Release liner removal from within wearable medical device applicators

Abstract

An applicator assembly includes a housing, a cap releasably secured to the housing, and a wearable sensor device disposed within the housing. The sensor device includes a sensor tail with a sensing element for detecting characteristics of bodily fluid beneath the patient's skin. A pressure-sensitive adhesive layer on the sensor device allows the sensor device to be affixed to the patient's skin by selectively activating an actuation device within the housing. Activating the actuation device moves the sensor device from an initial stowed position within the housing to an actuated position wherein the adhesive layer protrudes from the housing. The applicator assembly includes a release liner covering at least part of the adhesive layer that is removable prior to securing the sensor device to the patient's skin.

Description

RELEASE LINER REMOVAL FROM WITHIN WEARABLE MEDICAL DEVICE APPLICATORSCROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 624,052 filed January 23, 2024, the entire content of which is incorporated by reference herein.BACKGROUND OF THE DISCLOSURE

[0002] One evolution in healthcare technology is the rise of wearable medical equipment to monitor patient progress, and in some cases, provide treatment. This wearable medical equipment may include sensor devices that provide real-time data, increase patient engagement and help guide care plans for chronic disease management. One example of a wearable sensor device is a continuous glucose monitor with a sterile sensor tail inserted through the skin of a patient to contact a bodily fluid. The sensor device maybe maintained on the patient's skin for periods of days or weeks, allowing the patient to avoid more traditional monitoring methods such as periodic finger pricks to draw blood and test glucose levels in the blood.

[0003] Some of the most common sensor devices may be affixed to the patient's skin with an applicator that inserts the sensor tail through the patient's skin and causes a durable pressure sensitive adhesive (PSA) layer on the sensor device to contact the skin. Since the applicators are often stored up to two (2) years after manufacturing, the efficacy of the PSA may be compromised before a patient has an opportunity to affix the sensor device to their skin. Although many sensor devices may be able to operate for longer, the PSA may begin to fail after only ten (10) to fourteen (14) days. Additionally, if the applicator or the PSA is mishandled by the patent, the sensor device may become prematurely detached, may be rendered unsterile and / or may otherwise not function properly. To ensure long-lasting and effective attachment of wearable sensor devices, applicators should allow for even non-trained users to properly apply the wearable medical device on each and every attempt.SUMMARY OF THE DISCLOSURE

[0004] Various details of the present disclosure are hereinafter summarized to provide a basic understanding. This summary is not an extensive overview of the disclosure and is neither intended to identify certain elements of the disclosure, nor to delineate the scope thereof. Rather, the primary purpose of this summary is to present some concepts of the disclosure in a simplified form prior to the more detailed description that is presented hereinafter.

[0005] According to an embodiment consistent with the present disclosure, an applicator assembly includes a housing, a cap releasably secured to the housing and a wearable sensor device disposed within the housing. The wearable sensor device includes a sensor body, a sensor tail extending from the sensor body and including a sensing element operable to detect a characteristic of a bodily fluid of a patient and a pressure-sensitive adhesive layer on the sensor body and operable to affix the sensor body to the patient. The applicator assembly further includes an actuation mechanism disposed within the housing and selectively operable to move the wearable sensor device from an pre-activation position wherein the sensor device is stowed within the housing to a postactivation position in which the pressure-sensitive adhesive layer protrudes from the housing such that the adhesive layer may be secured to the patient's skin while the sensor tail extends through the patient's skin to contact the bodily fluid. At least one release liner at least partially covers the adhesive layer while the cap is secured to the housing and is removable from the adhesive layer prior to securing the adhesive layer to the patient's skin.

[0006] According to another example embodiment consistent with the present disclosure, an applicator assembly comprises a housing including a receptacle defining an interior chamber therein and a sheath selectively movable from a pre-activation position where the sheath protrudes from the receptacle and a post-activation position where the sheath is received within the interior chamber of the receptacle. A wearable sensor device is disposed within the housing and is circumscribed by the sheath in the pre-activation position. The wearable sensor device includes a sensor body, a sensor tail extending from the sensor body and including a sensing element operable to detect a characteristic of a bodily fluid of a patient and a pressure-sensitive adhesive layer on the sensor body operable to affix the sensor body to the patient. The adhesive layer protrudes from the housing when the sheath is in the post-activation position. An actuation mechanism is disposed within the housing and is selectively operable to move the sheath from the pre-activation position to the post-activation position such that the adhesive layer may be secured to the patient's skin while the sensor tail extends through the patient's skin to contact the bodily fluid. The applicator assembly further includes at least one release liner at least partially covering the adhesive layer while the sheath is in the pre-activation position and removable from the adhesive layer in response to actuation of the actuation mechanism.

[0007] According to still another example embodiment consistent with the present disclosure, a method of applying a wearable sensor device to a patent's skin includes (a) opening a cap with respect to a housing of an applicator to expose a wearable sensor device disposed within the housing, (b) removing at least one release liner from an adhesive layer on the sensor device, (c) activating an actuation mechanism within the housing subsequent to removing the at least onerelease liner to thereby move the wearable sensor device from an initial stowed position in the housing to an actuated position in which the pressure-sensitive adhesive layer protrudes from the housing and (d) securing the sensor device to the patient's skin in response to activating the actuation mechanism such that the adhesive layer is secured to the patient's skin while a sensor tail of the sensor device extends through the patient's skin to contact a bodily fluid.

[0008] According to still another example embodiment consistent with the present disclosure, a packaging assembly includes an outer packaging structure and an applicator disposed within the outer packaging structure. The applicator includes a housing, a cap releasably secured to the housing and a wearable sensor device disposed within the housing and including a pressuresensitive adhesive layer on the sensor body operable to affix the sensor device to a patient. The applicator further includes at least one release liner at least partially covering the adhesive layer and including a grasping tab attached to the outer packaging structure.

[0009] Any combinations of the various embodiments and implementations disclosed herein can be used in a further embodiment, consistent with the disclosure. These and other aspects and features can be appreciated from the following description of certain embodiments presented herein in accordance with the disclosure and the accompanying drawings and claims.BRIEF DESCRIPTION OF THE DRAWINGS

[0010] FIG. 1A is a front view of an applicator for a wearable sensor device including a housing, a cap and a release liner protruding through the cap in accordance with one or more aspects of the present disclosure.

[0011] FIG. IB a partial, cross-sectional side view of the applicator of FIG. 1A illustrating the release liner covering a pressure sensitive adhesive (PSA) layer on the sensor device disposed within the housing.

[0012] FIG. 1C is an enlarged view of the applicator illustrating the release liner in a folded configuration around a sensor tail and / or a cannula according to aspects of the present disclosure.

[0013] FIG. ID is a perspective view of the release liner illustrating a central opening through which the sensor tail and / or cannula may protrude and a relief slit extending from the central opening to facilitate removal of the release liner from the sensor device in accordance with one or more aspects of the present disclosure.

