Assembly for securing a glucose monitoring device and related techniques

Abstract

An assembly for securing a glucose monitoring device and related techniques are disclosed. The assembly may include a retainer member configured to fit loosely over the glucose monitoring device without attaching or connecting to it. To that end, the retainer member and a housing of the glucose monitoring device may include respective interfacing features configured to interface with one another. The assembly further may include an adhesive overpatch configured to adhere to the retainer member and the user's skin without adhering to the glucose monitoring device. In accordance with some embodiments, removal of the adhesive overpatch from the user's skin may effectuate simultaneous removal of the retainer member from the glucose monitoring device without compromising adhesion of the glucose monitoring device to the user's skin or disrupting placement of its implanted sensor.

Description

[0001] Atty. Docket No. : SANV 24.02 PCT

[0002] ASSEMBLY FOR SECURING A GLUCOSE MONITORING DEVICE AND RELATED TECHNIQUES

[0003] FIELD OF THE DISCLOSURE

[0004] The present disclosure relates to glucose monitoring devices and, more particularly, to glucose monitoring devices wearable on the skin of a user.

[0005] BACKGROUND

[0006] Continuous glucose monitoring (CGM) devices allow users to assess their glucose levels without needing to periodically perform invasive sampling techniques, such as finger pricks. Instead, CGM devices interface directly with a user’s skin and periodically transmit glucose level data for user review. Typically, adhesive tape is used to hold the CGM device on the user’s skin.

[0007] SUMMARY

[0008] One example embodiment provides an assembly for securing a glucose monitoring device to a user’s skin. The assembly includes a retainer member configured to be disposed over the glucose monitoring device such that the glucose monitoring device at least partially resides within an interior space of the retainer member, wherein the retainer member fits loosely over a housing of the glucose monitoring device and at least partially covers an adhesive pad portion of the glucose monitoring device. The assembly further includes an adhesive overpatch configured to be disposed over the retainer member. In assembly with the glucose monitoring device, the adhesive overpatch adheres to the retainer member and the user’s skin but does not adhere to the housing and the adhesive pad portion of the glucose monitoring device. Removal of the adhesive overpatch from the user’s skin effectuates simultaneous removal of the retainer member from the glucose monitoring device without compromising adhesion of the glucose monitoring device to the user’s skin or disrupting placement of an implanted sensor of the glucose monitoring device.

[0009] In some cases, the retainer member includes a main body portion configured to at least partially surround a sidewall of the housing of the glucose monitoring device. In some such instances, the main body portion is further configured to at least partially overhang an upper surface of the housing of the glucose monitoring device. In some other such instances, the main body portion includes at least one interfacing feature configured to interface with at Atty. Docket No. : SANV 24.02 PCT least one corresponding interfacing feature of the housing of the glucose monitoring device. In some example instances, the at least one interfacing feature of the main body portion is configured to be received by the at least one corresponding interfacing feature of the housing of the glucose monitoring device without becoming frictionally stuck therein. In some other example instances, at least one of: the at least one interfacing feature of the main body portion includes a recessed feature; and the at least one corresponding interfacing feature of the housing of the glucose monitoring device includes a raised feature. In some specific cases, the raised feature is configured to be at least partially received within the recessed feature. In some other example instances, the at least one interfacing feature of the main body portion is located at an edge or comer of the main body portion. In some specific cases, the at least one interfacing feature of the main body portion includes a plurality of interfacing features, each of which is located at a different edge or corner of the main body portion. In some other example instances, the at least one interfacing feature of the main body portion includes a plurality of interfacing features; and the at least one corresponding interfacing feature of the housing of the glucose monitoring device includes a plurality of corresponding interfacing features. In some specific cases, at least one of: the plurality of interfacing features of the main body portion is arranged in a plus-shaped or X-shaped manner about the main body portion; and the plurality of corresponding interfacing features of the housing of the glucose monitoring device is arranged in a plus-shaped or X-shaped manner about the housing.

[0010] In some cases, the retainer member includes a flange portion. In some such instances, the flange portion is configured to intervene physically between the adhesive overpatch and the adhesive pad portion of the glucose monitoring device. In some other such instances, the flange portion extends radially from a base of a sidewall of the retainer member. In some other such instances, in adhering to the retainer member in assembly with the glucose monitoring device, the adhesive overpatch adheres to the flange portion. In some other such instances, the flange portion includes at least one opening formed therein. In some example instances, the at least one opening includes a plurality of openings distributed around the flange portion.

[0011] In some cases, the retainer member is at least partially constructed from a medicalgrade plastic. In some such instances, the medical -grade plastic includes at least one of: polyethylene; polypropylene; polycarbonate; and a polycarbonate and acrylonitrile butadiene styrene (ABS) blend. In some cases, the retainer member is at least partially constructed from a liquid injection molding (LIM)-compatible material. Atty. Docket No. : SANV 24.02 PCT

[0012] In some cases, in being configured to be disposed over the glucose monitoring device, the retainer member is configured to directly physically contact the housing of the glucose monitoring device. In some cases, in being configured to be disposed over the glucose monitoring device, at least one layer or structure which is distinct from the retainer member physically intervenes between the retainer member and the housing of the glucose monitoring device. In some such instances, the at least one layer or structure includes at least one of a cushion layer; a protective barrier layer; and an antimicrobial layer.

[0013] In some cases, the retainer member is substantially elliptical, circular, or oval in shape. In some cases, the retainer member is substantially polygonal in shape.

