Focused sterilization and sterilized sub-assemblies for analyte monitoring systems

Abstract

Arrangement for providing a glucose sensor, comprising: comprising a sensor control device: an electronics enclosure, comprising: a shell with an outer circumference and a first opening, and a holder which can be engaged with the outer circumference of the casing to define an interior of the electronics housing, wherein the holder has a second opening which is aligned with the first opening; a collar that is positioned in the electronics housing and can be engaged with the casing near the first opening, the collar having a central opening that is axially aligned with the first opening of the casing and the second opening of the holder; a printed circuit board that is arranged inside the electronics housing and comprises a variety of electronic modules; a glucose sensor comprising a proximal section and a distal section, wherein the proximal section is electrically coupled to the circuit board inside the electronics housing, and wherein the distal section extends from a bottom of the electronics housing and is configured to extend under the skin of a user to measure a glucose level in a body fluid; an adhesive patch that is attached to the underside of the electronics housing and configured to attach the sensor control device to a user's skin; a needle hub with a needle, wherein the needle hub is configured to engage with the collar, and wherein the needle has a distal section extending from the underside of the electronics housing; a sensor cap comprising a first section, a second section and an inner chamber, wherein the first section is detachably connected to the underside of the electronics housing, and wherein the inner chamber accommodates the distal section of the glucose sensor and the distal section of the needle.

Description

BACKGROUND

[0001] Diabetes is an incurable chronic disease in which the body does not produce insulin, a hormone produced by the pancreas that regulates blood sugar, or does not use it properly. When blood sugar levels rise, such as after a meal, insulin lowers blood sugar levels by moving glucose from the blood into the body's cells. If the pancreas does not produce enough insulin (a condition known as type 1 diabetes) or does not use insulin properly (a condition known as type 2 diabetes), glucose remains in the blood, which can lead to hyperglycemia, or abnormally high blood sugar levels.

[0002] If symptoms of diabetes are not carefully monitored and treated, numerous complications can occur, including diabetic ketoacidosis, nonketotic hyperosmolar coma, cardiovascular disease, stroke, kidney failure, foot ulcers, eye damage, and nerve damage. Traditionally, monitoring has involved pricking an individual finger to draw blood and testing the blood for glucose levels. More recent advances have enabled continuous and long-term blood glucose monitoring using biological sensors that remain in contact with bodily fluids for periods of days, weeks, or longer.

[0003] Analytical monitoring systems have been developed, for example, to support long-term monitoring of body fluid analytes such as glucose. These systems typically include a sensor applicator configured to place a biological sensor in contact with a body fluid. Specifically, during the release of the sensor into a user's skin, at least a portion of the sensor is positioned beneath the skin surface, for example, in the subcutaneous or dermal tissue.

[0004] It is essential that devices implanted in the body or positioned under the skin are sterile upon insertion. Sterilization can involve any number of processes that effectively eliminate or kill transmissible agents such as bacteria, fungi, or viruses. If these transmissible agents are not eliminated from the device, they can be significantly harmful to the user's health and safety.

[0005] Some, but not all, analyte monitoring systems may require separate sterilization processes to sterilize the sensor and electronic components. For example, electron beam sterilization is an example of radiation sterilization that can be used to sterilize the sensor. However, radiation sterilization can damage the electronic components associated with the sensor. Consequently, the electronic components are usually sterilized via chemical gas sterilization using, for example, ethylene oxide. However, ethylene oxide can damage the chemicals applied to the sensor. Thus, integrating the electronics and sensor into a single unit can complicate the sterilization process.

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

[0007] The following figures are included to illustrate specific aspects of the present disclosure and should not be considered as exclusive embodiments. The disclosed subject matter is capable of substantial modifications, alterations, combinations, and equivalents in form and function without departing from the scope of protection of this disclosure. Fig. Figure 1 is a conceptual diagram illustrating an exemplary analyte monitoring system that may integrate one or more embodiments of the present disclosure. Fig. 2A-2G are progressive views of the assembly and application of the system of Fig. 1, which integrates a two-part architecture. Fig. 3A and Fig. Figure 3B shows isometric or side views of an exemplary sensor control device. Fig. 4A and Fig. 4B are isometric or exploded views of the connector arrangement of the Fig. 3A-3B. Fig. 5A and Fig. 5B are exploded or isometric bottom views of the electronics housing of the Fig. 3A-3B. Fig. 6A and Fig. Figure 6B shows side and cross-sectional views of the sensor applicator. Fig. 1 with the cap attached to it of Fig. 2B. Fig. 7A is an enlarged cross-sectional side view of the sensor control device of Fig. 6B, mounted inside the cap of Fig. 6B. Fig. Figure 7B is an enlarged cross-sectional side view of another embodiment of the sensor control device of Fig. 6B, mounted inside the sensor applicator of Fig. 6B. Fig. Figures 8-12 are schematic diagrams of exemplary external sterilization arrangements according to one or more embodiments of the present disclosure. Fig. Figure 13 is an isometric view of an exemplary sensor control device. Fig. 14A is a side view of the sensor applicator from Fig. 1. Fig. Figure 14B is a cross-sectional side view of the sensor applicator of Fig. 14A. Fig. Figure 15 is a cross-sectional side view of the sensor applicator of Fig. 14A and another example embodiment of the external sterilization arrangement of Fig. 14B according to one or more additional embodiments. Fig. Figure 16 is a cross-sectional side view of the sensor applicator of Fig. 14A and another example embodiment of the external sterilization arrangement of Fig. 14B according to one or more additional embodiments. Fig. 17A and Fig. Figure 17B shows isometric top and bottom views of an example of the external sterilization setup of Fig. 14B according to one or more embodiments. Fig. Figure 18 is an isometric view of an exemplary sensor control device. Fig. 19A is a side view of the sensor applicator from Fig. 1. Fig. 19B is a cross-sectional side view of the sensor applicator of Fig. 3A. Fig. 20A-20C are different views of the applicator use of Fig. 19B according to one or more embodiments of the disclosure. Fig. 21 is another cross-sectional side view of the sensor applicator from Fig. 19A, which shows a hybrid sterilization arrangement according to one or more embodiments of the disclosure. Fig. 22A and Fig. Figures 22B are isometric or cross-sectional views of another embodiment of the applicator insert. Fig. 20A-20C. Fig. Figure 23 is a diagram of an exemplary analyte monitoring system that may integrate one or more embodiments of the present disclosure. Fig. Figure 24 is a schematic diagram of an exemplary internal sterilization arrangement according to one or more additional embodiments of the present disclosure. Fig. Figure 25 is a schematic diagram of a further exemplary internal sterilization arrangement according to one or more additional embodiments of the present disclosure. Fig. 26A and Fig. Figure 26B shows isometric or side views of an exemplary sensor control device. Fig. 27A and Fig. Figure 27B shows isometric or exploded views of the connector arrangement. Fig. 26A-26B. Fig. 27C is an isometric exploded view of the plug and the protective ampoule. Fig. 28A and Fig. 28B are exploded or isometric bottom views of the electronics housing of the Fig. 26A-26B. Fig. 29A and Fig. Figure 29B shows side or cross-sectional views of the sensor applicator. Fig. 1 with the cap attached to it of Fig. 2B. Fig. 30 is a perspective view of an example design of the cap of the Fig. 29A-29B. Fig. Figure 31 is a cross-sectional side view of the sensor control device positioned inside the cap. Fig. 32A and Fig. Figures 32B are isometric or side views of an exemplary sensor control device. Fig. 33A and Fig. Figures 33B are perspective top and bottom exploded views of the sensor control device. Fig. 32A-32B. Fig. 34A and Fig. Figure 34B shows side or cross-sectional views of the sensor applicator. Fig. 1 with the cap attached to it of Fig. 2B. Fig. Figure 35 is an enlarged cross-sectional side view of the sensor control device mounted inside the sensor applicator. Fig. Figure 36 is an enlarged cross-sectional bottom view of the sensor control device mounted on top of the cap pile. Fig. Figures 37A-37C are isometric, side and bottom views of an exemplary sensor control device. Fig. 38A and Fig. Figure 38B are isometric top and bottom exploded views of the sensor control device of the Fig. 37A-37C. Fig. Figures 39A-39D show an exemplary arrangement of the sensor control device of the Fig. 37A-37C. Fig. 40A and Fig. Figure 40B shows side or cross-sectional side views of a sensor applicator with the pre-assembled sensor control device arranged therein. Fig. 37A-37C. Fig. Figures 41A-41B are enlarged cross-sectional views of the sensor control device during an exemplary irradiation sterilization. Fig. Figure 42 is a plot that graphically represents the approximate penetration depth as a function of the e-beam energy level for a one-sided e-beam sterilization (or irradiation) process. Fig. Figure 43 is a cross-sectional side view of a sensor applicator with the pre-assembled sensor control device arranged therein. Fig. 37A-37C according to one or more additional embodiments. Fig. Figure 44 is a side view of an exemplary sensor control device. Fig. Figure 45 is an exploded view of the sensor control device of Fig. 44. Fig. 46A is a cross-sectional side view of the assembled sealed sub-assembly of Fig. 45 according to one or more embodiments. Fig. Figure 46B is a cross-sectional side view of the fully assembled sensor control device of Fig. 44. Fig. 47A and Fig. Figure 47B shows side or cross-sectional side views of an example embodiment of the sensor applicator. Fig. 1 with the cap attached to it of Fig. 2B. Fig. Figure 48 is a perspective view of an example design of the cap of the Fig. 47A-47B. Fig. 49 is a cross-sectional side view of the interior of the cap. Fig. 47A-47B positioned sensor control device. Fig. 50A and Fig. Figures 50B are isometric or side views of another exemplary sensor control device. Fig. 51A and Fig. Figure 51B shows isometric top and bottom views of the sensor control device. Fig. 50A-50B. Fig. Figure 52 is a cross-sectional side view of an assembled sealed partial arrangement according to one or more embodiments. Fig. Figures 53A-53C are progressive cross-sectional side views showing the assembly of the sensor applicator with the sensor control device of the Fig. Show 50A-50B. Fig. 54A and Fig. 54B are perspective or top views of the cap pile of Fig. 53C according to one or more additional embodiments. Fig. 55 is a cross-sectional side view of the area inside the cap of the Fig. 12 positioned sensor control device of the Fig. 50A-50B. Fig. 56A and Fig. Figure 56B shows cross-sectional side views of the sensor applicator ready for use with the sensor control device at a target monitoring location. Fig. Figures 57A-57C are progressive cross-sectional side views showing the assembly and disassembly of an example embodiment of the sensor applicator with the sensor control device of the Fig. Show 50A-50B. Fig. Figure 58A is an isometric bottom view of the housing according to one or more embodiments. Fig. 58B is an isometric bottom view of the housing with the casing and other components positioned at least partially inside it. Fig. Figure 59 is an enlarged cross-sectional side view of the sensor applicator with the sensor control device installed therein according to one or more embodiments. Fig. 60A is an isometric top view of the cap according to one or more embodiments. Fig. Figure 60B is an enlarged cross-sectional view of the engagement between the cap and the housing according to one or more embodiments. Fig. 61A and Fig. Figure 61B shows isometric views of the sensor cap or ring according to one or more embodiments. Fig. Figure 62 is an isometric top view of an exemplary sensor control device according to one or more embodiments of the present disclosure. Fig. Figure 63 is a schematic side view of an exemplary sensor applicator according to one or more embodiments of the present disclosure. Fig. 64A and Fig. Figure 64B shows isometric exploded views of the sensor applicator and sensor control device of the Fig. 62 and Fig. 63. Fig. 65A-65D are progressive cross-sectional side views of the sensor applicator of the Fig. 63 and 64A-64B, which illustrate the exemplary use of a sensor control device according to one or more embodiments. Fig. Figure 66 is an enlarged cross-sectional side view of an engagement between the sensor mount and the sensor control device of the Fig. 65A-65D according to one or more embodiments. Fig. Figure 67 is an isometric exploded view of another sensor applicator with the sensor control device of Fig. 62 according to one or more additional embodiments. Fig. 68A-68D are progressive cross-sectional side views of the sensor applicator of Fig. 67, which illustrate the exemplary use of the sensor control device according to one or more embodiments. Fig. Figure 69A is an enlarged schematic view of the needle hub and fingers of the sensor receptacle. Fig. 69B and Fig. Figures 69C are enlarged schematic views of the fingers interacting with the upper section of the needle sheath. Fig. Figures 70A-70B are enlarged cross-sectional side views of the exemplary engagement between the sensor receptacle and the sensor control device according to one or more embodiments. Fig. 71A and Fig. Figures 71B are isometric or cross-sectional side views of an exemplary sensor mount according to one or more embodiments of the present disclosure. Fig. 72A and Fig. 72B are enlarged cross-sectional side views of the sensor mount of the Fig. 71A-71B, which holds the sensor control device, according to one or more embodiments. Fig. 73A and Fig. Figure 73B shows side or cross-sectional side views of an exemplary sensor applicator according to one or more embodiments. Fig. 74A and Fig. Figures 74B are isometric top and bottom views of the internal applicator cover of Fig. 73B. Fig. Figure 75 is an isometric view of an example embodiment of the sensor cap of Fig. 73B according to one or more embodiments. Fig. Figure 76 is an isometric cross-sectional side view of the sensor cap of Fig. 75, which are covered by the internal applicator cover of the Fig. 74A-74B is included, according to one or more embodiments. Fig. Figure 77 shows the progressive removal of the applicator cap from Fig. 73A and the internal applicator cover of the Fig. 74A-74B from the sensor applicator of the Fig. 73A-73B according to one or more embodiments. Fig. Figure 78 is a schematic diagram of an exemplary sensor applicator according to one or more additional embodiments of the present disclosure. Fig. Figure 79 is an exploded view of an exemplary sensor control device according to one or more additional embodiments. Fig. 80 is a bottom view of an embodiment of the sensor control device of Fig. 79. Fig. 81A and Fig. Figure 81B are isometric or side views of a sensor control device in accordance with one or more embodiments of the present disclosure. Fig. 82 is a perspective exploded view of the sensor control device of Fig. 81A. Fig. Figure 83 is a cross-sectional side view in perspective of an exemplary sensor control device arrangement, which includes a sensor control device of Fig. 81A within the sensor applicator, wherein the sensor control device is connected to the analyte monitoring system of Fig. 1 is compatible. Fig. Figure 84 is an enlarged cross-sectional side view of the sensor control device assembly of Fig. 83. Fig. 85 is a bottom view of some elements of the sensor control device arrangement of Fig. 83, wherein the elements include the sensor control device held in a sensor carrier of the sensor applicator. Fig. Figure 86 is a schematic diagram of an exemplary sterilization arrangement according to one or more embodiments of the present disclosure. Fig. Figure 87 is a schematic diagram of a further exemplary sterilization arrangement according to one or more embodiments of the present disclosure. Fig. Figure 88A is a schematic bottom view of another exemplary sterilization arrangement according to one or more embodiments of the present disclosure. Fig. 88B and Fig. Figures 88C are schematic bottom views of alternative embodiments of the sterilization arrangement of the Fig. 88A according to one or more additional embodiments of the present disclosure. Fig. Figure 89 is an isometric schematic view of an exemplary sensor control device according to one or more embodiments. Fig. Figure 90 is a schematic diagram of another exemplary sterilization arrangement according to one or more embodiments. Fig. 91A and Fig. Figure 91B are side or isometric views of an exemplary sensor control device according to one or more embodiments of the present disclosure. Fig. 92A and Fig. Figure 92B are isometric exploded top and bottom views of the sensor control device of Fig. 2 according to one or more embodiments. Fig. Figure 93 is a cross-sectional side view of the sensor control device of the Fig. 91A-91B and 92A-92B according to one or more embodiments. Fig. Figure 93A is an isometric exploded view of a section of another embodiment of the sensor control device of the Fig. 91A-91B and 92A-92B. Fig. 94B is an isometric top view of the sensor cap of the Fig. 91A-91B and 92A-92B. Fig. 95A and Fig. Figure 95B shows side or cross-sectional side views of an exemplary sensor applicator according to one or more embodiments. Fig. 96A and Fig. 96B are perspective or top views of the cap pile of Fig. 95B according to one or more embodiments. Fig. Figure 97 is a cross-sectional side view of the sensor control device positioned within the applicator cap according to one or more embodiments. Fig. Figure 98 is a cross-sectional view of a sensor control device showing an exemplary interaction between the sensor and the tip. Fig. Figure 99 is a cross-sectional side view of an exemplary analyte monitoring system housing used to accommodate at least one section of a sensor control device. Fig. Figure 100A is an enlarged cross-sectional side view of the coupling between the sensor applicator and the cap as defined by the dashed frame of Fig. 99 was indicated. Fig. Figure 100B is an enlarged cross-sectional side view of the coupling between the sensor applicator and the cap as shown by the dashed frame of Fig. 99 indicated during or after chemical gas sterilization. Fig. Figure 101 is a cross-sectional side view of another exemplary analyte monitoring system housing used to enclose at least one section of the sensor control device of Fig. 1 to record. Fig. 102A-102C represent results of a finite element analysis corresponding to the coupling between the housing and the cap during the exemplary chemical gas sterilization. Fig. Figure 103 is an isometric view of an exemplary sensor control device. Fig. 104A and Fig. Figure 104B shows isometric exploded views of the sensor control device of Fig. 103 according to one or more embodiments. Fig. Figure 105 is a cross-sectional side view of the assembled sensor control device of the Fig. 104A-104B according to one or more embodiments. Fig. Figure 106 is an isometric view of another exemplary sensor control device. Fig. 107A and Fig. Figure 107B shows isometric exploded views of the sensor control device of Fig. 106 according to one or more embodiments. Fig. Figure 108 is a cross-sectional side view of the assembled sensor control device of the Fig. 107A-107B according to one or more embodiments. Fig. Figure 109 is an isometric view of an exemplary forming process for manufacturing a sensor control device in accordance with the principles of the present disclosure. Fig. 110A-110E represent the ongoing production of the sensor control device from Fig. 109 according to one or more embodiments. Fig. 111A is a top view of the sensor control device of Fig. 109 in preparation for a pressure test and / or vacuum sealing according to one or more embodiments. Fig. Figure 111B is a cross-sectional side view of the sensor control device of Fig. 109 with a compressor. Fig. Figure 112 is a partial cross-sectional side view of an exemplary sensor control device according to one or more embodiments. Fig. Figure 113 is a cross-sectional side view of an exemplary sensor applicator according to one or more embodiments. Fig. 114A and Fig. Figures 114B are perspective top and bottom views of the example design of the plug. Fig. 27A-27B. Fig. 115A and Fig. 115B are perspective views showing an example of the design of the connecting element. Fig. Show 27A-27B in the open and closed states. Fig. Figure 116 is a perspective view of an example embodiment of the sensor. Fig. 27A-27B. Fig. 117A and Fig. Figure 117B is a perspective bottom view or top view showing an example embodiment of a sensor module arrangement. Fig. 118A and Fig. Figures 118B are partial close-up views of an example embodiment of the sensor connector. Fig. 114A-114B, which has special axial stiffening features. Fig. Figure 119 is a side view of an exemplary sensor according to one or more embodiments of the disclosure. Fig. 120A and Fig. Figure 120B are isometric and isometric partial exploded views of an exemplary fastener arrangement according to one or more embodiments. Fig. 120C is an isometric bottom view of the connecting element of the Fig. 120A-120B. Fig. 121A and Fig. Figure 121B shows isometric and isometric partial exploded views of another exemplary connecting element arrangement according to one or more embodiments. Fig. 121C is an isometric bottom view of the connecting element of the Fig. 121A-121B. DETAILED DESCRIPTION

[0008] The present application relates generally to systems, devices and methods for assembling an applicator and a sensor control device for use in an in vivo analyte monitoring system.

[0009] Fig. Figure 1 is a conceptual diagram illustrating an exemplary analyte monitoring system 100, which may incorporate one or more embodiments of the present disclosure. A wide variety of analytes can be detected and quantified using the system 100 (hereinafter referred to as "the system 100"), including, but not limited to, acetylcholine, amylase, bilirubin, cholesterol, human chorionic gonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA, fructosamine, glucose, glumatine, growth hormones, 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... B., but not limited to, antibiotics (e.g. gentamicin, vancomycin and the like), digitoxin, digoxin, abuse drugs, theophylline and warfarin can also be detected.

[0010] As shown, the system 100 comprises a sensor applicator 102 (alternatively referred to as an "insert"), a sensor control device 104 (also referred to as an "in vivo analyte sensor control device"), and a readout device 106. The sensor applicator 102 is used to release the sensor control device 104 to a target monitoring site on a user's skin (e.g., the user's arm). Once released, the sensor control device 104 is held in position on the skin by an adhesive patch 108 coupled to the underside of the sensor control device 104. A section of a sensor 110 extends from the sensor control device 104 and is positioned so that it can be placed transcutaneously or otherwise held beneath the user's skin surface for the duration of the monitoring period.

[0011] An inserter may be included to facilitate the insertion of the Sensor 110 into tissue. The inserter may, for example, contain a needle, often referred to as a "point." Alternatively, the inserter may contain other types of devices, such as a sheath or a blade. The inserter may be temporarily positioned near the Sensor 110 before it is inserted into the tissue and then withdrawn afterward. While present, the inserter can assist in the insertion of the Sensor 110 into tissue by opening an access pathway for the Sensor 110 to follow. For example, the inserter may penetrate the epidermis to provide an access pathway to the dermis, enabling subcutaneous implantation of the Sensor 110. Once the access pathway has been opened, the inserter can be withdrawn, thus eliminating any risk while the Sensor 110 remains in place.In illustrative embodiments, the inserter may be solid or hollow, beveled or not beveled, and / or round or non-round in cross-section. In more specialized embodiments, suitable inserters may have a cross-sectional diameter and / or tip design similar to an acupuncture needle, which may have a cross-sectional diameter of approximately 250 micrometers. However, it should be understood that suitable inserters may have a larger or smaller cross-sectional diameter if required for specific applications.

[0012] In some embodiments, a tip of the inserter (if present) can be angled over the endpoint of the sensor 110, so that the inserter first penetrates the tissue and opens an access path for the sensor 110. In other explanatory embodiments, the sensor 110 can be located within a cavity or groove of the inserter, the inserter similarly opening an access path for the sensor 110. In each case, the inserter is then withdrawn after assisting the insertion of the sensor 110. Furthermore, the inserter (the tip) can be made of a variety of materials, such as metals and plastics.

[0013] When the sensor control device 104 is correctly assembled, the sensor is brought into communication (e.g., electrically, mechanically, etc.) with one or more electrical components or sensor electronics contained in the sensor control device 104. In some applications, for example, the sensor control device 104 may contain a printed circuit board (PCB) with a data processor (e.g., an application-specific integrated circuit or ASIC) mounted on it, and the sensor 110 may be operationally coupled to the data processor, which in turn may be coupled to an antenna and a power source.

[0014] The sensor control device 104 and the reading device 106 are configured to communicate with each other via a local communication path or connection 112, which may be wired or wireless, unidirectional or bidirectional, and encrypted or unencrypted. According to some embodiments, the reading device 106 can be both an output medium for viewing the analyte concentrations and warnings or messages determined by the sensor 110 or a processor associated with it, and it can also allow one or more user inputs. The reading device 106 can be a general-purpose smartphone or a dedicated electronic reading device. Although only one reading device 106 is shown, in special cases multiple reading devices 106 may be present.

[0015] The reading device 106 can also communicate with a remote terminal 114 and / or a trusted computer system 116 via communication path(s) / connection(s) 118 or 120, which can also be wired or wireless, unidirectional or bidirectional, and encrypted or unencrypted. Alternatively, the reading device 106 can also communicate with a network 122 (e.g., a mobile network, the internet, or a cloud server) via a communication path / connection 124. The network 122 can further communicate with the remote terminal 114 via communication path / connection 126 and / or the trusted computer system 116 via communication path / connection 128.

[0016] Alternatively, the sensor control device 104 can communicate directly with the remote terminal 114 and / or the trusted computer system 116 without an interposed reading device 106. For example, according to some embodiments, the sensor 110 can communicate with the remote terminal 114 and / or the trusted computer system 116 via a direct communication link to the network 122, as described in U.S. Patent No. 10,136,816, which is incorporated herein by reference in its entirety.

[0017] Any suitable protocol for electronic communication can be used for any of the communication paths or connections, such as near-field communication (NFC), radio frequency identification (RFID), BLUETOOTH® or BLUETOOTHO low-energy protocols, WiFi, or the like. According to some embodiments, the remote terminal 114 and / or the trusted computer system 116 may be accessible to persons who are not primary users and who have an interest in the user's analyte values. The reading device 106 may include a display device 130 and an optional input component 132. According to some embodiments, the display device 130 may include an interface for a touch-sensitive screen.

[0018] In some embodiments, the sensor control device 104 can automatically forward data to the reading device 106. For example, analyte concentration data can be communicated automatically and periodically, such as at a specific frequency when data is received or after a specific time interval has elapsed, with the data being stored in memory until transmission (e.g., every minute, every five minutes, or another predetermined interval). In other embodiments, the sensor control device 104 can communicate with the reading device 106 in a non-automatic manner and not according to a set schedule. For example, data from the sensor control device 104 can be communicated using RFID technology when the sensor electronics are brought within communication range of the reading device 106.Until the data is communicated to the reading device 106, it remains stored in a memory of the sensor control device 104. This means that a patient does not need to remain near the reading device 106 at all times and can instead upload the data when convenient. In further embodiments, a combination of automatic and non-automatic transmission can be implemented. For example, data transmission can then continue automatically until the reading device 106 is no longer within the communication range of the sensor control device 104.

[0019] The sensor control device 104 is frequently contained within the sensor applicator 104 in a so-called "two-part" architecture, which requires final assembly by a user before the sensor 110 can be correctly deployed to the target monitoring location. Specifically, the sensor 110 and the associated electrical components contained within the sensor control device 104 are provided to the user in several (two) packages, and the user must open the packaging and follow instructions to manually assemble the components before the sensor 110 is deployed to the target monitoring location with the sensor applicator 102.

[0020] However, recent advancements in sensor control device and sensor applicator designs have led to a one-piece architecture. This allows the system to be shipped to the user in a single, sealed package, eliminating the need for any final assembly. Instead, the user simply opens the package and deploys the sensor control device to the target monitoring location. This one-piece system architecture offers advantages by eliminating component parts, various manufacturing process steps, and user assembly. As a result, packaging and waste are reduced, and the potential for user error or system contamination is minimized.

[0021] In the illustrated embodiment, the system 100 can comprise a "two-part" architecture that requires final assembly by a user before the sensor 110 can be correctly deployed to the target monitoring location. Specifically, the sensor 110 and the associated electrical components contained in the sensor control device 104 are provided to the user in several (two) packages, each of which may or may not be sealed with a sterile barrier, but which are enclosed in at least one package. The user must open the package and follow instructions to manually assemble the components and then deploy the sensor 100 to the target monitoring location using the sensor applicator 102.

[0022] Fig. 2A-2G are progressive views of the assembly and application of System 100, which integrates a two-part architecture. Fig. 2A and Fig. 2B represents the first and second packages, respectively, that are provided to the user for final assembly. In particular, it represents Fig. 2A a sensor container or insert 202, which has a removable lid 204. The user prepares the sensor insert 202 by removing the lid 204, which acts as a sterile barrier to protect the internal contents of the sensor insert 202 and otherwise maintain a sterile internal environment. Removing the lid 204 exposes a platform 206 positioned within the sensor insert 202, and a connector assembly 207 (partially visible) is arranged within the platform 206 or otherwise strategically embedded therein. The connector assembly 207 contains a sensor module (not shown) and a tip module (not shown). The sensor module carries the sensor 110 ( Fig. 1), and the tip module carries an associated tip which is used to assist in the transcutaneous release of the sensor 110 under the user's skin during application of the sensor control device 104 ( Fig. 1).

[0023] Fig. Figure 2B shows the sensor applicator 102 and the preparation of the sensor applicator 102 for final assembly by the user. The sensor applicator 102 includes a housing 208, which is sealed at one end with an applicator cap 210. In some embodiments, an O-ring or another type of seal can seal a coupling between the housing 208 and the applicator cap 210. In at least one embodiment, the O-ring or seal can be cast onto the housing 208 or the applicator cap 210. The applicator cap 210 provides a barrier that protects the contents of the sensor applicator 102. In particular, the sensor applicator 102 includes an electronics housing (not shown) that holds the electrical components for the sensor control device 102 ( Fig. 1), and the applicator cap 210 may or may not maintain a sterile environment for the electrical components. Preparing the sensor applicator 102 involves 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 disposed of.

[0024] Fig. Figure 2C illustrates how the user inserts the sensor applicator 102 into the sensor insert 202. The sensor applicator 102 contains a sheath 212 configured to be received by the platform 206, temporarily unlocking the sheath 212 relative to the housing 208 and also temporarily unlocking the platform 206 relative to the sensor insert 202. Moving the housing 208 forward into the sensor insert 202 causes the connector assembly 207 ( Fig. 2A), which is arranged within the sensor insert 202, which contains the sensor and the tip modules, is coupled to the electronics housing which is arranged within the sensor applicator 102.

[0025] In Fig. In step 2D, the user removes the sensor applicator 102 from the sensor insert 202 by proximal retraction of the housing 208 in relation to the sensor insert 202.

[0026] Fig. 2E depicts the base or interior of the sensor applicator 102 after removal from the sensor insert 202 ( Fig. 2) The sensor applicator 102 is removed from the sensor insert 202, which contains the fully assembled sensor control device 104, and positioned for release at the target monitoring site. As shown, a tip 220 extends from the base of the sensor control device 104 and carries a portion of the sensor 110 within a hollow or recessed section. The tip 220 is configured to penetrate the skin of a user, thereby placing the sensor 110 in contact with bodily fluids.

[0027] The Fig. 2F and Fig. Figure 2G illustrates an exemplary release of the sensor control device 104 at a target monitoring location 222, such as the back of the user's arm. Fig. Figure 2F shows how the user moves the sensor applicator 102 forward to the target monitoring location 222. Upon contact with the skin at the target monitoring location 222, the sheath 212 folds into the housing 208, allowing the sensor control device 104 ( Fig. 2E and Fig. 2G) moved forward in contact with the skin. Using the tip 220 ( Fig. 2E) the sensor 110 ( Fig. 2E) moved transcutaneously into the patient's skin at the target monitoring site 222.

