requires additional parts, packaging, process steps, and final assembly by the user, which introduces the possibility of user error. According to the present disclosure, any device requiring terminal sterilization can be properly sterilized using an internal sterilization assembly designed to focus sterilizing radiation (e.g., beam, wave, energy, etc.) toward the component parts requiring sterilization while preventing the transmitted radiation from damaging or destroying sensitive electronic components.

[0356] Figure 23is a schematic diagram of an example internal sterilization assembly 2300 according to one or more embodiments of the present disclosure. Internal sterilization assembly 2300 (hereinafter "assembly 2300") may be designed and otherwise configured to facilitate sterilization of a medical device 2302. Medical device 2302 may comprise a type of healthcare product that includes any device, mechanism, assembly, or system requiring terminal sterilization of one or more component parts. Suitable examples of medical device 2302 include, but are not limited to, ingestible products, cardiac rhythm management (CRM) devices, subcutaneous sensing devices, externally mounted medical devices, drug delivery devices, or any combination thereof.

[0357] In the illustrated embodiment, medical device 2302 includes a subcutaneous sensing device or "sensor control device," also referred to as an "in vivo analyte sensor control device." As illustrated, medical device 2302 can be housed within a sensor applicator 2304 (alternatively referred to as an "inserter"), and cap 2306 can be removably coupled to sensor applicator 2304. Medical device 2302 includes a housing 2308, a part 2310 requiring sterilization, and one or more radiation-sensitive components 2312. In some embodiments, part 2310 may include a sensor extending from housing 2308. In at least one embodiment, part 2310 may also include a sharp prong, which may also require sterilization and may aid in implanting the sensor beneath the user's skin. As illustrated, part 2310 may extend at an angle from the bottom of housing 2308, but may alternatively extend perpendicularly from the bottom or from another surface of housing 2308. Furthermore, as illustrated, the feature 2310 may extend from one end of the housing 2308 or otherwise be offset from the centerline of the housing 2308, but may alternatively extend concentrically with the housing without departing from the scope of the present disclosure.

[0358] Sensor applicator 2304 is used to deliver medical device 2302 to a target monitoring location on a user's skin (e.g., a user's arm). In some embodiments, cap 2306 may be threaded onto sensor applicator 2304 and removed from sensor applicator 2304 by unscrewing cap 2306 from engagement with sensor applicator 2304. Once cap 2306 is removed, the user may then use sensor applicator 2304 to position medical device 2302 at the target monitoring location on the user's body. Part 2310 is positioned so that it can be transcutaneously positioned and otherwise retained beneath the surface of the user's skin. In some embodiments, medical device 2302 may be spring-loaded to eject from sensor applicator 2304. Once delivered, medical device 2302 may be held in place on the skin using an adhesive patch (not shown) coupled to the bottom of medical device 2302.

[0359] In the illustrated embodiment, the radiation-sensitive component 2312 can be mounted to a printed circuit board (PCB) 2314 positioned within the housing 2308. The radiation-sensitive component 2312 can include one or more electronic modules, such as, but not limited to, a data processing unit (e.g., an application-specific integrated circuit or "ASIC"), 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 can include a radiation-sensitive chemical solution or analyte (e.g., an active agent, a drug, a biologic, etc.). In such embodiments, the medical device 2302 can alternatively include a hypodermic needle or syringe, and the chemical solution or analyte can be positioned within an ampoule within the medical device 2302.

[0360] Medical device 2302 can be subjected to radiation sterilization 2316 to properly sterilize component 2310 for use. Suitable radiation sterilization 2316 processes include, but are not limited to, electron beam (e-beam) radiation, gamma ray radiation, X-ray radiation, or any combination thereof. Cap 2306 can define a collimator 2318 that allows radiation 2316 to impinge on component 2310 and sterilize it. However, cap 2306 can also act as a radiation shield, helping to prevent (block) propagating radiation 2316 from damaging or destroying radiation-sensitive component(s) 2312. To achieve this, cap 2306 can be made of a material that reduces or prevents radiation 2316 from penetrating therethrough.

[0361] More specifically, cap 2306 can be made of a material having a density sufficient to absorb a dose of the energy of the delivered beam of radiation 2316. In some embodiments, for example, cap 2306 can be made of any material having a mass density greater than 0.9 grams per cubic centimeter (g / cc). However, in other embodiments, suitable materials can have a mass density less than 0.9 g / cc without departing from the scope of the present disclosure. Suitable materials for cap 2306 include, but are not limited to, high-density polymers (e.g., polyethylene, polypropylene, polystyrene, polytetrafluoroethylene, etc.), metals (e.g., lead, stainless steel, aluminum, etc.), any combination thereof, or any material having a mass density greater than 0.9 g / cc.

[0362] As illustrated, the collimator 2318 generally includes an aperture or passageway extending at least partially through the cap 2306. The collimator 2318 defines a sterilization zone 2320 configured to focus radiation 2316 toward the part 2310. In the illustrated embodiment, the part 2310 can be received within the sterilization zone 2320 for sterilization. The collimator 2318 can exhibit any suitable cross-sectional shape necessary to focus the radiation 2316 on the part 2310 for sterilization. In the illustrated embodiment, for example, the collimator 2318 is conical or frustoconical in shape. However, in other embodiments, the collimator 2318 can exhibit a polygonal cross-sectional shape, such as a cube, a rectangle (e.g., including a parallelogram), or a pyramid, without departing from the scope of this disclosure. In still other embodiments, the collimator 2318 can exhibit a circular cross-sectional shape with parallel sides.

[0363] In the illustrated embodiment, the collimator 2318 provides a first aperture 2322a and a second aperture 2322b, wherein the first aperture 2322a and the second aperture 2322b are defined at opposite ends of the sterile zone 2320. The first aperture 2322a can allow radiation 2316 to enter the sterile zone 2320 and impinge on the part 2310, and the second aperture 2322b can be configured to receive the part 2310 into the sterile zone 2320. In embodiments where the collimator 2318 is conical or frustoconical in shape, the second aperture 2322b can have a diameter that is smaller than the diameter of the first aperture 2322a. In such embodiments, for example, the size of the second aperture 2322b can range from approximately 0.5 mm to approximately 3.0 mm, and the size of the first aperture 2322a can range from approximately 5.0 mm to approximately 16.0 mm. However, as will be appreciated, the respective diameters of the first aperture 2322a and the second aperture 2322b can be larger or smaller than the ranges provided herein without departing from the scope of the present disclosure. In fact, the diameters of the first aperture 2322a and the second aperture 2322b can be scaled to the size of the device and need only be large enough to allow a sufficient dose of radiation to be impinged upon the part 2310. Furthermore, in at least one embodiment, the collimator 2318 can be cylindrical in shape, with the first aperture 2322a and the second aperture 2322b exhibiting the same diameter.

[0364] In some embodiments, a cap seal 2324 (shown in phantom) can be positioned at the opening of the collimator 2318, or at the first orifice 2322a. The cap seal 2324 can comprise a radiolucent microbial barrier. In some embodiments, for example, the cap seal 2324 can be made of a synthetic material (e.g., flash-spun high-density polyethylene fiber), such as TYVEK® available from DuPont®. However, in other embodiments, the cap seal 2324 can include, but is not limited to, tape, paper, foil, or any combination thereof. In yet other embodiments, the cap seal 2324 can comprise a thinned portion of the cap 2306 without departing from the scope of this disclosure. In such embodiments, the first orifice 2322a would be omitted.

[0365] Cap seal 2324 can seal a portion of sterilization zone 2320 to isolate part 2310 from external contamination while allowing radiation 2316 to pass therethrough to sterilize part 2310. In some embodiments, a desiccant (not shown) can be disposed within sterilization zone 2320.

[0366] In some embodiments, the assembly 2300 can also include a barrier shield 2326 positioned within the housing 2308. The barrier shield 2326 can be configured to help block radiation 2316 (e.g., electrons) from propagating within the housing 2308 toward the radiation-sensitive component(s) 2312. The barrier shield 2326 can be made of any of the materials mentioned above for the cap 2306. In the illustrated embodiment, the barrier shield 2326 is positioned vertically within the housing 2308, but can alternatively be positioned at any other angle configuration suitable for protecting the radiation-sensitive component(s) 2312.

[0367] Figure 24 is a schematic diagram of another example interior sterilization assembly 2400 according to one or more additional embodiments of the present disclosure. The interior sterilization assembly 2400 (hereinafter "assembly 2400") can be similar in some aspects to Figure 23 The assembly 2300 is similar to, and therefore may be best understood by reference thereto, wherein like reference numerals designate like parts that are not again described in detail. Figure 23 Similar to assembly 2300 of FIG. 24, for example, assembly 2400 can be designed and otherwise configured to assist in sterilizing a medical device 2402 that can be sterilized with Figure 23 Similar to the medical device 2302. Figure 23 Similar to medical device 2302 , medical device 2402 may include a sensor control device, but may alternatively include any healthcare product mentioned herein.

[0368] As illustrated, the medical device 2402 can be housed within a sensor applicator 2404, and more specifically within a pocket 2406 defined in the sensor applicator 2404. In some embodiments, a desiccant (not shown) can be disposed within the pocket 2406. Figure 23 Similar to medical device 2302, medical device 2402 may include a housing 2308, a part to be sterilized 2310, and radiation-sensitive component(s) 2312. In some embodiments, assembly 2400 may also include a barrier shield 2326, as generally described above. As illustrated, part 2310 may extend vertically from the bottom of housing 2308, but may alternatively extend at an angle or from another surface. Furthermore, as illustrated, part 2310 may extend along the centerline of housing 2308, but may alternatively extend off-center from the centerline without departing from the scope of the present disclosure.

[0369] Sensor applicator 2404 is used to deliver medical device 2402 to a target monitoring location on a user's skin (e.g., a user's arm). As illustrated, sensor applicator 2404 may include a spring-loaded button 2408 at least partially received within sensor applicator 2404. Button 2408 extends within a channel 2409 defined in sensor applicator 2404 and, at its bottom end, can engage with the top of housing 2308. In at least one embodiment, when the bottom of button 2406 engages housing 2308, a sealing interface is formed. Medical device 2402 can be deployed from recess 2406 for use by pressing button 2408 downward, which acts on housing 2308 and thereby pushes medical device 2402 distally out of recess 2406 and away from sensor applicator 2404. Feature 2310 is positioned so that it can be transcutaneously positioned and otherwise retained beneath the surface of the user's skin. Once delivered, the medical device 2402 may be held in place on the skin using an adhesive patch (not shown) coupled to the bottom of the medical device 2402 .

[0370] Prior to use, the medical device 2402 can be subjected to radiation sterilization 2316 to properly sterilize the part 2310. In the illustrated embodiment, the radiation sterilization 2316 is directed to the top of the sensor applicator 2404, and the button 2408 defines a collimator 2410 that allows the radiation 2316 to impinge on the part 2310 and sterilize it. As illustrated, the collimator 2410 generally includes an aperture or passage extending at least partially through the button 2408. The collimator 2410 focuses the radiation 2316 toward the part 2310 and can exhibit any suitable cross-sectional shape necessary to focus the radiation 2316 on the part 2310 for sterilization. In the illustrated embodiment, for example, the collimator 2410 is at least partially conical or frustoconical in shape. However, in other embodiments, without departing from the scope of the present disclosure, the collimator 2410 may exhibit a polygonal cross-sectional shape, such as a cube, a rectangle (e.g., including a parallelogram), or a pyramid. In still other embodiments, the collimator 2410 may exhibit a circular cross-sectional shape with parallel sides.

[0371] However, portions of the sensor applicator 2404 and button 2408 may also act as a radiation shield that helps prevent (blocks) propagating radiation 2316 from damaging or destroying the radiation sensitive component(s) 2312 (except by passing through the collimator 2410). To accomplish this, the sensor applicator 2404 and button 2408 may be constructed with Figure 23 2404. In at least one embodiment, the sterilizing radiation 2316 can be emitted from a device or machine that is configured to focus and / or aim the radiation 2316 directly into the collimator 2410 and thereby mitigate exposure of the radiation 2316 to adjacent portions of the sensor applicator 2404.

