Apparatuses, systems, and methods for liner removal for medical devices

Abstract

The present examples relate generally to apparatuses, systems, and methods for deploying a medical device to skin of a host. The apparatuses, systems, and methods may be directed to removing a liner for a medical device so that the medical device may couple to the skin of the host. The medical device may comprise an on-skin wearable medical device.

Description

0985-PCTUS01 PATENTAPPARATUSES, SYSTEMS, AND METHODS FOR LINER REMOVAL FOR MEDICAL DEVICES INCORPORATION BY REFERENCE TO RELATED APPLICATION(S)

[0001] This application claims the benefit of U.S. Provisional Patent Application No.63 / 740,024, filed December 30, 2024, the entire contents of which are incorporated by reference herein.BACKGROUNDField

[0002] Apparatuses, systems, and methods for deploying and attaching a medical device to skin of a host. More particularly, apparatuses, systems, and methods are provided for deploying and attaching a transcutaneous analyte sensor to a host.Description of the Related Technology

[0003] Diabetes mellitus is a disorder in which the pancreas cannot create sufficient insulin (Type 1 or insulin dependent) and / or in which insulin is not effective (Type 2 or noninsulin dependent). In the diabetic state, the victim suffers from high blood sugar, which can cause an array of physiological derangements associated with the deterioration of small blood vessels, for example, kidney failure, skin ulcers, or bleeding into the vitreous of the eye. A hypoglycemic reaction (low blood sugar) can be induced by an inadvertent overdose of insulin, or after a normal dose of insulin or glucose-lowering agent accompanied by extraordinary exercise or insufficient food intake.

[0004] Conventionally, a person with diabetes carries a self-monitoring blood glucose (SMBG) monitor, which typically requires uncomfortable finger pricking methods. Due to the lack of comfort and convenience, a person with diabetes normally only measures his or her glucose levels two to four times per day. Unfortunately, such time intervals are spread so far apart that the person with diabetes likely finds out too late of a hyperglycemic or hypoglycemic condition, sometimes incurring dangerous side effects. Glucose levels may be alternatively monitored continuously by a measurement system including an on-skin sensor assembly. The sensor assembly may have a wireless transmitter which transmits measurement data to a receiver which can process and display information based on the measurements.

[0005] The process of applying the sensor to the person is important for such a system to be effective and user friendly. The application process should result in the on-skin sensor assembly being attached to the person in a state where it is capable of sensing the analyte (e.g.,- 1 - 4924-6933-72190985-PCTUS01 PATENTglucose) level information, communicating the sensed data to the transmitter, and transmitting the analyte level information to the receiver.

[0006] Exemplary prior art systems are disclosed in, e.g., U.S. Patent Publication No.2014 / 0088389, U.S. Patent Publication No. 2013 / 0267813, and 2018 / 0368771, owned by the assignee of the present application and herein incorporated by reference in their entireties.

[0007] This Background is provided to introduce a brief context for the Summary and Detailed Description that follow. This Background is not intended to be an aid in determining the scope of the claimed subject matter nor be viewed as limiting the claimed subject matter to implementations that solve any or all of the disadvantages or problems presented above.SUMMARY

[0008] The present systems and methods relate to apparatuses, systems, and methods for deploying and attaching a medical device to skin of a host. More particularly, apparatuses, systems, and methods are provided for deploying and attaching a transcutaneous analyte sensor to a host. The various examples of the present apparatuses, systems, and methods may have several features, no single one of which is solely responsible for their desirable attributes. Without limiting the scope of the present examples as expressed by the claims that follow, their more prominent features now will be discussed briefly. After considering this discussion, and particularly after reading the section entitled “Detailed Description,” one will understand how the features of the present examples provide the advantages described herein.

[0009] In a first aspect, a system is provided. The system may comprise an on-skin wearable medical device configured to be deployed to skin and including a patch having a first surface for engaging the skin; a housing configured to retain the on-skin wearable medical device; an insertion assembly configured to move from a raised position to a lowered position to insert at least a portion of the on-skin wearable medical device into the skin; and a component positioned within the housing and configured to: prevent the insertion assembly from moving from the raised position to the lowered position when the component is disposed in a first position within the housing, and allow the insertion assembly to move from the raised position to the lowered position after the component is withdrawn from the housing.

[0010] Implementations of the examples may include one or more of the following. The system may include activation element for activating the insertion assembly to move from the raised position to the lowered position when actuated by a user, wherein the component is configured to disable the activation element to prevent the activation element from activating the insertion assembly when the component is disposed in the first position. The component - 2 - 4924-6933-72190985-PCTUS01 PATENTmay be configured to enable the activation element upon the component being at least partially withdrawn from the housing. The system may include a coupler including a first coupling member and a second coupling member, the first coupling member configured to be in an engaged configuration with the second coupling member to retain the insertion assembly in the raised position, the first coupling member being releasable from the second coupling member to allow the insertion assembly to move to the lowered position. The activation element may be configured to release the first coupling member from the second coupling member when the activation element is enabled and actuated by the user. The component may be configured to disable the activation element by impeding movement of the first coupling member relative to the second coupling member. The component may include a backstop feature configured to abut a portion of the first coupling member to impede movement of the first coupling member relative to the second coupling member. The backstop feature may comprise a rib. The activation element may be disposed on a side of the housing. The activation element may be at least one of a button, a switch, a toggle, a slide, a trigger, a knob, a rotating member, or a portion of the housing that deforms and / or flexes. The housing may be configured to be gripped by a user. The insertion assembly may include at least one spring for inserting at least the portion of the on-skin wearable medical device into the skin. The insertion assembly may be configured to insert a needle into the skin. The system may include a retraction assembly for retracting the needle from the skin. The housing may include an internal cavity for retaining the on-skin wearable medical device. The component may include a body configured to extend axially within the internal cavity. The housing may include an opening at an end portion of the internal cavity for the on-skin wearable medical device to pass through. The system may include a coupler including a first coupling member engaged with a second coupling member to retain the insertion assembly in the raised position, and wherein the body of the component includes a first portion for abutting a portion of the first coupling member to impede movement of the first coupling member relative to the second coupling member and a second portion axially spaced from the first portion. The first portion may comprise a rib protruding from the body. The second portion may be configured to be positioned at the opening. The body of the component may include a grip portion positioned at the second portion and configured to be gripped by the user to at least partially withdraw the component from the housing. The grip portion may be configured to be gripped with a single finger. The grip portion may comprise a ring or a tab. The grip portion may be coupled to the second portion via a living hinge. The component may include one or more guides configured to prevent rotation of the component relative to the housing upon the component being withdrawn from the housing. The one or - 3 - 4924-6933-72190985-PCTUS01 PATENTmore guides may be configured to engage an interior surface of the housing to prevent rotation of the component relative to the housing upon the component being withdrawn from the housing. The component may include an engagement portion configured to engage a portion of the housing to retain the component within the housing. The engagement portion may comprise a detent. The component may include a sheath for covering a needle. The on-skin wearable medical device may include a transcutaneous analyte sensor. The component may include a sheath for covering a needle, the sheath including a layer configured to allow sterilizing gas to permeate through the layer to contact at least a portion of the needle or at least a portion of the transcutaneous analyte sensor. The component may comprise a plastic material. The component may comprise a molded plastic. The system may include a liner positioned on the first surface. The component may be further configured to engage the liner and at least partially decouple the liner from the first surface upon the component being at least partially withdrawn from the first surface. The component may be configured to asymmetrically decouple the liner from the first surface upon the component being at least partially withdrawn from the first surface. The component may be configured to peel the liner from the first surface upon the component being at least partially withdrawn from the first surface. The component may include a body configured to extend axially within an internal cavity of the housing, the body including a first portion for engaging the liner and a second portion axially spaced from the first portion. The first surface may be an adhesive surface. The system may include a barrier layer disposed over an opening of the housing. The barrier layer may comprise a gas permeable film. The barrier layer may be made from Tyvek®. The barrier layer may provide a sterile environment between the housing and an outside environment. The barrier layer may be configured to be removed from the housing prior to the on-skin wearable medical device being deployed. The component may be coupled to the barrier layer. The housing may comprise an applicator housing or a cartridge housing that is configured to be inserted into a housing of an applicator for deployment of the on-skin wearable medical device.

[0011] In a second aspect, a system is provided. The system may include an on-skin wearable medical device configured to be deployed to skin and including a patch having a first surface for engaging the skin; a liner positioned on the first surface; a housing having an internal cavity for retaining the on-skin wearable medical device and the housing having an opening at an end portion of the internal cavity for the on-skin wearable medical device to pass through; a barrier layer configured to cover and seal the opening; and a liner removal component positioned within the internal cavity of the housing and configured to engage the- 4 - 4924-6933-72190985-PCTUS01 PATENTliner and at least partially decouple the liner from the first surface upon the liner removal component being at least partially withdrawn from the first surface.

[0012] Implementations of the examples may include one or more of the following. The barrier layer may be a flexible barrier layer. The housing may be configured to be gripped by a user. The system may include an insertion assembly configured to move from a raised position to a lowered position to insert at least a portion of the on-skin wearable medical device into the skin. The liner removal component may be configured to prevent the insertion assembly from moving from the raised position to the lowered position when the liner removal component is disposed in a first position within the housing. The system may include an activation element for activating the insertion assembly to move from the raised position to the lowered position when actuated by a user. The liner removal component may be configured to disable the activation element to prevent the activation element from activating the insertion assembly when the liner removal component is disposed in a first position within the housing. The liner removal component may be configured to enable the activation element upon the liner removal component being at least partially withdrawn from the first surface. The system may include a coupler including a first coupling member and a second coupling member, the first coupling member configured to be in an engaged configuration with the second coupling member to retain the insertion assembly in the raised position, the first coupling member being releasable from the second coupling member to allow the insertion assembly to move to the lowered position. The activation element may be configured to release the first coupling member from the second coupling member when the activation element is enabled and actuated by the user. The liner removal component may be configured to disable the activation element by impeding movement of the first coupling member relative to the second coupling member. The liner removal component may include a backstop feature configured to abut a portion of the first coupling member to impede movement of the first coupling member relative to the second coupling member. The backstop feature may comprise a rib. The liner removal component may include a body configured to extend axially within the internal cavity of the housing, the body of the liner removal component including a first portion for abutting a portion of the first coupling member to impede movement of the first coupling member relative to the second coupling member and a second portion axially spaced from the first portion. The first portion may comprise a rib protruding from the body. The second portion may be configured to be positioned at the opening. The body of the liner removal component may include a grip portion positioned at the second portion and configured to be gripped by a user for at least partially withdrawing the liner removal component from the first surface. The grip portion - 5 - 4924-6933-72190985-PCTUS01 PATENTmay be configured to be gripped with a single finger. The grip portion may comprise a ring or a tab. The grip portion may be coupled to the second portion via a living hinge. The activation element may be disposed on a side of the housing. The activation element may be at least one of a button, a switch, a toggle, a slide, a trigger, a knob, a rotating member, or a portion of the housing that deforms and / or flexes. The insertion assembly may include at least one spring for inserting at least the portion of the on-skin wearable medical device into the skin. The insertion assembly may be configured to insert a needle into the skin. The system may include a retraction assembly for retracting a needle from the skin. The liner removal component may include a body configured to extend axially within the internal cavity of the housing. The liner removal component may include one or more guides configured to prevent rotation of the liner removal component relative to the housing upon the liner removal component being withdrawn from the first surface. The one or more guides may be configured to engage an interior surface of the housing to prevent rotation of the liner removal component relative to the housing upon the liner removal component being withdrawn from the first surface. The liner removal component may include an engagement portion configured to engage a portion of the housing to retain the liner removal component within the housing. The engagement portion may comprise a detent. The liner removal component may include a sheath for covering a needle. The on-skin wearable medical device may include a transcutaneous analyte sensor. The liner removal component may include a sheath for covering a needle, the sheath including a layer configured to allow sterilizing gas to permeate through the layer to contact at least a portion of the needle or at least a portion of the transcutaneous analyte sensor. The liner removal component may comprise a plastic material. The liner removal component may comprise molded plastic. The first surface may be an adhesive surface. The liner removal component may be configured to asymmetrically decouple the liner from the first surface upon the liner removal component being at least partially withdrawn from the first surface. The liner removal component may be configured to peel the liner from the first surface upon the liner removal component being at least partially withdrawn from the first surface. The barrier layer may comprise a gas permeable film. The barrier layer may be made from Tyvek®. The barrier layer may provide a sterile environment between the housing and an outside environment. The barrier layer may be configured to be removed from the housing prior to the on-skin wearable medical device being deployed. The liner removal component may include a body configured to extend axially within the internal cavity of the housing, the body including a first portion for engaging the liner and a second portion axially spaced from the first portion. The housing may- 6 - 4924-6933-72190985-PCTUS01 PATENTcomprise an applicator housing or a cartridge housing that is configured to be inserted into a housing of an applicator for deployment of the on-skin wearable medical device.

[0013] In a third aspect, a system is provided. The system may include an on-skin wearable medical device configured to be deployed to skin and including a patch having a first surface for engaging the skin; a liner positioned on the first surface; a housing having an internal cavity for retaining the on-skin wearable medical device and the housing having an opening at an end portion of the internal cavity for the on-skin wearable medical device to pass through; a barrier layer configured to seal the opening; and a liner removal component positioned within the housing and configured to engage the liner and the barrier layer and at least partially decouple the liner from the first surface upon the liner removal component being at least partially withdrawn from the first surface.

[0014] Implementations of the examples may include one or more of the following. The barrier layer may be a flexible barrier layer. The liner removal component may include a body configured to extend axially within the internal cavity. The body of the liner removal component may include a first portion for engaging the liner and a second portion axially spaced from the first portion and for engaging the barrier layer. The first portion may be coupled to the liner via an adhesive. The second portion may be positioned at the opening. At least a portion of the first portion may comprise the liner. The barrier layer may be configured to be removed from the housing prior to the on-skin wearable medical device being deployed. The barrier layer may be configured to be peeled from the housing to be removed from the housing. The barrier layer may be configured to withdraw the liner removal component from the first surface upon the barrier layer being removed from the housing. The barrier layer may include a grip portion configured to be gripped by a user for removing the barrier layer from the housing. The grip portion may be configured to be gripped with a single finger. The liner removal component may be coupled to the barrier layer at an outer edge portion of the barrier layer that is adjacent the grip portion. The liner removal component may be coupled to the barrier layer at a first edge portion of the barrier layer and at a second edge portion of the barrier layer that is opposite the first edge portion. The liner removal component may include a central opening such that the liner removal component comprises two halves. The liner removal component may comprise a foldable material. The liner removal component may be configured to be in a butterfly-shape fold. The liner removal component may be coupled to the barrier layer via an adhesive. The liner removal component may include a liner portion that forms the liner. The liner removal component may comprise a flexible material having a plurality of folds. The liner removal component may be configured to extend from an interior - 7 - 4924-6933-72190985-PCTUS01 PATENTsurface of the barrier layer to the patch. The liner removal component may be Z-shaped and has a first portion for engaging the liner and a second portion that is axially spaced from the first portion and for engaging the barrier layer. The liner removal component may comprise bellows. The liner removal component may include a body having a first portion for engaging the liner and a second portion, the second portion being axially spaced from the first portion and configured to couple to an outer surface of the barrier layer. The first portion of the liner removal component may be configured to couple to the liner at an outer edge of the liner such that the first portion is offset from a center of the liner. The liner removal component may include a grip portion positioned at the second portion of the liner removal component, the grip portion being configured to be gripped by a user for withdrawing the liner removal component from the first surface. The grip portion may be configured to be gripped with a single finger. The barrier layer may be configured to be removed from the housing upon the grip portion being pulled in an axial direction relative to the housing. The grip portion may comprise a ring or a tab. The liner may include a cut extending from an outer edge of the liner to an aperture of the liner. The liner removal component may comprise a spring. The liner removal component may include a hinge feature configured to engage the housing. The liner removal component may be configured to rotate about the hinge feature upon the barrier layer being peeled off of the housing. The liner removal component may be U-shaped and has a first leg and a second leg, and a central portion positioned between the first leg and the second leg. A distal end portion of the first leg may be configured to be coupled to the barrier layer, and the hinge feature is configured to be positioned at a distal end portion of the second leg. The central portion may be configured to engage the liner. The central portion may include a cutout portion for a needle or a sheath for the needle. The second leg may be shorter than the first leg. The liner removal component may comprise a stamped rigid material. The liner removal component may comprise a molded rigid material. The liner removal component may include one or more living hinges. The liner removal component may include one or more guides configured to prevent rotation of the liner removal component relative to the housing upon the liner removal component being withdrawn from the first surface. The one or more guides may be configured to engage an interior surface of the housing to prevent rotation of the liner removal component relative to the housing upon the liner removal component being withdrawn from the first surface. The liner removal component may include a first portion for engaging the liner and a second portion positioned at the opening of the housing and axially apart from the first portion. The liner removal component may include a grip portion positioned at the second portion and configured to be gripped by a user for decoupling the liner from the first - 8 - 4924-6933-72190985-PCTUS01 PATENTsurface. The grip portion may comprise one or more flanges. The barrier layer may be ring shaped. The housing may include an interior surface, the interior surface having a first channel and a second channel that is opposite the first channel, with the liner removal component being configured to extend between the first channel and the second channel. The liner removal component may comprise a flexible lid that is configured to be positioned over the opening of the housing to form the barrier layer. The flexible lid may comprise a rubber material or a silicone material and includes a lip for engaging the housing. The liner removal component may comprise a body that extends from an interior surface of the flexible lid to the liner for engaging the liner. A central portion of the flexible lid may extend into the internal cavity of the housing such that an interior surface of the flexible lid engages the liner. The barrier layer may comprise a gas permeable film. The barrier layer may comprise Tyvek®. The barrier layer may provide a sterile environment between the housing and an outside environment. The liner removal component may include a sheath for covering a needle. The on-skin wearable medical device may include a transcutaneous analyte sensor. The liner removal component may include a sheath for covering a needle, the sheath including a layer configured to allow sterilizing gas to permeate through the layer to contact the needle or at least a portion of the transcutaneous analyte sensor. The liner removal component may comprise a plastic material. The first surface may be an adhesive surface. The liner removal component may be configured to asymmetrically decouple the liner from the first surface upon the liner removal component being at least partially withdrawn from the first surface. The liner removal component may be configured to peel the liner from the first surface upon the liner removal component being at least partially withdrawn from the first surface. The housing may comprise an applicator housing or a cartridge housing that is configured to be inserted into a housing of an applicator for deployment of the on-skin wearable medical device. The liner removal component may be nonthreaded.

[0015] In a fourth aspect, a system is provided. The system may include an on-skin wearable medical device configured to be deployed to skin and including a patch having a first surface for engaging the skin; a liner positioned on the first surface; a housing having an internal cavity for retaining the on-skin wearable medical device and the housing having an opening at an end portion of the internal cavity for the on-skin wearable medical device to pass through; and a nonthreaded liner removal component configured to: seal the opening, engage the liner, and at least partially decouple the liner from the first surface upon the liner removal component being at least partially withdrawn from the first surface.- 9 - 4924-6933-72190985-PCTUS01 PATENT

[0016] Implementations of the examples may include one or more of the following. The liner removal component may include a body configured to extend axially within the internal cavity. The body of the liner removal component may include a first portion for engaging the liner and a second portion axially spaced from the first portion and for sealing the opening. The first portion may be coupled to the liner with an adhesive. The second portion may be coupled to a bottom outer surface of the housing with an adhesive such that the liner removal component seals the opening of the housing. The second portion may be positioned at the opening of the housing. The liner removal component may form a cavity within the internal cavity of the housing. The cavity formed by the liner removal component may have an opening positioned at the end portion of the internal cavity of the housing. The liner removal component may be configured to be removed from the housing prior to the on-skin wearable medical device being deployed. The liner removal component may be configured to be withdrawn from the first surface in an axial direction relative to the housing to be removed from the housing. The liner removal component may include one or more guides configured to prevent rotation of the liner removal component relative to the housing upon the liner removal component being withdrawn from the first surface. The one or more guides may be configured to engage an interior surface of the housing to prevent rotation of the liner removal component relative to the housing upon the liner removal component being withdrawn from the first surface. The liner removal component may include a sealing member. The sealing member may be configured to form a seal between the liner removal component and the housing for sealing the opening of the housing. The liner removal component may include a body configured to extend axially within the internal cavity, the body including a first portion for engaging the liner and a second portion axially spaced from the first portion and positioned at the opening. The liner removal component may include a sealing member, the sealing member being coupled to the second portion and configured to form a seal between the second portion and the housing. The liner removal component may include one or more retention features that extend from the second portion and are configured to engage corresponding retention features of the housing to retain the liner removal component within the housing. The one or more retention features of the liner removal component may be configured to engage one or more protrusions of the housing or one or more concave portions of the housing, the one or more protrusions being configured to protrude radially outwardly relative to the housing, and the one or more protrusions and the one or more concave portions each being positioned on an outer surface of the housing. The one or more retention features of the liner removal component may be configured to disengage from the corresponding retention features of the - 10 - 4924-6933-72190985-PCTUS01 PATENThousing upon a portion of the one or more retention features of the liner removal component being pressed radially inwardly relative to the housing by a user. The one or more retention features of the liner removal component may be configured to disengage from the corresponding retention features of the housing upon the liner removal component being withdrawn from the first surface in an axial direction relative to the housing. The sealing member may comprise a gasket or an O-ring. The sealing member may comprise an adhesive. The liner removal component may include a grip portion, the grip portion being configured to be gripped by a user for pulling the liner removal component in an axial direction relative to the housing to decouple the liner from the first surface. The grip portion may be configured to be gripped with a single finger. The grip portion may comprise one or more flanges configured to protrude radially inwardly from the liner removal component relative to the housing. The system may include a gas permeable layer positioned on an end surface of the housing that is opposite of the opening of the housing. The liner removal component may provide a sterile environment between the housing and an outside environment. The liner removal component may include a sheath for covering a needle. The on-skin wearable medical device may include a transcutaneous analyte sensor. The liner removal component may include a sheath for covering a needle, the sheath including a layer configured to allow sterilizing gas to permeate through the layer to contact the needle or at least a portion of the transcutaneous analyte sensor. The liner removal component may comprise a plastic material. The liner removal component may comprise a molded material or a stamped material. The first surface may be an adhesive surface. The liner removal component may be configured to asymmetrically decouple the liner from the first surface upon the liner removal component being at least partially withdrawn from the first surface. The liner removal component may be configured to peel the liner from the first surface upon the liner removal component being at least partially withdrawn from the first surface. The housing may comprise an applicator housing or a cartridge housing that is configured to be inserted into a housing of an applicator for deployment of the on-skin wearable medical device.

[0017] In a fifth aspect, a method is provided. The method may comprise at least partially withdrawing a liner removal component from a first surface of an on-skin wearable medical device to at least partially decouple a liner from the first surface, the on-skin wearable medical device being retained within an internal cavity of a housing, the housing including an opening at an end portion of the internal cavity for the on-skin wearable medical device to pass through, the opening being sealed by a barrier layer that is coupled to the liner removal- 11 - 4924-6933-72190985-PCTUS01 PATENTcomponent; and deploying the on-skin wearable medical device to skin from the housing with the first surface contacting the skin.

[0018] Implementations of the examples may include one or more of the following. The barrier layer may be a flexible barrier layer. The liner removal component may include a body extending axially within the internal cavity. At least a portion of the liner removal component may be positioned at the opening of the housing. The liner removal component may include a first portion axially spaced from a second portion, the first portion engaging the liner. The second portion of the liner removal component may be coupled to the barrier layer. The second portion of the liner removal component may form the barrier layer. The second portion of the liner removal component may comprise a flexible lid that forms the barrier layer, the flexible lid having a lip that is configured to engage the housing and seal the opening. The method may further comprise at least partially removing the barrier layer from the housing to at least partially withdraw the liner removal component from the first surface. The method may further comprise gripping a grip portion of the barrier layer to at least partially remove the barrier layer from the housing. The method may further comprise pulling the grip portion of the barrier layer in an axial direction relative to the housing to at least partially remove the barrier layer from the housing. The liner removal component may include a first portion axially spaced from a second portion, the first portion engaging the liner and the second portion being positioned at the opening of the housing, and further comprising gripping a grip portion positioned at the second portion to at least partially withdraw the liner removal component from the first surface. The method may further comprise pulling the grip portion of the liner removal component in an axial direction relative to the housing to at least partially withdraw the liner removal component from the first surface. Partially withdrawing the liner removal component from the first surface may at least partially remove the barrier layer from the housing. The liner removal component may include one or more guides configured to prevent rotation of the liner removal component relative to the housing upon the liner removal component being at least partially withdrawn from the first surface. The on-skin wearable medical device may include a transcutaneous analyte sensor. The first surface may be an adhesive surface. The on-skin wearable medical device may include a patch having the first surface. The method may further comprise inserting a needle from the housing into the skin. The method may further comprise retracting the needle from the skin to the housing. The liner removal component may include a sheath for covering at least a portion of a needle or at least a portion of a transcutaneous analyte sensor. At least a portion of the sheath may include a layer configured to allow sterilizing gas to permeate through the layer to contact at least the - 12 - 4924-6933-72190985-PCTUS01 PATENTportion of the needle or at least the portion of the transcutaneous analyte sensor. The liner removal component may be nonthreaded. The housing may comprise an applicator housing or a cartridge housing that is configured to be inserted into a housing of an applicator for deployment of the on-skin wearable medical device.

[0019] Any of the features of an example of any of the aspects, including but not limited to any examples of any of the first through fifth aspects referred to above, is applicable to all other aspects and examples identified herein, including but not limited to any examples of any of the first through fifth aspects referred to above. Moreover, any of the features of an example of the various aspects, including but not limited to any examples of any of the first through fifth aspects referred to above, is independently combinable, partly or wholly with other examples described herein in any way, e.g., one, two, or three or more examples may be combinable in whole or in part. Further, any of the features of an example of the various aspects, including but not limited to any examples of any of the first through fifth aspects referred to above, may be made optional to other aspects or examples. Any aspect or example of a method can be performed by a system or apparatus of another aspect or example, and any aspect or example of a system or apparatus can be configured to perform a method of another aspect or example, including but not limited to any examples of any of the first through fifth aspects referred to above.

[0020] This Summary is provided to introduce a selection of concepts in a simplified form. The concepts are further described in the Detailed Description section. Elements or steps other than those described in this Summary are possible, and no element or step is necessarily required. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended for use as an aid in determining the scope of the claimed subject matter. The claimed subject matter is not limited to implementations that solve any or all disadvantages noted in any part of this disclosure.BRIEF DESCRIPTION OF THE DRAWINGS

[0021] These and other features, aspects, and advantages are described below with reference to the drawings, which are intended to illustrate, but not to limit, the disclosure. In the drawings, like reference characters denote corresponding features consistently throughout similar examples.

[0022] FIG. 1 illustrates a schematic view of a continuous analyte sensor system.

[0023] FIG. 2A illustrates a top perspective view of an on-skin sensor assembly.- 13 - 4924-6933-72190985-PCTUS01 PATENT

[0024] FIG. 2B illustrates a bottom perspective view of the on-skin sensor assembly of FIG. 2A in an assembled state.

[0025] FIG. 2C illustrates a top perspective view of the on-skin sensor assembly of FIG. 2A in an assembled state.

[0026] FIG. 3 illustrates a perspective assembly view of an on-skin sensor assembly.

[0027] FIG. 4 illustrates a perspective view of an on-skin sensor assembly.

[0028] FIG. 5 illustrates a perspective view of an applicator system for an on-skin sensor assembly of an analyte sensor system.

[0029] FIG. 6 illustrates an exploded perspective view of the applicator system of FIG.5.

[0030] FIGS. 7-9 illustrate several cross-sectional views of the applicator system of FIGS. 5 and 6, taken along the section line A-A’ of FIG. 5, during operation.

[0031] FIGS. 10-12 illustrate several cross-sectional views of the applicator system of FIGS. 5 and 6, taken along the section line B-B’ of FIG. 5, during operation.

[0032] FIGS. 13 and 14 illustrate magnified views of some features of the applicator system of FIGS. 5 and 6.

[0033] FIGS. 15 and 16 illustrate magnified views of some features of the applicator system of FIGS. 5 and 6.

[0034] FIG. 17 illustrates a perspective partial cutaway view of the needle carrier assembly, hub, and on-skin sensor assembly of the applicator system of FIGS. 5 and 6.

[0035] FIG. 18 illustrates a cross-sectional view of the hub and on-skin sensor assembly of the applicator system of FIGS. 5 and 6.

[0036] FIG. 19 illustrates a top view of a portion of the needle carrier assembly and hub of FIGS. 5 and 6.

[0037] FIGS. 20A and 20B illustrate perspective views of locking features for needles for use in an applicator for an analyte sensor system.

[0038] FIGS. 21-23 illustrate several cross-sectional views, and various features and operating positions, of yet another applicator for an on-skin sensor assembly of an analyte sensor system.

[0039] FIG. 24 illustrates a perspective view of various features of the applicator system ofFIGS. 21-23.

[0040] FIGS. 25 A and 25B illustrate cross-sectional views of yet another sensor retention element for an applicator for an analyte sensor system.

[0041] FIG. 26A illustrates a cross-sectional view of a system.- 14 - 4924-6933-72190985-PCTUS01 PATENT

[0042] FIG. 26B illustrates a perspective view of a liner removal component.

[0043] FIG. 26C illustrates a cross-sectional schematic view of a liner upon a liner removal component.

[0044] FIG. 26D illustrates a cross-sectional view of the system shown in FIG. 26 A.

[0045] FIG. 26E illustrates a perspective bottom view of the system shown in FIG.26A.

[0046] FIG. 26F illustrates a perspective view of a liner removal component.

[0047] FIG. 26G illustrates a cross-sectional view of the system shown in FIG. 26A.

[0048] FIG. 27A illustrates a cross-sectional view of a system.

[0049] FIG. 27B illustrates a bottom view of a liner.

[0050] FIG. 27C illustrates a bottom view of a barrier layer.

[0051] FIG. 27D illustrates a perspective view of a grip portion of a liner removal component.

[0052] FIG. 27E illustrates a cross-sectional view of a system.

[0053] FIG. 28A illustrates a cross-sectional view of a system.

[0054] FIG. 28B illustrates a bottom view of the liner removal component and the barrier layer shown in FIG. 28A.

[0055] FIG. 29A illustrates a perspective bottom view of a system.

[0056] FIG. 29B illustrates a cross-sectional view of the system shown in FIG. 29A, with the liner removal component and the barrier layer shown in FIG. 29A partially withdrawn from the surface of the on-skin wearable medical device.

[0057] FIG. 30 illustrates a perspective bottom view of a system.

[0058] FIG. 31 illustrates a perspective bottom view of a system.

[0059] FIG. 32 illustrates a perspective bottom view of a system.

[0060] FIG. 33 illustrates a perspective bottom view of a system.

[0061] FIG. 34A illustrates a cross-sectional view of a system.

[0062] FIG. 34B illustrates a perspective top view of the system shown in FIG. 34A.

[0063] FIG. 34C illustrates a perspective top view of the liner removal component shown in FIG. 34 A.

[0064] FIG. 35 A illustrates a cross-sectional view of a system.

[0065] FIG. 35B illustrates a bottom view of the system shown in FIG. 35 A.

[0066] FIG. 35C illustrates a perspective bottom view of a system.

[0067] FIG. 35D illustrates a perspective bottom view of a system.

[0068] FIG. 35E illustrates a perspective bottom view of a system.- 15 - 4924-6933-72190985-PCTUS01 PATENT

[0069] FIG. 36A illustrates a perspective bottom view of a system.

[0070] FIG. 36B illustrates a side view of the liner removal component shown in FIG.36 A.

[0071] FIG. 36C illustrates a perspective bottom view of the system shown in FIG.36 A.

[0072] FIG. 37 illustrates a perspective bottom view of a system.

