Focused sterilized and sterilized subassembly for analyte monitoring system

Abstract

An analyte monitoring system comprising: a sensor applicator; a cap coupled to the sensor applicator; a sensor control device positioned within the sensor applicator and including an electronics housing; the sensor extends from the bottom of the electronic equipment shell; a sharp hub positioned adjacent to the top of the electronic device housing; a sharpen carried by the sharpen hub and extending through the electronics housing and from a bottom of the electronics housing; and a collimator positioned within the cap and defining a sterilization zone that receives a sensor and a sharp object extending from a bottom of the electronics housing.

Description

Background Art

[0001] Diabetes is an incurable, chronic disease in which the body does not produce or does not properly use 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 I diabetes) or the body does not properly use insulin (a condition known as type II 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, renal 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 body fluid analytes (such as glucose). The analyte monitoring system typically includes a sensor applicator that is configured to place the biosensor in contact with the body 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 surface, such as in 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 greatly detrimentally affect the health and safety of the user.

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

[0006] These problems 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) so that each component can be packaged and sterilized separately 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 to be 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] Figure 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, respectively.

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

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

[0013] Fig. 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] Fig. 7A yes Figure 6B An enlarged cross-sectional side view of a sensor control device mounted on 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 within the sensor applicator.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

[0036] Fig.29A and Fig.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] Fig.30 yes Figure 29A-29B A perspective view of an example embodiment of a cap.

[0038] Fig.31 is a cross-sectional side view of a sensor control device positioned within a cap.

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

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

[0041] Fig.34A and Fig.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] Fig.35 is an enlarged cross-sectional side view of a sensor control assembly mounted within a sensor applicator.

[0043] Fig.36 is an enlarged cross-sectional bottom view of the sensor control unit mounted on top of the cap post.

[0044] Figure 37A-Figure 37C An isometric view, side view, and bottom view of an example sensor control device, respectively.

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

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

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

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

[0049] Fig.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] Fig.43 is a cross-sectional side view of a sensor applicator according to one or more additional embodiments, wherein Figure 37A-Figure 37C A preassembled sensor control device is arranged in the sensor applicator.

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

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

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

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

[0055] Fig.47A and Fig.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] Fig.48 yes Figure 47A-47B A perspective view of an example embodiment of a cap.

[0057] Fig.49 is located in Figure 47A-47B A cross-sectional side view of the sensor control device within the cap.

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

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

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

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

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

[0063] Fig.55 is located in Fig.12 B- Fig.12 C's cap Figure 50A-Figure 50B A cross-sectional side view of a sensor control device.

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

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

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

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

[0068] Fig.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] Fig.60A is an isometric top view of a cap according to one or more embodiments.

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

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

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

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

[0074] Fig.64A and Fig.64B yes Fig.62 and Fig.63 An exploded isometric view of the sensor applicator and sensor controls.

[0075] Figure 65A-Figure 65D According to one or more embodiments Fig.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] Fig.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] Fig.67 According to one or more additional embodiments, Fig.62 An exploded isometric view of another sensor applicator of a sensor control device.

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

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

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

[0081] Fig.70A and Fig.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] Fig.71A and Fig.71B 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] Fig.72A and Fig.72B A holding sensor control device according to one or more embodiments Figure 71A-Figure 71B Magnified cross-sectional side view of the sensor holder.

[0084] Fig.73A and Fig.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] Fig.74A and Fig.74B They are Fig.73B Isometric top and bottom views of the inner applicator cover.

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

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

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

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

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

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

[0092] Fig.81A and Fig.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] Fig.82 yes Fig.81A Exploded perspective top view of a sensor control device.

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

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

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

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

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

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

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

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

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

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

[0104] Fig.92A and Fig.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] Fig.93 According to one or more embodiments Figure 91A-Figure 91B and Figure 92A-Figure 92B A cross-sectional side view of a sensor control device.

[0106] Fig.93A yes Figure 91A-Figure 91B and Figure 92A-Figure 92B An exploded isometric view of a portion of another embodiment of a sensor control device. Fig.94A yes Figure 91A-Figure 91B and Figure 92A-Figure 92B Isometric bottom view of the base.

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

[0108] Fig.95A and Fig.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] Fig.96A and Fig.96B According to one or more embodiments Fig.95B Perspective and top view of the cap column.

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

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

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

[0113] Fig.100A Is it Fig.99 An enlarged cross-sectional side view of the interface between the sensor applicator and the cap indicated by the dashed box.

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

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

[0116] Figure 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] Fig.103 is an isometric view of an example sensor control device.

[0118] Fig.104A and Fig.104B According to one or more embodiments Fig.103 An exploded isometric view of the sensor control device.

[0119] Fig.105 According to one or more embodiments Figures 104A-104B A cross-sectional side view of the assembled sensor control unit.

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

[0121] Fig.107A and Fig.107B According to one or more embodiments Fig.106 An exploded isometric view of the sensor control device.

[0122] Fig.108 According to one or more embodiments Figures 107A-107B A cross-sectional side view of the assembled sensor control unit.

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

[0124] Figures 110A-110E Depicted is a diagram of a method according to one or more embodiments Fig.109 Incremental manufacturing of sensor-controlled devices.

[0125] Fig.111A is provided for pressure testing and / or vacuum sealing according to one or more embodiments Fig.109 Top view of the sensor control device.

[0126] Fig.111B Has a compressor Fig.109 A cross-sectional side view of a sensor control device.

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

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

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

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

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

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

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

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

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

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

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

[0138] Fig.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 1 is a conceptual diagram depicting an example analyte monitoring system 100 that may include one or more embodiments of the present disclosure. System 100 (hereinafter "system 100") may be used to detect and quantify a variety of analytes, including but not limited to acetylcholine, amylase, bilirubin, cholesterol, 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. The concentration of drugs such as, but not limited to, antibiotics (e.g., gentamicin, vancomycin, etc.), digitoxin, digoxin, anesthetics (drugs of abuse), theophylline, and warfarin may also be determined.

[0141] As illustrated, 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 maintained in place on the skin using an adhesive patch 108 coupled to the bottom of the sensor control device 104. A portion of the sensor 110 extends from the sensor control device 104 and is positioned so that it can be transcutaneously positioned and otherwise maintained below 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 include, for example, a needle often referred to as a "sharp". Alternatively, the introducer may include other types of devices, such as a sheath or a blade. The introducer may reside near sensor 110 before tissue insertion, and then withdrawn afterwards. When present, the introducer may facilitate the 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 to allow subcutaneous implantation of sensor 110. After opening the access pathway, the introducer may be withdrawn (retracted) so that it does not cause harm while sensor 110 remains in place. In an illustrative embodiment, the introducer may be solid or hollow, beveled or non-beveled, and / or circular or non-circular in cross section. In a more particular embodiment, a suitable introducer may be comparable to an acupuncture needle in cross-sectional diameter and / or tip design, and an acupuncture needle may have a cross-sectional diameter of about 250 microns. However, it will be appreciated that a suitable introducer 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) may 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 may 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. In addition, the introducer (sharp) may 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 smart phone or a dedicated electronic reader instrument. Although only one reader device 106 is shown, multiple reader devices 106 may exist 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 a communication path / link 124. The network 122 may further be communicatively coupled to the remote terminal 114 via a communication path / link 126 and / or to the trusted computer system 116 via a 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. Pat. 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), or Low energy protocols, 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 optional input components 132. According to some embodiments, the display 130 may include a touch screen interface.

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

[0150] The sensor control device 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 device 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] Recently, however, advanced designs of sensor control devices and sensor applicators have resulted in a one-piece architecture that allows the system to be shipped to the user in a single sealed package that does not require any final user assembly steps. Instead, the user need only open one package and then deliver the sensor control device to the target monitoring location. The 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 location. 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 at least enclosed in the package. The user must open the package and follow instructions to manually assemble these components, and then use the sensor applicator 102 to deliver the sensor 110 to the target monitoring location.

[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 which are provided to a user for final assembly. More specifically, Figure 2A A sensor container or tray 202 having a removable cover 204 is depicted. The user prepares the sensor tray 202 by removing the cover 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 cover 204 exposes a platform 206 positioned within the sensor tray 202, and a plug assembly 207 (partially visible) disposed within the platform 206 and otherwise strategically embedded within the platform. 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, which is used to apply 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 a 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 components for the sensor control device 104 ( Figure 1) and the applicator cap 210 may or may not maintain a sterile environment for the electrical components. Preparation of the sensor applicator 102 includes decoupling the housing 208 from the applicator cap 210, which can be achieved 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 connected to an electronic device housing disposed within the sensor applicator 102, the plug assembly including a sensor module and a sharp object module.

[0156] exist Figure 2D , 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 device 104 fully assembled therein and positioned for delivery to a target monitoring location. As illustrated, a sharp object 220 extends from the bottom of the sensor control device 104 and carries a portion of the sensor 110 into a hollow or recessed portion thereof. The sharp object 220 is configured to penetrate the skin of a user 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 ) to engage with the skin. 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, wherein the sensor control device 104 is successfully attached to the user's skin. The adhesive patch 108 ( Figure 1 ) adheres to the skin to fix 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 the sensor applicator 102 to be sterilized in separate sterilization processes that are unique to the contents of each package and are otherwise incompatible with the contents of the other 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 electronic housing of the sensor control device 104. Therefore, if the sensor applicator 102 containing the electronic housing of the sensor control device 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 includes 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 Figure 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 302 (alternatively referred to as a "puck") may be similar in some aspects to a sensor control device 302. Figure 1 The sensor control device 302 is similar to the sensor control device 104 of FIG. 1 and is therefore best understood with reference thereto. The sensor control device 302 may replace 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 that 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 included in the one-piece system architecture. Unlike the two-piece architecture system, for example, the user is not required to open multiple packages and finally assemble the sensor control device 302. Instead, when received by the user, the sensor control device 302 is already fully assembled and properly positioned within the sensor applicator 102. In order to use the sensor control device 302, the user only needs to break a barrier (e.g., Figure 2B The applicator cap 210 is then quickly delivered to the sensor control device 302 to the target monitoring location.

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

[0167] The electronic device housing 304 may include a shell 306 and a base 308 that can be matched with the shell 306. The shell 306 can be fixed to the base 308 via a variety of methods, such as snap-fit ​​engagement, interference fit, sonic welding, or one or more mechanical fasteners (e.g., screws). In some cases, the shell 306 can be fixed to the base 308 so that a sealed interface is generated therebetween. In such an embodiment, a gasket or other type of sealing material can be positioned at or near the outer diameter (periphery) of the shell 306 and the base 308, and the two parts are fixed together to compress the gasket and thereby generate a sealed interface. In other embodiments, an adhesive can be applied to the outer diameter (periphery) of one or both of the shell 306 and the base 308. The adhesive fixes the shell 306 to the base 308 and provides structural integrity, but can also seal the interface between the two parts and thereby isolate the interior of the electronic device housing 304 from external contamination. If the sensor control device 302 is assembled in a controlled environment, it may not be necessary to terminally sterilize the internal electrical components. In contrast, the adhesive connection 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 to Figure 2A Plug assembly 310 may be similar to plug assembly 207 of the electronic device housing 304. For example, plug assembly 310 may include a sensor module 312 (partially visible) that may be interconnected with a sharp object module 314 (partially visible). Sensor module 312 may be configured to carry and otherwise include sensor 316 (partially visible), and sharp object module 314 may be configured to carry and otherwise include sharp object 318 (partially visible) that is used to help deliver sensor 316 transcutaneously to the user's skin during application of sensor control device 302. As illustrated, corresponding portions of sensor 316 and sharp object 318 extend from electronic device housing 304, and more particularly extend from the bottom of base 308. An exposed portion of sensor 316 may be received within a hollow or recessed portion of sharp object 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 plug 402 is an isometric view and an exploded view 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 shown, a channel 406 may be defined as passing 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 that are configured to snap onto a connector provided on the electronic device housing 304 ( Figure 3A-3B ) in the corresponding feature on the bottom of the .

[0170] Sensor 316 includes tail 408, flag 410, and neck 412 interconnecting tail 408 and flag 410. Tail 408 can be configured to extend at least partially through passage 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 received percutaneously beneath the user's skin, and the chemical included thereon helps facilitate analyte monitoring in the presence of body 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. Figure 4A-4B 410 and the compliant carbon-impregnated polymer module(s) therein. The compliant carbon-impregnated polymer module(s) provide electrical contacts 420 (three shown) configured to connect between the sensor 316 and the electronic device housing 304 ( Figure 3A-3B ) provide conductive communication between corresponding circuit contacts within the sensor 316. The connector 404 may be made of silicone rubber and may 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] The sharps module 314 includes a sharp 318 and a sharps hub 422 that carries the sharps 318. The sharps 318 include an elongated shaft 424 and a sharps tip 426 at the distal end of the shaft 424. The shaft 424 can be configured to extend through the channel 406 and extend distally from the plug 402. In addition, the shaft 424 can include a hollow or recessed portion 428 that at least partially circumscribes the tail 408 of the sensor 316. The sharps tip 426 can be configured to penetrate the skin while carrying the tail 408 to contact the active chemical present on the tail 408 with the body fluid.

[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 the base 308 operate as opposing clamshell halves that enclose or otherwise substantially enclose the sensor control device 302 ( Figure 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, wherein 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 an antenna or otherwise communicate 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 ( Figure 4A-4B A battery 510 may also be housed within the electronic device housing 304 and is configured to power the sensor control device 302 .

[0178] exist Figure 5B In the embodiment, a plug receptacle 512 may be defined in the bottom of the base 308 and a plug assembly 310 ( Figure 4A-4B ) can be received and connected to the electronic device housing 304, thereby fully assembling the sensor control device 302 ( Figure 3A-3B ). Plug 402 ( Figure 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 with the deflectable arms 407 ( Figure 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 ( Figure 4A-4B ) is properly coupled to the electronic device housing 304, one or more circuit contacts 516 (three are shown) defined on the underside of the PCB 502 can be connected to the connector 404 ( Figure 4A-4B ) of the electrical contact 420 ( Figure 4A-4B ) for conductive connection.

[0179] Fig. 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 to the sensor applicator. More specifically, Figure 6A-6B Depicted is 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 may adversely affect the sensor 316. In at least one embodiment, for example, the back side of the seal 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 the present disclosure, and if Figure 6B As seen in FIG. 1 , 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 threadedly connected to the housing 208 and include a tamper ring 602. When the applicator cap 210 is rotated (e.g., unscrewed) relative to the housing 208, the tamper 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. Figure 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 of a variety of rigid materials. In some embodiments, for example, the housing 208 can be made of a thermoplastic polymer such as polyketone. In other embodiments, the housing 208 can be made of 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 of 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 a 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 can generally help support the sensor control device 302 when it is contained within the sensor applicator 102. In some embodiments, the collimator 606 can 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 can include 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 can be omitted from the packaging received by the user, but is otherwise used when the sensor applicator 102 is sterilized and prepared for delivery.

[0185] The collimator 606 can be designed to receive and help protect parts of the sensor control device 302 that need to be sterile and isolate the sterile components of the sensor applicator 102 from microbial contamination from other locations within the sensor control device 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 sharp object 318, such as extending from the bottom of the electronic device 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 the present disclosure.

[0186] When the sensor control device 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 sharp 318 can be positioned within a sealed area 610 at least partially defined by the sterile zone 608. The sealed area 610 is configured to isolate the sensor 316 and the sharp 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 be used alternatively, including but not limited to low energy X-ray radiation. In some embodiments, radiation sterilization 612 can be delivered by continuous treatment 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 time the radiation sterilization 612 is activated to provide a directed radiation pulse. Then, the radiation sterilization 612 is 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 sharp object 318. More specifically, the holes or passages in the sterilization area 608 allow the radiation to be transmitted to impinge on the sensor 316 and the sharp object 318 and sterilize them, while the remaining portion of the collimator 606 prevents (blocks) the propagating radiation from damaging or damaging the electronic components within the electronic device 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 frustoconical in shape. However, in other embodiments, the sterilization zone 608 can exhibit a polygonal cross-sectional shape, such as cubic, rectangular (e.g., including parallelograms), or pyramidal, without departing from the scope of the present disclosure.

[0190] In the illustrated embodiment, the sterilization zone 608 provides a first orifice 614a at a first end and a second orifice 614b at a second end opposite the first end. The first orifice 614a can be configured to receive the sensor 316 and the sharp object 318 into the sterilization zone 608, and the second orifice 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 smaller diameter 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 between about 0.5mm and about 3.0mm, and the size of the second orifice 614b may be in the range between about 5.0mm and about 16.0mm. However, as will be understood, without departing from the scope of the present 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 scope 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 be irradiated on the sensor 316 and the sharp object 318. In addition, in at least one embodiment, the sterilization zone 608 may be cylindrical in shape, wherein the first orifice 614a and the second orifice 614b exhibit the same diameter.