[0014] Another example embodiment provides a system including: the assembly as variously described above; and the glucose monitoring device. In some such instances, the glucose monitoring device is configured as a continuous glucose monitoring (CGM) device. In some other such instances, the glucose monitoring device includes at least one of an electrode or implantable sensor; a transmitting, receiving, and / or transceiving element; and a power supply.

[0015] The features and advantages described herein are not all-inclusive and, in particular, many additional features and advantages will be apparent to one of ordinary skill in the art in view of the drawings, specification, and claims. Moreover, it should be noted that the language used in the specification has been selected principally for readability and instructional purposes and not to limit the scope of the inventive subject matter.

[0016] BRIEF DESCRIPTION OF THE DRAWINGS

[0017] FIG. 1 illustrates a first isometric view of a system configured in accordance with an embodiment of the present disclosure.

[0018] FIG. 2 illustrates a second isometric view of a system configured in accordance with an embodiment of the present disclosure.

[0019] FIG. 3 illustrates a top-down plan view of a system configured in accordance with an embodiment of the present disclosure.

[0020] FIG. 4 illustrates a bottom-up plan view of a system configured in accordance with an embodiment of the present disclosure.

[0021] FIG. 5 illustrates a first side elevation view of a system configured in accordance with an embodiment of the present disclosure.

[0022] FIG. 6 illustrates a second side elevation view of a system configured in accordance with an embodiment of the present disclosure. Atty. Docket No. : SANV 24.02 PCT

[0023] FIG. 7 illustrates a first exploded isometric view of a system configured in accordance with an embodiment of the present disclosure.

[0024] FIG. 8 illustrates a second exploded isometric view of a system configured in accordance with an embodiment of the present disclosure.

[0025] FIG. 9 illustrates a first isometric view of a glucose monitoring device configured in accordance with an embodiment of the present disclosure.

[0026] FIG. 10 illustrates a second isometric view of a glucose monitoring device configured in accordance with an embodiment of the present disclosure.

[0027] FIG. 11 illustrates a top-down plan view of a glucose monitoring device configured in accordance with an embodiment of the present disclosure.

[0028] FIG. 12 illustrates a first side elevation view of a glucose monitoring device configured in accordance with an embodiment of the present disclosure.

[0029] FIG. 13 illustrates a second side elevation view of a glucose monitoring device configured in accordance with an embodiment of the present disclosure.

[0030] FIG. 14 illustrates a first isometric view of a retainer member configured in accordance with an embodiment of the present disclosure.

[0031] FIG. 15 illustrates a second isometric view of a retainer member configured in accordance with an embodiment of the present disclosure.

[0032] FIG. 16 illustrates a first side elevation view of a retainer member configured in accordance with an embodiment of the present disclosure.

[0033] FIG. 17 illustrates a second side elevation view of a retainer member configured in accordance with an embodiment of the present disclosure.

[0034] FIG. 18 illustrates an isometric view of an adhesive overpatch configured in accordance with an embodiment of the present disclosure.

[0035] FIG. 19 illustrates a bottom -up plan view of an adhesive overpatch configured in accordance with an embodiment of the present disclosure.

[0036] FIG. 20 is a flow diagram illustrating a method of applying a system to a user’s skin, in accordance with an embodiment of the present disclosure.

[0037] FIG. 21 is a flow diagram illustrating a method of partially removing a system from a user’s skin, in accordance with an embodiment of the present disclosure.

[0038] These and other features of the present embodiments will be understood better by reading the following detailed description, taken together with the figures herein described. The accompanying drawings are not intended to be drawn to scale. In the drawings, each identical or nearly identical component that is illustrated in various figures may be Atty. Docket No. : SANV 24.02 PCT represented by a like numeral. For purposes of clarity, not every component may be labeled in every drawing.

[0039] DETAILED DESCRIPTION

[0040] An assembly for securing a glucose monitoring device and related techniques are disclosed. The assembly may include a retainer member configured to fit loosely over the glucose monitoring device without attaching or connecting to it. To that end, the retainer member and a housing of the glucose monitoring device may include respective interfacing features configured to interface with one another. The assembly further may include an adhesive overpatch configured to adhere to the retainer member and the user’s skin without adhering to the glucose monitoring device. In accordance with some embodiments, removal of the adhesive overpatch from the user’s skin may effectuate simultaneous removal of the retainer member from the glucose monitoring device without compromising adhesion of the glucose monitoring device to the user’s skin or disrupting placement of its implanted sensor. Numerous configurations and variations will be apparent in light of this disclosure.

[0041] General Overview

[0042] Some existing approaches to securing a continuous glucose monitoring (CGM) device to the skin of a user involve use of a single adhesive overpatch that adheres directly to both the CGM device and the underlying region of the user’s skin. Consequently, removal of the adhesive overpatch (e.g., for replacement thereof) compromises adhesion of the CGM device to the user’s skin and, in most cases, the CGM device itself is pulled away with the overpatch, withdrawing its implantable sensor from the user’s skin. In such instances, a full redeployment of the CGM device would be required to restore continuous glucose monitoring capabilities for the user.