[0073] FIG. 38A illustrates a cross-sectional view of a system.

[0074] FIG. 38B illustrates a side view of a liner removal component.

[0075] FIG. 39A illustrates a cross-sectional view of a system.

[0076] FIG. 39B illustrates a perspective bottom view of the system shown in FIG.39 A.

[0077] FIG. 39C illustrates a cross-sectional view of a system.

[0078] FIG. 39D illustrates a cross-sectional view of a system.

[0079] FIG. 39E illustrates a perspective view of a system.

[0080] FIG. 39F illustrates a perspective view of a system.

[0081] FIG. 40A illustrates a cross-sectional view of a system.

[0082] FIG. 40B illustrates a bottom perspective view of the system shown in FIG.40A.

[0083] FIG. 41 A illustrates a cross-sectional view of a system.

[0084] FIG. 4 IB illustrates a bottom perspective view of the system shown in FIG.41A.

[0085] FIG. 41C illustrates a side view of a liner removal component.

[0086] FIG. 42 illustrates a bottom view of a liner.

[0087] FIGS. 43 A-43D illustrate schematic views of steps for manufacturing a system.DETAILED DESCRIPTION

[0088] The following description and examples illustrate some example implementations of the disclosure in detail. Those of skill in the art will recognize that there are numerous variations and modifications of the disclosure that are encompassed by its scope. Accordingly, the description of a certain example implementation should not be deemed to limit the scope of the present disclosure.

[0089] FIG. l is a diagram depicting an example medical device system in accordance with some example implementations. The medical device system may comprise a continuous analyte monitoring system 100. The continuous analyte monitoring system 100 may include - 16 - 4924-6933-72190985-PCTUS01 PATENTan analyte sensor system 102 comprising an on-skin sensor assembly 160 configured to be fastened to skin of a host (also referred to as a patient) via a base.

[0090] In examples, other forms of medical device systems may be utilized, including other forms of monitoring systems, medicament delivery systems, or other therapeutic systems. In examples, an on-skin wearable medical device may be utilized that may comprise an on-skin sensor assembly, or a medicament delivery medical device, among other forms of on-skin wearable medical devices.

[0091] As shown in FIG. 1, the analyte sensor system 102 may be operatively connected to a host and a plurality of display devices 110-114 according to certain aspects of the present disclosure. Example display devices 110-114 may include computers such as smartphones, smartwatches, tablet computers, laptop computers, and desktop computers. In some examples, display devices 110-114 may be Apple Watches, iPhones, and iPads made by Apple Inc., or iOS, Windows, or Android operating-system devices. It should be noted that display device 114 alternatively or in addition to being a display device, may be a medicament delivery device that can act cooperatively with analyte sensor system 102 to deliver medicaments to the host. Analyte sensor system 102 may include a sensor electronics module 140 and a continuous analyte sensor 138 associated with sensor electronics module 140. Sensor electronics module 140 may be in direct wireless communication with one or more of the plurality of display devices 110-114 via wireless communications signals. As will be discussed in greater detail below, display devices 110-114 may also communicate amongst each other and / or through each other to analyte sensor system 102. For ease of reference, wireless communications signals from analyte sensor system 102 to display devices 110-114 can be referred to as “uplink” signals 128. Wireless communications signals from, e.g., display devices 110-114 to analyte sensor system 102 can be referred to as “downlink” signals 130. Wireless communication signals between two or more of display devices 110-114 may be referred to as “crosslink” signals 132. Additionally, wireless communication signals can include data transmitted by one or more of display devices 110-113 via “long-range” uplink signals 136 (e.g., cellular signals) to one or more remote servers 190 or network entities, such as cloud-based servers or databases, and receive long-range downlink signals 142 transmitted by remote servers 190.

[0092] In examples shown by FIG. 1, one of the plurality of display devices may be a custom display device 111 specially designed for displaying certain types of displayable sensor information associated with analyte values received from the sensor electronics module 140 (e.g., a numerical value and an arrow, in some examples). In some examples, one of the - 17 - 4924-6933-72190985-PCTUS01 PATENTplurality of display devices may be a handheld device 112, such as a mobile phone based on the Android operating system, iOS operating system, or other operating system, a palm-top computer and the like, where handheld device 112 may have a relatively larger display and be configured to display a graphical representation of the continuous sensor data (e.g., including current and historic data). Other display devices can include other hand-held devices, such as a tablet 113, a smart watch 110, a medicament delivery device 114, a blood glucose meter, and / or a desktop or laptop computer.

[0093] It should be understood that in the case of display device 114, which may be a medicament delivery device in addition to or instead of a display device, the alerts and / or sensor information provided by continuous analyte sensor 138 vis-a-vis sensor electronics module 140, can be used to initiate and / or regulate the delivery of the medicament to host.

[0094] During use, a sensing portion of sensor 138 may be disposed under the host’s skin and a contact portion of sensor 138 can be electrically connected to sensor electronics module 140. Electronics module 140 can be engaged with a housing (e.g., a base) which is attached to a patch that may engage the skin of the host. The patch may be an adhesive patch, in examples. In some examples, electronics module 140 is integrally formed with the housing. Furthermore, electronics module 140 may be disposable and directly coupled to the patch.

[0095] Continuous analyte sensor system 100 can include a sensor configuration that provides an output signal indicative of a concentration of an analyte. The output signal including (e.g., sensor data, such as a raw data stream, filtered data, smoothed data, and / or otherwise transformed sensor data) is sent to the receiver.

[0096] In some examples, analyte sensor system 102 includes a transcutaneous glucose sensor, such as is described in U.S. Patent Publication No. 2011 / 0027127, the entire contents of which are hereby incorporated by reference. In some examples, sensor system 102 includes a continuous glucose sensor and comprises a transcutaneous sensor (e.g., as described in U.S. Pat. No. 6,565,509, as described in U.S. Pat. No. 6,579,690, and / or as described in U.S. Pat. No. 6,484,046). The contents of U.S. Pat. No. 6,565,509, U.S. Pat. No. 6,579,690, and U.S. Pat. No. 6,484,046 are hereby incorporated by reference in their entirety.

[0097] Various signal processing techniques and glucose monitoring system examples suitable for use with the examples described herein are described in U.S. Patent Publication No. 2005 / 0203360 and U.S. Patent Publication No. US-2009-0192745-A1, the contents of which are hereby incorporated by reference in their entirety. The sensor can extend through a housing, which can maintain sensor 138 on, in or under the skin and / or can provide for electrical connection of sensor 138 to sensor electronics in sensor electronics module 140.- 18 - 4924-6933-72190985-PCTUS01 PATENT

[0098] In some examples, description of a base, a housing, a wearable, and / or a transmitter of on-skin sensor assembly 160 may be interchangeable. In other examples, a base and a housing of on-skin sensor assembly 160 may be different in the sense that they may be separate components from sensor electronics module 140, e.g., from a transmitter or receiver.

[0099] In several examples, sensor 138 is in a form of a wire. A distal end of the wire can be formed, e.g., having a conical shape (to facilitate inserting the wire into the tissue of the host). Sensor 138 may comprise an elongate analyte sensor, and may include an elongate conductive body, such as an elongate conductive core (e.g., a metal wire) or an elongate conductive core coated with one, two, three, four, five, or more layers of material, each of which may or may not be conductive. The elongate analyte sensor may be long and thin, yet flexible and strong. For example, in some examples, the smallest dimension of the elongate conductive body is less than 0.1 inches, less than 0.075 inches, less than 0.05 inches, less than 0.025 inches, less than 0.01 inches, less than 0.004 inches, less than 0.002 inches, less than 0.001 inches, and / or less than 0.0005 inches.

[0100] Sensor 138 may have a circular shaped cross section. In some examples, the cross section of the elongated conductive body can be ovoid, rectangular, triangular, polyhedral, star-shaped, C-shaped, T-shaped, X-shaped, Y-shaped, irregular, or the like. In some examples, a conductive wire electrode is employed as a core. In other examples, sensor 138 may be disposed on a substantially planar substrate. To such an electrode, one or two additional conducting layers may be added (e.g., with intervening insulating layers provided for electrical isolation). The conductive layers can be comprised of any suitable material. In certain examples, it may be desirable to employ a conductive layer comprising conductive particles (i.e., particles of a conductive material) in a polymer or other binder.

[0101] In some examples, the materials used to form the elongated conductive body (e.g., stainless steel, titanium, tantalum, platinum, platinum-iridium, iridium, certain polymers, and / or the like) can be strong and hard, and therefore can be resistant to breakage. For example, in several examples, the ultimate tensile strength of the elongated conductive body is greater than 80 kPsi and less than 140 kPsi, and / or the Young’s modulus of the elongate conductive body is greater than 160 GPa and less than 220 GPa. The yield strength of the elongate conductive body can be greater than 58 kPsi and less than 2200 kPsi.

[0102] Electronics module 140 can be releasably or permanently coupled to sensor 138. Electronics module 140 can include electronic circuitry associated with measuring and processing the continuous analyte sensor data. Electronics module 140 can be configured to perform algorithms associated with processing and calibration of the sensor data. For example,- 19 - 4924-6933-72190985-PCTUS01 PATENTelectronics module 140 can provide various aspects of the functionality of a sensor electronics module as described in U.S. Patent Publication No. 2009 / 0240120 and U.S. Patent Publication No. 2012 / 0078071, the entire contents of which are incorporated by reference herein. Electronics module 140 may include hardware, firmware, and / or software that enable measurement of levels of the analyte via a glucose sensor, such as sensor 138.

[0103] For example, electronics module 140 can include a potentiostat, a power source for providing power to sensor 138, signal processing components, data storage components, and a communication module (e.g., a telemetry module) for one-way or two-way data communication between electronics module 140 and one or more receivers, repeaters, and / or display devices, such as devices 110-114. Electronic components can be affixed to a printed circuit board (PCB), or the like, and can take a variety of forms. The electronic components can take the form of an integrated circuit (IC), such as an Application-Specific Integrated Circuit (ASIC), a microcontroller, and / or a processor. The electronics module 140 may include sensor electronics that are configured to process sensor information, such as storing data, analyzing data streams, calibrating analyte sensor data, estimating analyte values, comparing estimated analyte values with time-corresponding measured analyte values, analyzing a variation of estimated analyte values, and the like. Examples of systems and methods for processing sensor analyte data are described in more detail in U.S. Pat. No. 7,310,544, U.S. Pat. No. 6,931,327, U.S. Patent Publication No. 2005 / 0043598, U.S. Patent Publication No.2007 / 0032706, U.S. Patent Publication No. 2007 / 0016381, U.S. Patent Publication No.2008 / 0033254, U.S. Patent Publication No. 2005 / 0203360, U.S. Patent Publication No.2005 / 0154271, U.S. Patent Publication No. 2005 / 0192557, U.S. Patent Publication No.2006 / 0222566, U.S. Patent Publication No. 2007 / 0203966 and U.S. Patent Publication No.2007 / 0208245, the contents of which are hereby incorporated by reference in their entirety. Electronics module 140 may communicate with the devices 110-114, and / or any number of additional devices, via any suitable communication protocol. Example communication methods or protocols include radio frequency; Bluetooth; universal serial bus; any of the wireless local area network (WLAN) communication standards, including the IEEE 802.11, 802.15, 802.20, 802.22 and other 802 communication protocols; ZigBee; wireless (e.g., cellular) telecommunication; paging network communication; magnetic induction; satellite data communication; a proprietary communication protocol, open source communication protocol, and / or any suitable wireless communication method.- 20 - 4924-6933-72190985-PCTUS01 PATENT

[0104] Additional sensor information is described in U.S. Patent No. 7,497,827 and U.S. Patent No. 8,828,201. The entire contents of U.S. Patent No. 7,497,827 and U.S. Patent No. 8,828,201 are incorporated by reference herein.

[0105] Any sensor shown or described herein can be an analyte sensor; a glucose sensor; and / or any other suitable sensor. A sensor described in the context of any implementation can be any sensor described herein or incorporated by reference. Sensors shown or described herein can be configured to sense, measure, detect, and / or interact with any analyte.

[0106] As used herein, the term “analyte” is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a substance or chemical constituent in a biological fluid (for example, blood, interstitial fluid, cerebral spinal fluid, lymph fluid, urine, sweat, saliva, etc.) that can be analyzed. Analytes can include naturally occurring substances, artificial substances, metabolites, or reaction products.

[0107] In some implementations, the analyte for measurement by the sensing regions, devices, systems, and methods is glucose. However, other analytes are contemplated as well, including, but not limited to ketone bodies; acetyl-CoA; acarboxyprothrombin; acylcarnitine; adenine phosphoribosyl transferase; adenosine deaminase; albumin; alpha-fetoprotein; amino acid profiles (arginine (Krebs cycle), histidine / urocanic acid, homocysteine, phenylalanine / tyrosine, tryptophan); andrenostenedione; antipyrine; arabinitol enantiomers; arginase; benzoylecgonine (cocaine); biotinidase; biopterin; c-reactive protein; carnitine; camosinase; CD4; ceruloplasmin; chenodeoxycholic acid; chloroquine; cholesterol; cholinesterase; cortisol; testosterone; choline; creatine kinase; creatine kinase MM isoenzyme; cyclosporin A; d-penicillamine; de-ethylchloroquine; dehydroepiandrosterone sulfate; DNA (acetylator polymorphism, alcohol dehydrogenase, alpha I -antitrypsin, cystic fibrosis, Duchenne / Becker muscular dystrophy, glucose-6-phosphate dehydrogenase, hemoglobin A, hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F, D-Punjab, betathalassemia, hepatitis B virus, HCMV, HIV-I, HTLV-I, Leber hereditary optic neuropathy, MCAD, RNA, PKU, Plasmodium vivax, sexual differentiation, 21 -deoxy cortisol); desbutylhalofantrine; dihydropteridine reductase; diptheria / tetanus antitoxin; erythrocyte arginase; erythrocyte protoporphyrin; esterase D; fatty acids / acylglycines; triglycerides; glycerol; free B-human chorionic gonadotropin; free erythrocyte porphyrin; free thyroxine (FT4); free tri -iodothyronine (FT3); fumarylacetoacetase; galactose / gal- 1 -phosphate; galactose- 1 -phosphate uridyltransferase; gentamicin; glucose-6-phosphate dehydrogenase;- 21 - 4924-6933-72190985-PCTUS01 PATENTglutathione; glutathione perioxidase; glycocholic acid; glycosylated hemoglobin; halofantrine; hemoglobin variants; hexosaminidase A; human erythrocyte carbonic anhydrase I; 17-alpha-hydroxyprogesterone; hypoxanthine phosphoribosyl transferase; immunoreactive trypsin; lactate; lead; lipoproteins ((a), B / A-l, 13); lysozyme; mefloquine; netilmicin; phenobarbitone; phenytoin; phytanic / pristanic acid; progesterone; prolactin; prolidase; purine nucleoside phosphorylase; quinine; reverse tri-iodothyronine (rT3); selenium; serum pancreatic lipase; sissomicin; somatomedin C; specific antibodies (adenovirus, anti-nuclear antibody, anti-zeta antibody, arbovirus, Aujeszky’s disease virus, dengue virus, Dracunculus medinensis, Echinococcus granulosus, Entamoeba histolytica, enterovirus, Giardia duodenalisa, Helicobacter pylori, hepatitis B virus, herpes virus, HIV-1, IgE (atopic disease), influenza virus, Leishmania donovani, leptospira, measles / mumps / rubella, Mycobacterium leprae, Mycoplasma pneumoniae, Myoglobin, Onchocerca volvulus, parainfluenza virus, Plasmodium falciparum, poliovirus, Pseudomonas aeruginosa, respiratory syncytial virus, rickettsia (scrub typhus), Schistosoma mansoni, Toxoplasma gondii, Trepenoma pallidium, Trypanosoma cruzi / rangeli, vesicular stomatis virus, Wuchereria bancrofti, yellow fever virus); specific antigens (hepatitis B virus, HIV-1); acetone (e.g., succinylacetone); acetoacetic acid; sulfadoxine; theophylline; thyrotropin (TSH); thyroxine (T4); thyroxine-binding globulin; trace elements; transferrin; UDP-galactose-4-epimerase; urea; uroporphyrinogen I synthase; vitamin A; white blood cells; and zinc protoporphyrin. Salts, sugar, protein, fat, vitamins, and hormones naturally occurring in blood or interstitial fluids can also constitute analytes in certain examples. The analyte can be naturally present in the biological fluid or endogenous, for example, a metabolic product, a hormone, an antigen, an antibody, and the like. Alternatively, the analyte can be introduced into the body or exogenous, for example, a contrast agent for imaging, a radioisotope, a chemical agent, a fluorocarbon-based synthetic blood, or a drug or pharmaceutical composition, including but not limited to insulin; glucagon; ethanol; cannabis (marijuana, tetrahydrocannabinol, hashish); inhalants (nitrous oxide, amyl nitrite, butyl nitrite, chlorohydrocarbons, hydrocarbons); cocaine (crack cocaine); stimulants (amphetamines, methamphetamines, Ritalin, Cylert, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine); depressants (barbiturates, methaqualone, tranquilizers such as Valium, Librium, Miltown, Serax, Equanil, Tranxene); hallucinogens (phencyclidine, lysergic acid, mescaline, peyote, psilocybin); narcotics (heroin, codeine, morphine, opium, meperidine, Percocet, Percodan, Tussionex, Fentanyl, Darvon, Talwin, Lomotil); designer drugs (analogs of fentanyl, meperidine, amphetamines, methamphetamines, and phencyclidine, for example, Ecstasy); anabolic steroids; and nicotine. The metabolic products of drugs and pharmaceutical - 22 - 4924-6933-72190985-PCTUS01 PATENTcompositions are also contemplated analytes. Analytes such as neurochemicals and other chemicals generated within the body can also be analyzed, such as, for example, ascorbic acid, uric acid, dopamine, noradrenaline, 3-methoxytyramine (3MT), 3,4-dihydroxyphenylacetic acid (DOPAC), homovanillic acid (HVA), 5-hydroxytryptamine (5HT), 5-hydroxyindoleacetic acid (FHIAA), and intermediaries in the Citric Acid Cycle.

[0108] Any of the features described in the context of at least FIG. 1 can be applicable to all aspects and implementations identified herein. Moreover, any of the features of an implementation is independently combinable, partly or wholly with other implementations described herein in any way, e.g., one, two, or three or more examples may be combinable in whole or in part. Further, any of the features of an example may be made optional to other aspects or examples. Any aspect or example of a method can be performed by a system or apparatus of another aspect or example, and any aspect or example of a system can be configured to perform a method of another aspect or example.

[0109] FIG. 2A illustrates a perspective view of an exemplary on-skin wearable medical device, in the form of an on-skin sensor assembly 200, which is configured to be deployed to skin. The on-skin sensor assembly 200 may include a housing or base 202. The housing or base 202 may be configured to be worn on skin of a host and may include a distal surface for facing towards the skin and a proximal surface 203 facing opposite the distal surface. The housing or base 202 may include an opening 205 for an insertion element to be retracted proximally through from the skin. A patch 204 such as an adhesive patch can couple the base 202 to the skin 206 of the host. The patch 204 may be positioned on the distal surface of the housing or base 202. In some examples, the adhesive patch 204 may include an engaging surface for engaging the skin 206 and including an adhesive suitable for skin adhesion, for example a pressure sensitive adhesive (e.g., acrylic, rubber-based, or other suitable type) bonded to a carrier substrate (e.g., spun lace polyester, polyurethane film, or other suitable type) for skin attachment, though any suitable type of adhesive is also contemplated. An applicator system can engage the adhesive patch 204 to the skin 206.

[0110] The on-skin sensor assembly 200 may include an electronics unit 208 (e.g., a transmitter) which may comprise a glucose sensor module 210 coupled to an analyte sensor such as a transcutaneous analyte sensor (e.g., a glucose sensor) 212 and to the housing or base 202. The glucose sensor module 210 may be secured to the housing or base 202 (e.g., via retention elements such as snap fits and / or interference features, adhesive, welding, etc.) to ensure analyte sensor 212 (e.g., glucose sensor) is coupled to base 202. In alternative examples,- 23 - 4924-6933-72190985-PCTUS01 PATENTthe sensor module 210 and the housing or base 202 are preassembled or manufactured as a single component.[oni] After the on-skin sensor assembly 200 is deployed to a user’s (e.g., a host’s) skin, a user (or an applicator) can couple the electronics unit 208 to the on-skin sensor assembly 200 via retention elements such as snap fits and / or interference features. The electronics unit 208 can measure and / or analyze glucose indicators sensed by the transcutaneous analyte sensor (e.g., a glucose sensor) 212. The electronics unit 208 can transmit information (e.g., measurements, analyte data, glucose data) to a remotely located device (e.g., 110-114 shown in FIG. 1).

[0112] The on-skin sensor assembly 200 may be attached to the host with use of an applicator adapted to provide convenient and secure application. Such an applicator may also be used for attaching the electronics unit 208 to housing or base 202, inserting the sensor 212 through the host’s skin, and / or connecting the sensor 212 to the electronics unit 208. Once the electronics unit 208 is engaged with the housing or base 202 and the sensor 212 has been inserted into the skin 206 (and is connected to the electronics unit 208), the on-skin sensor assembly 200 can detach from the applicator.

[0113] FIGS. 2B and 2C illustrate perspective views of the electronics unit 208 coupled to the base 202 via retention elements such as snap fits and / or interference features. In examples, the electronics unit 208 and the base 202 may be coupled together by adhesive, welding, or other bonding techniques. The patch 204 may be attached to the distal face of the base 202 and may be configured to couple the on-skin sensor assembly 200 to the skin. The on-skin sensor assembly 200 may be disposable or reusable.

[0114] FIG. 3 illustrates an example of an on-skin wearable medical device in the form of an on-skin sensor assembly 300 with an electronics unit 302 configured to insert into a cavity 304 of the base or housing 306. The base or housing 306 may be configured to be worn on skin of a host and may include a distal surface for facing towards the skin and a proximal surface 305 facing opposite the distal surface. The electronics unit 302 may include one or more tabs 308 that couple to a portion of the housing 306 and allow the electronics unit 302 to be retained by the housing 306. The housing 306 may include an opening 310 for an insertion element to be retracted proximally through from the skin. The opening 310 may allow the insertion element (such as a needle) to pass through to deploy the transcutaneous analyte sensor 312 to the skin. The patch 314 may further include an aperture 316 that may allow the sensor 312 and the insertion element to pass through. The electronics unit 302 may couple to the housing 306 prior to or following deployment of the sensor 312 to the host’s skin.- 24 - 4924-6933-72190985-PCTUS01 PATENT

[0115] FIG. 4 illustrates an example of an on-skin wearable medical device in the form of an on-skin sensor assembly 400, in which the electronics unit is integral with the housing 402. The housing 402 may be configured to be worn on skin of a host and may include a distal surface for facing towards the skin and a proximal surface 403 facing opposite the distal surface. The on-skin sensor assembly 400 is shown on the skin 404, with the patch 406 engaging the skin 404.

[0116] The examples of FIGS. 2A-4 may each include an engaging surface for engaging the skin. The engaging surface may be positioned on the patch in examples, for example on a distal surface of the patch or may have another position in examples. The engaging surface may comprise an adhesive surface in examples configured to adhere to the skin. The adhesive can be configured for adhering to skin. Additional adhesive information is described in U.S. Patent No. 11,219,413, which was filed on August 25, 2015. The entire contents of U.S. Patent No. 11,219,413 are incorporated by reference herein. The engaging surface in examples may be covered with a liner prior to deployment to the host’s skin.

[0117] FIG. 5 illustrates a system for deploying an on-skin wearable medical device to skin. The system may comprise an applicator system in examples. The system may include an applicator 500 for an on-skin sensor assembly of an analyte sensor system, according to some examples. In examples, other forms of systems may be utilized.

[0118] The applicator 500 may include an applicator housing 501, which may include an outer housing 504 and an inner housing 506 (marked in FIG. 6), and other forms of housings in examples. The applicator housing 501 may be configured to retain the on-skin wearable medical device in examples. The applicator 500 may include a deployment mechanism that may be configured to deploy the on-skin wearable medical device to skin. The deployment mechanism, for example, may include one or more retention elements for retaining the on-skin wearable medical device and releasing the on-skin wearable medical device from the applicator housing 501 to the skin in examples. The deployment mechanism may include an insertion assembly for inserting at least a portion of the on-skin wearable medical device into the skin. The insertion assembly may drive a portion of the on-skin wearable medical device, such as the insertion element and the sensor, into the skin of the host. The deployment mechanism may include a retraction assembly for retracting the portion of the on-skin wearable medical device from the skin, such as an insertion element.

[0119] In examples, the applicator 500 may include an activation element 502 disposed on a side of applicator 500, for example, on a side of the outer housing 504 of the applicator 500. In some examples, the activation element 502 may be a button, a switch, a toggle, a slide,- 25 - 4924-6933-72190985-PCTUS01 PATENTa trigger, a knob, a rotating member, a portion of the applicator 500 that deforms and / or flexes or any other suitable mechanism for activating the insertion and / or retraction assembly of the applicator 500. In some examples, the activation element 502 may be disposed in any location, e.g., a top, upper side, lower side, or any other location of the applicator 500. The applicator 500 may be large enough for a host to grasp with a hand and push, or otherwise activate, the activation element 502 with, for example, a thumb, or with an index finger and / or a middle finger (or any other portion of the host’s hand).

[0120] The applicator 500 may be configured with one or more safety features such that the applicator 500 is prevented from activating until the safety feature is deactivated. In one example, the one or more safety features prevents the applicator 500 from activating unless the applicator 500 is pressed against the skin of a host with sufficient force. Moreover, as will be described in more detail in connection with one or more of FIGS. 6-20B below, the applicator 500 may be further configured such that one or more components therein retract based at least in part on the one or more components pushing against the skin of the host with a force exceeding a predetermined threshold, rather than based on the one or more components translating beyond a predetermined and static distal position. In other words, the applicator 500 may implement force-based retraction triggering rather than being limited to displacementbased retraction triggering.

[0121] FIG. 6 illustrates an exploded perspective view of the applicator 500 of FIG. 5, according to some examples. The applicator 500 may include the outer applicator housing 504 comprising the activation element 502. The outer applicator housing 504 may be configured to be gripped by a user in examples. The outer applicator housing 504 may be configured to translate in a distal direction by a force applied by a host to the applicator 500, specifically to the inner housing 506, thereby aligning the activation element 502 in a position that allows the applicator 500 to fire. Further explanation of the alignment process will be explained below.

[0122] The inner housing 506 may be configured to house at least one or more mechanisms utilized to apply an on-skin sensor assembly 508 to skin of a host. A distal surface 510 of a bottom opening of the inner housing 506 may define a bottom surface of the applicator 500. In some examples, upon pressing the applicator 500 against skin of the host, skin may deform in a substantially convex shape at the distal surface 510 such that at least a portion of a surface of skin disposed at the bottom opening of the applicator inner housing 506 extends into the bottom opening of the inner housing 506 beyond a plane defined by the distal surface 510 in a proximal direction.- 26 - 4924-6933-72190985-PCTUS01 PATENT

[0123] As shown in FIG. 7, the housing 501, and particularly the inner housing 506 may include an internal cavity 503 for retaining the on-skin wearable medical device. The internal cavity 503 may have a distal end portion 505 at the opening for the on-skin wearable medical device to pass through. A proximal end portion 507 of the internal cavity 503 may include the on-skin wearable medical device coupled to a needle carrier assembly 516.

[0124] Referring back to FIG. 6, in some examples, a first barrier layer 512 may be disposed over one or more apertures in the inner housing 506, for example, an aperture 514 through which at least a portion of the activation element 502 may be configured to extend through during activation of the applicator 500. In such examples, a portion of the activation element 502 may be configured to pierce or deform a first barrier layer 512 upon activation of the applicator 500. The first barrier layer 512 may comprise a gas permeable material such as Tyvek, or a non-gas permeable material such as metallic foil, polymer film, elastomer, or any other suitable material.

[0125] The applicator 500 may further comprise the needle carrier assembly 516, including a needle hub 518 configured to couple an insertion element 520 to the needle carrier assembly 516. In some other examples, the insertion element 520 may be directly coupled to the needle carrier assembly 516. The insertion element 520 may be configured to insert at least a portion of a sensor of the on-skin sensor assembly 508 into the skin of the host. In some examples, the insertion element 520 comprises a needle, for example, an open sided-needle, a needle with a deflected-tip, a curved needle, a polymer-coated needle, a hypodermic needle, or any other suitable type of needle or structure. In yet other examples, the insertion element 520 may be integrally formed with the sensor and may be sufficiently rigid to be inserted partially into the skin of the host with minimal or no structural support.

[0126] Applicator 500 may further include a holder 522 releasably coupled to needle carrier assembly 516 and configured to guide needle carrier assembly 516 and on-skin sensor assembly 508 while coupled to the needle carrier assembly 516, for example, at least during translation from a proximal position to a distal insertion position. As will be described in more detail below, the on-skin sensor assembly 508 may be stripped or released from the holder 522 and / or the needle carrier assembly 516 once the on-skin sensor assembly 508 is disposed on the skin of the host. For example, one or more retention elements may release the on-skin wearable medical device from the applicator housing 501.

[0127] Applicator 500 may further comprise an insertion assembly configured to translate insertion element 520, needle hub 518, needle carrier assembly 516, and on-skin sensor assembly 508 from a proximal position, in the distal direction, to a distal insertion - 27 - 4924-6933-72190985-PCTUS01 PATENTposition. Such an insertion assembly may include at least one spring for inserting at least a portion of the on-skin wearable medical device into the skin. The insertion assembly may include a first spring 524. First spring 524 may be a compression spring, or any suitable type of spring, and may have a first end in contact with or coupled to inner applicator housing 506 and a second end in contact with or coupled to holder 522. First spring 524 is configured to, upon activation of the insertion assembly, translate holder 522, needle carrier assembly 516, needle hub 518, insertion element 520 and on-skin sensor assembly 508, in the distal direction to the distal insertion position. Substantially at the distal insertion position, needle carrier assembly 516 may decouple from holder 522 and on-skin sensor assembly 508.

[0128] Applicator 500 may further comprise a retraction assembly for retracting the insertion element (e.g., needle) from the skin. The retraction assembly may be configured to translate needle carrier assembly 516, needle hub 518 and insertion element 520, in the proximal direction, from the distal insertion position to a proximal retracted position. In some examples the initial proximal position may be the same as the proximal retracted position. In other examples, the initial proximal position may be different from the proximal retracted position. Such a retraction assembly may include at least one spring. The retraction assembly may include a second spring 526. Second spring 526 may be a compression spring, or any suitable type of spring, and may have a first end contacting or coupled to holder 522 and a second end in contact with or coupled to at least one spring retention element (e.g., 528a, 528b in FIGS. 10-14), at least until retraction. Second spring 526 is configured to translate needle carrier assembly 516, needle hub 518, and insertion element 520 in the proximal direction from the distal insertion position to the proximal retracted position in response to on-skin sensor assembly 508 contacting skin of the host, and / or reaching a limit of travel with a force exceeding a predetermined threshold sufficient to cause first end of second spring 526 to overcome the at least one spring retention element (e.g., 528a, 528b in FIGS. 10-14). In some examples, a stop feature (not shown) may be disposed at a bottom of applicator 500, e.g., on a distal portion of inner housing 506. Such a stop feature may be configured to contact one or more of on-skin sensor assembly 508, needle carrier assembly 516, or holder 522 in the distal insertion position.

[0129] In some examples, a second barrier layer 530 may be disposed over the bottom opening of inner housing 506. Second barrier layer 530 may comprise a gas permeable material such as Tyvek, or a non-gas permeable material such as metallic foil, film. In some examples, second barrier layer 530 may be removed by the host prior to use of applicator 500. In examples comprising one or both of first and second barrier layers 512, 530, such layers may - 28 - 4924-6933-72190985-PCTUS01 PATENTprovide a sterile environment between applicator 500 and the outside environment and / or may allow ingress and egress of gas such as during sterilization.