[0028] Fig. Figure 2G shows the user withdrawing the sensor applicator 102 from the target monitoring site, with the sensor control device 104 successfully attached to the user's skin. The adhesive patch 108 ( Fig. 1), which is attached to the underside of the sensor control device 104, adheres to the skin to secure the sensor control device 104 in place. The tip 220 ( Fig. 2E) is automatically retracted when the housing 208 has moved completely forward to the target monitoring location 222, while the sensor 110 ( Fig. 2E) is left in position to measure analyte values.

[0029] For the system with a two-part architecture, the sensor insert 202 ( Fig. 2A) and the sensor applicator 102 ( Fig. 2B) are provided to the user as separate packages, thus requiring the user to open each package and assemble the system. In some applications, the discrete, sealed packages allow the sensor insert 202 and the sensor applicator 102 to be sterilized in separate sterilization processes that are unique to the contents of each package and otherwise incompatible with the contents of the other.

[0030] In particular, the sensor insert 202, which contains the connector assembly 207 ( Fig. 2A), which includes sensor 110 ( Fig. 1 and Fig. 2E) and the peak 220 ( Fig. 2E), can be sterilized using irradiation sterilization, such as electron beam (or “e-beam”) irradiation. However, irradiation sterilization can damage the electrical components located within the electronics housing of the sensor control device 104. Consequently, if the sensor applicator 102, which contains the electronics housing of the sensor control device 104, needs to be sterilized, it can be sterilized by another method, such as chemical gas sterilization using, for example, ethylene oxide. However, chemical gas sterilization can damage the enzymes or other chemical or biological preparations contained on the sensor 110.Because of this incompatibility of sterilization, the sensor insert 202 and the sensor applicator 102 can be sterilized in separate sterilization processes and then packaged separately, thus requiring the user to finally assemble the components upon receipt.

[0031] According to embodiments of the present disclosure, the system can be 100 ( Fig. 1) comprise a one-piece architecture that incorporates sterilization techniques specifically designed for a one-piece architecture. The one-piece architecture allows the System 100 to be delivered to the user in a single sealed package that requires no final assembly steps by the user. Rather, the user only needs to open a package and then release the sensor control device at the target monitoring location, as described above with reference to the Fig. The 2E-2G system is generally described. The one-piece system architecture described here can prove advantageous by 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 system contamination is decreased. Sterilization with focused electron beam and collimator

[0032] The Fig. 3A and Fig. Figure 3B are isometric or side views of an exemplary sensor control device 302 according to one or more embodiments of the present disclosure. The sensor control device 302 (alternatively referred to as the “puck”) may be similar in some respects to the sensor control device 104 of Fig. 1 and can therefore best be understood with reference to it. The sensor control device 2302 can control the sensor control device 104 of Fig. 1 replace and can therefore be used together with the sensor applicator 102 ( Fig. 1) used, which releases the sensor control device 302 for a target monitoring location on the skin of a user.

[0033] The sensor control device 302 can, however, be integrated into a single-part system architecture. Unlike the system with a two-part architecture, for example, it is not necessary for a user to open multiple packages and finally assemble the sensor control device 302. Rather, upon receipt by the user, the sensor control device 302 is already fully assembled and correctly positioned within the sensor applicator 102. To use the sensor control device 302, the user only needs to break through a barrier (e.g., the applicator cap 210 of the sensor applicator). Fig. 2B), before immediately releasing the sensor control device 302 at the target monitoring location.

[0034] As shown, the sensor control device 302 includes an electronics housing 304, which is generally disk-shaped and may have a circular cross-section. In other embodiments, however, the electronics housing 304 may have a different cross-sectional shape, such as an oval (e.g., pill-shaped), a circular-rectangular intermediate shape, or a polygon, without deviating from the scope of the disclosure. The electronics housing 304 may be configured to accommodate or otherwise contain various electrical components used to operate the sensor control device 302.

[0035] The electronic enclosure 304 can include a shell 306 and a mount 308 that can be joined to the shell 306. The shell 306 can be attached to the mount 308 in a variety of ways, such as a snap-fit, press fit, sonic welding, or one or more mechanical fasteners (e.g., screws). In some cases, the shell 306 can be attached to the mount 308 in such a way as to create a sealed coupling between them. In such embodiments, a gasket or other type of sealing material can be positioned on or near the outer diameter (circumferential surface) of the shell 306 and the mount 308, and joining the two components together can compress the gasket, thereby creating a sealed coupling.In other embodiments, an adhesive can be applied to the outer diameter (circumferential surface) of the casing 306 and / or the holder 308. The adhesive secures the casing 306 and the holder 308 and provides structural integrity; it can also seal the coupling between the two components, thereby isolating the interior of the electronics housing 304 from external contamination. If the sensor control device 302 is assembled in a controlled environment, it may not be necessary to perform final sterilization of the internal electrical components. Rather, the adhesive coupling can provide a sufficiently sterile barrier for the assembled electronics housing 304.

[0036] The sensor control device 302 may further include a connector assembly 310, which may be coupled to the electronics housing 304. The connector assembly 310 may differ in some respects from the connector assembly 207. Fig. 2A similar. For example, the connector assembly 310 can include a sensor module 312 (partially visible) that can be connected to the tip module 314 (partially visible). The sensor module 312 can be configured to carry and otherwise contain a sensor 316 (partially visible), and the tip module 314 can be configured to carry and otherwise contain a tip 318 (partially visible) to assist in the transcutaneous deployment of the sensor 316 under the skin of a user during application of the sensor control device 302. As shown, corresponding portions of the sensor 316 and the tip 318 extend from the electronics housing 304 and, in particular, from the base of the holder 308. The exposed portion of the sensor 316 can be contained within a hollow or recessed portion of the tip 318. The remaining portion of the sensor 316 is positioned inside the electronics housing 304.

[0037] The Fig. 4A and Fig. Figure 4B shows isometric or exploded views of the connector assembly 310 according to one or more embodiments. The sensor module 312 can include the sensor 316, a connector 402, and a connecting element 404. The connector 402 can be designed to receive and support both the sensor 316 and the connecting element 404. As shown, a channel 406 can be defined through the connector 402 to receive a section of the sensor 316. Furthermore, the connector 402 can provide one or more deflectable arms 407 configured to snap into corresponding features provided on the base of the electronics housing 304. Fig. 3A-3B).

[0038] The sensor 316 comprises an extension 408, a flag 410, and a neck 412 connecting the extension 408 and the flag 410. The extension 408 can be configured to extend at least partially through the channel 406 and distal to the connector 402. The extension 408 contains an enzyme or other chemical or biological agent, and in some embodiments, a membrane can cover the agent. In use, the extension 408 is absorbed transcutaneously beneath the skin of a user, and the agent contained therein assists in analyte monitoring in the presence of body fluids.

[0039] The flag 410 can comprise a generally flat surface that includes one or more sensor contacts 414 (three are in Fig. 4B shown) arranged thereon. The sensor contact(s) 414 can be configured to align with a corresponding number of compliant carbon-impregnated polymer modules (not shown) encapsulated within the connecting element 404.

[0040] The connecting element 404 contains one or more hinges 418 that allow the connecting element 404 to move between open and closed positions. The connecting element 404 is in the Fig. 4A-4B is shown in the closed state, but can pivot to the open state to accommodate the flag 410 and the flexible carbon-impregnated polymer module(s) therein. The flexible carbon-impregnated polymer module(s) provide electrical contacts 420 (three are shown) configured for conductive communication between the sensor 316 and corresponding circuit arrangement contacts provided within the electronics housing 304 ( Fig. 3A-3B). The connecting element 404 can be made of silicone rubber and can serve as a moisture barrier for the sensor 316 when assembled in a compressed state and after application to a user's skin.

[0041] The tip module 314 includes the tip 318 and a needle hub 422 that supports the tip 318. The tip 318 includes an elongated shaft 424 and a tip tip 416 at its distal end. The shaft 424 can be configured to extend through the channel 406 and distal to the connector 402. The shaft 424 can also include a hollow or recessed section 428 that at least partially surrounds the extension 408 of the sensor 316. The tip tip 416 can be configured to penetrate the skin while supporting the extension 408, thereby bringing the active chemistry present on the extension 408 into contact with body fluids.

[0042] The needle hub 422 can include a small hub cylinder 430 and a hub snap latch 432, each of which can be configured to help connect the plug assembly 310 (and the entire sensor control device 302) to the sensor applicator 102 ( Fig. 1) to couple.

[0043] The Fig. 5A and Fig. Figure 5B shows exploded or isometric bottom views of the electronics housing 304 according to one or more embodiments. The casing 306 and the mounting 308 function as opposing hinged housing halves that contain the various electronic components of the sensor control device 302 ( Fig. 3A-3B) enclose or otherwise substantially encapsulate.

[0044] A printed circuit board (PCB) 502 can be positioned within the electronics housing 304. Several electronic modules (not shown) can be mounted to the PCB 502, which may, but are not limited to, include a data processing unit, resistors, transistors, capacitors, inductors, diodes, and switches. The data processing unit may, for example, comprise 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. In particular, the data processing unit may be configured to perform data processing functions, such functions, but are not limited to, filtering and encoding data signals, each corresponding to a user-seen analyte value.The data processing unit can also include an antenna for communicating with the reading device 106 (. Fig. 1) contain or otherwise communicate with her.

[0045] As shown, the housing 306, the bracket 308, and the PCB 502 each define corresponding central openings 504, 506, and 508, respectively. When the electronic housing 304 is assembled, the central openings 504, 506, and 508 align coaxially to accommodate the connector assembly 310 ( Fig. 4A-4B). A battery 510 can also be included in the electronics housing 304 and configured to power the sensor control device 302.

[0046] In Fig. 5B can define a socket 512 in the base of the bracket 308 and provide a location for the connector assembly 310 ( Fig. 4A-4B) can be taken up and coupled to the electronics housing 304, thereby enabling the sensor control device 302 ( Fig. 3A-3B) fully assembled. The profile of connector 402 ( Fig. 4A-4B) can be shaped to match or complement the socket 512, and the socket 512 can provide one or more snap bars 514 (two are shown) configured with the deflectable arms 497 ( Fig. 4A-4B) of the connector 402 to couple and receive it. The connector assembly 310 is coupled to the electronic housing 304 by moving the connector 402 forward into the socket 512 and allowing the deflectable arms 407 to snap into the corresponding snap-in tabs 514. When the connector assembly 310 ( Fig. 4A-4B) is correctly coupled to the electronic housing 304, one or more circuit arrangement contacts 516 (three are shown), which are defined on the underside of the PCB 502, can establish conductive communication with the electrical contacts 420 ( Fig. 4A-4B) of the connecting element 404 ( Fig. 4A-4B).

[0047] Fig. 6A and Fig. Figure 6B shows side or cross-sectional views of the sensor applicator 102 with the applicator cap 210 coupled to it. In particular, the Fig. Figures 6A-6B show how, according to at least one embodiment, the sensor applicator 102 could be sent to and received by a user. In some embodiments, however, the sensor applicator 102 could furthermore be sealed within a pouch (not shown) and delivered to the user inside the pouch. The pouch can be made of a variety of materials that help to prevent the ingress of moisture into the sensor applicator 102, which could adversely affect the sensor 316. In at least one embodiment, the sealed back side could be made of a film. Any of the sensor applicators described or discussed herein can be sealed within the pouch and delivered to the user.

[0048] According to the present revelation and as in Fig. As shown in Figure 6B, the sensor control device 302 is already assembled and installed within the sensor applicator 102 before it is delivered to the user. The applicator cap 210 can be connected to the housing 208 via a thread and may contain a tamper-evident ring 602. When the applicator cap 210 is rotated (e.g., unscrewed) relative to the housing 208, the tamper-evident ring 602 may break, thereby releasing the applicator cap 210 from the sensor applicator 102. The user can then release the sensor control device 302 to the target monitoring location, as generally described above with reference to the Fig. 2E-2G is described.

[0049] In some embodiments, as noted above, the applicator cap 210 can be attached to the housing 208 via a sealed engagement to protect the internal components of the sensor applicator 102. In at least one embodiment, an O-ring or other type of seal can seal the coupling between the housing 208 and the applicator cap 210. The O-ring or seal can be a separate component or, alternatively, cast onto the housing 208 and the applicator cap 210.

[0050] The housing 208 can be made from a variety of rigid materials. In some embodiments, for example, the housing 208 can be made from a thermoplastic polymer such as polyketone. In other embodiments, the housing 208 can be made from a cyclic olefin copolymer (COC), which can help prevent moisture from entering the interior of the sensor applicator 102. As can be seen, any of the housings described or discussed here can be made from polyketone or COC.

[0051] With specific reference to Fig. 6B The sensor control device 302 can be loaded into the sensor applicator 102 by merging the needle hub 422 with a sensor carrier 604, which is contained in the sensor applicator 102. Once the sensor control device 302 is merged with the sensor carrier 604, the applicator cap 210 can then be attached to the sensor applicator 102.

[0052] In the illustrated embodiment, a collimator 606 is positioned within the applicator cap 210 and can generally contribute to supporting the sensor control device 302 while 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 cast with or overmolded onto the applicator cap 210. In other embodiments, the collimator 606 can comprise a separate structure that is fitted into or attached to the applicator cap 210 without departing from the scope of the disclosure. In still other embodiments, as discussed below, the collimator 606 can be omitted from the packaging received by the user but used elsewhere while the sensor applicator 102 is sterilized and prepared for shipment.

[0053] The collimator 606 can be designed to contain and help protect parts of the sensor control device 302 that must be sterile, and to 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 sterilization zone 608 (alternatively referred to as a "sterile barrier housing" or a "sterile sensor path") configured to contain the sensor 316 and the tip 318 as they extend from the base of the electronics housing 304. The sterilization zone 608 can generally include a hole or passage that extends at least partially through the body of the collimator 606.In the illustrated embodiment, the sterilization zone 608 extends through the entire body of the collimator 606, but alternatively it can extend only partially through it without deviating from the scope of protection of the disclosure.

[0054] When the sensor control device 302 is loaded into the sensor applicator 102 and the applicator cap 210 with the collimator 606 is attached to it, the sensor 316 and the tip 318 can be positioned within a sealed area 610, which is at least partially defined by the sterilization zone 608. The sealed area 610 is configured to isolate the sensor 316 and the tip 318 from external contamination and can include (enclose) selected sections of the interior of the electronics housing and the sterilization zone 608 of the collimator 606.

[0055] While positioned within the sensor applicator 102, the fully assembled sensor control device 302 can be subjected to irradiation sterilization 612. The irradiation sterilization 612 can, for example, include electron beam irradiation; however, other sterilization methods may be used alternatively, including, but not limited to, low-energy X-ray irradiation. In some embodiments, the irradiation sterilization 612 can be performed either by continuous irradiation or by pulsed beam irradiation. In pulsed beam irradiation, the irradiation sterilization beam 612 is focused on a target location, and the component part or device to be sterilized is moved to the target location, at which point the irradiation sterilization 612 is activated to provide a directed irradiation pulse.The irradiation sterilization unit 612 is then switched off, and another component part or device to be sterilized is moved to the destination, and the process is repeated.

[0056] The collimator 606 can be configured to focus the radiation (e.g., rays, waves, energy, etc.) from the irradiation sterilization 612 onto the components that require sterility, such as the sensor 316 and the tip 318. Specifically, the hole or passage of the sterilization zone 608 allows the radiation to pass through so that it strikes and sterilizes the sensor 316 and the tip 318, while the remaining sections of the collimator 606 prevent (or inhibit) the propagating radiation from destroying or damaging the electronic components within the electronics housing 304.

[0057] The sterilization zone 608 can have any suitable cross-sectional shape necessary to correctly focus the radiation onto the sensor 316 and the tip 318 for sterilization. In the illustrated embodiment, for example, the sterilization zone 608 is round and cylindrical, but could alternatively have a polygonal cross-sectional shape, such as cubic or rectangular (which includes, for example, a parallelogram), without deviating from the scope of protection of the disclosure.

[0058] In the illustrated embodiment, the sterilization zone 608 provides a first opening 614a at a first end and a second opening 614b at a second end opposite the first end. The first opening 614a can be configured to receive the sensor 316 and the tip 318 into the sterilization zone 608, and the second opening 614b can allow the radiation (e.g., rays, waves, etc.) from the irradiation sterilization 612 to enter the sterilization zone 608 and strike the sensor 316 and the tip 318.

[0059] In embodiments where the sterilization zone 608 has a conical or frustoconical shape, the first opening 614a may have a diameter smaller than the diameter of the second opening 614b. In such embodiments, for example, the size of the first opening 614a may be between about 0.5 mm and about 3.0 mm, and the size of the second opening 614b may be between about 5.0 mm and about 16.0 mm. However, as can be seen, the respective diameters of the first and second openings 614a,b may be larger or smaller than the ranges specified herein without deviating from the scope of the disclosure, depending on the application. In fact, the diameters of the first and second openings 614a,b only need to be large enough to ensure that a sufficient dose of radiation reaches the sensor 316 and the tip 318.Furthermore, in at least one embodiment the sterilization zone 608 can have a cylindrical shape, wherein the first and second openings 614a,b have identical diameters.

[0060] The body of the collimator 606 reduces or eliminates the penetration of the irradiation sterilization 612 through the body material and thus prevents damage to the electronic components within the electronic 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; however, it could alternatively comprise any material having a mass density similar to or greater than that of polyethylene. In some embodiments, the material for the collimator 606 could, for example, but is not limited to, a metal (e.g., lead, stainless steel) or a high-density polymer.

[0061] In at least one embodiment, the design of the collimator 606 can be modified so that the collimator 606 can be made of a material having a mass density of less than 0.9 grams per cubic centimeter (g / cc), yet still function to reduce or eliminate the impact of the irradiation sterilization 612 on the electronic components within the electronic housing 304. To achieve this, in some embodiments the size (e.g., the length) of the collimator 606 can be increased so that the propagating electrons from the irradiation sterilization 612 have to pass through a larger amount of material before potentially impacting sensitive electronics. The larger amount of material can help to absorb or disperse the dose of the irradiation sterilization 612, rendering it harmless to the sensitive electronics.In other embodiments, however, the opposite may also be true. In particular, the size (e.g., the length) of the collimator 606 can be reduced as long as the material for the collimator 606 exhibits a sufficiently high mass density.

[0062] In addition to the radiation-shielding properties of the collimator body 606, in some embodiments one or more shields 616 (one is shown) can be positioned inside the sensor housing 304 to protect sensitive electronic components from radiation while the sensor control device 302 is undergoing irradiation sterilization 612. The shield 616 can, for example, be positioned between a data processing unit 618 and the radiation source (e.g., an electron beam accelerator). In such embodiments, the shield 616 can be positioned adjacent to and otherwise aligned with the data processing unit 618 and the radiation source to block or attenuate the radiation exposure (e.g., the electron beam irradiation or energy) that could otherwise damage the sensitive electronic circuitry of the data processing unit 618.

[0063] Shield 616 may be made of any material capable of blocking (or substantially blocking) the passage of radiation. Suitable materials for Shield 616 include, but are not limited to, lead, tungsten, ferrous metals (e.g., stainless steel), copper, tantalum, osmium, or any combination thereof. Suitable metals may be corrosion-resistant, austenitic, and any non-magnetic metal with a density ranging from about 5 grams per cubic centimeter (g / cc) to about 15 g / cc. Shield 616 may be produced by a variety of manufacturing technologies, including, but not limited to, stamping, casting, injection molding, sintering, two-stage casting, or any combination thereof.

[0064] In other embodiments, however, the shield 616 may contain a metal-filled thermoplastic polymer, such as, but not limited to, polyamide, polycarbonate, or polystyrene. In such embodiments, the shield 616 may be produced by mixing the shielding material with an adhesive matrix and distributing the combination onto molded components or, alternatively, directly onto the data processing unit 618. Furthermore, in such embodiments, the shield 616 may comprise an enclosure that encapsulates (or substantially encapsulates) the data processing unit 618.

[0065] In some embodiments, a collimator seal 620 can be applied to the end of the collimator 606 to seal the sterilization zone 608 and thus the sealed area 610. As shown, the collimator seal 620 can seal the second opening 614b. The collimator seal 620 can be applied before or after the irradiation sterilization 612. In embodiments where the collimator seal 620 is applied before performing the irradiation sterilization 612, the collimator seal 620 can be made of a radiolucent microbial barrier material that allows irradiation to propagate through it. With the collimator seal 620 in place, the sealed area 610 can maintain a sterile environment for the assembled sensor control device 302 until the user removes (unscrews) the applicator cap 210.

[0066] In some embodiments, the collimator seal 620 may comprise two or more layers of different materials. The first layer may be made of a synthetic material (e.g., a fibrillated [flash-spun] high-density polyethylene fiber), such as Tyvek®, available from DuPont®. Tyvek® is very durable and puncture-resistant, and allows vapor penetration. The Tyvek® layer may be applied before or after irradiation sterilization 612, and following irradiation sterilization 612, a film or other vapor- and moisture-resistant material layer may be sealed (e.g., heat-sealed) over the Tyvek® layer to prevent the ingress of contaminants and moisture into the sterilization zone 608 and the sealed area 610.In other embodiments, the collimator seal 620 may comprise only a single protective layer applied to the end of the collimator 606. In such embodiments, the single layer is gas-permeable for the sterilization process but is also capable of providing protection against moisture and other harmful elements once the sterilization process is complete. Accordingly, the collimator seal 620 can function as a moisture and contamination barrier without deviating from the scope of protection described in the disclosure.

[0067] It is noted that, although the sensor 316 and the tip 318 generally extend concentrically from the base of the electronics housing 304 and into the sterilization zone 608 with a center line of the sensor applicator 102 and the applicator cap 210, an eccentric arrangement is considered here. In particular, in at least one embodiment, the sensor 316 and the tip 318 can extend eccentrically from the base of the electronics housing 304 to the center line of the sensor applicator 102 and the applicator cap 210. In such embodiments, the collimator 606 can be redesigned or otherwise configured so that the sterilization zone 608 is also positioned eccentrically to accommodate the sensor 316 and the tip 318 without deviating from the scope of protection of the disclosure.

[0068] In some embodiments, the collimator 606 may comprise a first or “inner” collimator, which may be incorporated into the applicator cap 210 or otherwise into the sensor applicator 102, as generally described above. A second or “outer” collimator (not shown) may also be included in the assembly (or manufacturing) process or otherwise used to assist in sterilizing the sensor applicator 102. In such embodiments, the outer collimator may be positioned outside the sensor applicator 102 and the applicator cap 210 and may be used concurrently with the inner collimator 606 to assist in focusing the irradiation sterilization 612 onto the sensor 316 and the tip 318.

[0069] In one embodiment, for example, the outer collimator can initially receive the irradiation sterilization 612. Similar to the inner collimator 606, the outer collimator can provide or define a hole or passage extending through it. The irradiation sterilization beams 612 passing through the passage of the outer collimator can be focused and received into the sterilization zone 608 of the inner collimator 606 via the second opening 614b. Accordingly, the outer collimator can operate to prefocus the radiation energy, and the inner collimator can then fully focus the irradiation energy onto the sensor 316 and the tip 318.

[0070] In some embodiments, the inner collimator 606 can be omitted if the outer collimator is capable of correctly and completely focusing the irradiation sterilization 612 to properly sterilize the sensor 315 and the tip 318. In such embodiments, the sensor applicator can be positioned adjacent to the outer collimator and subsequently subjected to the irradiation sterilization 612, and the outer collimator can prevent radiation energy from damaging the sensitive electronics within the electronics housing 304. Furthermore, in such embodiments, the sensor applicator 102 can be delivered to the user without the inner collimator 606 being positioned within the applicator cap 210, thus eliminating complexity in manufacturing and use.

[0071] Fig. Figure 7A is an enlarged cross-sectional side view of the sensor control device 302 mounted within the applicator cap 210 according to one or more embodiments. As stated above, sections of the sensor 316 and the tip 318 can be arranged within the sealed area 610 and thereby isolated from external contamination. The sealed area 610 can include (enclose) selection sections of the interior of the electronics housing 304 and the sterilization zone 608 of the collimator 606. In one or more embodiments, the sealed area 610 can be defined or otherwise formed by at least a first seal 702a, a second seal 702b, and the collimator seal 620.

[0072] The first seal 702a can be arranged to seal the coupling between the needle hub 422 and the top of the electronic housing 304. In particular, the first seal 702a can seal the coupling between the needle hub 422 and the casing 306. Furthermore, the first seal 702a can surround the first central opening 504 defined in the casing 306, thus preventing contaminants from migrating into the interior of the electronic housing 304 through the first central opening 504. In some embodiments, the first seal 702a can form part of the needle hub 422. For example, the first seal 702a can be cast onto the needle hub 422. In other embodiments, the first seal 702a can be cast onto the top of the casing 306. In still other embodiments, the first seal 702a can form a separate structure, such as a...comprising an O-ring or the like, which is inserted between the needle hub 422 and the top of the casing 306, without deviating from the scope of protection of the disclosure.

[0073] The second seal 702b can be arranged to seal the coupling between the collimator 606 and the base of the electronics housing 304. In particular, the second seal 702b can be arranged to seal the coupling between the bracket 308 and the collimator 606, or alternatively between the collimator 606 and the base of the connector 402 as it is received in the base of the bracket 308. In applications that include the connector 402, as shown, the second seal 702b can be configured to seal the socket 512 or to surround it in some other way. In embodiments that omit the connector 402, the second seal 702b can alternatively seal the second central opening 506 ( Fig. 5A), which is defined in the holder 308. Consequently, the second seal 702b can prevent contaminants from moving into the sterilization zone 608 of the collimator, and also from moving into the interior of the electronics housing 304 via the socket 512 (or alternatively the second central opening 506).

[0074] In some embodiments, the second seal 702b can form part of the collimator 606. For example, the second seal 702b can be cast onto the upper end of the collimator 606. In other embodiments, the second seal 702b can be cast onto the connector 402 or the base of the holder 308. In still other embodiments, the second seal 702b can comprise a separate structure, such as an O-ring or the like, which is inserted between the collimator 606 and the connector 402 or the base of the holder 308, without departing from the scope of protection of the disclosure.

[0075] When loading the sensor control device 302 into the sensor applicator 102 ( Fig. 6B) and attaching the applicator cap 210 to the sensor applicator 102 compress the first and second seals 702a,b, creating corresponding sealed couplings. The first and second seals 702a,b can be made of a variety of materials capable of creating a sealed coupling between opposing structures. Suitable materials include, but are not limited to, silicone, a thermoplastic elastomer (TPE), polytetrafluoroethylene (PTFE or Teflon®), and any combination thereof.

[0076] As discussed above, the collimator seal 520 can be configured to seal the floor of the sterilization zone 608 and thus the floor of the sealed area 610. Accordingly, the first and second seals 702a,b and the collimator seal 620 each create corresponding barriers at their respective sealing locations. The combination of these seals 702a,b and 620 enables the sealed area 610, which contains the sensor 316 and the tip 318, to be finally sterilized.

[0077] Fig. Figure 7B is an enlarged cross-sectional side view of a further embodiment of the sensor control device 302 mounted within the sensor applicator 102 according to one or more embodiments. In particular, it shows Fig. 7B Alternative embodiments of the first and second seals 702a,b are described. The first seal 702a is again arranged to seal the coupling between the needle hub 422 and the top of the electronics housing 304, and in particular to seal the first central opening 504 defined in the housing. In the illustrated embodiment, however, the first seal 702a can be configured to seal both axially and radially. In particular, when the sensor control device 302 is inserted into the sensor carrier 602, the needle 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 elements 704 of the sensor carrier 604 and one or more radially extending elements 706 of the sensor carrier 604.Such a double pre-tensioned engagement compresses the first seal 702a both axially and radially, thereby enabling the first seal 702a to seal against the top of the electronic housing 304 in both radial and axial directions.

[0078] The second seal 702b is again arranged to seal the coupling between the collimator 606 and the base of the electronics housing 304, and in particular between the holder 308 and the collimator 606, or alternatively between the collimator 606 and the base of the connector 402 as it is received in the base of the holder 308. In the illustrated embodiment, however, the second seal 702b can extend into the sterilization zone 608 and define or otherwise provide a cylindrical shaft 708 with a size to receive the sensor 316 and the tip 1408 as they extend from the base of the holder 308. In some embodiments, a desiccant 710 can be positioned within the cylindrical shaft to help maintain a low-humidity environment for moisture-sensitive biological components.

[0079] In some embodiments, the second seal 702b can be omitted, and the collimator 606 can be directly coupled to the electronics housing 304. In particular, in at least one embodiment, the collimator 606 can be coupled to the underside of the holder 308 by a thread. In such embodiments, the collimator 606 can provide or otherwise define a threaded extension configured to mesh with the threaded opening defined in the base of the holder 308. Coupling the collimator 606 to the holder 308 by a thread can seal the coupling between the collimator 606 and the base of the electronics housing 304 and thus act to isolate the sealed area 610.Furthermore, in such embodiments, the pitch and gauge of the threads defined on the collimator 606 and the holder 308 can correspond to those of the threaded engagement between the applicator cap 210 and the sensor applicator 102. As a result, when the applicator cap 210 is screwed onto or off the sensor applicator 102, the collimator 606 can be screwed onto or off the electronics housing 404 accordingly.

