Docket No. A0130.0366.WO OVERBANDAGE ASSEMBLY FOR ANALYTE MONITORING DEVICE CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Provisional Application Serial No. 63/642,427, filed May 3, 2024, which is hereby expressly incorporated by reference herein in its entirety for all purposes. FIELD [0002] The subject matter of this disclosure generally relates to systems, devices, and methods relating to analyte monitoring devices. More specifically, this disclosure relates to securing an analyte monitoring device to a body of a user with an overbandage assembly. BACKGROUND [0003] Analyte monitoring devices may be worn on a body of a patient to monitor analyte levels in a bodily fluid of the patient. This may help to monitor the status or progress of a disease, the patient’s reaction to a course of treatment, and the change in analyte levels resulting from various events, such as meals, exercise, sleep, or administration of medication, among others. Monitoring analyte levels may allow a patient or healthcare provider (HCP) to detect or predict an adverse event to allow the patient or HCP to intervene and take corrective action. Analyte levels may also be used for health and wellness, such as for helping patients to monitor their analyte response to meals or exercise, and to achieve fitness or weight loss goals. Analyte monitoring may be beneficial for athletes to determine analyte levels during exercise. [0004] Some analyte monitoring devices may monitor glucose. Glucose levels can be particularly important to monitor for patients with diabetes. A detected glucose level may indicate one or more glucose disorders, such as hypoglycemia or hyperglycemia, among others. Monitoring glucose levels may help a patient to maintain glucose levels in a target range and to take corrective action, such as eating a meal to increase low glucose levels, or to take insulin or other medications to reduce glucose levels. Glucose monitoring devices may also provide alerts to the patient to warn the patient of low or high glucose levels, to rising or falling glucose levels, or to predicted high or low glucose levels. Thus, glucose monitoring is an important aspect of disease management for patients with diabetes. [0005] The introduction of personal continuous monitoring devices have increased the frequency of glucose data available to a patient and their health care professional. In some instances, a
Docket No. A0130.0366.WO continuous monitoring device is worn on the body of a patient. For example, a continuous glucose monitoring device (“CGM device”) may include a glucose sensor to generate a signal indicative of a glucose level of a patient from the bodily fluid. The CGM device may include an adhesive pad configured to secure the housing to a skin surface of the patient. SUMMARY OF THE INVENTION [0006] Aspects described herein relate to an analyte monitoring system, for example a glucose monitoring system that includes a glucose monitoring device. While embodiments disclosed herein may be described with reference to glucose as an analyte, other analytes may instead or additionally be contemplated and within the scope of the embodiments of the disclosure. For example, the analytes may include ketones, lactate, or alcohol. Further, additional analytes may include oxygen, hemoglobin A1C, acetyl choline, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA, fructosamine, glutamine, growth hormones, hormones, peroxide, prostate-specific antigen, prothrombin, RNA, thyroid stimulating hormone, troponin and others. The glucose monitoring device may include a housing. The glucose monitoring device may include a glucose sensor. The glucose sensor may include a first portion arranged within the housing. The glucose sensor may include a second portion configured to be positioned below a skin surface and in contact with a bodily fluid to generate a signal indicative of a glucose level of a user (e.g., a patient). The glucose monitoring device may include sensor electronics arranged within the housing. The sensor electronics may be coupled to the first portion of the glucose sensor. The sensor electronics may comprise a processor. The sensor electronics may comprise wireless communications circuitry. The glucose monitoring device may include an adhesive pad. The adhesive pad may be coupled to a first side of the housing and may be configured to secure the first side of the housing to the skin surface of the user. Some aspects of the invention relate to an overbandage assembly for securing a housing of a continuous glucose monitor to a skin surface of a user. The overbandage assembly may be comprised by a glucose monitoring system as described herein. The overbandage assembly may be configured to contact a second side of the housing located opposite the first side of the housing. The overbandage assembly includes a backing layer. The backing layer may comprise a central portion. An outer portion may surround the central portion. An adhesive layer is disposed on a first side of the backing layer. A first liner is disposed on the adhesive layer. The adhesive layer is located between the first liner and the backing layer. A second liner may be disposed on the first side of the backing layer. The second liner may overlap the first liner. A third liner may
Docket No. A0130.0366.WO be disposed on the first side of the backing layer. The third liner may overlap the first liner. The third liner may overlap the second liner. Advantageously, liners that are arranged in an overlapping fashion can be configured to be removed sequentially. The central portion may be configured to cover at least a portion of the second side of the housing of the glucose monitoring device. The adhesive layer may be configured to secure the outer portion of the skin surface of the user to secure the overbandage assembly to the skin surface of the user. [0007] A locator may be coupled to the overbandage assembly. The locator may be configured to facilitate positioning of the central portion over the housing. [0008] The locator may have a stepped cross-sectional shape. The stepped cross-sectional shape may include a longer leg and a shorter leg. The longer leg is positioned closer to the housing than the shorter leg when the overbandage assembly is secured to the skin surface of the user. Having a stepped cross-sectional shape as described may simplify manufacturing of the locator by limiting thick sections of material. [0009] The locator may have a shape that corresponds to a shape of the housing. The locator may extend around at least a portion of a perimeter of the housing when the overbandage assembly is secured to the skin surface of the user. [0010] The locator may be more rigid than the backing layer. [0011] The adhesive layer may be disposed on the outer portion, and the adhesive layer is not disposed on the central portion. In such embodiments, the adhesive layer may secure the outer portion to the skin surface of the user to secure the overbandage assembly to the skin surface of the user. [0012] The adhesive layer may be disposed on the outer portion, and the adhesive layer is disposed on the central portion. Advantageously, such implementations promote adhering of the backing layer to the housing of the analyte monitoring device. [0013] The central portion may be configured to adhere to the second side of the housing when the overbandage assembly is secured to the skin surface of the user. [0014] The backing layer may define a plurality of apertures. The plurality of apertures may extend entirely through the backing layer. [0015] Each aperture of the plurality of apertures may have an oval shape. [0016] A minor axis of each aperture of the plurality of apertures may be approximately aligned with a radial axis extending from a center of the overbandage assembly. Aligning the minor axis with the radial axis allows for increased radial strain relative to apertures that have a different shape and/or orientation than described.
Docket No. A0130.0366.WO [0017] The first liner may cover a first part of the outer portion. The second liner may cover a second part of the outer portion. The third liner may cover the central portion. [0018] The outer portion may have a width that extends between an inner diameter of the outer portion and an outer diameter of the outer portion. The first liner may have a width that approximately matches the width of the outer portion. The second liner may have a width that approximately matches the width of the outer portion. [0019] The third liner may have a diameter that is larger than the inner diameter of the outer portion. [0020] The housing may define a port extending through the second side of the housing. The port may advantageously allow moisture to exit from underneath the housing. The central portion may define an opening extending through the central portion. The opening may be sized such that the central portion covers a portion of the second side of the housing when the overbandage assembly is secured to the skin surface of the user. The port extending through the second side of the housing may be uncovered when the overbandage assembly is secured to the skin surface of the user. This may help to allow moisture underneath the housing to pass through the port to the environment. [0021] Aspects of the invention also relate to an overbandage assembly for securing a housing of a continuous glucose monitor to a skin surface of a user. The overbandage assembly may be comprised by a glucose monitoring system as described herein. The glucose monitoring system may include a glucose monitoring device. The glucose monitoring device may include a housing. The glucose monitoring device may include a glucose sensor. The glucose sensor may include a first portion arranged within the housing. The glucose sensor may include a second portion configured to be positioned below a skin surface and in contact with a bodily fluid to generate a signal indicative of a glucose level of a user (e.g., a patient). The glucose monitoring device may include sensor electronics arranged within the housing. The sensor electronics may be coupled to the first portion of the glucose sensor. The sensor electronics may comprise a processor. The sensor electronics may comprise wireless communications circuitry. The glucose monitoring device may include an adhesive pad. The adhesive pad may be coupled to a first side of the housing and may be configured to secure the first side of the housing to the skin surface of the user. The overbandage assembly may be configured to be secured to the skin surface of the user. The overbandage assembly includes a backing layer with an inner edge that defines an opening. The opening may be configured to receive the housing. The housing may be configured to extend through the opening. Advantageously, this allows the overbandage assembly to rest flat on the
Docket No. A0130.0366.WO skin surface. An adhesive layer is disposed on a first side of the backing layer. A locator may be coupled to the backing layer. The locator may be concentric with the opening defined by the inner edge of the backing layer. The locator may have a diameter that is larger than a diameter of the housing. A first liner is disposed on the adhesive layer. The adhesive layer may be located between the first liner and the backing layer. A second liner may be disposed on the first side of the backing layer. The second liner may overlap the first liner. [0022] The locator may be more rigid than the backing layer. [0023] The locator may extend continuously around a perimeter of the housing when the overbandage assembly is secured to the skin surface of the user. [0024] The backing layer may define a plurality of apertures. The apertures may extend entirely through the backing layer. [0025] Each aperture of the plurality of apertures may have an oval shape. [0026] A minor axis of each aperture of the plurality of apertures may be approximately aligned with a radial axis extending from a center of the opening. Advantageously, this allows for increased radial strain relative to apertures that have a different shape and/or orientation than described. The increased radial strain allows the material of the backing layer to stretch in the direction of the minor axis as the backing layer is pulled in the direction of the minor axis during application of the overbandage assembly to the skin while limiting folding and/or bunching of the backing layer. [0027] The backing layer may have a width that extends between the inner edge and an outer edge. The first liner may have a width that approximately matches the width of the backing layer. The second liner may have a width that approximately matches the width of the backing layer. [0028] The overbandage assembly may comprise a third liner. The third liner may cover the opening. The third liner may be disposed on the first side of the backing layer. The third liner may overlap the first liner and the second liner. The overlapping arrangement of the lines allows the liners to be removed sequentially. [0029] Aspects of the invention also relate to an overbandage assembly for securing a housing of a continuous glucose monitor to a skin surface of a user. The overbandage assembly may be comprised by a glucose monitoring system as described herein. The continuous glucose monitoring system may include a glucose monitoring device. The glucose monitoring device may include a housing. The glucose monitoring device may include a glucose sensor. The glucose sensor may include a first portion arranged within the housing. The glucose sensor may include a second portion configured to be positioned below a skin surface and in contact with a bodily fluid
Docket No. A0130.0366.WO to generate a signal indicative of a glucose level of a user (e.g., a patient). The glucose monitoring device may include sensor electronics arranged within the housing. The sensor electronics may be coupled to the first portion of the glucose sensor. The sensor electronics may comprise a processor. The sensor electronics may comprise wireless communications circuitry. The glucose monitoring device may include an adhesive pad. The adhesive pad may be coupled to a first side of the housing and may be configured to secure the first side of the housing to the skin surface of the user. The overbandage assembly may be configured to be secured to the skin surface of the user. The overbandage assembly comprises a backing layer. The backing layer may have a body portion. The backing layer may have a plurality of foldable portions coupled to the body portion. A first adhesive layer is disposed on a first side of the body portion. A second adhesive layer may be disposed on a first side of each foldable portion of the plurality of foldable portions. A first liner is disposed on the adhesive layer. The adhesive layer may be located between the first liner and the first side of the body portion. A second liner may be disposed on the first side of each of the plurality of foldable portions. Each foldable portion of the plurality of foldable portions may have a folded configuration. In the folded configuration, each foldable portion of the plurality of foldable portions may overlap the body portion. Each foldable portion of the plurality of foldable portions may have an unfolded configuration. In the unfolded configuration, each foldable portion of the plurality of foldable portions may extend from the body portion in a radial direction. Advantageously, this allows the user flexibility to deploy additional folded portions to use additional adhesive throughout the sensor wear period. [0030] The body portion may form a first geometric shape. The plurality of foldable portions may form a second geometric shape when each foldable portion of the plurality of foldable portions is in the unfolded configuration. The second geometric shape may be different from the first geometric shape. [0031] At least one foldable portion of the plurality of foldable portions may overlap another foldable portion of the plurality of foldable portions when the plurality of foldable portions is in the folded configuration. [0032] Aspects of the invention also relate to an overbandage assembly for securing a housing of a continuous glucose monitor to a skin surface of a user. The overbandage assembly may be comprised by a glucose monitoring system as described herein. The continuous glucose monitoring system may include a glucose monitoring device. The glucose monitoring device may include a housing. The glucose monitoring device may include a glucose sensor. The glucose sensor may include a first portion arranged within the housing. The glucose sensor may include a
Docket No. A0130.0366.WO second portion configured to be positioned below a skin surface and in contact with a bodily fluid to generate a signal indicative of a glucose level of a user (e.g., a patient). The glucose monitoring device may include sensor electronics arranged within the housing. The sensor electronics may be coupled to the first portion of the glucose sensor. The sensor electronics may comprise a processor. The sensor electronics may comprise wireless communications circuitry. The glucose monitoring device may include an adhesive pad. The adhesive pad may be coupled to a first side of the housing and may be configured to secure the first side of the housing to the skin surface of the user. An overbandage assembly may be configured to contact a second side of the housing. The second side of the housing may be located opposite the first side of the housing. The overbandage assembly is comprises a backing layer. The backing layer may be configured to conform to a shape of the housing. The backing layer may comprise a central opening located at a center of the backing layer. The backing layer may comprise one or more radial opening surrounding the central opening. The central opening and radial openings may further increase flexibility of backing layer so that backing layer may better conform to the analyte monitoring device. The radial openings may extend radially outward from the central opening. The backing layer may comprise one or more slits extending radially outward from the central opening. An adhesive layer may be disposed on a first side of the backing layer. A liner is disposed on the adhesive layer. The adhesive layer is located between the first liner and the backing layer. An upper liner may be disposed on a second side of the backing layer. The upper liner may be more rigid than the backing layer. The upper liner may be more rigid than the adhesive layer. [0033] The backing layer may be transparent. Using an overbandage that is transparent may further secure the analyte monitoring device to the skin surface of the user while not drawing attention of an observer. More specifically, the apparent size of the analyte monitoring device to an observer is not increased when using an overbandage that is transparent. Further, the transparent overbandage may facilitate application and positioning of the overbandage relative to the analyte monitoring device, as the user can see the analyte monitoring device and adhesive pad through the overbandage. [0034] The radial openings may form one or more rings surrounding the central opening. [0035] The radial openings may form two discontinuous rings that are arranged concentrically. The discontinuous rings may surround the central opening. [0036] The radial openings may be radially symmetric about the central opening. [0037] The adhesive layer may comprise adhesive areas separated by channels.
