Antibacterial and bacteriostatic sensor system

Abstract

A sensor control device and a method for manufacturing the same are described. The sensor control device includes an electronics housing and a plug assembly. The electronics housing includes an upper shell matable with a lower mount having a skin-facing surface. The plug assembly is connected to the electronics housing and includes a sensor module having a sensor and a sharps module having a sharps. The plug assembly also includes a base portion having a skin-facing surface and a plug portion having a through lumen. At least a portion of the surface of the electronics housing or the plug assembly includes an antimicrobial agent. The antimicrobial agent can be a metal and / or a metal oxide.

Description

Technical Field

[0001] The present disclosure relates to antibacterial and bacteriostatic sensor systems.

[0002] Description of Research and Development by Federal Government Funds Not applicable.

Background Art

[0003] In order to monitor the health status of an individual, it may be essential to detect various analytes inside the individual. When the level of an analyte deviates from the normal level, it often indicates a physiological state such as a metabolic state or a disease that causes it, or an exposure to a specific environmental factor or stimulus. For example, glucose levels can be a particularly important detection and monitoring target for diabetic patients.

[0004] The monitoring of analytes inside an individual may be performed periodically or continuously over a certain period. Periodic analyte monitoring can be performed by collecting samples of body fluids such as blood at set time intervals and analyzing them outside the body. On the other hand, continuous analyte monitoring can be performed using one or more sensors implanted or placed in an individual's tissues such as the skin, subcutaneous, or intravenous, and the analysis can also be performed in vivo by the same sensors. Then, analyte data can be collected by the implanted sensors, and such data collection can be performed continuously, at planned time intervals, or sporadically according to the specific health needs of the individual and / or a predetermined analyte level.

[0005] The entire sensor or sensor system can also be implanted (e.g., surgically) within an individual, but it is more common to implant mainly the bioactive part and the communication path (e.g., a flexible circuit) part of the sensor into the body of the individual (e.g., through the skin) and leave one or more other components of the sensor outside the body. Thus, many sensors suitable for measuring analyte levels in vivo extend from a sensor housing designed to be worn "on-body," such as on the skin, for an extended period. Such on-body analyte sensors are particularly desirable because they do not require medical personnel to perform invasive sensor implantation surgery and are often directly attachable by the wearer.

[0006] While such on-body analyte sensors are desirable, they are not always problem-free to use. When attaching an on-body analyte sensor to the skin of a wearer, at least a part of the sensor can be implanted through the skin region by puncturing the skin with an introducer such as a needle. Thus, a percutaneous skin wound (i.e., an "insertion site" including the actual wound and the adjacent area) is created, and the on-body analyte sensor is set at a position suitable for monitoring the analyte, thereby leaving at least the active part of the sensor within the skin while the sensor is being worn. During both the attachment and the wearing of the sensor, microorganisms may enter the wound at the sensor insertion site and along any length (including the active region) of the sensor due to exposure to skin microorganisms and the external environment. There is a possibility that microorganisms may be present near the insertion site or may enter from an adjacent area including the external environment, creating an environment conducive to microorganism growth. However, if such microorganism growth occurs, it may harm the wearer or affect the function of the analyte sensor itself. Examples of the latter include reducing the sensor lifespan, causing errors or effects in the data obtained from the sensor, the recognition sensitivity, and the response time. SUMMARY OF THE INVENTION

[0007] This disclosure generally describes a body-worn analyte sensor system or sensor control device incorporating an antibacterial agent on at least a portion of a surface exposed to the environment. The sensor control device includes an electronic device housing and a plug assembly. The electronic device housing includes an upper shell that can be fitted to a lower mount having a surface facing the skin (skin-side surface). The plug assembly is connected to the electronic device housing and includes a sensor module having a sensor and a pointed body module having a pointed body. The plug assembly also includes a base having a skin-side surface and a plug portion having a frustoconical, circular, elliptical, or other shape with a through groove or through lumen. At least a portion of the surface of the electronic device housing or the plug assembly contains an antibacterial agent, which can be included, for example, in a coating or impregnated or incorporated into the bulk material constituting the electronic device housing and / or the plug assembly.

[0008] The following figures are included to illustrate certain aspects of the present disclosure and should not be regarded as limiting embodiments. The disclosed subject matter can be subject to numerous variations, modifications, combinations, and equivalents in form and function, without departing from the scope of the present disclosure.

Brief Description of the Drawings

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Mode for Carrying Out the Invention

[0010] If a body-worn analyte sensor is used for measuring the physiological concentrations of various analytes such as glucose, β-hydroxybutyric acid, uric acid, ketones, creatinine, ethanol, and lactate, many advantages are considered. However, although it is very convenient to continuously monitor analytes using an implantable sensor, there are certain challenges associated with this type of measurement. In the case of an intravenous analyte sensor, it is highly invasive and may cause discomfort to the wearer, especially when worn for a long period. On the other hand, many of the analyte sensors applied subcutaneously, interstitially, or to the skin cause less discomfort to the wearer and often provide sufficient measurement accuracy.

[0011] For non-intravenous in vivo glucose-responsive test substance sensors, several manufacturers have developed them over the past 20 years, and recently, some have obtained regulatory approval as devices for monitoring glucose levels in diabetic patients. In such glucose-responsive test substance sensors, glucose oxidase covalently bound to a polymer is used to facilitate the detection of glucose, and a transition metal complex (electron transfer agent or electron transfer mediator) is used to assist in the transfer of electrons released during glucose oxidation. These glucose-responsive test substance sensors respond rapidly to changes in glucose levels and exhibit stable sensor responses over a sensor wear period of up to 10 - 14 days or more. And in vivo glucose-responsive test substance sensors available from other manufacturers also share the common point of using glucose-related enzymes such as glucose oxidase (e.g., flavin adenine dinucleotide-dependent glucose dehydrogenase (FAD-GDH)) as the basis for detection, but the chemical principles and protocols of detection vary widely.

[0012] An in-vivo analyte sensor for measuring analytes such as glucose can be provided with a membrane that covers at least a part of the implantation portion of the analyte sensor. In one aspect, this membrane can improve the biocompatibility of the analyte sensor. In another aspect, the membrane can be permeable or semi-permeable to the analyte of interest, and by restricting the overall analyte flux to the active region of the analyte sensor (i.e., the (one or more) sensor elements), the membrane functions as a mass transfer restricting membrane. By restricting the access of the analyte to the (one or more) sensor elements of the analyte sensor with the mass transfer restricting membrane, an excessive load is not applied to the sensor (the sensor is not saturated), and the detection performance and accuracy can be improved. Such a membrane can have high specificity for restricting the movement of a specific analyte. In that case, since other substances permeate the membrane at a significantly different rate from the analyte, background signals and interference signals due to non-specific redox reactions with analyte molecules other than the analyte molecules of interest can be reduced.

[0013] In some cases, the wearing of a body-worn analyte sensor may be restricted for a long period (e.g., two weeks or more, or even longer). For example, the chemical properties of the analyte sensor can be made suitable for long-term wear. Additionally, it is also desirable to minimize the risk of infection and biofilm formation at the insertion site and in the active region of the analyte sensor or in its vicinity. If microorganisms enter into or near the operating parts such as the membrane of the analyte sensor and other active regions (i.e., (one or more) sensor elements), there is a risk of reduced accuracy and other functional losses, especially during long-term wear over several days or even several weeks. A body-worn in-vivo analyte sensor includes a sensor tail element that can be implanted (e.g., transdermally, dermally, subcutaneously, or intravenously) into the user's tissue. In some examples, as already described herein, the sensor tail includes one or more sensor elements at least at its distal tip. As used herein, the term "sensor tail" and its grammatical variations refer to a part of the analyte sensor that extends from the base of the parts outside the analyte sensor and at least a lower portion of which is inserted into the wearer's tissue. Generally, the sensor tail of the present disclosure includes one or more sensor elements at least at its lower portion (e.g., the distal tip or in its vicinity), as will be described in detail later in this specification. However, in other embodiments, the distal tip of the sensor tail may not include a sensor element, and the sensor element can be disposed at another portion along the sensor tail (e.g., a portion proximal to the distal tip). Regardless of how the sensor is implanted as a whole (e.g., whether the whole is implanted into the user's tissue or only a part is implanted), at least a part of the sensor tail and the sensor active region come into contact with body fluids when introduced into the wearer's tissue.

[0014] Moreover, the performance of the body-worn analyte sensor can be highly dependent on biological events local to or near the sensor tail. Typically, in order to accurately measure the analyte, the analyte sensor is designed to open a path that is not subject to interference (i.e., stable or predictable) for communicating with the (one or more) sensor elements. Similarly, the (one or more) sensor elements (and potentially other elements such as reference substances) must also maintain information transfer with the target body fluid in a manner that is not subject to interference, i.e., in a predictable manner. Further, in the case of an electrochemical sensor, the connections (e.g., electronic systems such as electrode connections) need to be stable for the analyte sensor to function properly. Therefore, during the useful life of the body-worn analyte sensor, it is important to maintain these paths and connections, and as part of this, it is also considered important to prevent the intrusion of microorganisms into the paths and connections.

[0015] Microorganisms can inhibit the function of the body-worn analyte sensor in various ways. Such inhibition can include, for example, chemical inhibition or physical inhibition. The antibacterial agents (including bacteriostatic agents) described herein are used to prevent or reduce the interference of microorganisms with the function of the analyte sensor, and can therefore be designed to counter any one or all types of inhibition that microorganisms may potentially cause.