[0130] A brief description of some aspects of the operation of applicator 500 follows with respect to FIGS. 7-9, which illustrate several cross-sectional views of applicator 500 of FIGS. 5 and 6 during operation, according to some examples. FIGS. 7-9 may correspond to applicator 500 cut along the section line A-A’ shown in FIG. 5, for example.

[0131] FIG. 7 illustrates a state of applicator 500 prior to activation. Holder 522 comprises an insertion assembly retention element 532 configured to contact inner housing 506, thereby immobilizing holder 522, needle carrier assembly 516, needle hub 518, insertion element 520 and on-skin sensor assembly 508, in the pre-activated state.

[0132] Needle carrier assembly 516 comprises a plurality of wearable retention and / or alignment elements 534a, 534b configured to extend through holder 522 and releasably couple on-skin sensor assembly 508 to holder 522 and / or to needle carrier assembly 516. Wearable retention elements 534a, 534b may comprise, e.g., arms, deflection element, tabs, detents, snaps or any other features capable of a retaining function. In some examples, wearable retention elements 534a, 534b may extend around rather than through holder 522. Although two wearable retention elements are illustrated, any number of wearable retention elements are contemplated. In some examples, wearable retention element(s) 534a, 534b may comprise snap fits, friction fits, interference features, elastomeric grips and / or adhesives configured to couple on-skin sensor assembly 508 with needle carrier assembly 516 and / or holder 522.

[0133] Inner housing 506 may comprise a spring 536 configured to contact outer housing 504 and maintain a predetermined spacing between outer housing 504 and inner housing 506 in the pre-activation orientation of FIG. 7. Spring 536 may be a compression spring, leaf spring, flex arm spring, a piece of foam or rubber, etc. In some other examples, outer housing 504 may comprise spring 536 and spring 536 may be configured to contact inner housing 506, in a reverse fashion from that shown in FIG. 7.

[0134] Activation of applicator 500 may include a host pressing applicator 500 against their skin with sufficient force to translate outer housing 504 in a distal direction, as shown by arrow 538, toward and with respect to inner housing 506 until activation element 502 is aligned with aperture 514 of inner housing 506 and insertion assembly retention element 532 of holder 522. Insertion assembly retention element 532 may comprise, e.g., an arm, a deflection element, a tab, a detent, a snap or any other feature capable of a retaining function. Once such an alignment is achieved, a host may initiate (e.g., push) activation element 502, as shown by arrow 540, thereby deflecting insertion assembly retention element 532 sufficiently to release - 29 - 4924-6933-72190985-PCTUS01 PATENTholder 522 from inner housing 506. In some other examples, applicator 500 may be configured such that activation element 502 may be activated first, but that actual insertion is not triggered until outer housing 504 is translated sufficiently in the distal direction toward and with respect to inner housing 506. In yet other examples, activation element 502 may be biased toward a center of applicator 500 such that activation element 502 need not be explicitly activated by the host but, instead, activation element 502 may be configured to automatically initiate insertion upon outer housing 504 being translated sufficiently in the distal direction toward and with respect to inner housing 506.

[0135] Such configurations provide several benefits. First, translation of outer housing 504 with respect to inner housing 506 before activation provides a measure of drop protection such that if applicator 500 is accidentally dropped, it may not prematurely fire. Second, spring 536 provides a force bias that the host has to affirmatively overcome by pressing applicator 500 into their skin prior to firing, thereby reducing the probability of activating applicator 500 before it is properly positioned. Further, the host may decide to not fire applicator 500 and discontinue pressing applicator 500 against their skin, in which spring 536 will bias against outer housing 504 and allow outer housing 504 to return to its initial state.

[0136] Holder 522, needle carrier assembly 516, needle hub 518, insertion element 520, on-skin sensor assembly 508, first spring 524 and second spring 526 are all shown in preactivation positions in FIG. 7.

[0137] FIG. 8 illustrates applicator 500 during insertion of on-skin sensor assembly 508 but before retraction of needle carrier assembly 516. First spring 524 drives holder 522, needle carrier assembly 516, needle hub 518, insertion element 520, and on-skin sensor assembly 508, in the distal direction toward the distal insertion position. FIG. 8 illustrates a position where on-skin sensor assembly 508 is in contact with skin of the host but where holder 522 is not yet fully driven, by first spring 524, into contact with on-skin sensor assembly 508 or skin of the host.

[0138] In some examples, masses of each of holder 522, needle carrier assembly 516, needle hub 518, insertion element 520, and on-skin sensor assembly 508 may be specifically designed to reduce or substantially eliminate a tendency of needle carrier assembly 516, needle hub 518, insertion element 520, and on-skin sensor assembly 508 to detach due to inertial forces from holder 522 while being driven in the distal direction during insertion. In some examples, a force exerted by first spring 524 may be selected to be sufficient for proper operation of applicator 500, while not so large as to further exacerbate such above-described inertially triggered detachment. In some examples, a spring (not shown) may be configured to exert a - 30 - 4924-6933-72190985-PCTUS01 PATENTforce against a portion of needle carrier assembly 516, for example in a distal direction, sufficient to prevent needle carrier assembly 516 from inertially triggered detaching from holder 522 during insertion.

[0139] FIG. 9 illustrates applicator 500 during activation, as needle carrier assembly 516, needle hub 518 and insertion element 520 are retracted in the proximal direction by second spring 526. In FIG. 9, first spring 524 has fully driven on-skin sensor assembly 508 to the skin of the host. In this position, second spring 526 is released from spring retention elements (e.g., 528a, 528b in FIGS. 10-14) and drives needle carrier assembly 516, needle hub 518, and insertion element 520 in the proximal direction from the distal insertion position. Upon needle carrier assembly 516 reaching the proximal retraction position, needle carrier retention element 542 of holder 522 engages with needle carrier assembly 516, thereby maintaining needle carrier assembly 516, needle hub 518 and insertion element 520 in a locked, retracted position limiting access to insertion element 520. Needle carrier retention element 542 may comprise, e.g., an arm, a deflection element, a tab, a detent, a snap or any other feature capable of a retaining function. In this retracted position, needle carrier assembly 516, needle hub 518, and insertion element 520 is prevented from travelling in a distal direction.

[0140] A further description of some aspects of the operation of applicator 500 follows with respect to FIGS. 10-12, which illustrate several cross-sectional views of applicator 500 of FIGS. 5 and 6 during operation, according to some examples. FIGS. 10-12 may correspond to applicator 500 cut along the section line B-B’ shown in FIG. 5, for example. For ease of illustration, needle hub 518 and insertion element 520 are not shown in FIGS. 10-12.

[0141] FIG. 10 illustrates a state of applicator 500 prior to activation. For ease of illustration, on-skin sensor assembly 508 is not illustrated in FIG. 10. Holder 522 comprises spring retention elements 528a, 528b configured to contact and retain a first end of second spring 526 in the pre-activated state, e.g., during insertion, while a second end of spring 526 is in contact with needle carrier assembly 516. Spring retention elements 528a, 528b may comprise, e.g., arms, deflection element, tabs, detents, snaps or any other features capable of a retaining function. Although two spring retention elements 528a, 528b are shown, at least one spring retention element is contemplated. In some examples, applicator 500 may include one spring retention element, as shown in FIGS. 21-24. In some examples, applicator 500 may include three spring retention elements. In some examples, applicator 500 may include four spring retention elements. In some examples, spring retention elements 528a, 528b are deflectable arms, rigid arms, deformable features, snaps, catches, or hooks. In some examples,- 31 - 4924-6933-72190985-PCTUS01 PATENTspring retention elements 528a, 528b may be actively deflected by one or more features within applicator 500.

[0142] Needle carrier assembly 516 comprises backstop features 544a, 544b, configured to prevent lateral deflection of spring retention elements 528a, 528b in the proximal starting position, e.g., at least during insertion, thereby supporting retention of second spring 526 between spring retention elements 528a, 528b and holder 522 until retraction. Although two backstop features are illustrated, any number of backstop features are contemplated. The number of backstop features may equal the number of spring retention elements.

[0143] FIG. 13 illustrates a magnified view of spring retention element 528b and backstop feature 544b. In FIG. 13, first spring 524 is driving holder 522, needle carrier assembly 516 and on-skin sensor assembly 508, in the distal direction toward the distal inserted position. Backstop feature 544b is shown engaged to spring retention element 528b, preventing spring retention element 528b from deflecting laterally, thereby preventing second spring 526 from releasing. As shown in FIG. 13, a proximal end of spring retention element 528b may be offset from a distal end of backstop feature 544b by a distance a. In some examples, distance a is the length required for spring retention element 528b to traverse along backstop feature 544b such that spring retention element 528b clears past backstop feature 544b. Backstop feature 544b may feature a ramp to guide spring retention element 528b. A distal end of needle carrier assembly 516 and a distal end of holder 522 may be offset from each other at least the same distance a to allow for spring retention element 528b to traverse distally past backstop feature 544b.

[0144] It may be appreciated that the frictional force between corresponding contacting surfaces of backstop feature 544b and spring retention element 528b may at least partly determine an amount of force to release spring retention element 528b from backstop feature 544b. This force may allow for lateral deflection of spring retention element 528b and thus allow the expansion of second spring 526. In some examples, the amount of force is at least 0.1 pounds. In some examples, the amount of force is at least 0.5 pounds. In some examples, the amount of force is at least 1 pound. In some examples, the amount of force is at least 2 pounds. In some examples, the amount of force is at least 3 pounds. In some examples, the amount of force is at least 4 pounds. In some examples, the amount of force is at least 5 pounds.

[0145] Although the figure shows backstop feature 544b preventing lateral deflection of spring retention element 528b in a radially outward direction, it is contemplated that an inverse structural relationship can be achieved. For instance, the ramped surface of spring retention element 528b can be reversed to face the opposite direction as shown in FIG. 13.- 32 - 4924-6933-72190985-PCTUS01 PATENTFurther, the ramped surface of spring retention element 528b may be biased in a radially inward direction by second spring 526 against backstop feature 544b. In such examples, backstop feature 544b may be located radially inward of spring retention element 528b.

[0146] Accordingly, in some examples, materials utilized to form holder 522 and needle carrier assembly 516 may be selected based on a desired amount of force to release spring retention element 528b for lateral deflection. Examples of such materials may include polycarbonate, ABS, PC / ABS, polypropylene, HIPS (High impact polystyrene), polybutylene terephthalate (PBT), polyoxymethylene (POM), acetal, polyacetal, polyformaldehyde, PTFE, high density polyethylene (HDPE), ultra-high-molecular-weight polyethylene (UHMWPE), nylon, polyethylene terephthalate (PET), thermoplastic elastomer (TPE), thermoplastic polyurethane (TPU), silicone thermoplastic elastomer (TPSiv), cyclo-olefin polymer (COP), cyclo-olefin copolymer (COC), and / or liquid-crystal polymer (LCP).

[0147] An angle 9 of a portion of spring retention element 528b in contact with second spring 526 may also affect the amount of frictional force to laterally deflect spring retention element 528b and so to release second spring 526. Accordingly, the angle 9 may be selected based on a desired amount of force to laterally deflect spring retention element 528b sufficiently to release second spring 526. In some examples, the angle 9 is at least 1 degree with respect to a vertical axis of the spring retention element 528b. In some examples, the angle 9 is at least 5 degrees. In some examples, the angle 9 is at least 19 degrees. In some examples, the angle 9 is at least 15 degrees. In some examples, the angle 9 is at least 29 degrees. In some examples, the angle 9 is about 39 to 45 degrees. In addition, the force profile of second spring 526 may affect a target amount of frictional force to laterally deflect spring retention element 528b. Accordingly, in some examples, the force profile of second spring 526 may be taken into account when selecting one or both of the materials for forming holder 522 and needle carrier assembly 516 and the angle 9 of the portion of spring retention element 528b in contact with second spring 526.

[0148] An angle 13 of spring retention element 528b with respect to a vertical axis may also affect the amount of frictional force to laterally deflect spring retention element 528b and so to release second spring 526. By contacting spring retention element 528b, second spring 526 may exert a force on spring retention element 528b at a distance d from a bottom of spring retention element 528b that causes a torque moment sufficient to induce a lateral deflection of spring retention element 528b.

[0149] FIG. 13 further illustrates needle carrier assembly 516 comprising a deflecting element 546 configured to contact spring retention element 528b and maintain spring retention - 33 - 4924-6933-72190985-PCTUS01 PATENTelement 528b in a laterally deflected orientation once second spring 526 has initially deflected spring retention element 528b and sufficiently driven needle carrier assembly 516 in the proximal direction, as will be shown in more detail in FIG. 14. Deflecting element 546 may prevent spring retention element 528b from contacting the windings of second spring 526 while second spring 526 is extending, smoothing the operation of applicator 500 and preventing energy released by second spring 526 and designed for driving needle carrier assembly 516 in the proximal direction from being absorbed by undesired contact with spring retention element 528b during the release of second spring 526.

[0150] In some examples, the angle 9 of the portion of spring retention element 528b in contact with second spring 526 may be substantially 90° (e.g., flat) and deflecting element 546 may have a ramped or angled surface in contact with spring retention element 528b in the position illustrated in FIG. 13. In such examples, deflecting element 546, in addition to the above-described functionality, may be configured to initially deflect spring retention element 528b as first spring 524 drives holder 522 from the position illustrated in FIG. 13 to the position illustrated in FIG. 14.

[0151] In some examples, inner housing 506 may comprise a protrusion 548 extending from inner housing 506 in the distal direction. Protrusion 548 may be configured to contact at least one of spring retention elements 528a, 528b and backstop features 544a, 544b in the preactivation state such that spring retention elements 528a, 528b are prevented from laterally deflecting until holder 522 and needle carrier assembly 516 have translated at least a predetermined minimum distance in the distal direction. Accordingly, protrusion 548 may provide a measure of drop protection such that applicator 500 may not prematurely fire in response to a concussive shock from being dropped before intentional activation.

[0152] Turning back to FIG. 10, inner housing 506 may further comprise an engagement element 550 configured to engage with a protrusion 552 of needle carrier assembly 516 upon needle carrier assembly 516 translating in the distal direction beyond a predetermined threshold, thereby preventing needle carrier assembly 516 from translating in the distal direction beyond the predetermined threshold. It is contemplated that this may ensure needle carrier assembly retraction in the event of an air firing or dry firing in which applicator 500 is somehow activated when not held against the skin of the host. In some examples, the predetermined threshold may correspond to the distal end of needle carrier assembly 516 extending beyond a point proximal to the distal end of inner housing 506, to a point substantially in line with the distal end of inner housing 506 or to a point distal of the distal end of inner housing 506. In some examples, engagement element 550 comprises a hook, a U- - 34 - 4924-6933-72190985-PCTUS01 PATENTshaped structure, a loop, a protrusion, or any other structure capable of engaging with protrusion 552 as described above.

[0153] FIG. 11 illustrates applicator 500 after activation, at a beginning of a force retraction feature process at or near the distal insertion position where on-skin sensor assembly 508 may be in contact with the skin of the host. First spring 524 has driven holder 522, needle carrier assembly 516, needle hub 518, insertion element, and on-skin sensor assembly 508, in the distal direction toward the distal insertion position (also may be referred to herein as the lowered position). During proper operation, holder 522 and on-skin sensor assembly 508 should be pressing against the skin of the host. However, FIG. 11 may also illustrate a dry fire condition, where applicator 500 is not properly pressed against the skin of the host before triggering applicator 500. Accordingly, upon first spring 524 driving holder 522 and needle carrier assembly 516 in the distal direction beyond the predetermined threshold, engagement element 550 contacts protrusion 552, which prevents needle carrier assembly 516 from traveling further in the distal direction, while holder 522 is driven sufficiently further in the distal direction such that backstop features 544a, 544b of needle carrier assembly 516 no longer contact spring retention elements 528a, 528b in the distal insertion position, thereby releasing the first end of second spring 526 and initiating retraction even when applicator 500 is dry fired. The insertion force provided by first spring 524 may be sufficient to additionally overcome the frictional force between corresponding contacting surfaces of backstop feature 544b and spring retention element 528b.

[0154] Turning to FIG. 14, first spring 524 has driven holder 522, needle carrier assembly 516 and on-skin sensor assembly 508 in the distal direction to the skin of the host. As first spring 524 drives holder 522, needle carrier assembly 516 and on-skin sensor assembly 508 against the skin of the host, the skin provides a counter force to the force generated by first spring 524. The skin may oppose the force of first spring 524 and bias against the distal end of on-skin sensor assembly 508. Because the distal end of holder 522 is offset from the distal end of on-skin sensor assembly 508 as shown in FIG. 13, the counter force provided by the skin is transferred to holder 522 as first spring 524 continues to drive holder 522 towards the skin while on-skin sensor assembly 508 is pressed against the skin. The counter force provided by the skin allows spring retention element 528b to displace past backstop feature 544b. Once spring retention element 528b has cleared distance a past backstop feature 544b, second spring 526 can laterally deflect spring retention element 528b, thereby releasing second spring 526, which drives needle carrier assembly 516 in the proximal direction. Alternatively, as described above in connection with FIG. 13, where the angle 9 of the portion of spring retention element - 35 - 4924-6933-72190985-PCTUS01 PATENT528b in contact with second spring 526 is substantially 90° (e.g., flat), the ramped or angled surface of deflecting element 546 in contact with spring retention element 528b deflects spring retention element 528b sufficiently to release second spring 526, which drives needle carrier assembly 516 in the proximal direction.

[0155] In some examples, engagement element 550 may engage protrusion 552 even when applicator 500 is pressed against the skin of a user. In such examples, engagement element 550 engages protrusion 552 as first spring 524 drives holder 522, needle carrier assembly 516, and on-skin sensor assembly 508 against the skin of the host. As explained above, engagement element 550 prevents needle carrier assembly 516 from moving distally when engagement element 550 engages protrusion 552. This allows spring retention elements 528a, 528b to separate away from backstop features 544a, 544b and allow for release of second spring 526. The engagement of engagement element 550 and protrusion 552 may add additional force to the counter force provided by the skin, thus increasing the energy needed to overcome the frictional engagement of spring retention elements 528a, 528b and backstop features 544a, 544b. In some instances, the engagement of engagement element 550 and protrusion 552 provides an immediate impulse force that converts at least some of the initial energy of first spring 524 into energy needed to overcome the frictional engagement of spring retention elements 528a, 528b and backstop features 544a, 544b. It is contemplated that such examples may benefit users with soft skin or higher body fat percentage.

[0156] Turning back to FIG. 12, which illustrates applicator 500 during activation, needle carrier assembly 516 is retracted in the proximal direction by second spring 526, as indicated by arrow 554. In FIG. 12, with backstop features 544a, 544b no longer immobilizing spring retention elements 528a, 528b, first end of second spring 526 pushes against spring retention elements 528a, 528b with sufficient force to deflect spring retention elements 528a, 528b in the distal insertion position when on-skin sensor assembly 508 is in contact with skin of the host, allowing second spring 526 to clear spring retention elements 528a, 528b and drive needle carrier assembly 516 in the proximal direction, thereby maintaining needle carrier assembly 516, needle hub 518 (see FIGS. 7-9) and insertion element 520 (see FIGS. 7-9) in a locked, retracted position even in the event of a dry fire.

[0157] FIGS. 15 and 16 illustrate magnified views of some features of an applicator, such as applicator 500, according to some examples.

[0158] In FIG. 15, first spring 524 (see FIGS. 6-12) is driving holder 522, as well as the needle carrier assembly and on-skin sensor assembly 508 in the distal direction, illustrated by arrow 556, toward the distal insertion position. Retention element 534b of the needle carrier - 36 - 4924-6933-72190985-PCTUS01 PATENTassembly is releasably coupled to on-skin sensor assembly 508. As illustrated, during insertion and near the distal inserted position, holder 522 is in contact with spring retention element 534b, preventing spring retention element 534b from deflecting laterally and thereby rigidly securing on-skin sensor assembly 508 to the needle carrier assembly.

[0159] In FIG. 16, second spring 526 (see FIGS. 6-12) is driving needle carrier assembly 516 in the proximal direction from the distal insertion position. Because holder 522 has been driven sufficiently in the distal direction, at the distal insertion position, holder 522 is no longer in contact with wearable retention element 534b. Accordingly, wearable retention element 534b is free to deflect laterally, thereby releasing on-skin sensor assembly 508 from wearable retention element 534b and thus from the needle carrier assembly 516. Needle carrier assembly 516 is now driven in the proximal direction by second spring 526, while on-skin sensor assembly 508 is secured to the skin of the host. Moreover, in some examples, because holder 522 is driven to the distal inserted position and substantially held in that position by first spring 524, holder 522 may press against one or both of on-skin sensor assembly 508 or an adhesive patch of on-skin sensor assembly 508, supporting one or both during attachment to the skin of the host.

[0160] FIG. 17 illustrates a perspective partial cutaway view of needle carrier assembly 516, needle hub 518, and on-skin sensor assembly 508 of applicator 500 of FIGS. 5 and 6, according to some examples. FIG. 18 illustrates a cross-sectional view of needle hub 518 and on-skin sensor assembly 508, according to some examples. FIG. 19 illustrates a top view of a portion of needle carrier assembly 516 and needle hub 518, according to some examples. The following is a description of these features with reference to FIGS. 17-19.

[0161] On-skin sensor assembly 508 comprises sensor assembly opening 560. Needle hub 518 is configured to couple insertion element 520 to needle carrier assembly 516 and to substantially maintain a desired orientation of insertion element 520 during insertion of the sensor of on-skin sensor assembly 508 into the skin of the host.

[0162] Needle hub 518 comprises a plurality of upper arms 562a, 562b, a plurality of lower arms 564a, 564b, and a base 566. Although two upper arms and two lower arms are illustrated, any number of arms, including a single upper and lower arm, are contemplated. In some examples, upper arms 562a, 562b and lower arms 564a, 564b may be flexible such that, when needle hub 518 is coupled to needle carrier assembly 516, upper arms 562a, 562b and lower arms 564a, 564b secure needle hub 518 in a desired orientation with respect to needle carrier assembly 516. For example, upper arms 562a, 562b may be configured to flex radially inward, such that when disposed through a carrier aperture 568 in needle carrier assembly 516,- 37 - 4924-6933-72190985-PCTUS01 PATENTupper arms 562a, 562b are in contact with an upper surface of needle carrier assembly 516 adjacent to carrier aperture 568 and lower arms 564a, 564b are in contact with a lower surface of needle carrier assembly 516 adjacent to carrier aperture 568. Such an arrangement allows a compliant fit between needle carrier assembly 516 and needle hub 518 where lower arms 564a, 564b deflect to allow upper arms 562a, 562b to expand after clearing surface of carrier aperture 568. The lower arms 564a, 564b can partially or fully relax to bias the needle hub in a distal direction and decrease the clearance between the needle hub and the needle carrier that would otherwise exist with a non-compliant fit. In addition, upper arms 562a, 562b and lower arms 564a, 564b also help to maintain contact between base 566 and a top surface of on-skin sensor assembly 508.

[0163] Base 566 comprises an anti-rotation feature. The anti-rotation feature may comprise a key having a shape complementary to at least a portion of sensor assembly opening 560 of on-skin sensor assembly 508 and may be configured to substantially prevent needle hub 518 from rotating about an axis 567 parallel to insertion element 520 with respect to on-skin sensor assembly 508, e.g., to prevent rotation of base 566 within sensor assembly opening 560. In addition, or the alternative, the upper surface of needle carrier assembly 516 adjacent to carrier aperture 568 may comprise a groove 570 configured to accept upper arms 562a, 562b when upper arms 562a, 562b are disposed through carrier aperture 568 in an orientation complementary to an orientation of groove 570, as illustrated in FIG. 19, thereby immobilizing needle hub 518 with respect to needle carrier assembly 516.

[0164] In some examples, base 566 further comprises a substantially flat surface configured to mate with a top surface or proximal surface of on-skin sensor assembly 508 and maintain insertion element 520 in a substantially perpendicular orientation to the top surface of on-skin sensor assembly 508, in some cases, when the anti-rotation feature of base 566 is engaged within sensor assembly opening 560 of on-skin sensor assembly 508.

[0165] Based at least upon the above-described features of needle hub 518, on-skin sensor assembly 508, and / or needle carrier assembly 516, base 566 allows easy assembly during manufacture, including but not limited to proper alignment and preassembly of insertion element 520 onto on-skin sensor assembly 508, and / or the ability to easily engage an assembly of needle hub 518, insertion element 520, sensor and on-skin sensor assembly 508 to other portions of assembled applicator 500.

[0166] FIGS. 20 A and 20B illustrate perspective views of locking features for insertion elements in the form of needles 600a, 600b for use in an applicator (e.g., applicator 500) for an analyte sensor system, according to some examples. For example, needle 600a of FIG. 20A - 38 - 4924-6933-72190985-PCTUS01 PATENTcomprises a locking feature comprising a ridge 602 configured to mate with a complementary-shaped feature within needle hub 518, for example. In the alternative, needle 600b of FIG. 20B comprises a locking feature comprising a groove 604 configured to mate with a complementary-shaped feature within needle hub 518, for example.

[0167] In yet another alternative, any insertion element described in this disclosure may comprise a locking feature that heat stakes the selected insertion element to needle hub 518, for example. In yet another alternative, any insertion element described in this disclosure may comprise a locking feature comprising one or more friction-fit or snap-fit elements securing the selected insertion element to needle hub 518, for example. In yet another alternative, any insertion element described in this disclosure may comprise a locking feature comprising complementary clamshell elements on the selected insertion element and needle hub 518, for example, configured to mate with one another. In yet another alternative, any insertion element described in this disclosure may comprise a locking element comprising one or more inserted molded elements configured to couple the selected insertion element to needle hub 518, for example.

[0168] During manufacture, applicator 500 may be assembled in stages. For example, and not limitation, if present, first barrier layer 512 may be affixed to inner housing 506. Insertion element 520 may be coupled to needle hub 518, which may then be coupled to on-skin sensor assembly 508. Second spring 526 may be placed into holder 522 or needle carrier assembly 516 and then needle carrier assembly 516 may be disposed into holder 522 and attached to needle hub 518 and to on-skin sensor assembly 508 via wearable retention elements 534a, 534b. First spring 524 may be disposed in holder 522, which may then be installed into inner housing 506. Inner housing 506 may be inserted into and secured to outer housing 504. If present, second barrier layer 530 may be affixed to inner housing 506. If a separate element, activation element 502 may then be disposed into outer housing 504. Any labeling, sterilizing and / or packaging may then be applied to applicator 500.

[0169] FIGS. 21-23 illustrate several cross-sectional views, and various features and operating positions, of another applicator 700 for an on-skin sensor assembly of an analyte sensor system, according to some examples.

[0170] Applicator 700 may include outer applicator housing 504 comprising activation element 502. Outer applicator housing 504 may be configured to translate in a distal direction under force applied by a host of applicator 700, thereby aligning activation element 502 in a position that allows applicator 700 to fire, an alignment illustrated by FIG. 21. As previously described in connection with applicator 500, in some examples, activation element 502 may be - 39 - 4924-6933-72190985-PCTUS01 PATENTdisposed in any location, e.g., a top, upper side, lower side, or any other location of applicator 700.

[0171] Applicator 700 further comprises inner housing 506, configured to house one or more mechanisms utilized to apply on-skin sensor assembly 508 to skin of a host. Distal surface 510 of a bottom opening of inner housing 506 may define a bottom surface of applicator 700. In some examples, upon pressing applicator 700 against the skin of the host, the skin may deform in a substantially convex shape at distal surface 510 such that at least a portion of a surface of the skin disposed at the bottom opening of applicator housing 506 extends into the bottom opening of inner housing 506, in a proximal direction, beyond a plane defined by distal surface 510.

[0172] Although not illustrated in FIGS. 21-23, inner housing 506 may comprise a spring 536 configured to contact outer housing 504 and maintain a predetermined spacing between outer housing 504 and inner housing 506 in the pre-activation orientation (see FIG.7). Spring 536 may be a compression spring, leaf spring, flex arm spring, a piece of foam or rubber, etc. In some other examples, outer housing 504 may comprise spring 536 and spring 536 may be configured to contact inner housing 506.

[0173] Applicator 700 may further comprise a needle carrier assembly 702. Needle carrier assembly 702 comprises wearable retention and / or alignment elements 534a, 534b configured to pass through holder 704 and releasably couple on-skin sensor assembly 508 to holder 704 and / or to needle carrier assembly 702. Although two wearable retention and / or alignment elements are illustrated, any number of wearable retention and / or alignment elements are contemplated.

[0174] Applicator 700 further comprises needle hub 518 configured to couple insertion element 520 to needle carrier assembly 702. Insertion element 520 is configured to insert sensor of on-skin sensor assembly 508 into skin of the host. In some examples, insertion element 520 comprises a needle, for example, an open sided-needle, a needle with a deflected-tip, a curved needle, a polymer-coated needle, a hypodermic needle, or any other suitable type of needle or structure. In yet other examples, insertion element 520 may be integrally formed with sensor, in which insertion element 520 may be sufficiently rigid to be inserted partially into skin of the host with minimal or no structural support.

[0175] Applicator 700 may further include holder 704 releasably coupled to needle carrier assembly 702 and configured to guide on-skin sensor assembly 508 while coupled to needle carrier assembly 702, e.g., at least during translation from a proximal position to a distal insertion position. As previously described in connection with applicator 500, on-skin sensor - 40 - 4924-6933-72190985-PCTUS01 PATENTassembly 508 may be stripped or released from holder 704 and / or needle carrier assembly 702 once on-skin sensor assembly 508 is disposed on the skin of the host.

[0176] Applicator 700 may further comprise an insertion assembly configured to translate insertion element 520, needle hub 518, and needle carrier assembly 702 from a proximal position, in the distal direction, to a distal insertion position. Such an insertion assembly may include first spring 524. First spring 524 may be a compression spring, or any suitable type of spring, and may have its first end in contact with or coupled to inner applicator housing 506 and its second end in contact with or coupled to holder 704. First spring 524 is configured to, upon activation of the insertion assembly, translate holder 704, needle carrier assembly 702, needle hub 518, insertion element 520 and on-skin sensor assembly 508, in the distal direction to the distal insertion position. Substantially at the distal insertion position, needle carrier assembly 702 may decouple from holder 704 and on-skin sensor assembly 508.

[0177] Applicator 700 may further comprise a retraction assembly configured to translate needle carrier assembly 702, needle hub 518 and insertion element 520, in the proximal direction, from the distal insertion position to a proximal retracted position. In some examples the initial proximal position may be the same as the proximal retracted position. In other examples, the initial proximal position may be different from the proximal retracted position. Such a retraction assembly may include a second spring 706. Second spring 706 may be a compression spring, or any suitable type of spring, and may have a first end contacting or coupled to holder 704 and a second end, comprising a tang 708 (e.g., a spring portion or spring end) disposed substantially along a diameter of second spring 706, in contact with or coupled to a spring retention element 710 of holder 704, at least until retraction. Spring retention element 710 may comprise, for example, an arm, a deflection element, a tab, a detent, a snap or any other feature capable of a retaining function. Spring retention element 710 may have substantially the same form and function as spring retention elements 528a, 528b of applicator 500 except as described below. Second spring 706 is configured to translate needle carrier assembly 702, needle hub 518, and insertion element 520 in the proximal direction from the distal insertion position to the proximal retracted position. Tang 708 of second spring 706 is released from spring retention element 710 in the distal insertion position when spring retention element 710 is not backed up by backstop element 712 and in response to tang 708 of second spring 706 pushing against spring retention element 710 with a force exceeding a predetermined threshold sufficient to overcome and deflect spring retention element 710.