[0080] Embodiments disclosed here include: A. An analyte monitoring system comprising a sensor applicator, a sensor control device positioned within the sensor applicator and containing an electronics housing, a sensor extending from the base of the electronics housing, a needle hub positioned adjacent to the top of the electronics housing, and a tip supported by the needle hub and extending through the electronics housing and from the base of the electronics housing. The analyte monitoring system further comprises a cap coupled to the sensor applicator and a collimator positioned within the cap, defining a sterilization zone that accommodates the sensor and the tip extending from the base of the electronics housing. B. A method for preparing an analyte monitoring system includes loading a sensor control device into a sensor applicator, wherein the sensor control device comprises an electronics housing, a sensor extending from a bottom of the electronics housing, a needle hub positioned adjacent to a top of the electronics housing, and a tip carried by the needle hub and extending through the electronics housing and from the bottom of the electronics housing.The method further comprises attaching a cap to the sensor applicator, wherein a collimator is arranged inside the cap and defines a sterilization zone that accommodates the sensor and the tip extending from the bottom of the electronics housing, sterilizing the sensor and the tip by irradiation sterilization while they are positioned within the sterilization zone, and preventing radiation from the irradiation sterilization from damaging electronic components inside the electronics housing, using the collimator. C. A method for preparing an analyte monitoring system includes loading a sensor control device into a sensor applicator, the sensor control device comprising an electronics housing, a sensor extending from a base of the electronics housing, a needle hub positioned adjacent to a top of the electronics housing, and a tip supported by the needle hub and extending through the electronics housing and from the base of the electronics housing. The method further comprises positioning the sensor applicator adjacent to a collimator, subjecting the sensor and the tip to irradiation sterilization, and preventing radiation from the irradiation sterilization from damaging the electronic components within the electronics housing by means of the collimator.

[0081] 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 comprises a passage extending at least partially through the collimator. Element 2: wherein the sterilization zone has a cross-sectional shape selected from the group consisting of round, cubic, rectangular, and any combination thereof. Element 3: wherein the sterilization zone defines a first opening at a first end and a second opening at a second end, and wherein the first opening accommodates the sensor and the tip extending from the base of the electronics housing, and a seal is arranged at the second opening.Element 4: further comprising a sealed area enclosing the sterilization zone and a section of the interior of the electronics housing, wherein the sealed area is defined by a first seal sealing a coupling between the needle hub and the top of the electronics housing, a second seal sealing a coupling between the collimator and the bottom of the electronics housing, and a third seal sealing one end of the sterilization zone. Element 5: wherein the first seal surrounds a central opening formed in the top of the electronics housing and prevents contaminants from migrating through the central opening into the section of the interior of the electronics housing, and wherein the second seal surrounds an opening defined in the bottom of the electronics housing and prevents contaminants from migrating through the opening into the section of the interior of the electronics housing.Element 6: wherein the first seal provides an axial and / or a radial seal. Element 7: wherein the second seal extends into the sterilization zone and defines a cylindrical shaft that accommodates the sensor and the tip. Element 8: further comprising a printed circuit board arranged within the electronics housing, 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 an irradiation 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.

[0082] Element 10: further comprising creating a sealed area when the cap is attached to the sensor applicator, wherein the sealed area includes the sterilization zone and a portion of the interior of the electronics housing. Element 11: wherein creating the sealed area comprises creating a coupling between the needle hub and the top of the electronics housing with a first seal, sealing a coupling between the collimator and the bottom of the electronics housing with a second seal, and sealing one end of the sterilization zone with a third seal. Element 12: wherein sealing the coupling between the needle hub and the top of the electronics housing with the first seal comprises providing an axial seal and / or a radial seal with the first seal.Element 13: wherein the collimator comprises an inner collimator, and the sterilization of the sensor and the tip by irradiation further comprises positioning the sensor applicator adjacent to an outer collimator located outside the sensor applicator, focusing the radiation with the outer collimator so that it is received by the inner collimator, and preventing the radiation from damaging the electronic components within the electronics housing, with the outer and the inner collimator. Element 14: wherein the sterilization zone defines a first opening at a first end of the collimator and a second opening at a second end of the collimator, and wherein the sterilization of the sensor and the tip comprises introducing the radiation into the sterilization zone through the second opening.Element 15: wherein preventing the radiation from the irradiation sterilization from damaging the electronic components comprises blocking the radiation with the collimator material. Element 16: wherein a printed circuit board is arranged inside the electronics housing and a data processing unit is mounted to the printed circuit board, wherein the method further comprises protecting the data processing unit from radiation from the irradiation sterilization process by means of a shield positioned inside the electronics housing.

[0083] Element 17: wherein positioning the sensor applicator adjacent to the collimator includes arranging the collimator so that it is located outside the sensor applicator during irradiation sterilization.

[0084] As a non-restrictive example, exemplary combinations applicable to A, B and C are: Element 2 with Element 3; Element 4 with Element 5; Element 4 with Element 6; Element 4 with Element 7; Element 8 with Element 9; Element 10 with Element 11; and Element 11 with Element 12. External sterilization setups

[0085] Just a quick look again Fig. 1. With reference to this, the sensor control device must be sterilized before being delivered to an end user to ensure the product is free of viable microorganisms. The sensor 110 is usually sterilized using irradiation sterilization, such as irradiation with an electron beam (“e-beam”). However, irradiation sterilization can damage the electronic components within the sensor control device 104, which are usually sterilized by chemical gas sterilization (e.g., using ethylene oxide). Chemical gas sterilization, however, can damage the enzymes or other chemical or biological preparations contained on the sensor 110.

[0086] In the past, this sterilization incompatibility was circumvented by separating the sensor 110 and the electronic components and sterilizing them individually. However, this approach requires additional parts, packaging, process steps, and final assembly by the user, introducing an opportunity for user error. According to the present disclosure, the sensor control device 104, or any device requiring final sterilization, can be properly sterilized using an external sterilization arrangement designed to focus sterilization radiation (e.g., rays, waves, energy, etc.) onto component parts requiring sterilization while simultaneously preventing the propagating radiation from destroying or damaging sensitive electronic components.

[0087] Fig. Figure 8 is a schematic diagram of an exemplary external sterilization arrangement 800 according to one or more embodiments of the present disclosure. The external sterilization arrangement 800 (hereinafter the “arrangement 800”) may be designed or otherwise configured to assist in the sterilization of a medical device. The medical device 802 may, for example, include a sensor control device which, in some respects, is similar to the sensor control device 104. Fig. 1. Similar to, but could alternatively include other types of medical devices, health products, or systems that require final sterilization of specific component parts. Examples of medical devices or health products that may incorporate the principles of this disclosure include, but are not limited to, ingestible products, cardiac rhythm management (CRM) devices, subcutaneous detection devices, externally attached medical devices, or any combination thereof.

[0088] The medical device 802 can include a housing 804, a part 806 requiring sterilization, and one or more radiation-sensitive components 808. In the illustrated embodiment, the radiation-sensitive component 808 can be mounted on a printed circuit board (PCB) 810 positioned within the housing 804, and the housing 804 can include an electronics enclosure for a sensor control device. The radiation-sensitive component 808 can include one or more electronic modules, such as, but not limited to, a data processing unit (e.g., an application-specific integrated circuit or ASIC), a resistor, a transistor, a capacitor, an inductor, a diode, and a switch. In other embodiments, however, the radiation-sensitive component 808 can include a radiation-sensitive chemical solution or analyte, as described here with reference to Fig. 12 is described.

[0089] In some embodiments, part 806 can include a sensor (e.g., sensor 110 from Fig. 1), extending from the housing 804. As shown, the part 806 may extend at an angle from the base of the housing 804, but alternatively it could extend perpendicular to the base or from another surface of the housing 804. In at least one embodiment, the part 806 may further include a tip, which may also require sterilization and may assist in implanting the sensor under a user's skin. In some embodiments, as shown, the part 806 may be encapsulated with a cap 812, which provides a sealed barrier that protects exposed portions of the part 806 (e.g., the sensor and the associated tip) until the part 806 is needed for use.

[0090] The medical device 802 can be subjected to irradiation sterilization 814 to properly sterilize the part 806 for use. Suitable processes for irradiation sterilization 814 include, but are not limited to, electron beam (e-beam) irradiation, gamma beam irradiation, X-ray irradiation, or any combination thereof. In embodiments that include the cap 812, the cap can be made of a material that allows the radiation 814 to propagate through it to aid the irradiation sterilization of the part 806. Suitable materials for the cap 812 include, but are not limited to, a non-magnetic metal (e.g., aluminum, copper, gold, silver, etc.), a thermoplastic, ceramic, rubber (e.g., ebonite), a composite material (e.g., fiberglass, carbon fiber reinforced polymer, etc.), an epoxy, or any combination thereof.In some embodiments, the cap 812 may be transparent or translucent, but on the other hand it may be opaque without deviating from the scope of protection of the disclosure.

[0091] The arrangement 800 may include a radiation shield 916 positioned outside the medical device 802 and configured to assist in the sterilization of the part 806 while preventing (inhibiting) propagating radiation 814 from destroying or damaging the radiation-sensitive component(s) 808. To achieve this, the radiation shield 816 may provide a collimator 818, which generally comprises a hole or passage extending at least partially through the body of the radiation shield 816. The collimator 818 defines a sterilization zone 820 configured to focus the radiation 814 onto the part 806. In the illustrated embodiment, the part 806 may also be included within the sterilization zone 820 for sterilization.

[0092] While focusing the radiation 814 (e.g., rays, waves, energy, etc.) towards the part 806, the radiation shield 816 can be made of a material that reduces or eliminates the penetration of the radiation 814 and thus prevents damage to the radiation-sensitive component(s) 808 within the housing 804. In other words, the radiation shield 816 can be made of a material having a density sufficient to absorb the dose of radiation energy that is released. In some embodiments, for example, the radiation shield 816 can be made of any material having a mass density greater than 0.9 grams per cubic centimeter (g / cc). In other embodiments, however, the mass density of a suitable material can be less than 0.9 g / cc without exceeding the scope of the disclosure.Suitable materials for radiation shielding 816 include, but are not limited to, a high-density polymer (e.g. polyethylene, polypropylene, polystyrene, polytetrafluoroethylene, etc.), a metal (e.g. lead, stainless steel, aluminum, etc.), any combination thereof, or any material having a mass density greater than 0.9 g / cc.

[0093] The collimator 818 can have any suitable cross-sectional shape necessary to focus the radiation onto the part 806 for sterilization. In the illustrated embodiment, for example, the collimator 818 has a round cross-sectional shape with parallel sides. In other embodiments, however, the collimator 818 can have a polygonal cross-sectional shape, such as cubic or rectangular (which, for example, contains a parallelogram), without deviating from the scope of the disclosure.

[0094] In the illustrated embodiment, the collimator 818 provides a first opening 822a and a second opening 822b, the first and second openings 822a,b being defined at opposite ends of the sterilization zone 820. The first opening 822a can allow the radiation 814 to enter the sterilization zone 820 and strike the part 806, and the second opening 822b can be configured to receive the part 806 into the sterilization zone 820. In embodiments where the collimator 818 has a conical or frustoconical shape, the second opening 822b can have a diameter smaller than the diameter of the first opening 822a. In such embodiments, for example, the size of the second opening 822b can be between about 0.5 mm and about 3.0 mm, and the size of the first opening 822a can be between about 5.0 mm and about 16.0 mm.It is understood, however, that the respective diameters of the first and second openings 822a,b may be larger or smaller than the ranges specified herein without this constituting a deviation from the scope of the disclosure. In fact, the diameters of the first and second openings 822a,b can be adapted to the size of the device and need only be large enough to ensure that a sufficient dose of radiation reaches the part 806. In at least one embodiment in which the collimator 828 is cylindrical, the first and second openings 822a,b have the same diameters.

[0095] In some embodiments, the arrangement 800 may further include a barrier shield 824 positioned within the housing 804. The barrier shield 824 may be configured to help block the radiation 814 (e.g., electrons) from propagating within the housing 804 to the radiation-sensitive component(s) 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 814 is positioned vertically within the housing 804, but it may alternatively be positioned in any other angular configuration suitable for protecting the radiation-sensitive component(s) 808.

[0096] Fig. Figure 9 is a schematic diagram of a further exemplary external sterilization arrangement 900 according to one or more additional embodiments of the present disclosure. The external sterilization arrangement 900 (hereinafter referred to as the “arrangement 900”) may be similar in some respects to the arrangement 800 of Fig. 8 and can therefore best be understood with reference to it, where the same reference numerals refer to similar components that are not described again. Similar to the arrangement 800, the arrangement 900 may be constructed or otherwise configured to contribute to sterilizing a medical device 902. In the embodiment shown, the medical device 902 may comprise a two-part sensor control device, but could alternatively comprise any of the medical devices mentioned herein with reference to the medical device 802.

[0097] As shown, the medical device 902 comprises a housing 904, a part 906 requiring sterilization, and one or more radiation-sensitive components 908 positioned within the housing 904. The housing 904 may contain packaging or an enclosure that contains the part 906 and the radiation-sensitive component(s) 908. The radiation-sensitive component(s) 908 may be any of the electronic modules referred to herein by reference to the radiation-sensitive component(s) 908. Fig. The items mentioned in section 8 include, for example, a needle / sensor assembly, and may be subjected to irradiation sterilization (814) to properly sterilize part 906 for use.

[0098] The arrangement 900 may include a radiation shield 910 positioned outside the medical device 902 and configured to help sterilize part 906 while preventing (inhibiting) 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 internal cavity 912 into which the medical device 902 may be positioned. Similar to the radiation shield 816 of Fig. 8. The radiation shield 910 may provide a collimator 914, which generally includes a hole or passage extending at least partially through the body of the radiation shield 910 and providing access to the cavity 912. The collimator 914 may define a sterilization zone 916, which helps to focus the radiation 814 to the part 906. The radiation shield 910 may be made of any of the materials mentioned above with reference to the radiation shield 816, in order to reduce or eliminate the passage of the radiation 814, except at the collimator 914, and thereby damage the radiation-sensitive component(s) 908 within the housing 904.

[0099] To properly sterilize part 906, the irradiation sterilization 814 can be directed at the medical device 902. The collimator 914 and the sterilization zone 916 can be configured to concentrate and / or focus the irradiation sterilization 814 on part 906, while the remaining sections of the radiation shield 910 prevent (inhibit) 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 sterilization zone 916 have a circular cross-sectional shape with parallel sides, but could alternatively have other cross-sectional shapes, such as cubic or polygonal.

[0100] In some embodiments, the arrangement 900 may further include the barrier shield 824, which is positioned inside the housing 904 to help block radiation 814 (e.g. electrons) from propagating inside the housing 904 to the radiation-sensitive component(s) 908.

[0101] Fig. Figure 10 is a schematic diagram of a further exemplary external sterilization arrangement 1000 according to one or more additional embodiments of the present disclosure. The external sterilization arrangement 1000 (hereinafter referred to as the “arrangement 1000”) may be similar in some respects to the arrangement 900 of Fig. 15 and can therefore best be understood with reference to it, where the same reference numerals refer to similar components that are not described again. Similar to the arrangement 900, the arrangement 1000 may be constructed or otherwise configured to contribute to sterilizing a medical device 1002. In the embodiment shown, the medical device 1002 may be a sensor control device similar to the sensor control device 104 of Fig. 1, but could alternatively include any of the medical devices mentioned here with reference to medical device 802 of Fig. The 8 mentioned are included.

[0102] As shown, the medical device 1102 comprises a housing 1004, a part 1006 requiring sterilization, and one or more radiation-sensitive components 1008 positioned within the housing 1004. In the illustrated embodiment, the housing 1004 can be an electronics housing for a sensor control device (e.g., the sensor control device 104 of Fig. 1) include, and the radiation-sensitive component(s) 1008 may be any of the electronic modules referred to here in relation to the radiation-sensitive component(s) 808 of Fig. 8 are mentioned. In some embodiments, part 1006 may include a sensor (e.g., sensor 110 of Fig. 1) include, extending from the housing 1004, and may further include a tip which also requires sterilization and is used to help implant the sensor under a user's skin.

[0103] The arrangement 1000 may include a radiation shield 1010 positioned outside the medical device 1002 and configured to help sterilize the part 1006 while preventing (inhibiting) propagating radiation 814 from destroying or damaging the radiation-sensitive component(s) 1008. The radiation shield 1010 may be made of any of the materials described above with reference to the radiation shield 816 of Fig. 8 are named to reduce or eliminate the passage of radiation 814 and thereby damage the radiation-sensitive component(s) 1008 inside the housing 1004.

[0104] In the illustrated embodiment, the radiation shield 1010 can define or otherwise provide an internal cavity 1012 into which the medical device 1002 can be positioned for sterilization. In some embodiments, the radiation shield 1010 can comprise a box, and the internal cavity 1012 can be formed inside the box. The radiation shield 1010 can also provide a collimator 1014 that extends at least partially through the body of the radiation shield 1010 and provides access to the cavity 1012. The collimator 1014 can define a sterilization zone 1016 that focuses the radiation 814 onto the part 1006 for sterilization.

[0105] To properly sterilize part 1006, the irradiation sterilization 814 can be directed at the medical device 1002. The collimator 1014 and the sterilization zone 1016 can concentrate and / or focus the irradiation sterilization 814 on part 1006, while the remaining sections of the radiation shield 1010 prevent (inhibit) the propagating radiation 814 from damaging the radiation-sensitive component(s) 1008 within the housing 1004. In the illustrated embodiment, the collimator 1014 has a round cross-sectional shape with parallel sides, but could alternatively have other cross-sectional shapes, such as cubic or polygonal.

[0106] Fig. Figure 11 is a schematic diagram of a further exemplary external sterilization arrangement 1100 according to one or more additional embodiments of the present disclosure. The external sterilization arrangement 1100 (hereinafter referred to as the “arrangement 1100”) may in some respects be similar to arrangements 800, 900 and 1000 of the Fig. 8, Fig. Arrangements 9 and 10 are similar and can therefore best be understood with reference to them. Similar to arrangements 800-1000, arrangement 1100 may be constructed or otherwise configured to contribute to sterilizing a medical device 1102. In the embodiment shown, the medical device 1102 may comprise a two-part sensor control device, but could alternatively comprise any of the medical devices mentioned herein with reference to medical device 802.

[0107] As shown, the medical device 1102 comprises a housing 1104, a part 1106 requiring sterilization, and one or more radiation-sensitive components 1108 positioned within the housing 1104. The radiation-sensitive component(s) 1108 can be any of the electronic modules referred to here by reference to the radiation-sensitive component(s) 808 of Fig. 8 are mentioned. In the illustrated embodiment, for example, part 1106 may contain a needle / sensor assembly and may be subjected to irradiation sterilization 814 to properly sterilize part 1106 for use.

[0108] The arrangement 1100 may include a radiation shield 1110 positioned outside the medical device 1102 and configured to help sterilize the part 1106 while preventing (inhibiting) propagating radiation 814 from damaging the radiation-sensitive component(s) 1108. The radiation shield 1110 may be made of any of the materials described above with reference to the radiation shield 816 of Fig. 8 are named to reduce or eliminate the passage of radiation 814 and thereby damage the radiation-sensitive component(s) 1108.

[0109] In the illustrated embodiment, the radiation shield 1110 can comprise a hinged housing structure containing a first section 1112a and a second section 1112b that can be joined (or snapped into place) with the first section 1112a. The radiation shield 1110 can also provide or otherwise define an internal cavity 1114 into which the medical device 1102 can be positioned for sterilization. In some embodiments, as shown, the first and second sections 1112a,b can interact to define a portion of the internal cavity 1114, such that when the first and second sections 1112a,b are correctly joined, the internal cavity 1114 is formed. In other embodiments, however, the internal cavity 1114 can be defined entirely within the first section 1112a or entirely within the second section 1112b.

[0110] In some embodiments, the arrangement 1100 may further include an absorber 1116 configured to protect the medical device 1102. In at least one embodiment, as shown, sections of the absorber 1116 may be provided by, or otherwise form part of, each of the first and second sections 1112a,b. In such embodiments, the internal cavity 1114 may be formed at least partially by the absorber 1116. The absorber 1116 may be made of a material that absorbs scattered radiation without causing the generation of bremsstrahlung protons. The material for the absorber 1116 may, for example, be any of the high-density polymers described here for radiation shielding 816. Fig. The 8 mentioned are included.

[0111] Similar to the radiation shielding 816 from Fig. 8. The radiation shield 1110 can provide a collimator. In the illustrated embodiment, however, the radiation shield 1110 provides or otherwise defines a first collimator 1118a and a second collimator 1118b, but could alternatively contain only one of the collimators 1118a,b without deviating from the scope of the disclosure. The first collimator 1118a generally comprises a hole or passage extending at least partially through the first section 1112a of the radiation shield 1110, and the second collimator 1118b generally comprises a hole or passage extending at least partially through the second section 1112b.Each collimator 1118a,b provides access to the internal cavity 1114, and the collimators 1118a,b together define a sterilization zone 1120 which contains the internal cavity 1114 and helps to focus the radiation 814 to the part 1106 for sterilization.

[0112] To properly sterilize part 1106, the medical device 1102 can be positioned within the internal cavity 1114, and the opposing sections 1112a,b can be joined to encapsulate the medical device 1102. Once correctly positioned within the cavity 1114, the medical device 1102 can be located within the sterilization zone 1120. The irradiation sterilizer 814 can then be directed at the medical device 1102 on opposite sides of the radiation shield 1110, and the collimators 1118a,b can concentrate and / or focus the irradiation sterilizer 814 onto part 1106 on opposite sides of part 1106. The remaining sections of the radiation shielding 1110 prevent (inhibit) the propagating radiation 814 from damaging the radiation-sensitive component(s) 1108 inside the housing 1104.In the embodiment shown, each collimator 1118a,b has a round cross-sectional shape, but could alternatively have other cross-sectional shapes, including, but not limited to, cubic or polygonal shapes.

[0113] In some embodiments, the arrangement 1100 may further include one or more barrier shields 824 (two are shown) positioned inside the housing 1104 to help block radiation 814 (e.g. electrons) from propagating inside the housing 1104 to the radiation-sensitive component(s) 1108.

[0114] Fig. Figure 12 is a schematic diagram of another exemplary external sterilization arrangement 1200 according to one or more additional embodiments of the present disclosure. The external sterilization arrangement 1200 (hereinafter referred to as the “arrangement 1200”) may be designed or otherwise configured to assist in sterilizing a medical device 1202, which in the illustrated embodiment comprises an injection needle or syringe. As shown, the medical device 1202 comprises a housing 1204 (e.g., a cylinder or ampoule), a part 1206 requiring sterilization, and one or more radiation-sensitive components 1208 positioned within the housing 1204. In the illustrated embodiment, the radiation-sensitive component 1208 may be a chemical solution or an analyte (e.g., an active agent, drug, biological preparation, etc.).) contain components that may be sensitive to irradiation, and part 1206 may include a needle designed to release the chemical solution.

[0115] In some embodiments, as shown, part 1206 can be enclosed or otherwise surrounded by a cap 1210 (e.g., a needle cap) that encapsulates part 1206. Furthermore, in at least one embodiment, the cap 1210 can be sealed to the housing 1204 by a sealing element 1212, such as an O-ring or the like. The cap 1210 and the sealing element 1212 can work together to provide a sterile barrier system that surrounds and protects exposed portions of the part until it is needed for use. Part 1206 can be subjected to irradiation sterilization 814 to properly sterilize it for use.

[0116] The arrangement 1200 can include a radiation shield 1214 positioned outside the medical device 1202 and configured to help sterilize part 1206 while preventing (inhibiting) propagating radiation 814 from damaging the radiation-sensitive component 1208. As shown, the radiation shield 1214 can provide a collimator 1216, which generally includes a hole or passage extending at least partially through the body of the radiation shield 1214 and defining a sterilization zone 1218 configured to focus the radiation 814 to part 1206 for sterilization. In the illustrated embodiment, part 1206 can also be included within the sterilization zone 1218.The collimator 1216 allows the radiation 814 to pass through so that it strikes and sterilizes part 1206, while the remaining sections of the radiation shield 1214 prevent (inhibit) the propagating radiation 814 from damaging the radiation-sensitive component(s) 1208 within the housing 1204. In the illustrated embodiment, the collimator 1216 has a round cross-sectional shape with parallel sides, but alternatively, it can have other cross-sectional shapes, such as polygonal or cubic, or any combination thereof.

[0117] In embodiments incorporating the cap 1210, the body of the cap 1210 may comprise a material that allows the propagation of radiation 814 through it to assist the irradiation sterilization of part 1206. Suitable materials for the cap 1210 may be the same as those described here for the cap 812 of Fig. 8 are mentioned.

[0118] In some embodiments, the arrangement 1200 may further include the barrier shield 824, which is positioned to help block the propagation of radiation 814 (e.g., electrons) within the housing 1204 to the radiation-sensitive component 1208 (e.g., the chemical solution). In the illustrated embodiment, the barrier shield 824 may define or otherwise provide a central opening 1220 configured to allow the radiation-sensitive component 1208 to exit the housing 1204 via the part 1206 (e.g., the needle). In other embodiments, the barrier shield 824 may provide a coiled path that allows the radiation-sensitive component 1208 to exit the housing 1204 via the part 1206.

[0119] Fig. Figure 13 is an isometric view of an exemplary sensor control device 1302 according to one or more additional embodiments of the present disclosure. The sensor control device 1302 may be identical or similar to the sensor control device 104 of Fig. 1 and can therefore be used together with the sensor applicator 102 ( Fig. 1) used to deploy the sensor control device 1302 for a target monitoring site on the skin of a user. Alternatively, the sensor control device 1302 can be characterized as a medical device similar to one or more of the medical devices 1402-1202 of the Fig. 8-12 are described here. Accordingly, the sensor control device 1302 may also require proper sterilization before use.

[0120] As shown, the sensor control device 1302 includes an electronics housing 1304, which is generally disk-shaped and may have a circular cross-section. In other embodiments, however, the electronics housing 1304 may have a different cross-sectional shape, such as an oval (e.g., pill-shaped), a circular-rectangular intermediate shape, or a polygon, without deviating from the scope of the disclosure. The electronics housing 1304 may be configured to accommodate or otherwise contain various electronic components used to operate the sensor control device 1302.

[0121] The electronic enclosure 1304 can include a shell 1306 and a mount 1308 that can be joined to the shell 1306. The shell 1306 can be attached to the mount 1308 in a variety of ways, such as a snap-fit, press fit, sonic welding, one or more mechanical fasteners (e.g., screws), or any combination thereof. In some cases, the shell 1306 can be attached to the mount 1308 in such a way as to create a sealed coupling between them. In such embodiments, a gasket or other type of sealing material can be positioned on or near the outer diameter (circumferential surface) of the shell 1306 and the mount 1308, and joining the two components together can compress the gasket, thereby creating a sealed coupling.In other embodiments, an adhesive can be applied to the outer diameter (circumferential surface) of the casing 1306 and / or the holder 1308. The adhesive secures the casing 1306 and the holder 1308 and provides structural integrity, but can also seal the coupling between the two components and thereby isolate the interior of the electronic housing 1304 from external contamination.

[0122] In the illustrated embodiment, the sensor control device 1302 may further include a connector assembly 1310, which may be coupled to the electronics housing 1304. The connector assembly 1310 may include a sensor module 1312 (partially visible), which may be connected to the tip module 1314 (partially visible). The sensor module 1312 may be configured to carry and otherwise contain a sensor 1316 (partially visible), and the tip module 1314 may be configured to carry and otherwise contain a tip 1318 (partially visible) to assist in the transcutaneous delivery of the sensor 1316 under the skin of a user during application of the sensor control device 1302. The tip module 1314 may include a needle hub 320 carrying the tip 1318.

[0123] As shown, corresponding sections of the sensor 1316 and the tip 1318 extend from the electronics housing 1304 and, in particular, from the base of the holder 1308. The exposed section of the sensor 1316 (alternatively referred to as the "extension") can be accommodated within a hollow or recessed section of the tip 1318. The remaining sections of the sensor 1316 are positioned inside the electronics housing 1304.

[0124] Fig. 14A is a side view of the sensor applicator 102 from Fig. 1. As shown, the sensor applicator 102 comprises a housing 1402 and an applicator cap 1404, which may be detachably coupled to the housing 1402. In some embodiments, the applicator cap 1404 may be connected to the housing 1402 via a thread and may include a tamper-evident ring 1406. When the applicator cap 1404 is rotated (e.g., unscrewed) relative to the housing 1402, the tamper-evident ring 1406 may break, thereby releasing the applicator cap 1404 from the sensor applicator 102. Once the applicator cap 1404 is removed, a user can then use the sensor applicator 102 to operate the sensor control device 1302 ( Fig. 13 and Fig. 14B) to position at a target monitoring location on the user's body.

[0125] In some embodiments, the applicator cap 1404 can be attached to the housing 1402 via a sealed engagement to protect the internal components of the sensor applicator 102. In at least one embodiment, an O-ring or another type of seal can seal the coupling between the housing 1402 and the applicator cap 1404. The O-ring or seal can be a separate component or, alternatively, cast onto the housing 1402 and the applicator cap 1404.

[0126] Fig. Figure 14B is a cross-sectional side view of the sensor applicator 102. As shown, the sensor control device 1302 can be incorporated into the sensor applicator 102, and the applicator cap 1404 can be coupled to the sensor applicator 102 to secure the sensor control device 1302 therein. The sensor control device 1302 can contain one or more radiation-sensitive components 1408 arranged within the electronics housing 1304. The radiation-sensitive component 1408 can include an electronic component or module, 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, for example, comprise an application-specific integrated circuit (ASIC) configured to implement one or more functions or routines associated with the operation of the sensor control device 1302. During operation, the data processing unit may perform data processing functions such as filtering and encoding data signals corresponding to a user-specified analyte value. The data processing unit may also include an antenna for communicating with the reading device 106. Fig. 1) contain or otherwise communicate with her.

[0127] In the illustrated embodiment, a cap filling 1410 can be positioned within the applicator cap 1404 and can generally contribute to supporting the sensor control device 1302 within the sensor applicator 102. In one or more embodiments, the cap filling 1410 can comprise an integral part or extension of the applicator cap 1404, such as being cast with or overmolded onto the applicator cap 1404. In other embodiments, the cap filling 1410 can comprise a separate structure that is fitted into or otherwise attached to the applicator cap 1404 without departing from the scope of protection of the disclosure.