[0043] As CGM technology has improved and sensor life has increased (e.g., from 7 to 10 to 14 to ultimately 21 days and beyond), the biocompatible adhesives that hold the overpatch and the CGM devices in place have non-trivial limitations. First, the adhesives used cannot be made so strong that removal of the CGM or overpatch would cause damage to the user’s skin. Second, the epidermis (i.e., the outer layer of skin) constantly renews itself. New cells are made in the lower layers of the epidermis, and these cells move to the surface within four to six weeks, eventually shedding off anything on the surface. This natural process gradually weakens the adhesive bond during this period, and replacement of the overpatch eventually becomes required. Atty. Docket No. : SANV 24.02 PCT

[0044] Thus, and in accordance with some embodiments of the present disclosure, an assembly for securing a glucose monitoring device and related techniques are disclosed. The assembly may include a retainer member configured to fit loosely over the glucose monitoring device without attaching or connecting to it. To that end, the retainer member and a housing of the glucose monitoring device may include respective interfacing features configured to interface with one another. The assembly further may include an adhesive overpatch configured to adhere to the retainer member and the user’s skin without adhering to the glucose monitoring device. In accordance with some embodiments, removal of the adhesive overpatch from the user’s skin may effectuate simultaneous removal of the retainer member from the glucose monitoring device without compromising adhesion of the glucose monitoring device to the user’s skin or disrupting placement of its implanted sensor.

[0045] As will be appreciated in light of this disclosure, the disclosed assembly may be compatible for use with any of a wide range of glucose monitoring devices, including continuous glucose monitoring (CGM) devices. In accordance with some embodiments, the disclosed assembly may be considered, in a general sense, to be a two-piece overpatch system for CGM and similar devices.

[0046] Some embodiments of the disclosed assembly may realize one or more advantages or benefits, as compared to existing approaches. For example, in accordance with some embodiments, use of an assembly configured as variously described herein may provide for easy replacement of the adhesive overpatch on an as-needed basis without risking disturbance of the underlying glucose monitoring device. Also, a retainer member configured as variously described herein may be reusable through substantially all of the functional life of the glucose monitoring device it is intended to cover, in accordance with some embodiments. Furthermore, with use of an assembly configured as variously described herein, the adhesive overpatch (and in some cases the retainer member as well) may be replaced when the adhesive begins to show signs of peeling or excessive soiling, in accordance with some embodiments. In this manner, an old adhesive overpatch may be removed so that a new overpatch may be placed over the glucose monitoring device to continue to protect that device.

[0047] Structure and Operation

[0048] FIGS. 1-8 illustrate several views of a system 100 configured in accordance with an embodiment of the present disclosure. As can be seen, system 100 may include a glucose monitoring device 110 and a securing assembly including both a retainer member 130 and an Atty. Docket No. : SANV 24.02 PCT adhesive overpatch 150, which may be assembled in a stacked arrangement as generally shown. Each of these elements is discussed in turn below. As described herein, the assembly of retainer member 130 and overpatch 150 may be configured, in accordance with some embodiments, to cooperatively provide a multi-piece securing assembly that helps to protect underlying device 110 while it is worn on a user’s skin.

[0049] As previously noted, system 100 may include a glucose monitoring device 110. FIGS. 9-13 illustrate several views of an example glucose monitoring device 110 configured in accordance with an embodiment of the present disclosure. As can be seen, device 110 may include a housing 112 and an adhesive pad portion 114, each of which is discussed in turn below. As a preliminary note, device 110, as a glucose monitoring element, may have any of a wide range of suitable configurations and include any of a wide range of suitable components typically employed for the function of monitoring glucose levels of a user, continuously or otherwise. For instance, device 110 may include any one or more of the following: an electrode or implantable sensor; transmitting and / or receiving (e.g., transmitter, receiver, transceiver) elements; and a power supply (e.g., a battery). In this sense, device 110 illustrated in the figures is intended primarily to serve as a placeholder example of a glucose monitoring device suitable for use, for instance, in system 100. Additional and / or different suitable configurations for device 110 with respect to its designated function of monitoring glucose levels will be apparent in light of this disclosure. Other details of device 110 germane to assembly of system 100 are provided below.

[0050] Housing 112 of device 110 may house, in part or in whole, any of the various constituent components of device 110. The geometry and dimensions of housing 112 may be customized, as desired for a given target application or end-use. In accordance with some embodiments, the exterior of housing 112 may include (e.g., may be formed with) one or more interfacing features 116 configured to interface directly or indirectly (e.g., via one or more intervening structures or layers) with corresponding interfacing feature(s) 138 of retainer member 130 (discussed below). More specifically, a given interfacing feature 116 (of housing 112) may be configured to interface with a corresponding interfacing feature 138 (of retainer member 130) in a loose-fitting manner, such that retainer member 130 freely may be engaged with and disengaged from underlying device 110 without disturbing (e.g., compromising) the interfacing of that device 110 with the user’s skin or dislodging any electrode or implanted sensor thereof.

[0051] A given interfacing feature 116 may be configured, in accordance with some embodiments, as a raised feature (e.g., a protrusion, projection, or tab) which extends along Atty. Docket No. : SANV 24.02 PCT and / or outward from sidewall 118 of housing 112. The geometry of a given interfacing feature 116 may be customized, as desired for a given target application or end-use. As can be seen from FIGS. 9-13, in some embodiments, a given interfacing feature 116 generally may be of rectangular or square geometry. It should be noted, however, that the present disclosure is not intended to be so limited, as in accordance with some other embodiments, a given interfacing feature 116 generally may be of closed-curve geometry or may be T- shaped, I-shaped, or U-shaped, to name a few options. In any case, the dimensions of a given interfacing feature 116, including the distance that it extends along and / or out from sidewall 118, may be customized, as desired for a given target application or end-use.

