Systems, apparatuses, and methods for cartridges and reusable applicators for medical devices

Abstract

The present apparatuses, systems, and methods relate to apparatuses, systems, and methods for medical devices. More particularly, apparatuses, systems, and methods are provided for applicator systems for medical devices, including cartridges and reusable applicators for medical devices. The applicator systems may include a transcutaneous analyte sensor for deployment to the skin of a host.

Description

PATENT - 0955-PCT01SYSTEMS, APPARATUSES, AND METHODS FOR CARTRIDGES AND REUSABLE APPLICATORS FOR MEDICAL DEVICESINCORPORATION BY REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No.63 / 740,206, filed December 30, 2024, the entire contents of which are incorporated by reference herein.BACKGROUND OF THE INVENTIONField of the Invention

[0002] Medical device apparatuses, systems, and methods. More particularly, apparatuses, systems, and methods are provided for applicator systems for medical devices. The medical devices may include a transcutaneous analyte sensor for deployment into the skin of 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] An applicator may be utilized to deploy an on-skin sensor assembly to a person. 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., glucose) level information,- 1 - 4918-3494-8739PATENT - 0955-PCT01communicating the sensed data to the transmitter, and transmitting the analyte level information to the receiver.

[0006] Exemplary systems are disclosed in, e.g., U.S. Patent Publication No.2014 / 0088389, U.S. Patent Publication No. 2013 / 0267813, and U.S. Patent Publication No.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 apparatuses, systems, and methods relate to apparatuses, systems, and methods for medical devices. More particularly, apparatuses, systems, and methods are provided for applicator systems for medical devices. The medical devices may include a transcutaneous analyte sensor for deployment to the skin of 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, an applicator system for an on-skin wearable medical device is provided. The system may include an insertion assembly configured to move from a first position to a second position to insert an analyte sensor into skin of a host; 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 first position, the first coupling member being releasable from the second coupling member to allow the insertion assembly to move to the second position; and a securement feature configured to impede movement of the first coupling member relative to the second coupling member to retain the first coupling member in the engaged configuration with the second coupling member.

[0010] Implementations of the embodiments may include one or more of the following. The insertion assembly may include a driver configured to drive the insertion assembly from-2 - 4918-3494-8739PATENT - 0955-PCT01the first position to the second position. The driver may comprise one or more springs. The first coupling member in the engaged configuration with the second coupling member may resist a force of the driver. The force may be a spring-bias force. The insertion assembly may be configured to insert a needle into the skin of the host to insert the analyte sensor into the skin of the host. A retraction assembly may be configured to retract the needle from the skin of the host. The retraction assembly may be configured to automatically retract the needle from the skin of the host after insertion of the analyte sensor into the skin of the host. The securement feature may be configured to attach to the first coupling member to retain the first coupling member in the engaged configuration with the second coupling member, and is configured to be released from the first coupling member to allow the first coupling member to release from the second coupling member. The securement feature may comprise at least one body configured to abut a portion of the first coupling member to retain the first coupling member in the engaged configuration with the second coupling member. The at least one body may be configured to be moved away from the portion of the first coupling member to allow the first coupling member to release from the second coupling member. An applicator housing and a cartridge configured to engage with the applicator housing may be provided, wherein the cartridge includes the securement feature. The analyte sensor may be positioned within the cartridge. An on-skin wearable housing may be positioned within the cartridge and being coupled to the analyte sensor, the on-skin wearable housing configured to be positioned on the skin of the host. The securement feature may include one or more deflectable tabs positioned on the cartridge and configured to abut a portion of the first coupling member to retain the first coupling member in the engaged configuration with the second coupling member. A sealing layer may be coupled to the cartridge, wherein the securement feature is a bonding material that bonds the sealing layer directly to the first coupling member. The bonding material may be an adhesive. The sealing layer may be removed prior to the first coupling member being released from the second coupling member to allow the insertion assembly to move to the second position for inserting the analyte sensor. A sealing layer may be coupled to the cartridge, wherein the securement feature is a body attached to the sealing layer and configured to abut a portion of the first coupling member to retain the first coupling member in the engaged configuration with the second coupling member. The sealing layer may be removed prior to the first coupling member being released from the second coupling member, and wherein removal of the sealing layer removes the body to allow the insertion assembly to move to the second position for inserting the analyte sensor. A sealing layer may be coupled to the cartridge, wherein the securement feature is a body positioned between a portion of the first - 3 - 49i8.3494.8739PATENT - 0955-PCT01coupling member and the sealing layer to retain the first coupling member in the engaged configuration with the second coupling member. The body may be configured to contact at least two sides of the first coupling member. The body may be a U-shaped body configured to surround at least a portion of the first coupling member. The sealing layer may maintain a position of the body in contact with the first coupling member. The sealing layer may be removed prior to the first coupling member being released from the second coupling member, and wherein removal of the sealing layer removes the body to allow the insertion assembly to move to the second position for inserting the analyte sensor. The first coupling member may be a deflectable arm and the second coupling member is a ledge. An actuator for pressing against the deflectable arm to release the deflectable arm from the ledge to allow the insertion assembly to move to the second position may be provided.

[0011] In a second aspect, a cartridge for use with an applicator for an on-skin wearable medical device is provided. The cartridge may include a cartridge housing; an analyte sensor retained by the cartridge housing, the analyte sensor configured to be moved relative to the cartridge housing from a first position to a second position to be inserted into skin of a host; 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 analyte sensor in the first position, the first coupling member being releasable from the second coupling member to allow the analyte sensor to move to the second position; and a securement feature configured to impede movement of the first coupling member relative to the second coupling member to retain the first coupling member in the engaged configuration with the second coupling member.