Docket No. A0130.0366.WO [0038] The adhesive areas may be arranged in a grid and the channels may be arranged at angles such that the channels intersect. [0039] The adhesive areas may be arranged in a radial array. A portion of the channels may be straight and extend linearly away from an opening defined by the adhesive layer in a radial direction, and a portion of the channels may be curved and extend radially outward from the opening defined by the adhesive layer. Having the channels extending from the opening in various orientations can direct moisture away from the opening and away from the skin surface regardless of the orientation of the skin surface. For example, the analyte monitoring device may be coupled to a triceps area of the user. The triceps area may have various orientations depending on the activity of the user (e.g., running, lifting weights, swimming, etc.). Having the channels disposed at various orientations relative to the opening will facilitate directing moisture away from the opening and the skin surface regardless of the orientation of the analyte monitoring device. [0040] The adhesive areas may be arranged in a linear array and the channels may be spaced at regular intervals across the adhesive layer. [0041] Aspects of the invention also relate to an overbandage assembly for securing a housing of a continuous glucose monitor to a skin surface of a user. The overbandage assembly may be comprised by a glucose monitoring system as described herein. The continuous glucose monitoring system may include a glucose monitoring device. The glucose monitoring device may include a housing. The glucose monitoring device may include a glucose sensor. The glucose sensor may include a first portion arranged within the housing. The glucose sensor may include a second portion configured to be positioned below a skin surface and in contact with a bodily fluid to generate a signal indicative of a glucose level of a user (e.g., a patient). The glucose monitoring device may include sensor electronics arranged within the housing. The sensor electronics may be coupled to the first portion of the glucose sensor. The sensor electronics comprise a processor. The sensor electronics may comprise wireless communications circuitry. The glucose monitoring device may include an adhesive pad. The adhesive pad is coupled to a first side of the housing and is configured to secure the first side of the housing to the skin surface of the user. The overbandage assembly may be configured to contact a second side of the housing. The second side of the housing may be located opposite the first side of the housing. The overbandage assembly may comprise a backing layer. The backing layer may have an inner edge that defines an opening. The opening may be configured to receive the housing. The housing may be configured to extend through the opening. An adhesive layer may be disposed on
Docket No. A0130.0366.WO a first side of the backing layer. An adhesive ring may be disposed on a second side of the backing layer. A locator may comprise a base coupled to the adhesive ring. The locator may comprise an extension extending from the base in a direction away from the backing layer. The extension may terminate in a lip that defines an opening having a diameter smaller than a diameter of the second side of the housing. The locator may comprise a first channel extending through the extension. The locator may comprise a second channel extending through the base. The second channel may define a space between the adhesive ring and the base. A liner is disposed on the adhesive layer. The adhesive layer is located between the first liner and the backing layer. An upper liner may be disposed on a second side of the backing layer. The upper liner may be more rigid than the backing layer. The upper liner may be more rigid than the adhesive layer. BRIEF DESCRIPTION OF THE DRAWINGS [0042] The accompanying drawings, which are incorporated herein and form a part of the specification, illustrate the present disclosure and, together with the description, further serve to explain the principles thereof and to enable a person skilled in the pertinent art to make and use the same. [0043] FIG.1 is a system overview of an analyte monitoring system, according to an embodiment. [0044] FIG.2A is a block diagram depicting an example embodiment of a reader device. [0045] FIGS.2B and 2C are block diagrams depicting example embodiments of analyte monitoring devices. [0046] FIG.3A is a top view of an overbandage assembly, according to an embodiment. [0047] FIG.3B is an exploded view of a portion of the overbandage assembly of FIG.3A, according to an embodiment. [0048] FIG.3C is a bottom view of the overbandage assembly of FIG.3A, according to an embodiment. [0049] FIG.3D is a cross-sectional view of the overbandage assembly of FIGS.3A-3B, according to an embodiment. [0050] FIG.3E is a cross-sectional view of the overbandage assembly of FIGS.3A-3B coupled to a portion of an analyte monitoring device, according to an embodiment. [0051] FIG.3F is a cross- sectional view of an overbandage assembly surrounding a portion of an analyte monitoring device, according to an embodiment.
Docket No. A0130.0366.WO [0052] FIG.3G is an exploded view of the overbandage assembly of FIGS.3A-3B, according to an embodiment. [0053] FIG.4A is a bottom view of an overbandage assembly, according to an embodiment. [0054] FIG.4B is a top view of the overbandage assembly of FIG.4A, according to an embodiment. [0055] FIG.4C is a cross-sectional view of the overbandage assembly of FIGS.4A-4B, according to an embodiment [0056] FIG.4D is a cross-sectional view of the overbandage assembly of FIGS.4A-4B coupled to a portion of the continuous glucose monitoring system of FIG.1, according to an embodiment. [0057] FIG.4E is an exploded view of the overbandage assembly of FIGS.4A-4D, according to an embodiment. [0058] FIG.4F is an exploded view of the overbandage assembly of FIGS.4A-4D, according to an embodiment. [0059] FIG.5A is a top view of an overbandage assembly in a folded configuration, according to an embodiment. [0060] FIG.5B is a top view of the overbandage assembly of FIG.5A in an unfolded configuration, according to an embodiment. [0061] FIG.5C is a cross-sectional view of the overbandage assembly of FIG.5A, according to an embodiment. [0062] FIG.5D is a cross-sectional view of the overbandage assembly of FIG.5C, according to an embodiment. [0063] FIG.6A is a top view of an overbandage assembly in an unfolded configuration, according to an embodiment. [0064] FIG.6B is a cross-sectional view of the overbandage assembly of FIG.6A, according to an embodiment. [0065] FIG.7A is an exploded view of an overbandage assembly, according to an embodiment. [0066] FIG.7B is a cross-sectional view of the overbandage assembly of FIG.7A, according to an embodiment. [0067] FIGS.7C-7E are bottom views of an adhesive layer of the overbandage assembly of FIG. 7A, according to various embodiments. [0068] FIG.8A is an exploded view of an overbandage assembly, according to an embodiment. [0069] FIG.8B is a cross-sectional view of the overbandage assembly of FIG.8A, according to an embodiment.
Docket No. A0130.0366.WO [0070] FIG.8C is a bottom view of a locator, according to an embodiment. DETAILED DESCRIPTION [0071] Reference will now be made in detail to representative embodiments illustrated in the accompanying drawings. References to “one embodiment,” “an embodiment,” “an exemplary embodiment,” etc., indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art to affect such a feature, structure, or characteristic in connection with other embodiments whether or not explicitly described. [0072] Analyte monitoring devices may be worn on a body of a user for monitoring one or more analytes in bodily fluid. By sensing (for example) a glucose level in a patient (e.g., a user) on a regular basis, a CGM device may provide both the patient and the healthcare professional with typical blood glucose levels of the patient. A CGM device is worn on the body of the patient, and the glucose sensor generates a signal indicative of the glucose level of the patient. In some instances, the CGM device may be worn on a triceps side of an arm of the patient. The CGM device may also be worn on a stomach of the patient. The CGM device is held on the skin of the patient via an adhesive pad that is typically attached to the CGM device to secure the CGM device to the skin upon insertion of a portion of the sensor under the skin of the patient. [0073] In some instances, the CGM device may become dislodged from the skin of the patient prior to an anticipated expiration of the CGM device (e.g., ten days, fourteen days, thirty days or more, etc.). For example, the CGM device may come in contact with an object (e.g., the patient may snag a piece of clothing on the CGM device, the patient may bump the CGM device against a doorframe, etc.), and the contact disengages a portion of the adhesive pad from the skin of the patient. As another example, oil from the skin of the patient may reduce the effectiveness of the adhesive pad, and the adhesive pad may disengage from the skin of the patient. Additionally, the adhesive pad may not be properly adhered to the skin of the patient upon application of the CGM device to the skin of the patient. In such cases, foreign objects (e.g., dust, liquid, etc.) may become lodged between the adhesive pad and the skin of the patient and cause the adhesive pad to disengage from the skin of the patient. Furthermore, moisture coming in contact with the analyte monitor (e.g., via sweating, showering, etc.) may cause the adhesive pad to become less
Docket No. A0130.0366.WO effective over time and may eventually cause the adhesive pad to disengage from the skin of the patient. As a result, the analyte monitoring device may not last the entire wear period, causing the user to have to replace the sensor more frequently. This can be inconvenient and can increase the expense of monitoring analytes. Thus, there is a need to provide additional features to better secure the CGM device to the skin of the patient. [0074] An analyte monitoring system includes an analyte monitoring device and an overbandage assembly. The analyte monitoring device may include a housing containing an analyte sensor configured to measure an analyte level in a bodily fluid under a skin surface. The housing may include an adhesive pad for securing the housing to the skin surface. The overbandage assembly includes a backing layer having an adhesive layer on one side for securing to the skin surface. The housing may have a port that extends through another side of the housing opposite the adhesive layer. The backing layer may have a central portion to be arranged over the housing, and an outer portion. The port may remain uncovered when the central portion is arranged over the housing. The central portion may include adhesive layer thereon or may be free of adhesive. Alternatively, the backing layer may have a central opening so that the housing passes through the central opening. [0075] The overbandage assembly may have one or more liners covering the adhesive layer. The liners may overlap. A first liner may cover a first part of the outer portion of the backing layer. A second liner may cover a second part of the outer portion of the backing layer. The second liner may overlap the first liner. A third liner may cover the central portion. The third liner may overlap the second liner. The third liner may additionally or alternatively overlap the first liner. [0076] The overbandage assembly may have one or more upper liners covering the backing layer. The upper liner may be more rigid than the backing layer. [0077] The overbandage assembly may have a locator. The locator may be configured to partially cover the housing. The locator may facilitate positioning of the central portion over the housing. The locator may be coupled to the backing layer. The locator may be concentric with the central opening of the backing layer. The locator may have a shape that corresponds to a shape of the housing. The locator may have a diameter that is larger than a diameter of the housing. The locator may extend around at least a portion of a perimeter of the housing. The locator may extend continuously around a perimeter of the housing. The locator may be more rigid than the backing layer. The locator may be transparent or translucent. The locator may include a channel extending through a base of the locator. The locator may alternatively or additionally include a channel extending through an extension of the locator.