[0052] Also, the quantity and arrangement of interfacing feature(s) 116 may be customized, as desired for a given target application or end-use. As can be seen from FIGS. 9-13, interfacing feature(s) 116 may be situated at one or more locations along sidewall 118 of housing 112, in some cases generally conforming to or sharing the local contour (if any) of sidewall 118. As can be seen further, in some embodiments, a given interfacing feature 116 may be situated at or otherwise proximate to one or more of the edges or corners of housing 112. In some cases, a single interfacing feature 116 may be provided at each edge / corner of housing 112. In some other cases, however, a given edge / corner may forego inclusion of an interfacing feature 116, such that the total quantity of interfacing features 116 is less than the total quantity of edges / corners present. In some embodiments, interfacing features 116 may be arranged in a generally cruciform (e.g., plus-shaped or X-shaped) manner about housing 112. In accordance with some embodiments, any two given interfacing features 116 may be offset from one another at an angle of about 90° or less (e.g., about 15° or less, about 30° or less, about 45° or less, about 60° or less, about 75° or less, or any other sub-range in the range of about 90° or less), as measured from a centroid (or other designated point) of housing 112. In accordance with some other embodiments, any two given interfacing features 116 may be offset at an angle of about 90-180° (e.g., about 90- 105°, about 105-120°, about 120-135°, about 135-150°, about 150-165°, about 165-180°, or any other sub-range in the range of about 90-180°), as measured from a centroid (or other designated point) of housing 112.

[0053] As noted above, device 110 also may include an adhesive pad portion 114, which may be configured to adhere device 110 to a user’s skin. To that end, adhesive pad portion 114 may include one or more adhesive materials disposed thereon. Also, as will be appreciated in light of this disclosure, the dimensions and geometry of adhesive pad portion 114 may be customized, as desired for a given target application or end-use. In some embodiments, Atty. Docket No. : SANV 24.02 PCT adhesive pad portion 114 may be substantially oval, elliptical, or circular in shape, though in other embodiments, other shapes (e.g., polygonal or otherwise) may be provided.

[0054] As previously noted, system 100 also may include a retainer member 130. FIGS. 14- 17 illustrate several views of a retainer member 130 configured in accordance with an embodiment of the present disclosure. As can be seen, retainer member 130 may include a main body portion 132 having an opening 134 (e.g., aperture) formed therein and a flange portion 136 extending from a periphery of main body portion 132. Each of these elements is discussed in turn below.

[0055] Generally, retainer member 130 may be configured to be disposed over device 110 such that, in assembly of system 100, (a) housing 112 resides, at least in part, within an interior space of main body portion 132 and (b) adhesive pad portion 114 resides, at least in part, adjacent (e.g., subjacent) to flange portion 136. In a more general sense, retainer member 130 may be configured to serve as a cage, cover, or holder, which, in assembly of system 100, fits over underlying device 110 without attaching or connecting to device 110. That is, retainer member 130 may be configured to at least partially enclose or encompass device 110 while retaining the ability to be mounted on and removed from device 110 freely. Additionally, retainer member 130 may be configured so as not to adhere to adhesive pad portion 114 of underlying device 110.

[0056] In accordance with some embodiments, retainer member 130 may be configured to interface directly with device 110, such that retainer member 130 and device 110 physically contact one another at one or more locations. In some other embodiments, however, retainer member 130 may be configured to interface indirectly with device 110 at one or more locations, such that one or more layers or structures physically intervene between retainer member 130 and device 110 in such location(s). For example, a cushion layer, a protective barrier layer, an antimicrobial layer, and / or other desired structure may be included between retainer member 130 and device 110, in accordance with some embodiments.

[0057] In accordance with some embodiments, main body portion 132 may be generally form-fitting of the exterior of housing 112 of device 110 without being tight-fitting thereto. To that end, the interior space in which device 110 is to reside may be dimensioned just slightly larger than device 110 such that, when retainer member 130 is disposed over device 110, device 110 does not become frictionally stuck within the interior space of retainer member 130. In this manner, retainer member 130 may be able to engage and disengage device 110 freely in assembly and disassembly of system 100. Atty. Docket No. : SANV 24.02 PCT

[0058] As can be seen from FIGS. 14-17, in some embodiments, main body portion 132 may be generally annular (e.g., ring-like) in shape, having an opening 134 (e.g., aperture) formed therein. In assembling system 100, main body portion 132 may surround, in part or in whole, sidewall(s) 118 of device 110 while also overhanging, in part or in whole, an upper surface 120 of device 110. Thus, at least a portion of upper surface 120 of device 110 may be accessible through overlying opening 134. In some cases, main body portion 132 may be substantially elliptical, circular, or oval in shape. In some other cases, however, main body portion 132 may be substantially polygonal (e.g., square, rectangular, etc.) in shape. In a more general sense, the overall shape of main body portion 132 and, more particularly, at least the shape of its interior space may be made compatible with the overall shape of housing 112 of device 110.

[0059] In accordance with some embodiments, main body portion 132 may include (e.g., may be formed with) one or more interfacing features 138 configured to interface directly or indirectly (e.g., via one or more intervening structures or layers) with corresponding interfacing feature(s) 116 of housing 112 (of device 110, discussed above). More specifically, a given interfacing feature 138 (of retainer member 130) may be configured to interface with a corresponding interfacing feature 116 (of housing 112) in a loose-fitting manner, such that retainer member 130 freely may be engaged with and disengaged from underlying device 110 without disturbing (e.g., compromising) the interfacing of that device 110 with the user’s skin or dislodging any electrode or implanted sensor thereof.