[0192] The body of the collimator 606 reduces or eliminates the radiation sterilization 612 from penetrating through the body material and thereby damaging the 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). An example material for the collimator 606 is polyethylene, but may alternatively include any material having a mass density similar to or greater than polyethylene. In some embodiments, for example, the material for the collimator 606 may 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 the collimator 606 can be altered so that the collimator 606 can be made of a material that has a mass density of less than 0.9 grams per cubic centimeter (g / cc), but still operates to reduce or eliminate radiation sterilization 612 from impinging on electronic components within the electronic device housing 304. To achieve this, in some embodiments, the size (e.g., length) of the collimator 606 can be increased so that the propagating electrons from the radiation sterilization 612 need to pass through a greater amount of material before potentially impinging on sensitive electronic devices. The greater amount of material can help absorb or dissipate the dose intensity of the radiation sterilization 612 so that it becomes harmless to sensitive electronic devices. However, in other embodiments, the opposite may be equally true. More specifically, the size (e.g., length) of the collimator 606 can be reduced as long as the material used for the collimator 606 exhibits a sufficiently large 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 when the sensor control device 302 is subjected to radiation sterilization 612. The shield 616 may be positioned, for example, 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 may otherwise damage sensitive electronic circuits of the data processing unit 618.

[0195] The shield 616 may be made of any material capable of blocking (or substantially blocking) the transmission of radiation. Suitable materials for the shield 616 include, but are not limited to, lead, tungsten, iron-based metals (e.g., stainless steel), copper, tantalum, tungsten, osmium, or any combination thereof. Suitable metals may be corrosion-resistant, austenitic, and any non-magnetic metal with a density ranging between about 5 grams per cubic centimeter (g / cc) and about 15 g / cc. The shield 616 may be manufactured via 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 include 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 include a housing that encapsulates (or substantially encapsulates) data processing unit 618.

[0197] In some embodiments, a collimator seal 620 may be applied to the end of the collimator 606 to seal the sterilization zone 608 and thus the sealing area 610. As illustrated, the collimator seal 620 may seal the second orifice 614b. The collimator seal 620 may 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 may be made of a radiation-permeable microbial barrier material that allows radiation to propagate through it. With the collimator seal 620 in place, the sealing area 610 is able to 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 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 fibers), such as those available from Obtained Highly durable and puncture resistant, yet steam permeable. Can be applied before or after radiation sterilization612 layer, and after radiation sterilization 612, can be The collimator seal 620 may be sealed (e.g., heat sealed) with a foil or other vapor and moisture resistant material 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 include only a single protective layer applied to the end of the collimator 606. In such embodiments, the single layer is gas permeable to the sterilization process, but once the sterilization process is completed, it is also able to protect from moisture and other harmful elements. Therefore, without departing from the scope of the present disclosure, the collimator seal 620 can operate as a moisture and contaminant layer.

[0199] Note that while the sensor 316 and sharp 318 extend from the bottom of the electronic device housing 304 and into the sterilization zone 608 that is generally concentric with the centerline of the sensor applicator 102 and the applicator cap 210, an eccentric arrangement is contemplated herein. More specifically, in at least one embodiment, the sensor 316 and sharp 318 may extend from the bottom of the electronic device housing 304 eccentric to 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 eccentrically positioned to receive the sensor 316 and sharp 318 without departing from the scope of the present 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 in 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 radiation sterilization 612 on the sensor 316 and sharps 318.

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

[0202] In some embodiments, the internal collimator 606 may 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 may be positioned adjacent to the external collimator and then subjected to the radiation sterilization 612, and the external collimator may prevent the radiation energy from damaging sensitive electronics within the electronics housing 304. Furthermore, in such embodiments, the sensor applicator 102 may be delivered to the user without the internal collimator 606 being positioned within the applicator cap 210, thereby eliminating the complexity of manufacturing and use.

[0203] Fig. 7A6 is an enlarged cross-sectional side view of the sensor control device 302 according to one or more embodiments, which is installed in the applicator cap 210. As indicated above, portions of the sensor 316 and the sharp object 318 can be arranged in the sealed area 610 and thereby isolated from external contamination. The sealed area 610 may include (surround) selected portions of the following: the interior of the electronic device housing 304 and the sterilization area 608 of the collimator 606. In one or more embodiments, the sealed area 610 can be defined by at least the first seal 702a, the second seal 702b, and the collimator seal 620 and otherwise formed by them.

[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. In addition, the first seal 702a can be circumscribed to the first central aperture 504 defined in the shell 306, so as to prevent 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 yet other embodiments, without departing from the scope of the present disclosure, the first seal 702a can include a separate structure inserted between the sharps hub 422 and the top surface of the shell 306, such as an O-ring or the like.

[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 seal 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 sterilization zone 608 of the collimator 606 and also prevent contaminants from migrating into the interior of the electronic device housing 304 via the plug receptacle 512 (or alternatively the second central aperture 506).

[0206] In some embodiments, the second seal 702b may form part of the collimator 606. For example, the second seal 702b may be overmolded onto the top of the collimator 606. In other embodiments, the second seal 702b may be overmolded onto the plug 402 or onto the bottom of the base 308. In still other embodiments, the second seal 702b may include a separate structure, such as an O-ring, etc., inserted between the collimator 606 and the bottom of the plug 402 or the 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 generate corresponding sealing interfaces. The first seal 702a and the second seal 702b can be made of a variety of materials that can generate a sealing interface between opposing structures. Suitable materials include, but are not limited to, silicone, thermoplastic elastomer (TPE), polytetrafluoroethylene (PTFE or ) 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 thus the bottom of the sealing area 610. Thus, the first seal 702a and the second seal 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 sealing area 610 containing 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 in 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 particularly 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 particularly, when the sensor control device 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. Such a dual biasing engagement compresses the first seal 702a both axially and radially, and thereby allows 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 may 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 may 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 may be omitted and the collimator 606 may be directly coupled to the electronic device housing 304. More specifically, in at least one embodiment, the collimator 606 may be threadedly coupled to the underside of the base 308. In such an embodiment, the collimator 606 may provide or otherwise define a threaded extension that is configured to cooperate with a threaded aperture defined in the bottom of the base 308. Threading the collimator 606 to the base 308 may seal the interface between the collimator 606 and the bottom of the electronic device housing 304, and thus operate to isolate the seal area 610. In addition, in such an embodiment, the pitch and specifications of the threads defined on the collimator 606 and the base 308 may match those of the threaded engagement between the applicator cap 210 and the sensor applicator 102. As a result, when the applicator cap 210 is threaded onto or unscrewed from the sensor applicator 102, the collimator 606 can be threaded onto or unscrewed from the electronics housing 404 accordingly.

[0212] Embodiments disclosed herein include:

[0213] A. An analyte monitoring system, the analyte monitoring system comprising: a sensor applicator; a sensor control device, which is positioned within the sensor applicator and includes: an electronic device housing; a sensor, which extends from the bottom of the electronic device housing; a sharps hub, which is positioned adjacent to the top of the electronic device housing; and a sharp, which is carried by the sharps hub and extends through the electronic device housing and extends from the bottom of the electronic device housing. The analyte monitoring system also includes: a cap, which is coupled to the sensor applicator; and a collimator, which is positioned within the cap and defines a sterilization zone, which receives the sensor and the sharp extending from the bottom of the electronic device housing.

[0214] B. 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 electronic device housing; a sensor extending from a bottom of the electronic device housing; a sharps hub positioned adjacent to a top of the electronic device housing; and a sharp carried by the sharps hub and extending through the electronic device housing and extending from the bottom of the electronic device 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 electronic device housing; sterilizing the sensor and sharp using radiation sterilization while they are positioned within the sterilization zone; and using the collimator to prevent radiation from the radiation sterilization from damaging electronic components within the electronic device housing.

[0215] C. 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 electronic device housing; a sensor extending from a bottom of the electronic device housing; a sharps hub positioned adjacent to a top of the electronic device housing; and a sharp carried by the sharps hub and extending through the electronic device housing and from the bottom of the electronic device 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 electronic device 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, truncated conical, cubic, rectangular, pyramidal, and any combination thereof. Element 3: wherein the sterilization zone is truncated conical 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 the bottom of the electronic device housing, and a seal is arranged at the second orifice. Element 4: also includes 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 of the electronic device housing and prevents contaminants from migrating into the portion of the interior of the electronic device housing via the central aperture, and wherein the second seal circumscribes an aperture defined in the bottom of the electronic device housing and prevents contaminants from migrating into the portion of the interior of the electronic device housing via the aperture. 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: further comprising: 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 a 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 mixed with a non-magnetic metal, and any combination thereof.

[0217] Element 10: Also includes 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 using a first seal to seal an interface between the sharps hub and the top of the electronic device housing, using a second seal to seal an interface between the collimator and the bottom of the electronic device housing, and using a third seal to seal an end of the sterilization zone. Element 12: Wherein, using the first seal to seal the interface between the sharps hub and the top of the electronic device housing includes using the first seal to provide one or both of an axial seal and a radial seal. Element 13: Wherein, the collimator includes an internal collimator, and sterilizing the sensor and the sharp using radiation sterilization also includes: positioning the sensor applicator adjacent to an external collimator disposed outside the sensor applicator; using the external collimator to focus radiation to be received by the internal collimator; and using the external collimator and the internal collimator to prevent radiation from damaging electronic components within the electronic device housing. 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 sharp object comprises introducing radiation into the sterilization zone via the second aperture. Element 15: wherein preventing radiation from radiation sterilization from damaging the electronic components comprises blocking the radiation using a material of the collimator. Element 16: wherein the printed circuit board is disposed within an electronic device housing and the data processing unit is mounted to the printed circuit board, the method further comprising protecting the data processing unit from radiation from the radiation sterilization process using a shield positioned within the electronic device housing.

[0218] Element 17: wherein positioning the sensor applicator adjacent to the collimator includes arranging the collimator such that it resides outside of 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 device 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 device 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 device 104, or any device requiring terminal sterilization, can be properly sterilized using an external sterilization assembly that is designed to focus sterilizing radiation (e.g., beam, wave, energy, etc.) toward the component parts that need to be sterilized while preventing the transmitted radiation from damaging or destroying sensitive electronic components.

[0223] Figure 8 800 according to one or more embodiments of the present disclosure. The exterior sterilization assembly 800 (hereinafter "assembly 800") can be designed and otherwise configured to assist in sterilizing a medical device 802. The medical device 802 can include, for example, Figure 1 The sensor control device 104 of the present invention 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 component parts. 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), a resistor, a transistor, a capacitor, an inductor, a diode, and a switch. However, in other embodiments, the radiation-sensitive component 808 may include a radiation-sensitive chemical solution or analyte, as described herein with reference to Fig.12 as described.

[0225] In some embodiments, part 806 may include a sensor extending from housing 804 (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 extend from another surface of housing 804. In at least one embodiment, part 806 may also include a sharp object, which may also need to be sterilized and may help implant the sensor under the user's skin. In some embodiments, as shown, part 806 may be encapsulated with a cap 812 that provides a sealing barrier that protects exposed portions of part 806 (e.g., the sensor and associated sharp object) until part 806 is needed for use.

[0226] The medical device 802 may be subjected to radiation sterilization 814 to properly sterilize the part 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 a cap 812, the cap 812 may be made of a material that allows radiation 814 to propagate through it, so as to facilitate radiation sterilization of the part 806. Suitable materials for the 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 polymers, etc.), epoxy resins, or any combination thereof. In some embodiments, the cap 812 may be transparent or translucent, but may be opaque in other cases without departing from the scope of the present 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 propagating radiation 814 from damaging or destroying the radiation sensitive component 808. To accomplish this, the radiation shield 816 may provide 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 that is 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 focusing radiation 814 (e.g., beam, wave, energy, etc.) toward part 806, radiation shield 816 can be made of a material that reduces or eliminates radiation 814 from penetrating therethrough and thereby damaging radiation sensitive components 808 within housing 804. In other words, radiation shield 816 can be made of a material with a density sufficient 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, the mass density of suitable materials can be less than 0.9 g / cc without departing from the scope of the present disclosure. Suitable materials for 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 yet 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 orifice 822a and a second orifice 822b, wherein the first orifice 822a and the second orifice 822b are defined at opposite ends of the sterilization zone 820. The first orifice 822a can allow the radiation 814 to enter the sterilization zone 820 and impinge on the part 806, and the second orifice 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 orifice 822b can have a smaller diameter than the diameter of the first orifice 822a. In such embodiments, for example, the size of the second orifice 822b can be in the range between about 0.5 mm and about 3.0 mm, and the size of the first orifice 822a can be in the range between about 5.0 mm and about 16.0 mm. However, as will be appreciated, the respective diameters of the first aperture 822a and the second aperture 822b may 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 may be scaled to the device size and need only be large enough to allow a sufficient dose of radiation to be impinged upon the part 806. Additionally, in at least one embodiment, the collimator 818 may 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 may also include a barrier shield 824 positioned within the housing 804. The barrier shield 824 may be configured to help block radiation 814 (e.g., electrons) from propagating within the housing 804 toward the radiation sensitive components 808. The barrier shield 824 may 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 may alternatively be positioned at any other angle configuration suitable for protecting the radiation sensitive components 808.

[0232] Fig. 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 used in some aspects with Figure 8 900 is similar to, and therefore may be best understood with reference to, assembly 800 of , wherein like reference numerals will refer to like parts 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 housing 904, parts 906 to be sterilized, and one or more radiation-sensitive components 908 positioned within housing 904. Housing 904 may include a package or housing containing parts 906 and (one or more) radiation-sensitive components 908. (One or more) radiation-sensitive components 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 the embodiment of the present invention, the radiation shield 910 may provide a collimator 914, which generally includes a hole or passage 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 sterilization 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] In order to properly sterilize the part 906, the sterilizing radiation 814 may be directed toward the medical device 902. The collimator 914 and the sterilizing zone 916 may 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] Fig.10 1 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 Fig.15 1000 is similar to 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 assembly 900, assembly 1000 may be designed and otherwise configured to aid in sterilizing medical device 1002. In the illustrated embodiment, medical device 1002 may include a Figure 1 The sensor control device 104 is similar to the sensor control device of the present invention, but may alternatively include the sensor control device described herein with respect to Figure 8 The medical device 802 refers to any medical device mentioned above.

[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 (one or more) radiation-sensitive components 808. In some embodiments, part 1006 may include a sensor extending from housing 1004 (e.g., Figure 1 The sensor 110) 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 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 provided as described above with respect to Figure 8 The radiation shield 816 is made of any of the materials 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 inner 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 inner 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 into the cavity 1012. The collimator 1014 can define a sterilization zone 1016 that focuses the radiation 814 toward the part 1006 for sterilization.

[0241] In order to properly sterilize the part 1006, the sterilizing radiation 814 may be directed toward the medical device 1002. The collimator 1014 and the sterilizing zone 1016 may 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] Fig.11 1 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 , Fig. 9 and Fig.10 1000 are similar to, and therefore may be best understood with reference to, assemblies 800, 900, and 1000 of the present invention. Similar to assemblies 800-1000, assembly 1100 may be designed and otherwise configured to aid in sterilizing a medical device 1102. In the illustrated embodiment, medical device 1102 may include a two-piece sensor control device, but may alternatively include any of the medical devices mentioned herein with respect to medical device 802.

[0243] As shown, the medical device 1102 includes a housing 1104, a part 1106 to be sterilized, and one or more radiation-sensitive components 1108 positioned within the housing 1104. The radiation-sensitive component(s) 1108 may include any of the components described herein. Figure 8 Any electronic module mentioned above 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 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 provided as described above with respect to Figure 8 The radiation shield 816 is made of any of the materials mentioned to reduce or eliminate radiation 814 from penetrating therethrough and thereby damaging the radiation sensitive component(s) 1108 .

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

[0246] In some embodiments, the assembly 1100 may also 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, materials 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. 11 , 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 typically includes a hole or passage extending at least partially through the first portion 1112a of the radiation shield 1110, and the second collimator 1118b typically includes a hole or passage extending at least partially through the second portion 1112b. Each collimator 1118a, 1118b provides an entrance into the inner cavity 1114, and the collimators 1118a, 1118b cooperatively define a sterilization zone 1120 that includes the inner cavity 1114 and helps focus the radiation 814 toward the part 1106 for sterilization.

[0248] To properly sterilize the part 1106, the medical device 1102 may be positioned within the interior cavity 1114, and the opposing portions 1112a, 1112b may be mated to encapsulate the medical device 1102. Once properly positioned within the cavity 1114, the medical device 1102 may be positioned within the sterilization zone 1120. The radiation sterilization 814 may then be directed at the medical device 1102 on opposite sides of the radiation shield 1110, and the collimators 1118a, 1118b may concentrate and / or focus the radiation sterilization 814 toward the part 1106 on opposite sides of the part 1106. The remaining portions of the radiation shield 1110 prevent (block) the propagating radiation 814 from damaging the radiation sensitive component(s) 1108 within the 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 (e.g., electrons) from propagating within housing 1104 toward radiation-sensitive component(s) 1108.