Docket No. A0130.0366.WO [0078] The backing layer may define a plurality of apertures. The apertures may extend entirely through the backing layer. Each aperture may have an oval shape. A minor axis of each aperture may be approximately aligned with a radial axis of the overbandage assembly to facilitate stretching in the radial direction. [0079] The backing layer may have one or more radial openings. The radial openings may surround a central opening. The radial openings may extend radially outward from the central opening. The radial openings may be radially symmetric about the central opening. [0080] The backing layer may be formed from a thin film material. The thin film material may be transparent. The thin film material may be translucent. The thin film material may allow vapor to pass through. [0081] The backing layer may have a body portion and a plurality of foldable portions coupled to the body portion. Each foldable portion of the plurality of foldable portions may have a folded configuration. In the folded configuration, each foldable portion may overlap the body portion. In the folded configuration, at least one foldable portion may overlap another foldable portion. Each foldable portion of the plurality of foldable portions may have an unfolded configuration. In the unfolded configuration, each foldable portion may extend from the body portion in a radial direction. The body portion may form a first geometric shape. The foldable portions may from a second geometric shape when each foldable portion is in the unfolded configuration. The second geometric shape may be different than the first geometric shape. [0082] The present subject matter will be described primarily with respect to analyte monitoring devices and sensors capable of measuring a glucose concentration, although detection and measurement of concentrations of other analytes are within the scope of the present disclosure. These other analytes can include, ketones, lactate, or alcohol. Further, additional analytes may include oxygen, hemoglobin A1C, acetyl choline, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA, fructosamine, glutamine, growth hormones, hormones, peroxide, prostate-specific antigen, prothrombin, RNA, thyroid stimulating hormone, troponin and others. The concentration of drugs, such as, for example, antibiotics (e.g., gentamicin, vancomycin, and the like), digitoxin, digoxin, drugs of abuse, theophylline, and warfarin, may also be monitored. The sensor can be configured to measure two or more different analytes at the same or different times. The analyte monitoring device can be coupled with two or more sensors, where one sensor is configured to measure a first analyte (e.g., glucose) and the other one or more sensors are configured to measure one or more different analytes (e.g., any of
Docket No. A0130.0366.WO those described herein). In other embodiments, a user can wear two or more analyte monitoring devices, each of which is capable of measuring a different analyte. [0083] FIG.1 is a conceptual diagram depicting an example embodiment of an analyte monitoring system 100 that includes a sensor applicator 150, an analyte monitoring device 102, and a reader device 120. Here, sensor applicator 150 can be used to deliver the analyte monitoring device 102, such as a CGM device, to a monitoring location on a user's skin where a glucose sensor 104 is maintained in position for a period of time by an adhesive pad 105. The analyte monitoring device 102 includes a housing 124. The housing 124 has a first side 126 coupled to the adhesive pad 105 and a second side 128 located opposite the first side. The glucose sensor 104 includes a first portion arranged within the housing 124 and a second portion configured to be positioned below a skin surface of the user. The second portion of the glucose sensor 104 is in contact with a bodily fluid, such as blood or interstitial fluid, such that the glucose sensor 104 generates a signal indicative of a glucose level of the user. To further maintain the glucose sensor 104 in position, an overbandage assembly 110 may be included with the analyte monitoring system 100. [0084] Analyte monitoring device 102 is further described in FIGS.2B and 2C, and can communicate with reader device 120 via a communication path 140 using a wired or wireless technique. Example wireless protocols include Bluetooth, Bluetooth Low Energy (BLE, BTLE, Bluetooth SMART, etc.), Near Field Communication (NFC) and others. Users can monitor applications installed in memory on reader device 120 using a display 122 and an input 121, and the device battery can be recharged using a power port 123. While only one reader device 120 is shown, analyte monitoring device 102 can communicate with multiple reader devices 120. Each of the reader devices 120 can communicate and share data with one another. More details about reader device 120 are set forth with respect to FIG.2A below. [0085] Reader device 120 can communicate with a local computer system 170 via a communication path 141 using a wired or wireless communication protocol. Local computer system 170 can include one or more of a laptop, desktop, tablet, phablet, smartphone, set-top box, video game console, or other computing device and wireless communication can include any of a number of applicable wireless networking protocols including Bluetooth, Bluetooth Low Energy (BTLE), Wi-Fi or others. Local computer system 170 can communicate via a communications path 143 with a network 190 similar to how reader device 120 can communicate via a communications path 142 with network 190, by a wired or wireless communication protocol as described previously. Network 190 can be any of a number of networks, such as
Docket No. A0130.0366.WO private networks and public networks, local area or wide area networks, and so forth. A trusted computer system 180 can include a server and can provide authentication services and secured data storage and can communicate via communications path 144 with network 190 by wired or wireless technique. [0086] FIG.2A is a block diagram depicting an example embodiment of a reader device 120. The reader device 120 may be configured as a smartphone. Here, reader device 120 can include a display 122, input 121, and a processing core 306 including a communications processor 322 coupled with a memory 323 and an applications processor 324 coupled with a memory 325. Included can be a separate memory 330, an RF transceiver 328 with an antenna 329, and a power supply 326 with a power management module 338. Further, reader device 120 can include a multi-functional transceiver 332 which can communicate over Wi-Fi, NFC, Bluetooth, BTLE, and GPS with an antenna 334. As understood by one of skill in the art, these components are electrically and communicatively coupled in a manner to make a functional device. [0087] FIGS.2B and 2C are block diagrams depicting example embodiments of analyte monitoring device 102 having glucose sensor 104 and sensor electronics 160 (including analyte monitoring circuitry) that can have the majority of the processing capability for rendering end- result data suitable for display to the user. In FIG.2B, a single semiconductor chip 161 is depicted that can be a custom application specific integrated circuit (ASIC). Shown within semiconductor chip 161 are certain high-level functional units, including an analog front end (AFE) 162, power management circuitry 164 (e.g., control circuitry), a processor 166, and wireless communication circuitry 168 (which can be implemented as a transmitter, receiver, transceiver, passive circuit, or otherwise according to the communication protocol). In this embodiment, both AFE 162 and processor 166 are used as analyte monitoring circuitry, but in other embodiments either circuit can perform the analyte monitoring function. Processor 166 can include one or more processors, microprocessors, controllers, and/or microcontrollers, each of which can be a discrete chip or distributed amongst (and a portion of) a number of different chips. [0088] A memory 163 may be included within ASIC 161 and can be shared by the various functional units present within ASIC 161, or can be distributed amongst two or more of them. Memory 163 may be a separate chip. Memory 163 can be volatile and/or non-volatile memory. In this embodiment, ASIC 161 is coupled with a power source, which can be a coin cell battery, or the like. AFE 162 interfaces with glucose sensor 104 and receives measurement data therefrom and outputs the data to processor 166 in digital form, which in turn processes the data
Docket No. A0130.0366.WO to arrive at the end-result glucose discrete and trend values, including the algorithms described in detail below. This data can then be provided to wireless communication circuitry 168 for sending, by way of antenna 171, to reader device 120 (not shown), for example, where minimal further processing is needed by the resident software application to display the data. [0089] FIG.2C is similar to FIG.2B but instead includes two discrete semiconductor chips 162 and 174, which can be packaged together or separately. Here, AFE 162 is resident on ASIC 161. Processor 166 is integrated with power management circuitry 164 and wireless communication circuitry 168 on chip 174. AFE 162 includes memory 163 and chip 174 includes memory 165, which can be isolated or distributed within. In one example embodiment, AFE 162 is combined with power management circuitry 164 and processor 166 on one chip, while wireless communication circuitry 168 is on a separate chip. In another example embodiment, both AFE 162 and wireless communication circuitry 168 are on one chip, and processor 166 and power management circuitry 164 are on another chip. It should be noted that other chip combinations are possible, including three or more chips, each bearing responsibility for the separate functions described, or sharing one or more functions for fail-safe redundancy. [0090] FIGS.3A-3G show various views of an overbandage assembly 310 according to an embodiment. FIG.3A is a top view of overbandage assembly 310. FIG.3B is an exploded view of a portion of the overbandage assembly 310. FIG.3C is a bottom view of overbandage assembly 310. FIG.3D is a cross-sectional view of the overbandage assembly 310 across B-B. FIG.3E is a cross-sectional view of the overbandage assembly 310 across A-A with the overbandage assembly 310 coupled to the analyte monitoring device 102. FIG.3F is a cross- sectional view of the overbandage assembly 310 across A-A with the overbandage assembly 310 coupled to the adhesive pad 105. FIG.3G is an exploded view of the overbandage assembly 310. The overbandage assembly 310 is configured to provide additional support to analyte monitoring device 102 to further adhere analyte monitoring device 102 to the skin of the patient. For example, the overbandage assembly 310 may be sized to at least partially cover the analyte monitoring device 102. The overbandage assembly 310 includes an adhesive portion to secure the overbandage assembly 310 to the skin of the patient such that the overbandage assembly 310 secures the analyte monitoring device 102 in place on the skin of the patient. In some embodiments, the adhesive portion of the overbandage assembly 310 may contact the analyte monitoring device 102 to secure the overbandage assembly 310 to the analyte monitoring device 102 in addition to securing the overbandage assembly 310 to the skin of the patient. In some
Docket No. A0130.0366.WO embodiments, the adhesive portion of the overbandage assembly 310 does not contact the analyte monitoring device 102. [0091] As shown, the overbandage assembly 310 includes a backing layer 312. The backing layer 312 is shown as having a circular shape, however the backing layer 312 may have other shapes. For example, the backing layer 312 may have an oval shape, a rectangular shape, or any other geometric or irregular shape. The backing layer 312 may be formed from a non-woven material. The backing layer 312 may be formed from a polymer material. The backing layer may be composed of a breathable or moisture-permeable material so that moisture may pass through backing layer. The backing layer 312 may have a moisture vapor transmission rate (MVTR) of between 100 and 2000 grams per meter squared per day, inclusive. In some embodiments, the backing layer 312 may have a MVTR of between 100 and 1000 grams per meter squared per day, inclusive. In some embodiments, the backing layer 312 may have a MVTR of between 100 and 1000 grams per meter squared per day, inclusive. In some embodiments, the backing layer 312 may have a MVTR of between 100 and 500 grams per meter squared per day, inclusive. In some embodiments, the backing layer 312 may be formed from polyurethane. The backing layer 312 may be formed from rubber. In some embodiments, the backing layer 312 may be formed from polyester, polyethylene, polypropylene, or other rigid thermoplastics that may have the desired characteristics. The backing layer 312 may be formed from any other material that exhibits the desired MVTR characteristics described herein. In some embodiments, MVTR can be determined by testing the material according to ASTM E96-80. [0092] The backing layer 312 includes a central portion 314. The central portion 314 defines an opening 318 that extends through the central portion 314. As shown, the opening 318 has a circular shape, however the opening 318 may have any geometric or irregular shape. In some embodiments, the opening 318 has a shape that corresponds to a shape of the housing 124. The opening 318 may be sized such that the central portion 314 contacts (e.g., covers) at least a portion of the second side 128 of the housing 124 when the overbandage assembly 310 is secured to the skin surface of the user. In some embodiments, the opening 318 may be sized such that the central portion 314 may not cover any portion of the housing 124 when the overbandage assembly 310 is secured to the skin surface of the user. For example, the opening 318 may surround at least a portion of the housing 124 when the overbandage assembly 310 is secured to the skin surface of the user. The opening may have a diameter that is greater than a diameter of the housing of the glucose monitoring device. In this way, the overbandage rests flat on the skin