[0014] FIG. 2A and FIG. 2B cross-sectional and enlarged partial, cross-sectional views, respectively, of an alternate embodiment of an applicator in which a pair of release liners cover the adhesive layer on the sensor device in accordance with aspects of the present disclosure.

[0015] FIG. 3A, FIG. 3B and FIG. 3C are partial, cross-sectional views of another embodiment of a wearable medical device applicator illustrating a sequence in which a rigid postcovering the adhesive layer on the sensor device is separated from the sensor device by opening a cap of the applicator in accordance with aspects of the present disclosure.

[0016] FIG. 3D is a partial perspective view of the applicator of FIGS. 3A-3C illustrating a bayonet-style connector defined between the cap and housing of the applicator to facilitate the separation of the rigid post from the PSA.

[0017] FIG. 4A, FIG. 4B and FIG. 4C are schematic views of another embodiment of a wearable medical device applicator illustrating a sequence in which a release liner coupled to a hinged cap of the applicator is separated from the sensor device by opening the cap in accordance with aspects of the present disclosure.

[0018] FIG. 5A, FIG. 5B and FIG. 5C are schematic views of another embodiment of a wearable medical device applicator illustrating a sequence in which a release liner coupled to a removable cap of the applicator is separated from a sensor device by removing the cap in accordance with aspects of the present disclosure.

[0019] FIG. 5D is a top view of the release liner of FIGS. 5A-5C.

[0020] FIG. 6A, FIG. 6B and FIG. 6C are schematic views of another embodiment of a wearable medical device applicator illustrating a sequence in which a folded release liner coupled to a removable cap of the applicator is unfolded and separated from the sensor device by removing the cap in accordance with aspects of the present disclosure.

[0021] FIG. 6D is a top view of the release liner of FIGS. 6A-6C.

[0022] FIG. 7A, FIG. 7B and FIG. 7C are schematic views of another embodiment of a wearable medical device applicator illustrating a sequence in which a spiral-cut release liner coupled to a removable cap of the applicator is unwound and separated from a sensor device by removing the cap in accordance with aspects of the present disclosure.

[0023] FIG. 7D is a top view of the release liner of FIGS. 7A-7C in an initial configuration wherein the release liner covers a PSA on the sensor device.

[0024] FIG. 7E is a perspective view of the release liner of FIGS. 7A-7C in an operational configuration wherein the is partially unwound.

[0025] FIG. 8A and FIG. 8B are partial perspective and enlarged side views, respectively, of another embodiment of a wearable medical device applicator illustrating a pair of release liners affixed to a housing of the applicator such that activation of the applicator removes the release liner from a sensor device in accordance with aspects of the present disclosure.

[0026] FIG. 8C, FIG. 8D and FIG. 8E are schematic views of the applicator of FIGS. 8A and 8B illustrating a sequence in which the release liners are removed and stowed along an inner wall of the housing as the applicator is activated.

[0027] FIG. 9A is a perspective view of another embodiment of a wearable medical device applicator illustrating a pair of release liners arranged such that movement of a sheath into a hollow receptacle of the housing draws the release liners from a sensor device into the hollow receptacle in accordance with aspects of the present disclosure.

[0028] FIG. 9B and FIG. 9C are cross-sectional perspective views of the applicator of FIG. 9A in pre-activation and post-activation configurations according to aspects of present disclosure.

[0029] FIG. 9D is a perspective view of one of one of the release liners of FIG. 9A in accordance with aspects of the present disclosure.

[0030] FIG. 10 is a perspective view of a packaging assembly for a wearable medical device applicator wherein a release liner of the applicator is coupled to an outer packaging structure such that removing the applicator from the outer packaging structure removes the release liner from a sensor device within the applicator in accordance with one or more aspects of the present disclosure.

[0031] FIG. 11 A, FIG. 11B and FIG. 11C are top views of release liners arranged to be removed from a sensor device by peeling the release liner in a circumferential direction around a cannula of the sensor device in accordance with one or more aspects of the disclosure.

[0032] FIG. 12A is a bottom view of a release liner including a ridge defined around a circumferential edge thereof in accordance with at least one aspect of the present disclosure.

[0033] FIG. 12B is an enlarged cross-sectional view of the ridge of FIG. 12A.

[0034] FIG. 13 is a bottom view of another embodiment of a release liner including a plurality of ridges defined within an interior region thereof in accordance with one or more aspects of the present disclosure.DETAILED DESCRIPTION

[0035] Embodiments of the present disclosure will now be described in detail with reference to the accompanying Figures. Like elements in the various figures may be denoted by like reference numerals for consistency. Further, in the following detailed description of embodiments of the present disclosure, numerous specific details are set forth in order to provide a more thorough understanding of the claimed subject matter. However, it will be apparent to one of ordinary skill in the art that the embodiments disclosed herein may be practiced without these specific details. In other instances, well-known features have not been described in detail to avoid unnecessarily complicating the description. Additionally, it will be apparent to one of ordinary skill in the art that the scale of the elements presented in the accompanying Figures may vary without departing from the scope of the present disclosure.

[0036] Embodiments in accordance with the present disclosure include applicators for affixing a wearable sensor device or other wearable medical equipment to a patient's skin. The sensor device may include a pressure sensitive adhesive (PSA) layer for engaging the patient's skin, and the adhesive layer may be covered by a release liner prior to activation of the applicator. The release liner may improve the efficacy of the PSA such that the sensor device may remain affixed to the patient's skin for 28 days or longer. Release liners are not typically included within applicators for wearable sensor devices at least since it may be difficult for users to safely and reliably remove the release liners without compromising the sterility and functionality of the sensor device. The release liner(s) of the present disclosure may be removed from the sensor device without compromising the sterility of the sensor device and with no significant risk of a patient failing to remove the release liner. The release liner may protrude prominently from a cap of the actuator such that the release liner may be removed by the user prior to removing the cap. In some embodiments, the release liner may be coupled to the cap, a housing of the applicator or an outer packaging structure such that the release liner may be automatically removed by unpacking, opening or activating the applicator.

[0037] FIG. 1A illustrates a medical device applicator 100 in accordance with one or more aspects of the present disclosure. The applicator 100 generally includes a housing 102 and a cap 104 releasably coupled to the housing 102. As illustrated, the cap 104 is secured to the housing 102 in a configuration in which the applicator 100 may be shipped to and received by a patient or other user. In this configuration, the cap 104 protects a sensor device 106 (FIG. IB) disposed within the housing 102 until the user is ready to apply the sensor device 106. The housing 102 and cap 104 may be constructed of plastic, metal or similar material, and may be releasably coupled to one another with a connector 108. In the illustrated embodiment, the connector 108 is a bayonet-style connector 108 which may release the cap 104 from the housing 102 in response to a small relative rotation (e.g., 5-10 degrees) of the cap 104 with respect to the housing 102. In other embodiments, the connector 108 may include threads, magnets, snap-fit or other types of fasteners without departing from the scope of the disclosure.