[0250] Fig.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") may be designed and otherwise configured to assist in sterilizing a medical device 1202, which in the illustrated embodiment includes a hypodermic needle or syringe. As illustrated, medical device 1202 includes 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 may include a chemical solution or analyte (e.g., an active agent, a drug, a biologic, etc.) that may be sensitive to radiation, and part 1206 may include a needle designed to deliver the chemical solution.

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

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

[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 cap 812 is the same as mentioned above.

[0254] In some embodiments, assembly 1200 may also include a barrier shield 824 positioned to help block radiation 814 (e.g., electrons) from propagating within housing 1204 toward radiation-sensitive component 1208 (e.g., chemical solution). In the illustrated embodiment, barrier shield 824 may define or otherwise provide a central aperture 1220 configured to allow radiation-sensitive component 1208 to exit housing 1204 via feature 1206 (e.g., needle). In other embodiments, barrier shield 824 may provide a tortuous path that allows radiation-sensitive component 1208 to exit housing 1204 via feature 1206.

[0255] Fig.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 control device 104 and can therefore be used with 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. Figure 8-Figure 12 The sensor control device 1302 may also require proper sterilization before use.

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

[0257] The electronic device housing 1304 may include a shell 1306 and a base 1308 that can cooperate with the shell 1306. The shell 1306 can be fixed to the base 1308 via a variety of ways, such as snap-fit ​​engagement, interference fit, sonic welding, one or more mechanical fasteners (e.g., screws) or any combination thereof. In some cases, the shell 1306 can be fixed to the base 1308 so that a sealed interface is generated therebetween. In such an embodiment, a gasket or other type of sealing material can be positioned at or near the outer diameter (periphery) of the shell 1306 and the base 1308, and the two components are fixed together to compress the gasket and thereby generate a sealed interface. In other embodiments, an adhesive can be applied to the outer diameter (periphery) of one or both of the shell 1306 and the base 1308. The adhesive fixes the shell 1306 to the base 1308 and provides structural integrity, but can also seal the interface between the two components and thereby isolate the interior of the electronic device housing 1304 from external contamination.

[0258] In the illustrated embodiment, the sensor control device 1302 may also include a plug assembly 1310 that can be coupled to the electronic device housing 1304. The plug assembly 1310 may include a sensor module 1312 (partially visible) that can be interconnected with a sharps module 1314 (partially visible). The sensor module 1312 may be configured to carry and otherwise include a sensor 1316 (partially visible), and the sharps module 1314 may be configured to carry and otherwise include a sharp 1318 (partially visible) that is used to assist in transcutaneously delivering the sensor 1316 to beneath the user's skin during application of the sensor control device 1302. The sharps module 1314 may include a sharps hub 1320 that carries the sharps 1318.

[0259] As illustrated, corresponding portions of sensor 1316 and sharp object 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 sharp object 1318. The remainder of sensor 1316 is positioned within the interior of electronic device housing 1304.

[0260] Fig.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 an anti-tampering ring 1406. When the applicator cap 1404 is rotated (e.g., unscrewed) relative to the housing 1402, the anti-tampering 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 ( Fig.13 and Fig. 14B ) is positioned at a 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] Fig. 14B14 is 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 may include one or more radiation-sensitive components 1408 disposed within the electronic device housing 1304. The radiation-sensitive component 1408 may 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 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 1302. In operation, the data processing unit may perform data processing functions, such as filtering and encoding of data signals corresponding to the sampled analyte levels of the user. The data processing unit may also include an antenna or otherwise communicate with an antenna for communicating with the reader device 106 ( Figure 1 ) communication.

[0263] In the illustrated embodiment, the 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 include 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 include a separate structure that fits within or is otherwise attached to the applicator cap 1404 without departing from the scope of the present disclosure.

[0264] The sensor control device 1302 and more particularly the distal end of the sensor 1316 and sharp object 1318 extending from the bottom of the electronic device housing 1304 can be sterilized while positioned within the sensor applicator 102. More specifically, the fully assembled sensor control device 1302 can be subjected to radiation sterilization 1412, which can be combined with the Figure 8-Figure 12 The radiation sterilization 1412 is similar to the radiation sterilization 814 of FIG. The radiation sterilization 1412 can be delivered by continuous treatment 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 time the radiation is activated to provide a directed pulse of radiation. Then, the radiation sterilization 1412 is 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 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 that is configured to help focus the radiation 1412 (e.g., beam, wave, energy, etc.) toward the components 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 parts to be sterilized. As illustrated, the cap filler 1410 can define a radial shoulder 1422 that is sized to receive the end of the radiation shield 1416 and otherwise cooperate with it, 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 the present disclosure.

[0267] The external collimator 1418 and the internal collimator 1420 can cooperatively define a sterilization 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 propagated radiation 1412 can traverse the sterilization zone 1424 to impinge on the sensor 1316 and the sharp object 1318 and sterilize them. However, the cap filler 1410 and the radiation shield 1416 can each be made of such materials that these materials substantially prevent the radiation 1412 from penetrating the (one or more) inner walls of the sterilization zone 1424 and thereby damaging the radiation sensitive components 1408 within the housing 1304. In other words, the cap filler 1410 and the radiation shield 1416 can each be made of a material having a density sufficient 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 may be altered so that one or both of cap fill 1410 and radiation shield 1416 may be made of a material having a mass density of less than 0.9 g / cc, but 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 may be increased so that propagating electrons from radiation sterilization 1412 need to pass through a greater amount of material before potentially impinging on radiation sensitive components 1408. A greater amount of material may help absorb or dissipate the dose intensity of radiation 1412 so that it becomes harmless to sensitive electronic devices. However, in other embodiments, the opposite may be equally true. More specifically, the size (e.g., length) of sterilization zone 1424 may be reduced so long as the materials used for cap fill 1410 and / or radiation shield 1416 exhibit a sufficiently large 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 frustoconical in shape. However, in other embodiments, without departing from the scope of the present disclosure, one or both of the external collimator 1418 and the internal collimator 1420 may exhibit a polygonal cross-sectional shape, such as a cube, a rectangle (e.g., including a parallelogram), or a pyramid. In yet other embodiments, one or both of the external collimator 1418 and the internal collimator 1420 may 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 strike 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 the embodiment where the sterilization zone 1424 is conical or truncated conical in shape, the diameter of the first orifice 1426a can be greater than the diameter of the second orifice 1426b. In such an embodiment, for example, the size of the first orifice 1426a can be in the range between about 5.0mm and about 16.0mm, and the size of the second orifice 1426b can be in the range between about 0.5mm and about 3.0mm. However, the corresponding diameters of the first orifice 1426a and the second orifice 1426b can be greater than or less than the range provided herein without departing from the scope of the present disclosure, and depending on the application. In fact, 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 an embodiment, a portion of the wall can extend a short distance at an angle different from an adjacent portion, or the wall can otherwise rise and fall 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 radiation-permeable microbial barrier. In some embodiments, for example, the cap seal 1428 can be made of a synthetic material (e.g., flash-spun high-density polyethylene fibers), such as from Available Cap seal 1428 may seal a portion of sterilization zone 1424 to help form a portion of a sealed area 1430 that is configured to isolate sensor 1316 and sharps 1318 from external contamination.

[0275] The sealing area 1430 may 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 may be defined by and otherwise formed of at least the cap seal 1428, the first or "top" seal 1432a, and the second or "bottom" seal 1432b. The cap seal 1428 and the top seal 1432a and the bottom seal 1432b may each form a corresponding barrier at their respective sealing locations, thereby allowing the sterilization zone 1424 containing the sensor 1316 and the sharp object 1318 to be terminally sterilized.

[0276] The top seal 1432a can be arranged to seal the sharps hub 1320 with the top (ie, Fig.13 The top seal 1432a can be formed as 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 be formed as 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, etc., inserted between the sharps hub 1320 and the top surface of the shell 1306 without departing from the scope of the present disclosure.

[0277] The bottom seal 1432b can be arranged to seal the cap filler 1410 with the bottom of the electronic device housing 1304 (ie, Fig.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, without departing from the scope of the present disclosure, the bottom seal 1432b can include a separate structure, such as an O-ring, etc., inserted between the cap filler 1410 and the bottom of the base 1308.

[0278] When the sensor control device 1302 is loaded into the sensor applicator 102 and the applicator cap 1404 is secured to the sensor applicator 102, the top seal 1432a and the bottom seal 1432b can be compressed and generate corresponding sealing interfaces. The top seal 1432a and the bottom seal 1432b can be made of a variety of materials that can generate a sealing interface between opposing structures. Suitable materials include, but are not limited to, silicone, thermoplastic elastomers (TPE), polytetrafluoroethylene (e.g., ) or any combination thereof.

[0279] Note that while the sensor 1316 and sharp 1318 extend from the bottom of the electronic device housing 1304 and into the sterilization zone 1424 that 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 1318 may extend from the bottom of the electronic device housing 1304 eccentric 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 eccentrically positioned to receive the sensor 1316 and sharp 1318 without departing from the scope of the present disclosure.

[0280] In some embodiments, the external sterilization assembly 1414 may also include a sterilization housing or "pod" 1434 coupled to or forming a portion of the radiation shield 1416. The sterilization pod 1434 provides and otherwise defines a chamber 1436 that is 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 the sharps 1318. The sterilization pod 1434 may be made of any of the materials mentioned herein for the radiation shield 1416 to help prevent the radiation 1412 from propagating through the walls of the sterilization pod 1434.

[0281] In some embodiments, the radiation shield 1416 may be removably coupled to the sterilization chamber 1434 using one or more mechanical fasteners 1438 (one shown), but may 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 may 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 desired.

[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 chamber 1434. The sterilization chamber 1434 may be removably coupled to the mounting tray 1440 using, for example, one or more mechanical fasteners 1442 (one is shown). The mounting tray 1440 may provide or define a central aperture 1444 that is sized to receive the sensor applicator 102 and may be aligned with the chamber 1436 to enable the sensor applicator 102 to enter the chamber 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] Fig.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 may be inverted and may define or otherwise provide a cap post 1502 that is sized to receive the distal ends of the sensor 1316 and sharp 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 sharp 1318 from external contamination. In the illustrated embodiment, the sealing area 1430 may be defined and otherwise formed by the cap post 1502 and the top seal 1432a and the bottom seal 1432b, which form corresponding barriers at their respective sealing locations. The top seal 1432a may again be arranged to seal the sharps hub 1320 from the top (i.e., Fig.13 The interface between the applicator cap 1404 and the electronic device housing 1306), and the bottom seal 1432b can be arranged to seal the applicator cap 1404 and the bottom of the electronic device housing 1304 (ie, Fig.13 In some embodiments, the bottom seal 1432b can be inserted between the cap column 1502 and the bottom of the electronic device housing 1304.

[0285] In the illustrated embodiment, the radiation shield 1416 can be positioned outside 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 the sharp 1318. In the illustrated embodiment, the cap post 1502 and portions of the sensor 1316 and the sharp 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 the sharp 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 region 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 zone 1504 and a second aperture 1506b at a second end of the sterile zone 1504. The first aperture 1506a allows radiation 1412 to enter the sterile zone 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 may also provide a location at which the sensor 1316 and the sharp 1318 positioned within the cap post 1502 may be received into the sterile zone 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 between about 5.0mm and about 16.0mm, and the size of the second orifice 1506b can be in the range between about 0.5mm and about 3.0mm, but can be alternatively greater than or less than the provided range without departing from the scope of the present disclosure. In fact, the size of the orifices 1506a, 1506b can vary according to the scale of the device. However, in other embodiments, the external collimator 1418 and the associated sterilization zone 1504 can be substantially cylindrical and otherwise 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] Fig.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 sharp object 1318 extending from the bottom of the electronic device 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 Fig.15 Unlike the cap column 1502 of the embodiment of the present invention, 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 connected to the cap column 1602. Fig. 14B The cap seal 1428 is similar and therefore will not be described again.

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

[0291] The outer collimator 1418 and the inner collimator 1608 can cooperatively define a sterilization zone 1610 that focuses radiation 1412 toward the sensor 1316 and the sharp object 1318. The propagated 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 frustoconical 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 the following: a first orifice 1612a that allows radiation 1412 to enter the sterilization zone 1610; and a second orifice 1612b that is positioned at or near the bottom opening to the cap column 1602 to focus the radiation 1412 at the sensor 1316 and the sharp object 1318 positioned within the cap column 1602. The diameter of the first orifice 1612a is greater than the diameter of the second orifice 1612b, and as with the previous embodiment, the size of the first orifice 1612a can be in the range between about 5.0 mm and about 16.0 mm, and the size of the second orifice 1612b can be in the range between about 0.5 mm and about 3.0 mm. In the illustrated embodiment, the external collimator 1418 collects the electrons of the radiation 1412 toward the bottom opening of the cap column 1602 and amplifies the electrons at the sensor 1316 and the sharp object 1318.

[0294] The cap seal 1604 may be disposed at the interface between the radiation shield 1416 and the cap post 1602 and / or the cap filler 1606. The cap seal 1604 may seal 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 sharp object 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, which form corresponding barriers at their respective sealing locations. The bottom seal 1432b may be arranged to seal the applicator cap 1404 with the bottom of the electronic device housing 1304 (i.e., Fig.13 The interface between the base 1308).

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

[0296] In some embodiments, assembly 1414 may also include a cover 1702 that may be mated with mounting tray 1440. Cover 1702 may include or define a plurality of apertures 1106 ( Fig. 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 component, comprising: a radiation shield that can be positioned outside a medical device, the medical device having parts that need to be sterilized and radiation-sensitive parts; and a collimator that is defined by the radiation shield and can be aligned with the parts that need to be sterilized, wherein the collimator focuses radiation from a radiation sterilization process toward the parts that need to be sterilized, and the radiation shield prevents the radiation from damaging the radiation-sensitive parts.

[0299] E. An external sterilization assembly, the 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: focusing radiation from a radiation sterilization process toward the sensor and the sharp using an external collimator defined by the radiation shield; and preventing radiation from damaging the radiation sensitive component using the radiation shield.

[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 components are 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 truncated cone, a pyramid, a circle, a cube, a rectangle, and any combination thereof. Element 4: also includes a cap that encapsulates the parts that need to be sterilized and provides a sealing barrier. Element 5: wherein the radiation shield defines an inner cavity that receives the medical device, and the collimator focuses radiation into the inner 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 truncated cone, 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 that is alignable with the chamber and sized to receive the sensor applicator; and a cover that is cooperable 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 in which the sensor and the sharp are received. Element 11: wherein the external collimator and the internal collimator each include a cross-sectional shape selected from the group consisting of: conical, truncated conical, pyramidal, circular, cubic, rectangular, and any combination thereof. Element 12: further comprising a cap seal disposed at an interface between the external collimator and the internal collimator. Element 13: wherein the cap is inverted and a cap post is provided for receiving a sensor and a sharp object. Element 14: wherein the external collimator and the cap post cooperatively define a sterilization zone, and the sensor and sharp object positioned within the cap post extend into the sterilization zone.

[0303] Element 15: wherein arranging the radiation shield outside the sensor applicator includes 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 also includes: 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 includes a cross-sectional shape selected from the group consisting of: conical, truncated conical, 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] Mixing sterilization components

[0306] Again briefly refer to Figure 1Before the sensor control device 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 device 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 device 104, or any device requiring terminal sterilization, can be properly sterilized using an external sterilization assembly that is designed to focus sterilizing radiation (e.g., beam, wave, energy, etc.) toward the component parts that need to be sterilized while preventing the transmitted radiation from damaging or destroying sensitive electronic components.

[0308] Fig.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 control device 104 and can therefore be used with the sensor applicator 102 ( Figure 1 ) is used in combination 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, the sensor control device 1802 includes an electronic device housing 1804 that is generally disc-shaped and may have a circular cross-section. However, in other embodiments, the electronic device housing 1804 may exhibit other cross-sectional shapes, such as oval (e.g., pill-shaped or egg-shaped), spherical, polygonal, or any combination thereof, without departing from the scope of the present disclosure. The electronic device housing 1804 may be configured to house or otherwise contain various electronic components for operating the sensor control device 1802.

[0310] The electronic device housing 1804 may include a shell 1806 and a base 1808 that can cooperate with the shell 1806. The shell 1806 can be fixed to the base 1808 via a variety of methods, such as snap-fit ​​engagement, interference fit, sonic or laser welding, one or more mechanical fasteners (e.g., screws) or any combination thereof. In some cases, the shell 1806 can be fixed to the base 1808 so that a sealed interface is generated therebetween. In such embodiments, a gasket or other type of sealing material can be positioned at or near the outer diameter (periphery) of the shell 1806 and the base 1808, and the two components are fixed together to compress the gasket and thereby generate a sealed interface. In other embodiments, an adhesive can be applied to the outer diameter (periphery) of one or both of the shell 1806 and the base 1808. The adhesive fixes the shell 1806 to the base 1808 and provides structural integrity, but can also seal the interface between the two components and thereby isolate the interior of the electronic device housing 1804 from external contamination.