[0012] Implementations of the embodiments may include one or more of the following. The cartridge housing may include an opening for the analyte sensor to be deployed through. The opening may be a lower opening, and the cartridge housing includes an upper opening for receiving a portion of an insertion assembly for insertion of the analyte sensor into the skin of the host. The first coupling member in the engaged configuration with the second coupling member may be configured to resist a pressing force of the insertion assembly to insert the analyte sensor into the skin of the host. The securement feature may be configured to attach to the first coupling member to retain the first coupling member in the engaged configuration with the second coupling member, and is configured to be released from the first coupling member to allow the first coupling member to release from the second coupling member. The securement feature may comprise at least one body configured to abut a portion of the first coupling member to retain the first coupling member in the engaged configuration with the -4 - 4918-3494-8739PATENT - 0955-PCT01second coupling member. The at least one body may be configured to be moved away from the portion of the first coupling member to allow the first coupling member to release from the second coupling member. An on-skin wearable housing may be positioned within the cartridge housing and being coupled to the analyte sensor, the on-skin wearable housing configured to be positioned on the skin of the host. The on-skin wearable housing may be configured to be moved relative to the cartridge housing from the first position to the second position. The securement feature may include one or more deflectable tabs configured to abut a portion of the first coupling member to retain the first coupling member in the engaged configuration with the second coupling member. The cartridge housing may include one or more openings for receiving a pressing surface for applying a force to the one or more deflectable tabs to move the one or more deflectable tabs to allow the first coupling member to release from the second coupling member. A sealing layer may be coupled to the cartridge housing, wherein the securement feature is a bonding material that bonds the sealing layer to the first coupling member. The bonding material may be an adhesive. The sealing layer may be removed prior to the first coupling member being released from the second coupling member to allow the analyte sensor to move to the second position. A sealing layer may be coupled to the cartridge housing, wherein the securement feature is a body attached to the sealing layer and configured to abut a portion of the first coupling member to retain the first coupling member in the engaged configuration with the second coupling member. The sealing layer may be removed prior to the first coupling member being released from the second coupling member to allow the analyte sensor to move to the second position. A sealing layer may be coupled to the cartridge housing, wherein the securement feature is a body positioned between a portion of the first coupling member and the sealing layer to retain the first coupling member in the engaged configuration with the second coupling member. The body may be configured to contact at least two sides of the first coupling member. The body may be a U-shaped body configured to surround at least a portion of the first coupling member. The sealing layer may maintain a position of the body in contact with the first coupling member. The sealing layer may be removed prior to the first coupling member being released from the second coupling member, and wherein removal of the sealing layer removes the body to allow the analyte sensor to move to the second position. The first coupling member may be a deflectable arm and the second coupling member is a ledge.

[0013] In a third aspect, an on-skin wearable system is provided. The on-skin wearable system may include an analyte sensor configured to be inserted into skin of a host; a wearable housing coupled to the analyte sensor and configured to be worn on the skin of the host, the - 5 - 49i8.3494.8739PATENT - 0955-PCT01wearable housing including a through-hole; a needle extending through the through-hole of the wearable housing and configured to guide the analyte sensor into the skin of the host, the needle extending along a longitudinal axis; and a needle hub coupled to the needle, the needle hub configured to be rotationally coupled about the longitudinal axis of the needle with an engagement portion of an applicator for the analyte sensor.

[0014] Implementations of the embodiments may include one or more of the following. A cartridge retaining the analyte sensor, the wearable housing, the needle, and the needle hub may be provided. The cartridge may include an opening covered with a sealing layer for the cartridge. The wearable housing may include a lower surface, and wherein the system further comprises a patch and a liner, the patch having an upper surface coupled to the lower surface of the wearable housing and the patch having a lower surface configured to attach to the skin of the host, and the liner covering the lower surface of the patch. The cartridge may be coupled to the liner such that a withdrawal movement of the wearable housing from the cartridge at least partially removes the liner from the patch. The needle hub may be configured to rotate about the longitudinal axis of the needle to rotationally couple with the engagement portion of the applicator. The needle may be configured to rotate about the longitudinal axis of the needle within the through-hole. A locking member configured to rotate about the longitudinal axis of the needle from a locked position to an unlocked position may be provided, the needle being locked to the wearable housing when the locking member is in the locked position and being removable from the wearable housing when the locking member is in the unlocked position. The locking member may comprise an elongate body, wherein the wearable housing includes an elongate slot, and wherein the elongate body is aligned with the elongate slot in the unlocked position and is rotationally offset from the elongate slot in the locked position. The needle hub may be configured to rotate the locking member about the longitudinal axis from the locked position to the unlocked position when the needle hub rotates about the longitudinal axis. The needle hub may include one or more engagement features for rotational engagement with a groove in the engagement portion of the applicator. The engagement features may include one or more protrusions. The groove may be an angled cam groove. The engagement portion may include a lock feature for locking the needle hub to the engagement portion. The lock feature may include a notch in the engagement portion of the applicator. The needle may include an elongate channel for receiving the analyte sensor, and wherein the needle is configured to rotate about the longitudinal axis relative to the analyte sensor. The applicator may be provided. The applicator may be a reusable applicator. The applicator may include one or more carriages configured to move from a raised position to a lowered position to deploy the analyte sensor - 6 - 49i8.3494.8739PATENT - 0955-PCT01into the skin of the host, and wherein the system further comprises a reset device configured to be pressed against the one or more carriages to move the one or more carriages back to the raised position from the lowered position after the one or more carriages have moved from the raised position to the lowered position to deploy the analyte sensor into the skin. The applicator may include an interior cavity for the analyte sensor to be deployed from, and the reset device is configured to be inserted into the interior cavity in a direction opposite a direction of deployment of the analyte sensor. A needle removal device configured to engage the needle after it has been used for at least partial insertion into the skin of the host and to remove the used needle from the engagement portion of the applicator may be provided. The needle removal device may be configured to mount to a reset device configured to be pressed against a portion of the applicator to reset an insertion assembly of the applicator.