[0038] A release liner 110 protrudes from cap 104 such that the release liner 110 is accessible to the user when the cap 104 is coupled to the housing 102. As described in greater detail below, the release liner 110 covers a pressure-sensitive adhesive (PSA) layer 112 on the sensor device 106 (FIG. IB) and may be removed from the sensor device 106 prior to removing the cap 104 from the housing 102. The release liner 110 may be constructed of flexible materials such as poly coated paper, film, or metalized film. The release liner 110 liner itself can be coated with silicone or non-silicone to ease separation from the adhesive layer 112 (FIG. 1C).

[0039] Referring to FIG. IB, the sensor device 106 is illustrated within the housing 102 of the applicator 100. The sensor device 106 generally includes a sensor base 114 and a flag or sensor tail 116 extending from the sensor base 114. As described in greater detail below, the sensor tail 116 may be partially obscured by a sharp shaft or cannula of the applicator 100. The sensor base 114 may include functional components of the sensor device 106 such as a transmitter, power source or other electronics. An adhesive layer 112 on the sensor base 114 may be employed to affix the sensor device 106 to a patient's skin after the cap 104 has been removed from the housing 102. The sensor tail 116 is circumscribed by the adhesive layer 112 and arranged to penetrate the patient's skin. The sensor tail 116 may include a sensing element (not shown) for engaging a bodily fluid after insertion through the skin of the patient. The cap 104 may include a needle guard 122 circumscribing the sensor tail 116 to protect the sensor tail 116 prior removal of the cap 104 from the housing 102.

[0040] The applicator 100 may include a spring 122 or other mechanism operably coupled to the sensor device 106 to move the sensor device 106 out of the housing 102 and onto the patient's skin. The spring 116 may be actuated to advance the sensor device 106 beyond a sheath 124 of the housing 102 such that the sensor tail 116 may penetrate the patient's skin. Once the sensor tail 116 has penetrated the skin, the adhesive layer 112 may abut the skin and affix the sensor device 106 to the patient. In some embodiments, the applicator 100 may include a sharp shaft or cannula to puncture the skin and permit entry of the sensor tail 116 through the skin. The cannula may be withdrawn from the patient's skin and does not remain in place on the patient with the sensor device 106. As used herein, the sensor tail 116 may be used to describe the portion of the sensor device 106 that remains in place on the patient and / or the cannula extending from the sensor base 114.

[0041] The release liner 110 covers the adhesive layer 112 and extends through an aperture 126 in the cap 104 such that a grasping tab 118 of the release liner 110 may be grasped by a user prior to removing the cap 104. The entire release liner 110 may be pulled through the aperture 126 such that removal of the release liner 110 does not compromise the sterility of the sensor device 106 within the applicator 100. In some embodiments, the cap 104 may include more than one aperture 126 defined therein. In the illustrated embodiment, the apertures 126 are radially aligned with the bayonet-style connectors 108 to ensure the grasping tab 118 extends freely through the aperture 126 when the cap 104 is coupled to the housing 102.

[0042] FIG. 1C illustrates the release liner 110 in a folded configuration over the adhesive layer 112. The release liner 110 includes a contact layer 128 engaged with the adhesive layer 112, and an overfold layer 130 extending over the contact layer 128. As illustrated, the release liner 110 includes a 180-degree fold 132 at a remote end 134 of the contact layer 128. The remote end 134 is opposed to and remote from an engagement end 136 of the release liner 110 where release liner110 may be pulled from the adhesive layer 112. The overfold layer 130 ensures that when the release liner 110 is pulled in the direction of arrow Al, the contact layer 128 begins to separate from the adhesive layer 112 at the remote end 134 of the contact layer 128.

[0043] Removing the release liner 110 from the remote end 134 to the engagement end 136 ensures that a skirt 138 of the adhesive layer 112 does not detach from the sensor base 114 or sustain other damage when the release liner 110 is removed. The skirt 138 is defined at a peripheral region of the adhesive layer 112 and extends over a circumferential edge 140 of the sensor base 114. The skirt 138 and may not be supported by the sensor base 114, a backing layer of other mechanism. The skirt 138 is flexible and facilitates securing the sensor device 106 to the patient's skin. However, if the skirt 138 is lifted as the release liner 110 is removed, the skirt 138 may become wrinkled, torn or may otherwise become less effective at securing the sensor device 106 to the patient's skin.

[0044] FIG. ID is a perspective view of the release liner 110. The contact layer 128 and the overfold layer 130 include aligned openings 142 extending therethrough. The aligned openings 142 may extend around the needle guard 120 (FIG. IB) of the cap 104 prior to removal of the cap 104 from the housing 102 (FIG. IB). A lateral relief slit 144 extends through the contact layer 128 and overfold layer 130 from the aligned openings 142 to the 180-degree fold 132. The lateral relief slit 144 allows the release liner 110 to open around the needle guard 120 as the release liner 110 is removed from the sensor device 106 (FIG. IB).

[0045] Referring to FIG. 2A, an alternate embodiment of a wearable medical device applicator 200 is illustrated in which a pair of release liners 202a, 202b cover the adhesive layer 112 on the sensor device 106. The release liners 202a, 202b each protrude through an opposed aperture 126 defined in the cap 104. A grasping tab 204a, 204b of each of the release liners 202a, 202b is prominently visible prior to removal of the cap 104 from the housing 102. The grasping tabs 204a, 204b may be pulled by a user to remove the release liners 204a, 204b from the sensor device 106 prior to removal of the cap 104 from the housing 102. By using a pair of release liners 202a, 202b, a force required to remove the release liners 202a, 202b may be reduced compared to embodiments where only a single release liner is employed (see, e.g., FIG. IB).

[0046] As illustrated in FIG. 2B, the release liner 202a includes a contact layer 206 and an overfold layer 208 separated by a 180-degree fold 210. Similarly, the release liner 202b includes a contact layer 212 and an overfold layer 214 separated by a 180-degree fold 216. The folds 210, 216 are located centrally on the adhesive layer 112, and the contact layers 206, 212 and overfold layers 208, 214 extend laterally from the folds 210, 216. The fold 210, 216 are laterally remote from the grasping tabs 204a, 204b (FIG. 2A) such that when a user pulls the release liners 202a, 202b in the direction of arrows A2, A3 from the grasping tabs 204a, 204b, the release liners 202a, 202b separate from the adhesive layer 114 beginning at the folds 210, 216. The contact layers 206, 212 thenseparate from a central region of the adhesive layer 112 toward the skirt 138. In this manner, the release liners 202a, 202b may be removed from the sensor device 106 without damaging or lifting the skirt 138.