Docket No. A0130.0366.WO surface. The opening may at least partially overlap an upper surface of the adhesive pad of the glucose monitoring device and also a skin surface of the user surrounding the adhesive pad 105. [0093] The backing layer 312 includes an outer portion 316 surrounding the central portion 314. In some embodiments, the outer portion 316 has a shape similar to the shape of the opening 318. In some embodiments, the outer portion 316 may have a shape that differs from the opening 318. In embodiments where the outer portion 316 has a circular shape, a diameter of the outer portion 316 may be larger than a diameter of the adhesive pad 105. In embodiments where the outer portion 316 has a non-circular shape, a largest dimension of the outer portion 316 may be larger than the diameter of the adhesive pad 105. Having a diameter or a largest dimension larger than the diameter of the adhesive pad 105 ensures that the backing layer 312 will contact the skin of the patient such that the overbandage assembly 310 can be secured to the skin of the patient. [0094] The backing layer 312 may comprise a plurality of apertures 340. Each of the plurality of apertures 340 may extend entirely through the backing layer 312. An aperture 342 of the plurality of apertures 340 is shown in FIG.3B and is representative of the plurality of apertures 340. As shown, each aperture 342 of the plurality of apertures 340 may have an oval shape. In some embodiments, each aperture 342 may have a different shape (e.g., circular, rectangular, or any other geometric or irregular shape). In some embodiments, each aperture 342 may be a slit (e.g., a narrow cut) extending through the backing layer 312. In embodiments where the aperture 342 has an oval shape, the aperture 342 has a major axis 344 and a minor axis 346. In some embodiments, a ratio of the relative sizes of the major axis 344 to the minor axis 346 may be between 1.1:1 and 10:1. In some embodiments, the ratio of the relative sizes of the major axis 344 to the minor axis 346 may be between 1.1:1 and 5:1. In some embodiments, the ratio of the relative sizes of the major axis 344 to the minor axis 346 may be between 1.1:1 and 2.5:1. In some embodiments, the minor axis 346 is approximately 0.25 millimeters (e.g., within ten percent of 0.25 mm). In some embodiments, the minor axis 346 may be between 0.1 mm and 10 mm. In some embodiments, the minor axis 346 may be between 0.1 mm and 5 mm. In some embodiments, the minor axis 346 may be between 0.1 mm and 2.5 mm. The plurality of apertures 340 are configured to wick moisture away from the skin of the patient. For example, a larger aperture 342 may allow more moisture to move away from the skin of the patient than a smaller aperture 342, thereby promoting better adhesion of the backing layer 312 to the skin of the patient. [0095] In some embodiments, spacing between each aperture 342 of the plurality of apertures 340 is approximately equal. For example, spacing between each aperture 342 of the plurality of
Docket No. A0130.0366.WO apertures 340 may be approximately 1 mm (e.g., within ten percent of 1 mm). In some embodiments, spacing between each aperture 342 of the plurality of apertures 340 may be, for example, 0.5 mm, 1.5 mm, 2 mm, or any value in between. The plurality of apertures 342 may be arranged in a regular or repeating pattern, such as in a grid pattern, among other layouts. The plurality of apertures 340 may be present on outer portion 316, central portion 314, or both. In some embodiments, a density of apertures may be greater in a first portion of backing layer than in a second portion. [0096] In some embodiments, the minor axis 346 of the aperture 342 is approximately aligned (e.g., within ten percent of exact alignment) with a radial axis 348 extending from a center 350 of the overbandage assembly 310. Thus, in embodiments where the overbandage assembly 310 is circular, a minor axis of each aperture 342 of the plurality of apertures 340 is approximately aligned with a radial axis extending from the center 350 of the overbandage assembly 310. Aligning the minor axis 346 with the radial axis 348 allows for increased radial strain relative to apertures that have a different shape and/or orientation than described. The increased radial strain allows the material of the backing layer 312 to stretch in the direction of the minor axis 346 as the backing layer 312 is pulled in the direction of the minor axis 346 during application of the overbandage assembly 310 to the skin while limiting folding and/or bunching of the backing layer 312. Stretching of the backing layer 312 may cause the shape of the aperture 342 to widen to a circular shape. Limiting folding and/or bunching of the backing layer 312 may allow the backing layer 312 to lay flat against the skin of the patient after the overbandage assembly 310 is applied, thereby decreasing instances where a portion of the backing layer 312 may catch on an external object and become dislodged from the skin of the patient. [0097] As shown in FIG.3D, the overbandage assembly 310 includes an adhesive layer 352. The adhesive layer 352 is disposed on a first side 354 (e.g., a skin-facing side) of the backing layer 312. The adhesive layer 352 is configured to contact the skin of the patient to secure the backing layer 312 (and thus, the overbandage assembly 310) to the skin of the patient. In some embodiments, the adhesive layer 352 is disposed on only a portion of the backing layer 312. For example, the adhesive layer 352 may be disposed on the outer portion 316 and not on the central portion 314 to limit adhering the backing layer 312 to the housing 124 of the analyte monitoring device 102. In such embodiments, the adhesive layer 352 may secure the outer portion 316 to the skin surface of the user to secure the overbandage assembly 310 to the skin surface of the user. In some embodiments, the adhesive layer 352 may be disposed on the outer portion 316 and on the central portion 314 to promote adhering the backing layer 312 to the housing 124 of the analyte
Docket No. A0130.0366.WO monitoring device 102. More specifically, in some embodiments the central portion 314 is configured to adhere to the housing 124 (e.g., the second side 128 of the housing 124) when the overbandage assembly 310 is secured to the skin surface of the user. [0098] The adhesive layer may be covered by one or more liners. In some embodiments, there are two liners, three liners, four liners, among other numbers of liners. One or more liners may cover outer portion 316. One or more liners may cover central portion 314. Liners may be arranged in an overlapping fashion. In this way, the liners are configured to be removed sequentially. [0099] As shown in FIGS.3C, 3D, and 3F, the overbandage assembly 310 includes a first liner 356 disposed on the adhesive layer 352. The adhesive layer is located between the first liner 356 and the backing layer 312. The first liner 356 is configured to cover the adhesive layer 352 prior to the overbandage assembly 310 being secured to the skin of the user to protect the adhesive layer 352, such as to prevent the overbandage assembly 310 from being inadvertently secured to another surface. Accordingly, the adhesive layer 352 is located between the first liner 356 and the backing layer 312. The first liner 356 is sized and shaped to cover a first part of the outer portion 316. More specifically, the first liner 356 may have a width that approximately matches (e.g., within ten percent of matching) a width of the outer portion. In embodiments in which the outer portion 316 has a circular shape, the outer portion 316 may have a width that extends between an inner diameter of the outer portion 316 and an outer diameter of the outer portion 316. In some embodiments, the outer portion 316 may have a width that extends between a diameter of the central portion 314 and the outer diameter of the outer portion 316. In some embodiments, the outer portion 316 may have a width that extends between the opening 318 and the outer diameter of the outer portion 316. [0100] The overbandage assembly 310 may include a second liner 358 disposed on the first side 354 of the backing layer 312. The second liner 358 is configured to cover the adhesive layer 352 in a manner similar to that described with reference to the first liner 356. The second liner 358 is sized and shaped to cover a second part of the outer portion 316. In some embodiments, the first part of the outer portion 316 and the second part of the outer portion 316 may be the same size. In some embodiments, the first part of the outer portion 316 and the second part of the outer portion 316 may be different sizes. The second liner 358 may have a width that approximately matches a width of the outer portion in a manner similar to that described above with reference to the first liner 356. In some embodiments, the second liner 358 overlaps the first liner 356. More specifically, a portion of the first liner 356 is disposed between the adhesive layer 352 and the
Docket No. A0130.0366.WO second liner 358. The first and second liners may be configured to fully cover the outer portion of the backing layer. The first and second liners may each have an arcuate shape, and may have a C- shape or an arc shape. [0101] The overbandage assembly 310 may include a third liner 360 disposed on the first side 354 of the backing layer 312. The third liner may cover a central portion of backing layer. The third liner may cover the adhesive on the central portion in embodiments having an adhesive central portion, or may cover a central opening in embodiments having a central opening. The third liner 360 may overlap both the first liner 356 and the second liner 358. In some embodiments, a portion of the third liner 360 covers the adhesive layer 352, another portion of the third liner 360 covers the opening 318, and a remainder of the third liner 360 overlaps portions of both the first liner 356 and the second liner 358. In some embodiments, the third liner 360 has a diameter that is larger than the inner diameter of the outer portion 316. Stated differently, the third liner 360 covers the central portion 314. [0102] To apply the overbandage assembly 310 to the skin of the user, the first liner 356, the second liner 358, and the third liner 360 are configured for sequential removal from the adhesive layer 352. For example, the user may remove the third liner 360 to expose the opening 318 or central adhesive area. In some embodiments the third liner 360 includes a tab 362 to aid in removal of the third liner 360. For example, the user may grip and pull the tab 362 to remove the third liner 360 from the overbandage assembly 310. The user may then align the opening 318 with the second side 128 of the housing 124. In some embodiments, the housing 124 defines a port 364 extending through the housing 124. The port 364 may allow moisture to exit from underneath the housing 124. In embodiments where the port 364 extends through the second side 128 of the housing 124, the user may align the opening 318 such that the port 364 is located within the opening 318. Thus, the port 364 may be uncovered when the overbandage assembly 310 is secured to the skin surface of the user. This may help to allow moisture underneath housing 124 to pass through the port 364 to the environment. In embodiments where the adhesive layer 352 is disposed on the first side 354 of the central portion 314 of the backing layer 312, the central portion 314 may be secured to the second side 128 of the housing 124 before removing the second liner 358 or the first liner 356. For example, the user may press the central portion 314 against the second side 128 of the housing 124, thereby causing the adhesive layer 352 to contact the second side 128 of the housing 124. In embodiments where the adhesive layer 352 is not disposed on the first side 354 of the central portion 314, the central portion 314 may be held in place by the user before removing the second liner 358 or the first liner 356.
Docket No. A0130.0366.WO [0103] While the central portion 314 is either secured to the second side 128 of the housing 124 (e.g., via the adhesive layer 352) or held in place on the second side 128 of the housing 124 (e.g., by the user holding the central portion 314 in place), the user may remove the second liner 358 to expose the adhesive layer 352 covered by the second liner 358. For example, the user may grasp the portion of the second liner 358 that overlaps the first liner 356 and then pull the second liner 358 off of the adhesive layer 352 to expose the adhesive layer 352. The user may then secure part of the outer portion 316 to the skin of the user by pressing the outer portion 316 against the skin of the user, thereby causing the adhesive layer 352 to contact the skin of the user. [0104] The user may then grasp and pull the first liner 356 to remove the first liner 356 from the outer portion 316 to expose the adhesive layer 352 covered by the first liner 356. In some embodiments, the first liner 356 may extend over a portion of the opening 318 to allow for the user to more easily grasp a portion of the first liner 356 for removal. In such embodiments, only part of the central portion 314 may be secured to the second side 128 of the housing 124 when the third liner 360 is removed. A remainder of the central portion 314 may be secured to the second side 128 of the housing 124 after the first liner 356 is removed. After removing the first liner 356 to expose the adhesive layer 352, the user may then secure the remainder of the outer portion 316 to the skin of the user by pressing the outer portion 316 against the skin of the user, thereby securing the overbandage assembly 310 to the skin of the user. In some embodiments, the first liner 356 includes a portion that is folded back on itself such that, when the second liner 358 is removed, the folded back portion of the first liner 356 provides a tab for the user to grip and pull to remove the first liner 356 from the adhesive layer 352. [0105] As shown in FIG.3E, when the overbandage assembly 310 is secured to skin surface 365 of the patient, a portion of the overbandage assembly 310 contacts the second side 128 of housing 124. An outer portion of overbandage assembly 310 contacts the skin surface 365 of the patient. A portion of overbandage assembly 310 contacts neither the skin surface 365 of the patient nor the second side 128 of the housing 124. Thus, the overbandage assembly 310 defines a space 366 where there is no contact between the overbandage assembly 310 and the skin of the patient. In some embodiments, the adhesive pad 105 that is coupled to the housing 124 is located within the space 366 such that the overbandage assembly 310 is not in contact with the adhesive pad 105. This may allow for removal of the overbandage assembly 310 without removing the analyte monitoring device 102. For example, a user may remove a first overbandage assembly and attach a second overbandage assembly while the analyte monitoring device 102 remains coupled to the user. Thus, multiple overbandages may be used in succession with a single analyte
Docket No. A0130.0366.WO monitoring device 102. In some embodiments, the overbandage assembly 310 is sized to be in contact with the adhesive pad 105 when the overbandage assembly 310 is secured to the skin surface 365 of the patient. [0106] As shown in FIG.3F, when the overbandage assembly 310 is secured to the skin surface 365 of the patient, a portion of the overbandage assembly 310 may contact a portion of the adhesive pad 105. For example, the opening 318 defined by the central portion 314 may be larger than the outer diameter of the housing 124, thereby allowing the housing 124 to extend through the opening 318 when the overbandage assembly 310 is secured to the skin surface 365 of the patient. [0107] FIGS.4A-4D show various views of an overbandage assembly 410. FIG.4A is a bottom view of an overbandage assembly 410, according to an embodiment. FIG.4B is a top view of the overbandage assembly 410 of FIG.4A, according to an embodiment. FIG.4C is a cross-sectional view of the overbandage assembly 410 of FIGS.4A-4B across C-C, according to an embodiment. FIG.4D is a cross-sectional view of the overbandage assembly 410 of FIGS.4A- 4B across C-C, when coupled to a portion of the analyte monitoring system 100 of FIG.1, according to an embodiment. FIG.4E is an exploded view of the overbandage assembly of the overbandage assembly 410. FIG.4F is another exploded view of the overbandage assembly 410. [0108] The structure and function of the overbandage assembly 410 is similar to that of the overbandage assembly 310 previously described, except for the differences noted below with reference to FIGS.4A-4F. [0109] The overbandage assembly 410 is shown to include a locator 468. Though the locator 468 is shown in FIGS.4A-4F, it should be noted that the locator 468 may be included in any of the other embodiments described herein. The locator 468 is configured to facilitate positioning of the central portion 314 over the housing 124. More specifically, the locator 468 is configured to provide tactile feedback to the user as the user attempts to accurately position the overbandage assembly 410 to secure the overbandage assembly 410 to the skin of the patient. For example, the locator 468 may be configured to at least partially surround, and may fully surround the housing 124 when the overbandage assembly 410 is accurately positioned. Thus, if the user attempts to shift the position of the overbandage assembly 410, the locator 468 may contact the housing 124 during the attempted shift to alert the user to limit shifting of the overbandage assembly 410 to maintain an accurate position. The locator 468 is further described below. [0110] The locator 468 is coupled to the backing layer 312. In some embodiments, the locator 468 may be secured to the backing layer 312 via the adhesive layer 352. For example, the locator