[0016] As a chemical interference, when microorganisms inhabit the insertion site, i.e., the implantation site (i.e., the space adjacent to the surface of the implanted sensor), they may affect the concentration of the analyte at the position adjacent to the (one or more) sensor elements. As a result, the measured value of the analyte may become an incorrect measurement value. For example, such microorganisms may cause the level of the analyte measured by the (one or more) sensor elements to be unnaturally increased or decreased. For example, when a microbial layer (e.g., a high-density microbial layer or biofilm) is formed, some of the one or more analytes to be measured, such as glucose, may be consumed before contacting the corresponding (one or more) sensor elements, which may cause the measured value of the analyte to be unnaturally decreased. As another example, when a body-worn analyte sensor measures the metabolite of a host cell as an analyte, if a microbial infection occurs at or near the sensor insertion site and the microorganism produces the same substance as the analyte (e.g., lactate) as a metabolite or other secreted substance (e.g., cytokine, enzyme), there may be an incorrect measurement of the analyte. That is, in such a case, the metabolite level of the microorganism may be added to the metabolite level of the host, which may cause the measured value to be unnaturally high. As still another assumed situation, it is also conceivable that microorganisms interfere with the measurement of the analyte sensor by causing an immune reaction at or near the sensor insertion site. For example, when the analyte to be measured is a metabolite of a host cell, if such an accumulation of host cells occurs due to infection, the measured value of the analyte may be unnaturally high. In addition, when microorganisms are present at the sensor implantation site, there is a risk of locally creating an environment that may affect the sensor function. For example, since microorganisms and eukaryotic cells produce acidic metabolites, in the case of an analyte sensor that detects pH, the measured value of the analyte may be unnaturally decreased or increased due to microbial infection and the accompanying immune reaction of the user. That is, the presence of microorganisms and the immune reaction thereto may increase the cell density and activate the metabolic activity of producing acids, which may lead to a decrease in pH and an incorrect measurement of the analyte.

[0017] Examples of physical hindrances include the formation of biofilms caused by the invasion of microorganisms such as infections at the sensor insertion site or the sensor tail. Generally, a biofilm is a dense network of microbial cells (e.g., bacterial cells) encapsulated in compounds such as DNA, proteins, and polysaccharides, which may cause mismeasurement of the analyte by the analyte sensor. For example, diffusion of one or more target analytes to the (one or more) sensor elements of the analyte sensor may be inhibited by the biofilm. Additionally, as another assumed situation, biofouling caused by adsorption of molecules such as proteins to the surface of the analyte sensor, particularly the (one or more) sensor elements of the analyte sensor, may inhibit the diffusion of one or more target analytes, resulting in an unnatural decrease in the measured value of the analyte. In certain situations, healing of the wound (e.g., healing of the insertion site of the body-worn analyte sensor) may cause the sensor membrane to dry out or lose moisture, effectively acting like a wall surrounding the (one or more) sensor elements and affecting the function of the analyte sensor. Furthermore, such drying of the membrane may also block the path to the (one or more) sensor elements of the analyte sensor. In some cases, the connection of various electrodes (e.g., working electrode, reference electrode, and / or counter electrode) may be lost directly due to microbial invasion (e.g., due to membrane drying or biofilm formation), or indirectly due to enhanced native immune cells in response to microbial invasion.

[0018] In view of these, in embodiments of the present disclosure, in order to reduce or prevent malfunction due to the intrusion of microorganisms, antibacterial properties are imparted to one or more parts of a body-worn analyte sensor by incorporating an antibacterial compound. As used herein, the terms "antimicrobial" or "antimicrobial agent" and their grammatical variations refer to substances or materials that are harmful (i.e., bactericidal) to microorganisms such as bacteria, fungi, viruses, protozoa, etc., or substances or materials that are bacteriostatic to these microorganisms (i.e., do not necessarily have to be harmful, but prevent or reduce the colony formation, increase, and / or growth of microorganisms). As used herein, the term "antimicrobial quality" is used synonymously with the term "antimicrobial characteristic", and "antimicrobial property" and its grammatical variations refer to the fact that any one or more parts of the analyte sensor described herein have harmfulness or bacteriostasis to microorganisms, and also encompass technologies such as any mechanism, structure, system, etc. that imparts the above-mentioned harmfulness or bacteriostasis to a tangible material including one or more parts of the analyte sensor described herein.

[0019] Generally, the formation of bacterial colonies in transdermal devices and their attachment sites is considered to be externally derived. For example, when an infection becomes apparent due to an extended device implantation period or contamination during attachment, bacterial colonies may be formed from bacteria inhabiting the skin. Embodiments of the present disclosure have the effect of reducing the risk of device contamination during attachment and protecting the transdermal sensor from skin flora. Suppressing the growth of bacteria caused during or after the implantation of an implantable sensor at the implantation site of the implantable sensor is considered beneficial for the implantable sensor.

[0020] Specifically, embodiments of the present disclosure utilize external components such as sensor mounts, shells, and / or plugs as systems for delivering antibacterial and bacteriostatic substances as means for reducing or suppressing chemical and physical inhibition from the aforementioned microorganisms. The antibacterial substance can be incorporated into the bulk material and integrated into the entire component (or laminated by overmolding). Additionally, for example, it can be applied as a thin layer on the (one or more) surfaces by sputtering coating or introduced into the outer region of the component by various impregnation methods for introducing an active agent.

[0021] Examples of surfaces containing an antibacterial agent include at least one of the upper shell of the electronic device housing, particularly the upward-facing surface of the upper shell, the skin-side surface of the lower mount, the skin-side surface of the base of the plug, the outward-facing surface of the frustum of the plug, the upward-facing surface of the frustum of the plug, and the outer surface of the frustum of the plug, but are not limited thereto.

[0022] The antibacterial agent may be contained in a coating applied to the (one or more) surfaces of the sensor control device, may be incorporated into the bulk material used for the inert components of the sensor control device, may be integrated into the entire material used for the inert components of the sensor control device, may be impregnated into at least a part of the surface of the inert components of the sensor control device, may be adhered to the surface of the inert components of the sensor control device by overmolding, and / or may be applied to the surface of the inert components of the sensor control device by sputtering coating to form an antibacterial agent-containing layer.

[0023] The antibacterial agent can be a metal such as silver, copper, zinc, and combinations thereof, and / or their oxides. For example, the antibacterial agent can contain, for example, silver and copper such as copper and silver thereon, and / or silver and copper thereon, and / or their oxides.

[0024] Also, the antibacterial agent may be a metal oxide. In that case, the coating or surface contains at least 2 wt% of the oxide, or at least 5 wt% of the oxide, or at least 7 wt% of the oxide, or at least 10 wt% of the oxide, or at least 15 wt% of the oxide, or at least 25 wt% of the oxide, or at least 50 wt% of the oxide, or at least 75 wt% of the oxide. A high-oxidation metal oxide layer may be formed on the surface of the sensor control device by sputtering coating, using at least 5% of the oxidizing agent, or at least 10% of the oxidizing agent, or at least 15% of the oxidizing agent, or at least 20% of the oxidizing agent, or at least 25% of the oxidizing agent, or at least 30% of the oxidizing agent, or about 5% to about 100% of the oxidizing agent, or about 10% to about 95% of the oxidizing agent, or about 40% to about 85% of the oxidizing agent, or about 50% to about 85% of the oxidizing agent, or about 60% to about 85% of the oxidizing agent for sputtering. As the oxidizing agent, for example, air or oxygen can be used.

[0025] Before explaining the analyte sensor system of the present disclosure in more detail, in order to better understand the embodiments of the present disclosure, first, a brief overview of the configuration of a suitable in-vivo analyte sensor and the sensor system using the analyte sensor will be described.

[0026] FIG. 1 is a conceptual diagram showing an example of an analyte monitoring system 100 that can incorporate one or more embodiments of the present disclosure. The analyte monitoring system 100 (hereinafter referred to as "system 100") may be the same as the analyte monitoring system described and illustrated in US Patent Application Publication No. 2016 / 0331283 (invention title "System, Devices, and Methods for Assembling an Applicator and Sensor Control Device"), or may be similar in some respects. Note that all the disclosure contents of this patent specification, regardless of its use, shall become a part of this specification by citation.

[0027] A variety of analytes can be detected and quantified using System 100. Such analytes can include, but are not limited to, acetylcholine, amylase, bilirubin, cholesterol, human chorionic gonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA, fructosamine, glucose, glutamine, growth hormone, hormones, ketones (e.g., ketone bodies), lactate, oxygen, peroxide, prostate specific antigen, prothrombin, RNA, thyroid stimulating hormone, and troponin. Also, the concentrations of drugs such as antibiotics (e.g., gentamicin, vancomycin, etc.), digitoxin, digoxin, abused drugs, theophylline, warfarin, etc. can be measured, but are not limited to these.

[0028] As shown in the figure, System 100 includes a sensor applicator 102 (also known as an "inserter"), a sensor control device 104 (also known as an "in vivo analyte sensor control device"), and a reading device 106. The sensor applicator 102 is used to deliver the sensor control device 104 to a target monitoring position on the user's skin. Once delivered, the sensor control device 104 is maintained in place on the skin by an adhesive patch 108 connected to the bottom of the sensor control device 104. A portion of the sensor 110 extends from the sensor control device 104 and is positioned to be held, such as by being placed transdermally under the user's skin surface during the monitoring period. Note that in the figure, the sensor applicator and the sensor are shown as two separate components, but it can also be an integrated unit with a sterile sensor and electronic equipment pre-incorporated into the applicator.

[0029] When the sensor control device 104 is correctly assembled, the sensor 110 is in a state of communicating with one or more electrical components or sensor electronics included in the sensor control device 104 (for example, an electrical communication state, a mechanical transmission state, etc.). More specifically, the sensor control device 104 can include a printed circuit board on which an application specific integrated circuit (ASIC) is mounted. In that case, the sensor 110 can be operably connected to the ASIC, and the ASIC can be connected to an antenna and a power source. The sensor control device 104 is configured to communicate with the reading device 106 via the first communication path 112 using any wired or wireless technology. Suitable wireless protocols for this include, but are not limited to, radio frequency (RF) transmission, Wi-Fi, Bluetooth (registered trademark), ZigBee (registered trademark), near field communication (NFC), infrared, or combinations thereof.