[0047] Referring to FIG. 3A, another embodiment of a wearable medical device applicator 300 is illustrated in an initial configuration in which the applicator 300 may be shipped to and received by a patient or other user. In the initial configuration, a cap 304 is coupled to the housing 102 by the bayonet-style connector 108, and a post 302 on the cap 304 is in direct contact with the adhesive layer 112 of the sensor device 106. The post 302 may extend downward within an interior of the cap 304 and may include a contact surface 306 at a lower end thereof in direct contact with the adhesive layer 112 such that the post 302 serves as a release liner preserving the effectiveness of the adhesive layer 112. In some embodiments, the contact surface 306 may be coated with silicone or another material to facilitate release of the cap 304 from the adhesive layer 112.

[0048] The cap 304 may also include a needle guard 308 that is slidable or otherwise movable within a cavity 310 defined within the post 302. The post 302 and the needle guard 308 may be constructed of plastic, metal or another relatively rigid material. The post 302 and the needle guard 308 are operably coupled to one another such that the needle guard 308 does not initially move with respect to the sensor device 106 when the cap 304 is removed from the housing 102. The post 302 and the needle guard 308 may be operably coupled to one another with a dynamic coupling 312. In the illustrated embodiment, the dynamic coupling 312 includes a pin 314 fixed to the post 302 and protruding into a channel 316 defined in the needle guard 308. The channel 316 is sized such that, in the initial configuration, a clearance may be defined between the pin 314 and the needle guard 308.

[0049] FIG. 3B illustrates the applicator 300 after an initial rotation of the cap 304 with respect to the housing 102. The connector 108 allows a small relative rotation (e.g., 5-10 degrees) between the cap 304 and the housing 102 as described in greater detail with detail below with reference to FIG. 3D. After the initial rotation, the contact surface 306 of the post 302 separates from the adhesive layer 112, and the needle guard 308 remains in place on the sensor device 106. The needle guard 308 prevents lift and rotation of the sensor device 106 when the cap 304 is opened. The clearance between the pin 314 and the needle guard 308 permits the initial rotation of the cap 304 without inducing movement of the needle guard 308.

[0050] FIG. 3C illustrates the applicator 300 after the initial rotation and lifting the cap 304 from the housing 102. The pin 314 engages the needle guard 308 at an upper end of the channel 316 and separates the needle guard 308 from the sensor device 106 as the cap is further lifted from the housing 102. The cap 304 may then be freely removed from the housing 102. In other embodiments, the dynamic coupling 312 may include a j -slot or similar mechanism recognized in the art.

[0051] FIG. 3D illustrates an exterior of the applicator 300 in the initial configuration. The bayonet-style connector 108 may facilitate the separation of the cap 304 from the housing 102 as illustrated in FIG. 3 A through FIG. 3C. The connector 108 includes a boss 318 on the cap protruding into a slot 320 defined in the housing 102. The slot 320 includes an angled portion 322 and a vertical lift portion 324. When the cap 304 is initially rotated with respect to the housing 102, the boss 318 moves through the angled portion 322 and the post 302 separates vertically from the adhesive layer 112 (see FIG. 3B). The angled portion 322 may extend rotationally a relatively small circumferential distance (e.g., 5-10 degrees) and a relatively small vertical distance (e.g., 3mm) to allow the post 302 to separate from the adhesive layer 112. Subsequently, the cap 304 may be lifted such that the boss 318 moves through the lift portion 324 to separate the needle guard 308 from the sensor device 106.

[0052] Referring to FIG. 4A, another example embodiment of a wearable medical device applicator 400 is illustrated in an initial configuration. The applicator 400 generally includes a housing 402 and a cap 404 coupled to one another by a hinge 406. The sensor device 106 is disposed within the housing 402 and the adhesive layer 112 is covered by a release liner 408. In the initial configuration, the release liner 408 maintains the effectiveness of the adhesive layer 112 until the user is ready to attach the sensor device 106 to the patient's skin. In the initial configuration, an activation tab 410 of the release liner 408 is fixedly coupled to an interior of the cap 404. The activation tab 410 may be firmly attached to the cap 404 by various mechanisms such as ultrasonic welding, adhesives, etc.

[0053] FIG. 4B illustrates the applicator 400 in a second configuration wherein the cap 404 is rotated about the hinge 406 to provide access to the sensor device 106. Since the release liner 408 is coupled to the cap 404 at the activation tab 410, the pivotal motion of the cap 404 with respect to the housing 402 induces the release liner 408 to separate from the adhesive layer 112.

[0054] FIG. 4C illustrates the applicator 400 in a third configuration where the cap 404 is fully open and the release liner 408 is fully removed from the adhesive layer 112. In the third configuration, the sensor device 106 is ready for application to the patient's skin. The release liner 408 may be removed in a one-step motion without handling the sensor device 106 or compromising the sterility of the sensor device 106. In the illustrated embodiment, release liner 408 does not include a 180-degree fold or an overfold layer (see, e.g., FIG. 1A and FIG. 2A). In other embodiments, a release liner 408 may be configured to include these features without departing from the scope of the disclosure.

[0055] Referring to FIG. 5A, another example embodiment of a wearable medical device applicator 500 is illustrated in an initial configuration. The applicator 500 generally includes a housing 502 and a cap 504 releasably coupled to one another. In some embodiments, the housing502 and the cap 504 may be coupled with a connector 108 (see, e.g., FIG. 1A and FIG. 2A) such that the cap 504 may be removed from the housing 502 with an initial rotation and simultaneous lift as indicated by the arrows illustrated above the cap 504. In the initial configuration, the sensor device 106 is disposed within the housing 502 and the adhesive layer 112 is covered by a release liner 506. The release liner 506 maintains the effectiveness of the adhesive layer 112 until the user is ready to attach the sensor device 106 to the patient's skin.

[0056] In the initial configuration, an activation tab 508 of the release liner 506 is fixedly coupled to an interior of the cap 504. The cap 504 includes a post 510 defining a cavity 512 therein. The cavity 512 may serve as a needle guard protecting the sensor tail 116 and / or cannula. The activation tab 508 may be firmly coupled to a flange 514 protruding radially from the post 510 by various mechanisms such as ultrasonic welding, adhesives, etc.

[0057] FIG. 5B illustrates the applicator 500 in a second configuration in which the initial rotation is complete and the cap 504 may be freely lifted from the housing 502. Since the release liner 506 is coupled to the cap 504 at the activation tab 508, the lifting motion of the cap 504 with respect to the housing 502 induces the release liner 506 to separate from the adhesive layer 112.

[0058] FIG. 5C illustrates the applicator 500 in a third configuration where the cap 504 is fully lifted and the release liner 506 is fully removed from the adhesive layer 112. In the third configuration, the sensor device 106 is ready for application to the patient's skin. The release liner 506 may be removed without handling the sensor device 106 or compromising the sterility of the sensor device 106.