Docket No. A0130.0366.WO 468 may be applied to the adhesive layer 352 prior to any liners that may be applied subsequently to protect the adhesive layer 352. In some embodiments, the locator 468 may be secured to the backing layer 312 prior to application of the adhesive layer 352 to the first side 354 of the backing layer 312. For example, the locator 468 may be coupled to the backing layer 312 using an adhesive that is different than the adhesive used in the adhesive layer 352. As another example, the locator 468 may be coupled to the backing layer 312 using methods that may not include an adhesive (e.g., sonic welding, chemical bonding, overmolding, etc.). Furthermore, in embodiments in which the adhesive layer 352 is not disposed on the first side of the central portion 314, the locator 468 may be secured to the backing layer 312 using another adhesive layer 453 that is distinct from the adhesive layer 352. [0111] The locator 468 may have a shape that corresponds to a shape of a perimeter of the housing 124. As shown in FIG 4A, the locator 468 has an annular or ring shape, and may be substantially circular. However, the shape of the locator 468 is not limited to a circular shape and can have any shape that corresponds to the shape of the housing 124 (e.g., oval, elliptical, rectangular, or any other geometric or irregular shape). In embodiments where the locator 468 has as circular shape, the locator 468 has a diameter that is the same as or slightly larger than a diameter of the housing 124. The diameter may be in a range of 1 mm to 10 mm greater than a diameter of housing so as to fit closely to housing. The locator 468 may be configured to fit closely to housing 124, or to leave a small gap therebetween. Thus, the locator 468 may be sized such that the locator 468 extends around at least a portion of a perimeter of the housing 124 when the overbandage assembly 410 is secured to the skin surface of the user. As shown, the locator 468 is a continuous structure. Thus, the locator 468 may extend continuously around the entire perimeter of the housing 124 when the overbandage assembly 410 is secured to the skin surface of the user. However, the locator 468 may be discontinuous in some embodiments. For example, the locator 468 may include one or more gaps to allow the overbandage assembly 410 to bend or flex where the one or more gaps occur. Thus, the locator 468 may extend around only a portion of the perimeter of the housing 124 when the overbandage assembly 410 is secured to the skin surface of the user. [0112] The locator 468 is approximately concentric (e.g., within ten percent of being concentric) with the center 350 of the opening 318 that is defined by an inner edge 470 of the backing layer 312. In some embodiments, the opening 318 is defined by the locator 468. For example, a diameter of the inner edge 470 may approximately match (e.g., within ten percent of matching) an inner diameter of the locator 468. In such embodiments, the central portion 314 of the backing
Docket No. A0130.0366.WO layer 312 may be omitted. In some embodiments, the opening 318 is sized to be larger than the size of the port 364 at the second side 128 of the housing 124 but smaller than the inner diameter of the locator 468. Thus, when the overbandage assembly 410 is secured to the skin of the user, the port 364 remains uncovered. [0113] The locator 468 is made of a material that is more rigid than the backing layer 312. For example, the locator 468 may be formed from a polymer having more rigidity than the backing layer 312. More specifically, the locator 468 may be formed from acrylonitrile butadiene styrene (ABS), polycarbonate (PC), polyethylene terephthalate glycol (PETG), high density polyethylene (HDPE) or any other type of polymer material that may have the desired rigidity. [0114] As shown in FIG.4C, the locator 468 may have a stepped cross-sectional shape. The locator 468 may include a longer leg 472 and a shorter leg 474 that is shorter than the longer leg 472 in a direction approximately perpendicular to the skin surface of the user. In some embodiments, the longer leg 472 may be located closer to the housing 124 than the shorter leg 474 when the overbandage assembly 410 is secured to the skin surface of the user. In some embodiments, the longer leg 472 may be located further from the housing 124 than the shorter leg 474 when the overbandage assembly 410 is secured to the skin surface of the user. Having a stepped cross-sectional shape as described may simplify manufacturing of the locator 468 by limiting thick sections of material. The locator 468 may have a cross-sectional shape different than the one depicted in FIG.4C. For example, the locator 468 may have a triangular cross- section, a rectangular cross-section, or any other cross-sectional shape that provides the functionality of the locator 468 described herein. [0115] As shown in FIGS.4C, 4E, and 4F, the overbandage assembly 410 may include liners to cover the adhesive layer 352. For example, the overbandage assembly 410 may have a first liner 476. The overbandage assembly 410 may have a second liner 478. The first liner 476 and the second liner 478 may be similar in structure and function to the first liner 356 and the second liner 358 of the overbandage assembly 310. For example, the second liner 478 may overlap the first liner 476 in a manner similar to that described with reference to the first liner 356 and the second liner 358. [0116] The overbandage assembly 410 may include a third liner 480 in embodiments where the adhesive layer 352 is disposed on the first side 354 of the central portion 314. In some embodiments, the third liner 480 is sized to cover the central portion 314. The third liner 480 may include a tab for the user to grasp and pull to remove the third liner 480 from the central portion 314. In some embodiments, the overbandage assembly 410 may include a fourth liner
Docket No. A0130.0366.WO 481. In such embodiments, the third liner 480 may cover less than the entirety of the central portion 314, and the fourth liner 481 may cover the remainder of the central portion 314. The fourth liner 481 may overlap the third liner 480 to allow the user to grasp and pull the fourth liner 481 to remove the fourth liner. In such embodiments, the third liner 480 may include a portion that is folded back on itself to provide the user a surface to grip and pull to remove the third liner 480 after the fourth liner 481 is removed. In embodiments in which the central portion 314 does not include the adhesive layer 352, the third liner 480 and the fourth liner 481 may be omitted. [0117] To apply the overbandage assembly 410 to the skin of the user, the third liner 480 is removed from the adhesive layer 352 to expose the adhesive layer 352. In embodiments in which a fourth liner is implemented, the fourth liner is removed and then the third liner 480 is removed to expose the adhesive layer 352 disposed on the central portion 314. The user then centers the overbandage assembly 410 over the housing 124 using the locator 468 to provide tactical feedback (e.g., based on contact between the locator 468 and the housing 124). The user then adheres the central portion 314 to the housing 124 by pressing down on the central portion 314. The user may then remove the second liner 478 and the first liner 476 sequentially in a manner similar to that described above with respect to the second liner 358 and the first liner 356 of the overbandage assembly 310 to secure the overbandage assembly 410 to the skin surface of the user. [0118] As shown in FIG.4D, when the overbandage assembly 410 is secured to the skin of the patient, the outer portion 316 contacts the skin surface 365 of the user. A portion of the overbandage assembly 410 contacts neither the skin of the patient nor the second side 128 of the housing 124. Thus, the overbandage assembly 410 defines a space 482 where there is no contact between the overbandage assembly 410 and the skin of the patient. In some embodiments, the adhesive pad 105 that is coupled to the housing 124 is located within the space 482 such that the overbandage assembly 410 is not in contact with the adhesive pad 105. In some embodiments, the overbandage assembly 410 is sized to be in contact with the adhesive pad 105 when the overbandage assembly 410 is secured to the skin of the user. In some embodiments, the locator 468 is sized to contact the skin surface of the user when the overbandage assembly 410 is secured to the skin surface of the user. In some embodiments, the locator 468 is sized such that there is no contact between the skin surface of the user and the locator 468 when the overbandage assembly 410 is secured to the skin surface of the user. [0119] In some embodiments, an overbandage assembly may include a central portion and a plurality of folded portions extending from the central portion. The central portion may be
Docket No. A0130.0366.WO configured to be adhered to an upper surface of the housing of the glucose monitoring device. The central portion may contact a portion of the skin surface or adhesive pad. The folded portions may include adhesive thereon. The adhesive may be covered by a liner for each folded portion. The folded portion may be folded over the central portion so that the folded portion overlaps the central portion. The folded portions may be unfolded to allow the adhesive of the folded portion to contact the skin. This may allow the user flexibility to deploy additional folded portions to use additional adhesive throughout the sensor wear period. [0120] FIGS.5A-5D show various views of an overbandage assembly 510. FIG.5A is a top view of an overbandage assembly 510 in a folded configuration, according to an embodiment. FIG.5B is a top view of the overbandage assembly 510 of FIG.5A in an unfolded configuration, according to an embodiment. FIG.5C is a cross-sectional view of the overbandage assembly 510 of FIG.5A across D-D, according to an embodiment. FIG.5D is a cross-sectional view of the overbandage assembly 510 of FIG.5A across D-D, according to an embodiment. [0121] The overbandage assembly 510 is configured to provide the user with multiple ways to couple the overbandage assembly 510 to the housing 124 to maintain adherence of the overbandage assembly 510 to the skin surface of the user over time. For example, the overbandage assembly 510 can initially be adhered to the skin surface of the user in a manner similar to those described above with reference to FIGS.3A-3G and FIGS.4A-4F. The overbandage assembly 510 can provide an additional way to secure the overbandage assembly 510 to the skin surface of the user if the initial coupling between the overbandage assembly 510 and the skin surface of the user degrades over time. The structure and operation of the overbandage assembly 510 is further described below. [0122] The overbandage assembly 510 includes a backing layer 584. The backing layer 584 has a body portion 586. The backing layer 584 has a plurality of foldable portions 588 coupled to the body portion 586. The backing layer 584 may be formed from a fabric or polymer material similar to that described with respect to the backing layer 312 (e.g., polyester, polyethylene, polypropylene, polyurethane, etc.). The body portion 586 is shown as having an octagonal shape, however the body portion 586 may have other shapes. For example, the body portion 586 may have a circular shape, an oval shape, a square shape, a rectangular shape, pentagonal, hexagonal, heptagonal, or any other geometric or irregular shape. The body portion 586 may define an opening 592 that extends through the body portion 586. As shown, the opening 592 has a circular shape, however the opening 592 may have any geometric or irregular shape.
Docket No. A0130.0366.WO [0123] A first adhesive layer 591 is disposed on a first side of the body portion 586. The first adhesive layer may be similar in structure and function to the adhesive layer 352 described with respect to FIGS.3A-3G and FIGS.4A-4F. A second adhesive layer 594 is disposed on a first side of each foldable portion 590 of the plurality of foldable portions 588. In some embodiments, the first adhesive layer 591 and the second adhesive layer 594 form a continuous layer of adhesive. In some embodiments, the first adhesive layer 591 and the second adhesive layer 594 form separate adhesive layers that are discontinuous. [0124] As shown in FIGS.5A and 5C, each foldable portion 590 of the plurality of foldable portions 588 has a folded configuration. Additionally, as shown in FIGS.5B and 5D, each foldable portion 590 of the plurality of foldable portions 588 has an unfolded configuration. In the folded configuration, each foldable portion 590 of the plurality of foldable portions 588 overlaps the body portion 586. In the unfolded configuration, each foldable portion 590 of the plurality foldable portions 588 extends from the body portion 586 in a radial direction. For example, the body portion 586 is located between the opening 592 and each of the foldable portions 590 of the plurality of foldable portions 588 when in the unfolded configuration. [0125] As described, the body portion 586 may form a first geometric shape (e.g., octagonal, hexagonal, etc.). In some embodiments, the plurality of foldable portions 588 forms a second geometric shape that is different from the first geometric shape of the body portion when each foldable portion 590 of the plurality of foldable portions 588 is in the unfolded configuration. For example, and a shown in FIG.5B, the plurality of foldable portions 588 may form a circle when each foldable portion 590 of the plurality of foldable portions 588 is in the unfolded configuration. [0126] To form the plurality of foldable portions 588, each foldable portion 590 of the plurality of foldable portions may be folded along a fold line 596 in a sequential manner to arrive at the octagonal shape shown in FIG.5A. Thus, at least one foldable portion 590 of the plurality of foldable portions 588 overlaps another foldable portion 590 of the plurality of foldable portions 588 when the plurality of foldable portions 588 is in the folded configuration. In some embodiments, at least one foldable portion 590 of the plurality of foldable portions 588 does not cover any of the remaining foldable portions 590 (e.g., at least one foldable portion 590 is located at the bottom of the foldable portions 588). In some embodiments, at least one foldable portion 590 of the plurality of foldable portions 588 is not covered by any of the remaining foldable portions 590 (e.g., at least one foldable portion 590 is located at the top of the foldable portions 588).