[0030] The user can monitor the applications installed in the memory of the reading device 106 using the screen 114 and the input unit 116. The reading device 106 can be charged using the power port 118. The application can include data transmitted from the sensor 110 and / or display information provided by the sensor 110. The reading device 106 can include, but is not limited to, computing devices such as dedicated portable devices and smartphones. The reading device 106 can communicate with the local computer system 120 via the second communication path 122 using any wired or wireless technology. The local computer system 120 can be composed of computing devices such as notebook computers, desktop computers, tablet terminals, phablets (devices combining a phone and a tablet terminal), smartphones, set-top boxes, video game consoles, etc., but is not limited thereto. The wireless protocol suitable for communicating via the second communication path 122 is the same as that of the first communication path 112.

[0031] The local computer system 120 can communicate with the network 124 via the third communication path 126, and the reading device 106 can communicate with the network 124 via the fourth communication path 128. The third communication path 126 and the fourth communication path 128 can be equipped with any wired or wireless technology described in this specification. As the network 124, many networks such as a private network, a public network, a local area network or a wide area network can be considered, and any of these networks can be used. The trusted computer system 130 can communicate with the network 124 via the fifth communication path 132 by any wired or wireless technology described in this specification. The trusted computer system 130 can include a server and can provide authentication services and secure data storage.

[0032] In the illustrated embodiment, the system 100 can have a so-called "two-piece" structure that can be normally delivered to the target monitoring position of the sensor 110 only after final assembly by the user. More specifically, the sensor 110 included in the sensor control device 104 and the electrical components related thereto are provided to the user in a plurality (two) of packages. Note that the individual packages may or may not be sealed with a sterile barrier, but are at least enclosed in the packaging. The user needs to open the packaging, manually assemble the components according to the instruction manual, and then deliver the sensor 110 to the target monitoring position with the sensor applicator 102.

[0033] Figures 2A-2G are process diagrams showing the assembly and use of a system 100 incorporating a two-piece structure. For further assembly aspects, reference is made to the specifications of International Application Nos. PCT / US2019 / 035797 (corresponding publication: International Publication No. WO 2019 / 236850), PCT / US2019 / 035810 (corresponding publication: International Publication No. WO 2019 / 236859), and PCT / US2019 / 035829 (corresponding publication: International Publication No. WO 2019 / 236876), the entire disclosures of which are hereby expressly incorporated by reference into this specification for any purpose. Figure 2A shows a first package and Figure 2B shows a second package, which are provided to the user for final assembly. More specifically, Figure 2A shows a sensor container (sensor tray) 202 having a removable lid 204. The user removes the lid 204 to prepare the sensor tray 202 for immediate use. The lid 204 functions as a sterile barrier for maintaining an internal sterile environment, such as protecting the contents of the sensor tray 202. Removing the lid 204 exposes a platform 206 disposed within the sensor tray 202. A plug assembly 207 (partially shown in Figure 2A) is disposed within the platform 206 and is otherwise carefully engineered and incorporated. The plug assembly 207 includes a sensor module (not shown) and a stylet module (not shown). The sensor module carries a sensor 110 (Figure 1), and the stylet module carries an attached stylet. This stylet assists the user in the percutaneous delivery of the sensor 110 subcutaneously upon attachment of the sensor control device 104 (Figure 1).

[0034] Figure 2B shows the sensor applicator 102 and a user who is preparing the sensor applicator 102 for final assembly. The sensor applicator 102 includes a housing 208 sealed at one end with a cap 210. The cap 210 serves as a barrier to protect the contents of the sensor applicator 102. Specifically, the sensor applicator 102 incorporates an electronic device housing (not shown) that holds electrical components for the sensor control device 104 (Figure 1), and the cap 210 may or may not maintain a sterile environment for the electrical components. Preparation of the sensor applicator 102 includes the step of removing the housing 208 from the cap 210. This removal can be achieved by turning the cap 210 and removing it from the housing 208. Thereafter, the cap 210 can be discarded or otherwise set aside.

[0035] Figure 2C shows the user inserting the sensor applicator 102 into the sensor tray 202. The sensor applicator 102 includes a sheath 212. When the sheath 212 is placed on the platform 206, the sheath 212 is configured to temporarily release the locking of the housing 208 and also temporarily release the locking of the platform 206 to the sensor tray 202. Inside the sensor tray 202, a plug assembly 207 (Figure 2A) including a sensor module and a sharp body module is disposed, and an electronic device housing is disposed inside the sensor applicator 102. When the housing 208 is inserted into the sensor tray 202, the plug assembly 207 (Figure 2A) is connected to the electronic device housing.

[0036] In Figure 2D, the user is removing the sensor applicator 102 from the sensor tray 202 by withdrawing the sensor tray 202 away from the body so that the housing 208 is brought closer to the body.

[0037] Figure 2E shows the bottom or interior of the sensor applicator 102 after it has been removed from the sensor tray 202 (Figure 2D). When the sensor applicator 102 is removed from the sensor tray 202, the assembly of the sensor control device 104 is complete within the sensor applicator 102, and the sensor control device 104 is set in a position suitable for delivery to the target monitoring position. At this time, as shown in the figure, the pointed body 220 extends from the bottom of the sensor control device 104 and holds a part of the sensor 110 within its hollow or concave portion. The pointed body 220 is configured to penetrate the user's skin, thereby bringing the sensor 110 into contact with body fluid.

[0038] Figures 2F and 2G show an example of the state of delivering the sensor control device 104 to a target monitoring position 222 such as the posterior part of the user's upper arm. Figure 2F shows the user advancing the sensor applicator 102 toward the target monitoring position 222. When the sheath 212 engages with the skin at the target monitoring position 222, the sheath 212 contracts and fits into the housing 208, whereby the sensor control device 104 (Figures 2E and 2G) advances to be able to engage with the skin. Then, with the help of the pointed body 220 (Figure 2E), the sensor 110 (Figure 2E) is percutaneously inserted at the target monitoring position 222 and enters the patient's skin.

[0039] Figure 2G shows the state where the user has properly attached the sensor control device 104 to the user's skin and is retracting the sensor applicator 102 from the target monitoring position. The adhesive patch 108 (Figure 1) attached to the bottom of the sensor control device 104 adheres to the skin, fixing the sensor control device 104 in a predetermined position. The pointed body 220 (Figure 2E) is automatically retracted when the housing 208 has advanced to the maximum at the target monitoring position 222. At this time, the sensor 110 (Figure 2E) is left in a predetermined position so that the level of the analyte can be measured.

[0040] Figures 3A and 3B are diagrams showing an example of a sensor control device 302 according to one or more embodiments of the present disclosure, where Figure 3A is an isometric view and Figure 3B is a side view. The sensor control device 302 (also referred to as a "puck") can be similar to the sensor control device 104 of Figure 1 in several respects and is thus considered to be best understood by referring to Figure 1. The sensor control device 302 can be a replacement for the sensor control device 104 of Figure 1. Thus, the sensor control device 302 can be used together with the sensor applicator 102 (Figure 1) to deliver the sensor control device 302 to a target monitoring position on a user's skin.

[0041] However, unlike the sensor control device 104 of Figure 1, the sensor control device 302 can be incorporated into a one-piece system structure. This structure is different from a two-piece structure. For example, the user does not need to open multiple packages to perform the final assembly of the sensor control device 302. That is, at the time the user receives it, the sensor control device 302 is in a state where the assembly is complete and is set in the correct position within the sensor applicator 102 (Figure 1). When using the sensor control device 302, the user only needs to open one barrier (e.g., the cap 210 of Figure 2B), and just by doing so, the sensor control device 302 can be quickly delivered to the target monitoring position.

[0042] As shown, the sensor control device 302 includes an electronic device housing 304. The electronic device housing 304 is substantially disk-shaped and can have a circular cross-section. However, in other embodiments, the electronic device housing 304 may exhibit other cross-sectional shapes such as oval or polygonal without departing from the scope of the present disclosure. The electronic device housing 304 can be configured to enclose, such as by housing various electrical components used to operate the sensor control device 302.

[0043] The electronic device housing 304 can include a shell 306 and a mount 308 that can be fitted to the shell 306. The shell 306 can be fixed to the mount 308 in various ways such as snap-fit engagement, interference fit, ultrasonic welding, or one or more mechanical fasteners (e.g., screws). In some cases, the shell 306 can be fixed to the mount 308 such that the interface between the shell 306 and the mount 308 becomes a sealing interface. In such embodiments, a sealing material of a type such as a gasket can be disposed at or near the outer diameter portion (periphery) of the shell 306 and the mount 308. In that case, when the shell 306 and the mount 308 are fixed to each other, the gasket is compressed and the interface is sealed. In other embodiments, an adhesive can also be applied to the outer diameter portion (periphery) of one or both of the shell 306 and the mount 308. The shell 306 is fixed to the mount 308 by the adhesive, whereby not only structural integrity can be obtained, but also the interface between the shell 306 and the mount 308 can be sealed to shield the interior of the electronic device housing 304 from external contamination. Also, if the assembly of the sensor control device 302 is performed in a controlled environment, it becomes unnecessary to perform final sterilization on the internal electrical components. That is, by connecting with an adhesive, a sufficient aseptic barrier can be provided for the electronic device housing 304 after assembly is completed.

[0044] In addition, the sensor control device 302 can further include a plug assembly 310 connectable to the electronic device housing 304. The plug assembly 310 can be similar to the plug assembly 207 in FIG. 2A in some respects. For example, the plug assembly 310 can include a sensor module 312 (partially shown) that can be interconnected with a sharp body module 314 (partially shown). The sensor module 312 can be configured to include a sensor 316 (partially shown) in a manner such as carrying it, and the sharp body module 314 can be configured to include a sharp body 318 (partially shown) in a manner such as carrying it. This sharp body 318 assists in the percutaneous delivery of the sensor 316 into the user's subcutaneous tissue when the sensor control device 302 is attached. As shown, the corresponding portions of the sensor 316 and the sharp body 318 extend from the electronic device housing 304, and more particularly, from the bottom of the mount 308. The exposed portion of the sensor 316 can be received within the hollow or recessed portion of the sharp body 318. And the remaining portion of the sensor 316 is disposed inside the electronic device housing 304. Further, the sensor control device 302 can further include a sensor protection vial 320. The sensor protection vial 320 acts as a protective barrier that covers the exposed portions of the sensor 316 and the sharp body 318 and protects these exposed portions during chemical gas sterilization.