[0059] FIG. 5D is a top view of the release liner 506. A central opening 516 extends through the release liner 506 such that the release liner 506 may not interfere with the sensor tail 116 (FIG. 5A). First and second lateral relief slits 518, 520 extend through the release liner 506. The first lateral relief slit 518 extends from the central opening 516 toward the activation tab 508 to permit the release liner 506 to open as the release liner 506 is partially lifted around the sensor tail 116 and / or cannula (see FIG. 5B). The second lateral relief slit 520 extends from the central opening 516 to an edge of the release liner, to facilitate a complete removal of the release liner 506 from the sensor device 106 (FIG. 5C).

[0060] Referring to FIG. 6A, another example embodiment of a wearable medical device applicator 600 is illustrated in an initial configuration. The applicator 600 generally includes the housing 502 and cap 504 as described above with reference to FIG. 5A. The applicator 600, however, includes a release liner 602 having a contact layer 604 in direct contact with the adhesive layer 112 of the sensor device 106 and an overfold layer 606 extending over the contact layer 604. The overfold layer 606 is connected to the contact layer 604 by a 180-degree fold 608 and includes an activation tab 610 fixedly coupled to the flange 514 of the cap 504.

[0061] FIG. 6B illustrates the applicator 600 in a second configuration in which the initial rotation is complete and the cap 504 may be freely lifted from the housing 502. Since the release liner 602 is coupled to the cap 504 at the activation tab 610, the lifting motion of the cap 504 with respect to the housing 502 induces the fold 608 to unfold and the contact layer contact layer 604 of the release liner 602 to begin to separate from the adhesive layer 112.

[0062] FIG. 6C illustrates the applicator 600 in a third configuration where the cap 504 is fully lifted and the contact layer 604 of the release liner 602 is fully removed from the adhesive layer 112. In the third configuration, the sensor device 106 is ready for application to the patient's skin. The release liner 602 may be removed from the adhesive layer 112 in a lateral direction from the fold 608 (remote from the activation tab 610) toward the activation tab 610. As described above, removing a release liner 602 in this manner may prevent the skirt 138 (FIG 1C) from lifting along with the release liner 602.

[0063] FIG. 6D is a top view of the release liner 602. A central opening 612 extends through both the contact layer 604 and the overfold layer 606 (FIG. 6A) of the release liner 602 such that the release liner 602 may not interfere with the sensor tail 116 (FIG. 6A). First and second lateral relief slits 614, 616 also extend through both layers 604, 606 the release liner 602. The first lateral relief slit 614 extends from the central opening 612 to the fold 608 to permit the release liner 602 to open as the release liner 602 is partially lifted around the sensor tail 116 and / or cannula (see FIG. 6B). The second lateral relief slit 616 extends from the central opening 612 toward the activation tab 610 to facilitate a complete removal of the release liner 602 from the sensor device 106 (FIG. 6C).

[0064] Referring to FIG. 7A, another example embodiment of a wearable medical device applicator 700 is illustrated in an initial configuration. The applicator 700 generally includes the housing 502 and cap 504 as described above with reference to FIG. 5A. The applicator 700, however, includes a spiral-cut release liner 702 in direct contact with the adhesive layer 112 of the sensor device 106. The release liner 702 includes an activation tab 704 fixedly coupled to the flange 514 of the cap 504 at a radially outer end of the release liner 702.

[0065] FIG. 7B illustrates the applicator 700 in a second configuration in which the cap 504 begins to be lifted from the housing 502. Since the release liner 702 is coupled to the cap 504 at the activation tab 704, the lifting motion of the cap 504 with respect to the housing 502 induces the release liner 702 to unwind from the adhesive layer 112.

[0066] FIG. 7C illustrates the applicator 700 in a third configuration where the cap 504 is nearly fully lifted from the housing 502 and the release liner 702 is nearly fully removed from the adhesive layer 112. In the third configuration, the release liner 702 is affixed to the adhesive layer 112 only at a central location adjacent the sensor tail 116. Unwinding the release liner 702 from theadhesive layer 112 in this manner may reduce a force applied to the sensor device 106 by removing the release liner 702.

[0067] FIG. 7D is a top view of the spiral-cut release liner 702 in a flat configuration, such as the release liner 702 may be configured when the applicator 700 is in the first configuration (FIG. 7 A). The activation tab 704 is disposed at a radially outer end of the spiral where the release liner 702 is affixed to the cap 504. In other embodiments (not shown), the activation tab 704 may be disposed at a radially inner end 706 of the spiral, and the release liner 702 may be lifted from the adhesive layer 112 from the inner end 706 toward a radially outer end 708.

[0068] FIG. 7E is a perspective view of the spiral-cut release liner 702 in an extended configuration, such as the release liner 702 may be configured when applicator 700 is in the third configuration (FIG. 7C). The activation tab 704 is lifted to unwind the release liner 702 from the radially outer end 708 toward the radially inner end 706.

[0069] Referring now to FIG. 8A, another embodiment of a wearable medical device applicator 800 is illustrated. The applicator 800 includes the sensor device 106 circumscribed by the sheath 124 of the housing 102. As described above, the applicator 800 may include an actuation mechanism (see FIG. 8B) that is actuatable to move the sensor device 106 with respect to the sheath 124 such that the adhesive layer 112 may be affixed to the patient's skin. The applicator 800 is configured to remove a pair of release liners 802a, 802b from the adhesive layer 112 in response to actuating the mechanism of the applicator 800.

[0070] The release liners 802a, 802b may each include a contact layer 804a, 804b and an overfold layer 806a, 806b with a 180-degree fold 808 therebetween. Actuation tabs, 810, 812 defined at lateral ends of the overfold layers 806a, 806b are firmly affixed to an interior of the sheath 124. In the illustrated embodiment, the applicator 800 includes a retaining ring 814 that secures the actuation tabs 810, 812 to the sheath 124. In other embodiments, the actuation tabs 810a, 810b may be secured to the sheath 124 with pins, adhesives or other securing mechanisms recognized in the art.

[0071] FIG. 8B illustrates the applicator 800 in an initial configuration with the sensor device 106 disposed within the sheath 124. In the initial configuration, the adhesive layer 112 of the sensor device 108 may be spaced from a circumferential edge 816 of the sheath 124 by a distance D. An actuation mechanism 818, for example spring 122 (FIG. IB) may be provided in the housing 102 to selectively move the sensor device 106 toward the circumferential edge 816. Thus, when the circumferential edge 816 is placed on a patent's skin, the user may activate the actuation mechanism 818 to advance the sensor device 106 toward the patient's skin and thereby adhere the sensor device 106 thereto. As described below, the release liners 802a, 802b are removed from the adhesive layer 112 in response to activating the actuation mechanism 818.