[0178] Needle carrier assembly 702 further comprises a backstop feature 712, configured to prevent lateral motion of spring retention element 710 of holder 704 in at least - 41 - 4924-6933-72190985-PCTUS01 PATENTthe proximal pre-activation position, thereby supporting retention of second spring 706 between spring retention element 710 and holder 704 until retraction. In the orientation shown in FIG. 21, second spring 706 is exerting a force against spring retention element 710 but backstop feature 712 prevents lateral deflection of retention element 710.

[0179] Holder 704 further comprises needle carrier retention element 542, which may comprise a deflectable arm, rigid arm, deformable feature, snap, catch, or hook. Upon needle carrier assembly 702 reaching the proximal retraction position after activation, needle carrier retention element 542 is configured to engage with needle carrier assembly 702, thereby maintaining needle carrier assembly 702, needle hub 518 and insertion element 520 in a locked, retracted position, limiting access to insertion element 520.

[0180] Although not illustrated in FIGS. 21-23, inner housing 506 of applicator 700 may further comprise engagement element 550 and needle carrier assembly 702 may further comprise protrusion 552 and may function substantially as previously described in connection with at least FIGS. 10-12.

[0181] Although not illustrated in FIGS. 21-23, inner housing 506 of applicator 700 may further comprise a protrusion extending from inner housing 506 in the distal direction, substantially as previously described protrusion 548. Similar to that previously described in connection with FIG. 13, this protrusion may be configured to contact at least one of spring retention element 710 and backstop feature 712 in the pre-activation state such that spring retention element 710 is prevented from laterally deflecting until holder 704 and needle carrier assembly 702 have translated at least a predetermined minimum distance in the distal direction. Accordingly, the protrusion may provide a measure of drop protection such that applicator 700 may not prematurely fire in response to a concussive shock from being dropped before activation.

[0182] Applicator 700 functions substantially similarly to applicator 500 with the exception that instead of utilizing spring retention elements 528a, 528b, which are disposed along an outside of second coil of spring 526 and are configured to contact and retain a coil of second spring 526, applicator 700 utilizes spring retention element 710, which is disposed along an inside of second spring 706 and is configured to contact and retain tang 708 of second spring 706 along a diameter of second spring 706. Disposing spring retention element 710 within and substantially along a center of second spring 706, as opposed to along an outside of second spring 706, further ensures that spring retention element 710 does not contact the coils of second spring 706 as second spring 706 extends during retraction, thereby smoothing the operation of applicator 700. In addition, the arrangement including spring retention element - 42 - 4924-6933-72190985-PCTUS01 PATENT710, as opposed to spring retention elements 528a, 528b mitigates the risk of, and difficulty ensuring that, multiple spring retention elements trigger or are overcome at substantially the same time.

[0183] FIG. 21 illustrates a state of applicator 700 prior to activation, according to some examples. Holder 704, needle carrier assembly 702, needle hub 518, insertion element 520, on-skin sensor assembly 508, first spring 524 and second spring 526 are all shown in preactivation positions.

[0184] Retention element 532 of holder 704 is in contact with inner housing 506, thereby immobilizing holder 704, and therefore also needle carrier assembly 702, needle hub 518, insertion element 520 and on-skin sensor assembly 508, in the pre-activated state.

[0185] Backstop feature 712 of needle carrier assembly 702 is in contact with and prevents spring retention element 710 from deflecting laterally, thereby ensuring spring retention element 710 retains tang 708 of second spring 706 in the loaded or pre-activation position shown.

[0186] Activation of applicator 700 may include a host pressing applicator 700 against their skin with sufficient force to translate outer housing 504 in a distal direction toward and with respect to inner housing 506 until activation element 502 is aligned with insertion assembly retention element 532 of holder 704, as shown in FIG. 21. Once such an alignment is achieved, a host may initiate activation element 502, thereby deflecting insertion assembly retention element 532 sufficiently to release holder 704 from inner housing 506. In some other examples, applicator 700 may be configured such that activation element 502 may be activated first, but that actual insertion is not triggered until outer housing 504 is translated sufficiently in the distal direction toward and with respect to inner housing 506. In yet other examples, activation element 502 may be biased toward a center of applicator 700 such that activation element 502 need not be explicitly activated by the host but, instead, activation element 502 may be configured to automatically initiate insertion upon outer housing 504 being translated sufficiently in the distal direction toward and with respect to inner housing 506.

[0187] FIG. 22 illustrates applicator 700 after activation and during insertion, according to some examples. First spring 524 drives holder 704, and so needle carrier assembly 702, needle hub 518, insertion element 520, and on-skin sensor assembly 508, in the distal direction toward the distal insertion position. FIG. 22 illustrates on-skin sensor assembly 508 in contact with skin of the host but where holder 704 is not yet fully driven, by first spring 524, into contact with on-skin sensor assembly 508 or skin of the host.- 43 - 4924-6933-72190985-PCTUS01 PATENT

[0188] In some examples, masses of each of holder 704, needle carrier assembly 702, needle hub 518, insertion element 520, and on-skin sensor assembly 508 may be specifically designed to reduce or substantially eliminate a tendency of needle carrier assembly 702, needle hub 518, insertion element 520, and on-skin sensor assembly 508 to detach from holder 704 while being driven in the distal direction during insertion. In some examples, a force exerted by first spring 524 may further be selected to be sufficient for proper operation of applicator 700, while not so large as to further exacerbate such above-described inertially triggered detachment. In some examples, a spring (not shown) may be configured to exert a force against a portion of needle carrier assembly 702, for example in the distal direction, sufficient to prevent needle carrier assembly 516 from inertially triggered detaching from holder 704 during insertion.

[0189] FIG. 23 illustrates applicator 700 after activation and at or near the distal insertion position, according to some examples. First spring 524 has driven holder 704, needle carrier assembly 702 and on-skin sensor assembly 508 in the distal direction to the distal inserted position. Since first spring 524 has driven holder 704 a short distance farther in the distal direction than needle carrier assembly 702, backstop feature 712 is no longer in contact with spring retention element 710, allowing second spring 706 (e.g., tang 708) to laterally deflect spring retention element 710, thereby releasing second spring 706, which drives needle carrier assembly 702 in the proximal direction. Alternatively, similar to that described above in connection with applicator 500 in FIG. 13, where the angle 9 of the portion of spring retention element 710 in contact with tang 708 of second spring 526 is substantially 90° (e.g., flat), spring retention element 710 may be biased to automatically deflect sufficiently to release second spring 526 once backstop feature 712 is no longer in contact with spring retention element 710, thereby freeing second spring 706 to drive needle carrier assembly 702 in the proximal direction. Although not shown in FIGS. 21-23, inner housing 506 may further comprise engagement element 550 configured to engage with a protrusion 552 of needle carrier assembly 702, and to function substantially as previously described in connection with at least FIGS. 10-12. In some examples, a stop feature (not shown) may be disposed at a bottom of applicator 700, e.g., on a distal portion of inner housing 506. Such a stop feature may be configured to contact one or more of on-skin sensor assembly 508, needle carrier assembly 702, or holder 704 in the distal insertion position.

[0190] Upon release of second spring 706, second spring 706 is configured to drive needle carrier assembly 702, needle hub 518 and insertion element 520, in the proximal direction. Although not shown in FIG. 23, as needle carrier assembly 702 travels to the - 44 - 4924-6933-72190985-PCTUS01 PATENTproximal retracted position, needle carrier retention element 542 may engage with needle carrier assembly 702, thereby retention needle carrier assembly 702, needle hub 518 and insertion element 520, in a locked, retracted position limiting access to insertion element 520.

[0191] FIG. 24 illustrates a perspective view of holder 704, first spring 524 and second spring 706 of applicator 700, according to some examples. FIG. 24 illustrates spring retention element 710, retention tang 708 of second spring 706 in an orientation within applicator 700 before retraction.

[0192] During manufacture, applicator 700 may be assembled in stages. For example, and not limitation, if present, as previously described in connection with applicator 500, first barrier layer 512 (see FIG. 6) may be affixed to inner housing 506. Insertion element 520 may be coupled to needle hub 518, which may then be coupled to on-skin sensor assembly 508. Second spring may be placed into holder 704 or needle carrier assembly 702 and then needle carrier assembly 702 may be disposed into holder 704 and attached to needle hub 518 and to on-skin sensor assembly via wearable retention elements 534a, 534b. First spring 524 may be disposed in holder 704, which may then be installed into inner housing 506. Inner housing 506 may be inserted into and secured to outer housing 504. If present, as previously described in connection with applicator 500, second barrier layers 530 (see FIG. 6) may be affixed to inner housing 506. If a separate element, activation element 502 may then be disposed into outer housing 504. Any labeling, sterilizing and / or packaging may then be applied to applicator 700.

[0193] Upon activation, an applicator as disclosed herein may insert a transcutaneous analyte sensor into the skin of a host by utilizing an insertion element (such as insertion element 520). Referring to FIG. 25A, the insertion element 520 may drive the transcutaneous analyte sensor 802 of the on-skin sensor assembly 800 into the host’s skin by the transcutaneous analyte sensor 802 extending along a channel of the insertion element 520. The insertion element 520 may be withdrawn with the transcutaneous analyte sensor 802 remaining within the skin, as represented in FIG. 25B. A patch 804 or other component of the on-skin sensor assembly 800 may include a surface 806 (which may be referred to as a first surface) for engaging the skin. The surface 806, for example, may comprise an adhesive surface. The adhesive can be configured for adhering to skin. Additional adhesive information is described in U.S. Patent No. 11,219,413, which was filed on August 25, 2015. The entire contents of U.S. Patent No.11,219,413 are incorporated by reference herein. The patch 804 may be coupled to a housing of the on-skin sensor assembly 800 in examples. The transcutaneous analyte sensor 802 may be coupled to the housing of the on-skin sensor assembly 800.- 45 - 4924-6933-72190985-PCTUS01 PATENT

[0194] A liner (not shown in FIGS. 25 A and 25B) may be positioned on the surface 806 in examples. The liner may cover the surface 806 and may protect the surface 806 from damage, deterioration, or other adverse effects. The liner, for example may comprise a sheet of material that covers the surface 806. The liner may have a proximal surface contacting the surface 806 and a distal surface facing opposite the proximal surface. The liner in examples, may be configured to reduce the possibility of an exposed surface 806 from deteriorating or otherwise losing adhesive properties prior to deployment. For example, during a sterilization process using a gas or other sterilization material, the liner may reduce the possibility of the surface 806 deteriorating. A sterilizing gas may comprise ethylene oxide (EtO) or another form of sterilizing gas as desired.

[0195] The liner, however, is to be decoupled from the surface 806 prior to deployment of the on-skin sensor assembly 800 to the skin. FIGS. 26A-26G illustrate an example of a system for deploying an on-skin wearable medical device to skin. The system includes an applicator 900 having a housing 902 configured to retain the on-skin wearable medical device, and a deployment mechanism configured to deploy the on-skin wearable medical device to the skin. The housing 902 (also may be referred to herein as an applicator housing) may be configured similarly as in examples of applicators and housings disclosed herein, including having an outer housing 904 and an inner housing 906 as disclosed in regard to the examples of FIGS. 5-24. The outer housing 904 for example, may be configured similarly as the outer housing 504 and the inner housing 906 may be configured similarly as the inner housing 506. The housing 902 may be configured to be gripped by a user in examples. Various other configurations of applicator housings may be utilized as desired. For example, one or more of the housings (e.g., an inner housing 906) may comprise a cartridge housing (see FIG. 29A, for example) that is configured to be inserted into (or configured to receive) an outer housing of an applicator for deployment of the on-skin wearable medical device in examples.

[0196] The applicator housing 902 may include an internal cavity 903 for retaining the on-skin wearable medical device. The housing 902 may include an opening 905 at an end portion 907 of the internal cavity 903 for the on-skin wearable medical device to pass through. The internal cavity 903 may include a proximal end portion 909 that may include the on-skin wearable medical device coupled to a needle carrier assembly. The applicator 900 may have a distal surface 943 (marked in FIG. 26E) positioned at the opening 905 and that defines a bottom outer surface of the applicator 900.

[0197] In examples, the applicator 900 may include a barrier layer 945 that may be disposed over the opening 905 of the housing 902 as shown in FIG. 26A, for example. The - 46 - 4924-6933-72190985-PCTUS01 PATENTbarrier layer 945 may be configured to cover and seal the opening 905, in examples. The barrier layer 945 may be thin and flexible (e.g., a flexible film). The barrier layer 945 may comprise a gas permeable material such as Tyvek, or a non-gas permeable material such as metallic foil. In examples, the barrier layer 945 may be removed by the user or host prior to deployment of the on-skin wearable medical device. The barrier layer 945 may provide a sterile environment between the housing 902 and an outside environment and / or may allow ingress and egress of gas such as during sterilization of the insertion element 915. The barrier layer 945 may be transparent or translucent. In examples, the barrier layer 945 may be opaque.

[0198] In examples, the barrier layer 945 may include a grip portion 947 configured to be gripped by a user for removing the barrier layer 945 from the housing 902. As shown in FIG. 26A, the grip portion 947 may be positioned at an outer edge of the barrier layer 945, for example. In examples, the grip portion 947 may comprise a tab, although other configurations of grip portions may be utilized as desired. In examples, the barrier layer 945 may be removed or withdrawn from the housing 902 in an axial direction relative to the housing 902. In examples, the barrier layer 945 may be removed or withdrawn from the housing 902 by being peeled off of the housing 902. The peeling may be in a horizontal direction relative to the surface 924 or the bottom surface 943 (marked in FIG. 26E) in examples, as the grip portion 947 is withdrawn from the housing 902 axially.

[0199] The barrier layer 945 may span the opening 905 at the bottom surface 943 of the housing 902 in examples. For example, the barrier layer 945 may be adhered or otherwise bonded to the bottom surface 943 and may cover the entirety of the opening 905. As such, a separate component such as a cap (e.g, a threaded cap) may be excluded from use, with the barrier layer 945 forming the entirety of the seal of the opening 905 due to the coupling with the bottom surface 943. The barrier layer 945 may couple to the bottom surface 943 without use of an intermediate component or structure in examples. Any other example as disclosed herein may utilize such a configuration (whether for a housing of an applicator or a housing of a cartridge). Other configurations may be utilized in examples.

[0200] For ease of illustration, certain components of the applicator 900 are not illustrated in FIG. 26A. However, the deployment mechanism of applicator 900 may be configured the same as or similarly to other forms of deployment mechanisms disclosed herein. The deployment mechanism may be configured the same as or similarly to the deployment mechanisms disclosed in regard to the examples of FIGS. 5-24. For example, the deployment mechanism may include one or more retention elements for retaining the on-skin wearable medical device and releasing the on-skin wearable medical device from the housing 902 to the - 47 - 4924-6933-72190985-PCTUS01 PATENTskin, in examples. The deployment mechanism may include an insertion assembly for inserting at least a portion of the on-skin wearable medical device into the skin. For example, the insertion assembly may include one or more springs 916. The one or more springs 916 may be a compression spring, or any suitable type of spring, and may have a first end in contact with or coupled to the inner housing 906 and its second end in contact with or coupled to holder 912. The one or more springs 916 may be configured to, upon activation of the insertion assembly, translate the holder, the needle carrier assembly, the needle hub, the insertion element, and the on-skin sensor assembly, in the distal direction to the distal insertion position. The insertion assembly may insert the insertion element (e.g., a needle) into the skin. The deployment mechanism may drive the insertion element to the skin upon the deployment mechanism deploying the on-skin wearable medical device to skin. The deployment mechanism may include a retraction assembly for retracting the insertion element from the skin. Other forms of deployment mechanisms may be utilized in examples as desired.

[0201] The applicator 900 may include an activation element 908 that may operate similarly as the activation element 502. The applicator 900 may include a needle carrier assembly that may operate similarly as the needle carrier assembly 516. The applicator 900 may include a hub (e.g., a needle hub) that may operate similarly as the needle hub 518. The applicator 900 may include an insertion element 915 (e.g., a needle) that may operate similarly as the insertion element 520. The applicator 900 may include springs that may operate similarly as the springs 524, 526. The applicator 900 may include retention elements that may operate similarly as the retention elements 534a, 534b. The applicator 900 may include the holder 912 that may operate similarly as the holder 522. For example, the holder 912 may comprise an insertion assembly retention element 949 (also referred to herein as a first coupling member) configured to engage an engagement portion 952 of the inner housing 906 (also referred to herein as a second coupling member), thereby immobilizing the holder 912, the needle carrier assembly, the needle hub, the insertion element 915, and the on-skin sensor assembly 508, in the pre-activated state (also may be referred to herein as the raised position). The insertion assembly retention element 949 may comprise, for example, an arm, a deflection element, a tab, a detent, a snap or any other feature capable of a retaining function. A host may initiate or activate (e.g., push) the activation element 908, as shown by arrow 951, thereby deflecting the insertion assembly retention element 949 sufficiently to release the holder 912 from the engagement portion 952 of the inner housing 906.- 48 - 4924-6933-72190985-PCTUS01 PATENT

[0202] Additional components of the applicators shown in FIGS. 5-24 may be utilized with the applicator 900. The applicator 900 may operate in a similar manner and provide similar function as the applicators shown in FIGS. 5-24.

[0203] The applicator 900 may be utilized to deploy an on-skin wearable medical device to skin. The on-skin wearable medical device may comprise the on-skin sensor assembly 508 shown in FIG. 6, for example, which may include a housing, a transcutaneous analyte sensor coupled to the housing, an electronics unit, and a patch 922. The on-skin sensor assembly 508 may have forms as shown in FIGS. 2A-4, for example, or other forms as desired.

[0204] The on-skin sensor assembly 508 may include a surface 924 (which may be referred to as a first surface) (marked in FIG. 26E) that may be utilized to engage the skin. As such, the surface 924 may contact the skin and may retain the on-skin sensor assembly 508 to the skin. The surface 924 may be positioned on the patch 922 of the on-skin sensor assembly 508. The surface 924 may comprise a distal surface of the on-skin sensor assembly 508 that faces opposite a proximal surface in examples. In examples, the surface 924 may comprise an adhesive surface as disclosed herein.

[0205] A liner 926 (marked in FIGS. 26C, 26D, and 26F) may be positioned on the surface 924 and cover the surface 924 and may protect the surface 924 from damage, deterioration, or other adverse effects, as disclosed herein. The liner 926, however, is to be decoupled from the surface 924 prior to deployment of the on-skin sensor assembly 508 to the skin.

[0206] Referring to FIG. 26 A, the system may include a liner removal component 928. The liner removal component 928 may be configured to engage the liner 926 positioned on the surface 924 and at least partially decouple the liner 926 from the surface 924 of the on-skin wearable medical device upon being at least partially withdrawn from the surface 924 of the on-skin wearable medical device. In examples, the liner removal component 928 may comprise a body configured to extend axially within the internal cavity 903 and to engage the liner 926 positioned on the surface 924 and at least partially decouple the liner 926 from the surface 924 of the on-skin wearable medical device upon being at least partially withdrawn from the surface 924 of the on-skin wearable medical device or removed from the housing 902.

[0207] The liner removal component 928 may include at least a portion that is configured to extend within the internal cavity 903. The liner removal component 928, for example, may extend axially within the internal cavity 903. The liner removal component 928 may include a first portion 930 that may be configured to engage the liner 926, and a second portion 932 that is spaced from the first portion 930. The second portion 932 may be axially - 49 - 4924-6933-72190985-PCTUS01 PATENTspaced from the first portion 930. The axial extent of the liner removal component 928 may provide a variety of benefits. For example, a user seeking to grip the liner removal component 928 to at least partially decouple the liner 926 may have a reduced possibility of deeply inserting the user’s fingers into the internal cavity 903 to at least partially decouple the liner 926 from the surface 924. Such a feature may enhance the ease with which the user may remove the liner 926. Further, the user may have a reduced possibility of contacting a tip of the insertion element 915 (e.g., a needle) and potentially injuring the user or dislodging the insertion element 915 or the transcutaneous analyte sensor from each other. Further, the user may have a reduced possibility of dislodging the on-skin sensor assembly 508 from the housing 902 inadvertently.

[0208] FIG. 26B illustrates a perspective view of the liner removal component 928 separated from the internal cavity 903. The first portion 930 of the liner removal component 928 may comprise a cover for a portion of the liner 926, that covers the liner 926 upon the surface 924 (marked in FIG. 26E). The cover may cover at least a portion of the surface 924. The first portion 930 of the liner removal component 928 may comprise a support for the liner 926, that supports the liner 926 upon the surface 924 until a desired time for decoupling of the liner 926 from the surface 924. The first portion 930 may comprise a substrate for the liner 926 to be positioned upon, and may have a flat shape as shown in FIG. 26B or another shape as desired. In examples, support provided by the liner removal component 928 may reduce the possibility of dislodging the on-skin wearable medical device from the applicator housing 902 through vibration, or shock (through distribution or drop events), or dislodgement of a transcutaneous analyte sensor from the insertion element 915. Other benefits may result from the support provided by the liner removal component 928 in examples.

[0209] In examples, the first portion 930 may engage the liner 926 utilizing one or more coupling surfaces 934 (marked in FIGS. 26B and 26C). In examples, the coupling surfaces 934 may comprise adhesive surfaces that couple the liner 926 to the first portion 930. The adhesive surfaces, for example, may comprise pressure sensitive adhesive, or other forms of adhesive surfaces as desired. The coupling surfaces 934 may have a variety of configurations. For example, FIG. 26B illustrates an annular shape for a coupling surface 934. Other configurations of coupling surfaces 934 may be utilized in examples as desired.

[0210] As illustrated in FIG. 26C, the coupling surfaces 934 may be offset from a center of the liner 926. The offset position of the coupling surfaces 934 relative to the center of the liner 926 results in the removal of the liner 926 from the surface 924 being asymmetric, which may allow for a peeling of the liner 926 from the surface 924. The peeling may be in a - 50 - 4924-6933-72190985-PCTUS01 PATENThorizontal direction relative to the surface 924 in examples, as the liner removal component 928 is withdrawn from the surface 924 axially. Such a peeling motion of the liner 926 may lessen the force required by a user to remove the entirety of the liner 926. The liner removal component 928 accordingly may be configured to asymmetrically decouple the liner 926 from the surface 924 upon the liner removal component 928 being at least partially withdrawn from the surface 924 or removed from the housing 902. The liner removal component 928 may be configured to peel the liner 926 from the surface 924 upon the liner removal component 928 being at least partially withdrawn from the surface 924 or removed from the housing 902.

[0211] Referring to FIGS. 26B and 26C, in examples, the first portion 930 may include an aperture 937 for the insertion element 915 and the transcutaneous analyte sensor to pass through (as shown in FIG. 26 A). In examples, the first portion 930 may include a sheath 939 configured to cover the insertion element 915, and particularly the tip of the insertion element 915. Thus, as a user (e.g., a host) grasps the liner removal component 928, a reduced possibility of contact with the insertion element 915 and the transcutaneous analyte sensor results. In examples, the sheath 939 may include a layer or portion configured to allow sterilizing gas to permeate through the layer or portion to contact at least a portion of the insertion element 915 or at least a portion of the transcutaneous analyte sensor.

[0212] Referring to FIGS. 26A and 26B, an intermediate portion 936 may be positioned between the first portion 930 and the second portion 932 and may provide a height between the first portion 930 and the second portion 932. The intermediate portion 936 may comprise a spacer body in examples, or may have another form as desired. As shown in FIGS. 26 A and 26B, the intermediate portion 936 may have an elongate beam-like shape, although other configurations may be utilized in examples as desired (e.g., a cylindrical shape).

[0213] The intermediate portion 936 in examples may be and / or include one or more guides 938 that may extend along channels 941 (marked in FIG. 26E) in the interior surface of the housing 902 that may prevent rotation and / or tilting of the liner removal component 928 prior to or during removal from the housing 902. The guides 938 may extend axially along the internal cavity 903 to orient the liner removal component 928 within the internal cavity 903. The guides 938 may prevent rotation of the first portion 930 to reduce the possibility of shear of the liner. A shear of the liner, for example, may cause the surface 924 to undesirably fold or crease onto itself in examples. The guides 938 may prevent tilting of the first portion 930 to reduce the possibility of one or more portions of the liner removal component 928, such as, for example, the sheath 939, from contacting or damaging the insertion element 915 or the sensor as the liner removal component 928 is withdrawn. In examples, the guides 938 may - 51 - 4924-6933-72190985-PCTUS01 PATENTreduce the possibility of rotation and / or tilting of the liner removal component 928 relative to the housing 902.

[0214] The second portion 932 may comprise a base for the liner removal component 928 in examples. In examples, the second portion 932 may be configured to be positioned at the opening 905 of the housing 902. As such, a user may have a reduced possibility of deeply extending the user’s fingers into the internal cavity 903 and potentially contacting or damaging the insertion element 915 or the transcutaneous analyte sensor. The second portion 932, in examples, may include an engagement portion 955 (marked in FIG. 26B) positioned at the second portion 932 and configured to engage a portion of the housing 902 to retain the liner removal component 928 within the housing 902. For example, the engagement portion 955 may be configured to engage a portion of the interior surface of the inner housing 906, such as, for example, a ledge or protrusion 957 disposed on the interior surface of the inner housing 906. The engagement portion 955 may comprise a detent, for example. The engagement portion 955 may, for example, provide drop protection by preventing the liner removal component 928 from becoming dislodged from the housing 902 when the applicator 900 is dropped. In examples, other configurations of engagement portions 955 and / or protrusions 957 may be utilized as desired.

[0215] In examples, the liner removal component 928 may have other forms of releasable securement to the applicator housing 902, for example, snaps, clamps, or other forms of securement may be utilized as desired.

[0216] The second portion 932 in examples, may include a grip portion 940 positioned at the second portion 932 and configured to be gripped by a user (e.g., grasped between a finger and thumb, or hooked using a single finger) to withdraw the liner removal component 928 from the surface 924 of the on-skin sensor assembly 508 or remove the liner removal component 928 from the housing 902. The grip portion 940, for example, may comprise a portion of the liner removal component 928 for gripping manually or through another method (e.g., using a finger, hook, or other tool) for removal from the housing 902. The grip portion 940 as shown in FIG. 26B may have a semi-annular shape that may be configured for grip. In examples, the grip portion 940 may comprise a ring or a tab. In examples, the grip portion 940 may extend between the guides 938 as shown in FIG. 26B.

[0217] In examples, the grip portion 940 may be coupled to the second portion 932 via one or more hinges 956. The one or more hinges 956 may comprise living hinges as shown in FIG. 26B, for example. In examples, other forms of hinges may be utilized as desired. The one or more hinges 956 may be configured such that the grip portion 940 is positioned within - 52 - 4924-6933-72190985-PCTUS01 PATENTthe internal cavity 903 of the housing 902 prior to the grip portion 940 being gripped by a user (e.g., at a resting state). Upon the grip portion 940 being gripped and pulled in an axial direction relative to the housing 902 to withdraw the liner removal component 928 from the surface 924, the grip portion 940 may rotate about the one or more hinges 956 such that the grip portion extends in the axial direction as shown in FIG. 26D, for example. As such, a user may have a reduced possibility of deeply extending the user’s fingers into the internal cavity 903 and potentially contacting or damaging the insertion element 915 or the transcutaneous analyte sensor. In examples, other configurations of grip portions and hinges may be utilized as desired.

[0218] The liner removal component 928 may have at least a portion configured to extend into the internal cavity 903. In examples, the liner removal component 928 may comprise an insert into the internal cavity 903 that may be covered by a barrier layer of the system (e.g., the flexible barrier layer 945).

[0219] FIG. 26C illustrates a schematic cross-sectional view of an arrangement of the liner 926 relative to the first portion 930. The coupling surfaces 934 may be positioned proximate the aperture 937 in the first portion 930, as well as apertures in the liner 926 and the patch 922, to couple the liner 926 to the first portion 930.

[0220] In operation, the barrier layer 945 shown in FIG. 26A may be removed from the housing 902. For example, a user may grip the grip portion 947 and pull the barrier layer 945 in an axial direction relative to the housing 902 to remove (e.g., peel) the barrier layer 945 from the housing 902. FIG. 26D, for example, illustrates the barrier layer 945 having been removed from the housing 902 with the second portion 932 of the liner removal component 928 exposed.

[0221] A user may accordingly grip and pull the liner removal component 928, for example, at the grip portion 940, causing the grip portion 940 to rotate about the one or more hinges 956 (for example, rotating about an axis extending in a direction normal to an axis of the applicator) such that the grip portion extends in the axial direction as shown in FIG. 26D, and such that further pulling on the grip portion in the axial direction serves to withdraw the liner removal component 928 from the surface 924 of the on-skin wearable medical device. The liner removal component 928 may be axially withdrawn from the internal cavity 903 of the housing 902. FIG. 26E illustrates a resulting configuration of the applicator 900, with the surface 924 exposed and able to be deployed to the skin in a manner disclosed herein.

[0222] FIG. 26F illustrates the liner 926 coupled to the liner removal component 928 upon being withdrawn from the housing 902.- 53 - 4924-6933-72190985-PCTUS01 PATENT

[0223] In examples, the liner removal component 928 may be configured to be reinserted into the internal cavity 903 following deployment of the on-skin wearable medical device. The liner removal component 928, for example, may be inserted proximally into the internal cavity 903 and the needle carrier assembly for example may be pressed proximally to accommodate the liner removal component 928.

[0224] In examples, the liner removal component 928 may not extend axially into the internal cavity 903. For example, in a configuration in which the surface 924 of the on-skin sensor assembly 508 is not positioned within an internal cavity then the liner removal component 928 may not need to extend into such a cavity. The liner removal component 928 may yet remain available for access and grip by a user if desired. In examples, other forms of liner removal components configured to extend axially within the internal cavity 903 may be utilized. For example, pull tabs or other forms of axially extending tethers may be utilized to at least partially decouple the liner from the surface 924.

[0225] FIG. 26G illustrates a schematic cross-sectional view of the insertion assembly retention element 949 or first coupling member engaged with the engagement portion 952 of the inner housing 906 or second coupling member thereby immobilizing the insertion assembly in the pre-activated state or raised position. As described herein, upon being activated by the activation element 908 (e.g., when the activation element 908 is actuated by a user), the insertion assembly may be configured to move from the raised position to the lowered position to insert at least a portion of the on-skin wearable medical device into the skin. For example, the activation element 908 may be configured to release the first coupling member 949 from the second coupling member 952 when the activation element 908 is enabled and actuated by a user.

[0226] In examples, the liner removal component 928 may be configured to disable the activation element 908 to prevent the activation element 908 from activating the insertion assembly. For example, the liner removal component 928 may be configured to disable the activation element 908 by impeding movement of the first coupling member 949 relative to the second coupling member 952. The liner removal component 928 may prevent the insertion assembly from moving from a raised position to a lowered position when the component 928 is disposed in a first position within the housing 902, and allow the insertion assembly to move from the raised position to the lowered position after the component 928 is withdrawn from the housing 902. The liner removal component 928 may include a backstop feature 953 configured to impede the movement of the first coupling member 949 relative to the second coupling member 952. The backstop feature 953 may abut a portion of the first coupling member 949- 54 - 4924-6933-72190985-PCTUS01 PATENTto impede movement of the first coupling member 949 relative to the second coupling member 952. In examples, the backstop feature 953 may comprise a rib coupled to the first portion 930. In examples, the backstop feature 953 may comprise a rib protruding from the body of the liner removal component 928. In examples, the first portion 930 may be for abutting a portion of the first coupling member 949 to impede movement of the first coupling member relative to the second coupling member 952. The liner removal component 928 may be configured to enable the activation element 908 upon the liner removal component 928 being at least partially withdrawn from the surface 924 such that the backstop feature 953 ceases to abut the first coupling member 949 as shown in FIG. 26D, for example. In examples, other forms of backstop features may be utilized as desired.

[0227] A backstop feature may be utilized with any example of liner removal component disclosed herein.

[0228] In examples, the liner removal component 928 may comprise a rigid material. For example, the liner removal component 928 may comprise a plastic material (e.g., a thermoplastic material) or a metal material. The liner removal component 928 may be formed by molding or stamping the rigid material, for example. In examples, the liner removal component 928 may comprise different materials and / or may be formed by different methods as desired.