[0128] The sensor control device 1302, and in particular the distal ends of the sensor 1316 and the tip 1318 extending from the base of the electronics housing 1304, can be sterilized while positioned within the sensor applicator 102. Specifically, the fully assembled sensor control device 1302 can be subjected to irradiation sterilization 1412, similar to the irradiation sterilization 814 of the Fig. The number of units can be 8-12. Irradiation sterilization 1412 can be performed either by continuous irradiation or by pulsed beam irradiation. In pulsed beam irradiation, the irradiation sterilization beam 1412 is focused on a target location, and the component or device to be sterilized is moved to the target location. At this point, the irradiation is activated to deliver a directed irradiation pulse. The irradiation sterilization 1412 is then switched off, and another component or device to be sterilized is moved to the target location, and the process is repeated.

[0129] According to the present disclosure, an external sterilization arrangement 1414 can be used to help focus the radiation 1412 when sterilizing the distal ends of the sensor 1316 and the tip 1318, while simultaneously preventing (inhibiting) the propagating radiation 1412 from damaging the radiation-sensitive component 1408. As shown, the external sterilization arrangement 1414 (hereinafter the “arrangement 1414”) can include a radiation shield 1416 that is 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 focus the radiation 1412 (e.g., rays, waves, energy, etc.) to the components to be sterilized.In particular, the external collimator 1418 allows the radiation 1412 to pass through to strike and sterilize the sensor and tip 1318, but prevents the radiation 1412 from damaging the radiation-sensitive component 1408 inside the electronic housing 1304.

[0130] In the illustrated embodiment, the external collimator 1418 is designed to align with an internal collimator 1420, which is defined by the cap filling 1410. Similar to the external collimator 1418, the internal collimator 1420 can help focus the radiation 1412 to the components to be sterilized. As shown, the cap filling 1410 can define a radial shoulder 1422 that is sized to accommodate or otherwise fit one end of the radiation shield 1416, and the external collimator 1418 transitions into the internal collimator 1420 at the radial shoulder 1422. In some embodiments, the transition between the external and internal collimators 1418, 1420 can then be continuous, flush, or seamless. In other embodiments, however, the transition can be discontinuous or step-like without deviating from the scope of protection of the disclosure.

[0131] The external and internal collimators 1418, 1420 can work together to define a sterilization zone 1424 that focuses the radiation 1412 and in which the distal ends of the sensor 1316 and the tip 1318 can be positioned. The propagating radiation 1412 can pass through the sterilization zone 1424 to strike and sterilize the sensor 1316 and the tip 1318. However, the cap filling 1410 and the radiation shield 1416 can each be made of materials that essentially prevent the radiation 1412 from penetrating the inner wall(s) of the sterilization zone 1424 and thereby damaging the radiation-sensitive component 1408 within the housing 1304. In other words, the cap filling 1410 and the radiation shielding 1416 can each be made of materials having a density sufficient to absorb the dose of released radiation energy.In some embodiments, for example, the cap filling 1410 and / or the radiation shielding 1416 may be made of a material having a mass density greater than 0.9 grams per cubic centimeter (g / cc). In other embodiments, however, the mass density of a suitable material may be less than 0.9 g / cc without deviating from the scope of the disclosure. Suitable materials for the cap filling 1410 and the radiation shielding 1416 include, but are not limited to, a high-density polymer (e.g., polyethylene, polypropylene, polystyrene, polytetrafluoroethylene, etc.), a metal (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 filling 1410 may be made of machined or 3D-printed polypropylene, and the radiation shielding 1416 may be made of stainless steel.

[0132] In some embodiments, the design of the sterilization zone 1424 may be modified so that the cap filling 1410 and / or the radiation shielding 1416 may be made of a material having a mass density of less than 0.9 g / cc, yet still function to prevent the irradiation sterilization 1412 from damaging the radiation-sensitive component 1408. In such embodiments, the size (e.g., the length) of the collimator 1424 may be increased so that the propagating electrons from the irradiation sterilization 1412 must pass through a larger quantity of material before potentially impacting the radiation-sensitive component 1408. The larger quantity of material may help to absorb or disperse the dose of the radiation 1412, rendering it harmless to the sensitive electronics. In other embodiments, however, the opposite may equally be true.In particular, the size (e.g. the length) of the sterilization zone 1424 can be reduced as long as the material for the cap filling 1410 and / or the radiation shielding 1416 has a sufficiently high mass density.

[0133] The sterilization zone 1424, defined by the external and internal collimators 1418, 1420, can have any suitable cross-sectional shape necessary to correctly focus the radiation 1412 onto the sensor 1316 and the tip 1318 for sterilization. In the illustrated embodiment, for example, the external and internal collimators 1418, 1420 have a circular cross-section with parallel sides. In other embodiments, however, the external and / or the collimator 1418, 1420 can have a polygonal cross-sectional shape, such as cubic or rectangular (e.g., containing a parallelogram), without deviating from the scope of the disclosure.

[0134] In the illustrated embodiment, the sterilization zone 1424 provides a first opening 1426a, defined by the external collimator 1418, and a second opening 1426b, defined by the internal collimator 1420, with the first and second openings 1426a,b being located at opposite ends of the sterilization zone 1424. The first opening 1426a allows the radiation 1412 to enter the sterilization zone 1424, and the second opening 1426b provides a location where the radiation 1412 can act on the sensor 1316 and the tip 1318. In the illustrated embodiment, the second opening 1426b also provides a location where the sensor 1316 and the tip 1318 can be accommodated within the sterilization zone 1424. In embodiments in which the sterilization zone 1424 has a round cross-section, the diameters of the first and second openings 1426a,b can be essentially the same.

[0135] In embodiments where the sterilization zone 1424 has a conical or frustoconical shape, the diameter of the first opening 1426a can be larger than the diameter of the second opening 1426b. In such embodiments, for example, the size of the first opening 1426a can be between about 5.0 nm and about 16.0 mm ID, and the size of the second opening 1426b can be between about 0.5 mm and about 3.0 mm. However, the respective diameters of the first and second openings 1426a,b can be larger or smaller than the ranges specified herein without deviating from the scope of the disclosure, depending on the application. In fact, the diameters of the first and second openings 1426a,b only need to be large enough to allow a sufficient radiation dose to reach the sensor 1316 and the tip 1318.

[0136] In the illustrated embodiment, the inner wall(s) of the sterilization zone 1424 (e.g., the outer and inner collimators 1418, 1420) extend between the first and second openings 1426a, b at a substantially constant angle relative to the centerline of the sensor applicator 102. The angle of the wall(s) can be any angle between 0° and 90° relative to the centerline of the sensor applicator 102. However, the angle of the wall(s) is preferably between 45° and 90° relative to the centerline of the sensor applicator 102. In other embodiments, however, the angle of the wall(s) can vary between the first and second openings 1426a, b without deviating from the scope of the disclosure. In such embodiments, parts of the wall(s) may extend over short distances at an angle that differs from adjacent parts, or the wall(s) may otherwise run in a wave-like manner between the first and the second opening 1426a,b.

[0137] In some embodiments, the sterilization zone 1424 defined by the outer and inner collimators 1418 can be substantially cylindrical and otherwise have a circular or polygonal cross-section. In such embodiments, the first and second openings 1426a,b can have identical diameters, and the walls of the sterilization zone 1424 can be substantially parallel between the first and second ends of the sterilization zone 1424.

[0138] In some embodiments, a cap seal 1428 (shown with dashed lines) may be arranged at the coupling between the cap filling 1410 and the radiation shield 1416. The cap seal 1428 may comprise a radiolucent microbial barrier. In some embodiments, the cap seal 1428 may, for example, be made of a synthetic material (e.g., a fibrillated, high-density polyethylene fiber), such as Tyvek®, available from DuPont®. The cap seal 1428 may seal a portion of the sterilization zone 1424 to help form part of a sealed area 1430 configured to isolate the sensor 1316 and the tip 1318 from external contamination.

[0139] The sealed area 1430 can contain (enclose) selection sections of the interior of the electronics housing 1304 and the sterilization zone 1424. In one or more embodiments, the sealed area 1430 can be defined or otherwise formed by at least the cap seal 1428, a first or "upper" seal 1432a, and a second or "lower" seal 1432b. The cap seal 1428 and the upper and lower seals 1432a,b can each create barriers at their respective sealing locations, thereby enabling the sterilization zone 1424, which includes the sensor 1316 and the tip 1318, to be finally sterilized.

[0140] The upper seal 1432a can be arranged to seal the coupling between the needle hub 1320 and the top of the electronics housing 1304 (i.e., the casing 1306 of Fig. 13) to seal and thereby prevent contaminants from migrating into the interior of the electronic housing 1304. In some embodiments, the upper seal 1432a can form part of the needle hub 1320, for example, by being cast onto the needle hub 1320. In other embodiments, however, the upper seal 1432a can form part of the top surface of the casing 1306 or be cast onto it. In still other embodiments, the upper seal 1432a can comprise a separate structure, such as an O-ring or the like, which is inserted between the needle hub 1320 and the top surface of the casing 1306 without departing from the scope of protection of the disclosure.

[0141] The lower seal 1432b can be arranged to seal the coupling between the cap filling 1410 and the bottom of the electronics housing 1304 (i.e., the bracket 1308 of Fig. 13) to seal. The lower seal 1432b can prevent contaminants from migrating into the sterilization zone 1424 and into the interior of the electronic housing 1304. In some embodiments, the lower seal 1432b can form part of the cap filling 1410, for example, by being poured onto the upper end of the cap filling 1410. In other embodiments, the lower seal 1432b can form part of the base of the holder 1308 or be poured onto it. In still other embodiments, the lower seal 1432b can comprise a separate structure, such as an O-ring or the like, which is inserted between the cap filling 1410 and the base of the holder 1308 without departing from the scope of protection of the disclosure.

[0142] When the sensor control device 1302 is loaded into the sensor applicator 102 and the applicator cap 1404 is attached to the sensor applicator 102, the upper and lower seals 1432a,b can be compressed, creating corresponding sealed couplings. The upper and lower seals 1432a,b can be made of a variety of materials capable of creating a sealed coupling between opposing structures. Suitable materials include, but are not limited to, silicone, a thermoplastic elastomer (TPE), polytetrafluoroethylene (e.g., TEFLON®), or any combination thereof.

[0143] It is noted that, although the sensor 1316 and the tip 1318 generally extend concentrically from the base of the electronics housing 1304 and into the sterilization zone 1424 with a center line of the sensor applicator 102 and the applicator cap 1404, an eccentric arrangement is considered here. In particular, in at least one embodiment, the sensor 1316 and the tip 1318 can extend eccentrically from the base of the electronics housing 1304 to the center line of the sensor applicator 102 and the applicator cap 1404. In such embodiments, the external and internal collimators 1418, 1420 can be redesigned or otherwise configured so that the sterilization zone 1424 is also positioned eccentrically to accommodate the sensor 1316 and the tip 1318 without deviating from the scope of protection of the disclosure.

[0144] In some embodiments, the external sterilization arrangement 1414 may further include a sterilization housing or “sleeve” 1434 that is coupled to or forms part of the radiation shield 1416. The sterilization sleeve 1434 provides or otherwise defines a chamber 1436 sized to accommodate all or part of the sensor applicator 102. Once correctly inserted (received) within the sterilization sleeve 1434, the sensor applicator 102 can be subjected to irradiation sterilization 1412 to sterilize the sensor 1316 and the tip 1318. The sterilization sleeve 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 sleeve 1434.

[0145] In some embodiments, the radiation shield 1416 can be detachably coupled to the sterilization sleeve 1434 using one or more mechanical fasteners 1438 (one of which is shown), but could also be detachably coupled via a press fit, a snap closure, etc. The detachable coupling of the radiation shield 1416 to the sterilization sleeve 1434 allows the radiation shield 1416 to be interchangeable with differently designed shields (of different sizes) to accommodate specific sterilization applications for varying types and designs of the sensor applicator 102. Accordingly, the sterilization sleeve 1434 can include a universal mount that allows the radiation shield 1416 to be exchanged, if necessary, with other shield designs that have different parameters for the external collimator 1418.

[0146] In some embodiments, the external sterilization arrangement 1414 may further include a mounting insert 1440 that is coupled to or forms part of the sterilization sleeve 1434. The sterilization sleeve 1434 may be detachably coupled to the mounting insert 1440 using, for example, one or more mechanical fasteners 1442 (one of which is shown). The mounting insert 1440 may provide or define a central opening 1444 sized to accommodate the sensor applicator 102 and aligned with the chamber 1436 to allow the sensor applicator 102 to enter the chamber 1436. As described below, in some embodiments the mounting insert 1440 may define multiple central openings 1444 for accommodating several corresponding sensor applicators for sterilization.

[0147] Fig. Figure 15 is a cross-sectional side view of the sensor applicator 102 and another example embodiment of the external sterilization arrangement 1414 according to one or more additional embodiments. As shown, the sensor control device 1302 is again incorporated into the sensor applicator 102, and the applicator cap 1404 is coupled to the housing 1402 to secure the sensor control device 1302 therein.

[0148] In the illustrated embodiment, the applicator cap 1404 can be inverted and can define or otherwise provide a cap post 1502 sized to accommodate the distal ends of the sensor 1316 and the tip 1318 extending from the base of the electronics housing 1304. The cap post 1502 helps to provide a portion of the sealed area 1430 configured to isolate the sensor 1316 and the tip 1318 from external contamination. In the illustrated embodiment, the sealed area 1430 can be defined or otherwise formed by the cap post 1502 and the upper and lower seals 1432a,b, which create appropriate barriers at their respective sealing locations. The upper seal 1432a can be rearranged to couple the needle hub 1320 and the upper end of the electronics housing 1304 (i.e., the casing 1306 of Fig. 13) to seal, and the lower seal 1432b can be arranged to provide a coupling between the applicator cap 1404 and the bottom of the electronics housing 1304 (i.e., the holder 1308 of Fig. 13) to seal. In some embodiments, the lower seal 1432b can be inserted between the cap post 1502 and the bottom of the electronics housing 1304.

[0149] In the illustrated embodiment, the radiation shield 1416 can be positioned outside the sensor applicator 102 and can extend into the reversed section of the applicator cap 1404. The external collimator 1418 provided by the radiation shield 1416 defines a sterilization zone 1504 configured to focus the radiation 1412 to the sensor 1316 and the tip 1318. In the illustrated embodiment, the cap post 1502 and sections of the sensor 1316 and the tip 1318, which are positioned inside the cap post 1502, extend into the sterilization zone 1504. Propagating radiation 1412 can pass through the sterilization zone 1504 to sterilize the sensor 1316 and the tip 1318, which are positioned inside the cap post 1502.However, as indicated above, the cap filling 1410 may be made of a material that substantially prevents the radiation 1412 from penetrating the wall(s) of the sterilization zone 1504 and thereby damaging the radiation-sensitive component 1408 inside the housing 1304.

[0150] In the illustrated embodiment, the external collimator 1418 defines a first opening 1506a at a first end of the sterilization zone 1504 and a second opening 1506b at the second end of the sterilization zone 1504. The first opening 1506a allows the radiation 1412 to enter the sterilization zone 1504, and the second opening 1506b provides a location where the radiation 1412 is focused onto the sensor 1316 and the tip 1318. The second opening 1506b can also provide a location where the sensor 1316 and the tip 1318, which are positioned inside the cap post 1502, can be received into the sterilization zone 1504.In the illustrated embodiment, the external collimator 1418 and the associated sterilization zone 1504 are substantially cylindrical or otherwise have a round or polygonal cross-section, wherein the first and second openings 1506a,b have substantially the same diameters and the walls of the sterilization zone 1504 are substantially parallel.

[0151] Fig. Figure 16 is a cross-sectional side view of the sensor applicator 102 and another example embodiment of the external sterilization arrangement 1414 according to one or more additional embodiments. As shown, the sensor control device 1302 is again incorporated into the sensor applicator 102, and the applicator cap 1404 is coupled to the housing 1402 to secure the sensor control device 1302 therein.

[0152] In the illustrated embodiment, the applicator cap 1404 can be reversed and can define or otherwise provide a cap post 1602 that is sized to accommodate the distal ends of the sensor 1316 and the tip 1318 extending from the base of the electronics housing 1304. Furthermore, the radiation shield 1416 can be positioned outside the sensor applicator 102 and can extend into the reversed section of the applicator cap 1404. In particular, the radiation shield 1416 can extend into the reversed section of the applicator cap 1404 and to the base of the cap post 1602. Unlike the cap post 1502 of Fig. 15 However, the bottom of the cap pile 1602 may be open. In some embodiments, a cap seal 1604 may be arranged at the coupling between the cap pile 1602 and the radiation shield 1416 to seal the open end of the cap pile 1602. The cap seal 1604 may be similar to the cap seal 1428 of Fig. It is 14B and will therefore not be described again.

[0153] In some embodiments, a cap filling 1606 can be positioned within the applicator cap 1404. In one or more embodiments, the cap filling 1606 can comprise an integral part or extension of the applicator cap 1404, such as being cast with or overmolded onto the applicator cap 1404. In other embodiments, the cap filling 1606 can comprise a separate structure that is fitted into or otherwise attached to the applicator cap 1404 without departing from the scope of the disclosure. The cap filling 1606 can also provide or otherwise define an internal collimator 1608 that can help focus the radiation 1412 to the components to be sterilized. In at least one embodiment, as shown, the cap post 1602 can be incorporated into the internal collimator 1608.

[0154] The external and internal collimators 1418, 1608 can work together to define a sterilization zone 1610 that focuses the radiation 1412 onto the sensor 1316 and the tip 1318. The propagating radiation 1412 can pass through the sterilization zone 1610 to reach and sterilize the sensor 1316 and the tip 1318. However, the cap filling 1606 and the radiation shield 1416 can each be made of any of the materials mentioned herein, which essentially prevent the radiation 1412 from penetrating the inner wall(s) of the sterilization zone 1610 and thereby damaging the radiation-sensitive component 1408 within the housing 1304. In at least one embodiment, the cap filling 1606 can be made of machined or 3D-printed polypropylene, and the radiation shielding 1416 can be made of stainless steel.

[0155] The external and internal collimators 1418, 1608 can jointly define a sterilization zone 1610 that focuses the radiation 1412 onto the sensor 1316 and the needle 1318. The propagating radiation 1412 can pass through the sterilization zone 1610 to reach and sterilize the sensor 1316 and the needle 1318. However, the cap filling 1606 and the radiation shielding 1416 can each consist of one of the materials mentioned here, which essentially prevent the radiation 1412 from penetrating the inner wall(s) of the sterilization zone 1610 and thereby damaging the radiation-sensitive component 1408 within the housing 1304. In at least one embodiment, the cap filling 1606 can be made of machined or 3D-printed polypropylene and the radiation shielding 1416 of stainless steel.

[0156] The external and internal collimators 1418, 1608 can have any suitable cross-sectional shape required to properly focus the radiation 1412 onto the sensor 1316 and the tip 1318 for sterilization. In the illustrated embodiment, for example, the external collimator 1418 is conical or frustoconical, and the internal collimator 1608 is substantially cylindrical with substantially parallel inner walls. However, in other embodiments, the external and internal collimators 1418, 1608 can have other cross-sectional shapes without deviating from the scope of the disclosure.

[0157] In the illustrated embodiment, the external collimator 1418 defines a first opening 1612a through which the radiation 1412 can enter the sterilization zone 1610, and a second opening 1612b, which is positioned at or near the lower opening of the cap post 1602 to focus the radiation 1412 onto the sensor 1316 and the tip 1318 positioned inside the cap post 160. The diameter of the first opening 1612a is larger than the diameter of the second opening 1612b, and as in previous embodiments, the size of the first opening 1612a can be between about 5.0 mm and about 16.0 mm, and the size of the second opening 1612b can be between about 0.5 mm and about 3.0 mm. In the illustrated embodiment, the external collimator 1418 directs the electrons of the radiation 1412 to the lower opening of the cap post 1602 and amplifies the electrons at the sensor 1316 and the needle 1318.

[0158] The cap seal 1604 can be arranged at the coupling between the radiation shield 1416 and the cap post 1602 and / or the cap infill 1606. The cap seal 1604 can seal a section of the sterilization zone 1610 to help form part of the sealed area 1430, which is configured to isolate the sensor 1316 and the tip 1318 from external contamination. The sealed area 1430 can include (enclose) selected sections of the interior of the electronics housing 1304 and the sterilization zone 1610. In the illustrated embodiment, the sealed area 1430 can be defined by the cap post 1602 and the upper and lower seals 1432a,b, which create appropriate barriers at their respective sealing locations, or it can be formed otherwise. The lower seal 1432b can be arranged to provide a coupling between the applicator cap 1404 and the bottom of the electronics housing 1304 (i.e.the bracket 1308 from . Fig. 13) to seal.

[0159] Fig. 17A and Fig. Figure 17B are isometric partial exploded top and bottom views of an example of the external sterilization arrangement 1414 according to one or more embodiments. In at least one embodiment, the arrangement 1414 can be designed or otherwise configured to accommodate and contribute to the sterilization of multiple sensor applicators 102 (i.e., with the sensor control devices positioned therein). In the embodiment shown, the mounting insert 1440 defines multiple central openings 1444 ( Fig. 17A), and several sterilization sleeves 1434 can be aligned at the central openings 1444 and coupled to the mounting insert 1440. The sensor applicators 102 can be accommodated within the sterilization sleeves 1434 via the central openings 1444, and each sterilization sleeve 1434 can have a corresponding shield 1416 ( Fig. 17B) exhibit which is coupled to it or otherwise forms part of it.

[0160] In some embodiments, the arrangement 1414 may further include a cover 1702 which can be joined with the mounting insert 1440. The cover 1702 may have several openings 1106 ( Fig. 17B) include or define that are sized to accommodate the upper ends of the sensor applicators 102 when the cover 1702 is placed on top of the mounting insert 1440. In some embodiments, the cover 1702 may be made of any of the materials mentioned herein for the radiation shield 1416 to help prevent the radiation sterilization from propagating through the walls of the assembly 1414. With the cover 1702 joined to the mounting insert 1414, the sensor applicators 102 may be encapsulated or otherwise enclosed within the assembly 1414.

[0161] Embodiments disclosed here include:

[0162] D. An external sterilization arrangement comprising a radiation shield that can be positioned outside a medical device having a part requiring sterilization and a radiation-sensitive component, and a collimator defined by the radiation shield that can be aligned with the part requiring sterilization, wherein the collimator focuses radiation from an irradiation sterilization process to the part requiring sterilization and the radiation shield prevents the radiation from damaging the radiation-sensitive component.

[0163] E. An external sterilization arrangement comprising a radiation shield that can be positioned outside a sensor applicator, which includes a housing, a cap coupled to the housing, and a sensor control device positioned inside the housing, wherein the sensor control device includes an electronics housing, a radiation-sensitive component located inside the electronics housing, and a sensor and tip extending from the electronics housing. The external sterilization arrangement further includes an external collimator defined by the radiation shield that can be aligned with the sensor and tip, wherein the external collimator focuses radiation from an irradiation sterilization process onto the sensor and tip, and the radiation shield prevents the radiation from damaging the radiation-sensitive component.

[0164] F. A method comprising arranging a radiation shield outside a sensor applicator comprising a housing, a cap coupled to the housing, and a sensor control device positioned inside the housing, wherein the sensor control device comprises an electronics housing, a radiation-sensitive component located inside the electronics housing, and a sensor and tip extending from the electronics housing. The method further comprises focusing radiation from an irradiation sterilization process onto the sensor and tip using an external collimator defined by the radiation shield, and preventing the radiation from damaging the radiation-sensitive component by means of the radiation shield.

[0165] Each of embodiments D, E, and F may include one or more of the following additional elements in any combination: Element 1: wherein the radiation shield is made of a material selected from the group consisting of a high-density polymer, a metal, and any combination thereof. Element 2: wherein the radiation-sensitive component is selected from the group consisting of an electronic module, a chemical solution, and any combination thereof. Element 3: wherein the collimator has a cross-sectional shape selected from the group consisting of round, cubic, rectangular, and any combination thereof. Element 4: further comprising a cap that encapsulates the part requiring sterilization and provides a sealed barrier.Element 5: wherein the radiation shield defines an internal cavity that accommodates the medical device, and the collimator focuses the radiation into the internal cavity.

[0166] 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 has a cross-sectional shape selected from the group consisting of round, cubic, rectangular, and any combination thereof. Element 8: further comprising a sterilization sleeve defining a chamber that receives at least a section of the sensor applicator, wherein the radiation shield is detachably coupled to the sterilization sleeve. Element 9: further comprising a mounting insert defining a central opening that can be aligned with the chamber and having a size to receive the sensor applicator, and a cover that can be joined with the mounting insert to enclose the sensor applicator.Element 10: wherein the external collimator can be aligned with an internal collimator defined by a cap filling positioned within the cap, and wherein the external and internal collimators interact to define a sterilization zone into which the sensor and tip are received. Element 11: wherein the external and internal collimators each comprise a cross-sectional shape selected from a group consisting of round, cubic, rectangular, and any combination thereof. Element 12: further comprising a cap seal arranged at a coupling between the external and internal collimators. Element 13: wherein the cap is inverted and provides a cap post that receives the sensor and tip.Element 14: wherein the external collimator and the cap post together define a sterilization zone and the sensor and tip, which are positioned inside the cap post, extend into the sterilization zone.

[0167] Element 15: wherein arranging the radiation shield outside the sensor applicator comprises positioning the sensor applicator within a chamber defined by a sterilization sleeve, wherein the radiation shield is detachably coupled to the sterilization sleeve. Element 16: wherein positioning the sensor applicator within the chamber defined by the sterilization sleeve further comprises extending the sensor applicator through the central opening defined by a mounting insert and aligned with the chamber, positioning a cover on the mounting insert and thereby enclosing the sensor applicator, and performing the irradiation sterilization process while the sensor applicator is enclosed by the cover. Element 17: wherein the external collimator has a cross-sectional shape selected from a group consisting of round, cubic, rectangular, and any combination thereof.

[0168] As a non-restrictive example, exemplary combinations applicable to D, E and F include: Element 8 with Element 9; Element 10 with Element 11; Element 10 with Element 12; Element 13 with Element 14; and Element 15 with Element 16. Hybrid sterilization setups

[0169] Just a quick look again Fig. 1. With reference to this, the sensor control device must be sterilized before being delivered to an end user to ensure the product is free of viable microorganisms. The sensor 110 is usually sterilized using irradiation sterilization, such as irradiation with an electron beam (“e-beam”). However, irradiation sterilization can damage the electronic components within the sensor control device 104, which are usually sterilized by chemical gas sterilization (e.g., using ethylene oxide). Chemical gas sterilization, however, can damage the enzymes or other chemical or biological preparations contained on the sensor 110.

[0170] In the past, this sterilization incompatibility was circumvented by separating the sensor 110 and the electronic components and sterilizing them individually. However, this approach requires additional parts, packaging, process steps, and final assembly by the user, introducing an opportunity for user error. According to the present disclosure, the sensor control device 104, or any device requiring final sterilization, can be properly sterilized using external sterilization arrangements designed to focus sterilization radiation (e.g., rays, waves, energy, etc.) onto component parts requiring sterilization while simultaneously preventing the propagating radiation from destroying or damaging sensitive electronic components.

[0171] Fig. Figure 18 is an isometric view of an exemplary sensor control device 1802 according to one or more embodiments of the present disclosure. The sensor control device 1802 may be identical or similar to the sensor control device 104 of Fig. 1 and can therefore be used together with the sensor applicator 102 ( Fig. 1) used to deploy the sensor control device 1802 for a target monitoring site on a user's skin. Accordingly, the sensor control device 1802 also requires proper sterilization before use.

[0172] As shown, the sensor control device 1802 includes an electronics housing 1804, which is generally disk-shaped and may have a circular cross-section. In other embodiments, however, the electronics housing 1804 may have a different cross-sectional shape, such as oval (e.g., pill- or egg-shaped), a circular-rectangular intermediate shape, a polygon, or any combination thereof, without deviating from the scope of the disclosure. The electronics housing 1804 may be configured to accommodate or otherwise contain various electronic components used to operate the sensor control device 1802.

[0173] The electronic enclosure 1804 can include a shell 1806 and a mount 1808 that can be joined to the shell 1806. The shell 1806 can be attached to the mount 1808 in a variety of ways, such as a snap-fit, press 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 attached to the mount 1808 in such a way that a sealed coupling is created between them. In such embodiments, a gasket or other type of sealing material can be positioned on or near the outer diameter (circumferential surface) of the shell 1806 and the mount 1808, and joining the two components together can compress the gasket, thereby creating a sealed coupling.In other embodiments, an adhesive can be applied to the outer diameter (the circumferential surface) of the casing 1806 and / or the holder 1808. The adhesive secures the casing 1806 and the holder 1808 and provides structural integrity, but can also seal the coupling between the two components and thereby isolate the interior of the electronic housing 1804 from external contamination.

[0174] In the illustrated embodiment, the sensor control device 1802 may optionally include a connector assembly 1810, which may be coupled to the electronics housing 1804. The connector assembly 1810 may include a sensor module 1812 (partially visible), which is to be connected to the tip module 1814 (partially visible). The sensor module 1812 may be configured to carry and otherwise contain a sensor 1816 (partially visible), and the tip module 1814 may be configured to carry and otherwise contain an inserter or tip 1818 (partially visible) to assist in the transcutaneous delivery of the sensor 1816 under the skin of a user during application of the sensor control device 1802. In the illustrated embodiment, the tip module 1814 includes a needle hub 1820 that carries the tip 1818.

[0175] As shown, corresponding sections of the sensor 1816 and the tip 1818 extend distally from the electronics housing 1804 and, in particular, from the base of the holder 1808. In at least one embodiment, the exposed section of the sensor 1816 (alternatively referred to as the "extension") can be received within a hollow or recessed section of the tip 1818. The remaining sections of the sensor 1816 are positioned inside the electronics housing 1804.

[0176] Fig. 19A is a side view of the sensor applicator 102 from Fig. 1. As shown, the sensor applicator 102 comprises a housing 1902 and an applicator cap 1904, which may be detachably coupled to the housing 1902. In some embodiments, the applicator cap 1904 may be connected to the housing 1902 via a thread and may include a tamper-evident ring 1906. When the applicator cap 1904 is rotated (e.g., unscrewed) relative to the housing 1902, the tamper-evident ring 1906 may break, thereby releasing the applicator cap 1904 from the sensor applicator 102. Once the applicator cap 1904 is removed, a user can then use the sensor applicator 102 to operate the sensor control device 1802 ( Fig. 18) to position at a target monitoring location on the user's body.