[0060] A given interfacing feature 138 may be configured, in accordance with some embodiments, as a recessed feature (e.g., a slot, channel, or groove) which extends along and / or outward from sidewall 140 of main body portion 132. The geometry of a given interfacing feature 138 may be customized, as desired for a given target application or enduse, and in at least some instances, may be intentionally comparable to that of an associated interfacing feature 116 of device 110. As can be seen from FIGS. 14-17, in some embodiments, a given interfacing feature 138 generally may be of rectangular or square geometry. It should be noted, however, that the present disclosure is not intended to be so limited, as in accordance with some other embodiments, a given interfacing feature 138 generally may be of closed-curve geometry or may be T-shaped, I-shaped, or U-shaped, to name a few options. In any case, the dimensions of a given interfacing feature 138 may be customized, as desired for a given target application or end-use. As will be appreciated in light of this disclosure, it may be desirable, at least in some instances, to ensure that a given Atty. Docket No. : SANV 24.02 PCT interfacing feature 138 is at least slightly larger in dimension(s) for compatible interfacing with a given corresponding interfacing feature 116 of device 110.

[0061] Also, the quantity and arrangement of interfacing feature(s) 138 may be customized, as desired for a given target application or end-use. As will be appreciated in light of this disclosure, the description provided above regarding the quantity and arrangement of interfacing feature(s) 116 of device 110 equally may apply here with respect to interfacing feature(s) 138 of retainer member 130, in accordance with some embodiments. In this manner, a given desired degree of compatibility between interfacing feature(s) 138 (of retainer member 130) and interfacing feature(s) 116 (of device 110) may be provided.

[0062] As previously noted, retainer member 130 also may be provided with (e.g., formed with) a flange portion 136 extending from a periphery of main body portion 132. In assembly of system 100, flange portion 136 may be configured (a) to cover at least a portion of underlying adhesive pad portion 114 of device 110 and (b) to be covered, at least in part, by adhesive overpatch 150 (discussed below). In this manner, flange portion 136 physically may intervene and, thus, prevent overpatch 150 from adhering to adhesive pad portion 114 in assembly of system 100, in accordance with some embodiments.

[0063] The geometry of flange portion 136 may be customized, as desired for a given target application or end-use, and in at least some instances, may be generally similar to that of main body portion 132. As can be seen from FIGS. 14-17, flange portion 136 generally may extend radially from the base of sidewall 140 of main body portion 132, the distance of such extension being at least sufficient to provide for the aforementioned protective coverage of adhesive pad portion 114 and coverage by overpatch 150. In any case, the dimensions of flange portion 136 may be customized, as desired for a given target application or end-use.

[0064] As can be seen further, in some cases, flange portion 136 may include (e.g., may be formed with) one or more openings 142 (e.g., apertures). A given opening 142 may be configured, in accordance with some embodiments, to reduce moisture retention by system 100 (e.g., in the case where system 100 becomes wet) and to contribute to the overall breathability of system 100 when disposed on a user’s skin. As will be appreciated in light of this disclosure, the dimensions and geometry of a given opening 142, as well as the quantity and arrangement of opening(s) 142, may be customized, as desired for a given target application or end-use. It should be noted, however, that flange portion 136 alternatively may be devoid of any such openings 142 (e.g., entirely or in one or more regions), in accordance with some other embodiments. Atty. Docket No. : SANV 24.02 PCT

[0065] Retainer member 130 may be constructed, in part or in whole, from any of a wide range of suitable materials, as will be apparent in light of this disclosure. In accordance with some embodiments, retainer member 130 may be formed, at least in part, by one or more polymers. For example, in some cases, retainer member 130 may be at least partially constructed from one or more medical-grade plastics, such as polyethylene, polypropylene, and / or polycarbonate, among others. In some embodiments, retainer member 130 may be at least partially constructed from a medical-grade polycarbonate and acrylonitrile butadiene styrene (ABS) blend. In some embodiments, retainer member 130 may be at least partially constructed from a liquid injection molding (LIM)-compatible material. Other suitable construction materials for retainer member 130 will depend on a given target application or end-use and will be apparent in light of this disclosure.

[0066] As previously noted, system 100 also may include an adhesive overpatch 150. FIGS. 18-19 illustrate several views of an adhesive overpatch 150 configured in accordance with an embodiment of the present disclosure. Overpatch 150 generally may be (or otherwise may include) an adhesive pad or bandage configured, in accordance with some embodiments, to (a) at least partially cover and adhere to underlying retainer member 130 and (b) adhere to a user’s skin in assembly of system 100 without (c) adhering to housing 112 or adhesive pad portion 114 of device 110. To such ends, overpatch 150 may have an adhesive side 154 (e.g., a bottom side or underside) with one or more adhesive materials disposed thereon. In assembly of system 100, adhesive side 154 may overlap flange portion 136, adhering thereto and to the user’s skin. In this manner, overpatch 150 may serve to secure retainer member 130 (a) in position over device 110 and (b) in contact with the user’s skin. Moreover, because flange portion 136 at least partially (e.g., completely or otherwise sufficiently) covers adhesive pad portion 114 of device 110, overpatch 150 is prevented from adhering to adhesive pad portion 114. Also, as will be appreciated in light of this disclosure, overpatch 150 may be constructed from one or more materials which, in accordance with some embodiments, contribute to it exhibiting one or more of the following characteristics: waterproof; breathable; flexible; stretchable; hypoallergenic; durable; and abrasionresistance.