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

[0312] As illustrated, corresponding portions of sensor 1816 and sharp object 1818 extend distally from electronic device housing 1804, and more particularly extend distally 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 sharp object 1818. The remainder of sensor 1816 is positioned within the interior of electronic device housing 1804.

[0313] Fig.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 an anti-tampering ring 1906. When the applicator cap 1904 is rotated (e.g., unscrewed) relative to the housing 1902, the anti-tampering 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 ( Fig.18 ) is positioned at a target monitoring location on the user's body.

[0314] Fig.19B 1904. As illustrated, the sensor control device 1802 may be received within the sensor applicator 102, and the applicator cap 1904 may be coupled to the housing 1902 to secure the sensor control device 1802 therein. The sensor control device 1802 may include one or more radiation-sensitive components 1908 disposed within the electronic device housing 1804. The radiation-sensitive component 1908 may 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 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 1802. In operation, the data processing unit may perform data processing functions, such as filtering and encoding of data signals corresponding to the sampled analyte levels of the user. The data processing unit may 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, the 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 include an integral portion or extension of the applicator cap 1904, such as molded with or overmolded onto the applicator cap 1904. In other embodiments, the applicator insert 1910 can include 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 axially securing the applicator insert 1910 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 sliding the radial alignment features 1916 longitudinally 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 features 1916 instead being provided on the sheath 1914 and the slots 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 device 1802 is installed in the sensor applicator 102, the distal ends of the sensor 1816 and the sharp object 1818 can extend from the bottom of the electronic device 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 the distal end of sensor 1816 and sharp object 1818 from external contamination. Microbial barrier 1926a can be made of a radiation transparent material, such as a synthetic material (e.g., flash spun high density polyethylene fiber). An example synthetic material includes Available However, in other embodiments, microbial barrier 1926a may include, but is not limited to, tape, paper, film, foil, or any combination thereof. In at least one embodiment, microbial barrier 1926a may include or otherwise be formed by a thinned portion of applicator insert 1910 without departing from the scope of the present disclosure.

[0319] In some embodiments, moisture barrier 1926b may be positioned or otherwise arranged at opening 1928 to applicator cap 1904. Similar to microbial barrier 1926a, moisture barrier 1926b may be configured to help isolate portions of sensor applicator 102 from external contamination. Moisture barrier 1926b may be made of any of the materials mentioned above with reference to microbial barrier 1926a. However, in at least one embodiment, without departing from the scope of the present disclosure, moisture barrier 1926b may include a thinned portion of applicator cap 1904. 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, Fig. 20A is an isometric top view of the applicator insert 1910, Fig. 20B is an isometric bottom view of the applicator insert 1910, and Fig. 20C 1 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. Fig.19B ) and sharp objects 1918( Fig.19B ), the top end 2004a is normally closed and the bottom end 2004b is normally 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 ( Fig.19B ) to assist in positioning the sensor control device 1802 ( Fig.19B ) to angularly (rotationally) orient the applicator insert 1910. Furthermore, similar to the arrangement of the radial alignment features 1916, the matable structure of the additional radial alignment features 2006 may alternatively be reversed, wherein the additional radial alignment features 2006 are alternatively provided on the sheath 1914 and the corresponding protrusions or tabs are provided on the applicator insert 1910.

[0322] As in Fig. 20A and Fig. 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 ( Fig.19B ) relative to the sensor control device 1802 ( Fig.19B ) to properly orient the applicator insert 1910. As illustrated, the 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 includes a cylindrical protrusion, but may alternatively include other types of structural features suitable for mating with corresponding features on the bottom of the sensor control device 1802. The sensor locating feature 2012, in combination with the radial alignment feature 1916 and the additional radial alignment feature 2006, may prove particularly advantageous in embodiments in which the sensor control device 1802 includes an eccentric 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. Fig. 20CAs best seen in FIG. 1 , the internal collimator 1920a can be defined by the applicator insert 1910 and can include a collimator insert 2014 and a gasket 2016. The internal collimator 1920a can be manufactured by first manufacturing or otherwise producing the collimator insert 2014. The applicator insert 1910 can then be overmolded onto the collimator insert 2014. Moreover, the collimator insert 2014 can be insert molded into the applicator insert 1910. Thus, the applicator insert 1910 can be made of a hard plastic. The gasket 2016 can then be molded onto the applicator insert 1910 in a second shot molding (overmolding) process.

[0324] The alignment insert 2014 may be made of a material that reduces or prevents the sterilizing radiation from penetrating therethrough. Suitable materials for the alignment 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 alignment insert 2014 may 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 in the sensor applicator 102 ( Fig.19B ) when helping with the electronic device housing 1804 ( Fig.19B ) to form a sealing interface with the bottom. Suitable materials for gasket 2016 include, but are not limited to, silicone, thermoplastic elastomer (TPE), polytetrafluoroethylene (e.g., ) or any combination thereof. As illustrated, the gasket 2016 can fill the gap 2018 defined by the applicator insert 1910 and can provide an annular protrusion 2020 that protrudes beyond the upper surface of the top 2004a of the body 2002 and / or protrudes from the upper surface of the top 2004a of the body 2002. The annular protrusion 2020 can prove to be advantageous not only in promoting a sealing interface, but also in helping to absorb tolerances when the applicator insert 1910 is installed in the sensor applicator 102. In addition, the mass of the gasket 2016 can also help absorb radiation during the sterilization process described below, thereby providing another layer of protection to prevent radiation transmission. In at least one embodiment, the gasket 2016 can be large enough or of a material that absorbs enough radiation so that the collimation insert 2014 can be omitted from the internal collimator 1920a.

[0326] Fig.21 According to one or more embodiments of the present disclosure Fig.19A1804, and the like. The sensor applicator 102 is another cross-sectional side view showing the 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 assist in sterilizing the sensor control device 1802 and more particularly the distal ends of the sensor 1816 and sharps 1818 extending from the bottom of the electronic device housing 1804 while they are positioned within the sensor applicator 102. More specifically, the fully assembled sensor control device 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] The radiation sterilization 2104 can be delivered by either continuous treatment radiation or by pulsed beam radiation. In pulsed beam radiation, the beam of the 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 time the radiation is activated to provide a directed 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 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 previously described above and the external collimator 1920b. As illustrated, the internal collimator 1920a can be arranged in the sensor applicator 102, and the external collimator 1920b can extend into the sensor applicator 102 (i.e., the applicator cap 1904) by penetrating the 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 sharp object 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 cooperate 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 the present 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 the radiation 2104 from penetrating the inner wall(s) of the sterilization zone 1922 and thereby damaging the radiation sensitive components 1908 within the electronic device housing 1804. Thus, the external collimator 1920b can be made of any material mentioned herein as being 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. In addition, however, as mentioned above, the gasket 2016 can also provide a degree of shielding or protection to prevent radiation from damaging the radiation sensitive components 1908.

[0331] The sterilization zone 1922 defined by the internal collimator 1920a and the external 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 internal collimator 1920a and the external collimator 1920b are both conical or frustoconical in shape. However, in other embodiments, without departing from the scope of the present disclosure, one or both of the internal collimator 1920a and the external collimator 1920b can exhibit a polygonal cross-sectional shape, such as a cube, a rectangle (e.g., including a parallelogram) or a pyramid. In yet other embodiments, one or both of the internal collimator 1920a and the external collimator 1920b can exhibit a circular cross-sectional shape with parallel sides.

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

[0333] In the embodiment where the sterilization zone 1922 is conical or truncated conical in shape, the diameter of the first orifice 2108a can be greater than the diameter of the second orifice 2108b. In such an embodiment, for example, the size of the first orifice 2108a can be in the range between about 5.0mm and about 16.0mm, and the size of the second orifice 2108b can be in the range between about 0.5mm and about 5.0mm. However, the corresponding diameters of the first orifice 2108a and the second orifice 2108b can be greater than or less than the range provided herein without departing from the scope of the present disclosure, and depending on the application. In fact, 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 may exhibit the same diameter. In such embodiments, the walls of the sterilization zone 1922 may or may not be substantially parallel between the first and second ends of the sterilization zone 1922.

[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 an embodiment, a portion of the wall can extend a short distance at an angle different from an adjacent portion, or the wall can rise and fall between the first orifice 2108a and the second orifice 2108b.

[0336] Microbial barrier 1926a can be installed at the interface between inner collimator 1920a and outer collimator 1920b and otherwise positioned at or near radial shoulder 2106. Microbial barrier 1926a can be present during the radiation sterilization process. As indicated above, microbial barrier 1926a can help seal at least a portion of sterilization zone 1922. More particularly, microbial barrier 1926a can seal a portion of sterilization zone 1922 to help form a portion of sealed area 2110, which is configured to isolate sensor 1816 and sharp objects 1818 from external contamination. Sealed area 2110 may include (surround) selected portions of the following: the interior of electronic device housing 1804 and sterilization zone 1922. In one or more embodiments, sealed area 2110 may be defined and otherwise formed by at least microbial barrier 1926a, first or "top" seal 2112a and second or "bottom" seal 2112b. The microbial barrier 1926a and the top and bottom seals 2112a, 2112b can each form a corresponding barrier 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, Fig.18 The top seal 2112a can be formed as 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 be formed as 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, etc., inserted between the sharps hub 1820 and the top surface of the shell 1806 without departing from the scope of the present disclosure.

[0338] The bottom seal 2112b may include a gasket 2016 ( Fig. 20C ), and more particularly includes an annular protrusion 2020 ( Fig. 20A and Fig. 20C In operation, bottom seal 2112b may be arranged to seal applicator insert 1910 with the bottom of electronic device housing 1804 (ie, Fig.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 device 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 that are capable of creating a sealing interface between opposing structures. Suitable materials include, but are not limited to, silicone, thermoplastic elastomers (TPE), polytetrafluoroethylene (e.g., ) 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 fixed 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, etc.

[0341] In some embodiments, electronic device housing 1804 may be filled with potting material 2114 that fills the void within sensor control device 1802. Potting material 2114 may include a biocompatible material that meets the requirements of ISO 10993. In some embodiments, for example, potting material 2114 may include urethane (such as, 3672) or silicone materials (such as those available from In other embodiments, the encapsulation material 2114 may include an acrylate adhesive material, such as that available from Obtained GE4949.

[0342] The potting material 2114 may also serve as an additional safety barrier for absorbing or deflecting the propagating radiation 2104. In at least one embodiment, for example, the potting material 2114 may exhibit an electron beam resistance of at least 85 kGy. Thus, instead of passing through the air that is typically present within the electronic device housing 1804, it may be necessary for the radiation 2104 to pass through the potting material 2114 before impinging on (one or more) radiation sensitive components 1908. Although the potting material 2114 may not include a high-density material, it may still serve as another level of radiation shielding. In addition, the potting material 2114 may also increase the robustness of the sensor control device 1802 and the electronic device housing 1804. Thus, if desired, the use of the potting material 2114 may allow the electronic device housing 1804 to be made of thinner materials.

[0343] Note that while the sensor 1816 and sharp 1818 extend from the bottom of the electronic device housing 1804 and into the sterilization zone 1922 that is generally concentric with the centerline of the sensor applicator 102 and the applicator cap 1904, an eccentric arrangement is contemplated herein. More specifically, in at least one embodiment, the sensor 1816 and sharp 1818 may extend from the bottom of the electronic device housing 1804 eccentric to the centerline of the sensor applicator 102 and the applicator cap 1904. In such an embodiment, the internal collimator 1920a and the external collimator 1920b may be redesigned and otherwise configured such that the sterilization zone 1922 is also eccentrically positioned to receive the sensor 1816 and sharp 1818 without departing from the scope of the present disclosure.

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

[0345] Embodiments disclosed herein include:

[0346] H. A sensor applicator, the sensor applicator comprising: a housing having a sensor control device disposed therein, the sensor control device including a sensor, a sharp, and a radiation-sensitive component; an applicator cap removably connected to the housing; an applicator insert positionable within the applicator cap and defining an internal collimator for receiving a distal end of 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 for sterilizing a sensor control device, the method comprising: positioning a sensor control device within a housing of a sensor applicator, the sensor control device including a sensor, a sharp, and a radiation-sensitive component; receiving distal ends of the sensor and the sharp within an internal collimator defined by an applicator insert; removably connecting 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 collaboratively focus radiation from a radiation sterilization process toward the sensor and the 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 extending 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 the 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 cooperating with one or more corresponding features provided on the sheath to rotationally orient the applicator insert relative to the sensor control device. Element 3: further comprising one or more sensor positioning features provided on the applicator insert and cooperating with one or more corresponding features on the sensor control device to rotationally orient the applicator insert relative to the sensor control device. Element 4: wherein the internal collimator includes a collimation insert, and the external collimator can be aligned 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 device to create a sealing 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 device.

[0350] Element 9: Also includes 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 includes: engaging the gasket against the bottom of the sensor control device 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 device. Element 11: Wherein, the internal collimator and the external collimator cooperatively define a sterilization zone for receiving sensors and sharp objects, the method further includes sealing at least a portion of the sterilization zone with a microbial barrier, the microbial barrier being positioned at the interface between the internal collimator and the external collimator. Element 12: Wherein, the internal collimator includes a collimation insert, and wherein aligning the external collimator with the internal collimator includes aligning the external collimator with the collimation 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 includes a microbial barrier positioned at an interface between the internal collimator and the external collimator. Element 15: Wherein, the internal collimator includes a collimation insert, and 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 16: Wherein, the internal collimator also includes a gasket that can be engaged with the bottom of the sensor control device to generate a sealed interface. Element 17: Wherein, the internal collimator and the external collimator cooperatively define a sterilization zone, wherein the sterilization zone exhibits a cross-sectional shape selected from the group consisting of: a cone, a truncated cone, a pyramid, a circle, a cube, a rectangle, and any combination thereof.

[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 some medical devices are delivered to an end user, they must be sterilized so that the product is rendered 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 on 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 that is designed to focus sterilizing radiation (e.g., beam, wave, energy, etc.) toward the component parts that need to be sterilized while preventing the transmitted radiation from destroying or damaging sensitive electronic components.

[0356] Fig.232300 , according to one or more embodiments of the present disclosure. The internal sterilization assembly 2300 (hereinafter "assembly 2300") may be designed and otherwise configured to assist in sterilizing a medical device 2302. The medical device 2302 may include a type of healthcare product that includes any device, mechanism, assembly, or system that requires terminal sterilization of one or more component parts. Suitable examples of the medical device 2302 include, but are not limited to, ingestible products, cardiac rhythm management (CRM) devices, subcutaneous sensing devices, externally mounted medical devices, drug delivery devices, or any combination thereof.

[0357] In the illustrated embodiment, the medical device 2302 includes a subcutaneous sensing device or a "sensor control device," which is also referred to as an "in vivo analyte sensor control device." As illustrated, the medical device 2302 can be housed in a sensor applicator 2304 (alternatively referred to as an "inserter"), and a cap 2306 can be removably coupled to the sensor applicator 2304. The medical device 2302 includes a housing 2308, a part 2310 that requires sterilization, and one or more radiation-sensitive components 2312. In some embodiments, the part 2310 may include a sensor extending from the housing 2308. In at least one embodiment, the part 2310 may also include a sharp object, which may also require sterilization and may help implant the sensor under the user's skin. As illustrated, the part 2310 may extend at an angle from the bottom of the housing 2308, but may alternatively extend vertically from the bottom or from another surface of the housing 2308. Furthermore, as illustrated, the feature 2310 may extend from one end of the housing 2308 or otherwise be offset from a 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 the target monitoring position on the user's skin (e.g., the user's arm). In some embodiments, cap 2306 may be threadedly connected to 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 can then use sensor applicator 2304 to position medical device 2302 at the target monitoring position on the user's body. Part 2310 is positioned so that it can be transcutaneously positioned and otherwise maintained below the surface of the user's skin. In some embodiments, medical device 2302 can be spring loaded to pop out from sensor applicator 2304. Once delivered, medical device 2302 can be maintained in place on the skin using an adhesive patch (not shown) at the bottom of medical device 2302.