[0177] Fig. Figure 19B is a cross-sectional side view of the sensor applicator 102. As shown, the sensor control device 1802 can be incorporated into the sensor applicator 102, and the applicator cap 1904 can be coupled to the housing 1902 to secure the sensor control device 1802 therein. The sensor control device 1802 can contain one or more radiation-sensitive components 1908 arranged within the electronics housing 1804. The radiation-sensitive component 1908 can comprise an electronic component or module, 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, for example, comprise an application-specific integrated circuit (ASIC) configured to implement one or more functions or routines associated with the operation of the sensor control device 1802. During operation, the data processing unit may perform data processing functions such as filtering and encoding data signals corresponding to a user-specified analyte value. The data processing unit may also include an antenna for communicating with the reading device 106 (. Fig. 1) contain or otherwise communicate with her.

[0178] In the illustrated embodiment, an applicator insert 1910 can be positioned within the applicator cap 1904 and can generally contribute to supporting the sensor control device 1802 within the sensor applicator 102. In one embodiment, the applicator insert 1910 can comprise an integral part or extension of the applicator cap 1904, such as being cast with or overmolded onto the applicator cap 1904. In other embodiments, the applicator insert 1910 can comprise a separate structure that is fitted into or otherwise attached to the applicator cap 1904 without departing from the scope of protection of the disclosure.In such embodiments, for example, screwing the applicator cap 1904 onto the housing 1908 can progressively move an inner surface 1912 of the applicator insert 1910 into axial and / or radial engagement with a bottom edge, surface or section of the applicator insert 1910 in order to secure the applicator insert 1910 inside the applicator cap 1904.

[0179] The sensor applicator 102 may further include a sheath 1914, and in some embodiments the applicator insert 1910 may engage with the sheath 1914 to rotatably fix the applicator insert 1910 within the applicator cap 1904. In particular, the applicator insert 1910 may provide or otherwise define one or more radial alignment features 1916 (one is shown) that can be aligned with a corresponding groove or slot 1918 defined in the sheath 1914. The radial alignment feature 1916 may, for example, comprise a rail, a flag, a tab, a projection or the like, which extends from the main body of the applicator insert 1910 and may, for example, be joined to the slot 1918 by sliding the radial alignment feature 1910 longitudinally into the slot 1918.A merging engagement between the radial alignment feature 1916 and the slot 1918 can also help to orient the applicator insert 1910 angularly (rotating) relative to the sensor control device 1802. However, as can be seen, the merging structures can alternatively be reversed, with the radial alignment feature 1916 instead positioned on the casing 1914 and the slot 1918 provided on the applicator insert 1910.

[0180] The applicator insert 1019 can provide or otherwise define an internal collimator 1920a, which forms part of a hybrid sterilization arrangement described in more detail below. The internal collimator 1920a can help define a section of a sterilization zone 1922, and in particular an upper section 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 tip 1818 can extend from the base of the electronics housing 1804 and be located in the upper section 1924.

[0181] In some embodiments, a microbial barrier 1926a can be positioned at an opening to the upper section 1924 of the sterilization zone 1922. The microbial barrier 1926a can help to seal at least a portion of the upper section 1924 of the sterilization zone 1922, thereby isolating the distal ends of the sensor 1816 and the tip 1818 from external contamination. The microbial barrier 1926a can be made of a radiolucent material, such as a synthetic material (e.g., a fibrillated, high-density polyethylene fiber). An example of a synthetic material is TYVEK®, available from DuPont®. In other embodiments, however, the microbial barrier 1926a can, but is not limited to, comprise a tape, paper, film, foil, or any combination thereof.In at least one embodiment, the microbial barrier 1926a can comprise a thinned section of the applicator insert 1910 or be formed by it in other ways, without deviating from the scope of protection of the disclosure.

[0182] In some embodiments, a moisture barrier 1926b can be positioned at an opening 1928 to the applicator cap 1904 or arranged otherwise. Similar to the microbial barrier 1926a, the moisture barrier 1926b can be configured to help isolate sections of the sensor applicator 102 from external contamination. The moisture barrier 1926b can be made of any of the materials mentioned above with reference to the microbial barrier 1926a. However, in at least one embodiment, the moisture barrier 1926b can comprise a thinned section of the applicator cap 1904 without deviating from the scope of protection of the disclosure. In such embodiments, the opening 1928 would not be necessary.

[0183] Fig. 20A-20C are different views of the applicator insert 1910 according to one or more embodiments of the disclosure. In particular, Fig. 20A an isometric top view, Fig. 20B is an isometric bottom view and Fig. Figure 20C is an isometric cross-sectional view of the applicator insert 1910. As shown, the applicator insert 1910 contains a generally cylindrical body 2002 having a first or upper end 2004a and a second or lower end 2004b opposite the upper end 2004a. The upper end 2004 is generally closed except for an opening 2005, which is sized to accommodate the sensor 1816 ( Fig. 19B) and the peak in 1918 ( Fig. 19B) thereby, and the lower end of 2004b is generally open.

[0184] The radial alignment feature 1916 described above is provided on a side wall of the body 2002. In some embodiments, additional radial alignment features 2008 (three are shown) may be provided or otherwise defined on the side wall of the body 2002. In the illustrated embodiment, the additional radial alignment features 2006 each comprise a pair of longitudinally extending tabs or projections 2008, which are angularly offset from one another on the side wall to work together to define a slot 2010 between them. The slot 2010 may be sized to accommodate a projection or tab located on the casing 1914 ( Fig. 19B) is provided to help to position the applicator insert 1910 relative to the sensor control device 1802 ( Fig. 19B) to be oriented angularly (rotating). In addition, similar to the arrangement of the radial alignment feature 1916, the joinable structures of the additional radial alignment features 2006 can alternatively be reversed, with the additional radial alignment features 2006 instead being provided on the sheath 1914 and the corresponding projection or tab being provided on the applicator insert 1910.

[0185] How best to in the Fig. 20A and Fig. As can be seen in Figure 20C, the applicator insert 1910 may further include one or more sensor fixing features 2012 which can also be used to help position the applicator insert 1910 relative to the sensor control device 1802 ( Fig. 19B) within the sensor applicator 102 ( Fig. 19B) to orient correctly. As shown, the sensor fixing features 2012 can be defined on the upper end 2004a of the body 2002 and extend axially from it. The sensor fixing features 2012 can be of a size that allows them to be received in corresponding openings defined in the base of the sensor control device 1802. In the illustrated embodiment, the sensor fixing features 2012 comprise cylindrical projections, but could alternatively comprise other types of structural features suitable for aligning with the corresponding features on the base of the sensor control device 1802.The sensor fixing features 2012 together with the radial alignment feature 1916 and the additional radial alignment features 2006 can prove to be particularly advantageous in embodiments in which the sensor control device 1802 comprises an eccentric orientation in which the sensor 1916 and the tip 1918 are not concentric with the center line of the sensor control device.

[0186] The internal collimator 1920a can be formed at the upper end 2004a of the applicator insert 1910 or provided otherwise. As is best done in Fig. As shown in Figure 20C, the internal collimator 1920a can be defined by the applicator insert 1910 and can include a collimating insert 2014 and a seal 2016. The internal collimator 1920a can be manufactured by first fabricating or otherwise producing the collimating insert 2014. The applicator insert 1910 can then be cast onto the collimating insert 2014. Alternatively, the collimating insert 2014 could be cast into the applicator insert 1910. Accordingly, the applicator insert 1910 can be made of a hard plastic. The seal 2016 can then be cast onto the applicator insert 1910 in a two-stage casting (overcasting) process.

[0187] The collimating insert 2014 can be made of a material that reduces or prevents the passage of sterilization radiation. Suitable materials for the collimating insert 2014 include, but are not limited to, a high-density polymer (e.g., polyethylene, polypropylene, polystyrene, polytetrafluoroethylene, polyamide, etc.), a metal (e.g., lead, tungsten, stainless steel, aluminum, etc.), a composite material, or any combination thereof. In some embodiments, the collimating insert 2014 can be made of any material having a mass density greater than 0.9 grams per cubic centimeter (g / cc).

[0188] The gasket 2016 can be made from any of the materials that contribute to a sealed coupling with the base of the electronics housing 1804 ( Fig. 19B) to form when the applicator insert 1910 is in the sensor applicator 102 ( Fig. 19B). Suitable materials for the seal 2016 include, but are not limited to, silicone, a thermoplastic elastomer (TPE), polytetrafluoroethylene (e.g., TEFLON®), or any combination thereof. As shown, the seal 2016 can fill a gap 2018 defined by the applicator insert 1910 and can provide an annular projection 2020 extending past and / or from the top of the upper end 2004a of the body 2002. The annular projection 2020 can prove advantageous not only by supporting a sealed coupling but also by helping to fill tolerances when the applicator insert 1901 is installed in the sensor applicator 102.Furthermore, the mass of the seal 2016 can also contribute to absorbing radiation during the sterilization process described below, thereby providing an additional protective layer against the propagation of radiation. In at least one embodiment, the seal 2016 can be large enough or made of a material that absorbs sufficient radiation so that the collimating insert 2014 can be omitted from the internal collimator 1920a.

[0189] Fig. Figure 21 is another cross-sectional side view of the sensor applicator 102. Fig. Figure 19A shows a hybrid sterilization arrangement 2102 according to one or more embodiments of the disclosure. The hybrid sterilization arrangement 2102, alternatively referred to as a "split collimation arrangement" or "cooperating collimation arrangement," can be used to help sterilize the sensor control device 1802, and in particular the distal ends of the sensor 1816 and the tip 1818 extending from the base of the electronics housing 1804, while they are positioned within the sensor applicator 102. In particular, the fully assembled sensor control device 1802 can be subjected to irradiation sterilization 2104 to sterilize the exposed portions of the sensor 1816 and the tip 1818.Suitable processes for irradiation sterilization 2104 include, but are not limited to, electron beam (e-beam) irradiation, gamma beam irradiation, X-ray irradiation or any combination thereof.

[0190] Irradiation sterilization 2104 can be performed either by continuous irradiation or by pulsed beam irradiation. In pulsed beam irradiation, the irradiation 2104 beam is focused on a target location, and the component or device to be sterilized is moved to the target location. At this point, the irradiation is activated to deliver a focused irradiation pulse. The irradiation 2104 is then switched off, and another component or device to be sterilized is moved to the target location, and the process is repeated.

[0191] According to the present disclosure, the hybrid sterilization arrangement 2102 can be used to help focus the radiation 2104 when sterilizing the distal ends of the sensor 1816 and the tip 1818, while simultaneously preventing (inhibiting) the propagating radiation 2104 from damaging the radiation-sensitive component 1908. As shown, the hybrid sterilization arrangement 2102 (hereinafter the “arrangement 2102”) can include the internal collimator 1920a described above and an external collimator 1920b. As shown, the internal collimator 1920a can be arranged inside 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 to the applicator cap 1904. The internal and external collimators 1920a,b can work together to define the sterilization zone 1922, which contains the radiation 2104 (e.g.,Rays, waves, energy, etc.) are focused to strike the sensor 1816 and the tip 1818 and sterilize them.

[0192] In the illustrated embodiment, the external collimator 1920b is designed to align itself with the internal collimator 1920a and, in particular, with the collimating insert 214. In at least one embodiment, the collimating insert 214 can, for example, define a radial shoulder 216 that is sized to receive or otherwise fit an end of the external collimator 1920b extending into the applicator cap 1904. The external collimator 1920b can transition into the internal collimator 1920a at the radial shoulder 2106. In some embodiments, the transition between the internal and external collimators 1920a,b can be continuous, flush, or seamless. In other embodiments, however, the transition can be discontinuous or stepped without deviating from the scope of the disclosure.

[0193] Similar to the collimating insert 214 of the internal collimator 1920a, the external collimator 1920b can be made of a material that essentially prevents the radiation 2104 from penetrating the inner wall(s) of the sterilization zone 1922 and thereby damaging the radiation-sensitive component 1908 within the electronic housing 1804. Accordingly, the external collimator 1920b can be made of any of the materials identified herein as suitable for the collimating insert 2014. In at least one embodiment, the collimating insert 2014 and the external collimator 1920b can each be made of stainless steel. However, as mentioned above, the seal 2016 can also provide a degree of shielding or protection against radiation damaging the radiation-sensitive component 1908.

[0194] The sterilization zone 1922, defined by the internal and external collimators 1920a,b, can have any suitable cross-sectional shape necessary to correctly focus the radiation 2104 onto the sensor 1816 and the tip 1818 for sterilization. In the illustrated embodiment, for example, the internal and external collimators 1920a,b have a circular cross-section with parallel sides. In other embodiments, however, the internal and / or external collimators 1920a,b can have a polygonal cross-sectional shape, such as cubic or rectangular (which, for example, contains a parallelogram), without deviating from the scope of the disclosure. In further embodiments, one or both of the internal and external collimators 1920a,b can have a circular cross-section with two parallel sides.

[0195] In the illustrated embodiment, the sterilization zone 1922 provides a first opening 2108a, defined by the external collimator 1920b, and a second opening 2108b, defined by the internal collimator 1920a, wherein the first and second openings 2108a,b are located at opposite ends of the sterilization zone 1922. The first opening 2108a allows the radiation 2104 to enter the sterilization zone 1922, and the second opening 2108b provides a location where the sensor 1816 and the tip 1818 can be inserted into the sterilization zone 1922.

[0196] In embodiments where the sterilization zone 1922 is conical or frustoconical, the diameter of the first opening 2108a may be larger than the diameter of the second opening 2108b. In such embodiments, for example, the size of the first opening 2108a may be between about 5.0 mm and about 16.0 mm, and the size of the second opening 21086 may be between about 0.5 mm and about 5.0 mm. However, the respective diameters of the first and second openings 2108a,b may be larger or smaller than the ranges specified herein without deviating from the scope of the disclosure, depending on the application. In fact, the diameters of the first and second openings 2108a,b only need to be large enough to allow a sufficient dose of radiation to reach the sensor 1816 and the tip 1818.

[0197] In embodiments in which the sterilization zone 1922 is substantially cylindrical and otherwise has a circular or polygonal cross-section, the first and second openings 2108a,b may have identical diameters. 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.

[0198] In the illustrated embodiment, the inner wall(s) of the sterilization zone 1922 (e.g., the inner and outer collimators 1920a,b) extend between the first and second openings 2108a,b at a substantially constant angle relative to the centerline of the sensor applicator 102. The angle of the wall(s) can be any angle between 0° and 90° relative to the centerline of the sensor applicator 102. However, the angle of the wall(s) can preferably be between 45° and 90° relative to the centerline. In other embodiments, however, the angle of the wall(s) can vary between the first and second openings 2108a,b without deviating from the scope of the disclosure. In such embodiments, parts of the wall(s) can extend over short distances at an angle that differs from adjacent parts, or the wall(s) can otherwise have a wavy shape between the first and second openings 2108a,b.

[0199] The microbial barrier 1926a can be installed at the coupling between the internal and external collimators 1920a,b and can otherwise be positioned at or near the radial shoulder. The microbial barrier 1926a can be present during the irradiation sterilization process. As stated above, the microbial barrier 1926a can help to seal at least a portion of the sterilization zone 1922. In particular, the microbial barrier 1926a can seal a portion of the sterilization zone 1922 to help form part of a sealed area 2110 configured to isolate the sensor 1816 and the tip 1818 from external contamination. The sealed area 2110 can include (enclose) selected portions of the interior of the electronics housing 1804 and the sterilization zone 1922.In one or more embodiments, the sealed area 2110 can be defined or otherwise formed by at least the microbial barrier 1926a, a first or "upper" seal 2112a, and a second or "lower" seal 2112b. The microbial barrier 1926a and the upper and lower seals 2112a,b can each correspond to barriers at their respective sealing locations, thereby enabling the sterilization zone 1922, which includes the sensor 1816 and the tip 1818, to be finally sterilized.

[0200] The upper seal 2112a can be arranged to seal the coupling between the needle hub 1820 and the top of the electronics housing 1804 (i.e., the casing 1806 of Fig. 18) to seal and thereby prevent contaminants from migrating into the interior of the electronic housing 1804. In some embodiments, the upper seal 2112a may form part of the needle hub 1820, for example, by being cast onto the needle hub 1820. In other embodiments, however, the upper seal 2112a may form part of the top surface of the casing 1806 or be cast onto it. In still other embodiments, the upper seal 2112a may comprise a separate structure, such as an O-ring or the like, which is inserted between the needle hub 1820 and the top surface of the casing 1806 without departing from the scope of protection of the disclosure.

[0201] The lower seal 211b can be used with the seal 2016 ( Fig. 20C) and in particular the ring-shaped lead 2020 ( Fig. 20A and Fig. 20C) overmolded onto the applicator insert 1920. In operation, the lower seal 2112b can be arranged to seal the coupling between the applicator insert 1910 and the base of the electronics housing 1804 (i.e., the holder 1808 of Fig. 18) to seal. The lower seal 2112b can prevent contaminants from migrating into the sterilization zone 1922 and into the interior of the electronic housing 1804.

[0202] When the sensor control device 1802 is loaded into the sensor applicator 102 and the applicator cap 1904 is attached to the sensor applicator 102, the upper and lower seals 2112a,b can be progressively compressed, creating corresponding sealed couplings. The upper and lower seals 2112a,b can be made of a variety of materials capable of creating a sealed coupling between opposing structures. Suitable materials include, but are not limited to, silicone, a thermoplastic elastomer (TPE), polytetrafluoroethylene (e.g., TEFLON®), or any combination thereof.

[0203] Once the irradiation 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 cover the opening 1928 in the applicator cap 1904. Upon delivery, a user can simply remove the applicator cap 1904 to prepare for the release of the sensor control device 1802. In at least one embodiment, removing the applicator cap 1904 simultaneously removes the applicator insert 1920, which may be received into the applicator cap 1904 in a manner that allows the applicator insert 1910 to be attached to the applicator cap 1904 for disassembly. In such embodiments, the applicator insert 1910 may, for example, be coupled to the applicator cap 1904 using a snap-fit ​​or the like.

[0204] In some embodiments, the electronics housing 1804 can be filled with an embedding material 2114 that fills gaps within the sensor control device 1802. The embedding material 2114 can comprise a biocompatible material that meets the requirements of ISO 10993. For example, in some embodiments, the embedding material 2114 can comprise a urethane material, such as Resinaid® 3672, or silicone materials, such as SI 5055 or SI 5240, available from Henkel®. In other embodiments, the embedding material 2114 can comprise an acrylic adhesive material, such as GE4949, available from Delo®.

[0205] The embedding material 2114 can also serve as an additional safety barrier for absorbing or deflecting propagating radiation 2104. In at least one embodiment, for example, the embedding material 2114 can exhibit an electron beam resistance of at least 85 kGy. Accordingly, it may be necessary for the radiation 2104 to pass through the embedding material 2114 before impacting the radiation-sensitive component(s) 1908, instead of passing through the air typically present within the electronics housing 1804. Although the embedding material 2114 cannot be a high-density material, it can nevertheless serve as an additional layer of radiation shielding. Furthermore, the embedding material 2114 can also increase the robustness of the sensor control device 1802 and the electronics housing 1804.As a result, the use of the embedding material 2114 may allow the electronics housing 1804 to be made from thinner materials, if desired.

[0206] It is noted that, although the sensor 1816 and the tip 1818 generally extend concentrically from the base of the electronics housing 1804 and into the sterilization zone 1922 with a center line of the sensor applicator 102 and the applicator cap 1904, an eccentric arrangement is considered here. In particular, in at least one embodiment, the sensor 1816 and the tip 1818 can extend eccentrically from the base of the electronics housing 1804 to the center line of the sensor applicator 102 and the applicator cap 1904. In such embodiments, the internal and external collimators 1920a,b can be redesigned or otherwise configured so that the sterilization zone 1922 is also positioned eccentrically to accommodate the sensor 1816 and the tip 1818 without deviating from the scope of the disclosure.

[0207] Fig. 22A and Fig. Figures 22B are isometric and cross-sectional side views of another embodiment of the applicator insert 1910. The applicator insert 1910, which is located in the Fig. The applicator insert shown in 22A-22B can, in most respects, be compared to the applicator insert 1910. Fig. 20A-20C will be similar. Unlike the 1910 applicator insert of the Fig. However, the applicator insert 1910 shows 20A-20C. Fig. 22A-22B an eccentric orientation, with the internal collimator 1920a eccentric to a midline 2202 ( Fig. 22B) of the body 2002. In such embodiments, the sensor control device 1802 ( Fig. 19B and Fig. 21) also show an eccentric orientation, so that the sensor 1816 ( Fig. 19B and Fig. 21) and the peak in 1818 ( Fig. 19B and Fig. 21) into the opening 2005, which is defined in the upper end 2004a of the applicator insert 1910. Furthermore, in such embodiments, the radial alignment feature 1916, the additional radial alignment features 2006, and the sensor fixing features 2012 can prove particularly advantageous in helping to align the applicator insert 1910 relative to the sensor control device 1802 within the sensor applicator 102 ( Fig. 19B and Fig. 21) to orient correctly.

[0208] Embodiments disclosed here include: H. A sensor applicator comprising a housing in which a sensor control device is arranged, the sensor control device comprising a sensor, a tip and a radiation-sensitive component, an applicator cap detachably coupled to the housing, an applicator insert that can be positioned within the applicator cap and defines an internal collimator that receives a distal end of the sensor and the tip, and an external collimator that can extend into the applicator cap, wherein the internal and external collimators work together to focus radiation from an irradiation sterilization process to the sensor and the tip while preventing the radiation from damaging the radiation-sensitive component. I. A method for sterilizing a sensor control device, comprising positioning the sensor control device within a housing of a sensor applicator, the sensor control device comprising a sensor, a tip, and a radiation-sensitive component, receiving a distal end of the sensor and the tip into an internal collimator defined by an applicator insert, detachably coupling an applicator cap to the housing and thereby securing the applicator insert within the applicator cap, extending an external collimator into the applicator cap and aligning the external collimator with the internal collimator, and cooperatingly focusing radiation from an irradiation sterilization process to the sensor and the tip with the internal and external collimators while simultaneously preventing the radiation from damaging the radiation-sensitive component. J. A hybrid sterilization arrangement comprising an applicator insert that can be positioned within an applicator cap of a sensor applicator, an internal collimator defined by the applicator insert to accommodate a distal end of a sensor and a tip of a sensor control device arranged within a housing of the sensor applicator, and an external collimator that can extend into the applicator cap and be aligned with the internal collimator, wherein the internal and external collimators work together to focus radiation from an irradiation sterilization process to the sensor and the tip while preventing the radiation from damaging the radiation-sensitive component.

[0209] Each of embodiments H, I, and J may include one or more of the following additional elements in any combination: Element 1: wherein the applicator insert engages with an inner surface of the applicator cap to 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 that can be joined with one or more corresponding features provided on the sheath to orient the applicator insert rotationally relative to the sensor control device.Element 3: further comprising one or more sensor fixing features provided on the applicator insert and capable of being coupled with one or more corresponding features on the sensor control device to orient the applicator insert rotationally relative to the sensor control device. Element 4: wherein the internal collimator includes a collimating insert and the external collimator can be aligned with the collimating insert. Element 5: wherein the collimating 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 seal capable of engaging with a base of the sensor control device to create a sealed coupling.Element 7: wherein the internal and external collimators interact to define a sterilization zone having a cross-sectional shape selected from the group consisting of round, cubic, rectangular, and any combination thereof. Element 8: further comprising an embedding material arranged within the sensor control device.

[0210] Element 9: further comprising engaging an inner surface of the applicator cap with the applicator insert and thereby axially securing the applicator insert within the applicator cap. Element 10: wherein the internal collimator comprises a seal, the method further comprising engaging the seal with a base of the sensor control device when the applicator insert is axially secured within the applicator cap, and creating a sealed coupling with the seal against the base of the sensor control device. Element 11: wherein the internal and external collimators interact to define a sterilization zone that accommodates the sensor and the tip, the method further comprising sealing at least a portion of the sterilization zone with a microbial barrier positioned at a coupling between the internal and external collimators.Element 12: wherein the internal collimator includes a collimating insert, and wherein aligning the external collimator with the internal collimator comprises aligning the external collimator with the collimating insert. Element 13: wherein the internal and external collimators, acting together, define a sterilization zone exhibiting a cross-sectional shape selected from the group consisting of round, cubic, rectangular, and any combination thereof.

[0211] Element 14: further comprising a microbial barrier positioned at a coupling between the internal and external collimators. Element 15: wherein the internal collimator comprises a collimating insert, and wherein the collimating 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 further comprises a seal that can engage with a base of the sensor control device to create a sealed coupling. Element 17: wherein the internal and external collimators, acting together, define a sterilization zone having a cross-sectional shape selected from the group consisting of round, cubic, rectangular, and any combination thereof.

[0212] As a non-restrictive example, exemplary combinations applicable to H, I and J include: Element 4 with Element 5; Element 4 with Element 6; Element 9 with Element 10; and Element 15 with Element 16. Internal sterilization arrangements

[0213] Before being shipped to an end user, some medical devices must be sterilized to eliminate viable microorganisms. However, some medical devices contain subcutaneous detection devices or sensors that require sterilization using irradiation, such as electron beam ("e-beam") irradiation. Irradiation sterilization can damage electronic components associated with the medical device, which are typically sterilized using chemical gas sterilization (e.g., using ethylene oxide). Furthermore, chemical gas sterilization can damage enzymes or other chemical or biological preparations contained within the subcutaneous detection devices.

[0214] In the past, this sterilization incompatibility was circumvented by separating the sub-skin detection devices and the electronic components and sterilizing them individually. However, this approach requires additional parts, packaging, process steps, and final assembly by the user, introducing an opportunity for user error. According to the present disclosure, any device requiring final sterilization can be properly sterilized using an internal sterilization arrangement designed to focus sterilization radiation (e.g., rays, waves, energy, etc.) to component parts requiring sterilization while simultaneously preventing the propagating radiation from destroying or damaging sensitive electronic components.

[0215] Fig. Figure 23 is a schematic diagram of an exemplary internal sterilization arrangement 2300 according to one or more embodiments of the present disclosure. The internal sterilization arrangement 2300 (hereinafter the “arrangement 2300”) may be designed or otherwise configured to assist in sterilizing a medical device. The medical device 2302 may comprise a type of health care product that includes any device, mechanism, or system that requires the 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 detection devices, externally mounted medical devices, drug delivery devices, or any combination thereof.

[0216] In the illustrated embodiment, the medical device 2302 comprises a subcutaneous sensing device or “sensor control device,” also referred to as an “in vivo analyte sensor control device.” As shown, the medical device 2302 can be contained within a sensor applicator 2304 (alternatively referred to as an “insert”), and a cap 2306 can be detachably coupled to the sensor applicator 2304. The medical device 2302 includes a housing 2308, a part 2310 requiring sterilization, and one or more radiation-sensitive components 2312. In some embodiments, the part 2310 can include a sensor extending from the housing 2308. In at least one embodiment, the part 2310 can further include a tip, which can also require sterilization and can assist in implanting the sensor under the skin of a user.As shown, part 2310 can extend at an angle from the base of the housing 2308, but could alternatively extend perpendicularly from the base or from any other surface of the housing 2308. Furthermore, as shown, part 2310 can extend offset from an end of the housing 2308 or otherwise from a centerline of the housing 2308, but could alternatively extend concentrically with the housing without deviating from the scope of protection of the disclosure.

[0217] The sensor applicator 2304 is used to release the medical device 2302 to a target monitoring site on a user's skin (e.g., the user's arm). In some embodiments, the cap 2306 can be threaded onto the sensor applicator 2304 and removed from the sensor applicator 2304 by unscrewing the cap 2306. Once the cap 2306 is removed, a user can then use the sensor applicator 2304 to position the medical device 2302 at a target monitoring site on the user's body. The part 2310 is positioned so that it can be placed transcutaneously or otherwise held beneath the surface of the user's skin. In some embodiments, the medical device 2302 can be spring-loaded for ejection from the sensor applicator 2304.Once released, the medical device 2302 can be held in position on the skin using an adhesive patch (not shown) coupled to the base of the medical device 2302.

[0218] In the illustrated embodiment, the radiation-sensitive component 2312 can be mounted on a printed circuit board (PCB) 2314, which is positioned within the housing 2308. The radiation-sensitive component 2312 can contain 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. In other embodiments, however, the radiation-sensitive component 2312 can contain a radiation-sensitive chemical solution or analytes (e.g., an active agent, drug, biological preparation, etc.).In such embodiments, the medical device 2302 may alternatively comprise an injection needle or syringe, and the chemical solution or analyte may be positioned within an ampoule of the medical device 2302.

[0219] The medical device 2302 can be subjected to irradiation sterilization 2316 to properly sterilize the part 2310 for use. Suitable processes for irradiation sterilization 2316 include, but are not limited to, electron beam (e-beam) irradiation, gamma beam irradiation, X-ray irradiation, or any combination thereof. The cap 2306 can define a collimator 2318 that allows the radiation 2316 to strike and sterilize the part 2310. However, the cap 2306 can also act as a radiation shield, helping to prevent (inhibit) the propagating radiation from destroying or damaging the radiation-sensitive component(s) 2312. To achieve this, the cap 2306 can be made of a material that reduces or prevents radiation 2316 from penetrating it.

[0220] In particular, the cap 2306 can be made of a material having a density sufficient to absorb the dose of the released radiation energy of the radiation 2316. 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). In other embodiments, however, the mass density of a suitable material can be less than 0.9 g / cc without departing from the scope of disclosure. Suitable materials for the cap 2306 include, but are not limited to, a high-density polymer (e.g., polyethylene, polypropylene, polystyrene, polytetrafluoroethylene, etc.), a metal (e.g., lead, stainless steel, aluminum, etc.), any combination thereof, or any material having a mass density greater than 0.9 g / cc.