[0229] The features of the examples of FIGS. 26A-26G may be utilized solely or in combination with any other example disclosed herein.

[0230] In examples, the liner removal component 928 may have other configurations than shown in FIGS. 26A-26G.

[0231] For example, FIGS. 27A-27E illustrate examples of a liner removal component 1000 configured similarly as the liner removal component 928 shown in FIGS. 26A-26G, yet the liner removal component 1000 is coupled to the barrier layer 945. The liner removal component 1000 may be configured to engage the liner 926 positioned on the surface 924 (shown in FIG. 26E) and at least partially decouple the liner 926 from the surface 924 of the on-skin wearable medical device upon being at least partially withdrawn from the surface 924 of the on-skin wearable medical device. In examples, the liner removal component 1000 may comprise a body configured to extend axially within the internal cavity 903 and to engage the liner 926 positioned on the surface 924, and at least partially decouple the liner 926 from the surface 924 of the on-skin wearable medical device upon being at least partially withdrawn from the surface 924 of the on-skin wearable medical device.- 55 - 4924-6933-72190985-PCTUS01 PATENT

[0232] The liner removal component 1000 may include a first portion 1004, a second portion 1006, and an intermediate portion 1008, each having features similar to the respective first portion 930, second portion 932, and intermediate portion 936 of the liner removal component 928, in examples, unless stated otherwise.

[0233] The first portion 1004 may be configured to engage the liner 926, with the second portion 1006 being axially spaced from the first portion 1004. The first portion 1004 of the liner removal component 1000 may engage the liner 926 utilizing one or more coupling surfaces 1010. In examples, the coupling surfaces 1010 may comprise adhesive surfaces that couple the liner 926 to the first portion 1004. The adhesive surfaces, for example, may comprise pressure sensitive adhesive, or other forms of adhesive surfaces as desired.

[0234] FIG. 27B illustrates a bottom view of the liner 926 and a cross-sectional view of the first portion 1004 of the liner removal component 1000 engaged with the liner 926. As illustrated in FIG. 27B, the first portion 1004 may be offset from a center of the liner 926. For example, the first portion 1004 may be coupled to the liner 926 at an outer edge of the liner 926. The offset position of the first portion 1004 relative to the center of the liner 926 results in the removal of the liner 926 from the surface 924 being asymmetric, which may allow for a peeling of the liner 926 from the surface 924. The peeling may be in a horizontal direction relative to the surface 924 in examples, as the liner removal component 1000 is withdrawn from the surface 924 axially. Such a peeling motion of the liner 926 may lessen the force required by a user to remove the entirety of the liner 926. The liner removal component 1000 accordingly may be configured to asymmetrically decouple the liner 926 from the surface 924 upon the liner removal component 1000 being at least partially withdrawn from the surface 924. The liner removal component 1000 may be configured to peel the liner 926 from the surface 924 upon the liner removal component 1000 being at least partially withdrawn from the surface 924. In examples, the liner 926 may include a cut 1019 that extends from the outer edge of the liner 926 to an aperture 1016 of the liner 926 as shown in FIG. 27B, for example. The cut 1019 of FIG. 27B may result in a circular or spiral peel of the liner, which may reduce the release force and may prevent the liner from contacting the insertion element 915.

[0235] Referring to FIG. 27 A, the intermediate portion 1008 may be positioned between the first portion 1004 and the second portion 1006 and may provide a height between the first portion 1004 and the second portion 1006. The intermediate portion 1008 may comprise a spacer body in examples, or may have another form as desired. As shown in FIG.27 A, the intermediate portion 1008 may have an elongate beam-like shape (e.g., a cylindrical beam), although other configurations may be utilized in examples as desired.- 56 - 4924-6933-72190985-PCTUS01 PATENT

[0236] The second portion 1006 may comprise a base for the liner removal component 1000, in examples. In examples, the second portion 1006 may be configured to be positioned at the opening 905 of the housing 902. The second portion 1006, in examples, may be coupled to the barrier layer 945. For example, the second portion 1006 may be coupled to an outer surface of the barrier layer 945 as shown in FIG. 27 A. The liner removal component 1000 may extend from the internal cavity 903 of the housing 902 through an aperture 1012 (marked in FIGS. 27A and 27C) in the barrier layer 945 such that at least a portion of the second portion 1006 is positioned outside of the internal cavity 903. The second portion 1006 may engage the barrier layer 945 utilizing one or more coupling surfaces 1014. In examples, the coupling surfaces 1014 may comprise adhesive surfaces that couple the barrier layer 945 to the second portion 1006. The adhesive surfaces, for example, may comprise pressure sensitive adhesive, or other forms of adhesive surfaces as desired. The coupling surfaces 1014 may seal the aperture 1012 of the barrier layer 945.

[0237] FIG. 27C illustrates a bottom view of a configuration of the barrier layer 945 with the second portion 1006 engaged with the outer surface of the barrier layer 945. The second portion 1006 may have a larger diameter than the intermediate portion 1008 and the aperture 1012. Accordingly, the intermediate portion 1008 may extend through the aperture 1012 until the second portion 1006 engages the barrier layer 945. By being coupled to the barrier layer 945, the liner removal component 1000 may be at least partially withdrawn from the surface 924 upon the barrier layer 945 being at least partially withdrawn or removed from the housing 902. Accordingly, at least partially withdrawing or removing the barrier layer 945 from the housing 902 at least partially decouples the liner 926 from the surface 924. Thus, removing the liner 926 from the surface 924 and removing the barrier layer 945 from the housing 902 may be accomplished with a single step (i.e., removing the barrier layer 945, e.g. by pulling on the grip portion 947).

[0238] Variations may be provided in examples. For example, the second portion 1006 in examples, may include a grip portion positioned at the second portion 1006 and configured to be gripped by a user to withdraw the liner removal component 1000 from the surface 924 of the on-skin sensor assembly 508. For example, FIG. 27D illustrates such a grip portion 1018. The grip portion 1018, for example, may comprise a portion of the liner removal component 1000 for gripping manually or through another method (e.g., using a finger, hook, or other tool) for removal from the housing 902. The grip portion 1018 as shown in FIG. 27D may have a base portion 1022 for coupling to the second portion 1006 and a tab or ring portion 1020 configured for grip or engagement with a finger, hook, or other tool. The base portion 1022- 57 - 4924-6933-72190985-PCTUS01 PATENTmay have an aperture 1024 that the intermediate portion 1008 extends through as shown in FIG. 27E, for example. The base portion 1022 may be positioned between the second portion 1006 and the barrier layer 945, in examples. The ring portion 1020, for example, may have an annular shape or a semi-annular shape. In examples, the ring portion 1020 may be coupled to the base portion 1022 via a living hinge 1026. As shown by arrow 1028 in FIG. 27E, the ring portion 1020 may rotate about the living hinge 1026 and away from the barrier layer 945 when the grip portion 1018 is pulled in an axial direction relative to the housing 902 (as shown by arrow 1030 in FIG. 27E). In examples, the grip portion 1018 may be integral with the second portion 1006. In examples, other configurations of grip portions may be utilized as desired.

[0239] In examples where the liner removal component includes the grip portion 1018, at least partially withdrawing or removing the liner removal component (e.g., via pulling the grip portion 1018) from the housing 902 or the surface 924 at least partially decouples the liner 926 from the surface 924 and at least partially removes the barrier layer 945 from the housing 902. Thus, removing the liner 926 from the surface 924 and removing the barrier layer 945 from the applicator may be accomplished with a single step (i.e., removing or withdrawing the liner removal component from the surface 924 or the housing 902, e.g. by pulling on the grip portion 1018).

[0240] In examples, the liner removal component 1000 may comprise a rigid material. For example, the liner removal component 1000 may comprise a plastic material (e.g., a thermoplastic material) or a metal material. The liner removal component 1000 may be formed by molding or stamping the rigid material, for example. In examples, the liner removal component 1000 may comprise different materials and / or may be formed by different methods as desired.

[0241] The features of the examples of FIGS. 27A-27E may be utilized solely or in combination with any other example disclosed herein.

[0242] Other configurations of liner removal components may be utilized in examples. FIGS. 28A and 28B illustrate examples of a liner removal component 1050 configured similarly as the liner removal component 1000 shown in FIGS. 27A-27E, yet the liner removal component 1050 may be coupled to an interior surface of the barrier layer 945. The liner removal component 1050 may be configured to engage the liner 926 positioned on the surface 924 (see FIG. 26E) and at least partially decouple the liner 926 from the surface 924 of the on-skin wearable medical device upon being at least partially withdrawn from the surface 924 of the on-skin wearable medical device. In examples, the liner removal component 1050 may comprise a body configured to extend axially within the internal cavity 903 and to engage the - 58 - 4924-6933-72190985-PCTUS01 PATENTliner 926 positioned on the surface 924 and at least partially decouple the liner 926 from the surface 924 of the on-skin wearable medical device upon being at least partially withdrawn from the surface 924 of the on-skin wearable medical device. The liner removal component 1050 may include a first portion 1052, a second portion 1054, and an intermediate portion 1056.

[0243] The first portion 1052 may be configured to engage the liner 926, with the second portion 1054 being axially spaced from the first portion 1052. The first portion 1052 of the liner removal component 1050 may engage the liner 926 utilizing one or more coupling surfaces 1058. In examples, the coupling surfaces 1058 may comprise adhesive surfaces that couple the liner 926 to the first portion 1052. The adhesive surfaces, for example, may comprise pressure sensitive adhesive, or other forms of adhesive surfaces as desired.

[0244] The first portion 1052 of the liner removal component 1050 may comprise a cover for a portion of the liner 926, that covers the liner 926 upon the surface 924. The cover may cover at least a portion of the surface 924. The first portion 1052 of the liner removal component 1050 may comprise a support for the liner 926, that supports the liner 926 upon the surface 924 until a desired time for decoupling of the liner 926 from the surface 924. The first portion 1052 may comprise a substrate for the liner 926 to be positioned upon, and may have a flat shape or another shape as desired.

[0245] The intermediate portion 1056 may be positioned between the first portion 1052 and the second portion 1054 and may provide a height between the first portion 1052 and the second portion 1054. The intermediate portion 1056 may comprise a spacer body in examples, or may have another form as desired. As shown in FIG. 28 A, the intermediate portion 1056 may have a flat shape, although other configurations may be utilized in examples as desired.

[0246] The second portion 1054 may comprise a base for the liner removal component 1050, in examples. In examples, the second portion 1054 may be configured to be positioned at the opening 905 of the housing 902. The second portion 1054 may be coupled to the barrier layer 945. For example, the second portion 1054 may be coupled to the interior surface of the barrier layer 945 as shown in FIG. 28 A. The second portion 1054 may engage the barrier layer 945 utilizing one or more coupling surfaces. In examples, the coupling surfaces may comprise adhesive surfaces that couple the barrier layer 945 to the second portion 1054. The adhesive surfaces, for example, may comprise pressure sensitive adhesive, or other forms of adhesive surfaces as desired.

[0247] FIG. 28B illustrates a bottom view of the barrier layer 945 with the second portion 1054 coupled to the interior surface of the barrier layer 945 and being visible through - 59 - 4924-6933-72190985-PCTUS01 PATENTthe transparent or translucent barrier layer 945. In examples, the liner removal component 1050 (e.g., at the first portion 1052) may include an aperture or cutout 1060 for the insertion element 915 and the transcutaneous analyte sensor to pass through, configured such that removal of the barrier layer 945 and withdrawal of the liner removal component 1050 does not result in the liner removal component 1050 contacting the insertion element 915 or the transcutaneous analyte sensor.

[0248] By being coupled to the barrier layer 945, the liner removal component 1050 may be at least partially withdrawn from the surface 924 upon the barrier layer 945 being at least partially withdrawn or removed from the housing 902. Accordingly, at least partially withdrawing or removing the barrier layer 945 from the housing 902 at least partially decouples the liner 926 from the surface 924. Thus, removing the liner 926 from the surface 924 and removing the barrier layer 945 from the housing 902 may be accomplished with a single step (i.e., removing the barrier layer 945, e.g. by pulling on the grip portion 947).

[0249] As illustrated in FIG. 28 A, in examples, the liner removal component 1050 may be Z-shaped when viewed from the side. For example, the first portion 1052 may extend along a plane that is substantially parallel to a plane that the second portion 1054 extends along, with the intermediate portion 1056 extending along a plane that is oblique to the planes the first and second portions 1052, 1054 extend along. The Z-shape of the liner removal component 1050 results in the removal of the liner 926 from the surface 924 being asymmetric, which may allow for a peeling of the liner 926 from the surface 924. The peeling may be in a horizontal direction relative to the surface 924 in examples, as the liner removal component 1050 is withdrawn from the surface 924 axially upon the barrier layer 945 being removed from the housing 902. Such a peeling motion of the liner 926 may lessen the force required by a user to remove the entirety of the liner 926. The liner removal component 1050 accordingly may be configured to asymmetrically decouple the liner 926 from the surface 924 upon the liner removal component 1050 being at least partially withdrawn from the surface 924. The liner removal component 1050 may be configured to peel the liner 926 from the surface 924 upon the liner removal component 1050 being at least partially withdrawn from the surface 924.

[0250] In examples, the liner removal component 1050 may comprise a spring. For example, the liner removal component 1050 may comprise a Z-shaped (when viewed from the side) spring. The liner removal component 1050 may be configured to compress in an axial direction relative to the housing 902, for example, during manufacture when the liner removal component 1050 is placed within the internal cavity 903 and the barrier layer 945 is applied to the housing 902. This compression of the liner removal component 1050 may serve to ensure - 60 - 4924-6933-72190985-PCTUS01 PATENTcontact between the liner removal component 1050 and the one or more components of the applicator (e.g., the applicator 900) it interfaces with, such as, for example, the liner 926 and / or the barrier layer 945, during assembly.

[0251] In examples, the liner removal component 1050 may comprise a rigid material. For example, the liner removal component 1050 may comprise a plastic material (e.g., a thermoplastic material) or a metal material. The liner removal component 1050 may be formed by molding or stamping the rigid material, for example. In examples, the liner removal component 1050 may comprise different materials and / or may be formed by different methods as desired.

[0252] The features of the examples of FIGS. 28A-28B may be utilized solely or in combination with any other example disclosed herein.

[0253] Other configurations of liner removal components may be utilized in examples. FIGS. 29A and 29B illustrate an example of a liner removal component 1102 configured similarly as the liner removal component 1050 shown in FIGS. 28A and 28B, yet the liner removal component 1102 is U-shaped when viewed from the side. Although FIGS. 29A and 29B illustrate the liner removal component positioned within a housing 1100, in examples, the liner removal component 1102 may be implemented with the housing 902 shown in FIG. 26 A, for example. The housing 1100 may be configured similarly as the housing 902 shown in FIG.26 A, with the housing 1100 being configured to retain the on-skin wearable medical device within an internal cavity 1118 of the housing 1100 and having an opening 1108 for the on-skin wearable medical device to deploy from similarly to the opening 905 of the housing 902. The barrier layer 945 may cover and seal the opening 1108 and may be coupled to a bottom surface 1122 (marked in FIG. 29B) of the housing 1100. In examples, the housing 1100 may correspond to or be the housing 902 or the inner housing 906 of the applicator 900 (see FIG.26A, for example). In examples, the housing 1100 may be a cartridge housing configured to be inserted into (or configured to receive) an applicator for deployment of the on-skin wearable medical device.

[0254] The liner removal component 1102 may be configured to engage the liner 926 positioned on the surface 924 (see FIG. 29B) and at least partially decouple the liner 926 from the surface 924 of the on-skin wearable medical device upon being at least partially withdrawn from the surface 924 of the on-skin wearable medical device. In examples, the liner removal component 1102 may comprise a body configured to extend axially within the internal cavity 1118 of the housing 1100 and to engage the liner 926 positioned on the surface 924 and at least partially decouple the liner 926 from the surface 924 of the on-skin wearable medical device - 61 - 4924-6933-72190985-PCTUS01 PATENTupon being at least partially withdrawn from the surface 924 of the on-skin wearable medical device. The liner removal component 1102 may include a first portion or first leg 1112, a second portion or second leg 1114, and a central portion 1116.

[0255] The first leg 1112 and the second leg 1114 may each be configured to extend axially within the internal cavity 1118, with the second leg 1114 being laterally spaced from the first leg 1112. The first leg 1112 may be configured to engage the barrier layer 945 at a distal end portion 1104 of the first leg 1112. The second leg 1114 may be configured to engage the barrier layer 945 at a distal end portion 1106 of the second leg 1114. The distal end portion 1104 of the first leg 1112 may be positioned laterally at or near the grip portion 947 of the barrier layer 945 and the distal end portion 1106 of the second leg 1114 may be positioned laterally opposite of the grip portion 947. In examples, the distal end portions 1104, 1106 of the liner removal component 1102 may be configured to be positioned axially at (e.g., coplanar with or nearly coplanar with) the opening 1108 of the housing 1100.

[0256] The distal end portions 1104, 1106 of the liner removal component 1102 may engage the barrier layer 945 utilizing one or more coupling surfaces. In examples, the coupling surfaces may comprise adhesive surfaces that couple the interior surface of the barrier layer 945 to the distal end portions 1104, 1106 of the liner removal component 1102. The adhesive surfaces, for example, may comprise pressure sensitive adhesive, or other forms of adhesive surfaces as desired.

[0257] In examples, the distal end portions 1104, 1106 of the liner removal component 1102 may be positioned within recesses 1120 (marked in FIG. 29B) of the bottom surface 1122 of the housing 1100 such that the distal end portions 1104, 1106 of the liner removal component 1102 may be flush with the bottom surface 1122 (e.g., to improve the ease of applying the barrier layer 945 to the housing 1100 and the liner removal component 1102).

[0258] The central portion 1116 may be positioned between the first leg 1112 and the second leg 1114 and may provide a width between the first leg 1112 and the second leg 1114. The central portion 1116 may be coupled to proximal end portions of each of the legs 1112, 1114. The central portion 1116 may be configured to engage the liner 926. The central portion 1116 may engage the liner 926 utilizing one or more coupling surfaces. In examples, the coupling surfaces may comprise adhesive surfaces that couple the liner 926 to the central portion 1116 of the liner removal component 1102. The adhesive surfaces, for example, may comprise pressure sensitive adhesive, or other forms of adhesive surfaces as desired. The central portion 1116 of the liner removal component 1102 may comprise a cover for a portion of the liner 926, that covers the liner 926 upon the surface 924. The cover may cover at least - 62 - 4924-6933-72190985-PCTUS01 PATENTa portion of the surface 924. The central portion 1116 of the liner removal component 1102 may comprise a support for the liner 926, that supports the liner 926 upon the surface 924 until a desired time for decoupling of the liner 926 from the surface 924. The central portion 1116 may comprise a substrate for the liner 926 to be positioned upon, and as shown in FIG. 29A may have a flat shape or another shape as desired. The central portion 1116 may be positioned at a different height, or extend in a different plane, than the respective distal end portions 1104, 1106. The legs 1112, 1114 may space the central portion 1116 from the distal end portions 1104, 1106 in an axial direction.

[0259] In examples, the liner removal component 1102 (e.g., at the central portion 1116) may include an aperture 1110 for the insertion element 915 and the transcutaneous analyte sensor to pass through, configured such that removal of the barrier layer 945 and withdrawal of the liner removal component 1102 does not result in the liner removal component 1102 contacting the insertion element 915 or the transcutaneous analyte sensor.

[0260] By being coupled to the barrier layer 945, the liner removal component 1102 may be at least partially withdrawn from the surface 924 upon the barrier layer 945 being at least partially withdrawn or removed from the housing 1100 (e.g., by being peeled off). Accordingly, at least partially withdrawing or removing the barrier layer 945 from the housing 1100 at least partially decouples the liner 926 from the surface 924. Thus, removing the liner 926 from the surface 924 and removing the barrier layer 945 from the housing 1100 may be accomplished with a single step (i.e., removing the barrier layer 945 from the housing 1100, e.g. by pulling on the grip portion 947).

[0261] In examples, the liner removal component 1102 may include a hinge portion or hinge feature 1124. The hinge feature 1124 may be positioned at the distal end portion 1106 of the second leg 1114, for example. The hinge feature 1124 may have an axis of rotation extending coplanar with (or in a plane parallel to) the opening 1108, and / or extending in a direction transverse to the peeling direction of the barrier layer 945, in examples. The hinge feature 1124 of the liner removal component 1102 may be configured to engage the housing 1100 such that the liner removal component 1102 rotates about the hinge feature 1124 upon the barrier layer 945 being removed or withdrawn from (e.g., peeled off of) the housing 1100 as shown in FIG. 29B, for example. In examples, the hinge feature 1124 may be configured to engage the bottom surface 1122 of the housing 1100.

[0262] The hinge feature 1124 of the liner removal component 1102 may result in the removal of the liner 926 from the surface 924 being asymmetric, which may allow for a peeling of the liner 926 from the surface 924. The peeling may be in a horizontal direction relative to - 63 - 4924-6933-72190985-PCTUS01 PATENTthe surface 924 in examples, as the liner removal component 1102 is withdrawn from the surface 924 axially upon the barrier layer 945 being removed from the housing 1100. As shown in FIG. 29B, the peeling of the liner 926 may be in the same horizontal direction as peeling of the barrier layer 945 off of the housing 1100, in examples. Such a peeling motion of the liner 926 may lessen the force required by a user to remove the entirety of the liner 926. The liner removal component 1102 accordingly may be configured to asymmetrically decouple the liner 926 from the surface 924 upon the liner removal component 1102 being at least partially withdrawn from the surface 924. The liner removal component 1102 may be configured to peel the liner 926 from the surface 924 upon the liner removal component 1102 being at least partially withdrawn from the surface 924.

[0263] In examples, the liner removal component 1102 may comprise a rigid material. For example, the liner removal component 1102 may comprise a plastic material (e.g., a thermoplastic material) or a metal material. The liner removal component 1102 may be formed by molding or stamping the rigid material, for example. In examples, the liner removal component 1102 may comprise different materials and / or may be formed by different methods as desired.

[0264] Variations may be provided in examples. FIG. 30 illustrates an example of a liner removal component 1102a. The liner removal component 1102a may be configured similarly as the liner removal component 1102 of FIGS. 29A and 29B, but instead of the hinge feature being configured to engage the bottom surface 1122 (see FIG. 29B) of the housing 1100, a hinge feature 1124a of the liner removal component 1102a may be configured to engage the interior surface of the housing 1100 as illustrated in FIG. 30, for example. The liner is not shown in FIG. 30, yet would be present upon the surface 924 prior to the liner removal component 1102a being withdrawn from the surface 924.

[0265] The liner removal component 1102a may be configured to engage the liner 926 positioned on the surface 924 (see FIG. 29B, for example) and at least partially decouple the liner 926 from the surface 924 of the on-skin wearable medical device upon being at least partially withdrawn from the surface 924 of the on-skin wearable medical device. In examples, the liner removal component 1102a may comprise a body configured to extend axially within the internal cavity 1118 of the housing 1100 and to engage the liner 926 positioned on the surface 924 and at least partially decouple the liner 926 from the surface 924 of the on-skin wearable medical device upon being at least partially withdrawn from the surface 924 of the on-skin wearable medical device. The liner removal component 1102a may include a first leg 1112a, a second leg 1114a, and a central portion 1116a each configured similarly to the first - 64 - 4924-6933-72190985-PCTUS01 PATENTleg 1112, the second leg 1114, and the central portion 1116, respectively, of the liner removal component 1102.

[0266] A distal end portion 1104a of the liner removal component 1102a may engage the barrier layer 945 utilizing one or more coupling surfaces. In examples, the coupling surfaces may comprise adhesive surfaces that couple the interior surface of the barrier layer 945 to the distal end portion 1104a of the liner removal component 1102a. An opposite distal end portion 1106a may engage the barrier layer 945 or may not engage the barrier layer 945. By being coupled to the barrier layer 945, the liner removal component 1102a may be at least partially withdrawn from the surface 924 upon the barrier layer 945 being at least partially withdrawn or removed from the housing 1100 (e.g., by being peeled off) similarly as the liner removal component 1102 of FIGS. 29 A and 29B, for example.

[0267] The liner removal component 1102a may include a hinge feature 1124a configured to engage the housing 1100 such that the liner removal component 1102a rotates about the hinge feature 1124a upon the barrier layer 945 being removed or withdrawn from (e.g., peeled off of) the housing 1100 similarly as the hinge feature 1124 of the liner removal component 1102 of FIGS. 29A and 29B. The hinge feature 1124a may be positioned adjacent the distal end portion 1106a of the second leg 1114a, for example. The hinge feature 1124a may be spaced from the distal end portion 1106a of the second leg 1114a of the liner removal component 1102a such that the hinge feature 1124a engages the interior surface of the housing 1100 within the internal cavity 1118 of the housing 1100. The hinge feature 1124a of the liner removal component 1102a may result in the removal of the liner 926 from the surface 924 being asymmetric, which may allow for a peeling of the liner 926 from the surface 924 similarly as the hinge feature 1124 of the liner removal component 1102 of FIGS. 29A and 29B. As illustrated in FIG. 30, in examples, the hinge feature 1124a may comprise one or more rods 1126 configured to engage the interior surface of the housing 1100 with the liner removal component 1102a configured to rotate about the one or more rods 1126 upon the barrier layer 945 being at least partially withdrawn from the housing 1100.

[0268] In examples, the liner removal component 1102a may comprise a rigid material. For example, the liner removal component 1102a may comprise a plastic material (e.g., a thermoplastic material) or a metal material. The liner removal component 1102a may be formed by molding or stamping the rigid material, for example. In examples, the liner removal component 1102a may comprise different materials and / or may be formed by different methods as desired.- 65 - 4924-6933-72190985-PCTUS01 PATENT

[0269] Variations may be provided in examples. FIG. 31 illustrates an example of a liner removal component 1102b. The liner removal component 1102b may include a first leg 1112b and a central portion 1116b each configured similarly as the first leg 1112 and the central portion 1116, respectively, of the liner removal component 1102. The liner removal component 1102b may be configured similarly as the liner removal components 1102, 1102a of FIGS. 29A-30, respectively, but with a second leg 1114b of the liner removal component 1102b being shorter than the first leg 1112b of the liner removal component 1102b. The liner is not shown in FIG. 31, yet would be present upon the surface 924 prior to the liner removal component 1102b being withdrawn from the surface 924.

[0270] In examples, the liner removal component 1102b (e.g., at the central portion 1116b) may include an aperture or sheath 1110a for the insertion element 915 and the transcutaneous analyte sensor to pass through, configured such that removal of the barrier layer 945 and withdrawal of the liner removal component 1102b does not result in the liner removal component 1102b contacting the insertion element 915 or the transcutaneous analyte sensor.

[0271] The liner removal component 1102b may be configured to engage the liner 926 positioned on the surface 924 (see FIG. 29B, for example) and at least partially decouple the liner 926 from the surface 924 of the on-skin wearable medical device upon being at least partially withdrawn from the surface 924 of the on-skin wearable medical device. In examples, the liner removal component 1102b may comprise a body configured to extend axially within the internal cavity 1118 of the housing 1100 and to engage the liner 926 positioned on the surface 924 and at least partially decouple the liner 926 from the surface 924 of the on-skin wearable medical device upon being at least partially withdrawn from the surface 924 of the on-skin wearable medical device.

[0272] A distal end portion 1104b of the first leg 1112b of the liner removal component 1102b may engage the barrier layer 945 utilizing one or more coupling surfaces. In examples, the coupling surfaces may comprise adhesive surfaces that couple the interior surface of the barrier layer 945 to the distal end portion 1104b of the liner removal component 1102b. By being coupled to the barrier layer 945, the liner removal component 1102b may be at least partially withdrawn from the surface 924 upon the barrier layer 945 being at least partially withdrawn or removed from the housing 1100 (e.g., by being peeled off) similarly as the liner removal component 1102 of FIGS. 29 A and 29B, for example.

[0273] The liner removal component 1102b may include a hinge feature 1124b configured to engage the housing 1100 such that the liner removal component 1102b rotates about the hinge feature 1124b upon the barrier layer 945 being removed or withdrawn from - 66 - 4924-6933-72190985-PCTUS01 PATENT(e.g., peeled off of) the housing 1100 similarly as the hinge feature 1124 of the liner removal component 1102 of FIGS. 29 A and 29B. The hinge feature 1124b may be positioned adjacent the liner 926, for example. The hinge feature 1124b may be at the plane or height of the central portion 1116b in examples. The hinge feature 1124b of the liner removal component 1102b may result in the removal of the liner 926 from the surface 924 being asymmetric, which may allow for a peeling of the liner 926 from the surface 924 similarly as the hinge feature 1124 of the liner removal component 1102 of FIGS. 29 A and 29B. Similar to the hinge feature 1124a of the liner removal component 1102a, the hinge feature 1124b of the liner removal component 1102b may be configured to engage the interior surface of the housing 1100 as illustrated in FIG. 31, for example.

[0274] In examples, the liner removal component 1102b may comprise a rigid material. For example, the liner removal component 1102b may comprise a plastic material (e.g., a thermoplastic material) or a metal material. The liner removal component 1102b may be formed by molding or stamping the rigid material, for example. In examples, the liner removal component 1102b may comprise different materials and / or may be formed by different methods as desired.

[0275] Other variations may be provided in examples. FIG. 32 illustrates an example of a liner removal component 1102c. The liner removal component 1102c may be configured similarly as the liner removal components 1102, 1102a of FIGS. 29A-30, respectively, but with the liner removal component 1102c including one or more living hinges. The liner is not shown in FIG. 32, yet would be present upon the central portion 1116c upon the liner removal component 1102c being withdrawn from the surface 924.

[0276] The liner removal component 1102c may be configured to engage the liner 926 positioned on the surface 924 (see FIG. 29B, for example) and at least partially decouple the liner 926 from the surface 924 of the on-skin wearable medical device upon being at least partially withdrawn from the surface 924 of the on-skin wearable medical device. In examples, the liner removal component 1102c may comprise a body configured to extend axially within the internal cavity 1118 of the housing 1100 and to engage the liner 926 positioned on the surface 924 and at least partially decouple the liner 926 from the surface 924 of the on-skin wearable medical device upon being at least partially withdrawn from the surface 924 of the on-skin wearable medical device. The liner removal component 1102c may include a first leg 1112c, a second leg 1114c, and a central portion 1116c each configured similarly to the first leg 1112, the second leg 1114, and the central portion 1116, respectively, of the liner removal component 1102 of FIGS. 29 A and 29B.- 67 - 4924-6933-72190985-PCTUS01 PATENT

[0277] In examples, the liner removal component 1102c (e.g., at the central portion 1116c) may include an aperture or sheath 1110b for the insertion element 915 and the transcutaneous analyte sensor to pass through, configured such that removal of the barrier layer 945 and withdrawal of the liner removal component 1102c does not result in the liner removal component 1102c contacting the insertion element 915 or the transcutaneous analyte sensor.

[0278] Distal end portions 1104c, 1106c of the liner removal component 1102c may engage the barrier layer 945 utilizing one or more coupling surfaces. In examples, the coupling surfaces may comprise adhesive surfaces that couple the interior surface of the barrier layer 945 to the distal end portions 1104c, 1106c of the liner removal component 1102c. By being coupled to the barrier layer 945, the liner removal component 1102c may be at least partially withdrawn from the surface 924 upon the barrier layer 945 being at least partially withdrawn or removed from the housing 1100 (e.g., by being peeled off) similarly as the liner removal component 1102 of FIGS. 29A and 29B, for example.