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

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

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

[0362] As illustrated, the collimator 2318 generally includes a hole or passage extending at least partially through the cap 2306. The collimator 2318 defines a sterilization zone 2320 that is configured to focus radiation 2316 toward the part 2310. In the illustrated embodiment, the part 2310 can be received in the sterilization zone 2320 for sterilization. The collimator 2318 can exhibit any suitable cross-sectional shape necessary to focus 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, without departing from the scope of the present disclosure, the collimator 2318 can exhibit a polygonal cross-sectional shape, such as a cube, a rectangle (e.g., including a parallelogram) or a pyramid. In yet 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 orifice 2322a and a second orifice 2322b, wherein the first orifice 2322a and the second orifice 2322b are defined at opposite ends of the sterilization zone 2320. The first orifice 2322a can allow the radiation 2316 to enter the sterilization zone 2320 and impinge on the part 2310, and the second orifice 2322b can be configured to receive the part 2310 into the sterilization zone 2320. In embodiments where the collimator 2318 is conical or frustoconical in shape, the second orifice 2322b can have a diameter that is smaller than the diameter of the first orifice 2322a. In such embodiments, for example, the size of the second orifice 2322b can be in a range between about 0.5 mm and about 3.0 mm, and the size of the first orifice 2322a can be in a range between about 5.0 mm and about 16.0 mm. However, as will be appreciated, the respective diameters of the first aperture 2322a and the second aperture 2322b may be larger or smaller than the ranges provided herein without departing from the scope of the present disclosure. In practice, the diameters of the first aperture 2322a and the second aperture 2322b may be scaled to the size of the device and need only be large enough to allow a sufficient dose of radiation to be irradiated onto the part 2310. Additionally, in at least one embodiment, the collimator 2318 may 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 aperture 2322a. The cap seal 2324 can include a radiation transparent microbial barrier. In some embodiments, for example, the cap seal 2324 can be made of a synthetic material (e.g., flash spun high density polyethylene fibers), such as those available from Obtained However, in other embodiments, the cap seal 2324 may include, but is not limited to, tape, paper, foil, or any combination thereof. In still other embodiments, without departing from the scope of the present disclosure, the cap seal 2324 may include a thinned portion of the cap 2306. In such an embodiment, the first aperture 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 may also include a barrier shield 2326 positioned within the housing 2308. The barrier shield 2326 may be configured to help block radiation 2316 (e.g., electrons) from propagating within the housing 2308 toward the radiation-sensitive component(s) 2312. The barrier shield 2326 may 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 may alternatively be positioned in any other angular configuration suitable for protecting the radiation-sensitive component(s) 2312.

[0367] Fig.24 2 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 Fig.23 The assembly 2300 of FIG. 1 is similar to, and therefore may be best understood by reference thereto, wherein like reference numerals represent like parts that are not described again in detail. Fig.23 Similar to assembly 2300 of the present invention, for example, assembly 2400 can be designed and otherwise configured to assist in sterilizing a medical device 2402 that can be sterilized with Fig.23 Similar to the medical device 2302. Fig.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 recess 2406 defined in the sensor applicator 2404. In some embodiments, a desiccant (not shown) can be disposed within the recess 2406. Fig.23Similar to the medical device 2302 of the present invention, the medical device 2402 may include a housing 2308, a part 2310 to be sterilized, and (one or more) radiation sensitive components 2312. In some embodiments, the assembly 2400 may also include a barrier shield 2326, as generally described above. 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. In addition, 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 the present disclosure.

[0369] The sensor applicator 2404 is used to deliver the medical device 2402 to a target monitoring location on the user's skin (e.g., the user's arm). As illustrated, the sensor applicator 2404 may include a spring-loaded button 2408 at least partially received in the sensor applicator 2404. The button 2408 extends in a channel 2409 defined in the sensor applicator 2404 and can engage with the top of the housing 2308 at its bottom end. In at least one embodiment, a sealing interface is formed when the bottom of the button 2406 engages with the housing 2308. By pressing the button 2408 downward, the medical device 2402 can be deployed from the recess 2406 for use, the button acting on the housing 2308 and thereby pushing the medical device 2402 distally and out of the recess 2406 and away from the sensor applicator 2404. The part 2310 is positioned so that it can be percutaneously positioned and otherwise maintained below 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] The medical device 2402 may 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 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 a hole or passage extending at least partially through the button 2408. The collimator 2410 focuses the radiation 2316 toward the part 2310 and may 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 yet 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 through the collimator 2410). To accomplish this, the sensor applicator 2404 and button 2408 may be made of Fig.23 The cap 2306 is made of a material similar to that of the cap 2306. In at least one embodiment, the radiation sterilization 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 reduce exposure of the radiation 2316 to adjacent portions of the sensor applicator 2404.

[0372] In some embodiments, a first seal 2412a (shown in phantom) may be positioned at the opening of the recess 2406, and a second seal 2412b may be disposed at the opening to the collimator 2410, at the top of the button 2406. The seals 2412a, 2412b may include a radiation-transmissive microbial barrier that is compatible with the Fig.23 The cap seal 2324 of the sensor applicator 2404 is similar. 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] Fig.252 is 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 Fig.23 and Fig.24 Components 2300 and 2400 are similar and therefore may be best understood by reference thereto, wherein like reference numerals represent like parts that are not described again in detail. Fig.23 and Fig.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 sterilized with Fig.23 and Fig.24 The medical devices 2302 and 2402 are similar. Fig.23 and Fig.24 Similar to medical devices 2302 and 2402, medical device 2502 may include a sensor control device, but may alternatively include any of the healthcare products mentioned herein.

[0374] As illustrated, the medical device 2502 can be housed within a sensor applicator 2504, which can include a spring loaded sheath 2506. The medical device 2502 can be positioned within a pocket 2508 at least partially defined by the sheath 2506. In some embodiments, a desiccant (not shown) can be disposed within the pocket 2508. Fig.23 and Fig.24 Similar to medical devices 2302 and 2402, medical device 2502 may include housing 2308, parts to be sterilized 2310, and radiation sensitive component(s) 2312. In some embodiments, assembly 2500 may also include 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. In addition, as illustrated, the part 2310 may extend along the centerline of the housing 2308, but may alternatively extend eccentrically to the centerline without departing from the scope of the present disclosure.

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

[0377] The medical device 2502 may 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 includes 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 may 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 yet 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 (block) 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 provided with a Fig.23 The cap 2306 may be made of a material similar to that of the cap 2306. However, in at least one embodiment, the sterilizing radiation 2316 may 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) may be positioned at the opening of the recess 2508, and a second seal 2512b may be disposed at the opening to the collimator 2510, at the top of the sensor applicator 2504. The seals 2512a, 2512b may include a radiation-permeable microbial barrier that is compatible with the sensor applicator 2504. Fig.23 The cap seal 2324 of the sensor applicator 2504 is similar. 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 contained 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 can be aligned with the part to be sterilized, wherein the collimator focuses radiation from a radiation sterilization process toward the part to be sterilized and prevents the radiation from damaging the radiation-sensitive component.

[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 electronic 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 truncated cone, 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 to be sterilized 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 device having a housing containing 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 of the medical device, wherein the collimator is defined to pass 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 contained within a recess at least partially defined by the sheath. Element 15: wherein the collimator is defined to pass 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] Fig.26A and Fig.26B2602 (alternatively referred to as a "disk") may be similar in some aspects to a sensor control device 2602. Figure 1 The sensor control device 2602 is similar to the sensor control device 104 of FIG. 1 and is therefore best understood by reference thereto. The sensor control device 2602 may replace 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 that 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 the present invention, the sensor control device 2602 can be included in a one-piece system architecture. Unlike the two-piece architecture, for example, the user is not required to open multiple packages and finally assemble the sensor control device 2602. Instead, when received by the user, the sensor control device 2602 is already fully assembled and properly positioned in the sensor applicator 102 ( Figure 1 ) To use the sensor control device 2602, the user only needs to open a barrier (e.g., Figure 2B Applicator cap 210), followed by rapid delivery of sensor control device 2602 to the target monitoring location.

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

[0388] The electronic device housing 2604 may include a shell 2606 and a base 2608 that may be mated with the shell 2606. The shell 2606 may be fixed to the base 2608 via a variety of means, such as snap-fit ​​engagement, interference fit, sonic welding, or one or more mechanical fasteners (e.g., screws). In some cases, the shell 2606 may be fixed to the base 2608 so that a sealed interface is generated therebetween. In such embodiments, a gasket or other type of sealing material may be positioned at or near the outer diameter (periphery) of the shell 2606 and the base 2608, and the two components may be fixed together to compress the gasket and thereby generate a sealed interface. In other embodiments, an adhesive may be applied to the outer diameter (periphery) of one or both of the shell 2606 and the base 2608. The adhesive fixes the shell 2606 to the base 2608 and provides structural integrity, but may also seal the interface between the two components and thereby isolate the interior of the electronic device housing 2604 from external contamination. If the sensor control device 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 to Figure 2A 2602. The plug assembly 2610 may be similar to the plug assembly 207 of the electronic device. For example, the plug assembly 2610 may include a sensor module 2612 (partially visible) that may be interconnected with a sharp object module 2614 (partially visible). The sensor module 2612 may be configured to carry and otherwise include a sensor 2616 (partially visible), and the sharp object module 2614 may be configured to carry and otherwise include a sharp object 2618 (partially visible) that is used to help deliver the sensor 2616 transcutaneously to the user's skin during application of the sensor control device 2602. As illustrated, corresponding portions of the sensor 2616 and the sharp object 2618 extend from the electronic device housing 2604, and more particularly extend from the bottom of the base 2608. The exposed portion of the sensor 2616 may be received in a hollow or recessed portion of the sharp object 2618. The remainder of the sensor 2616 is positioned within the interior of the 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 sensor 2616 and exposed portions of the sharps 2618 from the effects of gaseous chemical sterilization.

[0391] Fig.27A and Fig.27B2704, and are an isometric view and an exploded view of the plug assembly 2610 according to one or more embodiments. The sensor module 2612 may include a sensor 2616, a plug 2702, and a connector 2704. The plug 2702 may be designed to receive and support both the sensor 2616 and the connector 2704. As shown, a channel 2706 may be defined as passing 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 that are 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 tail 2708, flag 2710, and 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 membrane can cover the chemical. In use, tail 2708 is received percutaneously beneath the skin of a user, and the chemical included thereon helps facilitate analyte monitoring in the presence of body fluids.

[0393] Flag 2710 may include a generally planar surface having one or more sensor contacts 2714 ( Fig.27B The sensor contact(s) 2714 may 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 2616 and is provided in an electrical housing 2604 ( Figures 26A-26B ) provide 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] Sharp module 2614 includes a sharp 2618 and a sharp hub 2722 carrying sharp 2618. Sharp 2618 includes 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 extend distally from plug 2702. In addition, 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 contact active chemicals present on tail 2708 with bodily fluids.

[0396] The sharp object hub 2722 may include a hub cylinder 2730 and a hub snap detent 2732, each of which may be configured to help couple the plug assembly 2610 (and the entire sensor control device 2602) to the sensor applicator 102 ( Figure 1 ).

[0397] Specific references Fig.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 internal 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 at an intermediate position between the first end 2736a and the second end 2736b.

[0398] Fig.27C 2702 and the preservation bottle 2620. As illustrated, the plug 2702 can define an orifice 2742 that is configured to receive the preservation bottle 2620, and more particularly, the first end 2736a of the body 2734. The channel 2706 can terminate at the orifice 2742 so that when the preservation bottle 2620 is coupled to the plug 2702, components extending from the channel 2706 and extending distally will be received in the internal chamber 2738.

[0399] The preservation bottle 2620 can be removably connected 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 an embodiment, 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 easily peelable glue. As described below, after the sensor control device 2602 ( Figures 26A-26B ) can be separated from the plug 2702 before delivery to the target monitoring location on the user's skin.

[0400] Reference again Fig.27A and Fig.27B , the inner 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 inner chamber 2738 can be sealed or otherwise isolated to prevent substances that may adversely interact with the chemistry of the sensor 2616 from migrating into the inner chamber 2738. More specifically, the inner 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 enzymes provided on the tail 2708 (and other sensor components, such as membrane coatings that regulate analyte influx).

[0401] In some embodiments, the seal 2744 ( Fig.27B ) can provide a sealed barrier between the inner chamber 2738 and the external environment. In at least one embodiment, the seal 2744 can be disposed within the inner chamber 2738, but can alternatively be positioned outside the body 2734 without departing from the scope of the present disclosure. The distal portions of the sensor 2616 and the sharp object 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 object 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 retaining fluid 2746 ( Fig.27B) can be present within the inner chamber 2738, and the sensor 2616 and the distal portion of the sharp object 2618 can be immersed in or otherwise encapsulated by the preservation fluid 2746. The preservation fluid 2746 can create a sealing interface that prevents the sterilization gas from interacting with the enzyme provided on the tail 2708.

[0403] The plug assembly 2610 may be subjected to radiation sterilization to properly sterilize the sensor 2616 and the sharp object 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, the plug assembly 2610 may be subjected to radiation sterilization before the preservation bottle 2620 is coupled to the plug 2702. However, in other embodiments, the plug assembly 2610 may be sterilized after the preservation bottle 2620 is coupled to the plug 2702. In such embodiments, the body 2734 of the preservation bottle 2620 and the preservation fluid 2746 may include such materials and / or substances that allow radiation to propagate therethrough to facilitate radiation sterilization of the distal portions of the sensor 2616 and the sharp object 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 polymers, etc.), epoxies, or any combination thereof. In some embodiments, the material for body 2734 may be transparent or translucent, but may be opaque in other cases without departing from the scope of the present disclosure.

[0405] The preservation fluid 2746 may include any inert and biocompatible fluid (i.e., 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 may also allow radiation to propagate therethrough. The preservation fluid 2746 may include 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, gel (e.g., vaseline), wax, fresh water, saline, synthetic fluids, glycerol, 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 penetration of the sharp object 2618 and the sensor 2616 into 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] Fig.28A and Fig.28B 2604 according to one or more embodiments. The housing 2606 and the base 2608 operate as opposing clamshell halves that enclose or otherwise substantially enclose the 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, wherein 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 an antenna or otherwise communicate 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 ( Figures 27A-27B ). A battery 2810 may also be housed within the electronic device housing 2604 and is configured to power the sensor control device 2602.

[0410] exist Fig.28B 2808 and provides a location at which the plug assembly 2610 ( Figures 27A-27B ) can be received and connected to the electronic device housing 2604, thereby fully assembling the sensor control device 2602 ( Figure 26A-3BPlug 2702 ( Figures 27A-27C ) may be contoured to match or be shaped in a complementary manner to the plug receptacle 2812, and the plug receptacle 2812 may provide one or more snap tabs 2814 (two shown) that are configured to engage with 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 be coupled to the connector 2704 ( Figures 27A-27B ) of the electrical contacts 2720 ( Figures 27A-27B ) for conductive connection.

[0411] Fig.29A and Fig.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 to the sensor applicator. More specifically, Figures 29A-29B Depicts how the sensor applicator 102 may be shipped to and received by a user. Fig.29B As seen in FIG. 1 , 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 electronic device housing 2604, the plug assembly 2610 can be subjected to radiation sterilization to sterilize the distal portion of the sensor 2616 and the sharp object 2618. Once properly sterilized, the plug assembly 2610 can then be coupled to the electronic device housing 2604 as generally described above and thereby form 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 an anti-tampering ring 2902. When the applicator cap 210 is rotated (e.g., unscrewed) relative to the housing 208, the anti-tampering 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 in the sensor applicator 102, the sensor control device 2602 can be subjected to a gaseous chemical sterilization 2904 that is configured to sterilize the electronic device housing 2604 and any other exposed portions of the sensor control device 2602. To achieve 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 sharp object 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. Insulation may be accomplished 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 may be blocked with a seal 2912 (shown in phantom).

[0416] In some embodiments, the seal 2912 may include two or more layers of different materials. The first layer may be made of a synthetic material (e.g., flash spun high-density polyethylene fibers), such as those available from Obtained Highly durable and puncture resistant, yet vapor permeable. Can be applied prior to gaseous chemical sterilization process layer, and after the gaseous chemical sterilization process, The seal 2912 may include a seal (e.g., heat seal) of a foil or other vapor and moisture resistant material layer to prevent contaminants and moisture from entering the sterilization chamber 2906. In other embodiments, the seal 2912 may include only a single protective layer applied to the applicator cap 210. In such embodiments, 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 device 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 device 2602 to the user's skin from becoming dirty.

[0418] Fig.30 2 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 ( Fig.29A and Fig.29B ) of the applicator cap 210. 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 that is centrally located within the interior of the applicator cap 210 and extends proximally from the bottom thereof. The cap post 3004 may be configured to be included in the sensor applicator 102 ( Figures 29A-29B ) helps support the sensor control device when in. In addition, the cap column 3004 can define an opening 3006 that is configured to receive the storage 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 the preservation bottle 2620 to pass therethrough. In some embodiments, for example, the compliant feature(s) 3008 may include a collet-type device that includes a plurality of compliant fingers configured to flex radially outward to receive the preservation bottle 2620. However, in other embodiments, the compliant feature(s) 3008 may include an elastomer or another type of compliant material that is configured to expand radially to receive the preservation bottle 2620.