[0221] As shown, the collimator 2318 generally comprises a hole or passage that extends at least partially through the cap 2306. The collimator 2318 defines a sterilization zone 2320 configured to focus the radiation 2316 onto the part 2310. In the illustrated embodiment, the part 2310 may be accommodated within the sterilization zone 2320 for sterilization. The collimator 2318 may have any cross-sectional shape necessary to focus the radiation 2316 onto the part 2310 for sterilization. In the illustrated embodiment, for example, the collimator 2318 has a circular cross-sectional shape with parallel sides. However, in other embodiments, the collimator 2318 may have a polygonal cross-sectional shape, such as cubic or rectangular (which, for example, includes a parallelogram), without departing from the scope of the disclosure.

[0222] In the illustrated embodiment, the collimator 2318 provides a first opening 2322a and a second opening 2322b, wherein the first and second openings 2322a,b are defined at opposite ends of the sterilization zone 2320. The first opening 2322a can allow the radiation 2316 to enter the sterilization zone 2320 and strike the part 2310, and the second opening 2322b can be configured to receive the part 2310 into the sterilization zone 2320. In embodiments in which the collimator 2318 is cylindrical, the first and second openings 2322a,b have the same diameter.

[0223] In some embodiments, the cap seal 2324 (shown with dashed lines) can be positioned at the opening of the collimator 2318 and, on the other hand, at the first opening 2322a. The cap seal 2324 can comprise a radiolucent microbial barrier. In some embodiments, the cap seal 2324 can, for example, be made of a synthetic material (e.g., a fibrillated, high-density polyethylene fiber), such as Tyvek®, available from DuPont®. In other embodiments, however, the cap seal 2324 can, but is not limited to, comprise tape, paper, film, or any combination thereof. In still other embodiments, the cap seal 2324 can comprise a thinned section of the cap 2306 without deviating from the scope of the disclosure. In such embodiments, the first opening 233a would be omitted.

[0224] The cap seal 2324 can seal a section of the sterilization zone 2320 to isolate part 2310 from external contamination, while simultaneously allowing the radiation 2316 to pass through to sterilize part 2310. In some embodiments, a desiccant (not shown) can be arranged within the sterilization zone 2320.

[0225] In some embodiments, the arrangement 2300 may further include a barrier shield 2326 positioned within the housing 2308. The barrier shield 2326 may be configured to help block the radiation 2316 (e.g., electrons) from propagating within the housing 2308 to 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 it may alternatively be positioned in any other angular configuration suitable for protecting the radiation-sensitive component(s) 2312.

[0226] Fig. Figure 24 is a schematic diagram of a further exemplary internal sterilization arrangement 2400 according to one or more additional embodiments of the present disclosure. The internal sterilization arrangement 2400 (hereinafter referred to as the “arrangement 2400”) may be similar in some respects to the arrangement 2300 of Fig. 23 and can therefore best be understood with reference to it, where the same reference symbols represent similar components that are not described in detail again. Similar to arrangement 2300 of Fig. 23 The arrangement 2400 may, for example, be designed or otherwise configured to contribute to a medical device 2402 that is similar to the medical device 2302 of Fig. 23 can be similar, to sterilize. The medical device 2402 can be a sensor control device similar to the medical device 2302 of Fig. 23, but alternatively it can include any of the health products mentioned here.

[0227] As shown, the medical device 2402 can be incorporated into a sensor applicator 2404 and, in particular, into a recess 2406 defined in the sensor applicator 2404. In some embodiments, a desiccant (not shown) can be arranged within the recess 2406. Similar to the medical device 2302 of Fig. 23 The medical device 2402 can include the housing 2308, the part 2310 requiring sterilization, and the radiation-sensitive component(s) 2312. In some embodiments, the arrangement 2400 can further include the barrier shield 2326, as generally described above. As shown, the part 2310 can extend perpendicularly from the bottom of the housing 2308, but alternatively it could extend at an angle or from another surface. Furthermore, as shown, the part 2310 can extend along a centerline of the housing 2308, but alternatively it can extend eccentrically to the centerline without departing from the scope of protection of the disclosure.

[0228] The sensor applicator 2404 is used to deliver the medical device 2402 to a target monitoring site on a user's skin (e.g., the user's arm). As shown, the sensor applicator 2404 can include a spring-loaded button 2408 that is at least partially enclosed within the sensor applicator 2404. The button 2408 extends within a channel 2409 defined in the sensor applicator 2404 and can engage with the top of the housing 2308 at its lower end. In at least one embodiment, a sealed coupling is created where the base of the button 2408 engages with the housing 2308. The medical device 2402 can be deployed from the recess 2406 by pressing the button 2408, which acts on the housing 2308 and thereby pushes the medical device 2402 distally out of the recess 2406 and away from the sensor applicator 2404.Part 2310 is positioned so that it can be placed transcutaneously or otherwise held beneath the surface of the user's skin. Once released, the medical device 2402 can be held in position on the skin using an adhesive patch (not shown) coupled to the base of the medical device 2402.

[0229] The medical device 2402 can be subjected to irradiation sterilization 2316 to properly sterilize part 2310 before use. In the illustrated embodiment, the irradiation sterilization 2316 is directed at the upper end of the sensor applicator 2404, and the button 2408 defines a collimator 2410 that allows the radiation 2316 to strike and sterilize part 2310. As shown, the collimator 2410 generally comprises a hole or passage that extends at least partially through the button 2408. The collimator 2410 focuses the radiation 2316 onto part 2310 and can have any suitable cross-sectional shape necessary to focus the radiation 2316 onto part 2310 for sterilization. In the illustrated embodiment, for example, the collimator 2410 has a circular cross-section with parallel sides.In other embodiments, however, the collimator 2410 can have a polygonal cross-sectional shape, such as cubic or rectangular (which, for example, contains a parallelogram), without deviating from the scope of protection of the disclosure.

[0230] However, sections of the sensor applicator 2404 and the button 2408 can also act as a radiation shield, helping to prevent (inhibit) propagating radiation 2316 from destroying or damaging the radiation-sensitive component(s) 2312, except through the collimator 2410. To achieve this, the sensor applicator 2404 and the button 2408 can be made of a material similar to the material of the cap 2306 of Fig. 23. In at least one embodiment, the irradiation sterilization 2316 can be emitted from a device or machine configured to focus and / or aim the radiation 2316 directly into the collimator 2410, thereby reducing the exposure by radiation 2316 to adjacent sections of the sensor applicator 2404.

[0231] In some embodiments, a first seal 2412a (shown with dashed lines) can be positioned in the opening of the recess 2406, and a second seal 2314b can be arranged at the opening to the collimator 2410 at the top of the button 2406. The seals 2412a,b can comprise radiolucent microbial barriers, similar to the cap seal 2324 of Fig. 23. The first seal 2412a can seal the recess 2406 on the base 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 the radiation 2316 to pass through to sterilize the part 2310.

[0232] Fig. Figure 25 is a schematic diagram of a further exemplary internal sterilization arrangement 2500 according to one or more additional embodiments of the present disclosure. The external sterilization arrangement 2500 (hereinafter referred to as the “arrangement 2500”) may be similar in some respects to arrangements 2300 and 2400 of the Fig. 23 and Fig. 24 and can therefore best be understood with reference to it, where the same reference symbols represent similar components that are not described in detail again. Similar to arrangements 2300 and 2400 of the Fig. 23 and Fig. 24 The arrangement 2500 may, for example, be designed and otherwise configured to contribute to a medical device 2502 similar to the medical devices 2302 and 2402 of the Fig. 23 and Fig. 24 can be used to sterilize. The medical device 2502 can be a sensor control device similar to the medical devices 2302 and 2402 of the Fig. 23 and Fig. 24, but alternatively it can include any of the health products mentioned here.

[0233] As shown, the medical device 2502 can be incorporated into a sensor applicator 2504, which may include a spring-loaded casing 2506. The medical device 2502 can be positioned in a recess 2508, which is at least partially defined by the casing 2506. In some embodiments, a desiccant (not shown) may be arranged within the recess 2508. Similar to the medical devices 2302 and 2402 of Fig. 23 and Fig. 24 The medical device 2502 may include the housing 2308, the part 2310 requiring sterilization, and the radiation-sensitive component(s) 2312. In some embodiments, the arrangement 2500 may further include the barrier shield 2326, as generally described above.

[0234] As shown, part 2310 can extend perpendicularly from the base of the casing 2308, but could alternatively extend at an angle or from another surface. Furthermore, as shown, part 2310 can extend along a centerline of the casing 2308, but could alternatively extend eccentrically to the centerline without deviating from the scope of protection of the disclosure.

[0235] The sensor applicator 2504 is used to deliver the medical device 2502 to a target monitoring site on a user's skin (e.g., the user's arm). The medical device 2502 can be deployed from the recess 2508 by pressing the sheath 2506 against the user's skin, causing the sheath 2506 to fold inward into the body of the sensor applicator 2504. Once the sheath 2506 folds past the housing 2308, the medical device 2502 can be ejected from the sensor applicator 2504. Part 2310 is positioned so that it can be placed transcutaneously or otherwise held beneath the surface of the user's skin. Once released, the medical device 2502 can be held in position on the skin using an adhesive patch (not shown) coupled to the base of the medical device 2502.

[0236] The medical device 2502 can be subjected to irradiation sterilization 2316 to properly sterilize part 2310 before use. In the illustrated embodiment, the irradiation sterilization 2316 is directed onto the top of the sensor applicator 2504, which defines a collimator 2410 that allows the radiation 2316 to strike and sterilize part 2310. As shown, the collimator 2510 generally comprises a hole or passage extending through the body of the sensor applicator 2504. The collimator 2510 focuses the radiation 2316 onto part 2310 and can have any suitable cross-sectional shape necessary to focus the radiation 2316 onto part 2310 for sterilization. In the illustrated embodiment, for example, the collimator 2510 has a round cross-sectional shape with parallel sides.In other embodiments, however, the collimator 2510 can have a polygonal cross-sectional shape, such as cubic or rectangular (which, for example, contains a parallelogram), without deviating from the scope of protection of the disclosure.

[0237] However, the sensor applicator 2504 can also act as a radiation shield, helping to prevent (inhibit) propagating radiation 2316 from destroying or damaging the radiation-sensitive component(s) 2312, except through the collimator 2510. To achieve this, the sensor applicator 2504 can be made of a material similar to the material of the cap 2306 of Fig. 23. In at least one embodiment, however, the irradiation sterilization 2316 can be emitted from a device or machine configured to focus and / or aim the radiation 2316 directly at the collimator 2510 and thereby reduce the exposure by radiation 2316 to adjacent sections of the sensor applicator 2504.

[0238] In some embodiments, a first seal 2512a (shown with dashed lines) can be positioned at the opening of the recess 2508, and a second seal 2512b can be arranged at the opening to the collimator 2510 at the top of the sensor applicator 2504. The seals 2512a,b can comprise radiolucent microbial barriers, similar to the cap seal 2324 of Fig. 23. The first seal 2512a can seal the recess 2508 on the base 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 the radiation 2316 to pass through to sterilize the part 2310.

[0239] Embodiments disclosed here include: K. An internal sterilization arrangement comprising a sensor applicator, a medical device at least partially incorporated in the sensor applicator and a part requiring sterilization, and a radiation-sensitive component, and a cap detachably coupled to the sensor applicator and providing a collimator that can be aligned with the part requiring sterilization, wherein the collimator focuses radiation from an irradiation sterilization process to the part requiring sterilization and prevents the radiation from damaging the radiation-sensitive component.

[0240] The embodiment K may include 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 a combination thereof. Element 2: wherein the collimator comprises a cross-sectional shape selected from the group consisting of round, cubic, rectangular, and any combination thereof. Element 3: wherein the medical device comprises an in vivo analyte sensor control device, and the part requiring sterilization comprises a sensor and / or a tip extending from the housing of the in vivo analyte sensor control device. Element 4: wherein the transmitter and / or the tip extend at an angle from the base of the housing. Element 5: wherein the transmitter and / or the tip extend perpendicularly from the base of the housing.Element 6: wherein the sensor and / or the tip extend from the base of the housing along a centerline of the housing. Element 7: wherein the sensor and / or the tip extend from the base of the housing offset from a 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 a combination thereof. Element 10: wherein the medical device comprises an in vivo analyte sensor control device having a housing that accommodates the radiation-sensitive component, the internal sterilization arrangement further comprising a barrier shield positioned within the housing to block the propagation of radiation within the housing to the radiation-sensitive component.Element 11: further comprising a spring-loaded button that is at least partially received into the sensor applicator and can engage with an upper end of the medical device, the collimator being defined by the button. Element 12: further comprising a sealed coupling at the intersection of the button and the medical device. Element 13: wherein the button and / or the sensor applicator is made of a material selected from the group consisting of a high-density polymer, a metal, or any combination thereof. Element 14: wherein the sensor applicator includes a spring-loaded casing, and the medical device is received in a recess that is at least partially defined by the casing. Element 15: wherein the collimator is defined by the sensor applicator.

[0241] As a non-restrictive example, exemplary combinations applicable to A, B and C are: Element 3 with Element 4; Element 3 with Element 5; Element 3 with Element 6; Element 3 with Element 7; Element 8 with Element 9; Element 11 with Element 12; Element 11 with Element 13; and Element 14 with Element 15. One-piece biosensor design with sensor protection ampoule

[0242] The Fig. 26A and Fig. Figures 26B are isometric or side views of an exemplary sensor control device 2602 according to one or more embodiments of the present disclosure. The sensor control device 2602 (alternatively referred to as the “puck”) may be similar in some respects to the sensor control device 104 of Fig. 1 and can therefore best be understood with reference to it. The sensor control device 2602 can control the sensor control device 104 from Fig. 1 replace and can therefore be used together with the sensor applicator 102 ( Fig. 1), which releases the sensor control device 2602 for a target monitoring location on the skin of a user.

[0243] However, the sensor control device 2602 can be integrated into a one-piece system architecture, unlike the sensor control device 104 from Fig. 1. Unlike the two-part architecture, for example, it is not necessary for a user to open multiple packages and finally assemble the sensor control device 2602. Rather, the sensor control device 2602 is already fully assembled and correctly positioned within the sensor applicator 102 upon receipt by the user ( Fig. 1) To use the sensor control device 2602, the user only needs to open one barrier (e.g. the applicator cap 210 of Fig. 2B), before immediately releasing the sensor control device 2602 at the target monitoring location.

[0244] As shown, the sensor control device 2602 includes an electronics housing 2604, which is generally disk-shaped and may have a circular cross-section. In other embodiments, however, the electronics housing 2604 may have a different cross-sectional shape, such as oval or polygonal, without deviating from the scope of the disclosure. The electronics housing 2604 may be configured to accommodate or otherwise contain various electrical components used to operate the sensor control device 2602.

[0245] The electronic enclosure 2604 can include a shell 2606 and a mount 2608 that can be joined to the shell 2606. The shell 2606 can be attached to the mount 2608 in a variety of ways, such as a snap-fit, press fit, sonic welding, or one or more mechanical fasteners (e.g., screws). In some cases, the shell 2606 can be attached to the mount 2608 in such a way as to create a sealed coupling between them. In such embodiments, a gasket or other type of sealing material can be positioned on or near the outer diameter (circumferential surface) of the shell 2606 and the mount 2608, and joining the two components together can compress the gasket, thereby creating a sealed coupling.In other embodiments, an adhesive can be applied to the outer diameter (circumferential surface) of the casing 2606 and / or the holder 2608. The adhesive secures the casing 2606 and the holder 2608, providing structural integrity, and can also seal the coupling between the two components, thereby isolating the interior of the electronics housing 2604 from external contamination. If the sensor control device 2602 is assembled in a controlled environment, it may not be necessary to perform final sterilization of the internal electrical components. Rather, the adhesive coupling can provide a sufficiently sterile barrier for the assembled electronics housing 2604.

[0246] The sensor control device 2602 may further include a connector assembly 2610, which may be coupled to the electronics housing 2604. The connector assembly 2610 may differ in some respects from the connector assembly 207. Fig. 2A similar. For example, the connector assembly 2610 can include a sensor module 2612 (partially visible) that can be connected to the tip module 2614 (partially visible). The sensor module 2612 can be configured to carry and otherwise contain a sensor 2616 (partially visible), and the tip module 2614 can be configured to carry and otherwise contain a tip 2618 (partially visible) to help deliver the sensor 2616 transcutaneously under the skin of a user during application of the sensor control device 2602. As shown, corresponding portions of the sensor 2616 and the tip 2618 extend from the electronics housing 2604 and, in particular, from the base of the holder 2608. The exposed portion of the sensor 2616 can be contained within a hollow or recessed portion of the tip 2618.The remaining section of sensor 2616 is positioned inside the electronics housing 2604.

[0247] As discussed in more detail below, the sensor control device 2602 can further include a sensor protection ampoule 2620 which provides a protective barrier surrounding the exposed sections of the sensor 2616 and the tip 2618 and protecting them from chemical gas sterilization.

[0248] The Fig. 27A and Fig. Figures 27B are isometric or exploded views of the connector assembly 2610 according to one or more embodiments. The sensor module 2612 can include the sensor 2616, a connector 2702, and a connecting element 2704. The connector 2702 can be designed to receive and support both the sensor 2616 and the connecting element 2704. As shown, a channel 2706 can be defined through the connector 2702 to receive a section of the sensor 2616. Furthermore, the connector 2702 can provide one or more deflectable arms 2707 configured to snap into corresponding features provided on the base of the electronics housing 2604. Fig. 26A-26B).

[0249] The sensor 2616 comprises an extension 2708, a flag 2710, and a neck 2712 connecting the extension 2708 and the flag 2710. The extension 2708 can be configured to extend at least partially through the channel 2706 and distal to the connector 2702. The extension 2708 contains an enzyme or other chemical or biological preparation, and in some embodiments, a membrane can cover the chemical. In use, the extension 2708 is inserted transcutaneously under the skin of a user, and the chemical contained therein assists in analyte monitoring in the presence of body fluids.

[0250] The flag 2710 can comprise a generally flat surface that includes one or more sensor contacts 2714 (three are in Fig. 27B) arranged thereon. The sensor contact(s) 2714 can be configured to align with a corresponding number of compliant carbon-impregnated polymer modules (the tops of which are shown in 2720) encapsulated within the connecting element 2704.

[0251] The connecting element 2704 contains one or more hinges 2718, which allow the connecting element 2704 to move between open and closed positions. The connecting element 2704 is in the Fig. 27A-27B is shown in the closed state, but can pivot to the open state to accommodate the flag 2710 and the compliant carbon-impregnated polymer module(s) therein. The compliant carbon-impregnated polymer module(s) provide electrical contacts 2720 (three are shown) configured for conductive communication between the sensor 2616 and corresponding circuit arrangement contacts provided within the electrical housing 2604 ( Fig. 26A-26B). The connecting element 2704 can be made of silicone rubber and can serve as a moisture barrier for the sensor 2616 when assembled in a compressed state and after application to a user's skin.

[0252] The tip module 2614 includes the tip 2618 and a needle hub 2722 that supports the tip 2618. The tip 2618 includes an elongated shaft 2724 and a tip tip 2726 at the distal end of the tip 2724. The shaft 2724 can be configured to extend through the channel 2706 and distal to the connector 2702. The shaft 2724 can also include a hollow or recessed section 2728 that at least partially surrounds the extension 2708 of the sensor 2616. The tip tip 2726 can be configured to penetrate the skin while supporting the extension 2708, thereby bringing the active chemistry present on the extension 2708 into contact with body fluids.

[0253] The needle hub 2722 can include a small hub cylinder 2730 and a hub snap latch 2732, each of which can be configured to help connect the plug assembly 2610 (and the entire sensor control device 2602) to the sensor applicator 102 ( Fig. 1) to couple.

[0254] With specific reference to Fig. In embodiment 27B, the protective ampoule 2620 can comprise 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 can be open to provide access to an inner chamber 2738 defined within the body 2734. In contrast, the second end 2736b can be closed and can provide or otherwise define an enlarged head 2740. The enlarged head 2740 has an outer diameter larger than the outer diameter of the remaining sections of the body 2734. In other embodiments, however, the enlarged head 2740 can be positioned at an intermediate location between the first and second ends 2736a,b.

[0255] Fig. Figure 27C is an isometric exploded bottom view of the connector 2702 and the protective ampoule 2620. As shown, the connector 2702 can define an opening 2742 configured to receive the protective ampoule 2620 and, in particular, the first end 2736a of the body 2734. The channel 2706 can terminate at the opening 2742, so that components extending from and distal to the channel 2706 are received into the inner chamber 2738 when the protective ampoule 2620 is coupled to the connector 2702.

[0256] The protective ampoule 2620 can be detachably coupled to the connector 2702 at the opening 2742. In some embodiments, for example, the protective ampoule 2620 can be received into the opening 2742 by means of a press fit or a friction fit. In other embodiments, the protective ampoule 2620 can be secured within the opening 2742 with a breakable element (e.g., a shear ring) or a substance that can be broken open with minimal separation force. In such embodiments, for example, the protective ampoule 2620 can be secured within the opening 2742 with a mark (dot) of glue, a dab of wax, or the protective ampoule 2620 can contain an easily removable adhesive. As described below, the protective ampoule 2620 can be detached from the connector 2702 before the sensor control device 2602 ( Fig. 26A-26B) is released to the target monitoring site on the user's skin.

[0257] Back on the Fig. 27A and Fig. Referring to 27B, the inner chamber 2738 can be of a size and otherwise configured to accommodate the extension 2708, the distal end of the shaft 2724, and the tip 2726, collectively referred to as the “distal sections of the sensor 2616 and the tip 2618”. The inner chamber 2738 can be sealed or otherwise insulated to prevent substances that might interact adversely with the chemistry of the sensor 2616 from migrating into the inner chamber 2738. In particular, the inner chamber 2728 can be sealed to protect or isolate the distal sections of the sensor 2616 and the tip 2618 during the chemical gas sterilization process, since gases used during chemical gas sterilization can adversely affect the enzymes (and other sensor components such as membrane coatings that regulate the flow of the analyte) provided on the extension.

[0258] In some embodiments, a seal 2744 ( Fig. 27B) provide a sealed barrier between the inner chamber 2738 and the external environment. In at least one embodiment, the seal 2744 can be arranged in the inner chamber 2738, but could alternatively be positioned outside the body 2734 without deviating from the scope of protection of the disclosure. The distal sections of the sensor 2616 and the tip 2618 can penetrate the seal 2744 and extend into the inner chamber 2738; however, the seal 2744 can maintain a sealed coupling around the distal sections of the sensor 2616 and the tip 2618 to prevent the migration of contaminants into the inner chamber 2738. The seal 2744 can, for example, be made of a malleable polymer or a wax.

[0259] In other embodiments (or in addition to the seal 2744) a sensor protection fluid 2746 ( Fig. 27B) may be present in the inner chamber 2738, and the distal sections of the sensor 2616 and the tip 2618 may be immersed in or otherwise encapsulated by the protective fluid 2746. The protective fluid 2746 may create a sealed coupling that prevents sterilization gases from interacting with the enzymes provided on the extension 2708.

[0260] The connector assembly 2610 can be subjected to irradiation sterilization to properly sterilize the sensor 2616 and the tip 2618. Suitable processes for irradiation sterilization include, but are not limited to, electron beam (e-beam) irradiation, gamma beam irradiation, X-ray irradiation, or any combination thereof. In some embodiments, the connector assembly 2610 can be subjected to irradiation sterilization before coupling the protective ampoule 2620 to the connector 2702. In other embodiments, however, the connector assembly 2610 can be sterilized after coupling the protective ampoule 2620 to the connector 2702. In such embodiments, the body 2734 of the protective ampoule 2620 and the protective fluid 2746 may comprise materials and / or substances that allow radiation to propagate through them to assist irradiation sterilization of the distal sections of the sensor 2616 and the tip 2618.

[0261] Suitable materials for the body 2734 include, but are not limited to, a non-magnetic metal (e.g., aluminum, copper, gold, silver, etc.), a thermoplastic, ceramic, rubber (e.g., ebonite), a composite material (e.g., fiberglass, carbon fiber reinforced polymer, etc.), an epoxy resin, or any combination thereof. In some embodiments, the material for the body 2734 may be transparent or translucent, but it may also be opaque without departing from the scope of protection of the disclosure.

[0262] The protective fluid 2746 can comprise any inert and biocompatible fluid (i.e., liquid, gas, gel, wax, or any combination thereof) capable of encapsulating the distal portions of the sensor 2616 and the tip 2618. In some embodiments, the protective fluid 2746 can also allow radiation to propagate through it. The protective fluid 2746 can comprise a fluid that is insoluble in the chemical substances involved in chemical gas sterilization. Suitable examples of the protective fluid 2746 include, but are not limited to, silicone oil, mineral oil, a gel (e.g., petrolatum), a wax, fresh water, salt water, a synthetic fluid, glycerin, sorbitan esters, or any combination thereof. As can be seen, gels and fluids that are more viscous may be preferred so that the protective fluid 2746 does not flow easily.

[0263] In some embodiments, the protective fluid 2746 may contain an anti-inflammatory agent such as nitric oxide or another known anti-inflammatory agent. The anti-inflammatory agent may prove advantageous by minimizing a local inflammatory reaction caused by the penetration of the tip 2618 and the sensor 2616 into the user's skin. Inflammation has been observed to affect the accuracy of glucose readings, and the absorption of the anti-inflammatory agent may accelerate the healing process, leading to a faster attainment of accurate readings.

[0264] The Fig. 28A and Fig. Figures 28B are exploded or isometric bottom views of the electronics housing 2604 according to one or more embodiments. The casing 2606 and the holder 2608 function as opposing hinged housing halves that contain the various electronic components of the sensor control device 2602 ( Fig. 26A-26B) enclose or otherwise substantially encapsulate.

[0265] A printed circuit board (PCB) 2802 can be positioned within the electronics housing 2604. Several electronic modules (not shown) can be mounted to the PCB 2802, which may, but are not limited to, include a data processing unit, resistors, transistors, capacitors, inductors, diodes, and switches. The data processing unit may, for example, comprise 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. In particular, the data processing unit may be configured to perform data processing functions, such functions being, but not limited to, filtering and encoding data signals, each corresponding to a user-seen analyte value.The data processing unit can also include an antenna for communicating with the reading device 106 (. Fig. 1) contain or otherwise communicate with her.

[0266] As shown, the housing 2606, the bracket 2608, and the PCB 2802 each define corresponding central openings 2804, 2806, and 2808, respectively. When the electronic housing 2604 is assembled, the central openings 2804, 2806, and 2808 align coaxially to accommodate the connector assembly 2610 ( Fig. 27A-27B). A battery 2810 can also be included in the electronics housing 2604 and configured to power the sensor control device 2602.

[0267] In Fig. 28B can define a socket 2812 in the base of the bracket 2808 and provide a location for the plug assembly 2610 ( Fig. 27A-27B) can be taken up and coupled to the electronics housing 2604, thereby enabling the sensor control device 2602 ( Fig. 26A-26B) can be fully assembled. The profile of connector 2702 ( Fig. 27A-27B) can be shaped to match or complement the socket 2812, and the socket 2812 can provide one or more snap bars 2814 (two are shown) configured with the deflectable arms 2707 ( Fig. 27A-27B) of connector 2702 to couple and receive them. The connector assembly 2610 is coupled to the electronics housing 2604 by moving connector 2702 forward into socket 2812 and allowing the deflectable arms 2707 to engage in the corresponding snap-in tabs 2814. When the connector assembly 2610 ( Fig. 27A-27B) is correctly coupled to the electronic housing 2604, one or more circuit arrangement contacts 2816 (three are shown), which are defined on the underside of the PCB 2802, can establish conductive communication with the electrical contacts 2720 ( Fig. 27A-27B) of the connecting element 2704 ( Fig. 27A-27B).

[0268] Fig. 29A and Fig. Figures 29B are side or cross-sectional side views of an example embodiment of the sensor applicator 102 with the applicator cap 210 coupled to it. In particular, the Fig. 29A-29B, how the sensor applicator 102 could be sent to and received by a user. According to the present disclosure and as in Fig. As can be seen in Figure 29B, the sensor control device 2602 is already assembled and installed inside the sensor applicator 102 before it is delivered to the user.

[0269] As described above, the connector assembly 2610 can be subjected to irradiation sterilization before being coupled to the electronics housing 2604 in order to sterilize the distal sections of the sensor 2616 and the tip 2618. Once properly sterilized, the connector assembly 2610 can then be coupled to the electronics housing 2604 as generally described above, thereby forming the fully assembled sensor control device 2602. The sensor control device 2602 can then be loaded into the sensor applicator 102, and the applicator cap 210 can be coupled to the sensor applicator 102. The applicator cap 210 can be threaded to the housing 208 and may include a tamper-evident ring 2902. When the applicator cap 210 is rotated (e.g. unscrewed) relative to the housing 208, the tamper-evident ring 2902 may tear, thereby releasing the applicator cap 210 from the sensor applicator 102.

[0270] According to the present disclosure, the sensor control device 2602, while loaded into the sensor applicator 102, can be subjected to chemical gas sterilization 20,904, configured to sterilize the electronics housing 2604 and any other exposed sections of the sensor control device 2602. To achieve this, a chemical can be injected into a sterilization chamber 2906, which is defined by the sensor applicator 102 and the associated cap 210. In some applications, the chemical can be injected into the sterilization chamber 2906 through one or more passages 2908 defined in the applicator cap 210 at its proximal end 2910. Examples of chemicals that can be used for chemical gas sterilization 2904 include, but are not limited to, ethylene oxide, vaporized hydrogen peroxide and nitrogen oxides (e.g. nitrous oxide, nitrogen dioxide, etc.).

[0271] Since the distal sections of the sensor 2616 and the tip 2618 are sealed within the protective ampoule 2620, the chemicals used during the chemical gas sterilization process do not interact with the enzymes, chemistry, or biological preparations provided on the extension 2708.