[0279] The liner removal component 1102c may include a hinge feature 1124c configured to engage the housing 1100 such that the liner removal component 1102c rotates about the hinge feature 1124c upon the barrier layer 945 being removed or withdrawn from (e.g., peeled off of) the housing 1100 similarly as the hinge feature 1124 of the liner removal component 1102 of FIGS. 29A and 29B. The hinge feature 1124c may be positioned at the distal end portion 1106c of the second leg 1114c, for example. The hinge feature 1124c of the liner removal component 1102c may result in the removal of the liner 926 from the surface 924 being asymmetric, which may allow for a peeling of the liner 926 from the surface 924 similarly as the hinge feature 1124 of the liner removal component 1102 of FIGS. 29A and 29B. Similar to the hinge feature 1124a of the liner removal component 1102a, the hinge feature 1124c of the liner removal component 1102c may be configured to engage the interior surface of the housing 1100 as illustrated in FIG. 32, for example.

[0280] The first leg 1112c of the liner removal component 1102c may be coupled to the central portion 1116c at a proximal end portion of the first leg 1112c. In examples, the first leg 1112c may be coupled to the central portion 1116c via one or more living hinges 1130 positioned at the proximal end portion of the first leg 1112c. In examples, the distal end portion 1104c of the first leg 1112c may be coupled to the first leg 1112c via one or more living hinges 1128. The second leg 1114c of the liner removal component 1102c may be coupled to the central portion 1116c at a proximal end portion of the second leg 1114c. In examples, the second leg 1114c may be coupled to the central portion 1116c via one or more living hinges 1132 positioned at the proximal end portion of the second leg 1114c.- 68 - 4924-6933-72190985-PCTUS01 PATENT

[0281] The living hinges 1128, 1130, 1132 may cause the liner removal component 1102c to change from a U-shape side profile (e.g., similar to the shape of the liner removal component 1102 in FIG. 29A) to the L-shape side profile illustrated in FIG. 32 or a V-shape side profile upon the barrier layer 945 being removed or withdrawn from (e.g., peeled off) the housing 1100. For example, the distal end portion 1104c, the first leg 1112c, and the central portion 1116c may extend along the same dimension upon the barrier layer 945 being removed or withdrawn from (e.g., peeled off) the housing 1100 as illustrated in FIG. 32. The living hinges 1128, 1130, 1132 may each rotate about an axis that extends in the same dimension as an axis that the hinge feature 1124c of the liner removal component 1102c rotates about upon the barrier layer 945 being removed or withdrawn from (e.g., peeled off) the housing 1100. In examples, the living hinges 1128, 1130, 1132 may each rotate about an axis of rotation extending coplanar with (or in a plane parallel to) the opening 1108, and / or extending in a direction transverse to the peeling direction of the barrier layer 945.

[0282] In examples, the liner removal component 1102c may comprise a rigid material. For example, the liner removal component 1102c may comprise a plastic material (e.g., a thermoplastic material) or a metal material. The liner removal component 1102c may be formed by molding or stamping the rigid material, for example. In examples, the liner removal component 1102c may comprise different materials and / or may be formed by different methods as desired.

[0283] Other variations may be provided in examples. FIG. 33 illustrates an example of a liner removal component 1150 including similar features as the liner removal component 928 shown in FIGS. 26A-26G, yet the liner removal component 1150 may be coupled to the barrier layer 945. One or more hinges 1148 at alternate positions may further be utilized. The liner is not shown in FIG. 33, yet would be present upon the surface 924 prior to the liner removal component 1150 being withdrawn from the surface 924.

[0284] The liner removal component 1150 may be configured to engage the liner 926 positioned on the surface 924 and at least partially decouple the liner 926 from the surface 924 of the on-skin wearable medical device upon being at least partially withdrawn from the surface 924 of the on-skin wearable medical device. In examples, the liner removal component 1150 may comprise a body configured to extend axially within the internal cavity 1118 and to engage the liner 926 positioned on the surface 924 and at least partially decouple the liner 926 from the surface 924 of the on-skin wearable medical device upon being at least partially withdrawn from the surface 924 of the on-skin wearable medical device.- 69 - 4924-6933-72190985-PCTUS01 PATENT

[0285] The liner removal component 1150 may include a first portion 1138, a second portion 1144, and an intermediate portion 1146, each configured similarly as the respective first portion 930, second portion 932, and intermediate portion 936 of the liner removal component 928, in examples, unless stated otherwise.

[0286] The first portion 1138 may be configured to engage the liner, with the second portion 1144 being axially spaced from the first portion 1138. The first portion 1138 of the liner removal component 1150 may engage the liner 926 utilizing one or more coupling surfaces, similarly to the liner removal component 928, for example. In examples, the coupling surfaces may comprise adhesive surfaces that couple the liner 926 to the first portion 1138. The adhesive surfaces, for example, may comprise pressure sensitive adhesive, or other forms of adhesive surfaces as desired.

[0287] In examples, the first portion 1138 may include an aperture or cutout 1140 for the insertion element 915 (shown in FIG. 29 A for example) and the transcutaneous analyte sensor to pass through, configured such that removal of the barrier layer 945 and withdrawal of the liner removal component 1150 does not result in the liner removal component 1150 contacting the insertion element 915 or the transcutaneous analyte sensor.

[0288] The second portion 1144 may comprise a base for the liner removal component 1150, in examples. In examples, the second portion 1144 may be configured to be positioned at the opening 1108 of the housing 1100. The second portion 1144, in examples, may be coupled to the barrier layer 945. For example, the second portion 1144 may be coupled to the interior surface of the barrier layer 945 at the grip portion 947 as shown in FIG. 33. The second portion 1144 may engage the barrier layer 945 utilizing one or more coupling surfaces. In examples, the coupling surfaces may comprise adhesive surfaces that couple the barrier layer 945 to the second portion 1144. The adhesive surfaces, for example, may comprise pressure sensitive adhesive, or other forms of adhesive surfaces as desired. By being coupled to the barrier layer 945, the liner removal component 1150 may be at least partially withdrawn from the surface 924 upon the barrier layer 945 being at least partially withdrawn or removed from the housing 1100 (e.g., by being peeled off) similarly as the liner removal component 1000 of FIG. 27A, for example.

[0289] The intermediate portion 1146 may be positioned between the first portion 1138 and the second portion 1144 and may provide a height between the first portion 1138 and the second portion 1144. The intermediate portion 1146 may comprise a spacer body in examples, or may have another form as desired. As shown in FIG. 33, the intermediate portion 1146 may comprise multiple links or portions coupled together by one or more hinges 1148, although - 70 - 4924-6933-72190985-PCTUS01 PATENTother configurations may be utilized in examples as desired. The one or more hinges 1148 may be living hinges, in examples. In examples, the one or more hinges 1148 may rotate about one or more axes of rotation extending coplanar with (or in a plane parallel to) the opening 1108, and / or extending in a direction transverse to the peeling direction of the barrier layer 945. The one or more hinges 1148 may cause the liner removal component 1150 to straighten and extend in an axial direction relative to the housing 1100 upon the barrier layer 945 being at least partially withdrawn or removed from the housing 1100 (e.g., by being peeled off).

[0290] The intermediate portion 1146 in examples may include one or more guides 1142 that may extend into and engage channels 1134 in the interior surface of the housing 1100 that may prevent rotation and / or tilting of the liner removal component 1150 prior to or during removal from the housing 1100. The guides 1142 may extend laterally across the internal cavity 1118 to orient the liner removal component 1150 within the internal cavity 1118. The guides 1142 may prevent rotation of the first portion 1138 to reduce the possibility of shear of the liner. A shear of the liner, for example, may cause the surface 924 to undesirably fold or crease onto itself in examples. The guides 1142 may prevent tilting of the liner removal component 1150 to reduce the possibility of one or more portions of the liner removal component 1150 from contacting or damaging the insertion element 915 or the sensor as the liner removal component 1150 is withdrawn. In examples, the guides 1142 may reduce the possibility of rotation and / or tilting of the liner removal component 1150 relative to the housing 1100.

[0291] In examples, the liner removal component 1150 may comprise a rigid material. For example, the liner removal component 1150 may comprise a plastic material (e.g., a thermoplastic material) or a metal material. The liner removal component 1150 may be formed by molding or stamping the rigid material, for example. In examples, the liner removal component 1150 may comprise different materials and / or may be formed by different methods as desired.

[0292] The features of the examples of FIGS. 29A-33 may be utilized solely or in combination with any other example disclosed herein.

[0293] Other configurations of liner removal components may be utilized in examples. FIGS. 34A-34C illustrate an example of a liner removal component 1200. The liner removal component 1200 may be configured similarly as the liner removal component 1000 shown in FIG. 27 A, yet the liner removal component 1200 may include a grip portion 1220 (marked in FIG. 34B) within the internal cavity 903 of the housing 902. The liner removal component 1200 may further be coupled to the interior surface of the barrier layer 945. The liner removal - 71 - 4924-6933-72190985-PCTUS01 PATENTcomponent 1200 may be configured to engage the liner 926 positioned on the surface 924 and at least partially decouple the liner 926 from the surface 924 of the on-skin wearable medical device upon being at least partially withdrawn from the surface 924 of the on-skin wearable medical device. In examples, the liner removal component 1200 may comprise a body configured to extend axially within the internal cavity 903 and to engage the liner 926 positioned on the surface 924 and at least partially decouple the liner 926 from the surface 924 of the on-skin wearable medical device upon being at least partially withdrawn from the surface 924 of the on-skin wearable medical device.

[0294] FIG. 34A illustrates a perspective partial cross-sectional view of the liner removal component 1200 within the housing 902. FIG. 34B illustrates a perspective bottom view of the liner removal component 1200 within the housing 902. FIG. 34C illustrates a perspective view of the liner removal component 1200 withdrawn from the housing 902. The liner is not shown in FIG. 34C, yet would be present upon the first portion 1202 upon the liner removal component 1200 being removed from the housing 902.

[0295] Referring to FIGS. 34A-34C, the liner removal component 1200 may include at least a portion that is configured to extend axially within the internal cavity 903. The liner removal component 1200 may include a first portion 1202, a second portion 1204, and an intermediate portion 1206. The first portion 1202 may be configured to engage the liner, with the second portion 1204 being axially spaced from the first portion 1202. The first portion 1202 of the liner removal component 1200 may engage the liner 926 utilizing one or more coupling surfaces 1212 (marked in FIG. 34C), similarly to the liner removal component 928, for example. In examples, the coupling surfaces 1212 may comprise adhesive surfaces that couple the liner 926 to the first portion 1202. The adhesive surfaces, for example, may comprise pressure sensitive adhesive, or other forms of adhesive surfaces as desired.

[0296] In examples, the first portion 1202 may include an aperture 1214 (marked in FIG. 34C) for the insertion element 915 and the transcutaneous analyte sensor to pass through (as shown in FIG. 34A). In examples, the first portion 1202 may include a sheath 1208 configured to cover the insertion element 915, and particularly the tip of the insertion element 915. Thus, as a user grasps the liner removal component 1200, a reduced possibility of contact with the insertion element 915 and the transcutaneous analyte sensor results. In examples, the sheath 1208 may include a layer or portion configured to allow sterilizing gas to permeate through the layer or portion to contact at least a portion of the insertion element 915 or at least a portion of the transcutaneous analyte sensor.- 72 - 4924-6933-72190985-PCTUS01 PATENT

[0297] The intermediate portion 1206 may be positioned between the first portion 1202 and the second portion 1204 and may provide a height between the first portion 1202 and the second portion 1204. The intermediate portion 1206 may comprise a spacer body in examples, or may have another form as desired. As shown in FIGS. 34A-34C, the intermediate portion 1206 may have a cylindrical shape, although other configurations may be utilized in examples as desired.

[0298] The intermediate portion 1206 in examples may include one or more guides 1216 that may extend along channels 1218 in the interior surface of the housing 902 that may prevent rotation and / or tilting of the liner removal component 1200 prior to or during removal from the housing 902. The guides 1216 may extend axially along the internal cavity 903 to orient the liner removal component 1200 within the internal cavity 903. The guides 1216 may prevent rotation of the first portion 1202 to reduce the possibility of shear of the liner. A shear of the liner, for example, may cause the surface 924 to undesirably fold or crease onto itself in examples. The guides 1216 may prevent tilting of the liner removal component 1200 to reduce the possibility of one or more portions of the liner removal component 1200, such as, for example, the sheath 1208, from contacting or damaging the insertion element 915 or the sensor as the liner removal component 1200 is withdrawn. In examples, the guides 1216 may reduce the possibility of rotation and / or tilting of the liner removal component 1200 relative to the housing 902.

[0299] The second portion 1204 may comprise a base for the liner removal component 1200, in examples. In examples, the second portion 1204 may be configured to be positioned at the opening 905 of the housing 902. The second portion 1204, in examples, may be coupled to the barrier layer 945. For example, the second portion 1204 may be coupled to the interior surface of the barrier layer 945 around a perimeter surface 1222 of the second portion 1204 as shown in FIG. 34B, for example. In examples, the second portion 1204 may engage the barrier layer 945 utilizing one or more coupling surfaces. In examples, the coupling surfaces may comprise adhesive surfaces that couple the barrier layer 945 to the second portion 1204. The adhesive surfaces, for example, may comprise pressure sensitive adhesive, or other forms of adhesive surfaces as desired. By being coupled to the barrier layer 945, the liner removal component 1200 may at least partially withdraw or remove the barrier layer 945 from the housing 902 upon the liner removal component 1200 being at least partially withdrawn from the surface 924.

[0300] The second portion 1204 in examples, may include a grip portion 1220 (marked in FIG. 34B) positioned at the second portion 1204 and configured to be gripped by a user (e.g.,- 73 - 4924-6933-72190985-PCTUS01 PATENTgrasped between a finger and thumb, or hooked using a single finger) to withdraw the liner removal component 1200 from the surface 924 of the on-skin sensor assembly 508. The grip portion 1220, for example, may comprise a portion of the liner removal component 1200 for gripping manually or through another method (e.g., using a finger, hook, or other tool) for removal from the housing 902. The grip portion 1220 as shown in FIG. 34B may comprise one or more flanges or ledges that may be configured for grip.

[0301] The liner removal component 1200 may form a cavity 1210 within the internal cavity 903. As shown in FIG. 34B, in examples, the barrier layer 945 may be ring shaped and may surround an aperture 1224 such that the cavity 1210 of the liner removal component 1200 is not covered by the barrier layer 945. The uncovered cavity 1210 may allow a user to grip the grip portion 1220 (e.g., insert a finger into the cavity 1210 to hook the grip portion 1220) to withdraw the liner removal component 1200 from the surface 924 of the on-skin sensor assembly 508.

[0302] In examples, the liner removal component 1200 may comprise a rigid material. For example, the liner removal component 1200 may comprise a plastic material (e.g., a thermoplastic material) or a metal material. The liner removal component 1200 may be formed by molding or stamping the rigid material, for example. In examples, the liner removal component 1200 may comprise different materials and / or may be formed by different methods as desired.

[0303] The features of the examples of FIGS. 34A-34C may be utilized solely or in combination with any other example disclosed herein.

[0304] Other configurations of liner removal components may be utilized in examples.

[0305] FIGS. 35A and 35B illustrate examples of a liner removal component 1300. The liner removal component 1300 may be configured to engage the liner 926 positioned on the surface 924 and at least partially decouple the liner 926 from the surface 924 of the on-skin wearable medical device upon being at least partially withdrawn from the surface 924 of the on-skin wearable medical device. In examples, the liner removal component 1300 may comprise a body configured to extend axially within the internal cavity 903 and to engage the liner 926 positioned on the surface 924 and at least partially decouple the liner 926 from the surface 924 of the on-skin wearable medical device upon being at least partially withdrawn from the surface 924 of the on-skin wearable medical device.

[0306] FIG. 35 A illustrates a cross-sectional view of the liner removal component 1300 within the housing 902. FIG. 35B illustrates a bottom view of the liner removal component 1300 within the housing 902 (at an orthogonal or 90 degree view from the view shown in FIG.- 74 - 4924-6933-72190985-PCTUS01 PATENT35 A). The barrier layer is not shown in FIG. 35B, yet would be present upon the bottom surface of the housing 902 prior to the liner removal component 1300 being removed from the housing 902.

[0307] Referring to FIGS. 35A and 35B, the liner removal component 1300 may include a first portion 1302, a second portion 1304, and an intermediate portion 1306. The first portion 1302 may be configured to engage the liner, with the second portion 1304 being axially spaced from the first portion 1302. The first portion 1302 of the liner removal component 1300 may engage the liner 926 utilizing one or more coupling surfaces, similarly to the liner removal component 928 of FIG. 26A, for example. In examples, the coupling surfaces may comprise adhesive surfaces that couple the liner 926 to the first portion 1302. The adhesive surfaces, for example, may comprise a pressure sensitive adhesive, or other forms of adhesive surfaces as desired.

[0308] The second portion 1304 may comprise a base for the liner removal component 1300, in examples. In examples, the second portion 1304 may be configured to be positioned at the opening 905 of the housing 902. The second portion 1304, in examples, may be coupled to the barrier layer 945. For example, the second portion 1304 may be coupled to the interior surface of the barrier layer 945. The second portion 1304 may engage the barrier layer 945 utilizing one or more coupling surfaces. In examples, the coupling surfaces may comprise adhesive surfaces that couple the barrier layer 945 to the second portion 1304. The adhesive surfaces, for example, may comprise pressure sensitive adhesive, or other forms of adhesive surfaces as desired. By being coupled to the barrier layer 945, the liner removal component 1300 may be at least partially withdrawn from the surface 924 upon the barrier layer 945 being at least partially withdrawn or removed from the housing 902 (e.g., by being peeled off) similarly as the liner removal component 1000 of FIG. 27 A, for example.

[0309] The intermediate portion 1306 may be positioned between the first portion 1302 and the second portion 1304 and may provide a height between the first portion 1302 and the second portion 1304. The intermediate portion 1306 may comprise a spacer body in examples, or may have another form as desired.

[0310] As shown in FIGS. 35A and 35B, the liner removal component 1300 may have a thin and substantially planar shape (with the thin and planar shape extending perpendicular into the page in FIG. 35 A), although other configurations may be utilized in examples as desired. For example, the thin and planar shape of the liner removal component 1300 may span within the internal cavity 903 (in a plane) and extend between channels 1308 in the interior surface of the housing 902 that may prevent rotation and / or tilting of the liner removal - 75 - 4924-6933-72190985-PCTUS01 PATENTcomponent 1300 prior to or during removal from the housing 902. The liner removal component 1300 may extend axially along the internal cavity 903 within the channels 1308 to orient the liner removal component 1300 within the internal cavity 903.

[0311] In examples, the liner removal component 1300 may include a cutout or aperture 1310 for the insertion element 915 and the transcutaneous analyte sensor to pass through. The aperture 1310 may extend from the first portion 1302 to the second portion 1304, for example. The aperture 1310 may form a sheath or tunnel around the insertion element 915 that extends to the barrier layer 945 (with the thin and planar shape of the liner removal component 1300 extending radially outward from the aperture 1310 in a plane). Thus, as a user (e.g., a host) grasps the liner removal component 1300, a reduced possibility of contact with the insertion element 915 and the transcutaneous analyte sensor results. The aperture 1310 and / or the tunnel or sheath of the liner removal component 1300 may be oval shaped as illustrated in FIG. 35B, for example. Other shapes may be utilized as desired. FIG. 35C, for example, illustrates a variation of the liner removal component 1300 that includes an aperture 1310a and a tunnel or sheath 1311 having a circular shape.

[0312] The aperture 1310 of the liner removal component 1300 and the aperture 1310a of the liner removal component of FIG. 35C may each have a center that is positioned on a respective widthwise axis (e.g., axis 1307 shown in FIG. 35C) of the liner removal components. Accordingly, the aperture 1310 and the sheath of the liner removal component 1300, and the aperture 1310a and the sheath 1311 of the liner removal component of FIG. 35C, may each be bisected by the respective widthwise axis of the liner removal components. Other configurations of apertures and sheaths or tunnels may be utilized as desired.

[0313] FIG. 35D, for example, illustrates a variation of the liner removal component 1300 in the form of a liner removal component 1300a that includes an aperture 1310b having a center that is positioned laterally offset or adjacent from a widthwise axis 1307a of the liner removal component 1300a. Accordingly, a tunnel or sheath 1311a of the liner removal component 1300a is not bisected by the widthwise axis 1307a of the liner removal component 1300a. The liner removal component 1300a may comprise a planar portion 1315 and the sheath 1311a coupled to the planar portion 1315. The planar portion 1315 may extend along the widthwise axis 1307a. The sheath 131 la may be laterally offset or adjacent from the widthwise axis 1307a. Other configurations may be utilized as desired.

[0314] FIG. 35E illustrates a variation of the liner removal component 1300a in the form of a liner removal component 1300b that comprises a first planar portion 1315a and a second planar portion 1315b, and a tunnel or sheath 1311b coupled to the first planar portion - 76 - 4924-6933-72190985-PCTUS01 PATENT1315a. The first planar portion 1315a may correspond to the planar portion 1315 of the liner removal component 1300a, and the sheath 1311b may correspond to the sheath 1311a of the liner removal component 1300a. Accordingly, the liner removal component 1300b may be similar as the liner removal component 1300a except for the addition of the second planar portion 1315b. The first planar portion 1315a may extend along a widthwise axis 1307b of the liner removal component 1300b. The second planar portion 1315b may extend along an axis 1313 that is transverse or perpendicular to the widthwise axis 1307a. The axis 1313 may bisect the sheath 1311b and / or an aperture 1310c of the liner removal component 1300b in examples.

[0315] In examples, the liner removal components 1300, 1300a, 1300b may comprise a rigid material. Forexample, the liner removal components 1300, 1300a, 1300b may comprise a plastic material (e.g., a thermoplastic material) or a metal material. The liner removal components 1300, 1300a, 1300b may be formed by molding or stamping the rigid material, for example. In examples, the liner removal components 1300 may comprise different materials and / or may be formed by different methods as desired.

[0316] The features of the examples of FIGS. 35A-35E may be utilized solely or in combination with any other example disclosed herein.

[0317] Other configurations of liner removal components may be utilized in examples.

[0318] FIGS. 36A-36C illustrate an example of a liner removal component 1400 configured to at least partially decouple a liner from the surface 924 upon the liner removal component 1400 being at least partially withdrawn from the surface 924. The liner removal component 1400 may be coupled to the barrier layer 945 and may include a liner portion that may form the liner. The liner removal component 1400 may include a body configured to extend axially within the internal cavity 1118 of the housing 1100.

[0319] For example, the liner removal component 1400 may include a first portion 1402, a second portion 1404, and an intermediate portion 1406. The first portion 1402 of the liner removal component 1400 may form a liner that is disposed on the surface 924 similar to the liner 926, for example.

[0320] The second portion 1404 may be configured to be positioned at the opening 1108 of the housing 1100. The second portion 1404 may be axially spaced from the first portion 1402. The second portion 1404, in examples, may be coupled to the barrier layer 945. For example, the second portion 1404 may be coupled to the interior surface of the barrier layer 945 at a first edge portion 1405 of the barrier layer 945 and at a second edge portion 1407 of the barrier layer 945 that is opposite the first edge portion 1405. The second portion 1404 may engage the barrier layer 945 utilizing one or more coupling surfaces. In examples, the coupling - 77 - 4924-6933-72190985-PCTUS01 PATENTsurfaces may comprise adhesive surfaces that couple the barrier layer 945 to the second portion 1404. The adhesive surfaces, for example, may comprise pressure sensitive adhesive, or other forms of adhesive surfaces as desired. By being coupled to the barrier layer 945, the liner removal component 1400 may be at least partially withdrawn from the surface 924 thereby at least partially decoupling the liner from the surface 924 upon the barrier layer 945 being at least partially withdrawn or removed from the housing 1100 (e.g., by being peeled off).

[0321] The intermediate portion 1406 may be positioned between the first portion 1402 and the second portion 1404 and may provide a height between the first portion 1402 and the second portion 1404. The intermediate portion 1406 may comprise a spacer body in examples, or may have another form as desired.

[0322] In examples, the liner removal component 1400 may include an aperture 1408 for the insertion element 915 and the transcutaneous analyte sensor to pass through, configured such that removal of the barrier layer 945 and withdrawal of the liner removal component 1400 does not result in the liner removal component 1400 contacting the insertion element 915 or the transcutaneous analyte sensor.

[0323] FIG. 36B illustrates a side view of the liner removal component 1400 engaged with the patch 922 and isolated from the housing 1100. The liner removal component 1400 may comprise multiple layers of a flexible foldable material, which may be folded upon each other with a central opening 1410 between the layers such that the liner removal component 1400 comprises two halves or two mirrored halves. For example, as shown in FIG. 36B, the first portion 1402 may be disposed on the surface 924 of the patch 922 and the intermediate portion 1406 may fold upon the first portion 1402 forming the central opening 1410. The liner removal component 1400 may be arranged in a butterfly-shape fold configuration having a plurality of folds.

[0324] As shown in FIG. 36C, the removal of first portion 1402 (i.e., the liner) from the surface 924 may be asymmetric, which may further allow for a peeling of the liner. The peeling may be in a horizontal direction relative to the surface 924 in examples, as the liner removal component 1400 is withdrawn from the surface 924 axially upon the barrier layer 945 being removed from the housing 1100. Such a peeling motion of the liner may lessen the force required by a user to remove the entirety of the liner. The liner removal component 1400 accordingly may be configured to asymmetrically decouple the liner from the surface 924 upon the liner removal component 1400 being at least partially withdrawn from the surface 924. The liner removal component 1400 may be configured to peel the liner from the surface 924 upon the liner removal component 1400 being at least partially withdrawn from the surface 924.- 78 - 4924-6933-72190985-PCTUS01 PATENT

[0325] The features of the examples of FIGS. 36A-36C may be utilized solely or in combination with any other example disclosed herein.

[0326] Other configurations of liner removal components may be utilized in examples.

[0327] FIG. 37 illustrates an example of a liner removal component 1450 configured to at least partially decouple the liner 926 from the surface 924 upon the liner removal component 1450 being at least partially withdrawn from the surface 924. The liner removal component 1450 may comprise a flexible and / or foldable material. The liner removal component 1450 may include a body configured to extend axially within the internal cavity 1118 of the housing 1100. The liner removal component 1450 may include a first portion 1452, a second portion 1454, and an intermediate portion 1456. As shown in FIG. 37, the first portion 1452 may be substantially flat and disposed on the liner 926. The first portion 1452 of the liner removal component 1450 may engage the liner 926 utilizing one or more coupling surfaces. In examples, the coupling surfaces may comprise adhesive surfaces that couple the liner 926 to the first portion 1452. The adhesive surfaces, for example, may comprise pressure sensitive adhesive, or other forms of adhesive surfaces as desired.

[0328] The second portion 1454 may be configured to be positioned at the opening 1108 of the housing 1100. The second portion 1454 may be axially spaced from the first portion 1452. The second portion 1454, in examples, may be coupled to the barrier layer 945. For example, the second portion 1454 may be coupled to the interior surface of the barrier layer 945 at an outer edge portion of the barrier layer 945 that is adjacent the grip portion 947. The second portion 1454 may engage the barrier layer 945 utilizing one or more coupling surfaces. In examples, the coupling surfaces may comprise adhesive surfaces that couple the barrier layer 945 to the second portion 1454. The adhesive surfaces, for example, may comprise pressure sensitive adhesive, or other forms of adhesive surfaces as desired. By being coupled to the barrier layer 945, the liner removal component 1450 may be at least partially withdrawn from the surface 924 thereby at least partially decoupling the liner 926 from the surface 924 upon the barrier layer 945 being at least partially withdrawn or removed from the housing 1100 (e.g., by being peeled off).

[0329] The intermediate portion 1456 may be positioned between the first portion 1452 and the second portion 1454 and may provide a height between the first portion 1452 and the second portion 1454. The intermediate portion 1456 may comprise a spacer body in examples, or may have another form as desired. As shown in FIG. 37, the intermediate portion 1456 may be positioned at an outer edge of the liner 926 and may extend axially along the interior surface of the housing 1100 (axially along the internal cavity 1118 of the housing 1100).- 79 - 4924-6933-72190985-PCTUS01 PATENT

[0330] In examples, the liner removal component 1450 may include an aperture 1458 for the insertion element 915 and the transcutaneous analyte sensor to pass through, configured such that removal of the barrier layer 945 and withdrawal of the liner removal component 1450 does not result in the liner removal component 1450 contacting the insertion element 915 or the transcutaneous analyte sensor.

[0331] The removal of the liner 926 from the surface 924 may be asymmetric, which may further allow for a peeling of the liner. The peeling may be in a horizontal direction relative to the surface 924 in examples, as the liner removal component 1450 is withdrawn from the surface 924 axially upon the barrier layer 945 being removed from the housing 1100. Such a peeling motion of the liner may lessen the force required by a user to remove the entirety of the liner. The liner removal component 1450 accordingly may be configured to asymmetrically decouple the liner 926 from the surface 924 upon the liner removal component 1450 being at least partially withdrawn from the surface 924. The liner removal component 1450 may be configured to peel the liner 926 from the surface 924 upon the liner removal component 1450 being at least partially withdrawn from the surface 924.

[0332] The features of the examples of FIG. 37 may be utilized solely or in combination with any other example disclosed herein.

[0333] Other configurations of liner removal components may be utilized in examples.

[0334] FIG. 38A illustrates an example of a liner removal component 1800 configured to at least partially decouple the liner 926 from the surface 924 (marked in FIG. 26E) upon the liner removal component 1800 being at least partially withdrawn from the surface 924. The liner removal component 1800 may include a body that is configured to extend axially within the internal cavity 903 of the housing 902. The liner removal component 1800 may be coupled to the barrier layer 945.

[0335] The liner removal component 1800 may be Z-shaped (when viewed from the side) as shown in FIG. 38 A. The liner removal component 1800 may include a first portion 1802, a second portion 1804, and an intermediate portion 1806. The first portion 1802 of the liner removal component 1800 may form a liner that is disposed on the surface 924 similar to the liner 926, for example. The first portion 1802 may comprise a liner portion that forms the liner. The first portion 1802 may engage the surface 924 utilizing one or more coupling surfaces 1808. In examples, the coupling surfaces 1808 may comprise adhesive surfaces that couple the patch 922 to the first portion 1802. The adhesive surfaces, for example, may comprise pressure sensitive adhesive, or other forms of adhesive surfaces as desired.- 80 - 4924-6933-72190985-PCTUS01 PATENT

[0336] The second portion 1804 may be configured to be positioned at the opening 905 of the housing 902. The second portion 1804 may be axially spaced from the first portion 1802. The second portion 1804, in examples, may be coupled to the barrier layer 945. For example, the second portion 1804 may be coupled to the interior surface of the barrier layer 945. The second portion 1804 may engage the barrier layer 945 utilizing one or more coupling surfaces 1810. In examples, the coupling surfaces 1810 may comprise adhesive surfaces that couple the barrier layer 945 to the second portion 1804. The adhesive surfaces, for example, may comprise pressure sensitive adhesive, or other forms of adhesive surfaces as desired. By being coupled to the barrier layer 945, the liner removal component 1800 may be at least partially withdrawn from the surface 924 thereby at least partially decoupling the liner from the surface 924 upon the barrier layer 945 being at least partially withdrawn or removed from the housing 902 (e.g., by being peeled off).

[0337] The intermediate portion 1806 may be positioned between the first portion 1802 and the second portion 1804 and may provide a height between the first portion 1802 and the second portion 1804. The intermediate portion 1806 may comprise a spacer body in examples, or may have another form as desired.

[0338] In examples, the liner removal component 1800 may include an aperture (e.g., at the first portion 1802) for the insertion element 915 and the transcutaneous analyte sensor to pass through, configured such that removal of the barrier layer 945 and withdrawal of the liner removal component 1800 does not result in the liner removal component 1800 contacting the insertion element 915 or the transcutaneous analyte sensor.