[0015] In a fourth aspect, an applicator system for an on-skin wearable medical device may be provided. The system may include a cartridge retaining an analyte sensor for insertion into skin of a host; an applicator for the analyte sensor, the applicator including an insertion assembly configured to move from a raised position to a lowered position to insert the analyte sensor into the skin of the host; and a reusable reset device configured to apply a force against at least a portion of the applicator to reset the insertion assembly to the raised position from the lowered position following insertion of the analyte sensor into the skin of the host.

[0016] Implementations of the embodiments may include one or more of the following. The applicator may include an interior cavity for the analyte sensor to be positioned within, and the reusable reset device is configured to be inserted into the interior cavity to reset the insertion assembly to the raised position from the lowered position. The applicator may be configured to deploy the analyte sensor from the interior cavity to the skin of the host in a first direction, and the reusable reset device is configured to insert into the interior cavity in a second direction that is opposite the first direction to reset the insertion assembly. The reusable reset device may include a pressing surface for pressing against at least a portion of the insertion assembly to reset the insertion assembly. The applicator may include a lock feature for locking the insertion assembly in the lowered position following insertion of the analyte sensor into the skin of the host, and the reusable reset device includes an unlock feature for unlocking the lock feature to allow the insertion assembly to move to the raised position from the lowered position following insertion of the analyte sensor into the skin of the host. The unlock feature may include a body for applying a force to the lock feature to unlock the lock feature. A needle may be provided, and wherein the applicator is configured to insert the needle into the skin of the host to guide the analyte sensor into the skin of the host, and the applicator system further - 7 - 4918-3494-8739PATENT - 0955-PCT01comprises a needle removal device configured to engage with the used needle to withdraw the used needle from the applicator. The needle removal device may include a sheath for covering the used needle. The applicator may include an interior cavity for the analyte sensor to be positioned within, and the needle removal device is configured to be inserted into the interior cavity to engage with the used needle. The needle removal device may be configured to releasably couple with the reusable reset device. The insertion assembly may include at least one carriage for moving from the raised position from the lowered position to insert the analyte sensor into the skin of the host. A needle may be provided, and wherein the applicator is configured to insert the needle into the skin of the host to guide the analyte sensor into the skin of the host, and wherein the applicator includes a retraction assembly configured to retract the needle from the skin of the host. The reusable reset device may include a body that is separate from the cartridge. The cartridge may retain a needle and an on-skin wearable housing, the needle being configured to guide the analyte sensor into the skin of the host, and the on-skin wearable housing being coupled to the analyte sensor. The needle may extend along a longitudinal axis, and the cartridge retains a needle hub coupled to the needle, the needle hub configured to be rotationally coupled about the longitudinal axis of the needle with an engagement portion of the applicator.

[0017] In a fifth aspect, a needle hub and an on-skin sensor assembly is provided, wherein the needle hub is configured to apply the on-skin sensor assembly to a skin of a host, the needle hub comprising: a central body; and one or more engagement features for rotational engagement with a groove in an engagement portion of an applicator for applying the on-skin sensor assembly.

[0018] Implementations of the embodiments may include one or more of the following. The engagement portion may include a lock feature for locking the needle hub to the engagement portion. The groove may be an angled cam groove. The needle hub may be configured to be rotationally coupled about a longitudinal axis of a needle with the engagement portion of the applicator. The needle hub may be configured to rotate a locking member about the longitudinal axis from the locked position to the unlocked position when the needle hub rotates about the longitudinal axis. A needle assembly comprising the needle hub and on-skin sensor assembly of any one of the foregoing may be provided; and a needle coupled to the needle hub. The needle may extend through a through-hole of a housing of the on-skin sensor assembly and is configured to guide an analyte sensor into the skin of the host, and wherein the needle extends along a longitudinal axis. A locking member may be provided. The locking- 8 - 4918-3494-8739PATENT - 0955-PCT01member may be coupled to the needle. The locking member may comprise an elongate body shaped to align with a shape of a through-hole of a housing of the on-skin sensor assembly.

[0019] In a sixth aspect, a reusable reset device for an applicator of an analyte sensor may be provided. The reusable reset device may include a pressing surface for pressing against at least a portion of an insertion assembly of the applicator to reset the insertion assembly.

[0020] Implementations of the embodiments may include one or more of the following. An unlock feature for unlocking a lock feature of the applicator to allow the insertion assembly to move to a raised position from a lowered position following insertion of the analyte sensor into skin of a host may be provided. The reusable reset device may be configured to apply a force against at least a portion of the applicator to reset the insertion assembly to a raised position from a lowered position following insertion of the analyte sensor into skin of a host. The reusable reset device may be configured to be inserted into an interior cavity of the applicator to reset the insertion assembly to a raised position from a lowered position. The reusable reset device may be configured to insert into the interior cavity in a direction that is opposite an insertion direction to reset the insertion assembly.

[0021] In a seventh aspect, a reusable applicator system for an analyte sensor. The applicator system may include a reusable applicator for insertion of the analyte sensor into skin of a host; and a disposable cartridge configured to be coupled to the reusable applicator for use in insertion of the analyte sensor into the skin of the host, wherein the disposable cartridge is configured to be removed from the reusable applicator after insertion of the analyte sensor into the skin of the host, and wherein the disposable cartridge is configured to retain within an interior of the disposable cartridge: the analyte sensor; a wearable housing coupled to the analyte sensor and configured to be worn on the skin of the host, a needle extending through a through-hole of the wearable housing and configured to guide the analyte sensor into the skin of the host, and a needle hub coupled to the needle.