[0067] The geometry of overpatch 150 may be customized, as desired for a given target application or end-use. As can be seen from FIGS. 18-19, in some embodiments, overpatch 150 may be generally annular (e.g., ring-shaped) in geometry, having formed therein an opening 152 (e.g., aperture) through which both housing 112 (of device 110) and main body portion 132 (of retainer member 130) may extend, at least partially, in assembly of Atty. Docket No. : SANV 24.02 PCT system 100. In some cases, overpatch 150 may be substantially elliptical, circular, or oval in shape. In some other cases, however, overpatch 150 may be substantially polygonal (e.g., square, rectangular, etc.) in shape. In a more general sense, the overall shape of overpatch 150 and its opening 152 may be made compatible with the respective shapes of retainer member 130 and device 110. In any case, the dimensions of overpatch 150 and its opening 152 may be customized, as desired for a given target application or end-use.

[0068] Generally, opening 152 may be configured to accommodate both retainer member 130 and device 110 such that, in assembly of system 100, retainer member 130 and device 110 at least partially extend through opening 152. The positioning of opening 152 in the body of overpatch 150 may be customized, as desired for a given target application or end-use. In some cases, opening 152 may be substantially centrally located in overpatch 150, whereas in other cases, opening 152 may be offset from the center (e.g., eccentric) of the body of overpatch 150.

[0069] Methodologies

[0070] FIG. 20 is a flow diagram illustrating a method 200 of applying a system 100 to a user’s skin in accordance with an embodiment of the present disclosure. As can be seen, method 200 may begin as in block 202 with disposing (e.g., deploying, mounting, installing, or otherwise situating) a glucose monitoring device 110 on the skin of a user. In being so disposed, an adhesive pad portion 114 of device 110 may adhere to the user’s skin.

[0071] Method 200 may continue as in block 204 with disposing (e.g., positioning, installing, or otherwise situating) retainer member 130 over device 110 on the user’s skin. In being so disposed, flange portion 136 of retainer member 130 may cover, in part or in whole, an adhesive pad portion 114 of device 110. Moreover, in being so disposed, retainer member 130 may cover a sidewall 118 and / or upper surface 120 of device 110. Furthermore, as discussed herein, retainer member 130 may fit loosely over device 110 on the user’s skin such that, in removing retainer member 130 from device 110, (a) the interfacing of that device 110 with the user’s skin is not disturbed (e.g., compromised) and / or (b) any electrode or implanted sensor of device 110 is not dislodged, in accordance with some embodiments.

[0072] Method 200 may continue as in block 206 with disposing (e.g., adhering, attaching, or otherwise situating) adhesive overpatch 150 over retainer member 130 on the user’s skin. In being so disposed, device 110 and retainer member 130 may extend through an opening 152 of overpatch 150 such that overpatch 150 covers, in part or in whole, flange portion 136 of retainer member 130, adhering thereto without opportunity to adhere to adhesive pad portion Atty. Docket No. : SANV 24.02 PCT

[0073] 114 or housing 112 of device 110. Moreover, in being so disposed, overpatch 150 may adhere to the user’s skin, securing retainer member 130 (a) in position over device 110 and (b) in contact with the user’s skin.

[0074] FIG. 21 is a flow diagram illustrating a method 300 of partially removing a system 100 from a user’s skin in accordance with an embodiment of the present disclosure. As can be seen, method 300 may begin as in block 302 with detaching overpatch 150 from the skin of a user.

[0075] Method 300 may continue as in block 304 with determining whether retainer member 130 is still disposed (e.g., positioned, installed, or otherwise situated) over a glucose monitor device 110 on the user’s skin. In some cases, retainer member 130 may remain adhered to overpatch 150 and, thus, in removing overpatch 150, retainer member 130 simultaneously may be removed, and method 300 may terminate accordingly. In some other cases, only overpatch 150 may be removed (e.g., if there is no or otherwise negligible adhesion between overpatch 150 and retainer member 130), with retainer member 130 remaining in position over device 110. In such instances, method 300 may continue as in block 306 with separately removing retainer member 130 from device 110. In either case, as discussed herein, removal of overpatch 150 and retainer member 130 may be performed without (a) disturbing (e.g., compromising) the interfacing of that device 110 with the user’s skin and / or (b) dislodging any electrode or implanted sensor of device 110, in accordance with some embodiments.

[0076] Further Examples

[0077] The following examples pertain to some further embodiments of the disclosure, from which numerous permutations and combinations will be apparent.

[0078] Example 1 is an assembly for securing a glucose monitoring device to a user’s skin. The assembly includes a retainer member configured to be disposed over the glucose monitoring device such that the glucose monitoring device at least partially resides within an interior space of the retainer member, wherein the retainer member fits loosely over a housing of the glucose monitoring device and at least partially covers an adhesive pad portion of the glucose monitoring device. The assembly also includes an adhesive overpatch configured to be disposed over the retainer member. In assembly with the glucose monitoring device, the adhesive overpatch adheres to the retainer member and the user’s skin but does not adhere to the housing and the adhesive pad portion of the glucose monitoring device. Removal of the adhesive overpatch from the user’s skin effectuates simultaneous Atty. Docket No. : SANV 24.02 PCT removal of the retainer member from the glucose monitoring device without compromising adhesion of the glucose monitoring device to the user’s skin or disrupting placement of an implanted sensor of the glucose monitoring device.