[0339] The liner removal component 1800 may comprise multiple layers of a flexible foldable material, which may be folded upon each other. For example, as shown in FIG. 38 A, the first portion 1802 may be disposed on the surface 924 of the patch 922 and the intermediate portion 1806 may fold over the first portion 1802, with the second portion 1804 folding over the intermediate portion 1806. The liner removal component 1800 may be arranged in a Z-fold configuration having a plurality of folds. The folds of the liner removal component 1800 may enable the liner removal component 1800 to extend or telescope from the interior surface of the barrier layer 945 to the patch 922, in examples. The liner removal component 1800 may extend axially upon the barrier layer 945 being removed.

[0340] FIG. 38B illustrates a variation of the liner removal component 1800 of FIG.38 A. Instead of being Z-shaped, FIG. 38B illustrates a bellows-shaped liner removal component having the first portion 1802a for engaging the surface 924 of the patch 922, the second portion 1804a axially spaced from the first portion 1802a and for engaging the barrier - 81 - 4924-6933-72190985-PCTUS01 PATENTlayer 945, and the intermediate portion 1806a positioned between the first portion 1802a and the second portion 1804a. In examples, the liner removal component of FIG. 38B may comprise bellows. The liner removal component of FIG. 38B may have all the features of the liner removal component 1800 of FIG. 38A unless stated otherwise.

[0341] The features of the examples of FIGS. 38A and 38B may be utilized solely or in combination with any other example disclosed herein.

[0342] Other configurations of liner removal components may be utilized in examples.

[0343] FIGS. 39A and 39B illustrate an example of a liner removal component 1500 configured to at least partially decouple the liner from the surface 924 (marked in FIG. 26E) upon the liner removal component 1500 being at least partially withdrawn from the surface 924.

[0344] The liner removal component 1500 may comprise a single body insert that may extend axially within the internal cavity 903. The liner removal component 1500 may form a cavity 1514 within the internal cavity 903. The liner removal component 1500 may include a first portion 1502 for supporting the liner 926, a second portion 1504 positioned at the opening 905 of the internal cavity 903, and an intermediate portion 1506. The first portion 1502 of the liner removal component 1500 may engage the liner 926 utilizing one or more coupling surfaces, similarly to the liner removal component 928 of FIG. 26 A, for example. In examples, the coupling surfaces may comprise adhesive surfaces that couple the liner 926 to the first portion 1502. The adhesive surfaces, for example, may comprise pressure sensitive adhesive, or other forms of adhesive surfaces as desired. The first portion 1502 may be axially spaced from the second portion 1504. The first portion 1502 may include a sheath 1518 that covers the insertion element 915.

[0345] The intermediate portion 1506 may be positioned between the first portion 1502 and the second portion 1504 and may provide a height between the first portion 1502 and the second portion 1504. The intermediate portion 1506 may comprise a spacer body in examples, or may have another form as desired. As illustrated in FIGS. 39A and 39B, the intermediate portion 1506 may have a cylindrical shape, for example.

[0346] The intermediate portion 1506, in examples, may include an engagement portion 1516 positioned at the intermediate portion 1506 and configured to engage a portion of the housing 902 to retain the liner removal component 1500 within the housing 902. For example, the engagement portion 1516 may be configured to engage a portion of the interior surface of the housing 902. The engagement portion 1516 may comprise a detent, for example.- 82 - 4924-6933-72190985-PCTUS01 PATENT

[0347] In examples, the liner removal component 1500 may have other forms of securement to the housing 902, for example, snaps, clamps, or other forms of securement may be utilized as desired.

[0348] In examples, the second portion 1504 may be configured to be positioned at the opening 905 of the housing 902. The second portion 1504, in examples, may form the barrier layer. For example, the liner removal component 1500 may be configured to cover and seal the opening 905 of the housing 902. The second portion 1504 may include a sealing member 1508 configured to engage and form a seal between the housing 902 and the liner removal component 1500. The sealing member 1508 may comprise a gasket or an O-ring, for example. The sealing member 1508 may be positioned at a lip 1510 of the second portion 1504 that extends around a portion of the housing 902.

[0349] The second portion 1504 may comprise a grip portion for gripping by a user. For example, the second portion 1504 may be configured to be gripped by a user for withdrawing the liner removal component 1500 from the surface 924 in an axial direction relative to the housing 902 to at least partially decouple the liner 926 from the surface 924.

[0350] In examples, the liner removal component 1500 may be made of a flexible or rigid plastic. The liner removal component 1500 may comprise a base for the housing 902 and may cover the internal cavity 903.

[0351] The liner removal component 1500 may comprise a nonthreaded lid or cap in examples. As such, the liner removal component 1500 may be removed from the housing 902 by being pulled axially (without a threaded disengagement). Such a feature may reduce the complexity required to remove the liner removal component 1500. The lack of threading may reduce the rotational force required to remove the liner removal component 1500.

[0352] FIG. 39B illustrates a perspective view of the liner removal component 1500 covering the opening of the housing 902.

[0353] Variations may be provided in examples. In examples, the liner removal component 1500 may include one or more retention features 1520 that extend from the second portion 1504 and are configured to engage corresponding retention features of the housing 902 to retain the liner removal component within the housing 902. For example, FIG. 39C illustrates such a liner removal component 1500a. The liner removal component 1500a may have all the features of the liner removal component 1500 of FIG. 39A unless stated otherwise.

[0354] The one or more retention features 1520 of the liner removal component 1500a may include one or more deflection arms 1521, in examples. The retention features of the housing 902 may include one or more protrusions 1522 configured to protrude radially - 83 - 4924-6933-72190985-PCTUS01 PATENToutwardly relative to the housing 902. The deflection arms 1521 may be configured to engage the protrusions 1522 of the housing 902 to retain the liner removal component 1500a within the housing 902.

[0355] As illustrated in FIG. 39D, in a variation, the retention features of the housing 902 may include one or more concave portions 1524 with one or more deflection arms 1521a of the liner removal component being configured to engage the concave portions 1524 of the housing 902 to retain the liner removal component within the housing 902. The protrusions 1522 and the concave portions 1524 of the housing 902 may each be positioned on an outer surface of the housing 902, for example.

[0356] In examples, the one or more retention features may be configured to disengage from the corresponding retention features of the housing 902 upon a portion of the one or more retention features 1520 being pressed radially inwardly relative to the housing 902 by a user. Such a motion may produce a corresponding deflection of the deflection arms 1521, 1521a radially outward to release from the retention features of the housing 902.

[0357] In examples, the one or more retention features 1520 may be configured to disengage from the corresponding retention features of the housing 902 upon the liner removal component being withdrawn from the surface 924 in an axial direction relative to the housing 902 with a sufficient force.

[0358] In examples, the one or more retention features 1520 may be configured to disengage from the corresponding retention features of the housing 902 upon the liner removal component being rotated relative to the housing 902. FIG. 39E, for example, illustrates a variation of the liner removal component 1500a in the form of a liner removal component 1500b that includes one or more deflection arms 1521b. The liner removal component 1500b may have all the features of the liner removal component 1500a of FIG. 39C unless stated otherwise. The one or more deflection arms 1521b may be configured to disengage from the corresponding retention features of the housing 902 upon the liner removal component 1500b being rotated relative to the housing 902 (e.g., as illustrated by the curved arrow 1526 in FIG.39E). The retention features of the housing 902 may include one or more protrusions 1522a that are positioned on the outer surface of the housing 902 and configured to protrude radially outwardly relative to the housing 902. The one or more deflection arms 1521b may disengage from the respective protrusions 1522a upon the liner removal component 1500b being at least partially rotated (e.g., 10 degrees, 20 degrees, etc.) relative to the housing 902. Other configurations may be utilized as desired.- 84 - 4924-6933-72190985-PCTUS01 PATENT

[0359] Variations may be provided in examples. FIG. 39F, for example, illustrates an example of a liner removal component 1530 configured to at least partially decouple the liner from the surface 924 (marked in FIG. 26E) upon the liner removal component 1530 being at least partially withdrawn from the surface 924.

[0360] The liner removal component 1530 may comprise a single body insert that may extend axially within the internal cavity 903 (marked in FIG. 26A). The liner removal component 1530 may include a first portion 1532 for supporting the liner 926 (marked in FIG.39A), a second portion 1534 positioned at the opening 905 (marked in FIG. 26A) of the internal cavity 903, and an intermediate portion 1536. The first portion 1532 of the liner removal component 1530 may engage the liner 926 utilizing one or more coupling surfaces, similarly to the liner removal component 928 of FIG. 26A, for example. The first portion 1532 may be axially spaced from the second portion 1534. The first portion 1532 may include an aperture 1540 for the insertion element 915 (marked in FIG. 26 A) and the transcutaneous analyte sensor to pass through. At least a portion of the first portion 1532 and / or the intermediate portion 1536 may form a sheath that covers the insertion element 915.

[0361] The intermediate portion 1536 may be positioned between the first portion 1532 and the second portion 1534 and may provide a height between the first portion 1532 and the second portion 1534. The intermediate portion 1536 may comprise a spacer body in examples, or may have another form as desired. As illustrated in FIG. 39F, the intermediate portion 1536 may have a cone shape, for example. Other shapes may be utilized in examples as desired.

[0362] In examples, the second portion 1534 may be configured to be positioned at the opening 905 of the housing 902. The second portion 1534, in examples, may form the barrier layer. For example, the liner removal component 1530 may be configured to cover and seal the opening 905 of the housing 902 similar as the liner removal component 1500, for example. The second portion 1534 may include a sealing member 1508a configured to engage and form a seal between the housing 902 and the liner removal component 1530 similar as the sealing member 1508 of the liner removal component 1500. The sealing member 1508a may be positioned along an outer edge of the second portion 1534.

[0363] The second portion 1534 may comprise a grip portion for gripping by a user. For example, the second portion 1534 may be configured to be gripped by a user for withdrawing the liner removal component 1530 from the surface 924 in an axial direction relative to the housing 902 to at least partially decouple the liner 926 from the surface 924.- 85 - 4924-6933-72190985-PCTUS01 PATENT

[0364] In examples, the liner removal component 1530 may be made of a flexible or rigid plastic. The liner removal component 1530 may comprise a base for the housing 902 and may cover the internal cavity 903.

[0365] The liner removal component 1530 may comprise a nonthreaded lid or cap in examples. As such, the liner removal component 1530 may be removed from the housing 902 by being pulled axially (without a threaded disengagement). Such a feature may reduce the complexity required to remove the liner removal component 1530. The lack of threading may reduce the rotational force required to remove the liner removal component 1530.

[0366] In examples, the liner removal component 1530 may include one or more retention features similar as the liner removal component 1500b. For example, the liner removal component 1530 may include one or more deflection arms 1538 configured to disengage from corresponding retention features of the housing 902 upon the liner removal component 1530 being rotated relative to the housing 902 (e.g., similarly as the liner removal component 1500b of FIG. 39E). The retention features of the housing 902 may include one or more protrusions 1522a (marked in FIG. 39E) that are positioned on the outer surface of the housing 902 and configured to protrude radially outwardly relative to the housing 902. The one or more deflection arms 1538 may disengage from the respective protrusions 1522a upon the liner removal component 1530 being at least partially rotated (e.g., 10 degrees, 20 degrees, etc.) relative to the housing 902. Other configurations may be utilized as desired.

[0367] The features of the examples of FIGS. 39A-39F may be utilized solely or in combination with any other example disclosed herein.

[0368] Other configurations of liner removal components may be utilized in examples.

[0369] FIGS. 40A and 40B illustrate an example of a liner removal component 1550 configured to at least partially decouple the liner 926 from the surface 924 (marked in FIG.26E) upon the liner removal component 1550 being at least partially withdrawn from the surface 924.

[0370] The liner removal component 1550 may comprise a single body insert that may extend axially within the internal cavity 903 of the housing 902. The liner removal component 1550 may form a cavity 1568 within the internal cavity 903. The liner removal component 1550 may include a first portion 1552 for supporting the liner 926, a second portion 1554 positioned at the opening 905 of the internal cavity 903, and an intermediate portion 1556. The first portion 1552 of the liner removal component 1550 may engage the liner 926 utilizing one or more coupling surfaces, similarly to the liner removal component 928 of FIG. 26A, for example. In examples, the coupling surfaces may comprise adhesive surfaces that couple the - 86 - 4924-6933-72190985-PCTUS01 PATENTliner 926 to the first portion 1552. The adhesive surfaces, for example, may comprise pressure sensitive adhesive, or other forms of adhesive surfaces as desired. The first portion 1552 may be axially spaced from the second portion 1554. The first portion 1552 may include a sheath 1560 that covers the insertion element 915.

[0371] The intermediate portion 1556 may be positioned between the first portion 1552 and the second portion 1554 and may provide a height between the first portion 1552 and the second portion 1554. The intermediate portion 1556 may comprise a spacer body in examples, or may have another form as desired. As illustrated in FIG. 40A, the intermediate portion 1556 may have a cylindrical shape, for example.

[0372] The intermediate portion 1556 in examples may include one or more guides 1566 (marked in FIG. 40B) that may extend along channels in the interior surface of the housing 902 that may prevent rotation and / or tilting of the liner removal component 1550 prior to or during removal from the housing 902. The guides 1566 may extend axially along the internal cavity 903 to orient the liner removal component 1550 within the internal cavity 903. The guides 1566 may prevent rotation of the first portion 1552 to reduce the possibility of shear of the liner. A shear of the liner, for example, may cause the surface 924 to undesirably fold or crease onto itself in examples. The guides 1566 may prevent tilting of the liner removal component 1550 to reduce the possibility of one or more portions of the liner removal component 1550, such as, for example, the sheath 1560, from contacting or damaging the insertion element 915 or the sensor as the liner removal component 1550 is withdrawn. In examples, the guides 1566 may reduce the possibility of rotation and / or tilting of the liner removal component 1550 relative to the housing 902.

[0373] In examples, the second portion 1554 may be configured to be positioned at the opening 905 of the housing 902. The second portion 1554, in examples, may form a barrier layer. For example, the liner removal component 1550 may be configured to cover and seal the opening 905 of the housing 902. The second portion 1554 may include a sealing member 1558 configured to engage and form a seal between the housing 902 and the liner removal component 1550. The sealing member 1558 may comprise an adhesive, for example. The sealing member 1558 may be positioned at the second portion 1554 and on the bottom surface of the housing 902.

[0374] The second portion 1554 may include a grip portion 1564 configured for gripping by a user. For example, the grip portion 1564 may be configured to be gripped by a user (e.g., grasped between a finger and thumb, or hooked using a single finger) for withdrawing the liner removal component 1550 from the surface 924 in an axial direction - 87 - 4924-6933-72190985-PCTUS01 PATENTrelative to the housing 902 to at least partially decouple the liner 926 from the surface 924. The grip portion 1564 may comprise one or more flanges that extend radially inward from the second portion 1554 relative to the housing 902. A user or host may insert a finger into the cavity 1568 and hook around the flanges to pull the liner removal component 1550 axially.

[0375] In examples, the liner removal component 1550 may be made of a flexible or rigid plastic. The liner removal component 1550 may comprise a base for the housing 902 and may cover the internal cavity 903. The liner removal component 1550 may comprise a nonthreaded lid or cap in examples.

[0376] In examples, the housing 902 may include a gas permeable barrier layer 1562 that is positioned on a top surface opposite the bottom surface and opening 905 of the housing 902 for sterilization of the internal cavity 903, similar to the barrier layer 945, for example.

[0377] FIG. 40B illustrates a perspective view of the liner removal component 1550 covering the opening of the housing 902.

[0378] The features of the examples of FIGS. 40A and 40B may be utilized solely or in combination with any other example disclosed herein.

[0379] Other configurations of liner removal components may be utilized in examples.

[0380] FIGS. 41A and 41B illustrate an example of a liner removal component 1600 configured to at least partially decouple the liner from the surface 924 (marked in FIG. 26E) upon the liner removal component 1600 being at least partially withdrawn from the surface 924.

[0381] The liner removal component 1600 may comprise a single body insert that may extend axially within the internal cavity of the housing 902. The liner removal component 1600 may form a cavity 1614 within the internal cavity of the housing 902. The cavity 1614 formed by the liner removal component 1600 may have an opening positioned at the end portion of the internal cavity 903 of the housing 902. The liner removal component 1600 may include a first portion 1602 for supporting the liner 926, a second portion 1604 positioned at the opening of the internal cavity of the housing 902, and an intermediate portion 1606. The first portion 1602 of the liner removal component 1600 may engage the liner 926 utilizing one or more coupling surfaces, similarly to the liner removal component 928 of FIG. 26A, for example. In examples, the coupling surfaces may comprise adhesive surfaces that couple the liner 926 to the first portion 1602. The adhesive surfaces, for example, may comprise pressure sensitive adhesive, or other forms of adhesive surfaces as desired. The first portion 1602 may be axially spaced from the second portion 1604. The first portion 1602 may include a sheath 1610 that covers the insertion element 915.- 88 - 4924-6933-72190985-PCTUS01 PATENT

[0382] The intermediate portion 1606 may be positioned between the first portion 1602 and the second portion 1604 and may provide a height between the first portion 1602 and the second portion 1604. The intermediate portion 1606 may comprise a spacer body in examples, or may have another form as desired. As illustrated in FIG. 41 A, the intermediate portion 1606 may have a cylindrical shape, for example.

[0383] The intermediate portion 1606 in examples may include one or more guides 1616 (marked in FIG. 4 IB) that may extend along channels in the interior surface of the housing 902 that may prevent rotation and / or tilting of the liner removal component 1600 prior to or during removal from the housing 902. The guides 1616 may extend axially along the internal cavity of the housing 902 to orient the liner removal component 1600 within the internal cavity 903. The guides 1616 may prevent rotation of the first portion 1602 to reduce the possibility of shear of the liner. A shear of the liner, for example, may cause the surface 924 to undesirably fold or crease onto itself in examples. The guides 1616 may prevent tilting of the liner removal component 1600 to reduce the possibility of one or more portions of the liner removal component 1600, such as, for example, the sheath 1610, from contacting or damaging the insertion element 915 or the sensor as the liner removal component 1600 is withdrawn. In examples, the guides 1616 may reduce the possibility of rotation and / or tilting of the liner removal component 1600 relative to the housing 902.

[0384] The liner removal component 1600, in examples, may form a barrier layer. For example, the liner removal component 1600 may be configured to cover and seal the opening 905 of the housing 902. The liner removal component 1600 may be made from a sealing material, such as an elastomeric material (e.g., silicone or rubber). In examples, the second portion 1604 may be configured to be positioned at the opening 905 of the housing 902. The second portion 1604 may include a lip 1612 configured to engage the housing 902 and form a seal between the liner removal component 1600 and the housing 902.

[0385] The second portion 1604 may include a grip portion 1608 configured for gripping by a user. For example, the grip portion 1608 may be configured to be gripped by a user for withdrawing the liner removal component 1600 from the surface 924 in an axial direction relative to the housing 902 to at least partially decouple the liner 926 from the surface 924.

[0386] The liner removal component 1600 may comprise a base for the housing 902 and may cover the internal cavity 903. The liner removal component 1600 may comprise a nonthreaded lid or cap in examples. In examples, the liner removal component 1600 may- 89 - 4924-6933-72190985-PCTUS01 PATENTcomprise a flexible lid, with a central portion of the flexible lid extending into the internal cavity of the housing such that an interior surface of the flexible lid engages the liner 926.

[0387] FIG. 4 IB illustrates a perspective view of the liner removal component 1600 covering the opening of the housing 902.

[0388] FIG. 41C illustrates an example of a variation, in which a liner removal component 1650 is configured to at least partially decouple the liner from the surface 924 (marked in FIG. 26E) upon the liner removal component 1650 being at least partially withdrawn from the surface 924. Although FIG. 41C does not depict the housing 902, the liner removal component 1650 may be implemented with the housing 902 similarly to the liner removal component 1600 of FIGS. 41A and 41B, for example.

[0389] The liner removal component 1650 may be configured similarly to the liner removal component 1600 of FIGS. 41A and 41B, yet instead of having a large cylindrical intermediate portion that forms a cavity in the internal cavity 903 of the housing 902, the liner removal component 1650 may have a narrow post-like intermediate portion 1656 and a flat outer surface 1662 without a cavity.

[0390] The liner removal component 1650 may include a first portion 1652 for supporting the liner 926, a second portion 1654 positioned at the opening of the internal cavity of the housing 902, and the intermediate portion 1656. The first portion 1652 of the liner removal component 1650 may engage the liner 926 utilizing one or more coupling surfaces, similarly to the liner removal component 928 of FIG. 26 A, for example. The first portion 1652 may be axially spaced from the second portion 1654. The first portion 1652 and / or the intermediate portion 1656 may comprise a sheath that covers the insertion element 915.

[0391] The intermediate portion 1656 may be positioned between the first portion 1652 and the second portion 1654 and may provide a height between the first portion 1652 and the second portion 1654. The intermediate portion 1656 may comprise a spacer body in examples, or may have another form as desired. As illustrated in FIG. 41C, the intermediate portion 1656 may have a narrow cylindrical or post-like shape, for example.

[0392] The liner removal component 1650, in examples, may form a barrier layer similarly as the liner removal component 1600 of FIGS. 41A and 41B. For example, the liner removal component 1650 may be configured to cover and seal the opening 905 of the housing 902. The liner removal component 1650 may be made from a sealing material, such as silicone or rubber, for example. In examples, the second portion 1654 may be configured to be positioned at the opening 905 of the housing 902 and may comprise a flexible lid. In examples, the intermediate portion 1656 may comprise a body that extends from an interior surface of the - 90 - 4924-6933-72190985-PCTUS01 PATENTflexible lid to the liner 926 for engaging the liner 926. The second portion 1654 may include a lip configured to engage the housing 902 and form a seal between the liner removal component 1650 and the housing 902.

[0393] The second portion 1654 may include a grip portion 1658 configured for gripping by a user. For example, the grip portion 1658 may be configured to be gripped by a user for withdrawing the liner removal component 1650 from the surface 924 in an axial direction relative to the housing 902 to at least partially decouple the liner 926 from the surface 924.

[0394] The liner removal component 1650 may comprise a base for the housing 902 and may cover the internal cavity 903. The liner removal component 1650 may comprise a flexible lid in examples.

[0395] The features of the examples of FIGS. 41A-41C may be utilized solely or in combination with any other example disclosed herein.

[0396] Other configurations of liners may be utilized in examples herein.

[0397] In examples, a liner may include one or more curved cuts that may extend radially outward from the aperture of the liner. FIG. 42, for example, illustrates a plurality of curved cuts 1732a, b, c, d upon a liner. The curved cuts of FIG. 42 may result in a spiral peel of the liner when a liner removal component is withdrawn from the surface 924 in an axial direction relative to the housing 902, which may reduce the release force, yet increase the release distance.

[0398] The features of the examples of FIG. 42 may be utilized solely or in combination with any other example disclosed herein.

[0399] Various other configurations of liners may be utilized in examples herein.

[0400] In examples, a method may include manufacturing a system for deploying an on-skin wearable medical device. As shown in FIG. 43 A for example, the method may include providing a barrier layer 2002, a liner removal component 2004, and a patch 2006. The barrier layer 2002, the liner removal component 2004, and the patch 2006 may be configured similarly as examples of barrier layers, liner removal components, and patches disclosed herein, unless stated otherwise.

[0401] The barrier layer 2002 may include an aperture 2003 (marked in FIG. 43B). A first portion of the liner removal component 2004 may form a liner 2005, which may be coupled to the patch 2006, e.g. via an adhesive. In examples, the patch 2006 may include an adhesive or adhesive layer disposed on its upper surface (i.e., its proximal-facing surface, or the surface facing a direction away from the barrier layer). A second portion of the liner removal - 91 - 4924-6933-72190985-PCTUS01 PATENTcomponent 2004 may be coupled to the barrier layer 2002, e.g. via an adhesive. As shown in FIG. 43B for example, the method may include providing an on-skin wearable medical device 2009 and a housing 2008 for retaining the on-skin wearable medical device 2009. The on-skin wearable medical device 2009 and the housing 2008 may be configured similarly as examples of on-skin wearable medical devices and housings disclosed herein, unless stated otherwise. In examples, the on-skin wearable medical device 2009 may include an adhesive or adhesive layer disposed on its bottom surface (i.e., its distal-facing surface).

[0402] The barrier layer 2002 may be coupled to the liner removal component 2004, and the liner removal component 2004 may be coupled to the patch 2006, prior to assembly of the system, and prior to coupling of the barrier layer 2002 to the housing 2008. In examples, the barrier layer 2002 may be coupled to the liner removal component 2004, and the liner removal component comprising the liner 2005 may be coupled to the patch 2006, in one or more converting processes. The method may include placing the on-skin wearable medical device 2009 within the housing 2008. The on-skin wearable medical device 2009 may be placed within the housing 2008 with its bottom (distal-facing) surface exposed, i.e., without a patch covering or coupled to its bottom surface. The method may include applying the barrier layer 2002 over an opening of the housing 2008 such that the barrier layer 2002 covers the opening, and such that the liner removal component 2004, the liner 2005, and the patch 2006 are disposed within the housing 2008, yet unattached to the on-skin wearable medical device 2009.

[0403] The method may include inserting a tool 2010 through the aperture 2003 of the barrier layer 2002 as shown in FIG. 43 C, for example. The tool 2010 may extend through the aperture 2003 and into the internal cavity of the housing 2008 to engage at least one of the liner removal component 2004, the liner 2005, or the patch 2006. The tool 2010 may cause the liner removal component 2004 to extend or telescope until the patch 2006 engages the on-skin wearable medical device 2009. The patch 2006 may be coupled to the on-skin wearable medical device 2009 via an adhesive, such as a pressure sensitive adhesive, for example, which may be disposed on at least one of a surface of the patch 2006 or a surface of the on-skin wearable medical device 2009 as disclosed herein. In examples, the method may include applying a sufficient pressure with the tool 2010 against the patch 2006 to secure the patch 2006 to the on-skin wearable medical device 2009.

[0404] The method may include sealing the aperture 2003 with a sealing portion 2012 as shown in FIG. 43D, for example. The sealing portion 2012 may comprise a sticker, in examples. A method may be utilized to manufacture a system as shown in FIGS. 38A and 38B,- 92 - 4924-6933-72190985-PCTUS01 PATENTamong other systems disclosed herein. By providing a pre-converted barrier layer, telescoping liner removal component with attached liner, and patch; coupling the pre-converted assembly to an applicator housing containing an on-skin wearable medical device; extending a tool through an aperture in the barrier layer to couple the patch to the on-skin wearable medical device; and sealing the aperture in the barrier layer with a seal such as a sticker, assembly of a user-friendly system for deploying an on-skin wearable medical device may be simplified.

[0405] Although illustrated in FIG. 43A with a liner removal component having a Z-shaped side profile, example may additionally or alternatively include a liner removal component having a bellows-shaped side profile. In examples, the liner removal component may include one or more telescoping portions, which may be spaced apart from one another laterally or concentrically. In examples, the liner removal component, the liner, and the patch may include one or more apertures or cutouts (as viewed in the axial direction) for the insertion element and the transcutaneous analyte sensor to pass through, and configured such that extension of the liner removal component toward the on-skin wearable medical device (during assembly) and withdrawal of the liner removal component (in preparation for use) does not result in the liner removal component, the liner, or the patch contacting the insertion element or the transcutaneous analyte sensor

[0406] The features of the examples of FIGS. 43A-43D may be utilized solely or in combination with any other example disclosed herein.

[0407] Steps in the method may be rearranged, excluded, or added to as desired.

[0408] Additional benefits of liner removal components disclosed herein may include support for the liner, to provide robustness for the on-skin device in case of drop or other shock. Such features may further reduce the possibility of the sensor becoming dislodged from the insertion element (e.g., a needle). Further protection against user contact with the insertion element may be provided as well in examples herein.

[0409] In addition, any of the systems as disclosed herein may exclude use of a threaded cap for sealing a housing as desired. Such systems may reduce the complexity of the application process for a user (e.g., a host). Sealing of an interior of the housing may be provided by a variety of other methods as disclosed herein, including use of barrier layers coupled to housings, and a liner removal component sealing the interior of the housing, among other methods. In examples, a threaded cap may be utilized with any of the systems disclosed herein as desired.

[0410] The above description presents the best mode contemplated for carrying out the present invention, and of the manner and process of making and using it, in such full, clear,- 93 - 4924-6933-72190985-PCTUS01 PATENTconcise, and exact terms as to enable any person skilled in the art to which it pertains to make and use this invention. This invention is, however, susceptible to modifications and alternate constructions from that discussed above that are fully equivalent. Consequently, this invention is not limited to the particular examples disclosed. On the contrary, this invention covers all modifications and alternate constructions coming within the spirit and scope of the invention as generally expressed by the following claims, which particularly point out and distinctly claim the subject matter of the invention. While the disclosure has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive.

[0411] All references cited herein are incorporated herein by reference in their entirety. To the extent publications and patents or patent applications incorporated by reference contradict the disclosure contained in the specification, the specification is intended to supersede and / or take precedence over any such contradictory material.

[0412] Unless otherwise defined, all terms (including technical and scientific terms) are to be given their ordinary and customary meaning to a person of ordinary skill in the art, and are not to be limited to a special or customized meaning unless expressly so defined herein. It should be noted that the use of particular terminology when describing certain features or aspects of the disclosure should not be taken to imply that the terminology is being re-defined herein to be restricted to include any specific characteristics of the features or aspects of the disclosure with which that terminology is associated. Terms and phrases used in this application, and variations thereof, especially in the appended claims, unless otherwise expressly stated, should be construed as open ended as opposed to limiting. As examples of the foregoing, the term ‘including’ should be read to mean ‘including, without limitation,’ ‘including but not limited to,’ or the like; the term ‘comprising’ as used herein is synonymous with ‘including,’ ‘containing,’ or ‘characterized by,’ and is inclusive or open-ended and does not exclude additional, unrecited elements or method steps; the term ‘having’ should be interpreted as ‘having at least;’ the term ‘includes’ should be interpreted as ‘includes but is not limited to;’ the term ‘example’ is used to provide exemplary instances of the item in discussion, not an exhaustive or limiting list thereof; adjectives such as ‘known’, ‘normal’, ‘standard’, and terms of similar meaning should not be construed as limiting the item described to a given time period or to an item available as of a given time, but instead should be read to encompass known, normal, or standard technologies that may be available or known now or at any time in the future; and use of terms like ‘preferably,’ ‘preferred,’ ‘desired,’ or ‘desirable,’ and words of similar meaning should not be understood as implying that certain features are critical,- 94 - 4924-6933-72190985-PCTUS01 PATENTessential, or even important to the structure or function of the invention, but instead as merely intended to highlight alternative or additional features that may or may not be utilized in a particular example of the invention. Likewise, a group of items linked with the conjunction ‘and’ should not be read as requiring that each and every one of those items be present in the grouping, but rather should be read as ‘and / or’ unless expressly stated otherwise. Similarly, a group of items linked with the conjunction ‘or’ should not be read as requiring mutual exclusivity among that group, but rather should be read as ‘and / or’ unless expressly stated otherwise.

[0413] Where a range of values is provided, it is understood that the upper and lower limit, and each intervening value between the upper and lower limit of the range is encompassed within the examples.

[0414] With respect to the use of substantially any plural and / or singular terms herein, those having skill in the art can translate from the plural to the singular and / or from the singular to the plural as is appropriate to the context and / or application. The various singular / plural permutations may be expressly set forth herein for sake of clarity. The indefinite article ‘a’ or ‘an’ does not exclude a plurality. A single processor or other unit may fulfill the functions of several items recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. Any reference signs in the claims should not be construed as limiting the scope.