[0272] Once a desired level of sterility has been achieved within the sterilization chamber 2906, the gaseous solution is removed and the sterilization chamber 2906 is vented. Venting can be achieved by a series of evacuations followed by the circulation of nitrogen gas or filtered air through the sterilization chamber 2906. Once the sterilization chamber 2906 is properly vented, the openings can be closed with a seal 2912 (shown with dashed lines).

[0273] In some embodiments, the seal 2912 may comprise two or more layers of different materials. The first layer may be made of a synthetic material (e.g., a fibrillated, high-density polyethylene fiber), such as Tyvek®, available from DuPont®. Tyvek® is very durable and puncture-resistant, and allows vapor penetration. The Tyvek® layer may be applied prior to the chemical gas sterilization process, and following the chemical gas sterilization process, a film or other vapor- and moisture-resistant material layer may be sealed (e.g., heat-sealed) over the Tyvek® layer to prevent the ingress of contaminants and moisture into the sterilization chamber 2906. In other embodiments, the seal 2912 may comprise only a single protective layer applied to the applicator cap 210.In such embodiments, the single layer is gas-permeable for the sterilization process, but is also capable of protecting against moisture and other harmful elements once the sterilization process is complete.

[0274] With its integrated seal 2912, the applicator cap 210 provides a barrier against external contamination, thereby maintaining a sterile environment for the assembled sensor control device 2602 until the user removes (unscrews) the applicator cap 210. The applicator cap 210 can also create a dust-free environment during shipping and storage, preventing contamination of the adhesive patch 2914 used to attach the sensor control device 2602 to the user's skin.

[0275] Fig. Figure 30 is a perspective view of an example embodiment of the applicator cap 210 according to the present disclosure. As shown, the applicator cap 210 has a generally round cross-section and defines a series of threads 7302 which are used to couple the applicator cap 210 to the sensor applicator 102 ( Fig. 29A and Fig. 29B). The openings 2908 are also visible in the base of the applicator cap 210.

[0276] The applicator cap 210 can further provide or otherwise define a cap post 3004, which is located centrally inside the applicator cap 210 and extends proximal to the base therefrom. The cap post 3004 can be configured to help support the sensor control device 2602 while it is contained in the sensor applicator 102 ( Fig. 29A-29B). In addition, the cap post 3004 can define an opening 3006 configured to receive the protective ampoule 2620 when the applicator cap 210 is coupled with the sensor applicator 102.

[0277] In some embodiments, the opening 3006 in the cap post 3004 may include one or more compliant features 3008 that are stretchable or flexible to allow the protective ampoule 2620 to pass through. In some embodiments, the compliant feature(s) 3008 may, for example, comprise a clamping sleeve-type device containing multiple compliant fingers configured to bend radially outward to receive the protective ampoule 2620. In other embodiments, however, the compliant feature(s) 3008 may comprise an elastomer or another type of compliant material configured to expand radially to receive the protective ampoule 2620.

[0278] Fig. Figure 31 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 pile 3004 defines a pile chamber 3102 configured to receive the protective ampoule 2620. The opening 3006 in the cap pile 3004 provides access to the pile chamber 3102 and shows a first diameter D1. In contrast, the enlarged head 2740 of the protective ampoule 2620 exhibits a second diameter D2 that is larger than the first diameter D1 and larger than the outer diameter of the remaining sections of the protective ampoule 2620. Accordingly, when the protective ampoule 2026 is moved into the pile chamber 3102, the flexible feature(s) 3008 of the opening 3008 can bend (expand) radially outward to accommodate the enlarged head 2740.

[0279] In some embodiments, the enlarged head 2740 can provide or otherwise define an angled outer surface that contributes to radially outward biasing the compliant feature(s) 3008. However, the enlarged head 2740 can also define an upper shoulder 3104 that prevents the protective ampoule 2620 from retracting from the pile chamber 3102. In particular, the shoulder 3104 can include a pointed surface on the second diameter D2 that engages with the compliant feature(s) 3008 but does not force it to bend radially outward in the opposite direction.

[0280] As soon as the enlarged head 2740 passes the opening 3006, the flexible feature(s) 3008 bend back to (or towards) their natural state. In some embodiments, the flexible feature(s) may engage with the outer surface of the protective ampoule 2620, but may nevertheless allow the applicator cap 210 to rotate relative to the protective ampoule 2620. Accordingly, if a user rotates the applicator cap 210 relative to the sensor applicator 102 ( Fig. 29A-29B) removed, the protective ampoule 2620 remains stationary relative to the cap pile 3004.

[0281] When the applicator cap 210 is removed from the sensor applicator 102, thereby separating the sensor control device 2602 from the applicator cap 210, the shoulder 3104, which is defined on the enlarged head 2740, will engage with the compliant feature(s) 3008 at the opening 3006. Because the diameter of the shoulder 3104 is larger than the diameter of the opening 3006, the shoulder 3104 will wedge itself against the compliant feature(s) 3008, thereby separating the protective ampoule 2620 from the sensor control device 2602, thus exposing the distal sections of the sensor 2616 and the tip 2618. Accordingly, the flexible feature(s) 3008 can prevent the enlarged head 2740 from leaving the pile chamber 3102 via the opening 3006 when the applicator cap 210 is separated from the sensor applicator 102 and the sensor control device 206. The detached protective ampoule 2620 will fall into the pile chamber 3102 and remain there.

[0282] In some embodiments, instead of the opening 3006 containing the compliant feature(s) 3008 as generally described above, the opening 3006 may alternatively be threaded. In such embodiments, a small section near the distal end of the protective ampoule 2620 may also be threaded and configured to engage with the threads of the opening 3006. The protective ampoule 2620 may be received within the pile chamber 3102 by threaded rotation. Upon removal of the applicator cap 210 from the sensor applicator 102, the opposing threads on the opening 3006 and the protective ampoule 2620 connect, and the protective ampoule 2620 can be separated from the sensor control device 2602.

[0283] Accordingly, there are several advantages to integrating the sensor control device 2602 into the analyte monitoring system (e.g., the analyte monitoring system 100 from Fig. 1) Because the sensor control device 2602 is finally assembled in a controlled environment, tolerances can be reduced or eliminated altogether, allowing the sensor control device 2602 to be thin and small. Furthermore, because the sensor control device 2602 is finally assembled in a controlled environment, careful pre-inspection of the sensor control device 2602 can be performed at the factory, and thus the sensor unit is fully tested before packaging for final delivery.

[0284] Embodiments disclosed here include: L. A sensor control device comprising an electronics housing, a connector assembly that can be joined with the electronics housing, a sensor module comprising a sensor, a tip module comprising a tip, and a protective ampoule coupled to the connector assembly and defining an inner chamber, wherein distal sections of the sensor and tip can be received into the inner chamber and are isolated within the inner chamber from chemical gas sterilization. M. An analyte monitoring system comprising a sensor applicator, a sensor control device positioned within the sensor applicator and containing an electronics housing, a connector assembly coupled to the electronics housing and containing a sensor module with a sensor and a tip module with a tip, and a protective ampoule coupled to the connector assembly and defining an inner chamber. The analyte monitoring system further comprises a cap coupled to the sensor applicator to provide a barrier that seals the sensor control device within the sensor applicator, with distal portions of the sensor and tip being received into the inner chamber and isolated from chemical gas sterilization within the inner chamber. N. A method for preparing an analyte monitoring system, comprising loading a sensor control device into a sensor applicator, wherein the sensor control device comprises an electronics housing, a connector assembly that can be mated with the electronics housing, a sensor module comprising a sensor, a tip module comprising a tip, and a protective ampoule coupled to the connector assembly and defining an inner chamber. The method further comprises attaching a cap to the sensor applicator, thereby providing a barrier that seals the sensor control device within the sensor applicator, sterilizing the sensor control device by chemical gas sterilization while the sensor control device is positioned within the sensor applicator, and isolating distal portions of the sensor and the tip that are received in the inner chamber from the chemical gas sterilization.

[0285] 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 includes a connector and the protective ampoule is detachably coupled to the connector. Element 2: wherein the protective ampoule provides an enlarged head and the diameter of the enlarged head is larger than the diameter of the remaining sections of the protective ampoule. Element 3: further comprising a seal that provides a sealed barrier between the inner chamber and the exterior of the inner chamber, wherein the distal sections of the sensor and the tip penetrate the seal and extend into the inner chamber. Element 4: further comprising a protective fluid within the inner chamber that isolates the distal sections of the sensor and the tip from chemical gas sterilization.Element 5: wherein the distal portions of the sensor and the tip are at least partially immersed in the protective fluid. Element 6: wherein the protective fluid comprises an inert and biocompatible fluid selected from the group consisting of silicone oil, mineral oil, a gel, a wax, fresh water, salt water, a synthetic fluid, glycerin, sorbitan esters, and any combination thereof. Element 7: wherein the protective fluid contains an anti-inflammatory agent.

[0286] Element 8: wherein the cap provides a cap pile defining a pile chamber and an opening that receives an enlarged head of the protective ampoule into the pile chamber. Element 9: wherein the opening includes one or more compliant features that bend radially outward to receive the enlarged head. Element 10: wherein the one or more compliant features comprise multiple compliant fingers. Element 11: wherein the one or more compliant features prevent the enlarged head from exiting the pile chamber through the opening when the cap is separated from the sensor applicator and the sensor control device. Element 12: wherein the cap is rotatable relative to the protective ampoule when the protective ampoule is received into the pile chamber. Element 13: further comprising a protective fluid within the inner chamber that isolates the distal portions of the sensor and the tip from chemical gas sterilization.

[0287] Element 14: wherein loading the sensor control device into a sensor applicator is preceded by assembling the connector assembly, coupling the protective ampoule to the connector assembly so that the distal sections of the sensor and the tip are received into the inner chamber, and coupling the connector assembly to an electronics housing, thereby providing the sensor control device. Element 15: wherein coupling the protective ampoule to the connector assembly is preceded by sterilizing the connector assembly by irradiation. Element 16: wherein isolating the distal sections of the sensor and the tip from chemical gas sterilization comprises at least partial immersion of the distal sections of the sensor and the tip in a protective fluid present in the inner chamber.Element 17: wherein the cap provides a cap pile defining a pile chamber having one or more compliant features arranged at an opening to the pile chamber, and wherein attaching the cap to the sensor applicator comprises receiving an enlarged head of the protective ampoule into the pile chamber through the opening and bending the one or more compliant features radially outward to accommodate the enlarged head.

[0288] As a non-restrictive example, exemplary combinations applicable to L, M and N include: Element 4 with Element 5; Element 4 with Element 6; Element 4 with Element 7; Element 8 with Element 9; Element 9 with Element 10; Element 9 with Element 17; Element 8 with Element 12; Element 8 with Element 13; and Element 14 with Element 15. Isolating the one-piece sensor assembly using focused E-beam sterilization.

[0289] The Fig. 32A and Fig. Figures 32B are isometric or side views of an exemplary sensor control device 3202 according to one or more embodiments of the present disclosure. The sensor control device 3202 (alternatively referred to as the "puck") may be similar in some respects to the sensor control device 104 of Fig. 1 and can therefore best be understood with reference to it. In some applications, the sensor control device 3202 can be used with the sensor control device 104 of Fig. 1 replace and can therefore be used together with the sensor applicator 102 ( Fig. 1) used, which releases the sensor control device 3202 for a target monitoring location on the skin of a user.

[0290] However, the sensor control device 3202 can be integrated into a one-piece system architecture, unlike the sensor control device 104 from Fig. 1. Unlike the two-part architecture, for example, it is not necessary for a user to open multiple packages and fully assemble the sensor control device 3202 before use. Rather, the sensor control device 3202 is already fully assembled and correctly positioned within the sensor applicator 102 upon receipt by the user ( Fig. 1) To use the sensor control device 3202, the user only needs to open one barrier (e.g., removing the applicator cap 210 from Fig. 2B), before immediately releasing the sensor control device 3202 to the target monitoring location.

[0291] As shown, the sensor control device 3202 includes an electronics housing 3204, which is generally disk-shaped and may have a circular cross-section. In other embodiments, however, the electronics housing 3204 may have a different cross-sectional shape, such as oval or polygonal, without deviating from the scope of the disclosure. The electronics housing 3204 may be configured to accommodate or otherwise contain various electrical components used to operate the sensor control device 3202.

[0292] The electronic enclosure 3204 can include a shell 3206 and a mount 3208 that can be joined to the shell 3206. The shell 3206 can be attached to the mount 3208 in a variety of ways, such as a snap-fit ​​connection, a press fit, sonic (or ultrasonic) welding, the use of one or more mechanical fasteners (e.g., screws), or any combination thereof. In some embodiments, the coupling between the shell 3206 and the mount 3208 can be sealed. In such embodiments, a gasket or other type of sealing material can be positioned or applied to or near the outer diameter (circumferential surface) of the shell 3206 and the mount 3208. Attaching the shell 3206 to the mount 3208 can compress the sealing material, thereby creating a sealed coupling.In at least one embodiment, an adhesive can be applied to the outer diameter (circumferential surface) of the shell 3206 and / or the holder 3208, and the adhesive can not only attach the shell 3206 to the holder 3208, but can also seal the coupling.

[0293] In embodiments where a sealed coupling is created between the casing 3206 and the holder 3208, the interior of the electronics 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., by chemical gas sterilization). Rather, the sealed coupling can provide a sufficiently sterile barrier for the assembled electronics housing 3204.

[0294] The sensor control device 3202 can also include a sensor module 3210 (partially visible in Fig. 32B) and a tip module 3212 (partially visible). The sensor and tip modules 3210 and 3212 can be connected to each other and coupled to the electronics housing 3204. The sensor module 3210 can be configured to include a sensor 3214 ( Fig. 32B) to carry and otherwise contain, and the tip module 3212 can be configured to carry a tip 3216 ( Fig. 32B) to wear and otherwise contain to help release the sensor 3214 transcutaneously under the skin of a user during application of the sensor control device 3202.

[0295] As in Fig. As shown in Figure 32B, corresponding sections of the sensor 3214 and the tip 3216 extend from the electronics housing 3204 and, in particular, from the base of the holder 3208. The exposed section of the sensor 3214 may be contained within a hollow or recessed section of the tip 3216. The remaining section(s) of the sensor 3214 is / are positioned inside the electronics housing 3204.

[0296] An adhesive patch 3218 can be positioned on the underside of the holder 3208 or attached otherwise. Similar to the adhesive patch 108 from Fig. 1. The adhesive patch 3218 can be configured to attach and hold the sensor control device 3202 in position on the user's skin during operation. In some embodiments, a transfer adhesive 3220 can be inserted between the adhesive patch 3218 and the base of the holder 3208. The transfer adhesive 3220 can assist in the assembly process of the sensor control device 3202.

[0297] Fig. 33A and Fig. Figure 33B shows perspective exploded top and bottom views of the sensor control device 3202 according to one or more embodiments. As shown, the casing 3206 and the mount 3208 of the electronics housing 3204 function as opposing hinged housing halves that enclose or otherwise substantially encapsulate the various electronic components of the sensor control device 3202.

[0298] A printed circuit board (PCB) 3302 can be positioned inside the electronics housing 3204. As shown in Fig. As shown in Figure 33B, several 3304 electronic modules can be mounted on the underside of the 3302 PCB. Examples of 3304 electronic modules include, but are not limited to, resistors, transistors, capacitors, inductors, diodes, and switches. A 3306 data processing unit ( Fig. 33B) can also be mounted on PCB 3302 and may, for example, include 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. In particular, the data processing unit may be configured to perform data processing functions, such as filtering and encoding data signals, each corresponding to a user-seen analyte value. The data processing unit 3306 may also include an antenna for communicating with the readout device 106 ( Fig. 1) contain or otherwise communicate with her.

[0299] As shown, the casing 3206, the holder 3208, and the PCB 3302 each define corresponding central openings 3308a, 3308b, and 3308c, respectively. When the sensor control device 3202 is assembled, the central openings 3308a-c align coaxially with receiving sections of the sensor and tip module 3210, 3212.

[0300] A battery 3310 and a corresponding battery holder 3312 can also be included in the electronics housing 3204. The battery 3310 can be configured to supply power to the sensor control device 3202.

[0301] The sensor module 3210 can include the sensor 3214 and a connecting element 3314. The sensor 3214 includes an extension 3316, a flag 3318, and a neck 3320 that connects the extension 3316 and the flag 3318. The extension 3316 can be configured to extend through the central opening 3308b defined in the holder 3208 and extend distally from its underside. The extension 3316 contains an enzyme or other chemical or biological preparation, and in some embodiments, a membrane can cover the chemical. In use, the extension 3316 is absorbed transcutaneously beneath the skin of a user, and the chemical contained therein helps to support analyte monitoring in the presence of body fluids.

[0302] The flag 3318 can comprise a generally flat surface that includes one or more sensor contacts 3322 (three are in Fig. 33A) has arranged thereon. The flag 3318 can be configured to be received into the connecting element 3314, wherein the sensor contact(s) 3322 align with a corresponding number of compliant carbon-impregnated polymer modules (not shown) encapsulated in the connecting element 3314.

[0303] The connecting element 3314 contains one or more hinges 3324, which allow the connecting element 3314 to pivot between open and closed positions. The connecting element 3314 is in the Fig. 33A-33B is shown in the closed state, but can transition to the open state to accommodate the flag 3318 and the compliant carbon-impregnated polymer module(s) therein. The compliant carbon-impregnated polymer module(s) provide electrical contacts 3326 (three are shown in Fig. (33A shown) are ready, which are configured to provide conductive communication between the sensor 3214 and corresponding circuit arrangement contacts 3328 provided on the PCB 3302. When the sensor module 3210 is correctly coupled to the electronics housing 3204, the circuit arrangement contacts 3328 establish conductive communication with the electrical contacts 3326 of the connecting element 3314. The connecting element 3314 can be made of silicone rubber and can serve as a moisture barrier for the sensor 3314.

[0304] The tip module 3212 comprises the tip 3216 and a needle hub 3330 that supports the tip 3216. The tip 3216 includes an elongated shaft 3332 and a tip tip 3334 at its distal end. The shaft 3332 can be configured to extend through each of the coaxially aligned central openings 3308a-c and distal to the base of the mount 3208. Furthermore, the shaft 3332 can include a hollow or recessed section 3336 that at least partially surrounds the extension 3316 of the sensor 3214. The tip tip 3334 can be configured to penetrate the skin while supporting the extension 3316, thereby bringing the active chemistry of the extension 3316 into contact with body fluids.

[0305] The needle hub 3330 can contain a small hub cylinder 3338 and a hub snap latch 3340, each of which can be configured to help connect the sensor control device 3202 to the sensor applicator 102 ( Fig. 1) to couple.

[0306] Especially on Fig. Referring to 33A, in some embodiments the sensor module 3210 can be at least partially received in a sensor mounting recess 3342 contained in the electronic housing 3204. In some embodiments, the sensor mounting recess 3342 can comprise a separate structure, but alternatively it can form an integral part of or an extension of the mount 3208. The sensor mounting recess 3342 can be shaped or otherwise configured to receive and insert the sensor 3214 and the connecting element 3314. As shown, the sensor mounting recess 3342 defines an outer circumferential surface 3344, which generally surrounds the area where the sensor 3214 and the connecting element 3314 are to be received. In at least one embodiment, the outer circumferential surface 3344 can be sealed to the underside of the PCB 3302 when the electronic housing 3204 is fully assembled.In such embodiments, a seal (e.g. an O-ring or the like), an adhesive or another type of sealing material can be applied (arranged) on the outer circumferential surface 3344 and can function to seal the coupling between the sensor mounting recess 3342 and the PCB 3302.

[0307] Sealing the coupling between the sensor mounting recess 3342 and the underside of the PCB 3302 can help to create or define a sealed zone or area within the electronics housing 3204. The sealed area can prove advantageous by helping to insulate (protect) the extension 3316 of the sensor 3214 from potentially harmful sterilization gases during chemical gas sterilization.

[0308] Especially on Fig. 33B Referring to this, several channels or grooves 3346 may be provided or otherwise defined on the base of the holder 3208. As shown, the grooves 3346 may form several concentric rings in combination with several radially extending channels. The adhesive patch 3218 ( Fig. 32A-32B) can be attached to the underside of the holder 3208, and in some embodiments the transfer adhesive 3220 ( Fig. 32A-32B) are inserted between the adhesive patch 3218 and the base of the holder 3208. The grooves 3346 can prove advantageous by directing moisture away from the center of the electronic housing 3204 below the adhesive patch 3218.

[0309] In some embodiments, a cap pile sealing coupling 3348 may be defined on the base of the bracket 3208 at its center. As shown, the cap pile sealing coupling 3348 may comprise a substantially flat section of the base of the bracket 3208. The second central opening 308b is defined at the center of the cap pile sealing coupling 3348, and the grooves 3346 may surround the cap pile sealing coupling 3348. The cap pile sealing coupling 3348 may provide a sealing surface that can help to insulate (protect) the extension 3316 of the sensor 3214 from potentially harmful sterilization gases used during chemical gas sterilization.

[0310] Fig. 34A and Fig. Figures 34B are side and cross-sectional side views of the sensor applicator 102 with the applicator cap 210 coupled to it. In particular, the Fig. 34A-34B describes how the sensor applicator 102 could be sent to and received by a user. According to the present disclosure and as described in Fig. As shown in Figure 34B, the sensor control device 3202 is already assembled and installed inside the sensor applicator 102 before being delivered to the user. The applicator cap 210 can be connected to the housing 208 via a thread and may contain a tamper-evident ring 3402. When the applicator cap 210 is rotated (e.g., unscrewed) relative to the housing 208, the tamper-evident ring 3402 can break, thereby releasing the applicator cap 210 from the sensor applicator 102. The user can then release the sensor control device 3202 to the target monitoring location, as generally described above with reference to the Fig. 2E-2G is described.

[0311] With specific reference to Fig. 34B The sensor control device 3202 can be loaded into the sensor applicator 102 by merging the needle hub 3330 with the sensor carrier 3404, which is contained in the sensor applicator 102. In particular, the small hub cylinder 3338 and the hub snap latch 3340 can be received by corresponding matching features of the sensor carrier 3404.

[0312] Once the sensor control device 3202 is joined with the sensor carrier 3404, the applicator cap 210 can then be attached to the sensor applicator 102. As shown, the applicator cap 210 can provide or otherwise define a cap stake 3406 located centrally within the applicator cap 210 and extending proximal to its base. The cap stake 3406 can be configured to help support the sensor control device 3202 while it is contained within the sensor applicator 102. Furthermore, the cap stake 3406 can define a stake chamber 3408 configured to accommodate the sensor 3214 and the tip 3216 extending from the base of the electronics housing 3204.When the sensor control device 3202 is loaded into the sensor applicator 102, the sensor 3214 and the tip 3216 can be arranged in a sealed area 3410, which is at least partially defined by the pile chamber 3408 and is configured to isolate the sensor 3214 and the tip 3216 during chemical gas sterilization.

[0313] In some embodiments, prior to assembling and loading the sensor control device 3202 into the sensor applicator 102, the sensor and tip modules 3210, 3212 can be subjected to irradiation sterilization to sterilize the distal sections of the sensor 3214 and the tip 3216. Once properly sterilized, the sensor and tip modules 3210, 3212 can then be coupled to the electronics housing 3204, and the fully assembled sensor control device 3202 can then be loaded into the sensor applicator 102 as described above.

[0314] In other embodiments, however, the fully assembled sensor control device 3202 can first be loaded into the sensor applicator 102, and the sensor and tip modules 3210, 3212 can then be subjected to irradiation sterilization 3412 while positioned within the sensor applicator 102. The irradiation sterilization 3412 can, for example, include electron beam irradiation, but other sterilization methods can alternatively be used, including, but not limited to, gamma beam irradiation, X-ray irradiation, or any combination thereof.

[0315] In some embodiments, as shown, the sensor control device 3202 can be subjected to "focused" irradiation sterilization 3412, where the radiation (e.g., rays, waves, etc.) from the irradiation sterilization 3412 is applied only to the sensor and tip modules 3210, 3212 (e.g., the sensor 3214 and the tip 3216) and directed otherwise. In such embodiments, the electrical components 3304 ( Fig. 33B), which connects to PCB 3302 ( Fig. 33A-33B) are coupled, which are the data processing unit 3306 ( Fig. 33B) are located outside the range of the propagating radiation and are therefore not affected by the irradiation. For example, the electrical components 3304 and the data processing unit 3306 can be positioned on the PCB 3302 near its outer circumferential surface, so that they do not fall within the range (span) of the focused irradiation sterilization 3412. In other embodiments, this can be achieved by shielding the sensitive electrical components 3304 with suitable electromagnetic shielding.

[0316] According to the present disclosure, the sensor control device 3202, while loaded into the sensor applicator 102, can be subjected to chemical gas sterilization 3414 to sterilize the electronics housing 3204 and any other exposed sections of the sensor control device 3202. To achieve this, a chemical can be injected into a sterilization chamber 3416, which is defined by the sensor applicator 102 and the associated cap 210. In some applications, the chemical can be injected through one or more passages 3418 defined in the applicator cap 210 at its near end 3420. Exemplary chemicals that can be used for chemical gas sterilization 3414 include, but are not limited to, ethylene oxide, vaporized hydrogen peroxide, and nitrogen oxides (e.g., nitrous oxide, nitrogen dioxide, etc.).

[0317] Since the sensor 3214 and the tip 3216 are within the sealed area 3410, the chemicals used during the chemical gas sterilization process do not interact with the enzymes, chemistry, or biological preparations provided on the extension 3316.

[0318] Once a desired level of sterility has been achieved within the sterilization chamber 3416, the gaseous solution is removed and the sterilization chamber 3416 is vented. Venting can be achieved by a series of evacuations followed by the circulation of nitrogen gas or filtered air through the sterilization chamber 3416. Once the sterilization chamber 3416 is properly vented, the orifices 3418 can be covered with a seal 3422 (shown with dashed lines) applied to the proximal end 3420 of the applicator cap 210.

[0319] In some embodiments, the seal 3422 may comprise two or more layers of different materials. The first layer may be made of a synthetic material (e.g., a fibrillated, high-density polyethylene fiber), such as Tyvek®, available from DuPont®. Tyvek® is very durable and puncture-resistant, and allows vapor penetration. The Tyvek® layer may be applied prior to chemical gas sterilization 3414, and following chemical gas sterilization 3414, a film or other vapor- and moisture-resistant material layer may be sealed (e.g., heat-sealed) over the Tyvek® layer to prevent the ingress of contaminants and moisture into the sterilization chamber 3416. In other embodiments, the seal 3422 may comprise only a single protective layer applied to the applicator cap 210.In such embodiments, the single layer is gas-permeable for the sterilization process, but is also capable of protecting against moisture and other harmful elements once the sterilization process is complete.

[0320] With its integrated seal 3422, the applicator cap 210 provides a barrier against external contamination, thereby maintaining a sterile environment for the assembled sensor control device 3202 until the user removes (unscrews) the applicator cap 210. The applicator cap 210 can also create a dust-free environment during shipping and storage, preventing the adhesive patch 3218, used to attach the sensor control device 3202 to the user's skin, from becoming contaminated.

[0321] Fig. Figure 35 is an enlarged cross-sectional side view of the sensor control device 3202 mounted within the sensor applicator 102 with the applicator cap 210 attached thereto, according to one or more embodiments. As stated above, sections of the sensor 3214 and the tip 3216 can be arranged within the sealed area 3410 and thereby protected from substances that may interact adversely with the chemistry of the sensor 3214. In particular, the gases that are generated during chemical gas sterilization 3414 ( Fig. 34B) are used, which adversely affect the enzymes provided on the extension 3316 of the sensor 3214, and the sealed area 3410 protects the extension 3316 from the ingress of such chemicals.

[0322] As shown, the sealed area 3410 can contain (enclose) selection sections of the interior of the electronics housing 3204 and the pile chamber 3408 of the cap pile 3406. In one or more embodiments, the sealed area 3410 can be defined or otherwise formed by at least a first seal 3502a, a second seal 3502b, and a third seal 3502c. The first seal 3502a can be arranged to seal the coupling between the needle hub 3330 and the casing 3206. Furthermore, the first seal 3502a can surround the first central opening 3308a defined in the casing 3206, thus preventing fluids (e.g., gaseous chemicals) from migrating through the first central opening 3308a into the interior of the electronics housing 3204.

[0323] In some embodiments, the first seal 3502a can form part of the needle hub 3330. For example, the first seal 3502a can be cast onto the needle hub 3330. In other embodiments, the first seal 3502a can be cast onto the top surface of the casing 3206. In still other embodiments, the first seal 3502a can comprise a separate structure, such as an O-ring or the like, which is inserted between the needle hub 3330 and the top surface of the casing 3206, without departing from the scope of protection of the disclosure.

[0324] The second seal 3502b can be arranged to seal the coupling between the cap pile 3406 and the base of the support 3208, and the second seal 3502b can surround the second central opening 3208b defined by the support 3208. Consequently, the second seal 3502b can prevent fluids (e.g., gaseous chemicals) from migrating into the pile chamber 3408 of the cap pile 3406, and also from migrating through the second central opening 3308b into the interior of the electronics housing 3204.

[0325] In some embodiments, the second seal 3502b can form part of the cap pile 3406. For example, the second seal 3502b can be cast onto the upper end of the cap pile 3406. In other embodiments, the second seal 3502b can be cast onto the cap pile sealing coupling 3348 at the base of the support 3208. In still other embodiments, the second seal 3502b can comprise a separate structure, such as an O-ring or the like, which is inserted between the cap pile 3406 and the base of the support 3208 without departing from the scope of the disclosure.

[0326] When the sensor control device 3202 is loaded into the sensor applicator 102 and the applicator cap 210 is attached to the sensor applicator 102, the first and second seals 3502a,b are compressed, creating corresponding sealed couplings. The first and second seals 3502a,b can be made of a variety of materials capable of creating a sealed coupling between opposing structures. Suitable materials include, but are not limited to, silicone, a thermoplastic elastomer (TPE), polytetrafluoroethylene (Teflon®), rubber, an elastomer, or any combination thereof.