[0372] In some embodiments, a first seal 2412a (shown in phantom) can be positioned at the opening of the recess 2406, and a second seal 2412b can be disposed at the opening to the collimator 2410, at the top of the button 2406. The seals 2412a, 2412b can comprise a radiolucent microbial barrier. Figure 23 The cap seal 2324 is similar to that of the sensor applicator 2404. The first seal 2412a can seal the recess 2406 on the bottom of the sensor applicator 2404 to isolate the part 2310 from external contamination, and the second seal 2412b can seal the collimator 2410 while allowing radiation 2316 to pass therethrough to sterilize the part 2310.

[0373] Figure 25is a schematic diagram of another example interior sterilization assembly 2500 according to one or more additional embodiments of the present disclosure. The interior sterilization assembly 2500 (hereinafter "assembly 2500") can be similar in some aspects to Figure 23 and Figure 24 Components 2300 and 2400 are similar and therefore may be best understood with reference thereto, wherein like reference numerals designate like parts that are not described again in detail. Figure 23 and Figure 24 Similar to assemblies 2300 and 2400, for example, assembly 2500 may be designed and otherwise configured to assist in sterilizing a medical device 2502 that may be used with Figure 23 and Figure 24 The medical devices 2302 and 2402 are similar. Figure 23 and Figure 24 Similar to medical devices 2302 and 2402 , medical device 2502 may include a sensor control device, but may alternatively include any healthcare product mentioned herein.

[0374] As illustrated, a medical device 2502 can be housed within a sensor applicator 2504, which can include a spring-loaded sheath 2506. The medical device 2502 can be positioned within a pocket 2508 at least partially defined by the sheath 2506. In some embodiments, a desiccant (not shown) can be disposed within the pocket 2508. Figure 23 and Figure 24 Similar to medical devices 2302 and 2402, medical device 2502 may include a housing 2308, parts to be sterilized 2310, and radiation-sensitive component(s) 2312. In some embodiments, assembly 2500 may also include a barrier shield 2326, as generally described above.

[0375] As illustrated, the part 2310 may extend vertically from the bottom of the housing 2308, but may alternatively extend at an angle or from another surface. Additionally, as illustrated, the part 2310 may extend along the centerline of the housing 2308, but may alternatively extend eccentrically from the centerline without departing from the scope of this disclosure.

[0376] Sensor applicator 2504 is used to deliver medical device 2502 to a target monitoring location on a user's skin (e.g., a user's arm). Medical device 2502 can be deployed from recess 2508 for use by forcing sheath 2506 against the user's skin, thereby causing sheath 2506 to collapse into the body of sensor applicator 2504. Once sheath 2506 collapses beyond housing 2308, medical device 2502 can be discharged from sensor applicator 2504. Component 2310 is positioned so that it can be transcutaneously positioned and otherwise retained beneath the surface of the user's skin. Once delivered, medical device 2502 can be held in place on the skin using an adhesive patch (not shown) coupled to the bottom of medical device 2502.

[0377] The medical device 2502 can be subjected to radiation sterilization 2316 prior to use to properly sterilize the part 2310. In the illustrated embodiment, the radiation sterilization 2316 is directed to the top of the sensor applicator 2504, which defines a collimator 2510 that allows the radiation 2316 to impinge on the part 2310 and sterilize it. As illustrated, the collimator 2510 generally comprises a hole or passage extending through the body of the sensor applicator 2504. The collimator 2510 focuses the radiation 2316 toward the part 2310 and can exhibit any suitable cross-sectional shape necessary to focus the radiation 2316 on the part 2310 for sterilization. In the illustrated embodiment, for example, the collimator 2510 is conical or frusto-conical in shape. However, in other embodiments, without departing from the scope of the present disclosure, the collimator 2510 may exhibit a polygonal cross-sectional shape, such as a cube, a rectangle (e.g., including a parallelogram), or a pyramid. In still other embodiments, the collimator 2510 may exhibit a circular cross-sectional shape with parallel sides.

[0378] However, the sensor applicator 2504 may also act as a radiation shield that helps prevent (blocks) propagating radiation 2316 from damaging or destroying the radiation sensitive component(s) 2312, except by passing through the collimator 2510. To achieve this, the sensor applicator 2504 may be made of Figure 23 2306. However, in at least one embodiment, the sterilizing radiation 2316 can be emitted from a device or machine that is configured to focus and / or aim the radiation 2316 directly into the collimator 2510 and thereby mitigate exposure of the radiation 2316 to adjacent portions of the sensor applicator 2504.

[0379] In some embodiments, a first seal 2512a (shown in phantom) can be positioned at the opening of the pocket 2508, and a second seal 2512b can be disposed at the opening to the collimator 2510, at the top of the sensor applicator 2504. The seals 2512a, 2512b can comprise a radiolucent microbial barrier that is compatible with the sensor applicator 2504. Figure 23 The cap seal 2324 is similar to that of the sensor applicator 2504. The first seal 2512a can seal the recess 2508 on the bottom of the sensor applicator 2504 to isolate the part 2310 from external contamination, and the second seal 2512b can seal the collimator 2510 while allowing radiation 2316 to pass therethrough to sterilize the part 2310.

[0380] Embodiments disclosed herein include:

[0381] 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 removably coupled to the sensor applicator and providing a collimator that is alignable 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.

[0382] Embodiment K may have one or more of the following additional elements in any combination: Element 1: wherein the radiation-sensitive component is selected from the group consisting of: an electronics module, a chemical solution, and any combination thereof. Element 2: wherein the collimator comprises a cross-sectional shape selected from the group consisting of: a cone, a frustoconical, a pyramid, a circle, a cube, a rectangle, and any combination thereof. Element 3: wherein the medical device comprises an in vivo analyte sensor control device, and the part requiring sterilization comprises at least one of a sensor and a sharp object extending from a housing of the in vivo analyte sensor control device. Element 4: wherein the at least one of the sensor and the sharp object extends from the bottom of the housing at a certain angle. Element 5: wherein the at least one of the sensor and the sharp object extends perpendicularly from the bottom of the housing. Element 6: wherein the at least one of the sensor and the sharp object extends from the bottom of the housing along the centerline of the housing. Element 7: wherein the at least one of the sensor and the sharp object extends from the bottom of the housing in a manner offset from the centerline of the housing. Element 8: wherein the cap is made of a material having a mass density greater than 0.9 g / cc. Element 9: wherein the cap is made of a material selected from the group consisting of a high-density polymer, a metal, and any combination thereof. Element 10: wherein the medical device comprises an in vivo analyte sensor control unit having a housing housing a radiation-sensitive component, the internal sterilization assembly further comprising a barrier shield positioned within the housing to block radiation from propagating within the housing toward the radiation-sensitive component. Element 11: further comprising a spring-loaded button at least partially received within the sensor applicator and engageable with the top portion of the medical device, wherein the collimator is defined through the button. Element 12: further comprising a sealing interface at the intersection of the button and the medical device. Element 13: wherein at least one of the button and the sensor applicator is made of a material selected from the group consisting of a high-density polymer, a metal, and any combination thereof. Element 14: wherein the sensor applicator comprises a spring-loaded sheath, and the medical device is housed within a recess at least partially defined by the sheath. Element 15: wherein the collimator is defined through the sensor applicator.

[0383] As non-limiting examples, exemplary combinations suitable for A, B, and C include: 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.

[0384] One-piece biosensor design with sensor storage bottle

[0385] Figure 26A and Figure 26B2602 (alternatively referred to as a "disk") can be similar in some aspects to a sensor control device 2602. Figure 1 The sensor control device 2602 is similar to and therefore best understood by reference thereto. Figure 1 The sensor control device 104 and thus can be used with the sensor applicator 102 ( Figure 1 ) in conjunction with a sensor applicator, the sensor applicator delivers the sensor control device 2602 to a target monitoring location on the user's skin.

[0386] However, with Figure 1 In contrast to the sensor control device 104 of FIG. 1 , the sensor control device 2602 can be incorporated into a one-piece system architecture. Unlike a two-piece architecture, for example, the user is not required to open multiple packages and ultimately assemble the sensor control device 2602. Instead, upon receipt by the user, the sensor control device 2602 is already fully assembled and properly positioned in the sensor applicator 102 ( FIG. 1 ). Figure 1 ) in. To use the sensor control device 2602, the user only needs to open a barrier (e.g., Figure 2B ), and then quickly delivering the sensor control device 2602 to the target monitoring location.

[0387] As illustrated, sensor control device 2602 includes an electronics housing 2604 that is generally disk-shaped and may have a circular cross-section. However, in other embodiments, electronics housing 2604 may exhibit other cross-sectional shapes, such as oval or polygonal, without departing from the scope of this disclosure. Electronics housing 2604 may be configured to house or otherwise contain various electrical components used to operate sensor control device 2602.

[0388] Electronics housing 2604 may include a shell 2606 and a base 2608 that mates with shell 2606. Shell 2606 may be secured to base 2608 via various means, such as a snap-fit, an interference fit, sonic welding, or one or more mechanical fasteners (e.g., screws). In some cases, shell 2606 may be secured to base 2608 to create a sealed interface therebetween. In such embodiments, a gasket or other type of sealing material may be positioned at or near the outer diameter (perimeter) of shell 2606 and base 2608, and securing the two components together compresses the gasket, thereby creating a sealed interface. In other embodiments, an adhesive may be applied to the outer diameter (perimeter) of one or both of shell 2606 and base 2608. The adhesive secures shell 2606 to base 2608 and provides structural integrity, but also seals the interface between the two components, thereby isolating the interior of electronic devices housing 2604 from external contaminants. If sensor control unit 2602 is assembled in a controlled environment, terminal sterilization of the internal electrical components may not be required. In contrast, the adhesive connection may provide an adequate sterile barrier for the assembled electronic device housing 2604 .

[0389] Sensor control device 2602 may also include a plug assembly 2610 that can be coupled to electronic device housing 2604. Plug assembly 2610 may be similar in some aspects to Figure 2A Plug assembly 2610 may be similar to plug assembly 207. For example, plug assembly 2610 may include a sensor module 2612 (partially visible) that may be interconnected with a sharps module 2614 (partially visible). Sensor module 2612 may be configured to carry and otherwise include a sensor 2616 (partially visible), and sharps module 2614 may be configured to carry and otherwise include a sharps 2618 (partially visible) for facilitating transcutaneous delivery of sensor 2616 beneath the user's skin during application of sensor control device 2602. As illustrated, corresponding portions of sensor 2616 and sharps 2618 extend from electronic device housing 2604, and more specifically, from the bottom of base 2608. An exposed portion of sensor 2616 may be received within a hollow or recessed portion of sharps 2618. The remaining portion of sensor 2616 is positioned within the interior of electronic device housing 2604.

[0390] As discussed in more detail below, the sensor control device 2602 may also include a sensor preservation bottle 2620 that provides a preservation barrier that surrounds and protects the exposed portions of the sensor 2616 and sharps 2618 from the effects of gaseous chemical sterilization.

[0391] Figure 27A and Figure 27B26. The plug assembly 2610 is an isometric view and an exploded view, respectively, of 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 receive and support both the sensor 2616 and the connector 2704. As illustrated, a channel 2706 may be defined through the plug 2702 to receive a portion of the sensor 2616. In addition, the plug 2702 may provide one or more deflectable arms 2707 configured to snap onto a connector provided in the electronic device housing 2604 ( Figures 26A-26B ) in the corresponding feature on the bottom of the ).

[0392] Sensor 2616 includes a tail 2708, a flag 2710, and a neck 2712 interconnecting tail 2708 and flag 2710. Tail 2708 can be configured to extend at least partially through channel 2706 and distally from plug 2702. Tail 2708 includes an enzyme or other chemical or biological agent, and in some embodiments, the chemical can be covered by a membrane. In use, tail 2708 is transcutaneously received beneath the user's skin, and the chemical included thereon helps facilitate analyte monitoring in the presence of bodily fluids.

[0393] Flag 2710 may include a generally planar surface having one or more sensor contacts 2714 disposed thereon. Figure 27B The sensor contact(s) 2714 can be configured to align with a corresponding number of compliant carbon-impregnated polymer modules (tops of which are shown at 2720 ) encapsulated within the connector 2704 .