[0421] Fig.31 2 is a cross-sectional side view of the sensor control device 2602 positioned within the applicator cap 210 according to one or more embodiments. As shown, the cap column 3004 defines a column chamber 3102 that is configured to receive the preservation bottle 2620. The opening 3006 to the cap column 3004 provides access to the column chamber 3102 and exhibits a first diameter D 1 In contrast, the enlarged head 2740 of the preservation bottle 2620 exhibits a second diameter D 2, the second diameter is greater than the first diameter D 1 And is larger than the outer diameter of the rest of the preservation bottle 2620. Therefore, when the preservation bottle 2620 extends into the column chamber 3102, the (one or more) compliant features 3008 of the opening 3006 can be radially deflected (expanded) 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 compliance 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 portion of the second diameter D 2 A sharp surface at the tip of the compliant feature 3008 will engage but push 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 device 2602 is thereby separated from the applicator cap 210, the shoulder 3104 defined on the enlarged head 2740 will engage the compliant feature(s) 3008 at the opening 3006. Because the diameter of the shoulder 3104 is greater than the diameter of the opening 3006, the shoulder 3104 will engage against the compliant feature(s) 3008 and thereby separate the storage bottle 2620 from the sensor control device 2602, which exposes the distal portion of the sensor 2616 and the sharp object 2618. Therefore, when the applicator cap 210 is separated from the sensor applicator 102 and the sensor control device 2602, the compliant feature(s) 3008 can prevent the enlarged head 2740 from exiting the column chamber 3102 through the opening 3006. The separated storage bottle 2620 will fall into and remain in the column chamber 3102.

[0425] In some embodiments, instead of the opening 3006 including (one or more) compliance features 3008 as generally described above, the opening 3006 may be threaded instead. In such an embodiment, a small portion near the distal end of the preservation bottle 2620 may also be threaded and configured to threadably engage the threads of the opening 3006. The preservation bottle 2620 can be received in the column chamber 3102 via threaded rotation. However, when the applicator cap 210 is removed from the sensor applicator 102, the opening 3006 and the relative threads on the preservation bottle 2620 are engaged, and the preservation bottle 2620 can be separated from the sensor control device 2602.

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

[0427] Embodiments disclosed herein include:

[0428] L. A sensor control device, comprising: an electronic device housing; a plug assembly that can be matched with the electronic device housing and includes a sensor module having a sensor and a sharp object module having a sharp object; and a preservation vial that is connected to the plug assembly and defines an inner chamber, wherein the distal portion of the sensor and the sharp object can be received in the inner chamber and isolated from gaseous chemical sterilization in the inner 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 preservation bottle coupled to the plug assembly and defining an inner chamber. The analyte monitoring system further comprises a cap coupled to the sensor applicator to provide a barrier to seal the sensor control device within the sensor applicator, wherein distal portions of the sensor and sharps are received within the inner chamber and isolated from gaseous chemical sterilization within the inner 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 electronic device housing; a plug assembly that is matable with the electronic device housing and includes a sensor module having a sensor and a sharps module having a sharp; and a retention bottle that is coupled to the plug assembly and defines an internal chamber. The method also includes: securing a cap to the sensor applicator and thereby providing 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 that are 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 connected to the plug. Element 2: wherein the preservation bottle provides an enlarged head, and the diameter of the enlarged head is greater 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 the exterior of the inner chamber, wherein the distal portions of the sensor and the 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 the sharp from gaseous chemical sterilization. Element 5: wherein the distal portions of the sensor and the 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, glycerol, sorbitan esters, and any combination thereof. Element 7: wherein the preservation fluid comprises an anti-inflammatory agent.

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

[0433] Element 14: wherein loading the sensor control device into the sensor applicator is preceded by the steps of: assembling the plug assembly; coupling the preservation bottle to the plug assembly such that the distal portion of the sensor and the sharp are received within the internal chamber; and coupling the plug assembly to the electronic device housing and thereby providing the sensor control device. Element 15: wherein coupling the preservation bottle to the plug assembly is preceded by the steps of: sterilizing the plug assembly using radiation sterilization. Element 16: wherein isolating the distal portion of the sensor and the sharp from gaseous chemical sterilization includes at least partially immersing the distal portion of the sensor and the 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 includes: 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] Fig.32A and Fig.32B 3202 (alternatively referred to as a "disk") may be similar in some aspects to a sensor control device 3202. Figure 1 104 is similar to and therefore best understood by reference thereto. In some applications, 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 a sensor applicator that 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 the present invention, the sensor control device 3202 can be included in a one-piece system architecture. Unlike the 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, when received by the user, the sensor control device 3202 is already fully assembled and properly positioned in the sensor applicator 102 ( Figure 1) To use the sensor control device 3202, the user only needs to open a barrier (e.g., remove Figure 2B The applicator cap 210 is then quickly delivered to the sensor control device 3202 to the target monitoring location.

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

[0439] The electronic device housing 3204 may include a shell 3206 and a base 3208 that can cooperate with the shell 3206. The shell 3206 can be fixed to the base 3208 via a variety of ways, such as snap-fit ​​engagement, interference fit, sonic (or ultrasonic) welding, use of one or more mechanical fasteners (e.g., screws) or any combination thereof. In some embodiments, the interface between the shell 3206 and the base 3208 can be sealed. In such an embodiment, a gasket or other type of sealing material can be positioned or applied at or near the outer diameter (periphery) of the shell 3206 and the base 3208. The shell 3206 is fixed to the base 3208 to compress the sealing material and thereby generate a sealed interface. In at least one embodiment, an adhesive can be applied to the outer diameter (periphery) of one or both of the shell 3206 and the base 3208, and the adhesive can not only fix the shell 3206 to the 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 device 3202 is assembled in a controlled and sterile environment, it may not be necessary to sterilize the internal electrical components (e.g., via gaseous chemical sterilization). Instead, the sealed joint can provide an adequate sterile barrier for the assembled electronic device housing 3204.

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

[0442] like Fig.32B , corresponding portions of sensor 3214 and sharp object 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 object 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 the 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] Fig.33A and Fig.33B 3202 according to one or more embodiments. As illustrated, the shell 3206 and base 3208 of the electronic device housing 3204 operate as opposing clamshell halves that enclose or otherwise substantially enclose the various electronic components of the sensor control device 3202.

[0445] A printed circuit board (PCB) 3302 may be positioned within the electronic device housing 3204. Fig.33B As shown in FIG. 3 , a plurality of electronic modules 3304 may be mounted to the underside of PCB 3302. Example electronic modules 3304 include, but are not limited to, resistors, transistors, capacitors, inductors, diodes, and switches. Data processing unit 3306 ( Fig.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 illustrated, 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 the sharps module 3212 therethrough.

[0447] A battery 3310 and a corresponding battery base 3312 may also be housed within the electronic device housing 3204. The battery 3310 may 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 includes an enzyme or other chemical or biological agent, and in some embodiments, the membrane may cover the chemical. In use, the tail 3316 is received percutaneously under the user's skin, and the chemical included thereon helps facilitate analyte monitoring in the presence of body fluids.

[0449] The flag 3318 may include a generally planar surface having one or more sensor contacts 3322 ( Fig.33A The flag 3318 may be configured to be received within the connector 3314, wherein the sensor contact(s) 3322 are 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 state and a closed state. Figures 33A-33B 3318 and the compliant carbon impregnated polymer module(s) therein. The compliant carbon impregnated polymer module(s) provide electrical contacts 3326 ( Fig.33A 33), 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 act as a moisture barrier for the sensor 3214.

[0451] The sharps module 3212 includes a sharp 3216 and a sharps hub 3330 carrying 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 contact the active chemical of the tail 3316 with the body fluid.

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

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

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

[0455] Specifically refer to Fig.33B, a plurality of channels or grooves 3346 may be provided or otherwise defined on the bottom of the base 3208. As shown, 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 ) may be attached to the underside of the base 3208, and in some embodiments, the transfer adhesive 3220 ( Figures 32A-32B ) may be inserted between adhesive patch 3218 and the bottom of base 3208. Recess 3346 may prove advantageous in promoting moisture to escape underneath adhesive patch 3218 away from the center of electronic device housing 3204.

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

[0457] Fig.34A and Fig.34B 1 and 2 are side views and cross-sectional side views, respectively, of the sensor applicator 102 with the applicator cap 210 coupled to the sensor applicator. More specifically, Figures 34A-34B Depicts how the sensor applicator 102 may be shipped to and received by a user. Fig.34B As seen in FIG. 3 , the sensor control device 3202 has been assembled and installed within the sensor applicator 102 before being delivered to the user. The applicator cap 210 may be threaded onto the housing 208 and include an anti-tampering ring 3402. When the applicator cap 210 is rotated (e.g., unscrewed) relative to the housing 208, the anti-tampering 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. Figure 2E-2G Generally described.

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

[0459] Once the sensor control device 3202 is mated 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 device 3202 when it is contained within the sensor applicator 102. In addition, the cap post 3406 can define a post chamber 3408 that is configured to receive a sensor 3214 and a sharp object 3216, such as 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 sharp 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 sharp 3216 during gaseous chemical sterilization.

[0460] In some embodiments, the sensor module 3210 and the sharps module 3212 may 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 device 3202 into the sensor applicator 102. Once properly sterilized, the sensor module 3210 and the sharps module 3212 may then be coupled to the electronics housing 3204, and the fully assembled sensor control device 3202 may 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 the 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., beams, waves, 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 embodiments, the sensor control device 3202 ( Figures 33A-33B ) of electrical components 3304( Fig.33B )(including data processing unit 3306( Fig.33B)) can be positioned outside the range of the propagating radiation and thus will not be affected by the radiation. The electrical components 3304 and the data processing unit 3306, for example, can be positioned on the PCB 3302 and near its outer periphery so as not to fall within the range (span) of the focused radiation sterilization 3412. In other embodiments, this can be achieved by shielding the sensitive electrical components 3304 with appropriate electromagnetic shielding.

[0463] According to the present disclosure, when the sensor control device 3202 is loaded in the sensor applicator 102, the sensor control device 3202 can be subjected to gaseous chemical sterilization 3414 to sterilize the electronic device housing 3204 and any other exposed portions of the sensor control device 3202. To achieve 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. Insulation may be accomplished 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 fibers), such as Obtained Highly durable and puncture resistant, yet vapor permeable. Can be applied prior to gaseous chemical sterilization 3414 layer, and after gaseous chemical sterilization 3414, can be The seal 3422 may include a layer of foil or other vapor and moisture resistant material that is sealed (e.g., heat sealed) to the 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 is also able to protect from moisture and other harmful elements once the sterilization process is completed.

[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 device 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 device 3202 to the user's skin from becoming dirty.

[0468] Fig.35 34 is an enlarged cross-sectional side view of a sensor control device 3202 installed in a sensor applicator 102 and having an applicator cap 210 secured thereto, according to one or more embodiments. As indicated above, portions of the sensor 3214 and sharps 3216 may 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, in the gaseous chemical sterilization 3414 ( Fig.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 may 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 may be defined by and otherwise formed of at least a first seal 3502a, a second seal 3502b, and a third seal 3502c. The first seal 3502a may be arranged to seal the interface between the sharp object hub 3330 and the shell 3206. In addition, the first seal 3502a may be circumscribed to a first central orifice 3308a defined in the shell 3206 so as to prevent fluid (e.g., gaseous chemicals) from migrating into the interior of the electronic device housing 3204 via the first central orifice 3308a.

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

[0471] The second seal 3502b can be arranged to seal the interface between the cap column 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 fluid (e.g., gaseous chemicals) from migrating into the column chamber 3408 of the cap column 3406, and also prevent fluid (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 may form a portion of the cap post 3406. For example, the second seal 3502b may be overmolded onto the top of the cap post 3406. In other embodiments, the second seal 3502b may be overmolded onto the cap post sealing interface 3348 at the bottom of the base 3208. In still other embodiments, the second seal 3502b may include a separate structure, such as an O-ring, etc., inserted between the cap post 3406 and the bottom of the base 3208 without departing from the scope of the present disclosure.

[0473] When the sensor control device 3202 is loaded into the sensor applicator 102 and the applicator cap 210 is secured to the sensor applicator 102, the first seal 3502a and the second seal 3502b become compressed and generate corresponding sealing interfaces. The first seal 3502a and the second seal 3502b can be made of a variety of materials that can generate a sealing interface between opposing structures. Suitable materials include, but are not limited to, silicone, thermoplastic elastomer (TPE), polytetrafluoroethylene, Rubber, elastomer or any combination thereof.

[0474] The third seal 3502c can be arranged to seal the interface between the sensor base recess 3342 and the PCB 3302, and more particularly the interface between the outer perimeter 3344 of the sensor base recess 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 (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 recess 3342, and thus migrating into the column chamber 3408 to adversely react with the enzyme on the tail 3316.

[0475] The applicator cap 210 may 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 rotates 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 may frictionally engage the base 3208 and thereby cause the entire electronic device housing 3204 to perform 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 the embodiment of the present invention, the conical carrier clamping feature is generally defined on the exterior of the electronic device housing and is configured to cooperate 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 electronic device housing from rotating within the sensor applicator 102.

[0477] In contrast, the electronics housing 3204 of the presently disclosed sensor control device 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 radial biasing arms of the sensor base pocket 3342 may be positioned to engage the exterior surface 3504 to help center the sensor control device 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 radial biasing arms, which do not inhibit rotation of the electronics housing.

[0478] Fig.363406 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, and transfer adhesive 3220 is interposed between adhesive patch 3218 and base 3208.

[0479] The adhesive patch 3218 may block or otherwise cover the majority of the groove 3346 defined on the bottom of the base 3208. In addition, as illustrated, the adhesive patch 3218 may extend a short distance into the cap post sealing interface 3348. In order to enable the groove 3346 to properly direct moisture away from the center of the electronic device housing 3204 and the cap post sealing interface 3348, the adhesive patch 3218 (and transfer adhesive 3220, if included) may provide or otherwise define one or more channels 3602 that are aligned with the groove 3346 and otherwise arranged to be in fluid communication with the groove 3346. In the illustrated embodiment, the channel 3602 extends radially outward from the center of the electronic device housing 3204, but may alternatively be defined in other configurations and still interconnected with the 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 seal 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, the analyte monitoring system comprising: a sensor applicator; a sensor control device, which is positioned in the sensor applicator and includes: an electronic device housing having a shell and a base that can be matched with the shell; a printed circuit board, which is positioned in the electronic device housing; a sensor, which extends from the bottom of the base; a sharps hub, which is positioned adjacent to the top of the shell; and a sharp, which is carried by the sharps hub and extends through the electronic device housing and extends from the bottom of the base. The analyte monitoring system also includes: a cap, which is connected to the sensor applicator and provides a cap post that defines a column chamber, the column chamber receiving the sensor and the sharp extending from the bottom of the base; and a sealing area, which surrounds the column chamber and a portion of the interior of the electronic device housing, wherein the sealing area is defined by: a first seal, which seals the interface between the sharps hub and the shell; a second seal, which seals the interface between the cap post and the bottom of the base; and a third seal, which seals the interface between the base and the printed circuit board, and wherein portions of the sensor and the sharp reside within the sealing area 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 device into a sensor applicator, the sensor control device comprising: an electronic device housing having a shell and a base that can be mated with the shell; a printed circuit board positioned within the electronic device 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 electronic device housing and from the bottom of the base. The method also includes: securing a cap to the sensor applicator, wherein the cap provides a cap post defining a post chamber that receives the sensor and the sharp extending from the bottom of the base; forming a sealing area when the cap is secured to the sensor applicator, the sealing area surrounding the post chamber and a portion of the interior of the electronic device housing, wherein portions of the sensor and the sharp reside within the sealing area; sterilizing the sensor control device using gaseous chemical sterilization while the sensor control device is positioned within the sensor applicator; and isolating the portions of the sensor and the sharp that reside within the sealing area 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 into the portion of the interior of the electronic device housing via the central aperture. Element 2: wherein the second seal circumscribes a central aperture defined in the base and prevents fluid from migrating into the portion of the interior of the electronic device housing via the central aperture, and further prevents fluid from migrating into the column 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 column. Element 6: wherein the second seal is inserted between the cap column 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 the outer periphery of the sensor base recess. Element 9: wherein the third seal includes one of a gasket and an adhesive. Element 10: also includes: 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: also includes: 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 allows the sensor control device to rotate unimpeded relative to the sensor applicator when the cap is coupled to the sensor applicator.

[0485] Element 13: wherein forming a sealing area when the cap is secured to the sensor applicator includes sealing an interface between the sharps hub and the shell 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 the sharp using radiation sterilization; and assembling the sensor and sharps module to the electronic device housing. Element 15: wherein sterilizing the sensor control unit using gaseous chemical sterilization is preceded by the steps of sterilizing the sensor and the 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 electronic device 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 architecture with ASIC shielding, use of low-energy 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 a sensor control device 3702. Figure 1 The sensor control device 3702 is similar to the sensor control device 104 of FIG. 1 and is therefore best understood by 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. Figure 1 In contrast to the sensor control device 104, 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 the present invention, 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, when received 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 The applicator cap 210 is then quickly delivered to the sensor control device 3702 to the target monitoring location.