[0327] The third seal 3502c can be arranged to seal a coupling between the sensor holder recess 3342 and the PCB 3302, and in particular between the outer circumferential surface 3344 of the sensor holder recess 3342 and the underside of the PCB 3302. The third seal 3502c can comprise a gasket (e.g., an O-ring or the like), an adhesive, or another type of sealing material applied (arranged) on the outer circumferential surface 3344. In operation, the third seal 3502c can prevent fluids (e.g., gaseous chemicals, liquids, etc.) from migrating into the interior of the sensor holder recess 3342 and therefore into the pile chamber 3408 to react adversely with the enzymes on the extension 3316.

[0328] The applicator cap 210 can be attached to the sensor applicator 102 by screwing 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 moves forward until the second seal 3502b engages with the cap post sealing coupling 2248 at the base of the holder 3208. Upon engagement with the cap post sealing coupling 3348, the second seal 3502b can engage with the holder 3208 by friction, thereby causing the entire electronics housing 3402 to rotate in the same angular direction.

[0329] In state-of-the-art sensor control devices such as the sensor control device 104 from Fig. 1. Conical carrier gripping features are typically defined and configured on the exterior of the electronics housing to mesh with corresponding conical features provided on radially pre-tensioned arms of the sensor mounting recess 3342. A merging engagement between these corresponding conical features helps to prevent the electronics housing from rotating within the sensor applicator 102.

[0330] In contrast, the electronics housing 3204 of the now disclosed sensor control device 3202 provides or otherwise defines an angled or otherwise continuously smooth outer surface 3504 around its outer diameter (circumferential area). In some embodiments, as shown, the smooth outer surface 3504 may be provided on the mount 3208, but alternatively, it may be provided on the casing 3206 without departing from the scope of disclosure. One or more radially biased arms of the sensor mount recess 3342 may be positioned to engage with the outer surface 3504 to help center the sensor control device 3202 within the sensor applicator 102.When the electronic housing 3204 is forced to rotate by frictional engagement between the second seal 3502b and the base of the holder 3208, the outer surface 3504 slides into engagement with the radially pre-tensioned arms, which do not impede its rotation.

[0331] Fig. Figure 36 is an enlarged cross-sectional side view of the sensor control device 3202 positioned on top of the cap post 3406 according to one or more embodiments. As shown, the adhesive patch 3218 is positioned on the underside of the holder 3208, and the transfer adhesive 3220 is inserted between the adhesive patch 3218 and the holder 3208.

[0332] The adhesive patch 3218 can cover or otherwise obscure most of the grooves 3346 defined on the base of the holder 3208. Furthermore, as shown, the adhesive patch 3218 can extend a short distance into the cap pile sealing coupling 3348. To enable the grooves 3346 to properly direct moisture away from the center of the electronics housing 3202 and from the cap pile sealing coupling 3348, the adhesive patch 3218 (and the transfer adhesive 3220, if included) can provide or otherwise define one or more channels 3602 that are aligned with the grooves 3346 or otherwise arranged in fluid communication with them.In the illustrated embodiment, the channels 3602 extend radially outwards from the center of the electronic housing 3204, but may alternatively be defined in other configurations and nevertheless connect with the grooves 3346 to support fluid communication between them.

[0333] During operation, if moisture builds up around the center of the electronics housing 3204 and at the cap pile sealing coupling 3348, the moisture can flow via the channels 3602 into the grooves 3346. Once in the grooves 3346, the moisture can flow radially outwards beneath the adhesive patch 3218 and to the outer circumferential surface of the sensor control device 3202.

[0334] Embodiments disclosed here include: O. An analyte monitoring system comprising a sensor applicator, a sensor control device positioned within the sensor applicator, and an electronics housing having a shell and a holder that can be joined with the shell, a printed circuit board positioned within the electronics housing, a sensor extending from a base of the holder, a needle hub positioned adjacent to a top of the shell, and a tip carried by the needle hub and extending through the electronics housing and from the base of the holder.The analyte monitoring system further comprises a cap coupled to the sensor applicator, providing a cap pile defining a pile chamber that accommodates the sensor and the tip extending from the base of the holder, and a sealed area surrounding the pile chamber and a section of the interior of the electronics housing, wherein the sealed area is defined by a first seal sealing a coupling between the needle hub and the casing, a second seal sealing a coupling between the cap pile and the base of the holder, and a third seal sealing a coupling between the holder and the printed circuit board, and wherein sections of the sensor and the tip are located within the sealed area and are thereby isolated from chemical gas sterilization. P. A method for preparing an analyte monitoring system, loading a sensor control device into a sensor applicator, wherein the sensor control device comprises an electronics housing having a casing and a holder that can be joined with the casing, a printed circuit board positioned inside the electronics housing, a sensor module comprising a sensor extending from a base of the holder, and a tip module comprising a needle hub and a tip carried by the needle hub, the tip extending through the electronics housing and from the base of the holder.The method further comprises attaching the cap to the sensor applicator, wherein the cap provides a cap stake defining a stake chamber that accommodates the sensor and the tip extending from the base of the holder; creating a sealed area when the cap is attached to the sensor applicator, wherein the sealed area includes the stake chamber and a portion of the interior of the electronics housing, with portions of the sensor and the tip located within the sealed area; sterilizing the sensor control device by chemical gas sterilization while the sensor control device is positioned within the sensor applicator; and isolating the portions of the sensor and the tip located within the sealed area from the chemical gas sterilization.

[0335] 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 surrounds a central opening defined in the shell and prevents fluids from migrating through the central opening into the interior section of the electronics housing. Element 2: wherein the second seal surrounds a central opening defined in the holder and prevents fluids from migrating through the central opening into the interior section of the electronics housing, and further prevents fluids from migrating into the pile chamber. Element 3: wherein the first seal is cast onto the needle hub. Element 4: wherein the first seal is inserted between the needle hub and an upper surface of the shell. Element 5: wherein the second seal is cast onto the cap pile.Element 6: wherein the second seal is inserted between the cap post and an underside of the holder. Element 7: wherein the first and second seals are made of a material selected from the group consisting of silicone, a thermoplastic elastomer, polytetrafluoroethylene, and any combination thereof. Element 8: wherein the holder provides a sensor mounting recess that accommodates the sensor module at least partially within the electronics housing, and wherein the third seal is positioned on an outer circumferential surface of the sensor mounting recess. Element 9: wherein the third seal comprises a gasket and / or an adhesive.Element 10: further comprising multiple grooves defined on the base of the holder and a cap pile sealing coupling defined on the base of the holder at a center of the holder, wherein the second seal seals against the cap pile sealing coupling. Element 11: further comprising an adhesive patch coupled to the base of the holder and extending radially into the cap pile sealing coupling, and one or more channels defined in the adhesive patch and connecting to each other with the multiple grooves to facilitate fluid communication between the cap pile sealing coupling and the multiple grooves. Element 12: wherein the electronics housing defines an angled and smooth outer surface that allows the sensor control device to rotate freely relative to the sensor applicator when the cap is coupled to the sensor applicator.

[0336] Element 13: wherein creating the sealed area when the cap is attached to the sensor applicator comprises sealing a coupling between the needle hub and the sheath with a first seal, sealing a coupling between the cap post and the base of the holder with a second seal, and sealing a coupling between the holder and the circuit board with a third seal. Element 14: wherein loading the sensor control device into a sensor applicator is preceded by sterilizing the sensor and the tip by irradiation sterilization and assembling the sensor and tip module with the electronics housing. Element 15: wherein sterilizing the sensor control device by chemical gas sterilization is preceded by sterilizing the sensor and the tip by irradiation sterilization while the sensor control device is positioned within the sensor applicator.Element 16: wherein the irradiation sterilization is focused irradiation sterilization and / or low-energy irradiation sterilization. Element 17: wherein the electronics housing defines an angled and smooth outer surface, wherein the method further comprises enabling the sensor control device to rotate relative to the sensor applicator when the cap is attached to the sensor applicator.

[0337] As a non-restrictive example, exemplary combinations applicable to O and P include: Element 1 with Element 2; Element 1 with Element 3; Element 1 with Element 4; Element 1 with Element 5; Element 1 with Element 6; Element 1 with Element 7; Element 1 with Element 8; Element 3 with Element 4; Element 3 with Element 5; Element 3 with Element 6; Element 10 with Element 11; and Element 15 with Element 16. One-piece puck architecture with ASIC shielding, use of low and medium energy irradiation sterilization and magnetic deflection

[0338] The Fig. 37A and Fig. Figures 37B are isometric, side, and bottom views of an exemplary sensor control device 3702 according to one or more embodiments of the present disclosure. The sensor control device 3702 (alternatively referred to as a body patch or unit) may be similar in some respects to the sensor control device 104 of Fig. 1 and can therefore best be understood with reference to it. The sensor control device 3702 can control the sensor control device 104 from Fig. 1 replace and can therefore be used together with the sensor applicator 102 ( Fig. 1) can be used, which releases the sensor control device 3702 for a target monitoring location on the skin of a user. In contrast to the sensor control device 104 of Fig. However, various structural advantages and improvements allow the sensor control device 3702 to be integrated into a one-piece system architecture.

[0339] Unlike the sensor control device 104 from Fig. For example, it is not necessary for a user to open several packages and fully assemble the sensor control device 3702 before releasing it at the target monitoring location. Rather, the sensor control device 3702 can already be assembled and correctly positioned within the sensor applicator 102 upon receipt by the user. To use the sensor control device 3702, the user only needs to break through one barrier (e.g., the applicator cap 210 of Fig. 2B), before immediately releasing the sensor control device 3702 at the target monitoring location.

[0340] First on Fig. 37A Referring to this, the sensor control device 3702 comprises an electronics housing 3704, which is generally disc-shaped and may have a generally round cross-section. In other embodiments, however, the electronics housing 3704 may have a different cross-sectional shape, such as oval or polygonal, without deviating from the scope of the disclosure. The electronics housing 3704 may include a sleeve 3706 and a holder 3708, which can be joined with the sleeve 3706. An adhesive patch 3710 may be positioned on the underside of the holder 3708 or otherwise attached. Similar to the adhesive patch 108 of Fig. 1. The adhesive patch 3710 can be configured to attach and hold the sensor control device 3702 in position on the user's skin during operation.

[0341] In some embodiments, the shell 3706 can define a reference feature 3712. As shown, the reference feature 3712 can comprise a recess or hidden notch defined in the shell 3706 that extends a short distance into the interior of the electronics housing 3704. The reference feature 3712 can operate as a "reference c" feature configured to assist in supporting the control of the sensor control device 3702 in at least one degree of freedom during factory assembly. In contrast, earlier sensor control devices (e.g., the sensor control device 104 of Fig. 1) Typically, a tab extending radially from the side of the shell. The tab is used as an internal synchronization reference point, but must be removed at the end of production, followed by an inspection of the shell where the tab previously existed, adding complexity to the earlier production process.

[0342] The casing 3706 can also define a central opening 3714 which is large enough to accommodate a tip (not shown) that can extend through the center of the electronic housing 3704.

[0343] Fig. Figure 37B depicts a section of a sensor 3716 extending from the electronics housing 3704. The remaining section(s) of the sensor 3716 is / are positioned inside the electronics housing 3704. Similar to sensor 110 of Fig. 1. The exposed portion of sensor 3716 is configured to be positioned transcutaneously under the skin of a user during application. The exposed portion of sensor 3716 may contain an enzyme or other chemical or biological preparation, and in some embodiments, a membrane may cover the chemical.

[0344] The sensor control device 3702 provides structural improvements that result in a height H and a diameter D that can be smaller than previous sensor control devices (e.g., the sensor control device 104 from Fig. 1) In at least one embodiment, for example, the height H may be approximately 1 mm or more smaller than the height of previous sensor control devices, and the diameter D may be approximately 2 mm or more smaller than the diameter of previous sensor control devices.

[0345] Furthermore, the structural improvements of the sensor control device 3702 allow the casing 3706 to provide, or otherwise define, a chamfered or angled outer circumferential surface 3718. In contrast, previous sensor control devices typically required a rounded or outwardly curved outer circumferential surface to accommodate internal components. The reduced height H, the reduced diameter D, and the angled outer circumferential surface 3718 can each prove advantageous in providing a sensor control device 3702 that is thinner, smaller, and less prone to premature dislodgement by jamming on sharp corners or the like while attached to a user's skin.

[0346] Fig. 37C forms a central opening 3720 defined in the underside of the holder 3708. The central opening 3720 can be sized to accommodate a combination of tip (not shown) and sensor 3716, with the sensor 3716 being accommodated within a hollow or recessed section of the tip. When the electronics housing 3704 is assembled, the central opening 3720 aligns coaxially with the central opening 3714 ( Fig. 37A) of the shell 3706 ( Fig. 37A), and the tip penetrates the electronic housing by extending simultaneously through each central opening 3714, 3720.

[0347] Fig. 38A and Fig. Figures 38B are exploded top and bottom views of the sensor control device 3702 according to one or more embodiments. The casing 3706 and the mount 3708 function as opposing hinged housing halves that enclose or otherwise substantially encapsulate the various electronic components of the sensor control device 3702. As shown, the sensor control device 3702 may include a printed circuit board assembly (PCBA) 3802, which contains a printed circuit board (PCB) 3804 to which several electronic modules 3806 are coupled. Exemplary electronic modules 3806 include, but are not limited to, resistors, transistors, capacitors, inductors, diodes, and switches. Previous sensor control devices typically stack PCB components on only one side of the PCB. In contrast, in the sensor control device 3702, the PCB components 3806 may be distributed across the surface area of ​​both sides (i.e.,upper and lower surfaces) of the PCB 3804 are distributed.

[0348] In addition to the electronic modules 3806, the PCBA 3802 may also include a data processing unit 3808 mounted on the PCB 3804. The data processing unit may, for example, comprise an application-specific integrated circuit (ASIC) configured to implement one or more functions or routines associated with the operation of the sensor control device 3702. In particular, the data processing unit 3808 may be configured to perform data processing functions, such functions including, but not limited to, filtering and encoding data signals, each corresponding to a user-seen analyte value. The data processing unit 3808 may also include an antenna for communicating with the reading device 106 ( Fig. 1) contain or otherwise communicate with her.

[0349] A battery opening 3810 can be defined in the PCB 3804 and be sized to accommodate and insert a battery 3812 configured to power the sensor control device 3702. An axial battery contact 3814a and a radial battery contact 3814b can be coupled to the PCB 3804 and extend into the battery opening 3810 to facilitate the transfer of electrical energy from the battery 3812 to the PCB 3804. As their names suggest, the axial battery contact 3814a can be configured to provide an axial contact for the battery 3812, while the radial battery contact 3814b can provide a radial contact for the battery 3812. The arrangement of the battery 3812 within the battery opening 3810 with the battery contacts 3814a,b helps to reduce the height H ( Fig. 37B) of the sensor control device 3702, which allows the PCB 3804 to be centrally located and its components to be distributed on both sides (i.e., top and bottom surfaces). This also helps to reduce the chamfer 3718 ( Fig. 37B), which is provided in the electronic housing 3704, to enable.

[0350] The sensor 3716 can be located centrally relative to the PCB 3804 and include an extension 3816, a flag 3818, and a neck 3820 connecting the extension 3816 and the flag 3818. The extension 3816 can be configured to extend through the central opening 3720 of the holder 3708 for transcutaneous release under the skin of a user. Furthermore, the extension 3816 can incorporate an enzyme or other chemical to assist in analyte monitoring.

[0351] The flag 3818 can contain a generally flat surface that has one or more sensor contacts 3822 (three are in Fig. 38B) has arranged on it. The sensor contact(s) 3822 can be configured to connect to a corresponding one or more circuit arrangement contacts 3824 (three are shown in Fig. 38A), which are provided on the PCB 3804, to align and engage with them. In some embodiments, the sensor contact(s) 3822 may comprise a carbon-impregnated polymer printed or otherwise digitally applied to the flag 3818. Previous sensor control devices typically include a connecting element made of silicone rubber encapsulating one or more compliant carbon-impregnated polymer modules that serve as electrically conductive contacts between the sensor and the PCB. In contrast, the sensor contact(s) 3822 disclosed now provide a direct connection between the sensor 3716 and the PCB-3804 interface, eliminating the need for the connecting element from the prior art and advantageously reducing the height H ( Fig. 37B). Furthermore, eliminating the compliant carbon-impregnated polymer modules eliminates a significant circuit resistance and thus improves circuit conductivity.

[0352] The sensor control device 3702 may further include a compliant element 3826, which may be arranged such that it is inserted between the flag 3818 and the inner surface of the casing 3706. In particular, when the casing 3706 and the holder 3708 are assembled together, the compliant element 3826 may be configured to provide a passive bias load against the flag 3818, forcing the sensor contact(s) 3822 into continuous engagement with the corresponding circuit arrangement contact(s) 3824. In the illustrated embodiment, the compliant element 3826 is an elastomer O-ring, but could alternatively comprise any other type of bias device or mechanism, such as a compression spring or the like, without departing from the scope of protection of the disclosure.

[0353] The sensor control device 3702 can further include one or more electromagnetic shields, shown as a first shield 3828a and a second shield 3828b. The shields 3828a,b can be arranged between the casing 3706 and the support 3708; i.e., within the electronics housing 3704 ( Fig. 37A-37B). In the illustrated embodiment, the first shield 3828a is arranged above the PCB 3804, so that it points towards the top of the PCB 3804, and the second shield 3828b is arranged below the PCB 3804, so that it points towards the bottom of the PCB 3804.

[0354] The shields 3828a,b can be configured to protect sensitive electronic components from radiation while the sensor control device 3702 undergoes irradiation sterilization. In particular, at least one of the shields 3828a,b can be positioned such that it is inserted between the data processing unit 3808 and a radiation source, such as an electron beam accelerator. In some embodiments, for example, at least one of the shields 3828a,b can be positioned adjacent to and otherwise aligned with the data processing unit 3808 and the radiation source in order to block or attenuate the absorbed radiation dose that could otherwise damage the sensitive electronic circuitry of the data processing unit 3702.

[0355] In the illustrated embodiment, the data processing unit 3808 is inserted between the first and second shields 3828a,b, such that the first and second shields 3828a,b enclose the data processing unit 3808 at both ends in the axial direction. However, in at least one embodiment, only one of the shields 3828a,b may be necessary to properly protect the data processing unit 3808 during irradiation sterilization. For example, if the sensor control device 3702 is subjected to irradiation directed towards the base of the holder 3708, only the second shield 3828b may be required 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 irradiation sterilization directed towards the top of the casing 3706, only the first shield 3828a is required to be inserted between the data processing unit 3808 and the radiation source, and the second shield 3828b can be omitted. In other embodiments, however, both shields 3828a and 3828b can be used without deviating from the scope of protection of the disclosure.

[0356] The shields 3828a,b may be made of any material capable of attenuating (or substantially vaporizing) the passage of radiation. Suitable materials for the shields 3828a,b include, but are not limited to, lead, tungsten, ferrous metals (e.g., stainless steel), copper, tantalum, osmium, aluminum, carbon, or any combination thereof. Suitable metals for the shields 3828a,b may be corrosion-resistant, austenitic, and any non-magnetic metal with a density ranging from about 2 grams per cubic centimeter (g / cc) to about 23 g / cc. The shields 3828a,b may be produced by a variety of manufacturing technologies, including, but not limited to, stamping, casting, injection molding, sintering, two-stage casting, or any combination thereof.

[0357] In other embodiments, the shields 3828a,b may contain a metal-filled thermoplastic polymer, such as, but not limited to, polyamide, polycarbonate, or polystyrene. In such embodiments, the shields 3828a,b may be produced by mixing the shielding material with an adhesive matrix and distributing the combination onto molded components or, alternatively, directly onto the data processing unit 3808. Furthermore, in such embodiments, the shields 3828a,b may comprise an enclosure that encapsulates (or substantially encapsulates) the data processing unit 3808.In such embodiments, the shields 3828a,b may comprise a metal-filled thermoplastic polymer as mentioned above, or alternatively may be made of any of the materials mentioned herein which are capable of attenuating (or substantially attenuating) the passage of radiation.

[0358] The housing 3706 can accommodate a first synchronization bushing 3830a ( Fig. 38B) and a second synchronization bushing 3830b ( Fig. 38B) provide or otherwise define, and the bracket 3708 can provide a first synchronous pole 3832a ( Fig. 38A) and a second synchronous pile 3832b ( Fig. 38A) provide or otherwise define. Joining the first and second synchronization bushings 3830a,b with the first and second synchronization posts 3832a,b respectively will correctly align the casing 37056 with the bracket 3708.

[0359] Especially on Fig. Referring to 38A, the inner surface of the holder 3708 can provide or otherwise define several recesses or depressions configured to receive various component parts of the sensor control device 3702 when the shell 3706 is joined with the holder 3708. For example, the inner surface of the holder 3708 can define a battery positioning aid 3834 configured to receive a section of the battery 3812 when the sensor control device 3702 is assembled. An adjacent contact recess 3836 can be configured to receive a section of the axial contact 3814a.

[0360] Furthermore, several module recesses 3838 can be defined in the inner surface of the holder 3708 to accommodate the various electronic modules 3806 arranged on the base of the PCB 3804. Additionally, a shield positioning aid 3840 can be defined in the inner surface of the holder 3708 to accommodate at least a section of the second shield 3828b when the sensor control device 3702 is assembled. The battery positioning aid 3834, the contact recess 3836, the module recesses 3838, and the shield positioning aid 3840 all extend a short distance into the inner surface of the holder 3708, and as a result, the overall height H ( Fig. 37B) of the sensor control devices 3702 may be reduced compared to previous sensor control devices. The module recesses 3838 can help to reduce the diameter of the PCB 3804 by allowing PCB components to be arranged on both sides (i.e., top and bottom surfaces).

[0361] Still referring to Fig. 38A The holder 3708 can further include several carrier gripping features 3842 (two are shown) defined around the outer circumferential surface of the holder 3708. The carrier gripping features 3842 are axially offset from the base 3842 of the holder 3708, where a transfer adhesive (not shown) may be applied during assembly. In contrast to previous sensor control devices, which usually include conical carrier gripping features that intersect the base of the holder, the carrier gripping features 3842 now disclosed are offset from the plane (i.e., the base 3844) where the transfer adhesive is applied. This can prove advantageous by helping to ensure that the release system does not inadvertently adhere to the transfer adhesive during assembly.Furthermore, the now disclosed carrier gripping features 3842 eliminate the need for a hollowed-out transfer adhesive, which simplifies the manufacture of the transfer adhesive and eliminates the need to precisely align the transfer adhesive with the holder 3708. This also increases the bonding area and therefore the bond strength.

[0362] Referring to Fig. In embodiment 38B, the base 3844 of the holder 3708 can provide or otherwise define several grooves 3846, which can be defined on or near the outer circumferential surface of the holder 3708 and spaced at equal intervals from one another. A transfer adhesive (not shown) can be coupled to the base 3844, and the grooves can be configured to help transport (transfer) moisture away from the sensor control device 3702 and to the circumferential surface of the holder 3708 during use. In some embodiments, the spacing of the grooves 3846 between the module recesses 3838 ( Fig. 38A), which are defined on the opposite side (inner surface) of the holder 3708, are inserted. As can be seen, the alternating position of the grooves 3846 and the module recesses 3838 ensures that the opposing features on both sides of the holder 3708 do not overlap. This can help to maximize the use of the material of the holder 3708 and thereby help to achieve a minimum height H ( Fig. 37B) of the sensor control device 3702. The module recesses 3838 can also significantly reduce casting sag and improve the flatness of the base 3844 to which the transfer adhesive bonds.

[0363] Still on Fig. 38B Referring to this, the inner surface of the casing 3706 can also provide or otherwise define several recesses or depressions configured to accommodate various component parts of the sensor control device 3702 when the casing 3706 is joined with the mount 3708. For example, the inner surface of the casing 3706 can define an opposing battery positioning aid 3848, which is opposite the battery positioning aid 3834 ( Fig. 38A) of the bracket 3708 and is configured to accommodate a section of the battery 3812 when the sensor control device 3702 is assembled. Additionally, a shield positioning aid 3850 can be defined in the inner surface of the casing 3706 to accommodate at least a section of the first shield 3828a when the sensor control device 3702 is assembled. The opposing battery positioning aid 3848 and the shield positioning aid 3850 extend a short distance into the inner surface of the casing 3706, which helps to reduce the overall height H ( Fig. 37B) to reduce the sensor control device 3702.

[0364] A tip and sensor positioning aid 3852 can also be provided by the inner surface of the casing 3706 or otherwise defined on it. The tip and sensor positioning aid 3852 can be configured to accommodate both the tip (not shown) and a section of the sensor 3716. Furthermore, the tip and sensor positioning aid 3852 can be configured to align with a corresponding tip and sensor positioning aid 2054 ( Fig. 38A), which is provided on the inner surface of the bracket 3708, to align and / or match it.

[0365] The Fig. Figures 39A-39D show the progressive exemplary assembly of the sensor control device 3702 according to one or more embodiments. Fig. 39A, the battery 3812 has been loaded into the opposite battery positioning aid 3848, and the first shield 3828a has been loaded into the shield positioning aid 3850, which is defined in the inner surface of the casing 3706. The compliant element 3826 and the flag 3818 of the sensor 3716 can each be mounted on the first synchronization bushing 3830a. The extension 3816 of the sensor 3716 can be inserted into the tip and the sensor positioning aid 3852.

[0366] In Fig. 39B the PCB 3804 can be loaded into the casing 3706 to align the battery opening 3810 with the battery 3812, with the axial and radial battery contacts 3814a,b supporting electrical communication.

[0367] In Fig. 39C, the second shield 3828b has been loaded into the shield positioning aid 3840, which is defined in the inner surface of the holder 3708. The holder 3708 is now ready to be coupled with the shell 3706 ( Fig. 39A and Fig. 39B). To achieve this, the first and second synchronization bushings 3830a,b ( Fig. 39B) of the casing 3706 are aligned coaxially with the first and second synchronizing posts 3832a,b of the casing 3708, respectively. An adhesive can be applied to the casing 3706 and / or the support 3708 to fa...

Claims

[1] Arrangement for providing a glucose sensor, comprising: comprising a sensor control device: an electronics enclosure, comprising: a shell with an outer circumference and a first opening, and a holder which can be engaged with the outer circumference of the casing to define an interior of the electronics housing, wherein the holder has a second opening which is aligned with the first opening; a collar that is positioned in the electronics housing and can be engaged with the casing near the first opening, the collar having a central opening that is axially aligned with the first opening of the casing and the second opening of the holder; a printed circuit board that is arranged inside the electronics housing and comprises a variety of electronic modules; a glucose sensor comprising a proximal section and a distal section, wherein the proximal section is electrically coupled to the circuit board inside the electronics housing, and wherein the distal section extends from a bottom of the electronics housing and is configured to extend under the skin of a user to measure a glucose level in a body fluid; an adhesive patch that is attached to the underside of the electronics housing and configured to attach the sensor control device to a user's skin; a needle hub with a needle, wherein the needle hub is configured to engage with the collar, and wherein the needle has a distal section extending from the underside of the electronics housing; a sensor cap comprising a first section, a second section and an inner chamber, wherein the first section is detachably connected to the underside of the electronics housing, and wherein the inner chamber accommodates the distal section of the glucose sensor and the distal section of the needle. [2] Arrangement according to claim 1, further comprising: an applicator for applying the glucose sensor, which includes: an applicator housing configured to detachably fix the sensor control device within an interior of the applicator housing; and an applicator cap with a proximal end that is detachably connected to the applicator housing, wherein the applicator cap is configured to be detachably engaged with at least a part of the sensor cap. [3] Arrangement according to claim 2, wherein the applicator cap further comprises a cap post configured to accommodate at least a part of the sensor cap. [4] Arrangement according to claim 3, wherein the sensor cap further comprises one or more engagement features, wherein the cap post comprises a receiving feature with one or more compliant elements configured to receive the one or more engagement features of the sensor cap when connecting the applicator cap to the applicator housing, and wherein removing the applicator cap from the sensor cap releases the sensor cap from the underside of the electronics housing. [5] Arrangement according to claim 2, wherein the applicator cap further comprises a conical interior. [6] Arrangement according to claim 1, further comprising: an annular rib defined on an inner surface of the shell near the first opening; and a collar channel defined on an upper surface of the collar and compatible with the ring-shaped rib. [7] Arrangement according to claim 6, further comprising an adhesive provided in the collar channel to attach and seal the cover to the collar. [8] Arrangement according to claim 1, further comprising: a channel formed on an inner surface of the bracket near the second opening; and a ring-shaped lip formed on the underside of the collar that can engage with the channel. [9] Arrangement according to claim 8, further comprising an adhesive provided in the channel to attach and seal the collar on the holder to the channel. [10] Arrangement according to claim 1, further comprising a groove defined on an underside of the collar to accommodate a portion of the proximal part of the glucose sensor extending laterally into the interior of the electronics housing. [11] Arrangement according to claim 10, further comprising: a ring-shaped lip defined at the underside of the collar; and an adhesive provided in the ring-shaped lip to seal the glucose sensor to the groove. [12] Arrangement according to claim 1, further comprising a sealing element arranged between the needle hub and the collar. [13] Arrangement according to claim 12, wherein the sealing element comprises a rubber material. [14] Arrangement according to claim 12, wherein the sealing element extends at least partially through the first opening when the cover is connected to the collar. [15] Arrangement according to claim 1, wherein the proximal section of the glucose sensor has a flat surface containing a plurality of electrical contacts configured to make an electrical connection with the printed circuit board. [16] Arrangement according to claim 1, wherein the sensor cap includes an elastomeric plug which is arranged on the second section of the sensor cap. [17] Arrangement according to claim 16, wherein the elastomer plug is received in an inner diameter of the inner chamber of the sensor cap. [18] Arrangement according to claim 1, wherein the proximal section of the glucose sensor has a plurality of sensor contacts, the arrangement further comprising: a multitude of elements configured to establish a conductive connection between the multiple sensor contacts of the glucose sensor and the circuit board. [19] Arrangement according to claim 1, wherein an adhesive is applied to the outer circumference of the cover to attach the cover to the holder. [20] Arrangement according to claim 1, wherein the first part of the sensor cap is fragilely connected to the electronics housing.

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