[0394] The connector 2704 includes one or more hinges 2718 that enable the connector 2704 to move between an open state and a closed state. Figures 27A-27B 2604 ( Figures 26A-26B ) provides conductive communication between corresponding circuit contacts within the sensor 2616. Connector 2704 can be made of silicone rubber and can serve as a moisture barrier for sensor 2616 when assembled in a compressed state and after being applied to the user's skin.

[0395] Sharps module 2614 includes a sharp 2618 and a sharp hub 2722 that carries sharps 2618. Sharps 2618 include an elongated shaft 2724 and a sharp tip 2726 at the distal end of shaft 2724. Shaft 2724 can be configured to extend through channel 2706 and distally from plug 2702. Furthermore, shaft 2724 can include a hollow or recessed portion 2728 that at least partially circumscribes tail 2708 of sensor 2616. Sharp tip 2726 can be configured to penetrate the skin while carrying tail 2708 to allow active chemicals present on tail 2708 to contact bodily fluids.

[0396] Sharps hub 2722 may include hub cylinder 2730 and hub snap detent 2732, each of which may be configured to assist in coupling plug assembly 2610 (and the entire sensor control device 2602) to sensor applicator 102 ( Figure 1 ).

[0397] Specific references Figure 27B , the preservation bottle 2620 may include a generally cylindrical and elongated body 2734 having a first end 2736a and a second end 2736b opposite the first end 2736a. The first end 2736a may be open to provide access to an interior chamber 2738 defined within the body 2734. In contrast, the second end 2736b may be closed and may provide or otherwise define an enlarged head 2740. The enlarged head 2740 exhibits an outer diameter that is greater than the outer diameter of the remainder of the body 2734. However, in other embodiments, the enlarged head 2740 may be positioned intermediate between the first end 2736a and the second end 2736b.

[0398] Figure 27C is an exploded isometric bottom view of the plug 2702 and the preservation bottle 2620. As illustrated, the plug 2702 can define an aperture 2742 configured to receive the preservation bottle 2620, and more specifically, the first end 2736a of the body 2734. The passage 2706 can terminate at the aperture 2742 such that when the preservation bottle 2620 is coupled to the plug 2702, components extending distally from the passage 2706 will be received within the internal chamber 2738.

[0399] The preservation bottle 2620 can be removably coupled to the plug 2702 at the orifice 2742. In some embodiments, for example, the preservation bottle 2620 can be received in the orifice 2742 via an interference fit or a friction fit. In other embodiments, the preservation bottle 2620 can be secured in the orifice 2742 using a frangible member (e.g., a shear ring) or a substance that can be broken with minimal separation force. In such embodiments, for example, the preservation bottle 2620 can be secured in the orifice 2742 using label glue (a dot of glue), a small amount of wax, or the preservation bottle 2620 can include an easily peelable glue. As described below, after the sensor control device 2602 ( Figures 26A-26B ) The preservation bottle 2620 can be separated from the plug 2702 before delivery to the target monitoring location on the user's skin.

[0400] Reference again Figure 27A and Figure 27B , the internal chamber 2738 can be sized and otherwise configured to receive the tail 2708, the distal segment of the shaft 2724, and the sharp tip 2726 (collectively, the "distal portion of the sensor 2616 and sharp 2618"). The internal chamber 2738 can be sealed or otherwise isolated to prevent substances that could adversely interact with the chemistry of the sensor 2616 from migrating into the internal chamber 2738. More specifically, the internal chamber 2728 can be sealed to protect or isolate the distal portion of the sensor 2616 and sharp 2618 during a gaseous chemical sterilization process, as the gases used during gaseous chemical sterilization can adversely affect the enzyme provided on the tail 2708 (and other sensor components, such as membrane coatings that regulate analyte influx).

[0401] In some embodiments, seal 2744 ( Figure 27B ) can provide a sealed barrier between the inner chamber 2738 and the external environment. In at least one embodiment, a seal 2744 can be disposed within the inner chamber 2738, but can alternatively be positioned external to the body 2734 without departing from the scope of the present disclosure. The distal portions of the sensor 2616 and the sharp tip 2618 can penetrate the seal 2744 and extend into the inner chamber 2738, but the seal 2744 can maintain a sealed interface around the distal portions of the sensor 2616 and the sharp tip 2618 to prevent contaminants from migrating into the inner chamber 2738. The seal 2744 can be made of, for example, a flexible elastomer or wax.

[0402] In other embodiments (or in addition to seal 2744), sensor retention fluid 2746 ( Figure 27B) can reside within the inner chamber 2738, and the sensor 2616 and distal portion of the sharp 2618 can be immersed in or otherwise encapsulated by a preservation fluid 2746. The preservation fluid 2746 can create a sealing interface that prevents the sterilizing gas from interacting with the enzyme provided on the tail 2708.

[0403] Plug assembly 2610 can be sterilized by radiation to properly sterilize sensor 2616 and sharps 2618. Suitable radiation sterilization processes include, but are not limited to, electron beam (e-beam) radiation, gamma ray radiation, X-ray radiation, or any combination thereof. In some embodiments, plug assembly 2610 can be sterilized by radiation before coupling preservation vial 2620 to plug 2702. However, in other embodiments, plug assembly 2610 can be sterilized after coupling preservation vial 2620 to plug 2702. In such embodiments, body 2734 of preservation vial 2620 and preservation fluid 2746 can comprise materials and / or substances that permit radiation to propagate therethrough to facilitate radiation sterilization of distal portions of sensor 2616 and sharps 2618.

[0404] Suitable materials for body 2734 include, but are not limited to, non-magnetic metals (e.g., aluminum, copper, gold, silver, etc.), thermoplastics, ceramics, rubbers (e.g., hard rubber), composite materials (e.g., fiberglass, carbon fiber reinforced polymer, etc.), epoxies, or any combination thereof. In some embodiments, the material for body 2734 may be transparent or translucent, but may otherwise be opaque without departing from the scope of the present disclosure.

[0405] The preservation fluid 2746 can comprise any inert and biocompatible fluid (i.e., a liquid, gas, gel, wax, or any combination thereof) capable of encapsulating the distal portion of the sensor 2616 and the sharp object 2618. In some embodiments, the preservation fluid 2746 can also allow radiation to propagate therethrough. The preservation fluid 2746 can comprise a fluid that is insoluble in the chemicals involved in gaseous chemical sterilization. Suitable examples of the preservation fluid 2746 include, but are not limited to, silicone oil, mineral oil, gels (e.g., petrolatum), wax, fresh water, saline, synthetic fluids, glycerin, sorbitan esters, or any combination thereof. As will be appreciated, more viscous gels and fluids may be preferred so that the preservation fluid 2746 does not flow easily.

[0406] In some embodiments, the preservation fluid 2746 may include an anti-inflammatory agent, such as nitric oxide or another known anti-inflammatory agent. The anti-inflammatory agent may prove advantageous in minimizing the local inflammatory response caused by the sharp object 2618 and sensor 2616 penetrating the user's skin. It has been observed that inflammation can affect the accuracy of glucose readings, and by including an anti-inflammatory agent, the healing process may be accelerated, which may result in obtaining accurate readings more quickly.

[0407] Figure 28A and Figure 28B 2604 according to one or more embodiments. Shell 2606 and base 2608 operate as opposing clamshell halves that enclose or otherwise substantially enclose sensor control device 2602 ( Figures 26A-26B ) various electronic components.

[0408] A printed circuit board (PCB) 2802 may be positioned within the electronic device housing 2604. A plurality of electronic modules (not shown) may be mounted to the PCB 2802, including, but not limited to, a data processing unit, resistors, transistors, capacitors, inductors, diodes, and switches. The data processing unit may include, for example, an application specific integrated circuit (ASIC) configured to implement one or more functions or routines associated with the operation of the sensor control device 2602. More specifically, the data processing unit may be configured to perform data processing functions, where such functions may include, but are not limited to, filtering and encoding of data signals, each of which corresponds to a sampled analyte level of a user. The data processing unit may also include, or otherwise be in communication with, an antenna for communicating with the reader device 106 ( Figure 1 ) communication.

[0409] As shown, the shell 2606, the base 2608, and the PCB 2802 each define corresponding central apertures 2804, 2806, and 2808, respectively. When the electronic device housing 2604 is assembled, the central apertures 2804, 2806, and 2808 are coaxially aligned to receive the plug assembly 2610 therethrough ( Figures 27A-27B A battery 2810 may also be housed within the electronics housing 2604 and configured to power the sensor control device 2602 .

[0410] exist Figure 28B 28. In the embodiment of the present invention, a plug receptacle 2812 can be defined in the bottom of the base 2808 and provides a location at which the plug assembly 2610 ( Figures 27A-27B ) can be received and coupled to the electronics housing 2604, thereby fully assembling the sensor control device 2602 ( Figure 26A-3BPlug 2702 ( Figures 27A-27C ) can be contoured to match or be shaped in a complementary manner to the plug receptacle 2812, and the plug receptacle 2812 can provide one or more snap tabs 2814 (two shown) configured to engage the deflectable arms 2707 ( Figures 27A-27B ) interface connects and receives the deflectable arm. The plug assembly 2610 is coupled to the electronic device housing 2604 by advancing the plug 2702 into the plug receptacle 2812 and allowing the deflectable arm 2707 to lock into the corresponding snap tab 2814. When the plug assembly 2610 ( Figures 27A-27B ) is properly coupled to the electronic device housing 2604, one or more circuit contacts 2816 (three shown) defined on the underside of the PCB 2802 can mate with the connector 2704 ( Figures 27A-27B ) of the electrical contacts 2720 ( Figures 27A-27B ) for conductive connectivity.

[0411] Figure 29A and Figure 29B 1 and 2 are side views and cross-sectional side views, respectively, of an example embodiment of a sensor applicator 102 with an applicator cap 210 coupled thereto. More specifically, Figures 29A-29B Depicts how the sensor applicator 102 may be shipped to and received by a user. Figure 29B As seen in FIG, the sensor control device 2602 has been assembled and installed within the sensor applicator 102 before being delivered to the user.

[0412] As indicated above, before the plug assembly 2610 is coupled to the electronics housing 2604, the plug assembly 2610 can be subjected to radiation sterilization to sterilize the distal portion of the sensor 2616 and the sharps 2618. Once properly sterilized, the plug assembly 2610 can then be coupled to the electronics 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 threaded onto the housing 208 and include a tamper-evident ring 2902. When the applicator cap 210 is rotated (e.g., unscrewed) relative to the housing 208, the tamper-evident ring 2902 can shear and thereby release the applicator cap 210 from the sensor applicator 102.

[0413] According to the present disclosure, when the sensor control device 2602 is loaded into the sensor applicator 102, the sensor control device 2602 can be subjected to a gaseous chemical sterilization 2904 configured to sterilize the electronics housing 2604 and any other exposed portions of the sensor control device 2602. To accomplish this, chemicals can be injected into a sterilization chamber 2906 cooperatively defined by the sensor applicator 102 and the interconnected cap 210. In some applications, the chemicals can be injected into the sterilization chamber 2906 via one or more vents 2908 defined in the applicator cap 210 at its proximal end 2910. Example chemicals that can be used for the gaseous chemical sterilization 2904 include, but are not limited to, ethylene oxide, vaporized hydrogen peroxide, and nitrogen oxides (e.g., nitrous oxide, nitrogen dioxide, etc.).

[0414] Because the distal portion of the sensor 2616 and sharps 2618 are sealed within the preservation bottle 2620, the chemicals used during the gaseous chemical sterilization process do not interact with the enzymes, chemicals, or biological agents provided on the tail 2708.

[0415] Once the desired sterility assurance level has been achieved within the sterilization chamber 2906, the gaseous solution is removed and the sterilization chamber 2906 is inflated. Insufflation can be achieved by a series of vacuums followed by circulation of nitrogen or filtered air through the sterilization chamber 2906. Once the sterilization chamber 2906 is properly inflated, the vent 2908 can be blocked with a seal 2912 (shown in phantom).