Docket No. A0130.0366.WO [0127] A liner 598 may be disposed on the first adhesive layer 591 to cover the first adhesive layer 591. The liner 598 may be a single liner or may include multiple liners that overlap in a manner similar to that described with respect to the embodiments of FIGS.3A-3G and FIGS.4A- 4F. A liner 599 may be disposed on the first side of each foldable portion 590 of the plurality of foldable portions 588 to cover the second adhesive layer 594. The liner 599 may be a single liner or may include multiple liners that overlap. In some embodiments, the liner 598 and the liner 599 may form a single, continuous liner. In some embodiments, the liner 598 and the liner 599 may be separate liners that are discontinuous. [0128] To secure the overbandage assembly 510 to the skin of the user, the liner 598 is removed (either before or after aligning the opening 592 with the port 364) and the body portion 586 is secured to the second side 128 of the housing 124 via the first adhesive layer 591. The body portion 586 is secured to the skin surface of the user to secure the overbandage assembly 510 to the skin surface of the user. [0129] Over time, the first adhesive layer 591 may fail to adequately adhere the overbandage assembly 510 to the skin surface of the user. For example, liquid may infiltrate between the first adhesive layer 591 and the skin surface, thereby degrading the security of the connection between the first adhesive layer 591 and the skin surface of the user. In such instances, the user may remove the liner 599 from the second adhesive layer 594 and subsequently unfold each foldable portion 590 of the plurality of foldable portions 588. Each foldable portion 590 of the plurality of foldable portions 588 can be secured to the skin surface of the user via the second adhesive layer 594. Accordingly, the overbandage assembly 510 may remain secured to the skin surface of the user for a longer duration as compared to an overbandage assembly that does not include the plurality of foldable portions 588. [0130] FIGS.6A-6B show various views of an overbandage assembly 610. FIG.6A is a top view of an overbandage assembly 610 in an unfolded configuration, according to an embodiment. FIG.6B is a cross-sectional view of the overbandage assembly 610 of FIG.6A in a folded configuration, according to an embodiment. [0131] In some instances, a user may prefer to add more layers over time to secure the housing 124 to the skin of the user instead of having one component that includes multiple layers that can be used over time. For example, the overbandage assembly 610 of FIG.6A has a backing layer 679. The backing layer 679 may be formed from a polymer material similar to that described with respect to the backing layer 312. The backing layer 679 has a plurality of foldable portions 683 coupled to a body portion 681. Each foldable portion 685 of the plurality of foldable portions
Docket No. A0130.0366.WO 683 is coupled to the body portion 681 by a connection portion 687. The body portion 681 is shown as having a circular shape, however the body portion 681 have other shapes. In some embodiments, the body portion 681 may have a shape that corresponds to the shape of the housing 124. In addition, each foldable portion 685 of the plurality of foldable portions 683 may have a shape that corresponds to the shape of the body portion 681. [0132] The overbandage assembly 610 has a folded configuration shown in FIG.6B. The overbandage assembly 610 has an unfolded configuration shown in FIG.6A. In the folded configuration, each foldable portion 685 of the plurality of foldable portions 683 may be stacked on the body portion 681 and on each other. In the unfolded configuration, each foldable portion 685 of the plurality of foldable portions 683 extends from the body portion 681 in a radial direction. [0133] As shown in FIG.6B, a first adhesive layer 689 is disposed on a first side of the body portion 681. A liner 695 is disposed on the first adhesive layer 689 to cover the first adhesive layer 689. The first adhesive layer 689 is located between the liner 695 and the backing layer 679. A second adhesive layer 691 is disposed on a first side of each foldable portion 685 of the plurality of foldable portions 683. A liner 693 is disposed on the second adhesive layer 691 to cover the second adhesive layer 691. Each foldable portion 685 of the plurality of foldable portions 683 may have an associated adhesive layer and liner. [0134] To apply the overbandage assembly 610 to the housing 124, the user may remove the liner 695 to expose the first adhesive layer 689 to secure the body portion 681 to the second side 128 of the housing 124. Subsequently, the user may remove the liner 693 to expose the second adhesive layer 691 to secure one of the foldable portions 685 of the plurality of foldable portions 683 to the skin surface of the user. The user may then continue removing liners associated with subsequent foldable portions 685 to secure each foldable portion 685 of the plurality of foldable portions 683 to the skin surface of the user. [0135] FIGS.7A-7E show various views of an overbandage assembly 710 according to some embodiments. FIG.7A is an exploded view of the overbandage assembly 710. FIG.7B is a cross- sectional view of the overbandage assembly 710 across E-E adhered to the skin surface 365 of the user. FIGS.7C-7E are bottom views of an adhesive layer of the overbandage assembly 710 according to embodiments. [0136] In some instances, the user may prefer to use an overbandage that may be transparent. Using an overbandage that is transparent may further secure the analyte monitoring device 102 to the skin surface 365 of the user while not drawing attention of an observer. More specifically, the
Docket No. A0130.0366.WO apparent size of the analyte monitoring device 102 to an observer is not increased when using an overbandage that is transparent. Further, the transparent overbandage may facilitate application and positioning of the overbandage relative to the analyte monitoring device, as the user can see the analyte monitoring device and adhesive pad through the overbandage. [0137] The overbandage assembly 710 may include a backing layer 751. The backing layer 751 may include a transparent material that allows an observer to clearly see through the material. The backing layer 751 may include a thin film material. For example, the backing layer 751 may be formed from a material having a thickness of 25-1000 micrometers (microns). The backing layer 751 may include a polyurethane film. The polyurethane film may be an ester-based polyurethane, or an ether-based polyurethane. Polyurethane film has a high moisture vapor transfer rate relative to other films. Films may be beneficial as non-woven materials may absorb the adhesive, and as a result the adhesive becomes thinner over time which reduces the strength of attachment to the skin. The film does not similarly absorb the adhesive material. [0138] The film may have a shore A hardness of 85 to 95, 86 to 94, 87 to 93, or 88 to 92. The film may have a tear propagation resistance of 50 to 80 kN/m, 55 to 75 kN/m, or 60 to 70 kN/m. The backing layer 751 may have a MVTR of between 100 and 2000 grams per meter squared per day, inclusive, to allow passage of moisture (e.g., water vapor, etc.) through the backing layer 751. In some embodiments, the backing layer 751 may have a MVTR of between 100 and 1000 grams per meter squared per day, inclusive. In some embodiments, the backing layer 312 may have a MVTR of between 100 and 1000 grams per meter squared per day, inclusive. In some embodiments, the backing layer 751 may have a MVTR of between 100 and 500 grams per meter squared per day, inclusive. The backing layer 751 may be configured to conform to at least a portion of the housing 124. For example, the backing layer 751 may stretch as the user applies the overbandage assembly 710 over the housing 124 such that the backing layer 751 conforms to the shape of the housing 124. [0139] The backing layer 751 may define a plurality of openings 753 located at a central portion 752 of the backing layer 751. The plurality of openings 753 includes one or more central openings 755 and one or more radial openings 757 surrounding the central opening 755 or openings. The central opening 755 and radial openings 757 may provide for breathability and moisture permeability through backing layer 751. The central opening 755 and radial openings 757 may further increase flexibility of backing layer 751 so that backing layer 751 may better conform to the analyte monitoring device 102. The central opening 755 is located at the center of the backing layer 751. The radial openings 757 extend radially outward from the central opening
Docket No. A0130.0366.WO 755. In some embodiments, an outer diameter D1 of the radial openings 757 is the same as an outer diameter D2 of the second side 128 of the housing 124 of the analyte monitoring device 102. In some embodiments, the outer diameter D1 of the radial openings 757 may be smaller than the outer diameter D2 of the second side 128 of the housing 124 (see FIG.7B). Having the outer diameter D1 of the radial openings 757 the same as or smaller than the outer diameter D2 of the second side 128 of the housing 124 may allow the central portion 752 to stretch as the central portion 752 conforms to the second side 128 of the housing 124 without causing warping or wrinkling of the backing layer 751. [0140] In some embodiments, the central opening 755 is a circular opening. The radial openings 757 may each have an arc-shape. The radial openings 757 may form one or more rings surrounding the central opening 755. Each radial opening 757 may have the same dimensions. In some embodiments, radial openings 757 may have different dimensions. Radial openings 757 may be arranged at a fixed interval. In FIG.7A, radial openings 757 form two discontinuous rings that are concentrically arranged, and which surround central opening 755. In FIG.7A, each ring comprises five radial openings 757 each forming an arc of a circular ring. However, it is understood that fewer or additional radial openings may be present. [0141] As shown, the radial openings 757 are radially symmetric about the central opening 755. This radial symmetry provides flexibility to the user when applying the overbandage assembly 710. For example, the user may apply the overbandage assembly 710 in any rotational orientation over the analyte monitoring device 102, and at least one of the central opening 755 or the radial openings 757 will be positioned over the port 364 such that at least a portion of the port 364 remains uncovered when the overbandage assembly 710 is secured to the skin surface 365 of the user. [0142] The backing layer 751 may define one or more slits 756 that extend entirely through the backing layer 751 and extend radially outward from central opening 755. The slits 756 may have a function similar to the plurality of apertures 340. For example, the slits 756 may expand as the backing layer 751 conforms to the shape of the housing 124 to relieve any stresses or strains that may otherwise build in the backing layer 751 if the slits 756 were not present. [0143] The overbandage assembly 710 includes an adhesive layer 759 disposed on a first side of the backing layer 751. The adhesive layer 759 may be sized such that the adhesive layer 759 contacts the skin surface 365 of the user and does not contact the housing 124 or the adhesive pad 105. For example, the adhesive layer 759 may define an opening 765 that has a diameter that is larger than a diameter of the housing 124 and is larger than a diameter of the adhesive pad 105.