[0045] Figures 4A and 4B are diagrams showing a plug assembly 310 according to one or more embodiments, where Figure 4A is an isometric view and Figure 4B is an exploded view. The sensor module 312 can include a sensor 316, a plug 402, and a connector 404. The plug 402 can be designed to receive and support both the sensor 316 and the connector 404. As shown, a groove 406 for receiving a part of the sensor 316 can also be defined by passing through the plug portion 409. The plug portion can take any shape, for example, a frustum of a cone, a circular shape, an elliptical shape, etc. Further, the plug 402 can also have one or more flexible arms 407. These flexible arms 407 are configured to snap-engage with corresponding shaped portions provided on the bottom surface of the electronic device housing 304 (Figures 3A and 3B).

[0046] The sensor 316 includes a tail portion 408, a flag portion 410, and a neck portion 412. The neck portion 412 interconnects the tail portion 408 and the flag portion 410. The tail portion 408 can be configured such that at least a part of it extends distally from the plug 402 through the groove 406. The tail portion 408 contains a chemical substance or a biological substance such as an enzyme, and in some embodiments, the chemical substance can be covered with a membrane. In use, the tail portion 408 is percutaneously inserted into the user's subcutaneous tissue, and the chemical substance contained in the tail portion 408 promotes the monitoring of the analyte in the presence of body fluid.

[0047] The flag portion 410 can have a substantially flat surface, and one or more sensor contacts 414 (three in Figure 4B) are arranged on this substantially flat surface. Inside the connector 404, the same number of carbon-impregnated polymer modules (the upper part of which is indicated by reference numeral 420 in the figure) that are compatible with the sensor contacts 414 are encapsulated, and the sensor contacts 414 can be arranged to be aligned with these carbon-impregnated polymer modules.

[0048] Connector 404 includes one or more hinges 418. Due to the hinges 418, the connector 404 can transition between an open state and a closed state. In FIGS. 4A and 4B, the connector 404 in the closed state is shown, but the connector 404 can pivot to an open state, and in the open state, the flag portion 410 and the conformable carbon-impregnated polymer module can be inserted into the connector 404. The (one or more) conformable carbon-impregnated polymer modules provide electrical contacts 420 (three in the figure). Corresponding circuit contacts are provided in the electronic device housing 304 (FIGS. 3A and 3B), and the electrical contacts 420 are configured to ensure a conductive connection between the sensor 316 and the circuit contacts. The connector 404 can be made of silicone rubber and can function as a moisture barrier for the sensor 316 during assembly in a compressed state and after attachment to the user's skin.

[0049] The piercing module 314 includes a piercing body 318 and a piercing hub 422 that carries the piercing body 318. The piercing body 318 has an elongated shaft 424 and a piercing tip 426 located at the distal end of the shaft 424. The shaft 424 can be configured to extend distally from the plug 402 through the groove 406. Further, the shaft 424 can have a hollow or recessed portion 428 that surrounds at least a portion of the tail 408 of the sensor 316. The piercing tip 426 can be configured to penetrate the skin while carrying the tail 408 and bring the active chemical substance on the tail 408 into contact with the body fluid.

[0050] The piercing hub 422 can include a hub small cylindrical portion 430 and a hub snap claw 432. Both of these can be configured to assist in connecting the plug assembly 310 (and thus the entire sensor control device 302) to the sensor applicator 102 (FIG. 1).

[0051] Referring now in detail to FIG. 4B, the protective vial 320 can comprise an elongate body 434 that is generally cylindrical. The body 434 has a first end 436a and a second end 436b that is opposite the first end 436a. The first end 436a can be an open end, thereby providing access to an internal chamber 438 defined within the body 434. On the other hand, the second end 436b can be a closed end and can define an enlarged head 440, such as by providing an enlarged head 440. The enlarged head 440 exhibits an outer diameter that is larger than the outer diameter of the remainder of the body 434. However, in other embodiments, the enlarged head 440 can be located at an intermediate position between the first end 436a and the second end 436b.

[0052] FIG. 4C is an exploded isometric bottom view of the plug 402 and the protective vial 320. As shown, the plug 402 can define an opening 442. The opening 442 is configured to receive the protective vial 320, and more particularly, the first end 436a of the body 434. The groove 406 can terminate at the opening 442 such that when the protective vial 320 is connected to the plug 402, the internal chamber 438 receives a component that extends outside (distally) of the groove 406. Further details regarding the protective vial 320 are described in the specification of International Application No. PCT / US19 / 32848, filed Jun. 10, 2019, the entire disclosure of which is hereby incorporated by reference in its entirety for all purposes.

[0053] The plug assembly 310 can be properly sterilized by radiation sterilization, including the sensor 316 and the sharp body 318. Suitable radiation sterilization processes include, but are not limited to, electron beam (e-beam) irradiation, gamma ray irradiation, X-ray irradiation, or combinations thereof. In some embodiments, the plug assembly 310 can be radiation sterilized before connecting the protective vial 320 to the plug 402. However, in other embodiments, the plug assembly 310 can also be radiation sterilized after connecting the protective vial 320 to the plug 402. In such embodiments, the body 434 of the protective vial 320 and the preservation solution 446 can be composed of materials and / or substances through which radiation can pass and propagate, so that the distal portions of the sensor 316 and the sharp body 318 can be easily sterilized by radiation.

[0054] FIGS. 5A and 5B are diagrams showing an electronic device housing 304 according to one or more embodiments, FIG. 5A is an exploded view, and FIG. 5B is an isometric bottom view. The shell 306 and the mount 308 substantially enclose various electronic components of the sensor control device 302 (FIGS. 3A and 3B) in a manner such as surrounding them, like a pair of opposing clam shells.

[0055] The printed circuit board (PCB) 502 can be disposed within the electronic device housing 304. Multiple electronic modules (not shown) can be mounted on the printed circuit board 502. Examples of mountable electronic modules include, but are not limited to, data processing units, resistors, transistors, capacitors, inductors, diodes, switches, etc. The data processing unit can include, for example, an application specific integrated circuit (ASIC) configured to implement one or more functions or routines related to the operation of the sensor control device 302. More specifically, the data processing unit can be configured to perform data processing functions. Examples of data processing functions include, but are not limited to, filtering and encoding of each data signal corresponding to the analyte level collected from the user. Also, the data processing unit can include an antenna for communicating with the reading device 106 (FIG. 1) or can communicate with such an antenna.

[0056] As shown, the shell 306, the mount 308, and the printed circuit board 502 each define a corresponding central opening 504, 506, 508. When the electronic device housing 304 is assembled, the central openings 504, 506, 508 are coaxially aligned, and a plug assembly 310 (FIGS. 4A and 4B) is inserted into the aligned central openings 504, 506, 508. The electronic device housing 304 can also house a battery 510 therein, and the battery 510 can be configured to power the sensor control device 302.

[0057] In FIG. 5B, a plug receptacle 512 can be defined at the bottom of the mount 308. The plug receptacle 512 can define a position for inserting a plug assembly 310 (FIGS. 4A and 4B) to connect to the electronic device housing 304. By inserting the plug assembly 310 into the plug receptacle 512, the assembly of the sensor control device 302 (FIGS. 3A and 3B) is completed. The outer shape of the plug 402 (FIGS. 4A to 4C) can be adapted to (complementary in shape to) the plug receptacle 512. The plug receptacle 512 can have one or more snap - engagement ledge portions 514 (two are shown). The snap - engagement ledge portions 514 are configured to engage with the flexible arms 407 (FIGS. 4A and 4B) of the plug 402 and receive the flexible arms 407. By inserting the plug 402 into the plug receptacle 512 and thereby locking each flexible arm 407 to the corresponding snap - engagement ledge portion 514, the plug assembly 310 is connected to the electronic device housing 304. When the plug assembly 310 (FIGS. 4A and 4B) is properly connected to the electronic device housing 304, one or more circuit contacts 516 (three in the figure) defined on the lower side of the printed circuit board 502 can be conductively connected to the electrical contacts 420 (FIGS. 4A and 4B) of the connector 404.

[0058] The inert components of the sensor assembly are components that can be used to deliver bioactive substances to the surfaces and regions adjacent to and / or surrounding the exterior of the (one or more) sensors, and optionally within the implantation site. For example, the inert components of the sensor assembly can be manufactured to have antibacterial properties or to contain antibacterial agents. This enables the sustained delivery of antibacterial agents from the inert components to regions such as the surface of the sensor assembly and the skin adjacent thereto. It is thought that such sustained delivery allows for the long-term delivery of antibacterial agents in a controlled manner from the inert components. That is, a sensor system comprising inert components containing antibacterial agents is considered to have self-preserving properties (a state where no separate preservative is required).

[0059] It is considered that there are many advantages in the manufacture of inert components having antibacterial properties. For example, the sensor lifespan can be extended by suppressing the growth and invasion of microorganisms. Also, the sensor accuracy can be improved even under poor sensor conditions such as when an infection has occurred. Further, it is thought that this multi-layered technology can also suppress the infiltration of immune cells into the sensor implantation site. Also, inert components having antibacterial properties are considered to be able to achieve a high immune cell density and tissue encapsulation because they suppress microorganisms and do not cause an immune reaction due to infection in the host. Additionally, this sensor can be used, for example, at sites where an infection has occurred or at sites with reduced function such as the skin and wound bed. Also, an antibacterial agent that has little or no effect on the function of the sensor can be selected.

[0060] It is also possible to improve the sensor function by attaching an antibacterial agent to the inert component by sputtering coating. Further, air or oxygen can be introduced during sputtering, whereby an oxide film with higher (improved) antibacterial properties can be obtained compared to a film with a low oxidation amount. Also, by blending an antibacterial agent as a raw material or forming a film through an impregnation process, it is possible to elute the antibacterial agent and form an inert component that has improved the sensor function.