[0416] In some embodiments, the seal 2912 may comprise two or more layers of different materials. The first layer may be made of a synthetic material (e.g., flash-spun high-density polyethylene fibers) such as Tyvek® available from DuPont®. Tyvek® is highly durable and puncture-resistant, yet allows vapor permeability. The Tyvek® layer may be applied prior to the gaseous chemical sterilization process, and after the gaseous chemical sterilization process, a layer of foil or other vapor- and moisture-resistant material may be sealed (e.g., heat-sealed) over the Tyvek® layer to prevent contaminants and moisture from entering the sterilization chamber 2906. In other embodiments, the seal 2912 may comprise only a single protective layer applied to the applicator cap 210. In such embodiments, the single layer is gas-permeable to the sterilization process, but also provides protection from moisture and other harmful elements once the sterilization process is complete.

[0417] With the seal 2912 in place, the applicator cap 210 provides a barrier against external contamination and thereby maintains a sterile environment for the assembled sensor control assembly 2602 until the user removes (unscrews) the applicator cap 210. The applicator cap 210 also creates a dust-free environment during shipping and storage that prevents the adhesive patch 2914 used to secure the sensor control assembly 2602 to the user's skin from becoming contaminated.

[0418] Figure 30 is a perspective view of an example embodiment of an applicator cap 210 according to the present disclosure. As illustrated, the applicator cap 210 has a generally circular cross-section and defines a plurality of holes for coupling the applicator cap 210 to the sensor applicator 102 ( Figure 29A and Figure 29B ) is provided with a series of threads 7302. A vent 2908 is also visible in the bottom of the applicator cap 210.

[0419] The applicator cap 210 may further provide and otherwise define a cap post 3004 centrally located within the interior of the applicator cap 210 and extending proximally from the bottom thereof. The cap post 3004 may be configured to be positioned within the sensor applicator 102 ( Figures 29A-29B ) helps support the sensor control device when in. In addition, the cap post 3004 can define an opening 3006 that is configured to receive the preservation bottle 2620 when the applicator cap 210 is coupled to the sensor applicator 102.

[0420] In some embodiments, the opening 3006 to the cap post 3004 may include one or more compliant features 3008 that are expandable or flexible to allow passage of the vial 2620 therethrough. In some embodiments, for example, the compliant feature(s) 3008 may include a collet-type device comprising a plurality of compliant fingers configured to flex radially outward to receive the vial 2620. However, in other embodiments, the compliant feature(s) 3008 may include an elastomer or another type of compliant material configured to expand radially to receive the vial 2620.

[0421] Figure 31is a cross-sectional side view of the sensor control device 2602 positioned within the applicator cap 210, according to one or more embodiments. As illustrated, the cap post 3004 defines a post chamber 3102 configured to receive a preservation bottle 2620. An opening 3006 leading to the cap post 3004 provides access to the post chamber 3102 and exhibits a first diameter D1. In contrast, the enlarged head 2740 of the preservation bottle 2620 exhibits a second diameter D2 that is greater than the first diameter D1 and greater than the outer diameter of the remainder of the preservation bottle 2620. Thus, when the preservation bottle 2620 is extended into the post chamber 3102, the compliant feature(s) 3008 of the opening 3006 can flex (expand) radially outward to receive the enlarged head 2740.

[0422] In some embodiments, the enlarged head 2740 may provide or otherwise define an angled outer surface that helps bias the compliant feature(s) 3008 radially outward. However, the enlarged head 2740 may also define an upper shoulder 3104 that prevents the vial 2620 from reversing out of the column chamber 3102. More specifically, the shoulder 3104 may include a sharpened surface at the second diameter D2 that engages but forces the compliant feature(s) 3008 to flex radially outward in the opposite direction.

[0423] Once the enlarged head 2740 passes around the opening 3006, the compliant feature(s) 3008 flex back to (or toward) their natural state. In some embodiments, the compliant feature(s) 3008 may engage the outer surface of the storage bottle 2620 but still allow the applicator cap 210 to rotate relative to the storage bottle 2620. Thus, when the user moves the applicator cap 210 relative to the sensor applicator 102 ( Figures 29A-29B ) When the applicator cap 210 is rotated to remove the applicator cap 210, the preservation bottle 2620 can remain stationary relative to the cap column 3004.

[0424] When the applicator cap 210 is removed from the sensor applicator 102, and the sensor control assembly 2602 is thereby separated from the applicator cap 210, the shoulder 3104 defined on the enlarged head 2740 engages the compliant feature(s) 3008 at the opening 3006. Because the diameter of the shoulder 3104 is larger than the diameter of the opening 3006, the shoulder 3104 engages the compliant feature(s) 3008 and thereby separates the preservation bottle 2620 from the sensor control assembly 2602, exposing the distal portions of the sensor 2616 and the sharps 2618. Thus, when the applicator cap 210 is separated from the sensor applicator 102 and the sensor control assembly 2602, the compliant feature(s) 3008 prevent the enlarged head 2740 from exiting the column chamber 3102 through the opening 3006. The separated preservation bottle 2620 falls into and remains in the column chamber 3102.

[0425] In some embodiments, instead of the opening 3006 including the compliant feature(s) 3008 as generally described above, the opening 3006 can alternatively be threaded. In such embodiments, a small portion near the distal end of the preservation bottle 2620 can also be threaded and configured to threadably engage the threads of the opening 3006. The preservation bottle 2620 can be received within the column chamber 3102 via rotation of the threads. However, when the applicator cap 210 is removed from the sensor applicator 102, the opening 3006 and the opposing threads on the preservation bottle 2620 engage, and the preservation bottle 2620 can be separated from the sensor control device 2602.

[0426] Therefore, the inclusion of the sensor control device 2602 into the analyte monitoring system (e.g., Figure 1 Several advantages exist in the analyte monitoring system 100 of the present invention. Because the sensor control unit 2602 is finally assembled in a controlled environment, tolerances can be reduced or completely eliminated, which allows the sensor control unit 2602 to be thin and small. In addition, because the sensor control unit 2602 is finally assembled in a controlled environment, the sensor control unit 2602 can be thoroughly pre-tested at the factory, thereby fully testing the sensor unit before being packaged for final delivery.

[0427] Embodiments disclosed herein include:

[0428] L. A sensor control device comprising: an electronics housing; a plug assembly engageable with the electronics housing and comprising a sensor module having a sensor and a sharps module having a sharp; and a preservative vial coupled to the plug assembly and defining an internal chamber, wherein distal portions of the sensor and sharps are receivable within the internal chamber and isolated from gaseous chemical sterilization within the internal chamber.

[0429] M. An analyte monitoring system comprising: a sensor applicator; a sensor control device positioned within the sensor applicator and comprising: an electronics housing; a plug assembly coupled to the electronics housing and comprising a sensor module having a sensor and a sharps module having a sharp; and a retention vial coupled to the plug assembly and defining an interior chamber. The analyte monitoring system further comprises a cap coupled to the sensor applicator to provide a barrier that seals the sensor control device within the sensor applicator, wherein distal portions of the sensor and sharps are received within the interior chamber and isolated from gaseous chemical sterilization within the interior chamber.

[0430] N. A method of preparing an analyte monitoring system, the method comprising: loading a sensor control device into a sensor applicator, the sensor control device comprising: an electronics housing; a plug assembly engageable with the electronics housing and comprising a sensor module having a sensor and a sharps module having a sharp; and a retention vial coupled to the plug assembly and defining an internal chamber. The method further comprises: securing a cap to the sensor applicator to thereby provide a barrier that seals the sensor control device within the sensor applicator; sterilizing the sensor control device using gaseous chemical sterilization while the sensor control device is positioned within the sensor applicator; and isolating distal portions of the sensor and sharps received within the internal chamber from the gaseous chemical sterilization.

[0431] Each of embodiments L, M, and N may have one or more of the following additional elements in any combination: Element 1: wherein the sensor module further comprises a plug, and the preservation bottle is removably coupled to the plug. Element 2: wherein the preservation bottle provides an enlarged head, and the diameter of the enlarged head is larger than the diameter of the remainder of the preservation bottle. Element 3: further comprising a seal providing a sealing barrier between the inner chamber and an exterior of the inner chamber, wherein the distal portions of the sensor and sharp penetrate the seal and extend into the inner chamber. Element 4: further comprising a preservation fluid within the inner chamber, the preservation fluid isolating the distal portions of the sensor and sharp from gaseous chemical sterilization. Element 5: wherein the distal portions of the sensor and sharp are at least partially immersed in the preservation fluid. Element 6: wherein the preservation fluid comprises an inert and biocompatible fluid selected from the group consisting of silicone oil, mineral oil, gel, wax, fresh water, saline, synthetic fluid, glycerin, sorbitan esters, and any combination thereof. Element 7: wherein the preservation fluid includes an anti-inflammatory agent.

[0432] Element 8: wherein the cap provides a cap post defining a post chamber and an opening that receives the enlarged head of the preservation bottle into the post chamber. Element 9: wherein the opening includes one or more compliant features that flex radially outward to receive the enlarged head. Element 10: wherein the one or more compliant features include a plurality of compliant fingers. Element 11: wherein, upon separation of the cap from the sensor applicator and the sensor control device, the one or more compliant features prevent the enlarged head from exiting the post chamber through the opening. Element 12: wherein, when the preservation bottle is received in the post chamber, the cap is rotatable relative to the preservation bottle. Element 13: further comprising a preservation fluid within the inner chamber that isolates the sensor and distal portion of the sharp from gaseous chemical sterilization.

[0433] Element 14: wherein, prior to loading the sensor control unit into the sensor applicator, the steps of: assembling the plug assembly; coupling the preservation bottle to the plug assembly such that the distal portion of the sensor and sharp are received within the internal chamber; and coupling the plug assembly to the electronics housing to thereby provide the sensor control unit. Element 15: wherein, prior to coupling the preservation bottle to the plug assembly, the steps of: sterilizing the plug assembly using radiation sterilization. Element 16: wherein isolating the distal portion of the sensor and sharp from gaseous chemical sterilization comprises at least partially immersing the distal portion of the sensor and sharp in a preservation fluid present within the internal chamber. Element 17: wherein the cap provides a cap post defining a column chamber having one or more compliant features disposed at an opening to the column chamber, and wherein securing the cap to the sensor applicator comprises: receiving an enlarged head of the preservation bottle into the column chamber via the opening; and flexing the one or more compliant features radially outward to receive the enlarged head.

[0434] As non-limiting examples, exemplary combinations suitable for L, M, and N include: 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.

[0435] Isolated one-piece sensor design with focused electron beam sterilization

[0436] Figure 32A and Figure 32B 3202 (alternatively referred to as a "disk") can be similar in some aspects to a sensor control device 3202. Figure 1 The sensor control device 104 is similar to and therefore best understood by reference thereto. In some applications, the sensor control device 3202 may replace Figure 1 The sensor control device 104 and thus can be used with the sensor applicator 102 ( Figure 1 ) in conjunction with the sensor applicator, which delivers the sensor control device 3202 to a target monitoring location on the user's skin.

[0437] However, with Figure 1 In contrast to the sensor control device 104 of FIG. 1 , the sensor control device 3202 can be incorporated into a one-piece system architecture. Unlike a two-piece architecture, for example, the user is not required to open multiple packages and finally assemble the sensor control device 3202 before use. Instead, upon receipt by the user, the sensor control device 3202 is already fully assembled and properly positioned in the sensor applicator 102 ( FIG. 1 ). Figure 1 ) In order to use the sensor control device 3202, the user only needs to open a barrier (e.g., remove Figure 2B 210 ), and then quickly delivering the sensor control device 3202 to the target monitoring location.

[0438] As illustrated, sensor control device 3202 includes an electronics housing 3204 that is generally disc-shaped and may have a circular cross-section. However, in other embodiments, electronics housing 3204 may exhibit other cross-sectional shapes, such as oval or polygonal, without departing from the scope of this disclosure. Electronics housing 3204 may be configured to house or otherwise contain various electrical components used to operate sensor control device 3202.

[0439] Electronic device housing 3204 may include a shell 3206 and a base 3208 that can mate with shell 3206. Shell 3206 can be secured to base 3208 via a variety of means, such as a snap-fit ​​connection, an interference fit, sonic (or ultrasonic) welding, the use of one or more mechanical fasteners (e.g., screws), or any combination thereof. In some embodiments, the interface between shell 3206 and base 3208 can be sealed. In such embodiments, a gasket or other type of sealing material can be positioned or applied at or near the outer diameter (perimeter) of shell 3206 and base 3208. Securing shell 3206 to base 3208 can compress the sealing material and thereby create a sealed interface. In at least one embodiment, an adhesive can be applied to the outer diameter (perimeter) of one or both of shell 3206 and base 3208, and the adhesive can not only secure shell 3206 to base 3208 but also seal the interface.