Docket No. A0130.0366.WO In this way, the overbandage assembly 710 can be removed without pulling on the analyte monitoring device 102, as the overbandage assembly adhering to the analyte monitoring device housing or adhesive pad may result in unintentional removal of the analyte monitoring device 102 when the overbandage assembly 710 is removed. Further, the over-sizing of the opening 765 allows for some degree of user misalignment of the overbandage assembly 710 without applying adhesive to the analyte monitoring device 102. [0144] The adhesive layer 759 may be applied to the backing layer 751 in a ring or annular configuration. However, in some embodiments, adhesive layer 759 may have alternate patterns. Adhesive layer 759 may include one or more discontinuous portions in an annular arrangement. [0145] In some embodiments, the adhesive layer may include an acrylic adhesive. For example, the adhesive layer 759 may include a medical extended wear acrylic adhesive (e.g., manufactured by 3M). The adhesive layer 759 may include other adhesives such as silicone adhesives, polyisobutylene and other hydrocarbon adhesives, polyurethane adhesives, natural rubber adhesives, synthetic rubber adhesives, and the like. [0146] The overbandage assembly 710 may include one or more liners disposed on the adhesive layer. In FIG.7A, a liner 761 is disposed on the adhesive layer 759. The adhesive layer 759 is located between the liner 761 and the backing layer 751. The liner 761 is configured to cover the adhesive layer 759 prior to the overbandage assembly 710 being secured to the skin surface 365 of the user to protect the adhesive layer 759, such as to prevent the overbandage assembly 710 from being inadvertently secured to another surface. The liner 761 may have a width W1 that approximately matches (e.g., within ten percent of matching) a width W2 of the adhesive layer 759. The width may be measured in a radial direction of the overbandage assembly 710 from an outer perimeter to an inner perimeter defining the opening. [0147] The liner 761 may include a tab 762 for the user to grasp when removing the liner 761 from the adhesive layer 759. In some embodiments, the liner 761 may include perforations 764 that separate one portion of the liner 761 from another portion of the liner 761 when the tab 762 is pulled. The liner 761 may have a ring shape or annular shape. The liner 761 may fully cover adhesive layer 759. A first portion of the liner 761 may overlap a second portion of the liner 761. The tab 762 may extend radially outwardly and extend beyond a diameter of the backing layer 751 so that it may be easily grasped. In some embodiments, the liner 761 may include two liners each covering approximately half of the adhesive layer. For example, two liners may each have an arc-shape or C-shape. For example, the user may grasp and pull the tab 762, thereby separating the liner 761 at the perforations 764. The liner 761 may be removed from the adhesive
Docket No. A0130.0366.WO layer 759 by pulling the tab 762 around a circumference of the adhesive layer 759. In some embodiments, the liner 761 may be removed from the adhesive layer 759 in one piece. Removing the liner 761 in one piece may simplify the overbandage application process for the user by reducing the number of liners to be removed. After exposing the adhesive layer 759, the overbandage assembly 710 may be secured to the skin surface 365 of the user. [0148] The overbandage assembly 710 may include one or more upper liners. In FIG.7A, there is a single upper liner 763 disposed on a second side of the backing layer 751 (e.g., opposite the adhesive layer 759). The upper liner 763 is more rigid than the backing layer 751 and the adhesive layer 759. The higher rigidity provides the user with a surface that can be more easily manipulated when applying the overbandage assembly 710 to the skin surface 365 of the user as compared to manipulating the backing layer 751 alone. The upper liner 763 may be secured to the backing layer 751 with an adhesive that remains on the upper liner 763 after removal of the upper liner 763 from the backing layer 751. The upper liner may have a ring or annular shape and a central opening 770. The central opening 770 is provided so that the central opening 755 and the radial openings 757 remain uncovered. This allows the central portion 752 of the backing layer 751 to flex and conform to a shape of the housing 124 without interference by the upper liner 763. The upper liner 763 may include a tab 766. The tab 766 may extend radially outwardly beyond a diameter of the backing layer 751 so that it can be easily grasped. Tab 766 may extend from a different portion than tab 762. Tabs 762, 766 may be arranged on opposing sides of the overbandage assembly 710 so that tabs 762, 766 can be more easily manipulated separately. In some embodiments, tabs 762, 766 may be arranged in other angular orientations relative to each other. In some embodiments, tabs 762, 766 may be arranged in an orientation in which tabs 762, 766 offset from each other by 15 to 120 degrees. In some embodiments, tabs 762, 766 may be offset from each other by 15 to 90 degrees. In some embodiments, tabs 762,766 may be offset from each other by 15 to 45 degrees. Providing the tabs 762, 766 at angular orientations other than on opposing sides may aid the user in removing tabs 762, 766 by allowing the user to feel both tabs at the same hand position relative to the overbandage assembly. In some embodiments, an additional adhesive layer may be applied to maintain the angular orientation of the tabs 762, 766 relative to each other. Upper liner 763 may include one or more perforations 768 to aid in removal of the upper liner 763 from the backing layer 751 in a manner similar to that described with reference to the tab 762 and the perforations 764. [0149] To apply the overbandage assembly 710 to the skin surface 365, the user removes the liner 761 (e.g., by pulling the tab 762) from the adhesive layer 759. The user then positions the
Docket No. A0130.0366.WO backing layer 751 over the housing 124 such that the central portion 752 is generally aligned with the second side 128 of the housing 124. The upper liner 763 maintains the adhesive layer 759 at a distance from the skin surface 365 to prevent unintended coupling of the backing layer 751 to the skin surface 365 while positioning the backing layer 751 over the housing 124. After reaching the desired position, the user can press the backing layer 751 toward the skin surface 365 to adhere the backing layer 751 to the skin surface 365. When pressing the backing layer 751, the central opening 755 and the radial openings 757 may stretch to facilitate conforming the central portion 752 to the housing 124. The user can then remove the upper liner 763 (e.g., by pulling the tab 766) from the backing layer 751. After removal of the upper liner 763, the user may continue pressing the backing layer 751 to further conform the backing layer 751 to the housing 124 and the skin surface 365. The slits 756 may stretch to limit wrinkling as the backing layer 751 conforms to the housing 124 and the skin surface 365. In some embodiments, the user may position the backing layer 751 over the housing prior to removing the liner 761. [0150] As shown in FIGS.7B-7E, the adhesive layer 759 may be disposed on the first side of the backing layer 751 in various patterns. Although the patterns of adhesive are shown in FIGS.7B – 7E, it should be noted that the patterns may be included in any of the other embodiments described herein. The patterns may include adhesive areas 771 separated by channels 767. Each of the adhesive areas 771 defines channels 767 that are free of adhesive and that are configured to allow moisture to escape from the skin surface 365 of the user and from the overbandage assembly 710. The channels 767 may intersect with and extend from the opening 765 to allow moisture to escape from a portion of the skin surface 365 that may not be covered by either the adhesive layer 759 or the adhesive pad 105. FIG.7C shows the adhesive layer 759 arranged in a grid pattern. The grid may include the channels 767 arranged at an angle to one another such that the channels intersect. The channels may be perpendicular to one another. The adhesive areas 771 may have a generally square shape. However, in alternate embodiments grid may have diamond shape adhesive areas, rectangular shaped adhesive areas, or triangular shaped adhesive areas among others. [0151] FIG.7D shows the adhesive areas 771 arranged in a radial array defined by the channels 767. The channels 767 extend radially outward from the opening 765 in both a linear manner (e.g., a portion of the channels 767 are straight and extend linearly away from the opening 765 in a radial direction) and a circular manner (e.g., a portion of the channels 767 are curved or circularly shaped and extend radially outward from the opening 765). In some embodiments, the channels 767 may be spaced at regular intervals between the opening 765 and the outer diameter
Docket No. A0130.0366.WO of the adhesive layer 759. Having the channels 767 extending from the opening 765 in various orientations as shown in FIGS.7C-7D can direct moisture away from the opening 765 and away from the skin surface 365 regardless of the orientation of the skin surface 365. For example, the analyte monitoring device 102 may be coupled to a triceps area of the user. The triceps area may have various orientations depending on the activity of the user (e.g., running, lifting weights, swimming, etc.). Having the channels 767 disposed at various orientations relative to the opening 765 will facilitate directing moisture away from the opening 765 and the skin surface 365 regardless of the orientation of the analyte monitoring device 102. [0152] FIG.7E shows the adhesive layer 759 arranged in a linear array defined by the channels 767. In some embodiments, the channels 767 may be spaced at regular intervals across the adhesive layer 759. As shown, some of the channels 767 intersect with the opening 765, and some of the channels do not intersect with the opening 765. The channels 767 that intersect with the opening 765 may direct moisture away from the skin surface 365 located at the opening 765. The channels 767 that do not intersect with the opening 765 may direct moisture away from areas of the skin surface 365 spaced apart from the opening 765. Having some of the channels 767 isolated from the opening 765 may limit instances of the channels 767 directing moisture toward the opening 765 (e.g., instances where gravity may direct moisture toward the opening 765), which may limit moisture contacting the adhesive pad 105. [0153] FIG.8A is an exploded view of an overbandage assembly 810, according to an embodiment. FIG.8B is a cross-sectional view of the overbandage assembly 810 across F-F adhered to the skin surface 365 of the user, according to an embodiment. FIG.8C is a bottom view of a locator of the overbandage assembly 810. In some instances, a user may prefer to use an overbandage that has a defined shape that conforms to the shape of the housing 124. For example, a user may be active and engage in activities during which the likelihood of external contact with the analyte monitoring device 102 is high (e.g., contact sports) or the likelihood of moisture (e.g., sweat) contacting the overbandage assembly is high (e.g., aerobic activities such as running, biking, swimming, etc.). The overbandage having a defined shape may provide additional security when engaged in such activities. [0154] For example, the overbandage assembly 810 has a backing layer 879. The backing layer 879 may be formed from a thin film material similar to the backing layer 751 (e.g., an ester-based polyurethane, an ether-based polyurethane, etc.). The backing layer 879 comprises an inner edge 880 that defines an opening 881. In some embodiments, the opening 881 has a diameter that is larger than the diameter of the housing 124. In some embodiments, the opening 881 has a
Docket No. A0130.0366.WO diameter that is larger than the diameter of the adhesive pad 105. Thus, the opening 881 is sized such that the housing 124 extends through the opening 881 when the overbandage assembly 810 is secured to the skin surface 365 of the user. [0155] The overbandage assembly 810 may include an adhesive layer 887 disposed on a first side of the backing layer 879. The adhesive layer 887 defines an opening 889 that may be sized such that a diameter of the opening 889 approximately matches (e.g., within ten percent of matching) a diameter of the opening 881 and that an outer diameter of the adhesive layer 887 approximately matches an outer diameter of the backing layer 879. In some embodiments, the adhesive layer 887 is sized such that the adhesive layer 887 contacts the skin surface 365 and does not contact the housing 124. In some embodiments, the adhesive layer 887 may overlap a portion of the adhesive pad 105. In some embodiments, the adhesive layer 887 does not contact the adhesive pad 105. [0156] The adhesive layer 887 may be applied to the backing layer 879 in a ring or annular configuration. However, in some embodiments, the adhesive layer 887 may have alternate patterns. For example, the adhesive layer 887 may include one or more discontinuous patterns (e.g., similar to the patterns of the adhesive layer 759 shown in FIGS.7C-7E). [0157] In some embodiments, the adhesive layer may include an acrylic adhesive. For example, the adhesive layer 887 may include a medical extended wear acrylic adhesive (e.g., manufactured by 3M). The adhesive layer 887 may include other adhesives such as silicone adhesives, polyisobutylene and other hydrocarbon adhesives, polyurethane adhesives, natural rubber adhesives, synthetic rubber adhesives, and the like. [0158] The overbandage assembly 810 may include one or more liners disposed on the adhesive layer 887. For example, the overbandage assembly 810 includes a liner 891 disposed on the adhesive layer 887 such that the adhesive layer 887 is located between the liner 891 and the backing layer 879. The liner 891 is substantially similar to the liner 761 described with reference to FIGS.7A-7B such that the description of the liner 761 applies to the liner 891. [0159] The overbandage assembly 810 includes a locator 869 (shown in FIGS.8B-8C). The locator 869 is coupled to the backing layer 879 and is configured to contact at least a portion of the housing 124 when the overbandage assembly 810 is secured to the skin surface 365 of the user. In some embodiments, the locator 869 is coupled to the backing layer 879 by an adhesive ring 883 disposed on the backing layer 879. The adhesive ring 883 defines an opening 885. In some embodiments, the opening 885 has a size and shape that approximately matches (e.g., within ten percent of matching) the size and shape of the opening 881. In some embodiments, the
Docket No. A0130.0366.WO opening 885 has a diameter that is larger than the diameter of the opening 881. In some embodiments, the locator 869 may be coupled to the backing layer 879 in other ways. For example, the locator 869 may be coupled to the backing layer 879 via a welding process, a chemical bond, or any other bonding method that would secure the locator 869 to the backing layer 879. [0160] The locator 869 may be formed from an elastomeric material. In some embodiments, the locator 869 is more rigid than the adhesive layer 887 but is still configured to conform to contours of the body of the user. For example, the locator 869 may be formed from silicone, natural rubber, synthetic rubber (e.g., polybutadiene, ethylene propylene diene monomer (EPDM)), or any other type of material that may exhibit the desired characteristics described herein. In some embodiments, the locator 869 may be transparent or translucent. Being transparent or translucent may draw less attention to the overbandage assembly 810 from an observer than if the locator 869 were not transparent or translucent. [0161] The locator 869 is shown to include a base 871. The base 871 is coupled to the backing layer 879 via the adhesive ring 883. The locator 869 may include an extension 873 that extends away from the base 871 in a direction away from the backing layer 879. The extension 873 terminates in a lip 875. The lip 875 defines an opening 877. The opening 877 has a diameter that is smaller than the diameter of the second side 128 of the housing 124. Thus, the lip 875 contacts the second side 128 of the housing 124 when the overbandage assembly 810 is secured to the skin surface 365 of the user. In some embodiments, a height of the lip 875 from the skin surface 365 of the user may be smaller than a height of the second side 128 from the skin surface of the user. This difference in heights may allow the locator 869 to apply a compressive force to the housing 124 to maintain the position of the housing 124 relative to the skin surface 365 of the user. [0162] The locator 869 may include one or more channels 897 that extend through the base 871. The channels 897 may allow moisture (e.g., sweat, water, etc.) to exit the locator 869 to limit the moisture from reducing the effectiveness of the adhesive layer 887. For example, the channels 897 define a space between the adhesive ring 883 and the base 871 that allows moisture to exit the locator 869. The locator 869 may include one or more protrusions 895 that extend from an underside of the lip 875. The protrusions 895 are configured to contact the second side 128 of the housing 124 to maintain engagement between the locator 869 and the housing 124. The protrusions 895 may be distributed at regular intervals around the underside of the lip 875. In
Docket No. A0130.0366.WO areas of the lip 875 where the protrusions 895 are not present, the locator 869 may include one or more channels 899 that allow moisture to exit. [0163] The overbandage assembly 810 may include an upper liner 893 disposed on a side of the backing layer 879 opposite the adhesive layer 887. The upper liner 893 is substantially similar to the upper liner 763 described with reference to FIGS.7A-7B such that the description of the upper liner 763 applies to the upper liner 893. [0164] To apply the overbandage assembly 810 to the skin surface 365, the user removes the liner 891 (e.g., in a manner similar to that previously described with respect to the liner 761) from the adhesive layer 887. The user then positions the locator 869 over the housing 124. For example, contact between the locator 869 and the housing 124 may provide tactile feedback to the user to notify the user that the locator 869 (and thus, the overbandage assembly 810) is properly positioned. The upper liner 893 maintains the adhesive layer 887 at a distance from the skin surface 365 to prevent unintentional coupling of the backing layer 879 to the skin surface 365 while positioning the locator 869 and the backing layer 879 over the housing 124. After reaching the desired position, the user can press the locator 869 and/or the backing layer 879 to adhere the backing layer 879 to the skin surface 365. When pressing the locator 869 and/or the backing layer 879, the locator 869 may stretch and/or flex to conform to the body of the user. The user can then remove the upper liner 893 (e.g., in a manner similar to that previously described with respect to the upper liner 763). After removal of the upper liner 893, the user may continue pressing the backing layer 879 to adhere overbandage assembly 810 to the skin surface 365. In some embodiments, the user may position the locator 869 over the housing 124 prior to removing the liner 891. [0165] In some embodiments, various features of the disclosed embodiments may be combined. For example, in some embodiments an overbandage assembly may include a backing layer formed from a thin film material. The backing layer may be transparent or translucent. The overbandage assembly may include a locator coupled to the backing layer. The overbandage assembly may include a liner that covers an adhesive layer, such that the adhesive layer is located between the liner and the backing layer. The liner may be removed from the adhesive layer in one piece. The overbandage assembly may include an upper liner located on an opposite side of the backing layer from the liner. The upper liner may be removed from the backing layer in one piece. [0166] Exemplary embodiments are set forth in the following numbered clauses: 1. A continuous glucose monitoring system, comprising:
Docket No. A0130.0366.WO a glucose monitoring device, comprising: a housing, a glucose sensor comprising a first portion arranged within the housing and a second portion configured to be positioned below a skin surface and in contact with a bodily fluid to generate a signal indicative of a glucose level of a user, sensor electronics arranged within the housing and coupled to the first portion of the glucose sensor, wherein the sensor electronics comprise a processor and wireless communications circuitry, and an adhesive pad coupled to a first side of the housing and configured to secure the first side of the housing to the skin surface of the user; and an overbandage assembly configured to contact a second side of the housing located opposite the first side of the housing, the overbandage assembly comprising: a backing layer comprising a central portion and an outer portion surrounding the central portion, an adhesive layer disposed on a first side of the backing layer, a first liner disposed on the first side of the backing layer, a second liner disposed on the first side of the backing layer and overlapping the first liner, and a third liner disposed on the first side of the backing layer and overlapping the first liner and the second liner; wherein the central portion is configured to cover at least a portion of the second side of the housing of the glucose monitoring device, and wherein the adhesive layer is configured to secure the outer portion to the skin surface of the user to secure the overbandage assembly to the skin surface of the user. 2. The system of clause 1, further comprising a locator coupled to the overbandage assembly and configured to facilitate positioning of the central portion over the housing. 3. The system of clause 2, wherein the locator has a stepped cross-sectional shape that includes a longer leg and a shorter leg, the longer leg being positioned closer to the housing than the shorter leg when the overbandage assembly is secured to the skin surface of the user. 4. The system of clause 2, wherein the locator has a shape that corresponds to a shape of the housing such that the locator extends around at least a portion of a perimeter of the housing when the overbandage assembly is secured to the skin surface of the user. 5. The system of clause 2, wherein the locator is more rigid than the backing layer. 6. The system of any of the preceding clauses, wherein the adhesive layer is disposed on the outer portion and not the central portion.