[0490] First reference Fig.37A , 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 the present 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 adhesive patch 108 of , adhesive patch 3710 can be configured to secure and hold sensor control device 3702 in place on the user's skin during operation.

[0491] In some embodiments, shell 3706 may define reference feature 3712. As illustrated, reference feature 3712 may include a recess or blind pocket defined in shell 3706 and extending a short distance into the interior of electronic device housing 3704. Reference feature 3712 may operate as a "reference point c" feature that is configured to help facilitate control of sensor control device 3702 with 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 generally 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 once 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] Fig.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 the sensor 110 of the present invention, the exposed portion of the sensor 3716 is configured to be transcutaneously positioned beneath the user's skin during use. The exposed portion of the sensor 3716 may include an enzyme or other chemical or biological agent, and in some embodiments, the membrane may cover the chemical.

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

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

[0496] Fig.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 ( Fig.37A ) center opening 3714 ( Fig.37A ) are coaxially aligned and the sharp object penetrates the electronic device housing by extending through each center aperture 3714, 3720 simultaneously.

[0497] Fig.38A and Fig.38B3702 are exploded top views and bottom views of a sensor control device 3702 according to one or more embodiments, respectively. Shell 3706 and base 3708 operate as opposing clamshell halves that enclose or otherwise substantially encapsulate various electronic components of sensor control device 3702. As illustrated, sensor control device 3702 may include a printed circuit board assembly (PCBA) 3802 that includes a printed circuit board (PCB) 3804 having a plurality of electronic modules 3806 coupled thereto. 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 only on one side of the PCB. In contrast, PCB components 3806 in sensor control device 3702 may be dispersed around the surface area of ​​both sides (i.e., top and bottom surfaces) of PCB 3804.

[0498] In addition to the electronic 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) that is 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 communicate 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 seat a battery 3812 configured to power the sensor control device 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 the transfer of electrical power from the battery 3812 to the PCB 3804. As the names imply, the axial battery contacts 3814a may be configured to provide axial contacts for the battery 3812, while the radial battery contacts 3814b may provide radial contacts for the battery 3812. Positioning the battery 3812 within the battery aperture 3810 using the battery contacts 3814a, 3814b helps reduce the height H of the sensor control device 3702. Fig.37B ), which allows PCB 3804 to be centrally located and its components to be spread out on both sides (i.e., top and bottom surfaces). This also helps facilitate chamfer 3718 ( Fig.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 the user. In addition, 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 ( Fig.38B The sensor contact(s) 3822 may be configured to communicate with corresponding circuit contacts 3824 (eg, three are shown in FIG. 1 ) provided on the PCB 3804. Fig.38A The sensor contacts 3822 are aligned and engaged with the flag 3818 (three shown in FIG. 1 ). In some embodiments, the sensor contact(s) 3822 may include 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 currently 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 ( Fig.37B ). In addition, 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 arranged to be interposed between the flag 3818 and the inner surface of the shell 3706. More specifically, when the shell 3706 and the base 3708 are assembled to 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 to continuously engage 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 so that it faces the top surface of the PCB 3804, and the second shield 3828b is arranged below the PCB 3804 so 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 device 3702 is subjected to 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 doses that could otherwise damage sensitive electronic circuits of data processing unit 3808.

[0505] In the illustrated embodiment, the data processing unit 3808 is inserted between the first shield 3828a and the second shield 3828b, so that the first shield 3828a and the second shield 3828b are substantially placed at both ends of the data processing unit 3808 in the axial direction. However, in at least one embodiment, only one of the shields 3828a, 3828b may be necessary to properly protect the data processing unit 3808 during radiation sterilization. For example, if the sensor control device 3702 is subjected to radiation sterilization directed toward the bottom of the base 3708, only the second shield 3828b may need to be inserted between the data processing unit 3808 and the radiation source, and the first shield 3828a may be omitted. Alternatively, if the sensor control device 3702 is subjected to radiation sterilization directed toward the top of the housing 3706, only the first shield 3828a may need to be inserted between the data processing unit 3808 and the radiation source, and the 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] The shields 3828a, 3828b may be made of any material capable of attenuating (or substantially attenuating) radiation transmission. Suitable materials for the shields 3828a, 3828b include, but are not limited to, lead, tungsten, iron-based metals (e.g., stainless steel), copper, tantalum, tungsten, osmium, aluminum, carbon, or any combination thereof. Suitable metals for the shields 3828a, 3828b may be corrosion-resistant, austenitic, and any non-magnetic metal with a density ranging between about 2 grams per cubic centimeter (g / cc) and about 23 g / cc. The shields 3828a, 3828b may be manufactured via a variety of manufacturing techniques, including, but not limited to, stamping, casting, injection molding, sintering, double shot molding, or any combination thereof.

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

[0508] The housing 3706 may provide or otherwise define a first timing receptacle 3830a ( Fig.38B ) and the second timing jack 3830b ( Fig.38B ), and the base 3708 may provide or otherwise define a first timing column 3832a ( Fig.38A ) and the second timing column 3832b ( Fig.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] Specifically refer to Fig.38A, the inner surface of the base 3708 may provide or otherwise define a plurality of recesses or depressions configured to receive various component parts of the sensor control device 3702 when the housing 3706 is mated to the base 3708. For example, the inner surface of the base 3708 may define a battery locator 3834 configured to receive a portion of the battery 3812 when the sensor control device 3702 is assembled. The adjacent contact recess 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 can be reduced compared to existing sensor control devices. Fig.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 reference Fig.38A , the base 3708 may also include a plurality of carrier clamping features 3842 (two are shown) defined around the outer periphery of the base 3708. The carrier clamping features 3842 are axially offset from the bottom 3844 of the base 3708, and a transfer adhesive (not shown) may be applied at 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 currently disclosed carrier clamping features 3842 are offset from the plane (i.e., the bottom 3844) to which the transfer adhesive is applied. This can prove to be advantageous in helping to ensure that the delivery system does not accidentally stick to the transfer adhesive during assembly. In addition, the currently disclosed carrier clamping features 3842 eliminate the need for fan-shaped transfer adhesives, which simplifies the manufacture of transfer adhesives and eliminates the need to accurately time the transfer adhesive relative to the base 3708. This also increases the bonding area, and therefore increases the bonding strength.

[0512] refer to Fig.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 periphery of the base 3708 and spaced equidistantly from each other. 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 device 3702 and toward the periphery of the base 3708 during use. In some embodiments, the spacing of the grooves 3846 may be inserted into the module pockets 3838 ( Fig.38A As will be appreciated, alternating the po...

Claims

1. An analyte monitoring system comprising: a sensor applicator; a cap coupled to the sensor applicator; a sensor control device positioned within the sensor applicator and including an electronics housing; a sensor extending from a bottom of the electronic device housing; a sharps hub positioned adjacent a top portion of the electronic device housing; a sharp object carried by the sharp object hub and extending through the electronic device housing and extending from the bottom of the electronic device housing; as well as A collimator is positioned within the cap and defines a sterile zone that receives a sensor and a sharp object extending from a bottom of the electronic device housing.

2. The system according to claim 1, wherein: The sterile zone includes a passageway extending at least partially through the collimator.

3. The system according to claim 1, wherein: The sterilization zone comprises a cross-sectional shape selected from the group consisting of: conical, frustoconical, cubic, rectangular, pyramidal, and any combination thereof.

4. The system according to claim 1, wherein: The sterilization zone is frusto-conical and defines a first aperture at a first end and a second aperture at a second end, and wherein the first aperture receives a sensor and a sharp object extending from a bottom of the electronic device housing and a seal is disposed at the second aperture.

5. The system of claim 1 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 the interface between the sharps hub and the top of the electronic device housing; a second seal that seals the interface between the collimator and the bottom of the electronic device housing; and a third seal that seals the end of the sterilization zone.

6. The system according to claim 5, wherein: The first seal is circumscribed to a central aperture defined in the top 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 is circumscribed to an aperture defined in the bottom of the electronic device housing and prevents contaminants from migrating through the aperture into the portion of the interior of the electronic device housing.

7. The system according to claim 5, wherein: The first seal provides one or both of an axial seal and a radial seal.

8. The system according to claim 5, wherein: The second seal extends into the sterile field and defines a cylindrical well that receives the sensor and the sharps.

9. The system of claim 1, further comprising: A printed circuit board is arranged in the housing of the electronic device; a data processing unit mounted to the printed circuit board; and a shield positioned within the electronics housing to protect the data processing unit from radiation from the radiation sterilization process.

10. The system according to claim 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 mixed with a non-magnetic metal, and any combination thereof.

11. 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 electronic device housing; a sensor extending from a bottom of the electronic device housing; a sharp hub positioned adjacent to a top of the electronic device housing; and a sharp carried by the sharp hub and extending through the electronic device housing and from the bottom of the electronic device housing; securing a cap to the sensor applicator, wherein the collimator is disposed within the cap and defines a sterile zone configured to receive a sensor and a sharp object extending from a bottom of the electronic device housing; sterilizing the sensor and sharps using radiation sterilization while they are positioned within the sterile field; and Collimators are used to prevent radiation from radiation sterilization from damaging electronic components within the housing of the electronic device.

12. The method according to claim 11, further comprising: A sealing area is formed when the cap is secured to the sensor applicator that surrounds the sterilization zone and a portion of the interior of the electronic device housing.

13. The method according to claim 12, wherein: Forming a sealed 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.

14. The method according to claim 13, wherein: Utilizing the first seal to seal the interface between the sharps hub and the top of the electronic device housing includes utilizing the first seal to provide one or both of an axial seal and a radial seal.

15. The method according to claim 11, wherein: The collimator includes an internal collimator and sterilization of the sensor and sharps using radiation sterilization also includes: positioning the sensor applicator adjacent to an external collimator disposed externally of the sensor applicator; focusing the radiation using an external collimator for receipt by an internal collimator; and External collimators and internal collimators are used to prevent radiation from damaging electronic components within the housing of the electronic device.

16. The method according to claim 11, wherein: The sterilization zone defines a first aperture at the first end of the collimator and a second aperture at the second end of the collimator, and wherein sterilizing the sensor and the sharps includes introducing radiation into the sterilization zone through the second aperture.

17. The method according to claim 11, wherein: Preventing radiation from radiation sterilization from damaging electronic components includes utilizing materials of the collimator to block the radiation.

18. The method according to claim 11, wherein: The printed circuit board is disposed within the electronic device housing and the data processing unit is mounted to the printed circuit board, the method further comprising protecting the data processing unit from radiation from the radiation sterilization process using a shield positioned within the electronic device housing.

19. 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 electronic device housing; a sensor extending from a bottom of the electronic device housing; a sharp hub positioned adjacent to a top of the electronic device housing; and a sharp carried by the sharp hub and extending through the electronic device housing and from the bottom of the electronic device housing; positioning the sensor applicator adjacent to the collimator and subjecting the sensor and sharps to radiation sterilization; Collimators are used to prevent radiation from radiation sterilization from damaging electronic components within the housing of the electronic device.

20. The method according to claim 19, wherein: Positioning the sensor applicator adjacent the collimator includes arranging the collimator so that it resides outside of the sensor applicator during radiation sterilization.

21. An exterior sterilization assembly, comprising: a radiation shield that can be positioned externally to a medical device having parts that require sterilization and radiation-sensitive components; as well as a collimator, which is defined by the radiation shield and can be aligned with the part to be sterilized, Among them, a collimator focuses radiation from the radiation sterilization process toward the parts that need to be sterilized, and a radiation shield prevents the radiation from damaging radiation sensitive components.

22. The assembly of claim 21, 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.

23. The assembly of claim 21, wherein: The radiation sensitive component is selected from the group consisting of: an electronic module, a chemical solution, and any combination thereof.

24. The assembly of claim 21, wherein: The collimator comprises a cross-sectional shape selected from the group consisting of conical, frustoconical, pyramidal, circular, cubic, rectangular, and any combination thereof.

25. The assembly of claim 21, further comprising a cap that encloses the parts to be sterilized and provides a sealing barrier.

26. The assembly of claim 21, wherein: The radiation shield defines an inner cavity that receives the medical device, and the collimator focuses radiation into the inner cavity.

27. The assembly of claim 21, 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.

28. An exterior sterilization assembly, comprising: A radiation shield positionable external to a sensor applicator, the sensor applicator comprising: case; a cap coupled to the housing; and A sensor control device is positioned within the housing, The sensor control device includes an electronic device housing, a radiation sensitive component arranged in the electronic device housing, and a sensor and a sharp object extending from the electronic device housing; an external collimator defined by a radiation shield and alignable with the sensor and the sharp object, Among them, an external collimator focuses radiation from the radiation sterilization process toward sensors and sharps, and a radiation shield prevents radiation from damaging radiation sensitive components.

29. The assembly of claim 28, 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.

30. The assembly of claim 28, further comprising a sterilization chamber defining a chamber for receiving at least a portion of the sensor applicator, wherein A radiation shield is removably coupled to the sterilization chamber.

31. The assembly of claim 30, further comprising: a mounting tray defining a central aperture alignable with the chamber and sized to receive a sensor applicator; and a cover that can cooperate with the mounting tray to enclose the sensor applicator.

32. The assembly of claim 28, 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 sterile zone into which the sensor and the sharp are received.

33. The assembly of claim 32, wherein: The external collimator and the internal collimator each include a cross-sectional shape selected from the group consisting of: conical, frustoconical, pyramidal, circular, cubic, rectangular, and any combination thereof.

34. The assembly of claim 32, further comprising a cap seal disposed at an interface between the outer collimator and the inner collimator.

35. The assembly of claim 28, wherein: The cap is inverted and cap posts are provided to receive sensors and sharp objects.

36. The assembly of claim 35, wherein: The external collimator and the cap post cooperatively define a sterile zone, and the sensor and sharps positioned within the cap post extend into the sterile zone.

37. 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 includes an electronics housing, a radiation sensitive component disposed within the electronics housing, and a sensor and a sharp extending from the electronics housing; focusing radiation from the radiation sterilization process toward the sensor and the sharp object using an external collimator defined by the radiation shield; and Radiation shields are used to prevent radiation from damaging radiation sensitive components.

38. The method of claim 37, wherein: Disposing the radiation shield external to the sensor applicator includes positioning the sensor applicator within a chamber defined by a sterilization chamber to which the radiation shield is removably coupled.

39. The method of claim 38, wherein: Positioning the sensor applicator within a chamber defined by the sterilization chamber further comprises: extending a sensor applicator through a central aperture defined by the mounting tray and aligned with the cavity; positioning the cover on the mounting tray and thereby enclosing the sensor applicator; and While the sensor applicator is enclosed by the cover, the radiation sterilization process is performed.

40. The method of claim 38, 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.

41. A sensor applicator assembly comprising: a housing having a sensor control device disposed therein, the sensor control device including a sensor, a sharp object, and a radiation sensitive component; an applicator cap removably coupled to the housing; an applicator insert positionable within the applicator cap and defining an inner collimator at a distal end receiving the sensor and the sharps and an outer collimator extending into the applicator cap, Therein, an inner collimator and an outer collimator cooperate to focus radiation from a radiation sterilization process toward sensors and sharps while preventing the radiation from damaging radiation sensitive components.

42. The assembly of claim 41, wherein: The applicator insert engages an inner surface of the applicator cap to axially secure the applicator insert within the applicator cap.

43. The assembly of claim 41, further comprising: a sheath that extends 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 device.

44. The assembly of claim 41 further comprising one or more sensor locating features provided on the applicator insert and cooperable with one or more corresponding features on the sensor control device to rotationally orient the applicator insert relative to the sensor control device.

45. The assembly of claim 41, wherein: The inner collimator includes a collimation insert, and the outer collimator is alignable with the collimation insert.

46. ​​The assembly of claim 45, 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.

47. The assembly of claim 41, wherein: The internal collimator also includes a gasket that can engage with the bottom of the sensor control device to create a sealing interface.

48. The assembly of claim 41, wherein: The inner collimator and the outer collimator cooperatively define a sterilization zone that exhibits a cross-sectional shape selected from the group consisting of: conical, frustoconical, pyramidal, circular, cubic, rectangular, and any combination thereof.

49. The assembly of claim 41 further comprising a potting material disposed within the sensor control assembly.

50. The assembly of claim 41 further comprising a microbial barrier positioned at an interface between the inner collimator and the outer collimator.

51. A hybrid sterilization component, comprising: an applicator insert positionable within an applicator cap of the sensor applicator; an internal collimator defined by the applicator insert to receive a sensor and a distal end of a sharp object of a sensor control device disposed within a housing of the sensor applicator; as well as an external collimator which may extend into the applicator cap and may be aligned with the internal collimator, Therein, an inner collimator and an outer collimator cooperate to focus radiation from a radiation sterilization process toward sensors and sharps while preventing the radiation from damaging radiation sensitive components.