[0440] In embodiments where a sealed interface is formed between the shell 3206 and the base 3208, the interior of the electronic device housing 3204 can be effectively isolated from external contamination between the two components. In such embodiments, if the sensor control unit 3202 is assembled in a controlled and sterile environment, sterilization of the internal electrical components (e.g., via gaseous chemical sterilization) may not be necessary. Instead, the sealed joint can provide an adequate sterile barrier for the assembled electronic device housing 3204.

[0441] The sensor control device 3202 may further include a sensor module 3210 (in Figure 32B 3204). The sensor module 3210 and the sharps module 3212 may be interconnectable and coupled to the electronics housing 3204. The sensor module 3210 may be configured to carry and otherwise include the sensor 3214 ( Figure 32B ), and the sharps module 3212 can be configured to carry and otherwise include a sharp 3216 ( Figure 32B ), which is a sharp object used to help deliver the sensor 3214 transcutaneously beneath the user's skin during application of the sensor control device 3202.

[0442] like Figure 32B , corresponding portions of sensor 3214 and sharp prong 3216 extend from electronic device housing 3204, and more particularly, from the bottom of base 3208. An exposed portion of sensor 3214 may be received within a hollow or recessed portion of sharp prong 3216. The remaining portion(s) of sensor 3214 are positioned within the interior of electronic device housing 3204.

[0443] Adhesive patch 3218 may be positioned on and otherwise attached to the underside of base 3208. Figure 1 Similar to adhesive patch 108 of the embodiment of the present invention, adhesive patch 3218 can be configured to secure and maintain sensor control device 3202 in place on the user's skin during operation. In some embodiments, transfer adhesive 3220 can be inserted between adhesive patch 3218 and the bottom of base 3208. Transfer adhesive 3220 can help facilitate the assembly process of sensor control device 3202.

[0444] Figure 33A and Figure 33B 3202. FIG30 is an exploded perspective top view and bottom view, respectively, of sensor control device 3202 according to one or more embodiments. As illustrated, shell 3206 and base 3208 of electronic device housing 3204 operate as opposing clamshell halves that enclose or otherwise substantially enclose the various electronic components of sensor control device 3202.

[0445] A printed circuit board (PCB) 3302 may be positioned within the electronic device housing 3204. Figure 33B As shown in FIG, a plurality of electronic modules 3304 may be mounted to the underside of the PCB 3302. Example electronic modules 3304 include, but are not limited to, resistors, transistors, capacitors, inductors, diodes, and switches. Figure 33B ) may also be mounted to the PCB 3302 and may include, for example, an application specific integrated circuit (ASIC) configured to implement one or more functions or routines associated with the operation of the sensor control device 3202. More specifically, the data processing unit 3306 may be configured to perform data processing functions, such as filtering and encoding of data signals, each of which corresponds to a sampled analyte level of a user. The data processing unit 3306 may also include an antenna or otherwise communicate with an antenna for communicating with the reader device 106 ( Figure 1 ) communication.

[0446] As shown, the housing 3206, base 3208, and PCB 3302 each define corresponding central apertures 3308a, 3308b, 3308c, respectively. When the sensor control device 3202 is assembled, the central apertures 3308a-c are coaxially aligned to receive portions of the sensor module 3210 and sharps module 3212 therethrough.

[0447] A battery 3310 and a corresponding battery base 3312 can also be housed within the electronics housing 3204. The battery 3310 can be configured to power the sensor control device 3202.

[0448] 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 the tail 3316 and the flag 3318. The tail 3316 may be configured to extend through a central aperture 3308b defined in the base 3208 and extend distally from its underside. The tail 3316 may include an enzyme or other chemical or biological agent, and in some embodiments, the chemical may be covered by a membrane. In use, the tail 3316 is transcutaneously received beneath the user's skin, and the chemical included thereon helps facilitate analyte monitoring in the presence of bodily fluids.

[0449] Flag 3318 may include a generally planar surface having one or more sensor contacts 3322 disposed thereon. Figure 33A The flags 3318 may be configured to be received within the connector 3314 , with the sensor contact(s) 3322 aligned with a corresponding number of compliant carbon-impregnated polymer modules (not shown) encapsulated within the connector 3314 .

[0450] The connector 3314 includes one or more hinges 3324 that enable the connector 3314 to pivot between an open position and a closed position. Figures 33A-33B The compliant carbon impregnated polymer module(s) are depicted in a closed state, but can be transitioned to an open state to receive the flag 3318 and the compliant carbon impregnated polymer module(s) therein. The compliant carbon impregnated polymer module(s) provide electrical contacts 3326 ( Figure 33A 33 (three are shown in the figure), the electrical contacts are configured to provide conductive communication between the sensor 3214 and corresponding circuit contacts 3328 provided on the PCB 3302. When the sensor module 3210 is properly coupled to the electronic device housing 3204, the circuit contacts 3328 are in conductive communication with the electrical contacts 3326 of the connector 3314. The connector 3314 can be made of silicone rubber and can serve as a moisture barrier for the sensor 3214.

[0451] The sharps module 3212 includes a sharp 3216 and a sharps hub 3330 that carries the sharps 3216. The sharps 3216 include an elongated shaft 3332 and a sharps tip 3334 at the distal end of the shaft 3332. The shaft 3332 can be configured to extend through each of the coaxially aligned central apertures 3308a-c and extend distally from the bottom of the base 3208. In addition, the shaft 3332 can include a hollow or recessed portion 3336 that at least partially circumscribes the tail 3316 of the sensor 3214. The sharps tip 3334 can be configured to penetrate the skin while carrying the tail 3316 to allow the active chemical of the tail 3316 to contact bodily fluids.

[0452] The sharps hub 3330 may include a hub cylinder 3338 and a hub snap detent 3340, each of which may be configured to facilitate coupling the sensor control 3202 to the sensor applicator 102 ( Figure 1 ).

[0453] Specific reference Figure 33A In some embodiments, sensor module 3210 can be at least partially received within a sensor base recess 3342 included within electronics housing 3204. In some embodiments, sensor base recess 3342 can comprise a separate structure, but can alternatively form an integral part or extension of base 3208. Sensor base recess 3342 can be shaped and otherwise configured to receive and house sensor 3214 and connector 3314. As illustrated, sensor base recess 3342 defines an outer perimeter 3344 that generally circumscribes the area to be received by sensor 3214 and connector 3314. In at least one embodiment, outer perimeter 3344 can be sealed to the underside of PCB 3302 when electronics housing 3204 is fully assembled. In such embodiments, a gasket (e.g., an O-ring, etc.), adhesive, or another type of sealing material can be applied (disposed) at outer perimeter 3344 and operable to seal the interface between sensor base recess 3342 and PCB 3302.

[0454] Sealing the interface between the sensor base pocket 3342 and the underside of the PCB 3302 can help form or define a sealed area or region within the electronics housing 3204. The sealed region can prove advantageous in helping to isolate (protect) the tail portion 3316 of the sensor 3214 from potentially harmful sterilization gases used during gaseous chemical sterilization.

[0455] Specific reference Figure 33B , a plurality of channels or grooves 3346 may be provided or otherwise defined on the bottom of the base 3208. As illustrated, the grooves 3346 may be combined with the plurality of radially extending channels to form a plurality of concentric rings. Adhesive patch 3218 ( Figures 32A-32B ) can be attached to the underside of the base 3208, and in some embodiments, the transfer adhesive 3220 ( Figures 32A-32B ) can be inserted between adhesive patch 3218 and the bottom of base 3208. Groove 3346 can prove advantageous in promoting moisture to escape underneath adhesive patch 3218 away from the center of electronic device housing 3204.

[0456] In some embodiments, a post seal interface 3348 can be defined on the bottom of the base 3208 at the center of the base 3208. As illustrated, the post seal interface 3348 can include a substantially flat portion of the bottom of the base 3208. A second central aperture 3308b is defined at the center of the post seal interface 3348, and a groove 3346 can circumscribe the post seal interface 3348. The post seal interface 3348 can provide a sealing surface that can help isolate the tail portion 3316 of the sensor 3214 from potentially harmful sterilization gases used during gaseous chemical sterilization.

[0457] Figure 34A and Figure 34B 1 and 2 are side views and cross-sectional side views, respectively, of the sensor applicator 102 with the applicator cap 210 coupled thereto. More specifically, Figures 34A-34B Depicts how the sensor applicator 102 may be shipped to and received by a user. Figure 34B As seen in FIG, the sensor control device 3202 has been assembled and installed within the sensor applicator 102 prior to being delivered to the user. The applicator cap 210 may be threaded onto the housing 208 and include a tamper-evident ring 3402. When the applicator cap 210 is rotated (e.g., unscrewed) relative to the housing 208, the tamper-evident ring 3402 may shear and thereby release the applicator cap 210 from the sensor applicator 102. Thereafter, the user may deliver the sensor control device 3202 to the target monitoring location, as described above with reference to FIG. Figures 2E-2G Generally described.

[0458] Specific references Figure 34B , the sensor control device 3202 can be loaded into the sensor applicator 102 by mating the sharps hub 3330 with the sensor carrier 3404 included in the sensor applicator 102. More specifically, the hub cylinder 3338 and the hub snap detent 3340 can be received by corresponding mating features of the sensor carrier 3404.

[0459] Once the sensor control assembly 3202 is engaged with the sensor carrier 3404, the applicator cap 210 can then be secured to the sensor applicator 102. As illustrated, the applicator cap 210 can provide and otherwise define a cap post 3406 that is centrally located within the interior of the applicator cap 210 and extends proximally from the bottom thereof. The cap post 3406 can be configured to help support the sensor control assembly 3202 when contained within the sensor applicator 102. Additionally, the cap post 3406 can define a post cavity 3408 that is configured to receive, for example, a sensor 3214 and a sharp object 3216 extending from the bottom of the electronic device housing 3204. When the sensor control device 3202 is loaded into the sensor applicator 102, the sensor 3214 and the sharps 3216 can be arranged within a sealed area 3410, which is at least partially defined by the column chamber 3408 and is configured to isolate the sensor 3214 and the sharps 3216 during gaseous chemical sterilization.

[0460] In some embodiments, the sensor module 3210 and the sharps module 3212 can be subjected to radiation sterilization to sterilize the distal portions of the sensor 3214 and sharps 3216 prior to assembling and loading the sensor control unit 3202 into the sensor applicator 102. Once properly sterilized, the sensor module 3210 and the sharps module 3212 can then be coupled to the electronics housing 3204, and the fully assembled sensor control unit 3202 can then be loaded into the sensor applicator 102, as described above.

[0461] However, in other embodiments, the fully assembled sensor control device 3202 may first be loaded into the sensor applicator 102, and the sensor module 3210 and sharps module 3212 may then be subjected to radiation sterilization 3412 while positioned within the sensor applicator 102. Radiation sterilization 3412 may include, for example, electron beam radiation, although other sterilization methods may alternatively be used, including but not limited to gamma ray radiation, X-ray radiation, or any combination thereof.

[0462] In some embodiments, as illustrated, the sensor control device 3202 may be subjected to "focused" radiation sterilization 3412, wherein radiation (e.g., beam, wave, etc.) from the radiation sterilization 3412 is applied and otherwise directed only toward the sensor module 3210 and the sharps module 3212 (e.g., sensor 3214 and sharps 3216). In such an embodiment, the sensor control device 3202 is coupled to the PCB 3302 ( Figures 33A-33B ) of electrical components 3304 ( Figure 33B ) (including data processing unit 3306 ( Figure 33B)) can be positioned outside the range of the propagating radiation and, therefore, will not be affected by the radiation. Electrical components 3304 and data processing unit 3306, for example, can be positioned on PCB 3302 near its outer periphery so as not to fall within the range (span) of focused radiation sterilization 3412. In other embodiments, this can be achieved by shielding sensitive electrical components 3304 with appropriate electromagnetic shielding.