[0022] Implementations of the embodiments may include one or more of the following. A sealing layer covering an opening into the interior of the disposable cartridge may be provided. The reusable applicator may comprise one or more carriages configured to move from a raised position to a lowered position to deploy the analyte sensor into the skin of the host. A reset device configured to be pressed against the one or more carriages to move the one or more carriages back to the raised position from the lowered position after the one or more carriages have moved from the raised position to the lowered position to deploy the analyte sensor into the skin of the host may be provided. The one or more carriages may- 9 - 4918-3494-8739PATENT - 0955-PCT01comprise a needle carriage configured to be coupled with the needle hub of the disposable cartridge.

[0023] Any of the features of an embodiment of any of the aspects, including but not limited to any embodiments of any of the first through seventh aspects referred to above, is applicable to all other aspects and embodiments identified herein, including but not limited to any embodiments of any of the first through seventh aspects referred to above. Moreover, any of the features of an embodiment of the various aspects, including but not limited to any embodiments of any of the first through seventh aspects referred to above, is independently combinable, partly or wholly with other embodiments described herein in any way, e.g., one, two, or three or more embodiments may be combinable in whole or in part. Further, any of the features of an embodiment of the various aspects, including but not limited to any embodiments of any of the first through seventh aspects referred to above, may be made optional to other aspects or embodiments. Any aspect or embodiment of a method can be performed by a system or apparatus of another aspect or embodiment, and any aspect or embodiment of a system or apparatus can be configured to perform a method of another aspect or embodiment, including but not limited to any embodiments of any of the first through seventh aspects referred to above.

[0024] 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

[0025] 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.

[0026] FIG. 1 illustrates a schematic view of a continuous analyte sensor system.

[0027] FIG. 2A illustrates a top perspective assembly view of an on-skin sensor assembly.- 10 - 4918-3494-8739PATENT - 0955-PCT01

[0028] FIG. 2B illustrates a bottom perspective view of the on-skin sensor assembly of FIG. 2A in an assembled state.

[0029] FIG. 2C illustrates a top perspective view of the on-skin sensor assembly of FIG. 2A in an assembled state.

[0030] FIG. 3 illustrates a perspective assembly view of an on-skin sensor assembly.

[0031] FIG. 4 illustrates a perspective view of an on-skin sensor assembly.

[0032] FIG. 5 illustrates an upper perspective view of an applicator system.

[0033] FIG. 6 illustrates a lower perspective view of the applicator system of FIG. 5.

[0034] FIG. 7 illustrates an exploded perspective view of the applicator system of FIG.5.

[0035] FIG. 8 illustrates a cross sectional view of the applicator system of FIG. 5.

[0036] FIG. 9 illustrates an upper perspective view of a cartridge.

[0037] FIG. 10 illustrates an exploded perspective view of the cartridge of FIG. 9.

[0038] FIG. 11 illustrates a perspective view of components of the cartridge of FIG. 9.

[0039] FIG. 12 illustrates a cross sectional view of the cartridge shown in FIG. 9.

[0040] FIG. 13 illustrates a close up view of a portion of the cartridge shown in FIG.9.

[0041] FIG. 14 illustrates a cross sectional view of the applicator of FIG. 5 and the cartridge shown in FIG. 9.

[0042] FIG. 15 illustrates a cross sectional view of the applicator of FIG. 5 and the cartridge shown in FIG. 9.

[0043] FIG. 16 illustrates a cross sectional view of a cartridge shown in FIG. 9.

[0044] FIG. 17 illustrates a cross sectional view of a cartridge shown in FIG. 9.

[0045] FIG. 18 illustrates a close up view of a portion of the cartridge shown in FIG.9.

[0046] FIG. 19 illustrates a close up view of a portion of the cartridge shown in FIG.9.

[0047] FIG. 20 illustrates a cross sectional view of a cartridge shown in FIG. 9.

[0048] FIG. 21 illustrates a perspective view of an applicator system for an on-skin sensor assembly of an analyte sensor system.

[0049] FIG. 22 illustrates an exploded perspective view of the applicator system of FIG. 21.

[0050] FIGS. 23-25 illustrate several cross-sectional views of the applicator system of FIGS. 21 and 22, taken along the section line A- A’ of FIG. 21, during operation.- 11 - 4918-3494-8739PATENT- 0955-PCT01

[0051] FIGS. 26-28 illustrate several cross-sectional views of the applicator system of FIGS. 21 and 22, taken along the section line B-B’ of FIG. 21, during operation.

[0052] FIGS. 29 and 30 illustrate magnified views of some features of the applicator system of FIGS. 21 and 22.

[0053] FIGS. 31 and 32 illustrate magnified views of some features of the applicator system of FIGS. 21 and 22.

[0054] FIG. 33 illustrates a perspective partial cutaway view of the needle carriage, needle hub, and on-skin sensor assembly of the applicator system of FIGS. 21 and 22.

[0055] FIG. 34 illustrates a cross-sectional view of the needle hub and on-skin sensor assembly of the applicator system of FIGS. 21 and 22.

[0056] FIG. 35 illustrates a top view of a portion of the needle carriage and hub of FIGS. 21 and 22.

[0057] FIGS. 36A and 36B illustrate perspective views of needles for use in an applicator for an analyte sensor system.

[0058] FIG. 37 illustrates a side schematic cross sectional view of an applicator.