[0079] Example 2 includes the subject matter of any of Examples 1 and 3-28, wherein the retainer member comprises a main body portion configured to at least partially surround a sidewall of the housing of the glucose monitoring device.

[0080] Example 3 includes the subject matter of any of Examples 1-2 and 4-28, wherein the main body portion is further configured to at least partially overhang an upper surface of the housing of the glucose monitoring device.

[0081] Example 4 includes the subject matter of any of Examples 1-3 and 5-28, wherein the main body portion includes at least one interfacing feature configured to interface with at least one corresponding interfacing feature of the housing of the glucose monitoring device.

[0082] Example 5 includes the subject matter of any of Examples 1-4 and 6-28, wherein the at least one interfacing feature of the main body portion is configured to be received by the at least one corresponding interfacing feature of the housing of the glucose monitoring device without becoming frictionally stuck therein.

[0083] Example 6 includes the subject matter of any of Examples 1-5 and 7-28, wherein at least one of: the at least one interfacing feature of the main body portion comprises a recessed feature; and the at least one corresponding interfacing feature of the housing of the glucose monitoring device comprises a raised feature.

[0084] Example 7 includes the subject matter of any of Examples 1-6 and 8-28, wherein the raised feature is configured to be at least partially received within the recessed feature.

[0085] Example 8 includes the subject matter of any of Examples 1-7 and 9-28, wherein the at least one interfacing feature of the main body portion is located at an edge or corner of the main body portion.

[0086] Example 9 includes the subject matter of any of Examples 1-8 and 10-28, wherein the at least one interfacing feature of the main body portion comprises a plurality of interfacing features, each of which is located at a different edge or comer of the main body portion.

[0087] Example 10 includes the subject matter of any of Examples 1-9 and 11-28, wherein: the at least one interfacing feature of the main body portion comprises a plurality of interfacing features; and the at least one corresponding interfacing feature of the housing of the glucose monitoring device comprises a plurality of corresponding interfacing features. Atty. Docket No. : SANV 24.02 PCT

[0088] Example 11 includes the subject matter of any of Examples 1-10 and 12-28, wherein at least one of: the plurality of interfacing features of the main body portion is arranged in a plus-shaped or X-shaped manner about the main body portion; and the plurality of corresponding interfacing features of the housing of the glucose monitoring device is arranged in a plus-shaped or X-shaped manner about the housing.

[0089] Example 12 includes the subject matter of any of Examples 1-11 and 13-28, wherein the retainer member comprises a flange portion.

[0090] Example 13 includes the subject matter of any of Examples 1-12 and 14-28, wherein the flange portion is configured to intervene physically between the adhesive overpatch and the adhesive pad portion of the glucose monitoring device.

[0091] Example 14 includes the subject matter of any of Examples 1-13 and 15-28, wherein the flange portion extends radially from a base of a sidewall of the retainer member.

[0092] Example 15 includes the subject matter of any of Examples 1-14 and 16-28, wherein in adhering to the retainer member in assembly with the glucose monitoring device, the adhesive overpatch adheres to the flange portion.

[0093] Example 16 includes the subject matter of any of Examples 1-15 and 17-28, wherein the flange portion includes at least one opening formed therein.

[0094] Example 17 includes the subject matter of any of Examples 1-16 and 18-28, wherein the at least one opening comprises a plurality of openings distributed around the flange portion.

[0095] Example 18 includes the subject matter of any of Examples 1-17 and 19-28, wherein the retainer member is at least partially constructed from a medical-grade plastic.

[0096] Example 19 includes the subject matter of any of Examples 1-18 and 20-28, wherein the medical-grade plastic comprises at least one of: polyethylene; polypropylene; polycarbonate; and a polycarbonate and acrylonitrile butadiene styrene (ABS) blend.

[0097] Example 20 includes the subject matter of any of Examples 1-19 and 21-28, wherein the retainer member is at least partially constructed from a liquid injection molding (LIM)- compatible material.

[0098] Example 21 includes the subject matter of any of Examples 1-20 and 22-28, wherein in being configured to be disposed over the glucose monitoring device, the retainer member is configured to directly physically contact the housing of the glucose monitoring device.

[0099] Example 22 includes the subject matter of any of Examples 1-21 and 23-28, wherein in being configured to be disposed over the glucose monitoring device, at least one layer or Atty. Docket No. : SANV 24.02 PCT structure which is distinct from the retainer member physically intervenes between the retainer member and the housing of the glucose monitoring device.

[0100] Example 23 includes the subject matter of any of Examples 1-22 and 24-28, wherein the at least one layer or structure comprises at least one of: a cushion layer; a protective barrier layer; and an antimicrobial layer.

[0101] Example 24 includes the subject matter of any of Examples 1-23 and 25-28, wherein the retainer member is substantially elliptical, circular, or oval in shape.

[0102] Example 25 includes the subject matter of any of Examples 1-24 and 26-28, wherein the retainer member is substantially polygonal in shape.

[0103] Example 26 is a system. The system includes: the assembly including the subject matter of any of Examples 1-25 and 27-28; and the glucose monitoring device.

[0104] Example 27 includes the subject matter of any of Examples 1-26 and 28, wherein the glucose monitoring device is configured as a continuous glucose monitoring (CGM) device.

[0105] Example 28 includes the subject matter of any of Examples 1-27, wherein the glucose monitoring device comprises at least one of: an electrode or implantable sensor; a transmitting, receiving, and / or transceiving element; and a power supply.