[0415] It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases ‘at least one’ and ‘one or more’ to introduce claim recitations. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles ‘a’ or ‘an’ limits any particular claim containing such introduced claim recitation to examples containing only one such recitation, even when the same claim includes the introductory phrases ‘one or more’ or ‘at least one’ and indefinite articles such as ‘a’ or ‘an’ (e.g., ‘a’ and / or ‘an’ should typically be interpreted to mean ‘at least one’ or ‘one or more’); the same holds true for the use of definite articles used to introduce claim recitations. In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of ‘two recitations,’ without other modifiers,- 95 - 4924-6933-72190985-PCTUS01 PATENTtypically means at least two recitations, or two or more recitations). Furthermore, in those instances where a convention analogous to ‘at least one of A, B, and C, etc.’ is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., ‘a system having at least one of A, B, and C’ would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). In those instances where a convention analogous to ‘at least one of A, B, or C, etc.’ is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., ‘a system having at least one of A, B, or C’ would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). It will be further understood by those within the art that virtually any disjunctive word and / or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms. For example, the phrase ‘A or B’ will be understood to include the possibilities of ‘A’ or ‘B’ or ‘A and B.’

[0416] All numbers expressing quantities of ingredients, reaction conditions, and so forth used in the specification are to be understood as being modified in all instances by the term ‘about.’ Accordingly, unless indicated to the contrary, the numerical parameters set forth herein are approximations that may vary depending upon the desired properties sought to be obtained. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of any claims in any application claiming priority to the present application, each numerical parameter should be construed in light of the number of significant digits and ordinary rounding approaches.

[0417] Furthermore, although the foregoing has been described in some detail by way of illustrations and examples for purposes of clarity and understanding, it is apparent to those skilled in the art that certain changes and modifications may be practiced. Therefore, the description and examples should not be construed as limiting the scope of the invention to the specific examples and examples described herein, but rather to also cover all modification and alternatives coming with the true scope and spirit of the invention.- 96 - 4924-6933-7219

Claims

0985-PCTUS01 PATENTWHAT IS CLAIMED IS:

1. A system comprising:an on-skin wearable medical device configured to be deployed to skin and including a patch having a first surface for engaging the skin;a housing configured to retain the on-skin wearable medical device;an insertion assembly configured to move from a raised position to a lowered position to insert at least a portion of the on-skin wearable medical device into the skin; anda component positioned within the housing and configured to:prevent the insertion assembly from moving from the raised position to the lowered position when the component is disposed in a first position within the housing, and allow the insertion assembly to move from the raised position to the lowered position after the component is withdrawn from the housing.

2. The system of claim 1, further comprising an activation element for activating the insertion assembly to move from the raised position to the lowered position when actuated by a user, wherein the component is configured to disable the activation element to prevent the activation element from activating the insertion assembly when the component is disposed in the first position.

3. The system of claim 2, wherein the component is configured to enable the activation element upon the component being at least partially withdrawn from the housing.

4. The system of claim 2 or claim 3, further comprising a coupler including a first coupling member and a second coupling member, the first coupling member configured to be in an engaged configuration with the second coupling member to retain the insertion assembly in the raised position, the first coupling member being releasable from the second coupling member to allow the insertion assembly to move to the lowered position.

5. The system of claim 4, wherein the activation element is configured to release the first coupling member from the second coupling member when the activation element is enabled and actuated by the user.- 97 - 4924-6933-72190985-PCTUS01 PATENT6. The system of claim 4 or claim 5, wherein the component is configured to disable the activation element by impeding movement of the first coupling member relative to the second coupling member.

7. The system of claim 6, wherein the component includes a backstop feature configured to abut a portion of the first coupling member to impede movement of the first coupling member relative to the second coupling member.

8. The system of claim 7, wherein the backstop feature comprises a rib.

9. The system of any of claims 2-8, wherein the activation element is disposed on a side of the housing.

10. The system of any of claims 2-9, wherein the activation element is at least one of a button, a switch, a toggle, a slide, a trigger, a knob, a rotating member, or a portion of the housing that deforms and / or flexes.

11. The system of any of claims 1-10, wherein the housing is configured to be gripped by a user.

12. The system of any of claims 1-11, wherein the insertion assembly includes at least one spring for inserting at least the portion of the on-skin wearable medical device into the skin.

13. The system of any of claims 1-12, wherein the insertion assembly is configured to insert a needle into the skin.

14. The system of claim 13, further comprising a retraction assembly for retracting the needle from the skin.

15. The system of any of claims 1-14, wherein the housing includes an internal cavity for retaining the on-skin wearable medical device.

16. The system of claim 15, wherein the component includes a body configured to extend axially within the internal cavity.- 98 - 4924-6933-72190985-PCTUS01 PATENT17. The system of claim 16, wherein the housing includes an opening at an end portion of the internal cavity for the on-skin wearable medical device to pass through.

18. The system of claim 17, further comprising a coupler including a first coupling member engaged with a second coupling member to retain the insertion assembly in the raised position, and wherein the body of the component includes a first portion for abutting a portion of the first coupling member to impede movement of the first coupling member relative to the second coupling member and a second portion axially spaced from the first portion.

19. The system of claim 18, wherein the first portion comprises a rib protruding from the body.

20. The system of claim 18 or claim 19, wherein the second portion is configured to be positioned at the opening.

21. The system of any of claims 18-20, wherein the body of the component includes a grip portion positioned at the second portion and configured to be gripped by the user to at least partially withdraw the component from the housing.

22. The system of claim 21, wherein the grip portion is configured to be gripped with a single finger.

23. The system of claim 21 or claim 22, wherein the grip portion comprises a ring or a tab.

24. The system of any of claims 21-23, wherein the grip portion is coupled to the second portion via a living hinge.

25. The system of any of claims 1-24, wherein the component includes one or more guides configured to prevent rotation of the component relative to the housing upon the component being withdrawn from the housing.- 99 - 4924-6933-72190985-PCTUS01 PATENT26. The system of claim 25, wherein the one or more guides are configured to engage an interior surface of the housing to prevent rotation of the component relative to the housing upon the component being withdrawn from the housing.

27. The system of any of claims 1-26, wherein the component includes an engagement portion configured to engage a portion of the housing to retain the component within the housing.

28. The system of claim 27, wherein the engagement portion comprises a detent.

29. The system of any of claims 1-28, wherein the component includes a sheath for covering a needle.

30. The system of any of claims 1-29, wherein the on-skin wearable medical device includes a transcutaneous analyte sensor.

31. The system of claim 30, wherein the component includes a sheath for covering a needle, the sheath including a layer configured to allow sterilizing gas to permeate through the layer to contact at least a portion of the needle or at least a portion of the transcutaneous analyte sensor.

32. The system of any of claims 1-31, wherein the component comprises a plastic material.

33. The system of any of claims 1-32, wherein the component comprises molded plastic.

34. The system of any of claims 1-33, further comprising a liner positioned on the first surface.

35. The system of claim 34, wherein the component is further configured to engage the liner and at least partially decouple the liner from the first surface upon the component being at least partially withdrawn from the first surface.

36. The system of claim 34 or claim 35, wherein the component is configured to asymmetrically decouple the liner from the first surface upon the component being at least partially withdrawn from the first surface.- 100 - 4924-6933-72190985-PCTUS01 PATENT37. The system of any of claims 34-36, wherein the component is configured to peel the liner from the first surface upon the component being at least partially withdrawn from the first surface.

38. The system of any of claims 34-37, wherein the component includes a body configured to extend axially within an internal cavity of the housing, the body including a first portion for engaging the liner and a second portion axially spaced from the first portion.

39. The system of any of claims 1-38, wherein the first surface is an adhesive surface.

40. The system of any of claims 1-39, further comprising a barrier layer disposed over an opening of the housing.

41. The system of claim 40, wherein the barrier layer comprises a gas permeable film.

42. The system of claim 40 or claim 41, wherein the barrier layer is made from Tyvek®.

43. The system of any of claims 40-42, wherein the barrier layer provides a sterile environment between the housing and an outside environment.

44. The system of any of claims 40-43, wherein the barrier layer is configured to be removed from the housing prior to the on-skin wearable medical device being deployed.

45. The system of any of claims 40-44, wherein the component is coupled to the barrier layer.

46. The system of any of claims 1-45, wherein the housing comprises an applicator housing or a cartridge housing that is configured to be inserted into a housing of an applicator for deployment of the on-skin wearable medical device.

47. A system comprising:an on-skin wearable medical device configured to be deployed to skin and including a patch having a first surface for engaging the skin;- 101 - 4924-6933-72190985-PCTUS01 PATENTa liner positioned on the first surface;a housing having an internal cavity for retaining the on-skin wearable medical device and the housing having an opening at an end portion of the internal cavity for the on-skin wearable medical device to pass through;a barrier layer configured to cover and seal the opening; anda liner removal component positioned within the internal cavity of the housing and configured to engage the liner and at least partially decouple the liner from the first surface upon the liner removal component being at least partially withdrawn from the first surface.

48. The system of 47, wherein the barrier layer is a flexible barrier layer.

49. The system of claim 47 or claim 48, wherein the housing is configured to be gripped by a user.

50. The system of any of claims 47-49, further comprising an insertion assembly configured to move from a raised position to a lowered position to insert at least a portion of the on-skin wearable medical device into the skin.

51. The system of claim 50, wherein the liner removal component is configured to prevent the insertion assembly from moving from the raised position to the lowered position when the liner removal component is disposed in a first position within the housing.

52. The system of claim 50 or claim 51, further comprising an activation element for activating the insertion assembly to move from the raised position to the lowered position when actuated by a user.

53. The system of claim 52, wherein the liner removal component is configured to disable the activation element to prevent the activation element from activating the insertion assembly when the liner removal component is disposed in a first position within the housing.

54. The system of claim 52 or claim 53, wherein the liner removal component is configured to enable the activation element upon the liner removal component being at least partially withdrawn from the first surface.- 102 - 4924-6933-72190985-PCTUS01 PATENT55. The system of any of claims 52-54, further comprising a coupler including a first coupling member and a second coupling member, the first coupling member configured to be in an engaged configuration with the second coupling member to retain the insertion assembly in the raised position, the first coupling member being releasable from the second coupling member to allow the insertion assembly to move to the lowered position.

56. The system of claim 55, wherein the activation element is configured to release the first coupling member from the second coupling member when the activation element is enabled and actuated by the user.

57. The system of claim 55 or claim 56, wherein the liner removal component is configured to disable the activation element by impeding movement of the first coupling member relative to the second coupling member.

58. The system of any of claims 55-57, wherein the liner removal component includes a backstop feature configured to abut a portion of the first coupling member to impede movement of the first coupling member relative to the second coupling member.

59. The system of claim 58, wherein the backstop feature comprises a rib.

60. The system of any of claims 55-59, wherein the liner removal component includes a body configured to extend axially within the internal cavity of the housing, the body of the liner removal component including a first portion for abutting a portion of the first coupling member to impede movement of the first coupling member relative to the second coupling member and a second portion axially spaced from the first portion.

61. The system of claim 60, wherein the first portion comprises a rib protruding from the body.

62. The system of claim 60 or claim 61, wherein the second portion is configured to be positioned at the opening.- 103 - 4924-6933-72190985-PCTUS01 PATENT63. The system of any of claims 60-62, wherein the body of the liner removal component includes a grip portion positioned at the second portion and configured to be gripped by a user for at least partially withdrawing the liner removal component from the first surface.

64. The system of claim 63, wherein the grip portion is configured to be gripped with a single finger.

65. The system of claim 63 or claim 64, wherein the grip portion comprises a ring or a tab.

66. The system of any of claims 63-65, wherein the grip portion is coupled to the second portion via a living hinge.

67. The system of any of claims 52-66, wherein the activation element is disposed on a side of the housing.

68. The system of any of claims 52-67, wherein the activation element is at least one of a button, a switch, a toggle, a slide, a trigger, a knob, a rotating member, or a portion of the housing that deforms and / or flexes.

69. The system of any of claims 50-68, wherein the insertion assembly includes at least one spring for inserting at least the portion of the on-skin wearable medical device into the skin.

70. The system of any of claims 50-69, wherein the insertion assembly is configured to insert a needle into the skin.

71. The system of any of claims 47-70, further comprising a retraction assembly for retracting a needle from the skin.

72. The system of any of claims 47-71, wherein the liner removal component includes a body configured to extend axially within the internal cavity of the housing.- 104 - 4924-6933-72190985-PCTUS01 PATENT73. The system of any of claims 47-72, wherein the liner removal component includes one or more guides configured to prevent rotation of the liner removal component relative to the housing upon the liner removal component being withdrawn from the first surface.

74. The system of claim 73, wherein the one or more guides are configured to engage an interior surface of the housing to prevent rotation of the liner removal component relative to the housing upon the liner removal component being withdrawn from the first surface.

75. The system of any of claims 47-74, wherein the liner removal component includes an engagement portion configured to engage a portion of the housing to retain the liner removal component within the housing.

76. The system of claim 75, wherein the engagement portion comprises a detent.

77. The system of any of claims 47-76, wherein the liner removal component includes a sheath for covering a needle.

78. The system of any of claims 47-77, wherein the on-skin wearable medical device includes a transcutaneous analyte sensor.

79. The system of claim 78, wherein the liner removal component includes a sheath for covering a needle, the sheath including a layer configured to allow sterilizing gas to permeate through the layer to contact at least a portion of the needle or at least a portion of the transcutaneous analyte sensor.

80. The system of any of claims 47-79, wherein the liner removal component comprises a plastic material.

81. The system of any of claims 47-80, wherein the liner removal component comprises molded plastic.

82. The system of any of claims 47-81, wherein the first surface is an adhesive surface.- 105 - 4924-6933-72190985-PCTUS01 PATENT83. The system of any of claims 47-82, wherein the liner removal component is configured to asymmetrically decouple the liner from the first surface upon the liner removal component being at least partially withdrawn from the first surface.

84. The system of any of claims 47-83, wherein the liner removal component is configured to peel the liner from the first surface upon the liner removal component being at least partially withdrawn from the first surface.

85. The system of any of claims 47-84, wherein the barrier layer comprises a gas permeable film.

86. The system of any of claims 47-85, wherein the barrier layer is made from Tyvek®.

87. The system of any of claims 47-86, wherein the barrier layer provides a sterile environment between the housing and an outside environment.

88. The system of any of claims 47-87, wherein the barrier layer is configured to be removed from the housing prior to the on-skin wearable medical device being deployed.

89. The system of any of claims 47-88, wherein the liner removal component includes a body configured to extend axially within the internal cavity of the housing, the body including a first portion for engaging the liner and a second portion axially spaced from the first portion.

90. The system of any of claims 47-89, wherein the housing comprises an applicator housing or a cartridge housing that is configured to be inserted into a housing of an applicator for deployment of the on-skin wearable medical device.

91. A system comprising:an on-skin wearable medical device configured to be deployed to skin and including a patch having a first surface for engaging the skin;a liner positioned on the first surface;a housing having an internal cavity for retaining the on-skin wearable medical device and the housing having an opening at an end portion of the internal cavity for the on-skin wearable medical device to pass through;- 106 - 4924-6933-72190985-PCTUS01 PATENTa barrier layer configured to seal the opening; anda liner removal component positioned within the housing and configured to engage the liner and the barrier layer and at least partially decouple the liner from the first surface upon the liner removal component being at least partially withdrawn from the first surface.

92. The system of claim 91, wherein the barrier layer is a flexible barrier layer.

93. The system of claim 91 or claim 92, wherein the liner removal component includes a body configured to extend axially within the internal cavity.

94. The system of claim 93, wherein the body of the liner removal component includes a first portion for engaging the liner and a second portion axially spaced from the first portion and for engaging the barrier layer.

95. The system of claim 94, wherein the first portion is coupled to the liner via an adhesive.

96. The system of claim 94 or claim 95, wherein the second portion is positioned at the opening.

97. The system of any of claims 94-96, wherein at least a portion of the first portion comprises the liner.

98. The system of any of claims 91-97, wherein the barrier layer is configured to be removed from the housing prior to the on-skin wearable medical device being deployed.

99. The system of any of claims 91-98, wherein the barrier layer is configured to be peeled from the housing to be removed from the housing.

100. The system of any of claims 91-99, wherein the barrier layer is configured to withdraw the liner removal component from the first surface upon the barrier layer being removed from the housing.

101. The system of any of claims 91-100, wherein the barrier layer includes a grip portion configured to be gripped by a user for removing the barrier layer from the housing.- 107 - 4924-6933-72190985-PCTUS01 PATENT102. The system of claim 101, wherein the grip portion is configured to be gripped with a single finger.

103. The system of claim 101 or claim 102, wherein the liner removal component is coupled to the barrier layer at an outer edge portion of the barrier layer that is adjacent the grip portion.

104. The system of any of claims 91-103, wherein the liner removal component is coupled to the barrier layer at a first edge portion of the barrier layer and at a second edge portion of the barrier layer that is opposite the first edge portion.

105. The system of any of claims 91-104, wherein the liner removal component includes a central opening such that the liner removal component comprises two halves.

106. The system of any of claims 91-105, wherein the liner removal component comprises a foldable material.

107. The system of claim 106, wherein the liner removal component is configured to be in a butterfly-shape fold.

108. The system of any of claims 91-107, wherein the liner removal component is coupled to the barrier layer via an adhesive.

109. The system of any of claims 91-108, wherein the liner removal component includes a liner portion that forms the liner.

110. The system of any of claims 91-109, wherein the liner removal component comprises a flexible material having a plurality of folds.

111. The system of any of claims 91-110, wherein the liner removal component is configured to extend from an interior surface of the barrier layer to the patch.- 108 - 4924-6933-72190985-PCTUS01 PATENT112. The system of any of claims 91-111, wherein the liner removal component is Z-shaped and has a first portion for engaging the liner and a second portion that is axially spaced from the first portion and for engaging the barrier layer.

113. The system of any of claims 91-112, wherein the liner removal component comprises bellows.

114. The system of any of claims 91-113, wherein the liner removal component includes a body having a first portion for engaging the liner and a second portion, the second portion being axially spaced from the first portion and configured to couple to an outer surface of the barrier layer.

115. The system of claim 114, wherein the first portion of the liner removal component is configured to couple to the liner at an outer edge of the liner such that the first portion is offset from a center of the liner.

116. The system of claim 114 or claim 115, wherein the liner removal component includes a grip portion positioned at the second portion of the liner removal component, the grip portion being configured to be gripped by a user for withdrawing the liner removal component from the first surface.

117. The system of claim 116, wherein the grip portion is configured to be gripped with a single finger.

118. The system of claim 116 or claim 117, wherein the barrier layer is configured to be removed from the housing upon the grip portion being pulled in an axial direction relative to the housing.

119. The system of any of claims 116-118, wherein the grip portion comprises a ring or a tab.

120. The system of any of claims 91-119, wherein the liner includes a cut extending from an outer edge of the liner to an aperture of the liner.- 109 - 4924-6933-72190985-PCTUS01 PATENT121. The system of any of claims 91-120, wherein the liner removal component comprises a spring.

122. The system of any of claims 91-121, wherein the liner removal component includes a hinge feature configured to engage the housing.

123. The system of claim 122, wherein the liner removal component is configured to rotate about the hinge feature upon the barrier layer being peeled off of the housing.

124. The system of claim 122 or claim 123, wherein the liner removal component is U-shaped and has a first leg and a second leg, and a central portion positioned between the first leg and the second leg.

125. The system of claim 124, wherein a distal end portion of the first leg is configured to be coupled to the barrier layer, and the hinge feature is configured to be positioned at a distal end portion of the second leg.

126. The system of claim 124 or claim 125, wherein the central portion is configured to engage the liner.

127. The system of claim 126, wherein the central portion includes a cutout portion for a needle or a sheath for the needle.

128. The system of any of claims 124-127, wherein the second leg is shorter than the first leg.

129. The system of any of claims 91-128, wherein the liner removal component comprises a stamped rigid material.

130. The system of any of claims 91-129, wherein the liner removal component comprises a molded rigid material.

131. The system of any of claims 91-130, wherein the liner removal component includes one or more living hinges.- 110 - 4924-6933-72190985-PCTUS01 PATENT132. The system of any of claims 91-131, wherein the liner removal component includes one or more guides configured to prevent rotation of the liner removal component relative to the housing upon the liner removal component being withdrawn from the first surface.

133. The system of claim 132, wherein the one or more guides are configured to engage an interior surface of the housing to prevent rotation of the liner removal component relative to the housing upon the liner removal component being withdrawn from the first surface.

134. The system of any of claims 91-133, wherein the liner removal component includes a first portion for engaging the liner and a second portion positioned at the opening of the housing and axially apart from the first portion.

135. The system of claim 134, wherein the liner removal component includes a grip portion positioned at the second portion and configured to be gripped by a user for decoupling the liner from the first surface.

136. The system of claim 135, wherein the grip portion comprises one or more flanges.

137. The system of any of claims 91-136, wherein the barrier layer is ring shaped.

138. The system of any of claims 91-137, wherein the housing includes an interior surface, the interior surface having a first channel and a second channel that is opposite the first channel, with the liner removal component being configured to extend between the first channel and the second channel.

139. The system of any of claims 91-138, wherein the liner removal component comprises a flexible lid that is configured to be positioned over the opening of the housing to form the barrier layer.

140. The system of claim 139, wherein the flexible lid comprises a rubber material or a silicone material and includes a lip for engaging the housing.- Ill - 4924-6933-72190985-PCTUS01 PATENT141. The system of claim 139 or claim 140, wherein the liner removal component comprises a body that extends from an interior surface of the flexible lid to the liner for engaging the liner.

142. The system of any of claims 139-141, wherein a central portion of the flexible lid extends into the internal cavity of the housing such that an interior surface of the flexible lid engages the liner.

143. The system of any of claims 91-142, wherein the barrier layer comprises a gas permeable film.

144. The system of any of claims 91-143, wherein the barrier layer comprises Tyvek®.

145. The system of any of claims 91-144, wherein the barrier layer provides a sterile environment between the housing and an outside environment.

146. The system of any of claims 91-145, wherein the liner removal component includes a sheath for covering a needle.

147. The system of any of claims 91-146, wherein the on-skin wearable medical device includes a transcutaneous analyte sensor.

148. The system of claim 147, wherein the liner removal component includes a sheath for covering a needle, the sheath including a layer configured to allow sterilizing gas to permeate through the layer to contact the needle or at least a portion of the transcutaneous analyte sensor.

149. The system of any of claims 91-148, wherein the liner removal component comprises a plastic material.

150. The system of any of claims 91-149, wherein the first surface is an adhesive surface.

151. The system of any of claims 91-150, wherein the liner removal component is configured to asymmetrically decouple the liner from the first surface upon the liner removal component being at least partially withdrawn from the first surface.- 112 - 4924-6933-72190985-PCTUS01 PATENT152. The system of any of claims 91-151, wherein the liner removal component is configured to peel the liner from the first surface upon the liner removal component being at least partially withdrawn from the first surface.

153. The system of any of claims 91-152, wherein the housing comprises an applicator housing or a cartridge housing that is configured to be inserted into a housing of an applicator for deployment of the on-skin wearable medical device.

154. The system of any of claims 91-153, wherein the liner removal component is nonthreaded.

155. A system comprising:an on-skin wearable medical device configured to be deployed to skin and including a patch having a first surface for engaging the skin;a liner positioned on the first surface;a housing having an internal cavity for retaining the on-skin wearable medical device and the housing having an opening at an end portion of the internal cavity for the on-skin wearable medical device to pass through; anda nonthreaded liner removal component configured to:seal the opening,engage the liner, andat least partially decouple the liner from the first surface upon the liner removal component being at least partially withdrawn from the first surface.

156. The system of claim 155, wherein the liner removal component includes a body configured to extend axially within the internal cavity.

157. The system of claim 156, wherein the body of the liner removal component includes a first portion for engaging the liner and a second portion axially spaced from the first portion and for sealing the opening.

158. The system of claim 157, wherein the first portion is coupled to the liner with an adhesive.- 113 - 4924-6933-72190985-PCTUS01 PATENT159. The system of claim 157 or claim 158, wherein the second portion is coupled to a bottom outer surface of the housing with an adhesive such that the liner removal component seals the opening of the housing.

160. The system of claim 159, wherein the second portion is positioned at the opening of the housing.

161. The system of any of claims 155-160, wherein the liner removal component forms a cavity within the internal cavity of the housing.

162. The system of claim 161, wherein the cavity formed by the liner removal component has an opening positioned at the end portion of the internal cavity of the housing.

163. The system of any of claims 155-162, wherein the liner removal component is configured to be removed from the housing prior to the on-skin wearable medical device being deployed.

164. The system of any of claims 155-163, wherein the liner removal component is configured to be withdrawn from the first surface in an axial direction relative to the housing to be removed from the housing.

165. The system of any of claims 155-164, wherein the liner removal component includes one or more guides configured to prevent rotation of the liner removal component relative to the housing upon the liner removal component being withdrawn from the first surface.

166. The system of claim 165, wherein the one or more guides are configured to engage an interior surface of the housing to prevent rotation of the liner removal component relative to the housing upon the liner removal component being withdrawn from the first surface.

167. The system of any of claims 155-166, wherein the liner removal component includes a sealing member.

168. The system of claim 167, wherein the sealing member is configured to form a seal between the liner removal component and the housing for sealing the opening of the housing.- 114 - 4924-6933-72190985-PCTUS01 PATENT169. The system of claim 167 or claim 168, wherein the liner removal component includes a body configured to extend axially within the internal cavity, the body including a first portion for engaging the liner and a second portion axially spaced from the first portion and positioned at the opening.

170. The system of claim 169, wherein the liner removal component includes a sealing member, the sealing member being coupled to the second portion and configured to form a seal between the second portion and the housing.

171. The system of claim 170, wherein the liner removal component includes one or more retention features that extend from the second portion and are configured to engage corresponding retention features of the housing to retain the liner removal component within the housing.

172. The system of claim 171, wherein the one or more retention features of the liner removal component are configured to engage one or more protrusions of the housing or one or more concave portions of the housing, the one or more protrusions being configured to protrude radially outwardly relative to the housing, and the one or more protrusions and the one or more concave portions each being positioned on an outer surface of the housing.

173. The system of claim 171 or claim 172, wherein the one or more retention features of the liner removal component are configured to disengage from the corresponding retention features of the housing upon a portion of the one or more retention features of the liner removal component being pressed radially inwardly relative to the housing by a user.

174. The system of any of claims 171-173, wherein the one or more retention features of the liner removal component are configured to disengage from the corresponding retention features of the housing upon the liner removal component being withdrawn from the first surface in an axial direction relative to the housing.

175. The system of any of claims 167-174, wherein the sealing member comprises a gasket or an O-ring.- 115 - 4924-6933-72190985-PCTUS01 PATENT176. The system of any of claims 167-175, wherein the sealing member comprises an adhesive.

177. The system of any of claims 155-176, wherein the liner removal component includes a grip portion, the grip portion being configured to be gripped by a user for pulling the liner removal component in an axial direction relative to the housing to decouple the liner from the first surface.

178. The system of claim 177, wherein the grip portion is configured to be gripped with a single finger.

179. The system of claim 177 or claim 178, wherein the grip portion comprises one or more flanges configured to protrude radially inwardly from the liner removal component relative to the housing.

180. The system of any of claims 155-179, further comprising a gas permeable layer positioned on an end surface of the housing that is opposite of the opening of the housing.

181. The system of any of claims 155-180, wherein the liner removal component provides a sterile environment between the housing and an outside environment.

182. The system of any of claims 155-181, wherein the liner removal component includes a sheath for covering a needle.

183. The system of any of claims 155-182, wherein the on-skin wearable medical device includes a transcutaneous analyte sensor.

184. The system of claim 183, wherein the liner removal component includes a sheath for covering a needle, the sheath including a layer configured to allow sterilizing gas to permeate through the layer to contact the needle or at least a portion of the transcutaneous analyte sensor.

185. The system of any of claims 155-184, wherein the liner removal component comprises a plastic material.- 116 - 4924-6933-72190985-PCTUS01 PATENT186. The system of any of claims 155-185, wherein the liner removal component comprises a molded material or a stamped material.

187. The system of any of claims 155-186, wherein the first surface is an adhesive surface.

188. The system of any of claims 155-187, wherein the liner removal component is configured to asymmetrically decouple the liner from the first surface upon the liner removal component being at least partially withdrawn from the first surface.

189. The system of any of claims 155-188, wherein the liner removal component is configured to peel the liner from the first surface upon the liner removal component being at least partially withdrawn from the first surface.

190. The system of any of claims 155-189, wherein the housing comprises an applicator housing or a cartridge housing that is configured to be inserted into a housing of an applicator for deployment of the on-skin wearable medical device.

191. A method compri sing :at least partially withdrawing a liner removal component from a first surface of an on-skin wearable medical device to at least partially decouple a liner from the first surface, the on-skin wearable medical device being retained within an internal cavity of a housing, the housing including an opening at an end portion of the internal cavity for the on-skin wearable medical device to pass through, the opening being sealed by a barrier layer that is coupled to the liner removal component; anddeploying the on-skin wearable medical device to skin from the housing with the first surface contacting the skin.

192. The method of claim 191, wherein the barrier layer is a flexible barrier layer.

193. The method of claim 191 or claim 192, wherein the liner removal component includes a body extending axially within the internal cavity.

194. The method of claim 193, wherein at least a portion of the liner removal component is positioned at the opening of the housing.- 117 - 4924-6933-72190985-PCTUS01 PATENT195. The method of any of claims 191-194, wherein the liner removal component includes a first portion axially spaced from a second portion, the first portion engaging the liner.

196. The method of claim 195, wherein the second portion of the liner removal component is coupled to the barrier layer.

197. The method of claim 195 or claim 196, wherein the second portion of the liner removal component forms the barrier layer.

198. The method of any of claims 195-197, wherein the second portion of the liner removal component comprises a flexible lid that forms the barrier layer, the flexible lid having a lip that is configured to engage the housing and seal the opening.

199. The method of any of claims 191-198, further comprising at least partially removing the barrier layer from the housing to at least partially withdraw the liner removal component from the first surface.

200. The method of claim 199, further comprising gripping a grip portion of the barrier layer to at least partially remove the barrier layer from the housing.

201. The method of claim 200, further comprising pulling the grip portion of the barrier layer in an axial direction relative to the housing to at least partially remove the barrier layer from the housing.

202. The method of any of claims 191-201, wherein the liner removal component includes a first portion axially spaced from a second portion, the first portion engaging the liner and the second portion being positioned at the opening of the housing, and further comprising gripping a grip portion positioned at the second portion to at least partially withdraw the liner removal component from the first surface.

203. The method of claim 202, further comprising pulling the grip portion of the liner removal component in an axial direction relative to the housing to at least partially withdraw the liner removal component from the first surface.- 118 - 4924-6933-72190985-PCTUS01 PATENT204. The method of any of claims 191-203, wherein partially withdrawing the liner removal component from the first surface at least partially removes the barrier layer from the housing.

205. The method of any of claims 191-204, wherein the liner removal component includes one or more guides configured to prevent rotation of the liner removal component relative to the housing upon the liner removal component being at least partially withdrawn from the first surface.

206. The method of any of claims 191-205, wherein the on-skin wearable medical device includes a transcutaneous analyte sensor.

207. The method of any of claims 191-206, wherein the first surface is an adhesive surface.

208. The method of any of claims 191-207, wherein the on-skin wearable medical device includes a patch having the first surface.

209. The method of any of claims 191-208, further comprising inserting a needle from the housing into the skin.

210. The method of claim 209, further comprising retracting the needle from the skin to the housing.

211. The method of any of claims 191-210, wherein the liner removal component includes a sheath for covering at least a portion of a needle or at least a portion of a transcutaneous analyte sensor.

212. The method of claim 211, wherein at least a portion of the sheath includes a layer configured to allow sterilizing gas to permeate through the layer to contact at least the portion of the needle or at least the portion of the transcutaneous analyte sensor.

213. The method of any of claims 191-212, wherein the liner removal component is nonthreaded.- 119 - 4924-6933-72190985-PCTUS01 PATENT214. The method of any of claims 191-213, wherein the housing comprises an applicator housing or a cartridge housing that is configured to be inserted into a housing of an applicator for deployment of the on-skin wearable medical device.- 120 - 4924-6933-7219

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