[0059] FIG. 38 illustrates a side schematic cross sectional view of a cartridge.

[0060] FIG. 39 illustrates a perspective view of the cartridge of FIG. 38.

[0061] FIG. 40 illustrates a perspective view of a needle.

[0062] FIG. 41 illustrates a partial cut-away perspective view of an engagement portion of the applicator of FIG. 37.

[0063] FIG. 42 illustrates a side schematic cross sectional view of a needle engaged with a wearable housing.

[0064] FIG. 43 illustrates an upper plan view of a locking member in a locked position.

[0065] FIG. 44 illustrates a side schematic cross sectional view of the cartridge of FIG.38 approaching the applicator of FIG. 37.

[0066] FIG. 45 illustrates a side schematic cross sectional view of a needle engaged with a wearable housing at a viewing angle offset from the viewing angle of FIG. 42.

[0067] FIG. 46 illustrates a side schematic cross sectional view of the cartridge of FIG.38 engaged with the applicator of FIG. 37.

[0068] FIG. 47 illustrates an upper plan view of a locking member in an unlocked position.

[0069] FIG. 48 illustrates a side schematic cross sectional view of the on-skin sensor assembly of FIG. 38 engaged with the applicator of FIG. 37, with a cartridge housing being removed.- 12 - 4918-3494-8739PATENT - 0955-PCT01

[0070] FIG. 49 illustrates a side schematic cross sectional view of an on-skin sensor assembly being deployed to skin with the applicator of FIG. 37.

[0071] FIG. 50 illustrates a side schematic cross sectional view of a needle being retracted from skin.

[0072] FIG. 51 illustrates a perspective view of a needle removal device.

[0073] FIG. 52A illustrates a side schematic cross sectional view of the needle removal device of FIG. 51.

[0074] FIG. 52B illustrates a top schematic view of the needle removal device of FIG.51.

[0075] FIG. 53 illustrates a side schematic cross sectional view of a needle removal device.

[0076] FIG. 54 illustrates a side schematic cross sectional view of a needle removal device.

[0077] FIG. 55 illustrates a bottom view of a holder carriage.

[0078] FIG. 56 illustrates a perspective view of a reset device.

[0079] FIG. 57 illustrates a side schematic cross sectional view of the reset device of FIG. 56 being utilized.

[0080] FIG. 58 illustrates a side schematic cross sectional view of the reset device of FIG. 56 being utilized, with the needle removal device of FIG. 51 being withdrawn.

[0081] FIG. 59 illustrates a side schematic cross sectional view of the reset device of FIG. 56 being utilized.

[0082] FIG. 60 illustrates a side schematic cross sectional view of an applicator.

[0083] FIG. 61 illustrates a side schematic cross sectional view of a reset device.

[0084] FIG. 62 illustrates a cross sectional view of the cartridge shown in FIG. 9.

[0085] FIG. 63 illustrates a close up view of a coupler of a cartridge.

[0086] FIG. 64 illustrates a cross sectional view of a cartridge.

[0087] FIG. 65 A illustrates a bottom perspective view of a cartridge with a sealing layer removed.

[0088] FIG. 65B illustrates cross sectional view of the cartridge of FIG. 65 A.

[0089] FIG. 66 illustrates a cross sectional view of a cartridge.

[0090] FIG. 67 illustrates an upper perspective view of a cartridge.

[0091] FIG. 68 illustrates a side cross sectional view of the cartridge shown in FIG. 67.

[0092] FIG. 69 illustrates a cross sectional view of the cartridge shown in FIG. 67 inserted into an interior cavity of an applicator.- 13 - 4918-3494-8739PATENT - 0955-PCT01

[0093] FIG. 70 illustrates a cross sectional view of the cartridge shown in FIG. 67 approaching a portion of an applicator.

[0094] FIG. 71 illustrates a close up cross sectional view of the cartridge shown in FIG.67.DETAILED DESCRIPTION

[0095] The following description illustrates some examples 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 should not be deemed to limit the scope of the present disclosure.

[0096] FIG. 1 is a diagram depicting an example medical device system according to examples herein. The medical device system in examples may comprise a continuous analyte monitoring system 100. The continuous analyte monitoring system 100 may include an analyte sensor system 102 comprising an on-skin sensor assembly 160 configured to be fastened to the skin of a host via a base (not shown).

[0097] 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.

[0098] 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. The 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 - 14 - 4918-3494-8739PATENT - 0955-PCT01system 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.

[0099] 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 plurality of display devices may be a handheld device 112, such as a mobile phone based on the Android, iOS operating systems 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.

[0100] 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.

[0101] 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 housing may comprise a wearable housing. 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.

[0102] Continuous analyte monitoring 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.- 15 - 4918-3494-8739PATENT - 0955-PCT01

[0103] 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.

[0104] 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. 2009 / 0192745, 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.

[0105] 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.

[0106] 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.

[0107] 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 - 16 - 4918-3494-8739PATENT - 0955-PCT01certain 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. In examples, the sensor 138 may comprise a planar or flat sensor.

[0108] In some examples, the materials used to form the elongate 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.

[0109] 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, electronics 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.

[0110] 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.- 17 - 4918-3494-8739PATENT - 0955-PCT012008 / 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.[oni] 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.

[0112] 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 example 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.

[0113] 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.

[0114] In some examples, 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; acylcamitine; 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;- 18 - 4918-3494-8739PATENT - 0955-PCT01cyclosporin A; d-penicillamine; de-ethylchloroquine; dehydroepiandrosterone sulfate; DNA (acetylator polymorphism, alcohol dehydrogenase, alpha 1 -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-1, HTLV-1, 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; glutathione; 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, B); 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 - 19 - 4918-3494-8739PATENT - 0955-PCT01agent 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 compositions 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.