[0061] Inert components that can include an antibacterial agent during manufacturing also include components that are exposed to the environment after assembly of the sensor system. Examples of inert components that can include an antibacterial agent include components of the shell 306 and the plug assembly 310. Such elements include, for example, the upward-facing surface and outer peripheral lip of the shell 306 (see, for example, FIG. 5A), in particular, the downward-facing (skin-side) surface and lower outer peripheral lip of the mount 308 (see, for example, FIG. 5B), and the plug 402, in particular, the downward-facing (skin-side) surface of the plug 402 (see, for example, FIGS. 4C and 6A), the outward-facing surface of the plug portion 409 (see, for example, FIGS. 4B and 6B), the upward-facing surface of the plug portion 409 (see, for example, FIGS. 4B and 6C), and the outer and inner surfaces (groove 406) of the plug portion 409 (see, for example, FIGS. 4B, 6B, and 6C), but are not limited thereto. The plug portion 409 is shown in the figures as having a frustoconical shape, but can take any shape, for example, a frustoconical shape, a circular shape, an elliptical shape, etc.

[0062] Antibacterial and / or bacteriostatic substances or agents that can be used to suppress inhibition events associated with microorganisms include, but are not limited to, silver, copper, zinc, and combinations thereof (e.g., copper with silver thereon, silver with copper thereon, and oxides of any of silver, copper, zinc, etc.). These antibacterial and / or bacteriostatic substances or agents can be incorporated into the bulk material and incorporated into the entire component, or can be laminated by overmolding, applied as a thin layer on the (one or more) surfaces (e.g., by sputtering coating, etc.), or introduced into the outer region of the inert component by various impregnation methods for introducing antibacterial and / or bacteriostatic substances. Also, in order to enhance the adhesion of the antibacterial and / or bacteriostatic substance, the inert component can be primed with a thin layer of another metal or material such as titanium.

[0063] In some embodiments, metal-based antibacterial compounds may be particularly useful for imparting antibacterial properties to inert components (shell and plug assembly). Such metal-based antibacterial compounds include metal ions, metal oxides, metal salts, metal coordination compounds such as chelates, and the like. Specific examples of suitable metal-based antibacterial compounds include silver, silver chloride, silver-silver chloride, silver iodide, silver carbonate, silver nitrate, copper, copper sulfate, copper(II) oxalate, silver oxalate, magnetite, gold, gallium, platinum, palladium, titanium dioxide, zinc oxide, magnesium oxide, silicon dioxide, iron oxide, carbon dioxide, copper oxide, nitric oxide, carbon nanotubes, etc. (e.g., other antibacterial heavy metal ions and / or metal oxides), any alloys thereof, any salts thereof, any coordination complexes and / or chelates thereof, any combinations thereof, and one or more antibacterial compounds described herein with any combinations thereof added, but are not limited thereto.

[0064] In some embodiments, metal-containing nanoparticles can be used as the metal-based antibacterial agent. The metal-containing nanoparticles may, for example, have an antibacterial compound immobilized thereon by impregnation or may be entirely composed of the antibacterial compound. Without intending to be limiting, examples of the metal-containing nanoparticles can include any nanoparticles containing the metal-based antibacterial compounds described herein.

[0065] In some embodiments, the metal-based antibacterial agent layer can be applied by sputtering. In some embodiments, increasing the oxygen content in the sputtering process increases the amount of metal oxide in the metal-based antibacterial agent layer. The method can include sputtering a metal layer onto a substrate in a first atmosphere consisting essentially of an inert gas. Alternatively or in addition, the method includes forming a metal oxide-containing layer by sputtering a metal in a second atmosphere containing a mixture of an inert gas and an oxidizing agent. The oxidizing agent can constitute from about 0.5% to 100% of the second atmosphere by partial pressure, or about 5% to 95%, or about 15% to 60%, or about 20% to 60%, or about 30% to 60%, or about 40% to 60%, or about 50% to 60%. As the oxidizing agent, air, oxygen, ozone, or water can be used.

[0066] The inert component can comprise a coating containing some metal oxide. In one embodiment, the coating contains at least 2 wt% metal oxide, or at least 5 wt% metal oxide, or at least 10 wt% metal oxide, or at least 20 wt% metal oxide, or from about 30 wt% to about 40 wt% metal oxide, or from about 2 wt% to about 20 wt% metal oxide, or from about 10 wt% to about 30 wt% metal oxide.

[0067] The thickness of the metal or metal oxide layer can be at least about 500 angstroms, or about 750 angstroms, or from about 400 angstroms to about 1000 angstroms, or from about 500 angstroms to about 800 angstroms, or from about 1 μm to about 10 μm, or from about 5 μm to about 10 μm, or from about 500 angstroms to about 10 μm.

[0068] In other embodiments, the inert component can be formed of a material containing a metal, a metal salt, or a metal oxide. For example, the inert component can be formed using a polycarbonate containing a silver salt and a zinc salt, or a copper salt and a zinc salt, or a silver salt and a copper salt, or silver and zinc oxide, or copper oxide and zinc oxide, or silver oxide and copper oxide.

[0069] Accordingly, a particular sensor control device of the present disclosure can have the following configuration. That is, a particular sensor control device of the present disclosure includes an electronic device housing having an upper shell that can be fitted to a lower mount having a skin-side surface, and a plug assembly connected to the electronic device housing and including a sensor module having a sensor and a sharp body module having a sharp body, the plug assembly including a base having a skin-side surface and a plug portion having a through lumen, and at least a part of the surface of the electronic device housing or the plug assembly contains an antibacterial agent. The plug portion can take any shape and can be in a shape such as a frustum of a cone, circular, or elliptical.

[0070] In one embodiment, surfaces that can include the antibacterial agent include, but are not limited to, the upper shell of the electronic device housing, particularly the upward surface and the outer peripheral edge of the upper shell, the skin-side surface of the lower mount, the skin-side surface of the base of the plug, the outward-facing surface of the plug portion, the upward surface of the plug portion, and the outer surface of the plug portion. The plug portion can take any shape and can be in a shape such as a frustum of a cone, circular, or elliptical.

[0071] In other embodiments, the medical device can include a housing having a skin-side surface and a metal oxide-containing layer adjacent to the skin-side surface. The metal oxide-containing layer can be configured to contact the patient's skin and can contain at least about 5 wt% of a metal oxide. The medical device can be configured to contact the patient's skin for at least 10 days, or at least 12 days, or about 10 days to about 14 days, or at least several days, or at least 1 week, or at least several weeks.

[0072] In one embodiment, the antibacterial agent can be a metal and / or metal oxide such as silver, copper, zinc, and combinations thereof. For example, the antibacterial agent can include silver and copper, such as copper with silver on it or silver with copper on it.

[0073] In one embodiment, the antibacterial agent can be incorporated into a coating applied to the (one or more) surfaces of the sensor control device. Alternatively, the antibacterial agent can be incorporated into the bulk material used for the inert components of the sensor control device. Alternatively, the antibacterial agent can be incorporated into the entire material used for the inert components of the sensor control device. Alternatively, the antibacterial agent can be impregnated into at least a part of the surface of the inert components of the sensor control device. Alternatively, the antibacterial agent can be adhered to the surface of the inert components of the sensor control device by overmolding. Alternatively, the antibacterial agent can be applied to the surface of the inert components of the sensor control device by sputtering coating to form an antibacterial agent-containing layer.

[0074] In one embodiment, the antibacterial agent is contained in at least one layer adhered to the surface of an inert component (e.g., an electronic device housing or a plug assembly). Alternatively, the antibacterial agent is contained in at least two layers, or at least three layers, or at least four layers adhered to the surface of the inert component.

[0075] In other embodiments, the method includes the step of attaching an antibacterial agent-containing layer to the surface of the sensor control device, and the sensor control device can have the following configuration. That is, a specific sensor control device of the present disclosure includes an electronic device housing having a lower mount that can be fitted to a skin-side surface and an upper shell having an outer peripheral lip, and a plug assembly connected to the electronic device housing and including a sensor module having a sensor and a sharp body module having a sharp body, the plug assembly including a base having a skin-side surface and a plug portion having a through lumen. The surface of the sensor control device to which the antibacterial agent-containing layer is attached can be at least one of the upper shell, the outer peripheral lip, the skin-side surface of the lower mount, the skin-side surface of the base, and the plug portion. The plug portion can take any shape, and can be shaped like a frustum of a cone, circular, elliptical, or the like.

[0076] In other embodiments, the method includes the step of forming a metal-containing layer on the surface of the sensor control device by sputtering, and the sensor control device can have the following configuration. That is, a specific sensor control device of the present disclosure includes an electronic device housing having a lower mount that can be fitted to a skin-side surface and an upper shell having an outer peripheral lip, and a plug assembly connected to the electronic device housing and including a sensor module having a sensor and a sharp body module having a sharp body, the plug assembly including a base having a skin-side surface and a plug portion having a through lumen. The surface of the sensor control device on which the metal-containing layer is formed by sputtering can be at least one of the upper shell, the outer peripheral lip, the skin-side surface of the lower mount, the skin-side surface of the base, and the plug portion. The plug portion can take any shape, and can be shaped like a frustum of a cone, circular, elliptical, or the like.

[0077] In one embodiment, the above metal can be silver, copper, zinc, or a combination thereof.

[0078] In one embodiment, the sputtering onto the surface of the above metal is performed in an atmosphere containing an inert gas and an oxidizing agent. Argon can be used as the inert gas, and air or oxygen can be used as the oxidizing agent.

[0079] To better understand the disclosure of this specification, examples of various representative embodiments are described below. It should be noted that the following examples should not be read as limiting or defining the scope of the present invention.