[0072] FIG. 8C schematically illustrates the applicator 800 in the initial configuration where the contact layer 804a of the release liner 802a is directly coupled to the adhesive layer 112. The adhesive layer 112 is spaced from the circumferential edge 816 by the distance D, which may be greater than a length L (FIG. 8E) of the release liner 802a in some embodiments. The actuation tab 810 is securely affixed to the interior of the sheath 124 (e.g., by the retaining ring 814 (FIG. 8A).

[0073] FIG. 8D illustrates the applicator 800 in a second configuration wherein the actuation mechanism 818 (FIG. 8B) moves the sensor device 106 toward the circumferential edge 816. Since the actuation tab 810 is affixed to the interior of the sheath 124, the movement of the sensor device 106 peals the release liner 802a from the adhesive layer 112 from the central fold 808 (FIG. 8C) radially outwardly toward the sheath 124. The release liner 802a is stowed along the interior of the sheath 124.

[0074] FIG. 8E illustrates the applicator 800 in a third configuration wherein the sensor device 106 has been moved adjacent to the circumferential edge 816. The adhesive layer 112 protrudes beyond the sheath 124 such that the sensor device 106 may be secured to the patient's skin. The entire length L of the release liner 802a is positioned against the interior of the sheath 124. As illustrated in FIG. 8C through FIG. 8E, the release liner 802a may be removed from the adhesive layer 112 in response to actuating the actuation mechanism 818 (FIG. 8B) immediately prior to applying the adhesive layer 112 to the patient's skin, preserving the effectiveness of the adhesive layer 112 and the sterility of the sensor device 106.

[0075] Referring now to FIG. 9A, another embodiment of a wearable medical device applicator 900 is illustrated. The applicator 900 includes a housing 902 comprising a sheath 904 and a receptacle 906. The sheath 904 circumscribes a sensor device 106 and is selectively actuatable to move into the receptacle 906. The sheath 904 may be actuated by an actuation mechanism (see FIG. 8B) or other device that is operable to move the sheath 904 with respect to the receptacle sheath 904 and the sensor device 106.

[0076] The applicator 900 is configured to remove a pair of release liners 908a, 908b from the sensor device 106 in response to movement of the sheath 904 into the receptacle 906. As illustrated in FIG. 9A, the release liners 908a, 908b extend from an interior of the sheath 904 to an exterior of the receptacle 906. On the exterior of the receptacle 906, the release liners 908a are affixed to exterior flanges 910a, 910b. A boss 912 protrudes from each of the flanges 910a, 912b, and may facilitate affixing the respective release liner 908a, 908b to the flanges 910a, 912b. In some embodiments, the bosses 912 may engage a slot on a cap (not shown) to form a connector similar to the bayonet-style connector 108 (see, e.g., FIG. 1A and FIG. 2A) described above.

[0077] FIG. 9B illustrates the applicator 900 in an initial or pre-activation configuration where the release liners 908a, 908b cover the adhesive layer 112 of the sensor device 106 and thesheath 904 is disposed in a pre-activation position where the sheath 904 protrudes from the receptacle 906. In the initial configuration, the release liners 908a, 908b each pass between a lateral wall 914 of the sheath 904 and an annular chamber 916 defined within the receptacle 906. Thus, the release liners 908a, 908b intersect a path through which the sheath 904 may travel into the annular chamber 916. The sheath 904 includes guide walls 918 extending circumferentially between the lateral walls 914 and longitudinally into the annular chamber 916. The guide walls 918 may include longitudinal splines 920 to facilitate movement of the sheath 904 into the receptacle 906. In the illustrated embodiment, the lateral walls 914 and the exterior flanges 910a, 910b are generally flat and parallel with one another. The flat shape of the lateral walls 914 and the exterior flanges 910a, 910b ensure the release liners 908a, 908b do not curve in a circumferential direction. In other embodiments, the lateral walls 914 and / or the exterior flanges 910a, 910b may be curved.

[0078] The applicator 900 may be selectively moved to a post-activation configuration (FIG. 9C) with an actuation mechanism, e.g., 122 (FIG. IB) or 818 (FIG. 8B). The sheath 904 may be engaged with a patient's skin, and the actuation mechanism 122, 818 may be operated to move the sheath 904 with respect to the receptacle 906 in the direction of arrow A4 into the annular chamber 916. The lateral walls 914 may engage the release liners 908a, 908b and draw the release liners 908a, 908b into the annular chamber 916. Since the release liners 908a, 908b are affixed to the exterior flanges 910a, 910b, the release liners 908a, 908b are removed from the adhesive layer 112 in the direction of arrow A5.

[0079] FIG. 9C illustrates the applicator 900 in the post-activation configuration. The sheath 904 is received in the annular chamber 916 and the release liners 908a, 908b are wrapped around the lateral walls 914. The adhesive layer 112 of the sensor device 106 is exposed, e.g., the adhesive layer protrudes from the housing 902 such that the sensor device 106 may be affixed to the skin of a patient. In some embodiments, the adhesive layer 112 may be substantially flush with the sheath 124 in the post-activation position illustrated. The receptacle 906 and the sheath 904 may be removed from the patient's skin together, while the sensor device 106 may remain in place on the patient's skin.

[0080] FIG. 9D illustrates the release liner 908b in a folded configuration as the release liner 908b may be arranged with the applicator 900 the initial or pre-activation configuration (FIG. 9B). The release liner 908b includes a contact layer 922 which may be arranged in direct contact with the adhesive layer 112 and an overfold layer 924 separated from the contact layer 922 by a 180- degree fold 926. An actuation tab 928 includes an opening 930 through which the boss 912 (FIG. 9B) may be extended to facilitate affixing the release liner 908 to the exterior flange 910b of the receptacle 906. Since the exterior flange 910b and the lateral walls 914 are generally flat, the release liner 908b may be generally flat across a width W thereof. The flat shape of the release liner mayhelp to ensure that the release liner 908b does not wrinkle or tangle as the release liner 908b is removed from the adhesive layer 112.

[0081] Referring to FIG. 10, a packaging assembly 1000 is illustrated for a wearable medical device applicator 100. The packaging assembly 1000 includes an outer packaging structure 1002 for containing the applicator 100 therein. In the illustrated embodiment, the outer packaging structure 1002 is a cardboard box having a lid 1004 and base 1006. In other embodiments, the outer packaging structure 902 may be arranged as a tube or in a variety of other different shapes without departing from the scope of the disclosure. When the applicator 100 is disposed within the outer packaging structure 1002, the grasping tab 118 of the release liner 110 may be firmly attached to the base 1006 of the outer packing structure 1002. Thus, when the applicator 100 is withdrawn from the outer packaging structure 1002 through the open lid 1004, the release liner 110 may be pealed from the sensor device 106 (FIG. IB) and remain within the outer packaging structure outer packaging structure 1002. In this manner, the release liner 110 may be removed while preserving the effectiveness of the adhesive layer 112 (FIG. IB) and the sterility of the sensor device 106.