[0463] According to the present disclosure, when the sensor control device 3202 is loaded into the sensor applicator 102, the sensor control device 3202 can be subjected to gaseous chemical sterilization 3414 to sterilize the electronics housing 3204 and any other exposed portions of the sensor control device 3202. To accomplish this, chemicals can be injected into a sterilization chamber 3416 cooperatively defined by the sensor applicator 102 and the interconnected cap 210. In some applications, the chemicals can be injected through one or more vents 3418 defined in the applicator cap 210 at its proximal end 3420. Example chemicals that can be used for gaseous chemical sterilization 3414 include, but are not limited to, ethylene oxide, vaporized hydrogen peroxide, and nitrogen oxides (e.g., nitrous oxide, nitrogen dioxide, etc.).

[0464] Because the sensor 3214 and sharps 3216 are sealed within the sealed area 3410 , chemicals used during the gaseous chemical sterilization process do not interact with enzymes, chemicals, or biological agents provided on the tail 3316 .

[0465] Once the desired sterility assurance level has been achieved within the sterilization chamber 3416, the gaseous solution is removed and the sterilization chamber 3416 is inflated. Inflation may be achieved by a series of vacuums followed by circulation of nitrogen or filtered air through the sterilization chamber 3416. Once the sterilization chamber 3416 is properly inflated, the vent 3418 may be blocked with a seal 3422 (shown in phantom) applied to the proximal end 3420 of the applicator cap 210.

[0466] 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 (e.g., flash-spun high-density polyethylene fiber) such as Tyvek®, available from DuPont®. Tyvek® is highly durable and puncture-resistant, and allows vapor to pass through. The Tyvek® layer may be applied prior to gaseous chemical sterilization 3414, and after gaseous chemical sterilization 3414, a layer of foil or other vapor- and moisture-resistant material may be sealed (e.g., heat-sealed) over the Tyvek® layer to prevent contaminants and moisture from entering the sterilization chamber 3416. In other embodiments, the seal 3422 may include only a single protective layer applied to the applicator cap 210. In such embodiments, the single layer is gas permeable to the sterilization process, but also provides protection from moisture and other harmful elements once the sterilization process is complete.

[0467] With the seal 3422 in place, the applicator cap 210 provides a barrier against external contamination and thereby maintains a sterile environment for the assembled sensor control unit 3202 until the user removes (unscrews) the applicator cap 210. The applicator cap 210 also creates a dust-free environment during shipping and storage that prevents the adhesive patch 3218 used to secure the sensor control unit 3202 to the user's skin from becoming contaminated.

[0468] Figure 35 34 is an enlarged cross-sectional side view of a sensor control device 3202 installed within a sensor applicator 102 and with an applicator cap 210 secured thereto, according to one or more embodiments. As indicated above, portions of the sensor 3214 and sharps 3216 can be disposed within the sealed area 3410 and thereby protected from substances that may adversely interact with the chemistry of the sensor 3214. More specifically, during gaseous chemical sterilization 3414 ( Figure 34B ) may adversely affect the enzyme provided on the tail 3316 of the sensor 3214, and the sealing area 3410 protects the tail 3316 from the ingress of such chemicals.

[0469] As illustrated, the sealing area 3410 can include (surround) selected portions of the interior of the electronic device housing 3204 and the column chamber 3408 of the cap column 3406. In one or more embodiments, the sealing area 3410 can be defined by and otherwise formed from at least a first seal 3502a, a second seal 3502b, and a third seal 3502c. The first seal 3502a can be arranged to seal the interface between the sharps hub 3330 and the housing 3206. Furthermore, the first seal 3502a can circumscribe a first central aperture 3308a defined in the housing 3206 such that fluid (e.g., a gaseous chemical) is prevented from migrating into the interior of the electronic device housing 3204 via the first central aperture 3308a.

[0470] In some embodiments, the first seal 3502a can form part of the sharps hub 3330. For example, the first seal 3502a can be overmolded onto the sharps hub 3330. In other embodiments, the first seal 3502a can be overmolded onto the top surface of the shell 3206. In still other embodiments, the first seal 3502a can comprise a separate structure, such as an O-ring, interposed between the sharps hub 3330 and the top surface of the shell 3206 without departing from the scope of this disclosure.

[0471] The second seal 3502b can be arranged to seal the interface between the cap post 3406 and the bottom of the base 3208, and the second seal 3502b can circumscribe the second central aperture 3308b defined in the base 3208. Thus, the second seal 3502b can prevent fluids (e.g., gaseous chemicals) from migrating into the post chamber 3408 of the cap post 3406, and also prevent fluids (e.g., gaseous chemicals) from migrating into the interior of the electronic device housing 3204 via the second central aperture 3308b.

[0472] In some embodiments, the second seal 3502b can form part of the cap post 3406. For example, the second seal 3502b can be overmolded onto the top of the cap post 3406. In other embodiments, the second seal 3502b can be overmolded onto the cap post sealing interface 3348 at the bottom of the base 3208. In still other embodiments, the second seal 3502b can comprise a separate structure, such as an O-ring, inserted between the cap post 3406 and the bottom of the base 3208 without departing from the scope of this disclosure.

[0473] When the sensor control unit 3202 is loaded into the sensor applicator 102 and the applicator cap 210 is secured to the sensor applicator 102, the first seal 3502a and the second seal 3502b become compressed and form corresponding sealing interfaces. The first seal 3502a and the second seal 3502b can be made of a variety of materials capable of forming 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.

[0474] The third seal 3502c can be arranged to seal the interface between the sensor base pocket 3342 and the PCB 3302, and more particularly, the interface between the outer perimeter 3344 of the sensor base pocket 3342 and the underside of the PCB 3302. The third seal 3502c can include a gasket (e.g., an O-ring, etc.), an adhesive, or another type of sealing material applied (or arranged) at the outer perimeter 3344. In operation, the third seal 3502c can prevent fluids (e.g., gaseous chemicals, liquids, etc.) from migrating into the interior of the sensor base pocket 3342 and, therefore, into the column chamber 3408 to adversely react with the enzyme on the tail 3316.

[0475] The applicator cap 210 can be secured to the sensor applicator 102 by threading the applicator cap 210 onto the sensor applicator 102 via relative rotation. As the applicator cap 210 is rotated relative to the sensor applicator 102, the cap post 3406 advances until the second seal 3502b engages the cap post sealing interface 3348 at the bottom of the base 3208. Upon engaging the cap post sealing interface 3348, the second seal 3502b frictionally engages the base 3208 and thereby causes the entire electronic device housing 3204 to undergo a corresponding rotation in the same angular direction.

[0476] In the prior art sensor control device (such as, Figure 1 In the sensor control device 104 of FIG. 1 , a conical carrier clamping feature is generally defined on the exterior of the electronics housing and is configured to mate with a corresponding conical feature provided on the radial biasing arm of the sensor base recess 3342. The mating engagement between these corresponding conical features helps prevent the electronics housing from rotating within the sensor applicator 102.

[0477] In contrast, the electronics housing 3204 of the presently disclosed sensor control assembly 3202 provides or otherwise defines an angled and otherwise continuously smooth exterior surface 3504 around its outer diameter (perimeter). In some embodiments, as illustrated, the smooth exterior surface 3504 may be provided on the base 3208, but may alternatively be provided on the shell 3206 without departing from the scope of the present disclosure. One or more radially biasing arms of the sensor base pocket 3342 may be positioned to engage the exterior surface 3504 to help center the sensor control assembly 3202 within the sensor applicator 102. When the electronics housing 3204 is urged to rotate by frictional engagement between the second seal 3502b and the bottom of the base 3208, the exterior surface 3504 slidingly engages the radially biasing arms, which do not inhibit rotation of the electronics housing.

[0478] Figure 36 3406 is an enlarged cross-sectional bottom view of sensor control device 3202 positioned atop cap post 3406 according to one or more embodiments. As illustrated, adhesive patch 3218 is positioned on the underside of base 3208, with transfer adhesive 3220 interposed between adhesive patch 3218 and base 3208.

[0479] Adhesive patch 3218 can block or otherwise cover most of groove 3346 defined on the bottom of base 3208. Furthermore, as illustrated, adhesive patch 3218 can extend a short distance into cap post sealing interface 3348. To enable groove 3346 to properly direct moisture away from the center of electronic device housing 3204 and cap post sealing interface 3348, adhesive patch 3218 (and transfer adhesive 3220, if included) can provide or otherwise define one or more channels 3602 that are aligned with and otherwise arranged to be in fluid communication with groove 3346. In the illustrated embodiment, channel 3602 extends radially outward from the center of electronic device housing 3204, but can alternatively be defined in other configurations and still interconnect with groove 3346 to facilitate fluid communication therebetween.

[0480] In operation, when moisture accumulates around the center of electronic device housing 3204 and at cap post sealing interface 3348, the moisture can flow into groove 3346 via channel 3602. Once in groove 3346, the moisture can flow radially outward under adhesive patch 3218 and toward the outer perimeter of sensor control assembly 3202.

[0481] Embodiments disclosed herein include:

[0482] O. An analyte monitoring system comprising: a sensor applicator; a sensor control device positioned within the sensor applicator and comprising: an electronics housing having a shell and a base engageable with the shell; a printed circuit board positioned within the electronics housing; a sensor extending from a bottom of the base; a sharps hub positioned adjacent a top of the shell; and a sharp carried by the sharps hub and extending through the electronics housing and from a bottom of the base. The analyte monitoring system further comprises: a cap coupled to the sensor applicator and providing a cap post defining a post chamber that receives the sensor and the sharp extending from a bottom of the base; and a sealing region surrounding the post chamber and a portion of an interior of the electronics housing, wherein the sealing region is defined by: a first seal that seals an interface between the sharps hub and the shell; a second seal that seals an interface between the cap post and the bottom of the base; and a third seal that seals an interface between the base and the printed circuit board, and wherein portions of the sensor and sharp reside within the sealing region and are thereby isolated from gaseous chemical sterilization.

[0483] P. A method of preparing an analyte monitoring system, the method comprising loading a sensor control unit into a sensor applicator, the sensor control unit comprising: an electronics housing having a shell and a base engageable with the shell; a printed circuit board positioned within the electronics housing; a sensor module having a sensor extending from a bottom of the base; and a sharps module having a sharps hub and a sharp carried by the sharps hub, wherein the sharp extends through the electronics housing and from the bottom of the base. The method further comprises: securing a cap to the sensor applicator, wherein the cap provides a cap post defining a post cavity that receives the sensor and the sharp extending from the bottom of the base; forming a seal region when securing the cap to the sensor applicator, the seal region surrounding the post cavity and a portion of an interior of the electronics housing, wherein portions of the sensor and the sharp reside within the seal region; sterilizing the sensor control unit using gaseous chemical sterilization while the sensor control unit is positioned within the sensor applicator; and isolating the portions of the sensor and the sharp that reside within the seal region from the gaseous chemical sterilization.

[0484] Each of embodiments O and P may have one or more of the following additional elements in any combination: Element 1: wherein the first seal circumscribes a central aperture defined in the shell and prevents fluid from migrating through the central aperture into the portion of the interior of the electronic device housing. Element 2: wherein the second seal circumscribes a central aperture defined in the base and prevents fluid from migrating through the central aperture into the portion of the interior of the electronic device housing, and further prevents fluid from migrating into the post chamber. Element 3: wherein the first seal is overmolded onto the sharps hub. Element 4: wherein the first seal is inserted between the sharps hub and the top surface of the shell. Element 5: wherein the second seal is overmolded onto the cap post. Element 6: wherein the second seal is inserted between the cap post and the bottom surface of the base. Element 7: wherein the first seal and the second seal are made of a material selected from the group consisting of: silicone, thermoplastic elastomer, polytetrafluoroethylene, and any combination thereof. Element 8: wherein the base provides a sensor base recess that at least partially receives the sensor module within the electronic device housing, and wherein the third seal is positioned at an outer periphery of the sensor base recess. Element 9: wherein the third seal comprises one of a gasket and an adhesive. Element 10: further comprising: a plurality of grooves defined on the bottom of the base; and a cap post sealing interface defined on the bottom of the base at the center of the base, wherein the second seal seals against the cap post sealing interface. Element 11: further comprising: an adhesive patch coupled to the bottom of the base and extending radially into the cap post sealing interface; and one or more channels defined in the adhesive patch and interconnected with the plurality of grooves to facilitate fluid communication between the cap post sealing interface and the plurality of grooves. Element 12: wherein the electronic device housing defines an angled and smooth exterior surface that permits unimpeded rotation of the sensor control device relative to the sensor applicator when the cap is coupled to the sensor applicator.