Examples

[0080] Example 1: Zone of Inhibition Test The activity of the coating against Pseudomonas aeruginosa (PA, ATCC27317) as a relevant pathogen was evaluated using the Zone of Inhibition (ZOI) assay. First, the bacteria were cultured overnight in tryptic soy broth (TSB) (MP Biomedicals, USA) medium at 37°C. Next, this overnight culture of Pseudomonas aeruginosa was diluted 1:50 in TSB medium, and 100.0 μL of this solution was spread onto multiple 100×15 mm tryptic soy agar plates. Then, the sample was placed with the coated surface down, ensuring that the coating was in direct contact with the inoculated agar during lawn formation. These plates were cultured at 37°C for 24 hours and photographed.

[0081] As shown in Figure 7A, the coatings of copper, copper with a silver coating on it, silver with a copper coating on it, and a silver coating were tested (clockwise from the upper left). The coated surfaces were formed by sputtering, and a thin titanium layer was sputtered as a primer in advance to enhance adhesion. The coating of the plate shown in Figure 7B has a higher oxide level than the coating of the plate shown in Figure 7C. As can be seen from Figure 7B and Figure 7C, a larger zone of inhibition (the bright region surrounding the coating) was obtained for the coating with a higher oxide level compared to the coating with a lower oxide level.

[0082] The inhibitory zone test was also performed against methicillin-resistant Staphylococcus aureus (MRSA, ATCC 33591), Staphylococcus epidermidis (ATCC 12228), Enterococcus faecalis (ATCC 4082), as well as Streptococcus pyogenes (ATCC 19615), Pseudomonas aeruginosa (ATCC 27317), and Propionibacterium acnes (ATCC 6919) and methicillin-sensitive Staphylococcus aureus.

[0083] Example 2: Influence of enhanced oxidation on the appearance of the plug assembly After titanium coating the lower surface of the plug assembly, those coated with copper and then silver thereon (Figure 8A) and those coated with silver and then copper thereon (Figure 8B) were facilitated. The titanium layer was added to enhance the adhesion of the silver coating and copper coating.

[0084] As can be seen from Figures 8A and 8B, the effect of enhanced oxidation also appears on the appearance of the bottom surface of the plug assembly. Figure 8A shows the copper and the silver coating thereon, and Figure 8B shows the silver and the copper coating thereon.

[0085] The coated surface was formed by sputtering, and a thin titanium layer was sputtered as a primer in advance to enhance adhesion. A titanium layer was formed on the skin-side surface of the plug assembly, and a metal oxide-containing layer was formed by sputtering on the titanium layer.

[0086] Example 3: Bacterial adhesion / biofilm formation test The sample was left standing in the inoculated medium for a predetermined time (the predetermined time varies depending on the strain). After the predetermined time elapsed, the sample was taken out from the inoculated medium and labeled by live / dead staining. Then, the surface was imaged with a fluorescence microscope, and the number of adhering colony-forming units (CFUs) and biofilms were observed. Figure 9A shows the results of Pseudomonas aeruginosa, and Figure 9B shows the results of Staphylococcus aureus, respectively.

[0087] The bacterial adhesion / biofilm formation test was conducted on Pseudomonas aeruginosa (ATCC27317), Staphylococcus aureus (MRSA, ATCC33591), Staphylococcus epidermidis (ATCC12228), Streptococcus faecalis (ATCC4082), Streptococcus pyogenes (ATCC19615), Pseudomonas aeruginosa (ATCC27317), Propionibacterium acnes (ATCC6919), and methicillin-sensitive Staphylococcus aureus (UAMS-1).

[0088] Example 4: Logarithmic reduction test (also known as kill assay (ISO22196)) Furthermore, a coating test was also carried out in accordance with ISO22196, which defines a method for evaluating the antibacterial activity of a porous surface. This test examines the surface using a liquid bacterial culture. Multiple bacterial suspensions with different dilution ratios were prepared. The plug surface to be tested in this test was the skin-side surface of the plug (the same surface as the sputtering-coated plug surface). As the plug groups, in addition to the product plug (control group), three experimental groups were prepared: (1) Ag-doped resin-molded plug, (2) high-oxide Ti-Ag / Cu sputtering-coated plug, and (3) high-oxide Ti-Cu / Ag sputtering-coated plug. The Ag-doped resin-molded plug had the same shape and size as the plug in the control group and was a plug injection-molded from the antibacterial resin WithStand (PolyOne, Avon Lake, Ohio). This resin was doped with a silver salt and was considered to release silver ions. Each high-oxide Cu·Ag sputtering-coated plug was prepared by the method described above in the upper part of this specification. Each plug was attached to a custom-made holder so that the target surface faced upward and was horizontal to the ground (refer to the image). Then, the test was carried out with the plug mounted on the mount.

[0089] A growth / kill test was carried out for 24 hours in accordance with ISO22196. After culturing the recovered CFUs for 24 hours, the CFUs were counted to determine the effect. First, in the culture medium, 3×10 4 CFUs of Pseudomonas aeruginosa and 2×10 4CFU of Staphylococcus aureus was independently inoculated onto the surface of each plug. A glass coverslip was placed over the surface of the plug, and the bacteria were evenly distributed on the surface of the plug. This sample was cultured overnight. After overnight culture, either viable / dead staining and imaging or bacterial recovery and counting was performed on the sample. Bacterial recovery was performed by sonication of the plug in the medium. The total number of CFU per plug was measured with a particle counter.

[0090] Both of the two sputtering coating groups showed very strong growth resistance compared to the other groups, resulting in either killing all the bacteria or reducing the number of CFUs by several digits compared to time 0 (the number of CFUs seeded on each sample). No suppression of bacterial growth was observed in the control plug group or the Ag-doped plug group. In particular, the almost complete killing of methicillin-sensitive Staphylococcus aureus (UAMS-1) (see FIGS. 10A and 10B) and Pseudomonas aeruginosa (ATCC27317) (see FIGS. 10C and 10D) was noted as indicating excellent performance. Similar results to the CFU counting were obtained by viable (green) / dead (red) staining, showing that the viable bacteria on the surface of the sputtering coating plug were zero or nearly zero, while bacterial colonies were formed in the control plug group and the Ag-doped plug group after overnight culture.

[0091] The log reduction test was performed on Pseudomonas aeruginosa (ATCC27317), Staphylococcus aureus (MRSA, ATCC33591), Staphylococcus epidermidis (ATCC12228), Streptococcus faecalis (ATCC4082), as well as Streptococcus pyogenes (ATCC19615), Pseudomonas aeruginosa (ATCC27317), as well as Propionibacterium acnes (ATCC6919), and methicillin-sensitive Staphylococcus aureus.

[0092] As a summary and / or supplement to some of the embodiments described so far, various aspects of the present subject matter are shown below. It should be emphasized here that the interrelationships and interchangeability of the following embodiments are important. In other words, the features of the plurality of embodiments are emphasized on the fact that they can be combined with any other features, except when it is specified otherwise or when it lacks logical validity. Although not explicitly referred to the drawings below, the descriptions of the following paragraphs are reproductions and developments of the embodiments described in this specification.

[0093] In many embodiments, the sensor control device includes an electronic device housing having an upper shell that can be fitted into a lower mount having a skin-side surface, and a plug assembly connected to the electronic device housing and including a sensor module having a sensor and a pointed body module having a pointed body, the plug assembly including a base having a skin-side surface and a plug portion having a through lumen, and at least a part of the surface of the electronic device housing or the plug assembly contains an antibacterial agent.

[0094] In some embodiments, at least one of the upper shell, the skin-side surface of the lower mount, the skin-side surface of the base, and the plug portion contains an antibacterial agent. In some embodiments, the upper shell of the electronic device housing has an outer peripheral lip, and the outer peripheral lip contains an antibacterial agent. In some embodiments, the plug portion further includes an outward-facing surface of the plug portion, an upward-facing surface of the plug portion, an outer surface of the plug portion, and an inner surface of the plug portion, and at least one of the outward-facing surface of the plug portion, the upward-facing surface of the plug portion, the outer surface of the plug portion, and the inner surface of the plug portion contains an antibacterial agent. In some embodiments, the plug portion has a shape selected from the group consisting of frustum of a cone, circular, and elliptical.

[0095] In some embodiments, the antibacterial agent is a metal or a metal oxide.

[0096] In some embodiments, the antibacterial agent is selected from the group consisting of silver, copper, zinc, and combinations thereof.

[0097] In some embodiments, the antibacterial agent is contained in the coating. In some embodiments, the antibacterial agent is selected from the group consisting of silver, copper, zinc, and combinations thereof. In some embodiments, the antibacterial agent comprises copper with silver thereon, or silver with copper thereon.

[0098] In some embodiments, the antibacterial agent is incorporated into the bulk material used for the electronic device housing or the plug assembly.

[0099] In some embodiments, the antibacterial agent is incorporated throughout the material used for the electronic device housing or the plug assembly.

[0100] In some embodiments, the antibacterial agent impregnates at least a portion of the surface of the electronic device housing or the plug assembly.

[0101] In some embodiments, the antibacterial agent is attached to the electronic device housing or the plug assembly by overmolding.

[0102] In some embodiments, the antibacterial agent is applied to the electronic device housing or the plug assembly by sputtering coating to form an antibacterial agent-containing layer. In some embodiments, a titanium layer is attached to the electronic device housing before attaching the antibacterial agent-containing layer. In some embodiments, the antibacterial agent is a metal or a metal oxide. In some embodiments, the antibacterial agent-containing layer is a layer containing at least about 5 wt% of a metal oxide. In some embodiments, the antibacterial agent-containing layer is a layer containing from about 2 wt% to about 30 wt% of a metal oxide. In some embodiments, the antibacterial agent-containing layer has a thickness of from about 500 angstroms to about 10 μm. In some embodiments, the antibacterial agent is contained in at least one layer attached to the electronic device housing or the plug assembly. In some embodiments, the antibacterial agent is contained in at least two layers attached to the electronic device housing or the plug assembly.