[0115] Any of the features described in the context of at least FIG. 1 can be applicable to all aspects and examples identified herein. Moreover, any of the features of an example 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 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.

[0116] 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 base or wearable housing 202. The base or wearable housing 202 may be configured to be worn on skin of a host and may include a distal or lower surface for facing towards the skin and a proximal or upper surface 203 facing opposite the distal surface. The base or wearable housing 202 may include an opening or through-hole 205 for an insertion element (e.g., a needle) to be retracted proximally through from the skin. A patch 204 such as an adhesive patch can couple the housing 202 to the skin 206 of the host. The patch 204 may be positioned on the distal or lower surface of the base or housing 202. In some examples, the adhesive patch 204 may include an - 20 - 4918-3494-8739PATENT - 0955-PCT01engaging surface or lower surface for engaging the skin 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. In examples, the patch 204 may be an underlay patch. The underlay patch may be configured to be positioned beneath an overlay patch. An on-skin sensor assembly 200 may comprise an electronics unit 208 (e.g., a transmitter) which may further 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 housing 202.

[0117] An applicator system for an on-skin wearable medical device can apply the base or wearable housing 202 and the adhesive patch 204 or underlay patch to skin 206. The glucose sensor module 210 may be secured to housing 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 housing 202. In alternative examples, the sensor module 210 and housing 202 are preassembled or manufactured as a single component.

[0118] After the housing 202, patch 204, and analyte sensor 212 are deployed to a host’s or user’s skin, a user (or an applicator) can couple electronics unit 208 (e.g., a transmitter) to housing 202 via retention elements such as snap fits and / or interference features. Electronics unit 208 can measure and / or analyze glucose indicators sensed by transcutaneous analyte sensor (e.g., a glucose sensor) 212. 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).

[0119] On-skin sensor assembly 200 may be attached to the host with use of an applicator or applicator system adapted to provide convenient and secure application. Such an applicator or applicator system may also be used for attaching electronics unit 208 to housing 202, inserting sensor 212 through the host’s skin, and / or connecting sensor 212 to electronics unit 208.

[0120] FIG. 2B illustrates a perspective view of electronics unit 208 coupled to housing 202 via retention elements such as snap fits and / or interference features. In some examples, electronics unit 208 and housing 202 are coupled by adhesive, welding, or other bonding techniques. Patch 204, on a distal or lower surface of housing 202, is configured to couple sensor assembly 200 to the skin.

[0121] FIG. 2C illustrates a perspective view of on-skin sensor assembly 200. On-skin sensor assembly 200 may be disposable or may be reusable. FIG. 2C further illustrates - 21 - 4918-3494-8739PATENT - 0955-PCT01electronics unit 208 coupled to a housing 202, and adhesive patch 204 or underlay patch configured to be attached to on-skin sensor assembly 200, which, when combined, may be held within the applicator.

[0122] 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 wearable housing 306. The base or housing 306 may be configured to be worn on skin of a host and may include a distal or lower surface for facing towards the skin and a proximal or upper surface 305 facing opposite the lower 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 or through-hole 310 for an insertion element (e.g., a needle) to extend through and be retracted proximally through from the skin. The through-hole 310 may allow the insertion element to pass through to deploy the 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 into the host’s skin.

[0123] 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 wearable housing 402. The housing 402 may be configured to be worn on skin of a host and may include a distal or lower surface for facing towards the skin and a proximal or upper 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.

[0124] 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 or lower 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.

[0125] The examples of FIGS. 2A-4 may be utilized with any example herein.

[0126] FIG. 5 illustrates an example of an applicator system 410 that may be utilized in examples herein. The applicator system 410 may include an applicator 412 for deploying at least a portion of an on-skin wearable medical device to a host’s skin. The applicator 412 may - 22 - 4918-3494-8739PATENT - 0955-PCT01be utilized to insert an analyte sensor into a host’s skin in examples. The applicator 412 may comprise a reusable applicator in examples, or the features of the applicator 412 may be utilized in a non-reusable or single-use example.

[0127] International Application No. PCT / US2021 / 065788, having an international filing date of December 30, 2021, and published on July 7, 2022 as WO / 2022 / 147326 and titled “Reusable Applicators for Transcutaneous Analyte Sensors, and Associated Methods,” the entire contents of which are incorporated herein by reference for all purposes, discloses features of applicators, and applicator systems (including cartridges), any of which may be utilized in examples herein. Features of applicators and applicator systems (including cartridges) disclosed in regard to FIGS. 123-158, and 224-244 of International Application No. PCT / US2021 / 065788 for example may be utilized. Other features of applicators or applicator systems (including cartridges) disclosed in International Application No. PCT / US2021 / 065788 may be utilized in examples.

[0128] The applicator 412 includes an applicator housing 414. The applicator housing 414 may comprise a single component or multiple components. As shown in FIG. 7, the applicator housing 414 may include a side cover body 416, a lower body 418, and an upper cap 420. The components of the applicator housing 414 may be coupled together to form a single applicator housing 414.

[0129] The applicator housing 414 may be configured to be gripped by a user or host to apply an analyte sensor into the host’s skin and apply other components of an on-skin sensor assembly to the host’s skin. The applicator housing 414 may have a cylindrical shape with an outer surface configured to be gripped by an individual. Other shapes of the applicator housing 414 may be utilized as desired.

[0130] The applicator housing 414 may include a side portion 422 (formed by the side cover body 416), an upper or top portion 424 (formed by the upper cap 420) and a lower or bottom portion 426 including an opening 428 shown in FIG. 6 for the analyte sensor to be deployed from to be inserted into the host’s skin. The opening 428 may be configured for an insertion element (e.g., a needle) and an analyte sensor to pass through to insert the analyte sensor into the host’s skin.