[0485] Element 13: Wherein, forming a seal area when securing the cap to the sensor applicator includes sealing an interface between the sharp hub and the housing with a first seal, sealing an interface between the cap post and the bottom of the base with a second seal, and sealing an interface between the base and the printed circuit board with a third seal. Element 14: Wherein, loading the sensor control unit into the sensor applicator is preceded by the steps of sterilizing the sensor and sharp using radiation sterilization; and assembling the sensor and sharp module to the electronics housing. Element 15: Wherein, sterilizing the sensor control unit using gaseous chemical sterilization is preceded by the steps of sterilizing the sensor and sharp using radiation sterilization while the sensor control unit is positioned within the sensor applicator. Element 16: Wherein, the radiation sterilization is at least one of focused radiation sterilization and low-energy radiation sterilization. Element 17: Wherein, the electronics housing defines an angled and smooth exterior surface, the method further comprising: allowing the sensor control unit to rotate relative to the sensor applicator when the cap is secured to the sensor applicator.

[0486] As non-limiting examples, exemplary combinations suitable for O and P include: 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.

[0487] One-piece tray construction with ASIC shielding, use of low and medium energy radiation sterilization, and magnetic bias change

[0488] Figures 37A-37C 3702 (alternatively referred to as an on-body patch or unit) can be used in some aspects with Figure 1 The sensor control device 104 is similar to and therefore best understood with reference thereto. The sensor control device 3702 may replace Figure 1 The sensor control device 104 and thus can be used with the sensor applicator 102 ( Figure 1 ) is used in conjunction with the sensor applicator to deliver the sensor control device 3702 to the target monitoring location on the user's skin. However, Figure 1 In contrast to the sensor control device 104 of FIG. 1 , various structural advantages and improvements allow the sensor control device 3702 to be included in the one-piece system architecture.

[0489] and Figure 1Unlike the sensor control device 104 of FIG. 3 , for example, the user is not required to open multiple packages and finally assemble the sensor control device 3702 before delivering it to the target monitoring location. Instead, upon receipt by the user, the sensor control device 3702 may already be fully assembled and properly positioned within the sensor applicator 102. To use the sensor control device 3702, the user need only break a barrier (e.g., Figure 2B ), and then quickly delivering the sensor control device 3702 to the target monitoring location.

[0490] First reference Figure 37A , the sensor control device 3702 includes an electronic device housing 3704 that is generally disc-shaped and may have a generally circular cross-section. However, in other embodiments, the electronic device housing 3704 may exhibit other cross-sectional shapes, such as oval or polygonal, without departing from the scope of this disclosure. The electronic device housing 3704 may include a shell 3706 and a base 3708 that may mate with the shell 3706. An adhesive patch 3710 may be positioned on and otherwise attached to the underside of the base 3708. Figure 1 Similar to the adhesive patch 108 of FIG. 37 , the adhesive patch 3710 can be configured to secure and maintain the sensor control device 3702 in place on the user's skin during operation.

[0491] In some embodiments, the shell 3706 may define a reference feature 3712. As illustrated, the reference feature 3712 may include a recess or blind pocket defined in the shell 3706 and extending a short distance into the interior of the electronic device housing 3704. The reference feature 3712 may operate as a "datum point c" feature that is configured to help facilitate control of the sensor control device 3702 in at least one degree of freedom during factory assembly. In contrast, existing sensor control devices (e.g., Figure 1 The sensor control device 104 of the embodiment of the present invention typically includes a tab extending radially from the side of the shell. The tab is used as a timing reference point in the process, but it must be removed at the end of manufacturing, and then the shell where the tab was located must be inspected, which increases the complexity of the previous manufacturing process.

[0492] The shell 3706 may also define a central aperture 3714 that is sized to receive a sharp object (not shown) that may extend through the center of the electronic device housing 3704 .

[0493] Figure 37BA portion of sensor 3716 is depicted extending from electronic device housing 3704. The remaining portion(s) of sensor 3716 are positioned within the interior of electronic device housing 3704. Figure 1 Similar to sensor 110, the exposed portion of sensor 3716 is configured to be transcutaneously positioned beneath the user's skin during use. The exposed portion of sensor 3716 may include an enzyme or other chemical or biological agent, and in some embodiments, the membrane may cover the chemical.

[0494] Sensor control device 3702 provides structural improvements that result in a height H and diameter D that can be smaller than existing sensor control devices (e.g., Figure 1 In at least one embodiment, for example, the height H can be approximately 1 mm or more smaller than the height of existing sensor control devices, and the diameter D can be approximately 2 mm or more smaller than the diameter of existing sensor control devices.

[0495] Furthermore, the structural improvements to the sensor control device 3702 allow the housing 3706 to provide or otherwise define a chamfered or angled outer periphery 3718. In contrast, existing sensor control devices typically require a rounded or outwardly arched outer periphery to accommodate internal components. The reduced height H, reduced diameter D, and angled outer periphery 3718 may all prove advantageous in providing a sensor control device 3702 that is thinner, smaller, and less prone to premature detachment when attached to a user's skin due to catching on sharp objects, corners, and the like.

[0496] Figure 37C A central aperture 3720 is depicted as being defined in the underside of the base 3708. The central aperture 3720 may be sized to receive a combined sharp object (not shown) and a sensor 3716, wherein the sensor 3716 is received within a hollow or recessed portion of the sharp object. When the electronic device housing 3704 is assembled, the central aperture 3720 is aligned with the shell 3706 ( Figure 37A ) center orifice 3714 ( Figure 37A ) are coaxially aligned and the sharp object penetrates the electronic device housing by simultaneously extending through each central aperture 3714, 3720.

[0497] Figure 38A and Figure 38BFigures 3706 and 3708 are exploded top and bottom views, respectively, of sensor control device 3702 according to one or more embodiments. Shell 3706 and base 3708 operate as opposing clamshell halves that enclose or otherwise substantially encapsulate the various electronic components of sensor control device 3702. As illustrated, sensor control device 3702 may include a printed circuit board assembly (PCBA) 3802 comprising a printed circuit board (PCB) 3804 having a plurality of electronic modules 3806 coupled thereto. Example electronic modules 3806 include, but are not limited to, resistors, transistors, capacitors, inductors, diodes, and switches. Existing sensor control devices typically stack PCB components on only one side of the PCB. In contrast, PCB components 3806 in sensor control device 3702 can be dispersed across the surface area of ​​both sides (i.e., the top and bottom surfaces) of PCB 3804.

[0498] In addition to the electronics module 3806, the PCBA 3802 may also include a data processing unit 3808 mounted to the PCB 3804. The data processing unit 3808 may include, for example, an application specific integrated circuit (ASIC) configured to implement one or more functions or routines associated with the operation of the sensor control device 3702. More specifically, the data processing unit 3808 may be configured to perform data processing functions, where such functions may include, but are not limited to, filtering and encoding of data signals, each of which corresponds to a sampled analyte level of a user. The data processing unit 3808 may also include an antenna or otherwise be in communication with an antenna for communicating with the reader device 106 ( Figure 1 ) communication.

[0499] A battery aperture 3810 may be defined in the PCB 3804 and sized to receive and house a battery 3812 configured to power the sensor control unit 3702. Axial battery contacts 3814a and radial battery contacts 3814b may be coupled to the PCB 3804 and extend into the battery aperture 3810 to facilitate transmission of electrical power from the battery 3812 to the PCB 3804. As the names suggest, the axial battery contacts 3814a may be configured to provide axial contact for the battery 3812, while the radial battery contacts 3814b may provide radial contact for the battery 3812. Positioning the battery 3812 within the battery aperture 3810 using the battery contacts 3814a, 3814b helps reduce the height H ( Figure 37B ), which allows the PCB 3804 to be centrally located with its components spread out on both sides (ie, the top and bottom surfaces). This also helps facilitate the chamfer 3718 ( Figure 37B ) is provided on the electronic device housing 3704.

[0500] The sensor 3716 can be centrally located relative to the PCB 3804 and include a tail 3816, a flag 3818, and a neck 3820 interconnecting the tail 3816 and the flag 3818. The tail 3816 can be configured to extend through the central aperture 3720 of the base 3708 to be transcutaneously received beneath the skin of a user. Additionally, the tail 3816 can have an enzyme or other chemical included thereon to help facilitate analyte monitoring.

[0501] Flag 3818 may include a generally planar surface having one or more sensor contacts 3822 ( Figure 38B The sensor contact(s) 3822 may be configured to mate with corresponding circuit contacts 3824 (e.g., three are shown in FIG3804 ). Figure 38A 3804 ). In some embodiments, the sensor contact(s) 3822 may comprise a carbon impregnated polymer that is printed or otherwise digitally applied to the flag 3818. Existing sensor control devices typically include a connector made of silicone rubber that encapsulates one or more compliant carbon impregnated polymer modules that serve as conductive contacts between the sensor and the PCB. In contrast, the presently disclosed sensor contact(s) 3822 provide a direct connection between the sensor 3716 and the PCB 3804 connection, which eliminates the need for the prior art connector and advantageously reduces the height H ( Figure 37B ). Furthermore, eliminating the compliant carbon-impregnated polymer module eliminates significant circuit resistance and thus improves circuit conductivity.

[0502] The sensor control 3702 may also include a compliant member 3826 that may be positioned to be interposed between the flag 3818 and the inner surface of the housing 3706. More specifically, when the housing 3706 and the base 3708 are assembled with one another, the compliant member 3826 may be configured to provide a passive biasing load against the flag 3818 that forces the sensor contact(s) 3822 into continuous engagement with the corresponding circuit contact(s) 3824. In the illustrated embodiment, the compliant member 3826 is an elastomeric O-ring, but may alternatively include any other type of biasing device or mechanism, such as a compression spring, etc., without departing from the scope of the present disclosure.

[0503] The sensor control device 3702 may also include one or more electromagnetic shields, which are shown as a first shield 3828a and a second shield 3828b. The shields 3828a, 3828b may be arranged between the shell 3706 and the base 3708; that is, between the electronic device housing 3704 ( Figures 37A-37BIn the illustrated embodiment, the first shield 3828a is arranged above the PCB 3804 such that it faces the top surface of the PCB 3804, and the second shield 3828b is arranged below the PCB 3804 such that it faces the bottom surface of the PCB 3804.

[0504] Shields 3828a, 3828b can be configured to protect sensitive electronic components from radiation while sensor control unit 3702 is undergoing radiation sterilization. More specifically, at least one of shields 3828a, 3828b can be positioned to be interposed between data processing unit 3808 and a radiation source, such as an electron beam electron accelerator. In some embodiments, for example, at least one of shields 3828a, 3828b can be positioned adjacent to and otherwise aligned with data processing unit 3808 and the radiation source to block or mitigate radiation absorption dose that could otherwise damage sensitive electronic circuitry of data processing unit 3808.

[0505] In the illustrated embodiment, data processing unit 3808 is interposed between first shield 3828a and second shield 3828b, such that first shield 3828a and second shield 3828b are positioned substantially opposite data processing unit 3808 in an axial direction. However, in at least one embodiment, only one of shields 3828a and 3828b may be required to properly protect data processing unit 3808 during radiation sterilization. For example, if sensor control unit 3702 is subjected to radiation sterilization directed toward the bottom of base 3708, only second shield 3828b may need to be interposed between data processing unit 3808 and the radiation source, and first shield 3828a may be omitted. Alternatively, if sensor control unit 3702 is subjected to radiation sterilization directed toward the top of housing 3706, only first shield 3828a may need to be interposed between data processing unit 3808 and the radiation source, and second shield 3828b may be omitted. However, in other embodiments, two shields 3828a, 3828b may be employed without departing from the scope of the present disclosure.