[0103] In many embodiments, the method includes attaching an antimicrobial agent-containing layer containing an antimicrobial agent to the surface of a sensor control device. The sensor control device includes an electronic device housing having a lower mount that can be fitted to a skin-side surface and an upper shell having an outer peripheral lip, and a plug assembly connected to the electronic device housing and including a sensor module having a sensor and a sharp body module having a sharp body, the plug assembly including a base having a skin-side surface and a plug portion having a through lumen. The above surface of the sensor control device is at least one of the upper shell, the outer peripheral lip, the skin-side surface of the lower mount, the skin-side surface of the base, and the plug portion.

[0104] In some embodiments, the antimicrobial agent is a metal.

[0105] In some embodiments, the antimicrobial agent is a metal oxide.

[0106] In some embodiments, the antimicrobial agent is selected from the group consisting of silver, copper, zinc, and combinations thereof.

[0107] In some embodiments, the antimicrobial agent is copper and silver thereon, or silver and copper thereon.

[0108] In some embodiments, the method further includes attaching a layer of titanium to the surface of the sensor control device before the step of attaching the antimicrobial agent-containing layer to the surface of the sensor control device.

[0109] In some embodiments, the antibacterial agent-containing layer is deposited by sputtering. In some embodiments, the antibacterial agent is deposited in an atmosphere containing an inert gas and an oxidizing agent. In some embodiments, the atmosphere contains from about 5% to about 100% oxidizing agent by partial pressure. In some embodiments, the oxidizing agent is oxygen. In some embodiments, the antibacterial agent includes silver, copper, zinc, and combinations thereof. In some embodiments, the inert gas is argon. In some embodiments, a metal oxide is formed on the surface of the sensor control device.

[0110] In some embodiments, the antibacterial agent is a metal oxide and the antibacterial agent-containing layer contains at least about 85% metal oxide.

[0111] In some embodiments, the antibacterial agent is a metal oxide and the antibacterial agent-containing layer is a layer containing from at least about 2 wt% to about 98 wt% metal oxide.

[0112] In some embodiments, the step of attaching the antibacterial agent-containing layer to the plug portion includes attaching the antibacterial agent-containing layer to at least one of the outward-facing surface, upward-facing surface, outer surface, and inner surface of the plug portion.

[0113] In some embodiments, the plug portion has a shape selected from the group consisting of frustoconical, circular, and elliptical.

[0114] In many embodiments, the method includes forming, by sputtering, a metal-containing layer containing a metal on a surface of a sensor control device. The sensor control device includes an electronic device housing that is fitted to a lower mount having a skin-side surface and includes an upper shell having an outer peripheral lip, and a plug assembly connected to the electronic device housing and including a sensor module having a sensor and a sharp body module having a sharp body, the plug assembly including a base having a skin-side surface and a plug portion having a through lumen. The above surface of the sensor control device is at least one of the upper shell, the outer peripheral lip, the skin-side surface of the lower mount, the skin-side surface of the base, and the plug portion.

[0115] In some embodiments, the metal includes silver, copper, zinc, and combinations thereof.

[0116] In some embodiments, the metal is adhered to the surface of the sensor control device by sputtering in an atmosphere containing an inert gas and an oxidizing agent. In some embodiments, the inert gas is argon. In some embodiments, the oxidizing agent is oxygen. In some embodiments, the atmosphere contains an oxidizing agent at a partial pressure of about 5% to about 100%. In some embodiments, the atmosphere contains an oxidizing agent at a partial pressure of at least about 10%. In some embodiments, a metal oxide is formed on the above surface of the sensor control device.

[0117] In some embodiments, the method further includes forming, by sputtering, a layer of titanium on the surface of the sensor control device before the step of forming the metal-containing layer on the surface of the sensor control device by sputtering. In some embodiments, the step of forming the metal-containing layer on the plug portion by sputtering includes forming the metal-containing layer on at least one of the outward-facing surface of the plug portion, the upward-facing surface of the plug portion, the outer surface of the plug portion, and the inner surface of the plug portion by sputtering.

[0118] In some embodiments, the plug portion has a shape selected from the group consisting of frustoconical, circular, and elliptical.

[0119] In many embodiments, the medical device comprises a housing having a skin-side surface and a layer adjacent to the skin-side surface and containing a metal oxide, the layer being configured to contact the patient's skin, and the layer containing at least about 5 wt% of the metal oxide.

[0120] In some embodiments, the layer contains from about 2 wt% to about 98 wt% of the metal oxide.

[0121] In some embodiments, the medical device is configured to contact the patient's skin for at least 10 days.

[0122] In some embodiments, the medical device is configured to contact the patient's skin for from about 10 days to about 14 days.

[0123] In some embodiments, the layer is formed on the skin-side surface by a sputtering coating.

[0124] In some embodiments, the layer is formed on the skin-side surface by overmolding.

[0125] Unless otherwise specified, all numerical values representing quantities etc. in this specification and the related claims are to be understood as being modified by the term "about". Thus, unless otherwise indicated to the contrary, the numerical parameters set forth in the following specification and the appended claims are approximate values that may vary depending on the desired characteristics sought to be obtained by the embodiments of the present invention. At the very least, each numerical parameter should not be construed as limiting the application of the doctrine of equivalents to the claims, and at the very least, should be construed by applying the normal method of rounding numerical values in light of the reported significant digits.

[0126] This specification shows one or more exemplary embodiments incorporating various features. For clarity, not all functions of the physical embodiments are described or illustrated in this application. Of course, in developing a physical embodiment incorporating each embodiment of the present invention, numerous decisions specific to that embodiment are required to achieve the developer's goals. Such goals include, for example, meeting constraints such as system constraints, business constraints, and government-related constraints, which vary depending on the embodiment and the time. The developer's efforts for this may take a significant amount of time, but for those skilled in the art who benefit from this disclosure, such efforts will typically be within the scope of normal business operations.

[0127] In this specification, various systems, tools, and methods are described using the expression "comprising" for various components or steps, but these systems, tools, and methods may also "consist essentially of" or "consist of" only these various components and steps.

[0128] In this specification, when a plurality of items are listed together with the term "and" or "or" separating any of them, and there is an expression "at least one of" before the plurality of items, this expression "at least one of" modifies the entire list, not each element (i.e., each item) of the list. That is, the expression "at least one of" allows the meaning of encompassing at least one of any of the listed items, and / or at least one of any combination of the listed items, and / or at least one of each of the listed items. As an example, both expressions "at least one of A, B, and C" or "at least one of A, B, or C" mean only A, only B, or only C, and / or any combination of A, B, and C, and / or at least one of each of A, B, and C.