[0131] FIG. 6 illustrates a lower or bottom perspective view of the applicator 412. The applicator housing 414 includes a receiver or interior cavity 430 for receiving the analyte sensor or other components of the on-skin sensor assembly therein. The interior cavity 430 may be configured to receive a cartridge 432 (marked in FIG. 9) therein in examples. The cartridge 432 may engage with the applicator housing 414. The cartridge 432 may retain the analyte - 23 - 4918-3494-8739PATENT - 0955-PCT01sensor or other components of the on-skin sensor assembly (e.g., a wearable housing, a patch, and / or an electronics module) in examples. The cartridge 432 may be coupled to the applicator housing 414 by being inserted into the interior cavity 430. The cartridge 432 may be inserted into the interior cavity 430 axially through the opening 428 at the bottom of the applicator housing 414. In examples, the applicator 412 may deploy the analyte sensor from the interior cavity 430 in a direction opposite the direction of insertion of the cartridge 432 into the interior cavity 430.

[0132] In examples, a locking feature 434 (marked in FIG. 7) may be utilized to lock the cartridge 432 within the interior cavity 430 upon insertion of the cartridge 432 into the interior cavity 430.

[0133] FIG. 7 illustrates an assembly view of the applicator 412. The applicator 412 may include an insertion assembly configured to move from a raised position (or first position) to a lowered position (or second position) to insert the analyte sensor into the skin of the host. The insertion assembly may insert an insertion element or needle into the skin of the host to insert the analyte sensor into the skin of the host. The insertion assembly or insertion actuator, for example, may include an insertion carriage 436 and a driver 438 that is configured to drive the insertion assembly from the raised position to the lowered position. The driver 438 may comprise one or more springs in examples. The driver 438 may be configured to apply a springbias force to press the insertion carriage 436 in a distal or downward direction. In examples, the insertion carriage 436 may include a pressing surface 440 (marked in FIG. 8) configured to press against one or more components within the cartridge 432 to deploy the analyte sensor in examples.

[0134] Features of such a configuration that may be utilized are disclosed in regard to FIGS. 123-158, and 224-244 of International Application No. PCT / US2021 / 065788, the entire contents of which are incorporated herein by reference for all purposes.

[0135] The applicator 412 may include a control device 442 that may be operated by a user or host to initiate deployment of the analyte sensor. The control device 442 may comprise a button that may be pressed or another body that may be moved to initiate deployment. The control device 442 may be configured to be slid laterally to initiate deployment. The control device 442 may include a button surface 444 and an actuator in the form of a control arm or actuator arm 446. The actuator arm 446 may include a coupler release in the form of a pressing surface 448 configured to be pressed against a portion of a coupler 450 (marked in FIG. 62) to release the coupler 450.- 24 - 4918-3494-8739PATENT - 0955-PCT01

[0136] The applicator 412 may further comprise a biasing carriage 452 that may be biased towards the lower opening 428 of the applicator 412 by way of a biasing spring 454 that presses against the biasing carriage 452. The biasing carriage 452 may include stops 456 that may be configured to impede movement of the control device 442. Features of such a configuration that may be utilized are disclosed in regard to FIGS. 123-158, and 224-244 of International Application No. PCT / US2021 / 065788, the entire contents of which are incorporated herein by reference for all purposes.

[0137] FIG. 8 illustrates a side cross sectional view of the applicator 412, prior to operation of the control device 442.

[0138] FIGS. 9 and 10 illustrate a configuration of a cartridge 432 that may be utilized in examples herein. The cartridge 432 may be utilized with the applicator 412. Features of a cartridge that may be utilized in examples herein are disclosed in regard to FIGS. 123-158, and 224-244 of International Application No. PCT / US2021 / 065788, the entire contents of which are incorporated herein by reference for all purposes. The features of the cartridge and applicator system of FIGS. 224-232 of International Application No. PCT / US2021 / 065788 may be utilized. Other features of cartridges or applicator systems of International Application No. PCT / US2021 / 065788 may be utilized as desired. The cartridge 432 may comprise a non-reusable or single use cartridge in examples.

[0139] Referring to FIG. 10, the cartridge 432 may include an upper removable cover or upper sealing layer 460, a lower removable cover or lower sealing layer 462, and a body or cartridge housing 464. The cartridge housing 464 may include an upper opening 463 for receiving a portion of an insertion assembly of the applicator 412. The portion of the insertion assembly may insert through the upper opening 463 to insert the analyte sensor into the skin of the host. The cartridge housing 464 may include a bottom or lower opening 465 (marked in FIG. 14) for the analyte sensor to be deployed from. Other components of the on-skin sensor assembly may be deployed from the bottom or lower opening 465 in examples.

[0140] The cartridge housing 464 may retain the analyte sensor therein. The cartridge housing 464 may retain other components of an on-skin sensor assembly therein, including a wearable housing 466 and a patch 468 coupled to the wearable housing 466. In examples, an insertion element or needle 471 (marked in FIG. 14) may be positioned within the cartridge housing 464.

[0141] The cartridge 432 may include a retraction actuator or retraction assembly configured to retract the needle 471 from the host’s skin after insertion of the analyte sensor into the individual’s skin. The retraction actuator may be configured to automatically operate - 25 - 4918-3494-8739PATENT - 0955-PCT01upon the needle inserting the analyte sensor into the host’s skin. In the example of FIG. 10, the retraction actuator may be configured to activate based on a force of contact with the host’s skin at a deployment site of the analyte sensor, although in other examples other forms of activation (e.g., position-based activation) may be utilized. Forms of activation that may be utilized are disclosed in International Application No. PCT / US2021 / 065788, the entire contents of which are incorporated by reference for all purposes.