[0106] The foregoing description of example embodiments has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the present disclosure to the precise forms disclosed. Many modifications and variations are possible in light of this disclosure. It is intended that the scope of the present disclosure not be limited by this detailed description. Future-filed applications claiming priority to this application may claim the disclosed subject matter in a different manner and generally may include any set of one or more limitations as variously disclosed or otherwise demonstrated herein.

Claims

Atty. Docket No. : SANV 24.02 PCTCLAIMSWhat is claimed is:

1. An assembly for securing a glucose monitoring device to a user’s skin, the assembly comprising: a retainer member configured to be disposed over the glucose monitoring device such that the glucose monitoring device at least partially resides within an interior space of the retainer member, wherein the retainer member fits loosely over a housing of the glucose monitoring device and at least partially covers an adhesive pad portion of the glucose monitoring device; and an adhesive overpatch configured to be disposed over the retainer member; wherein in assembly with the glucose monitoring device, the adhesive overpatch adheres to the retainer member and the user’s skin but does not adhere to the housing and the adhesive pad portion of the glucose monitoring device; and wherein removal of the adhesive overpatch from the user’s skin effectuates simultaneous removal of the retainer member from the glucose monitoring device without compromising adhesion of the glucose monitoring device to the user’s skin or disrupting placement of an implanted sensor of the glucose monitoring device.

2. The assembly of claim 1, wherein the retainer member comprises a main body portion configured to at least partially surround a sidewall of the housing of the glucose monitoring device.

3. The assembly of claim 2, wherein the main body portion is further configured to at least partially overhang an upper surface of the housing of the glucose monitoring device.

4. The assembly of claim 2, wherein the main body portion includes at least one interfacing feature configured to interface with at least one corresponding interfacing feature of the housing of the glucose monitoring device.Atty. Docket No. : SANV 24.02 PCT5. The assembly of claim 4, wherein the at least one interfacing feature of the main body portion is configured to be received by the at least one corresponding interfacing feature of the housing of the glucose monitoring device without becoming frictionally stuck therein.

6. The assembly of claim 4, wherein at least one of: the at least one interfacing feature of the main body portion comprises a recessed feature; and the at least one corresponding interfacing feature of the housing of the glucose monitoring device comprises a raised feature.

7. The assembly of claim 6, wherein the raised feature is configured to be at least partially received within the recessed feature.

8. The assembly of claim 4, wherein the at least one interfacing feature of the main body portion is located at an edge or corner of the main body portion.

9. The assembly of claim 8, wherein the at least one interfacing feature of the main body portion comprises a plurality of interfacing features, each of which is located at a different edge or corner of the main body portion.

10. The assembly of claim 4, wherein: the at least one interfacing feature of the main body portion comprises a plurality of interfacing features; and the at least one corresponding interfacing feature of the housing of the glucose monitoring device comprises a plurality of corresponding interfacing features.

11. The assembly of claim 10, wherein at least one of: the plurality of interfacing features of the main body portion is arranged in a plusshaped or X-shaped manner about the main body portion; and the plurality of corresponding interfacing features of the housing of the glucose monitoring device is arranged in a plus-shaped or X-shaped manner about the housing.Atty. Docket No. : SANV 24.02 PCT12. The assembly of claim 1, wherein the retainer member comprises a flange portion.

13. The assembly of claim 12, wherein the flange portion is configured to intervene physically between the adhesive overpatch and the adhesive pad portion of the glucose monitoring device.

14. The assembly of claim 12, wherein the flange portion extends radially from a base of a sidewall of the retainer member.

15. The assembly of claim 12, wherein in adhering to the retainer member in assembly with the glucose monitoring device, the adhesive overpatch adheres to the flange portion.

16. The assembly of claim 12, wherein the flange portion includes at least one opening formed therein.

17. The assembly of claim 16, wherein the at least one opening comprises a plurality of openings distributed around the flange portion.

18. The assembly of claim 1, wherein the retainer member is at least partially constructed from a medical -grade plastic.

19. The assembly of claim 18, wherein the medical -grade plastic comprises at least one of: polyethylene; polypropylene; polycarbonate; and a polycarbonate and acrylonitrile butadiene styrene (ABS) blend.

20. The assembly of claim 1, wherein the retainer member is at least partially constructed from a liquid injection molding (LIM)-compatible material.

21. The assembly of claim 1, wherein in being configured to be disposed over the glucose monitoring device, the retainer member is configured to directly physically contact the housing of the glucose monitoring device.Atty. Docket No. : SANV 24.02 PCT22. The assembly of claim 1, wherein in being configured to be disposed over the glucose monitoring device, at least one layer or structure which is distinct from the retainer member physically intervenes between the retainer member and the housing of the glucose monitoring device.

23. The assembly of claim 22, wherein the at least one layer or structure comprises at least one of: a cushion layer; a protective barrier layer; and an antimicrobial layer.

24. The assembly of claim 1, wherein the retainer member is substantially elliptical, circular, or oval in shape.

25. The assembly of claim 1, wherein the retainer member is substantially polygonal in shape.

26. A system comprising: the assembly of any of claims 1-25; and the glucose monitoring device.

27. The system of claim 26, wherein the glucose monitoring device is configured as a continuous glucose monitoring (CGM) device.

28. The system of claim 26, wherein the glucose monitoring device comprises at least one of: an electrode or implantable sensor; a transmitting, receiving, and / or transceiving element; and a power supply.

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