[0129] Accordingly, the systems, tools, and methods of the present disclosure are well adapted to achieve the objects and advantages described herein, as well as those inherent to these systems, tools, and methods. The teachings of the present disclosure can be modified and implemented in various but equivalent manners that will be apparent to those skilled in the art who benefit from the teachings herein. Thus, the specific embodiments disclosed above are merely illustrative. Further, the details of the structures or designs shown herein are not intended to be limiting except as described in the claims that follow. Accordingly, it is clear that the specific exemplary embodiments disclosed above can be changed, combined, or modified, and the scope of the present disclosure is considered to include all such derivative forms. The systems, tools, and methods exemplified herein can be preferably implemented even in the absence of elements not specifically disclosed herein and / or optional elements disclosed herein. In this specification, the systems, tools, and methods are described in terms of various components or steps "comprising," "containing," or "including," but these systems, tools, and methods can also "consist essentially of" or "consist of" only these various components and steps. All numerical values and ranges disclosed above are subject to some variation. When a numerical range with a lower limit and an upper limit is disclosed, any numerical value and any sub-range included in that range are also considered to be specifically disclosed. In particular, any value range disclosed herein (ranges in the form of "about a to about b," "from approximately a to b," or "from approximately a - b") should be understood to define every number and range subsumed within that broad range. Also, the terms recited in the claims have their ordinary and customary meaning, unless explicitly and clearly defined by the patentee.Furthermore, in this specification, when the indefinite article "a" or "an" is used in the claims, it is defined to mean that there is one or more elements being led. In the case of a contradiction in the usage of a word or term between this specification and one or more documents such as patent documents that form part of this specification by reference, the definition according to the usage of this specification shall be adopted. Hereinafter, preferred embodiments of the present invention will be described item by item. Embodiment 1 An electronic device housing including an upper shell that can be fitted to a lower mount having a skin-side surface, A plug assembly connected to the electronic device housing and including a sensor module having a sensor and a pointed body module having a pointed body, the plug assembly including a base having a skin-side surface and a plug portion having a through lumen, A sensor control device including: The sensor control device, wherein at least a part of the surface of the electronic device housing or the plug assembly contains an antibacterial agent. Embodiment 2 The device according to Embodiment 1, wherein at least one of the upper shell, the skin-side surface of the lower mount, the skin-side surface of the base, and the plug portion contains the antibacterial agent. Embodiment 3 The upper shell of the electronic device housing has an outer peripheral lip, The device according to Embodiment 2, wherein the outer peripheral lip contains the antibacterial agent. Embodiment 4 The plug portion further includes an outward-facing surface of the plug portion, an upward-facing surface of the plug portion, an outer surface of the plug portion, and an inner surface of the plug portion, The device according to Embodiment 2, wherein at least one of the outward-facing surface of the plug portion, the upward-facing surface of the plug portion, the outer surface of the plug portion, and the inner surface of the plug portion contains the antibacterial agent. Embodiment 5 The device according to Embodiment 2, wherein the plug portion has a shape selected from the group consisting of a frustum of a cone, a circle, and an ellipse. Embodiment 6 The device according to Embodiment 1, wherein the antibacterial agent is a metal or a metal oxide. Embodiment 7 The device according to Embodiment 1, wherein the antibacterial agent is selected from the group consisting of silver, copper, zinc, and combinations thereof. Embodiment 8 The device according to Embodiment 1, wherein the antibacterial agent is contained in a coating. Embodiment 9 The device according to Embodiment 8, wherein the antibacterial agent is selected from the group consisting of silver, copper, zinc, and combinations thereof. Embodiment 10 The device according to embodiment 8, wherein the antibacterial agent contains copper and silver thereon, or silver and copper thereon. Embodiment 11 The device according to embodiment 1, wherein the antibacterial agent is incorporated into the bulk material used for the electronic device housing or the plug assembly. Embodiment 12 The device according to embodiment 1, wherein the antibacterial agent is incorporated into the entire material used for the electronic device housing or the plug assembly. Embodiment 13 The device according to embodiment 1, wherein the antibacterial agent impregnates at least a part of the surface of the electronic device housing or the plug assembly. Embodiment 14 The device according to embodiment 1, wherein the antibacterial agent is attached to the electronic device housing or the plug assembly by overmolding. Embodiment 15 The device according to embodiment 1, wherein the antibacterial agent is applied to the electronic device housing or the plug assembly by sputtering coating to form an antibacterial agent-containing layer. Embodiment 16 The device according to embodiment 15, wherein a titanium layer is attached to the electronic device housing before attaching the antibacterial agent-containing layer. Embodiment 17 The device according to embodiment 15, wherein the antibacterial agent is a metal or a metal oxide. Embodiment 18 The device according to embodiment 15, wherein the antibacterial agent-containing layer is a layer containing at least about 5 wt% of a metal oxide. Embodiment 19 The device according to embodiment 15, wherein the antibacterial agent-containing layer is a layer containing about 2 wt% to about 30 wt% of a metal oxide. Embodiment 20 The device according to embodiment 15, wherein the antibacterial agent-containing layer has a thickness of about 500 angstroms to about 10 μm. Embodiment 21 The device according to embodiment 15, wherein the antibacterial agent is contained in at least one layer attached to the electronic device housing or the plug assembly. Embodiment 22 The device according to embodiment 15, wherein the antibacterial agent is contained in at least two layers attached to the electronic device housing or the plug assembly. Embodiment 23 A method comprising the step of attaching an antibacterial agent-containing layer containing an antibacterial agent to the surface of a sensor control device, wherein the sensor control device comprises an electronic device housing that is fittable into a lower mount having a skin-side surface and an upper shell having an outer peripheral lip, A plug assembly connected to the electronic device housing and including a sensor module having a sensor and a pointed body module having a pointed body, the plug assembly comprising a base having a skin-side surface and a plug portion having a through lumen, A method, wherein the surface of the sensor control device is at least one of the upper shell, the outer peripheral lip, the skin-side surface of the lower mount, the skin-side surface of the base, and the plug portion. Embodiment 24 The method according to embodiment 23, wherein the antibacterial agent is a metal. Embodiment 25 The method according to embodiment 23, wherein the antibacterial agent is a metal oxide. Embodiment 26 The method according to embodiment 23, wherein the antibacterial agent is selected from the group consisting of silver, copper, zinc, and combinations thereof. Embodiment 27 The method according to embodiment 23, wherein the antibacterial agent is copper and silver thereon, or silver and copper thereon. Embodiment 28 The method according to embodiment 23, further comprising the step of depositing a layer of titanium on the surface of the sensor control device before the step of attaching the antibacterial agent-containing layer to the surface of the sensor control device. Embodiment 29 The method according to embodiment 23, wherein the antibacterial agent-containing layer is deposited by sputtering. Embodiment 30 The method according to embodiment 29, wherein the antibacterial agent is deposited in an atmosphere containing an inert gas and an oxidizing agent. Embodiment 31 The method according to embodiment 30, wherein the atmosphere contains about 5% to about 100% of the oxidizing agent by partial pressure. Embodiment 32 The method according to embodiment 30, wherein the oxidizing agent is oxygen. Embodiment 33 The method according to embodiment 30, wherein the antibacterial agent contains silver, copper, zinc, and combinations thereof. Embodiment 34 The method according to embodiment 30, wherein the inert gas is argon. Embodiment 35 The method according to embodiment 30, wherein a metal oxide is formed on the surface of the sensor control device. Embodiment 36 The method according to embodiment 23, wherein the antibacterial agent is a metal oxide and the antibacterial agent-containing layer contains at least about 85% of the metal oxide. Embodiment 37 The method according to embodiment 23, wherein the antibacterial agent is a metal oxide and the antibacterial agent-containing layer is a layer containing at least about 2% by weight to about 98% by weight of the metal oxide. Embodiment 38 The step of attaching the antibacterial agent-containing layer to the plug portion includes attaching the antibacterial agent-containing layer to at least one of the outward-facing surface of the plug portion, the upward-facing surface of the plug portion, the outer surface of the plug portion, and the inner surface of the plug portion, the method according to Embodiment 23. Embodiment 39 The method according to Embodiment 23, wherein the plug portion has a shape selected from the group consisting of a frustum of a cone, a circle, and an ellipse. Embodiment 40 A method comprising the step of forming a metal-containing layer containing a metal on the surface of a sensor control device by sputtering, wherein the sensor control device, an electronic device housing including a lower mount having a skin-side surface and an upper shell having an outer peripheral lip, and a plug assembly connected to the electronic device housing and including a sensor module having a sensor and a sharp body module having a sharp body, the plug assembly including a base having a skin-side surface and a plug portion having a through lumen, the surface of the sensor control device being at least one of the upper shell, the outer peripheral lip, the skin-side surface of the lower mount, the skin-side surface of the base, and the plug portion. Embodiment 41 The method according to Embodiment 40, wherein the metal includes silver, copper, zinc, and combinations thereof. Embodiment 42 The method according to Embodiment 40, wherein the metal is attached to the surface of the sensor control device by sputtering in an atmosphere containing an inert gas and an oxidizing agent. Embodiment 43 The method according to Embodiment 42, wherein the inert gas is argon. Embodiment 44 The method according to Embodiment 42, wherein the oxidizing agent is oxygen. Embodiment 45 The method according to Embodiment 42, wherein the atmosphere contains an oxidizing agent at a partial pressure of about 5% to about 100%. Embodiment 46 The method according to Embodiment 42, wherein the atmosphere contains an oxidizing agent at a partial pressure of at least about 10%. Embodiment 47 The method according to Embodiment 42, wherein a metal oxide is formed on the surface of the sensor control device. Embodiment 48 The method according to Embodiment 40, further comprising the step of forming a layer of titanium on the surface of the sensor control device by sputtering before the step of forming the metal-containing layer on the surface of the sensor control device by sputtering. Embodiment 49 The method according to embodiment 40, wherein the step of forming the metal-containing layer on the plug portion by sputtering includes the step of forming the metal-containing layer on at least one of the outer surface facing outward of the plug portion, the upper surface facing upward of the plug portion, the outer surface of the plug portion, and the inner surface of the plug portion by sputtering. Embodiment 50 The method according to embodiment 40, wherein the plug portion has a shape selected from the group consisting of a frustum of a cone, a circle, and an ellipse. Embodiment 51 A housing having a skin-side surface; A layer adjacent to the skin-side surface and containing a metal oxide; The layer is configured to contact the skin of the patient; A medical device, wherein the layer contains at least about 5 wt% of a metal oxide. Embodiment 52 The medical device according to embodiment 51, wherein the layer contains about 2 wt% to about 98 wt% of a metal oxide. Embodiment 53 The medical device according to embodiment 51, which is configured to contact the skin of the patient for at least 10 days. Embodiment 54 The medical device according to embodiment 51, which is configured to contact the skin of the patient for about 10 days to about 14 days. Embodiment 55 The medical device according to embodiment 51, wherein the layer is formed on the skin-side surface by a sputtering coating. Embodiment 56 The medical device according to embodiment 51, wherein the layer is formed on the skin-side surface by overmolding.

Description of Symbols

[0130] 100 Test Substance Monitoring System 102 Sensor Applicator 104, 302 Sensor Control Device 110, 316 Sensor 202 Sensor Tray 207, 310 Plug Assembly 208 Housing 220, 318 Sharp Body 304 Electronic Equipment Housing 306 Shell 308 Mount 312 Sensor Module 314 Sharp Body Module 320 Sensor Protection Vial 402 Plug 404 Connector 408 Tail 409 Plug portion 502 Printed circuit board 512 Plug receptacle

Claims

1. An electronic device housing comprising an upper shell that can be fitted to a lower mount having a skin-side surface, A plug assembly connected to the electronic device housing and including a sensor module having a sensor and a pointed body module having a pointed body, the plug assembly comprising a base having a skin-side surface and a plug portion having a through lumen, A sensor control device comprising: At least a part of the surface of the electronic device housing or the plug assembly contains an antibacterial agent, The antibacterial agent contains copper and silver thereon, or silver and copper thereon, and is an antibacterial agent-containing layer sputter-coated on the electronic device housing or the plug assembly, and a titanium layer is included under the antibacterial agent-containing layer. A sensor control device.

2. The device according to claim 1, wherein at least one of the upper shell, the skin-side surface of the lower mount, the skin-side surface of the base, and the plug portion contains the antibacterial agent.

3. The upper shell of the electronic device housing is provided with an outer peripheral lip, The device according to claim 2, wherein the outer peripheral lip contains the antibacterial agent.

4. The plug portion further comprises an outward-facing surface of the plug portion, an upward-facing surface of the plug portion, an outer surface of the plug portion, and an inner surface of the plug portion, The device according to claim 2, wherein at least one of the outward-facing surface of the plug portion, the upward-facing surface of the plug portion, the outer surface of the plug portion, and the inner surface of the plug portion contains the antibacterial agent.

5. The device according to claim 2, wherein the plug portion has a shape selected from the group consisting of a frustum of a cone, a circle, and an ellipse.

6. The device according to claim 1, wherein the antibacterial agent-containing layer is a layer containing at least 5 wt% metal oxide.

7. The device according to claim 1, wherein the antibacterial agent-containing layer is a layer containing 2 wt% to 30 wt% metal oxide.

8. The device according to claim 1, wherein the antibacterial agent-containing layer has a thickness of 50 nm to 10 μm.

9. The device according to claim 1, wherein the antibacterial agent is contained in at least one layer attached to the electronic device housing or the plug assembly.

10. The device according to claim 1, wherein the antibacterial agent is contained in at least two layers attached to the electronic device housing or the plug assembly.

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