52. A method for sterilizing a sensor control device, the method comprising: positioning a sensor control assembly within a housing of the sensor applicator, the sensor control assembly including the sensor, the sharp object, and the radiation-sensitive component; receiving the distal ends of the sensor and sharps within an internal collimator defined by the applicator insert; removably coupling the applicator cap to the housing and thereby securing the applicator insert within the applicator cap; extending an outer collimator into the applicator cap and aligning the outer collimator with the inner collimator; as well as Internal and external collimators are utilized to cooperatively focus radiation from the radiation sterilization process toward sensors and sharps while preventing the radiation from damaging radiation sensitive components.

53. The method of claim 52, further comprising engaging an inner surface of the applicator cap against the applicator insert and thereby axially securing the applicator insert within the applicator cap.

54. The method of claim 52, wherein: The internal collimator includes a gasket, the method further comprising: engaging the washer against the bottom of the sensor control assembly when the applicator insert is axially secured within the applicator cap; and With the gasket against the bottom of the sensor control unit, a sealing interface is created.

55. The method of claim 52, wherein: The inner collimator and the outer collimator cooperatively define a sterile zone for receiving the sensor and the sharps, the method further comprising sealing at least a portion of the sterile zone with a microbial barrier positioned at an interface between the inner collimator and the outer collimator.

56. The method of claim 52, wherein: The internal collimator includes a collimation insert, and wherein aligning the external collimator with the internal collimator includes aligning the external collimator with the collimation insert.

57. The method of claim 52, wherein: The inner collimator and the outer collimator cooperatively define a sterilization zone that exhibits a cross-sectional shape selected from the group consisting of: conical, frustoconical, pyramidal, circular, cubic, rectangular, and any combination thereof.

58. The method of claim 52, 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.

59. The method of claim 52, wherein: The internal collimator also includes a gasket that can engage with the bottom of the sensor control device to create a sealing interface.

60. The method of claim 52, wherein: The inner collimator and the outer collimator cooperatively define a sterilization zone that exhibits a cross-sectional shape selected from the group consisting of: conical, frustoconical, pyramidal, circular, cubic, rectangular, and any combination thereof.

61. An internal sterilization assembly, comprising: a sensor applicator; a medical device that is at least partially housed within the sensor applicator and has parts and radiation-sensitive components that require sterilization; as well as a cap that is removably coupled to the sensor applicator and provides a collimator that can be aligned with the part to be sterilized, Among other things, a collimator focuses radiation from the radiation sterilization process toward the parts that need to be sterilized and prevents the radiation from damaging radiation-sensitive components.

62. The assembly of claim 61, wherein: The radiation sensitive component is selected from the group consisting of: an electronic module, a chemical solution, and any combination thereof.

63. The assembly of claim 61, wherein: The collimator comprises a cross-sectional shape selected from the group consisting of conical, frustoconical, pyramidal, circular, cubic, rectangular, and any combination thereof.

64. The assembly of claim 61, wherein: The medical device includes an in vivo analyte sensor control device, and the parts requiring sterilization include at least one of a sensor and a sharp object extending from a housing of the in vivo analyte sensor control device.

65. The assembly of claim 64, wherein: The at least one of the sensor and the sharp object extends from the bottom of the housing at a certain angle.

66. The assembly of claim 64, wherein: in, The at least one of the sensor and the sharp object extends vertically from the bottom of the housing.

67. The assembly of claim 64, 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.

68. The assembly of claim 64, 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.

69. The assembly of claim 61, wherein: The cap is made of a material having a mass density greater than 0.9 g / cc.

70. The assembly of claim 61, wherein: The cap is made of a material selected from the group consisting of: a high density polymer, a metal, and any combination thereof.

71. The assembly of claim 61, wherein: The medical device includes an in vivo analyte sensor control device having a housing containing a radiation-sensitive component, and the inner sterilization assembly further includes a barrier shield positioned within the housing to block radiation from propagating within the housing toward the radiation-sensitive component.

72. The assembly of claim 61 further comprising a spring loaded button at least partially received within the sensor applicator and engageable with a top portion of the medical device, wherein The collimator is defined through the button.

73. The device of claim 72 further comprising a sealing interface at the intersection of the button and the medical device.

74. The assembly of claim 72, 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.

75. The assembly of claim 61, wherein: The sensor applicator includes a spring loaded sheath, and the medical device is received within a pocket at least partially defined by the sheath.

76. The assembly of claim 61, wherein: A collimator is defined through the sensor applicator.

77. A sensor control device, the sensor control device comprising: Electronic equipment housing; a printed circuit board positioned within the electronic device housing and having a data processing unit mounted thereto; a sensor extending from a bottom portion of the electronic device housing; a sharps module removably coupled to the electronics housing and having a sharp that extends through the electronics housing and receives a portion of the sensor extending from a bottom portion of the electronics housing; as well as At least one shield is positioned within the electronics housing to protect the data processing unit from radiation from the radiation sterilization process.

78. An analyte monitoring system, the analyte monitoring system comprising: a sensor applicator; a sensor control device positioned within the sensor applicator and including an electronics housing; a printed circuit board positioned within the electronic device housing and having a data processing unit mounted thereto; a sensor extending from a bottom portion of the electronic device housing; a sharps module removably coupled to the electronics housing and having a sharp that extends through the electronics housing and receives a portion of the sensor extending from a bottom portion of the electronics housing; at least one shield positioned within the electronics housing to protect the data processing unit from radiation from the radiation sterilization process; as well as A cap is coupled to the sensor applicator to provide a barrier to seal the sensor control assembly within the sensor applicator.

79. The system of claim 78, further comprising: a battery aperture defined in the printed circuit board; a battery received in the battery aperture; an axial battery contact coupled to the printed circuit board and extending into the battery aperture to facilitate electrical communication; and radial battery contacts coupled to the printed circuit board and extending into the battery apertures to facilitate electrical communication.

80. The system of claim 78, further comprising: one or more sensor contacts disposed on the sensor flag; and one or more circuit contacts provided on the printed circuit board and engageable with the one or more sensor contacts to facilitate direct connection between the sensor and the printed circuit board.

81. The system of claim 78, wherein: The at least one shield is interposed between the data processing unit and a radiation source to facilitate radiation sterilization.

82. The system of claim 78, wherein: The at least one shield includes a first shield facing a bottom of the printed circuit board and a second shield facing a top of the printed circuit board, and wherein the data processing unit is inserted between the first shield and the second shield.

83. The system of claim 78, wherein: The at least one shield comprises a housing enclosing the data processing unit.

84. The system of claim 78, wherein: The at least one shield is made of a non-magnetic metal exhibiting a density ranging between about 2 g / cc and about 23 g / cc.

85. The system of claim 78, wherein: The at least one shield is made of a non-magnetic metal having a density of at least 2.0 g / cc.

86. The system of claim 78, wherein: The at least one shield is formed from a thermoplastic polymer mixed with a non-magnetic metal having a density of at least 2.0 g / cc.

87. The system of claim 78, further comprising a plurality of electronic modules coupled to the top and bottom surfaces of the printed circuit board.

88. The system of claim 78, wherein: The electronic device housing comprises a base and a shell, wherein the base and the shell are fixed together and sealed by an adhesive.

89. The system of claim 78, wherein: The at least one shield comprises a magnet arranged to deflect radiation away from the data processing unit.

90. The system of claim 78, wherein: The at least one shield is interposed between the data processing unit and a radiation source that facilitates radiation sterilization of the sensor and the sharps.

91. The system of claim 78, wherein: The sensor control device is subjected to radiation sterilization while positioned within the sensor applicator and at energy levels ranging between about 0.1 MeV and about 10.0 MeV.

92. The system of claim 78, wherein: The at least one shield comprises a magnet arranged to deflect radiation away from the data processing unit.

93. The system of claim 78, further comprising a plurality of electronic modules coupled to the top and bottom surfaces of the printed circuit board.

94. The system of claim 93, wherein: A plurality of module pockets are defined in the inner surface of the base to accommodate the plurality of electronic modules.

95. The system of claim 88, wherein: The electronic device housing includes: a flag having one or more sensor contacts; and a compliant member arranged to be inserted between the flag and the inner surface of the housing and to provide a passive bias load against the flag to force the one or more sensor contacts to engage with corresponding one or more circuit contacts provided on the printed circuit board.

96. The system of claim 95, wherein: The compliant member includes an elastomeric O-ring.

97. A method of preparing an analyte monitoring system, the method comprising: Loading a sensor control assembly into the sensor applicator, the sensor control assembly comprising: Electronic equipment housing; a printed circuit board positioned within the electronic device housing and having a data processing unit mounted thereto; a sensor extending from a bottom portion of the electronic device housing; a sharps module removably coupled to the electronics housing and having a sharp that extends through the electronics housing and receives a portion of the sensor extending from a bottom of the electronics housing; and at least one shield positioned within the electronic device housing; securing the cap to the sensor applicator and thereby providing a barrier to seal the sensor control assembly within the sensor applicator; sterilizing the sensor and sharps using radiation sterilization while the sensor control unit is positioned within the sensor applicator; and The data processing unit is shielded from radiation from radiation sterilization using the at least one shield.

98. The method of claim 97, wherein: The at least one shield is inserted between the data processing unit and a radiation source to facilitate radiation sterilization, and wherein the at least one shield is made of a non-magnetic metal with a density of at least 2.0 g / cc, the method further comprising: performing radiation sterilization at an energy level ranging between about 0.1 MeV and about 10.0 MeV.

99. The method of claim 97, wherein: The electronic device housing includes a shell mateable with the base, and wherein loading the sensor control device into the sensor applicator is preceded by the step of sealing the shell to the base with an adhesive and thereby creating a sterile barrier.

100. The method of claim 97, wherein: The at least one shield comprises a magnet, and wherein shielding the data processing unit with the at least one shield comprises: generating a static magnetic field with the magnet; and redirecting radiation away from the data processing unit with the static magnetic field.

101. A sensor control device, the sensor control device comprising: An electronic device housing having a shell that can mate with a base; a printed circuit board positioned within the electronic device housing and defining a battery aperture sized to receive a battery; an axial battery contact extending into the battery aperture to provide electrical communication; as well as Radial battery contacts extend into the battery apertures to provide electrical communication.

102. The sensor control device according to claim 101 further comprising: at least one shield positioned within the electronic device housing; and a shield retainer defined in the interior surface of the shell or base to receive at least a portion of the at least one shield.

103. The sensor control device according to claim 102, wherein: The at least one shield comprises a first shield and a second shield, and wherein the shield locator comprises: a first shield locator defined in an inner surface of the shell to accommodate at least a portion of the first shield; and a second shield locator defined in an inner surface of the base to accommodate at least a portion of the second shield.

104. The sensor control device according to claim 101 further comprising: one or more timing jacks defined in one of the base or the housing; and one or more timing posts defined on the other of the base or the housing and sized to be received within the one or more timing receptacles to properly align the housing to the base.

105. The sensor control device according to claim 101, wherein: A battery locator is defined in an interior surface of at least one of the housing and the base and is sized to receive a portion of the battery.

106. The sensing control device according to claim 105, wherein: The inner surface of the at least one of the housing and the base further defines a contact pocket adjacent the battery retainer and sized to receive a portion of the axial contact.

107. The sensor control device of claim 101 further comprising a plurality of carrier clamping features defined around an outer periphery of the base and axially offset from a bottom of the base.

108. A sensor control device, the sensor control device comprising: An electronic device housing includes an upper cover fixable to a lower cover; a sensor electronics module positionable between the upper cover and the lower cover and including a sensor holder defining a channel; a sensor including a tail portion extendable through the passageway and a flag including one or more sensor contacts; a sharp object extendable through the electronic device housing, wherein the sharp object and the tail extend from a bottom of the electronic device housing; a printed circuit board (PCB) having one or more circuit contacts alignable with the one or more sensor contacts; a first adhesive substrate interposed between the flag and the sensor holder to secure the sensor to the sensor holder; and A second adhesive substrate is interposed between the flag and the PCB to secure the sensor to the PCB and facilitate electrical communication between the one or more sensor contacts and the one or more circuit contacts.

109. The apparatus of claim 108, further comprising a filler that can be positioned between the upper cover and the lower cover together with the sensor electronics module.

110. The device of claim 109, further comprising a third adhesive substrate interposed between the lower cover and the filler to secure the filler to the lower cover.

111. The apparatus of claim 109, wherein: The sensor electronics module also includes a cap that can cooperate with the sensor holder to help secure the sensor within the sensor electronics module.

112. The device according to claim 111, wherein The sensor electronics module also includes a third adhesive substrate interposed between the cap and the PCB to secure the cap to the PCB.

113. The apparatus of claim 108, wherein: The sensor holder may mate with the PCB.

114. The apparatus of claim 108, wherein: One or both of the upper cover and the lower cover are made of a material selected from the group consisting of: a film, a foil, a foam, a laminate, and any combination thereof.

115. The apparatus of claim 108, wherein: One or both of the upper cover and the lower cover are formed by a manufacturing process selected from the group consisting of: thermoforming, vacuum forming, injection molding, die cutting, stamping, compression molding, transfer molding, and any combination thereof.

116. The apparatus of claim 108, wherein: The upper cover is secured to the lower cover via at least one of: sonic welding, ultrasonic welding, laser welding, heat sealing, adhesive substrate, and any combination thereof.

117. A conversion method for manufacturing a sensor control device, comprising: positioning a sensor holder defining a channel on a base substrate; extending a tail of the sensor through the channel and securing a flag of the sensor to the sensor holder using a first adhesive substrate applied to a top portion of the sensor holder, wherein the flag includes one or more sensor contacts; positioning a printed circuit board (PCB) on the base substrate and surrounding the sensor holder, the PCB providing one or more circuit contacts alignable with the one or more sensor contacts; attaching the PCB to the flag using a second adhesive substrate applied to a top portion of the flag; facilitating electrical communication between the one or more sensor contacts and the one or more circuit contacts using a second adhesive substrate; Positioning the upper cover on the PCB and securing the upper cover to the base substrate to form an electronic device housing; trimming the base substrate around an outer perimeter of the electronic device housing; and The sharp point is extended through the electronic device housing, wherein the sharp point and the tail extend from a bottom of the electronic device housing.

118. The method of claim 117, wherein: The base substrate comprises a film of material disposed on a roll, and attaching the sensor holder to the base substrate is preceded by the steps of unrolling the base substrate from the roll and forming a hole in the base substrate.

119. The method of claim 117, wherein: Positioning the sensor holder on the base substrate includes securing the sensor holder to the base substrate using at least one of ultrasonic welding, heat sealing, an adhesive substrate, and any combination thereof.

120. The method of claim 117, wherein: The PCB defines a first lug and a second lug interconnected by a neck portion, and the one or more circuit contacts are provided on the second lug, and wherein attaching the PCB to the flag comprises: folding the second lug onto the first lug at the neck portion; and aligning the one or more circuit contacts with the one or more sensor contacts.

121. The method of claim 120, wherein: Each tab provides a battery contact, and the method further includes: applying a third adhesive substrate to the battery contacts on the first tab; attaching the battery to the third adhesive substrate, wherein the second adhesive substrate is further applied to the top of the battery; and folding the second tab onto the first tab so that the battery contacts on the second tab are aligned with the top of the battery, wherein the second adhesive substrate and the third adhesive substrate include a Z-axis anisotropic pressure adhesive tape that facilitates electrical communication between the battery and the battery contacts.

122. The method of claim 117, further comprising: Positioning a filler on the PCB and surrounding the sensor holder; and utilizing the filler to reduce vibration and stabilize the electronic module of the PCB.

123. The process of claim 117, further comprising: A third adhesive substrate is applied between the PCB and the upper cover to secure the upper cover to the PCB.

124. The method of claim 117, wherein: Positioning the upper cover on the PCB includes forming the upper cover using a process selected from the group consisting of: thermoforming, cold forming, vacuum forming, injection molding, die cutting, stamping, and any combination thereof.

125. The method of claim 117, wherein: Securing the upper cover to the base substrate includes sealing the upper cover to the base substrate using a process selected from the group consisting of sonic welding, ultrasonic welding, laser welding, heat sealing, using an adhesive substrate, and any combination thereof.

126. The method of claim 117, further comprising: forming a web extending from an outer perimeter of the electronic device housing and spanning the tab section, the web providing upper and lower layers that are sealed at the perimeter; facilitating fluid communication into an interior of an electronic device housing via the web and the apertures defined in the upper layer; and pressure testing the electronic device housing by injecting air into the electronic device housing through the orifice and the web.

127. The method of claim 126, further comprising: extracting air from the interior of the electronic device housing via the web and the aperture; and sealing the outer periphery of the electronic device housing under vacuum conditions.

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