[0506] Shields 3828a, 3828b can be made of any material capable of attenuating (or substantially attenuating) the transmission of radiation. Suitable materials for shields 3828a, 3828b include, but are not limited to, lead, tungsten, iron-based metals (e.g., stainless steel), copper, tantalum, tungsten, osmium, aluminum, carbon, or any combination thereof. Suitable metals for shields 3828a, 3828b can be corrosion-resistant, austenitic, and any non-magnetic metal with a density ranging from approximately 2 grams per cubic centimeter (g / cc) to approximately 23 g / cc. Shields 3828a, 3828b can be manufactured using a variety of manufacturing techniques, including, but not limited to, stamping, casting, injection molding, sintering, two-shot molding, or any combination thereof.

[0507] However, in other embodiments, shields 3828a, 3828b may comprise a metal-filled thermoplastic polymer, such as, but not limited to, polyamide, polycarbonate, or polystyrene. In such embodiments, shields 3828a, 3828b may be manufactured by mixing the shielding material in an adhesive matrix and dispensing the combination onto a formed component or otherwise directly onto data processing unit 3808. Furthermore, in such embodiments, shields 3828a, 3828b may comprise a housing that encapsulates (or substantially encapsulates) data processing unit 3808. In such embodiments, shields 3828a, 3828b may comprise a metal-filled thermoplastic polymer as described above, or alternatively, may be made of any material described herein that is capable of attenuating (or substantially attenuating) the transmission of radiation.

[0508] The housing 3706 may provide or otherwise define a first timing receptacle 3830a ( Figure 38B ) and the second timing jack 3830b ( Figure 38B ), and the base 3708 may provide or otherwise define a first timing post 3832a ( Figure 38A ) and the second timing column 3832b ( Figure 38A ). Mating the first and second timing receptacles 3830a, 3830b with the first and second timing posts 3832a, 3832b, respectively, will properly align the housing 3706 to the base 3708.

[0509] Specific reference Figure 38A, the inner surface of the base 3708 may provide or otherwise define a plurality of pockets or recesses configured to receive various component parts of the sensor control unit 3702 when the housing 3706 is mated to the base 3708. For example, the inner surface of the base 3708 may define a battery retainer 3834 configured to receive a portion of the battery 3812 when the sensor control unit 3702 is assembled. An adjacent contact pocket 3836 may be configured to receive a portion of the axial contact 3814a.

[0510] In addition, a plurality of module pockets 3838 may be defined in the inner surface of the base 3708 to accommodate various electronic modules 3806 arranged on the bottom of the PCB 3804. In addition, a shield retainer 3840 may be defined in the inner surface of the base 3708 to accommodate at least a portion of the second shield 3828b when the sensor control device 3702 is assembled. The battery retainer 3834, the contact pockets 3836, the module pockets 3838, and the shield retainer 3840 all extend a short distance into the inner surface of the base 3708, and as a result, the overall height H of the sensor control device 3702 may be reduced compared to existing sensor control devices. Figure 37B ). Module pockets 3838 may also help minimize the diameter of PCB 3804 by allowing PCB components to be arranged on both sides (ie, top and bottom surfaces).

[0511] Still refer to Figure 38A Base 3708 may also include a plurality of carrier clamping features 3842 (two shown) defined around the outer perimeter of base 3708. Carrier clamping features 3842 are axially offset from a bottom 3844 of base 3708, allowing for application of transfer adhesive (not shown) to the bottom of the base during assembly. In contrast to existing sensor control devices, which typically include conical carrier clamping features that intersect the bottom of the base, the presently disclosed carrier clamping features 3842 are offset from the plane to which the transfer adhesive is applied (i.e., bottom 3844). This may prove advantageous in helping to ensure that the delivery system does not inadvertently pick up transfer adhesive during assembly. Furthermore, the presently disclosed carrier clamping features 3842 eliminate the need for fan-shaped transfer adhesive, which simplifies transfer adhesive manufacturing and eliminates the need to accurately time the transfer adhesive relative to base 3708. This also increases the bonding area, and therefore, the bond strength.

[0512] refer to Figure 38B, the bottom 3844 of the base 3708 may provide or otherwise define a plurality of grooves 3846, which may be defined at or near the outer perimeter of the base 3708 and spaced equidistantly from one another. A transfer adhesive (not shown) may be coupled to the bottom 3844, and the grooves 3846 may be configured to help transport (transfer) moisture away from the sensor control unit 3702 and toward the perimeter of the base 3708 during use. In some embodiments, the spacing of the grooves 3846 may be inserted into the module pockets 3838 ( Figure 38A As will be appreciated, alternating the positions of the grooves 3846 and the module pockets 3838 ensures that opposing features do not extend into each other on either side of the base 3708. This can help maximize material usage for the base 3708 and thereby help maintain a minimum height H ( Figure 37B The mold pockets 3838 may also significantly reduce mold sink and improve the flatness of the bottom 3844 to which the transfer adhesive is bonded.

[0513] Still refer to Figure 38B , the inner surface of the shell 3706 may further provide or otherwise define a plurality of recesses or depressions configured to accommodate various components of the sensor control device 3702 when the shell 3706 is mated to the base 3708. For example, the inner surface of the shell 3706 may define opposing battery locators 3848 that may be arranged to align with the battery locators 3834 ( Figure 38A ) are opposite and are configured to accommodate a portion of the battery 3812 when the sensor control unit 3702 is assembled. In addition, a shield retainer 3850 can be defined in the inner surface of the shell 3706 to accommodate at least a portion of the first shield 3828a when the sensor control unit 3702 is assembled. The opposing battery retainers 3848 and shield retainer 3850 extend a short distance into the inner surface of the shell 3706, which helps reduce the overall height H ( Figure 37B ).

[0514] The sharp and sensor locator 3852 may also be provided by or otherwise defined on the inner surface of the shell 3706. The sharp and sensor locator 3852 may be configured to receive a sharp (not shown) and a portion of the sensor 3716. Furthermore, the sharp and sensor locator 3852 may be configured to align with a corresponding sharp and sensor locator 2054 (not shown) provided on the inner surface of the base 3708. Figure 38A ) alignment and / or mating.

[0515] Figures 39A-39D1 shows a progressive example assembly of a sensor control device 3702 according to one or more embodiments. Figure 39A 38. In the embodiment of the present invention, the battery 3812 is loaded into the opposing battery retainer 3848, and the first shield 3828a is loaded into the shield retainer 3850 defined in the inner surface of the shell 3706. The compliant member 3826 and the flag 3818 of the sensor 3716 can each be mounted to the first timing receptacle 3830a. The tail 3816 of the sensor 3716 can be inserted into the sharp object and the sensor retainer 3852.

[0516] exist Figure 39B , the PCB 3804 can be loaded into the housing 3706 to align the battery aperture 3810 with the battery 3812, and the axial battery contacts 3814a and radial battery contacts 3814b facilitate electrical communication.

[0517] exist Figure 39C , the second shield 3828b has been loaded into the shield retainer 3840 defined in the inner surface of the base 3708. The base 3708 is now ready to be coupled to the shell 3706 ( Figure 39A and Figure 39B To achieve this, the first timing jack 3830a and the second timing jack 3830b of the housing 3706 ( Figure 39B ) can be coaxially aligned with the first timing post 3832a and the second timing post 3832b of the base 3708, respectively. Adhesive can be applied to one or both of the shell 3706 and the base 3708 to secure the two components together. In one embodiment, for example, adhesive can be applied around the outer diameter (perimeter) of the shell 3706, and then the shell 3706 can ...

Claims

1. An assembly for delivering an analyte sensor, comprising: A sensor control device, the sensor control device comprising: an electronic device housing including a shell having a first aperture and a base secured to the shell to define an interior space, the base having a second aperture aligned with the first aperture; A circuit board, the circuit board is arranged in the inner space of the electronic device housing and includes a plurality of electronic device modules; an analyte sensor comprising: an in vivo portion extending through the second aperture and configured to measure an analyte level in a bodily fluid; an in vitro portion located within the interior space of the electronic device housing and comprising a plurality of electrical contacts coupled to the circuit board; and a sharp hub adapted to engage the sensor control device, the sharp hub carrying a sharp and including a mating member configured to extend through the first and second apertures and to extend distally from an underside of the base; a sensor cap having a first end, a second end, and an interior chamber, wherein the interior chamber receives at least a portion of the intracorporeal portion of the analyte sensor, and wherein the first end is removably coupled to the mating member to seal the interior chamber; and An applicator for delivering the analyte sensor, the applicator comprising: a housing including a sensor carrier configured to secure the sensor control device within an interior of the applicator; and an applicator cap removably coupled to the housing to seal the interior of the applicator, wherein when the applicator cap is coupled to the housing, the applicator cap engages with an engagement feature on the second end of the sensor cap, and wherein when the applicator cap is removed from the housing, the sensor cap disengages from the base and remains engaged with the applicator cap.

2. The assembly according to claim 1, wherein The first end of the sensor cap includes one or more internal flat threads, and the mating member includes one or more external flat threads corresponding to the one or more internal flat threads, and the sensor cap is removably connected to the base through engagement of the one or more external flat threads with the one or more internal flat threads.

3. The assembly according to claim 1, wherein: The sharp object includes a hollow portion configured to receive at least a portion of the analyte sensor.

4. The assembly according to claim 3, wherein: The hollow portion includes a non-circular cross-section.

5. The assembly according to claim 1, wherein: The sensor cap is configured to isolate the analyte sensor for sterilization.

6. The assembly according to claim 1, wherein: The applicator cap seals the interior of the applicator when the applicator cap is coupled to the housing.

7. The assembly according to claim 1, wherein: The sensor cap includes a desiccant cap disposed at the second end of the sensor cap.

8. The assembly according to claim 7, wherein: The desiccant cap defines the engagement feature of the sensor cap.

9. The assembly of claim 1, wherein: The interior chamber of the sensor cap includes a desiccant to maintain a target humidity level.

10. The assembly of claim 1, wherein: The applicator cap also includes a cap post configured to receive the engagement feature of the sensor cap.

11. The assembly according to claim 1, wherein: The shell includes an upper surface having a first aperture and a recess configured to facilitate control of the electronic device housing in at least one degree of freedom.

12. The assembly of claim 1, wherein: The plurality of electronic device modules are disposed on the top and bottom surfaces of the circuit board.

13. The assembly of claim 1, wherein: The circuit board includes a battery cutout portion sized to receive and seat a battery.

14. The assembly of claim 1, wherein: The base also includes a plurality of carrier clamping features along an outer perimeter of the base.

15. The assembly of claim 14, wherein: The plurality of carrier clamping features are configured to prevent the electronic device housing from rotating within the applicator.

16. The assembly of claim 1, further comprising an adhesive configured to secure the shell to the base, wherein the adhesive isolates an interior of the electronic device housing from external contaminants.

17. The assembly of claim 1, wherein: The first end of the sensor cap is removably coupled to the base to form a sterile barrier for the analyte sensor.

18. The assembly of claim 1 further comprising a collar located in the electronic device housing, wherein: The collar includes a central aperture axially aligned with the first aperture and the second aperture, wherein the sharp hub is adapted to engage the collar.

19. A method of assembling an analyte sensor for delivery, comprising: A sensor control device is provided, the sensor control device comprising: an electronic device housing, the electronic device housing comprising a shell having a first aperture and a base secured to the shell to define an interior space, the base having a second aperture aligned with the first aperture; a circuit board disposed within the interior space of the electronic device housing and comprising a plurality of electronic device modules; an analyte sensor comprising an in vivo portion extending through the aperture in the base and configured to measure analyte levels, an in vitro portion located within the interior space of the electronic device housing and comprising a plurality of electrical contacts coupled to the circuit board; a sharp hub adapted to engage with the sensor control device, the sharp hub carrying a sharp and comprising a mating member configured to extend through the first and second apertures and to extend distally from a lower side of the base; and a sensor cap having a first end, a second end, and an inner chamber, wherein the inner chamber receives at least a portion of the in vivo portion of the analyte sensor, and wherein the first end is removably coupled to the mating member to seal the inner chamber; and An applicator for delivering the analyte sensor is provided, the applicator comprising: A housing comprising a sensor carrier configured to secure the sensor control device within an interior of the applicator; and an applicator cap removably coupled to the housing to seal the interior of the applicator, wherein when the applicator cap is coupled to the housing, the applicator cap engages with an engagement feature on the second end of the sensor cap, and wherein when the applicator cap is removed from the housing, the sensor cap disengages from the base and remains engaged with the applicator cap.

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