[0082] Referring to FIGS. 11A through 11C, release liner 1102, 1104 and 1106 are illustrated, which are arranged to be removed from a sensor device 106 (FIG, IB) by peeling the release liner 1102, 1104, 1106 in a circumferential direction as indicated by the arrow A6. By removing the release liner 1102, 1104, 1106 in the direction of arrow A6, a cannula or sensor tail 116 of the sensor device 106 may be undisturbed by removing the release liner 1102, 1104, 1106. Each of the release liners 1102, 1104, 1106 includes a central opening 1108 through which the sensor tail 116 may be arranged, and a grasping or actuation tab 1110 extending on one lateral side of the release liner release liner 1102, 1104, 1106. The tab 1110 may be grasped by a user in some embodiments or may be affixed to a portion of an applicator or an outer packaging structure as described above. In some embodiments, the tab 1110 may be affixed to a cap (not shown) of an applicator that is arranged to be unscrewed from a housing. Thus, unthreading, twisting or other rotational motion of the cap with respect to the housing pulls the release liner 1102, 1104, 1106 from the sensor device in the direction of arrow A6.

[0083] The release liners 1102, 1104, 1106 may each include a 90-degree bend or fold 1112 at a proximal end of the tab 1110. The fold 1112 may facilitate affixing the tab 1110 to a cap or other structure. The tab 1110 may be affixed by adhesives, and in some embodiments, the tab 1110 may be mechanically captured in a notch of the cap. A cut 1114 extends from the tab 1110 to the central opening 1108, and ensures that the release liner 1102, 1104, 1106 detaches from the sensor device 106 in the direction of arrow A6.

[0084] FIG. 1 IB illustrates the release liner 1104, which includes a plurality of curved slits or perforations 1116 extending radially outward from the central opening 1108. The perforations1116 may allow for additional peel fronts to be established as the release liner 1104 is removed from the sensor device 106 (FIG. IB). Additional peel fronts may reduce stress on the adhesive layer 112 of the sensor device 106. In some embodiments, the number of perforations 1116 may be as few as three (3) and as many as twelve (12). The number of perforations 1116 provided may be selected depending on a tear strength of the release liner 1104. For example, the number of perforations 1116 selected should not permit the release liner 1104 to tear to an outer perimeter of the release liner 1104. Since the perforations 1116 do not extend to the outer perimeter, the outer perimeter may maintain contact with the adhesive layer 112 enhancing the effectiveness of the release liner 1104.

[0085] FIG. 11C illustrates the release liner 1106, which includes a plurality of curved slits or perforations 1120 extending radially inwardly from the outer perimeter 1118. The perforations 120 may be shorter in length than the perforations 116 illustrated in FIG. 1 IB.

[0086] Referring now to FIG. 12 A, a release liner 1202 includes a ridge 1204 defined around an outer circumferential edge 1206 thereof. The ridge 1204 protrudes from a face 1208 of the release liner 1202 such that the ridge 1204 may engage an adhesive layer 112 of a sensor device 106 to support the face 1208 above (spaced from) the adhesive layer 112. The ridge 1204 may form a seal to protect the adhesive layer 112 from outside contamination while minimizing engagement of the release liner 1202 with the adhesive layer 112. A separation force required to separate the release liner 1202 from the adhesive layer may thus be reduced. Although not shown in FIG. 12 A, in some embodiments, a ridge may also be formed around an inner circumferential edge 1210 of the release liner 1202.

[0087] FIG. 12B illustrates the ridge 1204 in greater detail. The ridge 1204 may be formed in a triangular shape by microreplication or a similar process. In some example embodiments, the ridge 1204 may extend to a height H above the face 1208 of about 0.01 inches and may extend inwardly from the circumferential edge 1206 by a span S of about 0.01 inches. In other embodiments, the ridge 1204 may be formed in a rectangular or other shape without departing from the scope of the disclosure.

[0088] Referring to FIG. 13, a release liner release liner 1302 includes a plurality of ridges 1304 defined within an interior region thereof in accordance with one or more aspects of the present disclosure. The ridges 1304 protrude from a lower face 1306 of the release liner 1302 in a radial overlapping pattern. When the ridges 1304 engage an adhesive layer 112 of a sensor device 106 (FIG. IB), a plurality of sealed pockets may be defined between the ridges 1304. The lower face 1306 may be separated from the adhesive layer 112 over 90 percent or more of a bonding area defined by the lower face 1306.

[0089] In other embodiments, the ridges 1304 may be arranged in rectangular or random patterns. Randomized ridges 1304 may permit die cutting of the release liner 1302 without aligningthe die to the protruding ridges 1304. The ridges 1304, 1204 described herein may be incorporated into any of the release liners described herein, including the contact surface 306 of the rigid post 302 (FIG. 3).

[0090] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, for example, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “contains”, “containing”, “includes”, “including,” “comprises”, and / or “comprising,” and variations thereof, when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0091] Terms of orientation are used herein merely for purposes of convention and referencing and are not to be construed as limiting. However, it is recognized these terms could be used with reference to an operator or user. Accordingly, no limitations are implied or to be inferred. In addition, the use of ordinal numbers (e.g., first, second, third, etc.) is for distinction and not counting. For example, the use of “third” does not imply there must be a corresponding “first” or “second.” Also, if used herein, the terms “coupled” or “coupled to” or “connected” or “connected to” or “attached” or “attached to” may indicate establishing either a direct or indirect connection, and is not limited to either unless expressly referenced as such.

[0092] While the disclosure has described several exemplary embodiments, it will be understood by those skilled in the art that various changes can be made, and equivalents can be substituted for elements thereof, without departing from the spirit and scope of the invention. In addition, many modifications will be appreciated by those skilled in the art to adapt a particular instrument, situation, or material to embodiments of the disclosure without departing from the essential scope thereof. Therefore, it is intended that the invention not be limited to the particular embodiments disclosed, or to the best mode contemplated for carrying out this invention, but that the invention will include all embodiments falling within the scope of the appended claims. Moreover, reference in the appended claims to an apparatus or system or a component of an apparatus or system being adapted to, arranged to, capable of, configured to, enabled to, operable to, or operative to perform a particular function encompasses that apparatus, system, or component, whether or not it or that particular function is activated, turned on, or unlocked, as long as that apparatus, system, or component is so adapted, arranged, capable, configured, enabled, operable, or operative.

Claims

CLAIMSThe invention claimed is:

1. An applicator assembly, comprising: a housing; a cap releasably secured to the housing; a wearable sensor device disposed within the housing and including: a sensor body; a sensor tail extending from the sensor body and including a sensing element operable to detect a characteristic of a bodily fluid of a patient; and a pressure-sensitive adhesive layer on the sensor body and operable to affix the sensor body to the patient; an actuation mechanism disposed within the housing and selectively operable to move the wearable sensor device from an pre-activation position wherein the sensor device is stowed within the housing to a post-activation position in which the pressure -sensitive adhesive layer protrudes from the housing such that the adhesive layer may be secured to the patient's skin while the sensor tail extends through the patient's skin to contact the bodily fluid; and at least one release liner at least partially covering the adhesive layer while the cap is secured to the housing, and removable from the adhesive layer prior to securing the adhesive layer to the patient's skin.