Docket No. A0130.0366.WO 7. The system of any of clauses 1-5, wherein the adhesive layer is disposed on the outer portion and the central portion. 8. The system of any of clauses 1-7, wherein the central portion is configured to adhere to the second side of the housing when the overbandage assembly is secured to the skin surface of the user. 9. The system of any of clauses 1-8, wherein the backing layer defines a plurality of apertures extending entirely through the backing layer. 10. The system of clause 9, wherein each aperture of the plurality of apertures has an oval shape. 11. The system of any of clauses 9-10, wherein a minor axis of each aperture of the plurality of apertures is approximately aligned with a radial axis extending from a center of the overbandage assembly. 12. The system of any of the preceding clauses, wherein the first liner covers a first part of the outer portion, the second liner covers a second part of the outer portion, and the third liner covers the central portion. 13. The system of clause 12, wherein the outer portion has a width that extends between an inner diameter of the outer portion and an outer diameter of the outer portion, wherein the first liner has a width that approximately matches the width of the outer portion, and wherein the second liner has a width that approximately matches the width of the outer portion. 14. The system of clause 13, wherein the third liner has a diameter that is larger than the inner diameter of the outer portion. 15. The system of any of the preceding clauses, wherein the housing defines a port extending through the second side of the housing, wherein the central portion defines an opening extending through the central portion, the opening sized such that the central portion covers a portion of the second side of the housing when the overbandage assembly is secured to the skin surface of the user, and the port extending through the second side of the housing is uncovered when the overbandage assembly is secured to the skin surface of the user. 16. A continuous glucose monitoring system, comprising: a glucose monitoring device, comprising: a housing, a glucose sensor comprising a first portion arranged within the housing and a second portion configured to be positioned below a skin surface and in contact with a bodily fluid to generate a signal indicative of a glucose level of a user,
Docket No. A0130.0366.WO sensor electronics arranged within the housing and coupled to the first portion of the glucose sensor, wherein the sensor electronics comprise a processor and wireless communications circuitry, and an adhesive pad coupled to a first side of the housing and configured to secure the first side of the housing to the skin surface of the user; and an overbandage assembly configured to be secured to the skin surface of the user, comprising: a backing layer having an inner edge that defines an opening, wherein the housing is configured to extend through the opening, an adhesive layer disposed on a first side of the backing layer, a locator coupled to the backing layer and concentric with the opening defined by the inner edge of the backing layer, the locator having a diameter that is larger than a diameter of the housing, a first liner disposed on the first side of the backing layer, and a second liner disposed on the first side of the backing layer and overlapping the first liner. 17. The system of clause 16, wherein the locator is more rigid than the backing layer. 18. The system of any of clauses 16-17, wherein the locator extends continuously around a perimeter of the housing when the overbandage assembly is secured to the skin surface of the user. 19. The system of any of clauses 16-18, wherein the backing layer defines a plurality of apertures extending entirely through the backing layer. 20. The system of clause 19, wherein each aperture of the plurality of apertures has an oval shape. 21. The system of any of clauses 19-20, wherein a minor axis of each aperture of the plurality of apertures is approximately aligned with a radial axis extending from a center of the opening. 22. The system of any of clauses 16-21, wherein the backing layer has a width that extends between the inner edge and an outer edge, wherein the first liner has a width that approximately matches the width of the backing layer, and wherein the second liner has a width that approximately matches the width of the backing layer. 23. The system of any of clauses 16-22, wherein the overbandage assembly further comprises a third liner to cover the opening, the third liner disposed on the first side of the backing layer and overlapping the first liner and the second liner. 24. A continuous glucose monitoring system, comprising: a glucose monitoring device, comprising: a housing,
Docket No. A0130.0366.WO a glucose sensor comprising a first portion arranged within the housing and a second portion configured to be positioned below a skin surface and in contact with a bodily fluid to generate a signal indicative of a glucose level of a user, sensor electronics arranged within the housing and coupled to the first portion of the glucose sensor, wherein the sensor electronics comprise a processor and wireless communications circuitry, and an adhesive pad coupled to a first side of the housing and configured to secure the first side of the housing to the skin surface of the user; and an overbandage assembly configured to be secured to the skin surface of the user, comprising: a backing layer having a body portion and a plurality of foldable portions coupled to the body portion, a first adhesive layer disposed on a first side of the body portion, a second adhesive layer disposed on a first side of each foldable portion of the plurality of foldable portions, a first liner disposed on the first side of the body portion, and a second liner disposed on the first side of each foldable portion of the plurality of foldable portions, wherein each foldable portion of the plurality of foldable portions has a folded configuration, in which each foldable portion of the plurality of foldable portions overlaps the body portion, and an unfolded configuration, in which each foldable portion of the plurality of foldable portions is extends from the body portion in a radial direction. 25. The system of clause 24, wherein the body portion forms a first geometric shape and the plurality of foldable portions form a second geometric shape that is different from the first geometric shape when each foldable portion of the plurality of foldable portions is in the unfolded configuration. 26. The system of any of clauses 24-25, wherein at least one foldable portion of the plurality of foldable portions overlaps another foldable portion of the plurality of foldable portions when the plurality of foldable portions is in the folded configuration. 27. A continuous glucose monitoring system, comprising: a glucose monitoring device, comprising: a housing,
Docket No. A0130.0366.WO a glucose sensor comprising a first portion arranged within the housing and a second portion configured to be positioned below a skin surface and in contact with a bodily fluid to generate a signal indicative of a glucose level of a user, sensor electronics arranged within the housing and coupled to the first portion of the glucose sensor, wherein the sensor electronics comprise a processor and wireless communications circuitry, and an adhesive pad coupled to a first side of the housing and configured to secure the first side of the housing to the skin surface of the user; and an overbandage assembly configured to contact a second side of the housing located opposite the first side of the housing, the overbandage assembly comprising: a backing layer configured to conform to a shape of the housing, the backing layer comprising a central opening located at a center of the backing layer, one or more radial openings surrounding the central opening and extending radially outward from the central opening, and one or more slits extending radially outward from the central opening, an adhesive layer disposed on a first side of the backing layer, a liner disposed on the adhesive layer, the adhesive layer being located between the first liner and the backing layer, and an upper liner disposed on a second side of the backing layer, the upper liner being more rigid than the backing layer and the adhesive layer. 28. The system of clause 27, wherein the backing layer is transparent. 29. The system of either of clauses 27 or 28, wherein the radial openings form one or more rings surrounding the central opening. 30. The system of any of clauses 27-29, wherein the radial openings form two discontinuous rings that are arranged concentrically, wherein the two discontinuous rings surround the central opening. 31. The system of any of clauses 27-30, wherein the radial openings are radially symmetric about the central opening. 32. The system of any of clauses 27-31, wherein the adhesive layer comprises adhesive areas separated by channels. 33. The system of clause 32, wherein the adhesive areas are arranged in a grid and the channels are arranged at angles such that the channels intersect. 34. The system of clause 32, wherein the adhesive areas are arranged in a radial array, wherein a portion of the channels are straight and extend linearly away from an opening defined
Docket No. A0130.0366.WO by the adhesive layer in a radial direction, and a portion of the channels are curved and extend radially outward from the opening defined by the adhesive layer. 35. The system of clause 32, wherein the adhesive areas are arranged in a linear array and the channels are spaced at regular intervals across the adhesive layer. 36. A continuous glucose monitoring system, comprising: a glucose monitoring device, comprising: a housing, a glucose sensor comprising a first portion arranged within the housing and a second portion configured to be positioned below a skin surface and in contact with a bodily fluid to generate a signal indicative of a glucose level of a user, sensor electronics arranged within the housing and coupled to the first portion of the glucose sensor, wherein the sensor electronics comprise a processor and wireless communications circuitry, and an adhesive pad coupled to a first side of the housing and configured to secure the first side of the housing to the skin surface of the user; and a backing layer having an inner edge that defines an opening, wherein the housing is configured to extend through the opening, an adhesive layer disposed on a first side of the backing layer, an adhesive ring disposed on a second side of the backing layer, a locator comprising: a base coupled to the adhesive ring, an extension extending from the base in a direction away from the backing layer, the extension terminating in a lip that defines an opening having a diameter smaller than a diameter of the second side of the housing, wherein the locator comprises a first channel extending through the extension and a second channel extending through the base, the second channel defining a space between the adhesive ring and the base, a liner disposed on the adhesive layer, the adhesive layer being located between the first liner and the backing layer, and an upper liner disposed on a second side of the backing layer, the upper liner being more rigid than the backing layer and the adhesive layer. 37. The system of clause 36, wherein the locator is transparent. 38. The system of either of clauses 36 or 37, wherein the locator is formed from an elastomeric material.
Docket No. A0130.0366.WO [0167] It is to be appreciated that the Detailed Description and the Summary section, but not the Abstract, is intended to be used to interpret the claims. The Abstract may set forth one or more but not all exemplary embodiments of the present invention as contemplated by the inventor(s), and thus, is not intended to limit the present invention and the appended claims in any way. [0168] The foregoing description of the specific embodiments will so fully reveal the general nature of the invention that others can, by applying knowledge within the skill of the art, readily modify and/or adapt for various applications such specific embodiments, without undue experimentation, without departing from the general concept of the present invention. Therefore, such adaptations and modifications are intended to be within the meaning and range of equivalents of the disclosed embodiments, based on the teaching and guidance presented herein. It is to be understood that the phraseology or terminology herein is for the purpose of description and not of limitation, such that the terminology or phraseology of the present specification is to be interpreted by the skilled artisan in light of the teachings and guidance. [0169] The breadth and scope of the present invention should not be limited by any of the above- described exemplary embodiments, but should be defined only in accordance with the claims and their equivalents.