2. An applicator assembly, comprising: a housing including: a receptacle defining an interior chamber therein; and a sheath selectively movable from a pre-activation position where the sheath protrudes from the receptacle and a post -activation position where the sheath is received within the interior chamber of the receptacle; a wearable sensor device disposed within the housing and circumscribed by the sheath in the pre-activation position, the wearable sensor device including: a sensor body; a sensor tail extending from the sensor body and including a sensing element operable to detect a characteristic of a bodily fluid of a patient; and a pressure-sensitive adhesive layer on the sensor body operable to affix the sensor body to the patient, the adhesive layer protruding from the housing when the sheath is in the post-activation position;an actuation mechanism disposed within the housing and selectively operable to move the sheath from the pre-activation position to the post-activation position such that the adhesive layer may be secured to the patient's skin while the sensor tail extends through the patient's skin to contact the bodily fluid; and at least one release liner at least partially covering the adhesive layer while the sheath is in the pre-activation position, and removable from the adhesive layer in response to actuation of the actuation mechanism.

3. The applicator assembly of claim 1 or claim 2, wherein the at least one release liner includes a contact layer in direct contact with the adhesive layer and an overfold layer separated from the contact layer by a 180-degree fold.

4. The applicator assembly of claim 3, wherein the 180-degree fold is disposed at a central region of the adhesive layer such that the at least one release liner may be removed from the adhesive layer from the central region to a skirt defined at a peripheral region of the adhesive layer.

5. The applicator assembly of any one of claims 1-4, wherein the sensor tail extends through a central opening defined in the release liner and wherein the release liner includes at least one relief slit extending from the central opening to permit the permit the release liner to open as the release liner is lifted around the sensor tail.

6. The applicator assembly of any one of claims 1 or 3-5, wherein the at least one release liner extends through an aperture defined in the cap such that a grasping tab at an end of the at least one release liner may be grasped by a user to pull the release liner through the aperture and thereby remove the release liner from the adhesive layer.

7. The applicator assembly of claim 6, wherein the cap is releasably secured to the housing with bayonet-style connector radially aligned with the aperture defined in the cap.

8. The applicator assembly of any one of claims 1 or 3-6, wherein the at least one release liner includes an activation tab at an end of the at least one release liner attached to the cap such that opening the cap with respect to the housing removes the at least one release liner from the adhesive layer.

9. The applicator assembly of claim 8, wherein the at least one release liner is arranged in a spiral and wherein the activation tab at the end of the at least one release liner is disposed at a radially outer end of the spiral.

10. The applicator assembly of any one of claims 2 to 5, wherein the at least one release liner includes an activation tab at an end thereof attached to the housing such that moving the sheath from the pre-activation position to the post-activation position removes the at least one release liner from the adhesive layer.

11. The applicator assembly of claim 10, wherein the sheath defines a circumferential edge which may be placed on a patent's skin to position the housing for activation of the actuation mechanism and wherein the activation tab is attached to an interior of the sheath.

12. The applicator assembly of claim 11, wherein the at least one release liner is stowed along the interior of the sheath in response to activation of the actuation mechanism.

13. The applicator assembly of claim 10, wherein the at least one release liner passes between a lateral wall of the sheath and the interior chamber of the receptacle when the sheath is in the pre-activation position.

14. The applicator assembly of claim 13, wherein the activation tab is coupled to a generally flat flange of the receptacle, and wherein the lateral wall is generally flat and parallel with the flange.

15. The applicator assembly of claim 14, wherein the flange includes a boss extending through an opening defined through the activation tab.

16. The applicator assembly of claim 1, wherein the release liner is defined on a lower end of a post extending toward the adhesive layer within an interior of the cap.

17. The applicator assembly of claim 16, wherein the cap further comprises a needle guard movable within a cavity defined within the post and coupled to the post with a dynamic coupling such that the needle guard does not move with respect to the adhesive layer in response to an initial rotation of the cap with respect to the housing and such that the needle guard is lifted from the adhesive layer in response to lifting the cap with respect to the housing.

18. The applicator assembly of any one of claims 1 to 17, wherein the at least one release liner includes at least one ridge protruding from a face of the release liner such that the at least one ridge engages the adhesive layer to support the face spaced from the adhesive layer.

19. The applicator assembly of claim 18, wherein the at least one ridge includes a ridge defined around an outer circumferential edge of the release liner.

20. The applicator assembly of any one of claims 1 to 19, wherein the at least one release liner includes a central opening through which the sensor tail protrudes and a plurality of curved perforations extending radially outward from the central opening.

21. A method of applying a wearable sensor device to a patent's skin, the method comprising: opening a cap with respect to a housing of an applicator to expose a wearable sensor device disposed within the housing; removing at least one release liner from an adhesive layer on the sensor device; activating an actuation mechanism within the housing subsequent to removing the at least one release liner to thereby move the wearable sensor device from an initial stowed position in the housing to an actuated position in which the pressure -sensitive adhesive layer protrudes from the housing; and securing the sensor device to the patient's skin in response to activating the actuation mechanism such that the adhesive layer is secured to the patient's skin while a sensor tail of the sensor device extends through the patient's skin to contact a bodily fluid.

22. The method of claim 21, wherein removing the at least one release liner includes grasping a grasping tab of the release liner and pulling the release liner through an aperture defined in the cap.

23. The method of claim 21, wherein removing the at least one release liner includes opening the cap and pulling the release liner from the adhesive layer with an actuation tab attached to the cap.

24. The method of claim 21, wherein removing the at least one release liner includes stowing the at least one release liner along an interior of a sheath within the housing in response to activating the actuation mechanism.

25. The method of claim 24, further comprising moving the sheath into an internal chamber of a receptacle in response to activating the activation mechanism and wherein the sheath engages the at least one release liner as the sheath moves into the internal chamber to stow the at least one release liner.

26. The method of claim 21, wherein removing the at least one release liner includes removing the applicator from an outer packaging structure and pulling the release liner from the adhesive layer with a grasping tab attached to the outer packaging structure.

27. A packaging assembly, comprising: an outer packaging structure; an applicator disposed within the outer packaging structure, the applicator including: a housing; a cap releasably secured to the housing; and a wearable sensor device disposed within the housing and including a pressure - sensitive adhesive layer on the sensor body operable to affix the sensor device to a patient; and at least one release liner at least partially covering the adhesive layer and including a grasping tab attached to the outer packaging structure.

28. The packaging assembly of claim 27, wherein the at least one release liner extends through an aperture defined in the cap.

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