[0142] The retraction actuator may include a first retraction carriage 470, a second retraction carriage 472 and a driver 474. The components of the retraction actuator may be positioned within the cartridge housing 464.

[0143] The first retraction carriage 470 may couple to a needle hub 476 of the needle 471 and may include arms 478 extending outward from the needle hub 476 and configured to contact interior portions of the cartridge housing 464 to rotationally orient the first retraction carriage 470 within the cartridge housing 464. The first retraction carriage 470 may include coupling members 480 in the form of protrusions for coupling to releasable couplers of a cartridge insertion carriage 482.

[0144] The second retraction carriage 472 may include a first coupling member 484 for coupling with a second coupling member 485 (marked in FIG. 62). The second coupling member 485 may comprise a portion of the cartridge housing 464 or another component as desired.

[0145] Referring to FIG. 11, the second retraction carriage 472 may include a channel 495 for receiving a portion of the cartridge insertion carriage 482 and for the needle hub 476 to pass through. The second retraction carriage 472 may include support surfaces 492 for abutting releasable couplers 490 of the cartridge insertion carriage 482 to prevent deflection of the releasable couplers 490 until a desired time.

[0146] Referring to FIG. 10, the second retraction carriage 472 may include pressing surfaces 493 for pressing against releasable couplers 494 of the cartridge insertion carriage 482.

[0147] The second retraction carriage 472 may further include one or more locks 486 protruding from the second retraction carriage 472 and configured to engage an interior portion of the cartridge housing 464 to prevent upward or inward pushing of the second retraction carriage 472 following insertion of the insertion element (e.g., needle 471). The second retraction carriage 472 may be configured to be pushed by the insertion carriage of the applicator (for example, an applicator insertion carriage 436 as shown in FIG. 7) to insert the needle 471 and analyte sensor into the individual’s skin. The second retraction carriage 472 in - 26 - 4918-3494-8739PATENT - 0955-PCT01embodiments may comprise an over travel carriage that is configured to over travel a position of the cartridge insertion carriage 482 upon insertion of the needle 471 and analyte sensor into the individual’s skin. The over travel may cause the first retraction carriage 470 to release and retract from the cartridge insertion carriage 482. The cartridge insertion carriage 482 may displace relative to the second retraction carriage 472 based on contact with the individual’s skin.

[0148] The cartridge 432 may further include the cartridge insertion carriage 482 for retaining the wearable housing 466. The cartridge insertion carriage 482 may be configured to be moved downward to a lowered position (from a raised position) via the motion of the second retraction carriage 472 to insert the needle 471 and analyte sensor into the individual’s skin. The cartridge insertion carriage 482 may include an internal cavity 488 for receiving the second retraction carriage 472.

[0149] The cartridge insertion carriage 482 may include one or more releasable couplers 490 for coupling to the coupling members 480 of the first retraction carriage 470. The releasable couplers 490 may be configured as support arms extending upward for coupling with the coupling members 480 of the first retraction carriage 470. The support arms may be configured to deflect outward from the coupling members 480 to release from the coupling members 480. The support arms may be biased to deflect outward with the support surfaces 492 (marked in FIG. 11) of the second retraction carriage 472 moved out of position relative to the support arms.

[0150] The releasable couplers 490 that couple the cartridge insertion carriage 482 to the first retraction carriage 470 may release the first retraction carriage 470 from the cartridge insertion carriage 482 to allow the driver 474 to move the first retraction carriage 470 in a direction away from the cartridge insertion carriage 482.

[0151] The cartridge insertion carriage 482 may include releasable couplers 494 that may be configured to engage the wearable housing 466 and retain the wearable housing 466 to the cartridge insertion carriage 482. The releasable couplers 494 may comprise deflectable arms that may be biased to engage the wearable housing 466 and may be deflectable outward to disengage and release from the wearable housing 466.

[0152] Referring to FIG. 13, the releasable couplers 494 may include upper contact surfaces 497 that may be configured to contact the pressing surfaces 493 of the second retraction carriage 472. The contact between the pressing surfaces 493 and the upper contact surfaces 497 may press the insertion carriage 482 away from the second retraction carriage 472 during use. The force required to deflect the releasable couplers 494 outward may comprise a - 27 - 4918-3494-8739PATENT - 0955-PCT01force that must be overcome for deployment of the wearable housing and retraction of the needle 471 upon contact with the individual’s skin.

[0153] The cartridge insertion carriage 482 may further include stops 496 for contacting an interior portion of the cartridge housing 464 to impede downward movement of the cartridge insertion carriage 482 upon release of the coupler 450 (marked in FIG. 62).

[0154] The driver 474 of the retraction actuator or retraction assembly may be configured to drive the insertion element (e.g., needle) out of the individual’s skin. The first retraction carriage 470 may be configured to slide relative to the cartridge housing 464 and may be configured to be slid by the driver 474 of the retraction actuator. The driver 474 may be configured as a spring configured to apply an upward force from the cartridge insertion carriage 482 towards the first retraction carriage 470. The driver 474 may be configured to be compressed between the cartridge insertion carriage 482 and the coupling members 480 of the first retraction carriage 470, as shown in FIG. 12 for example.

[0155] FIG. 11 illustrates a perspective view of the second retraction carriage 472 positioned within the cartridge insertion carriage 482. The needle 471 and needle hub 476 may pass through a central channel of the cartridge insertion carriage 482 in assembly, such that the coupling members 480 may engage with the releasable couplers 490 of the cartridge insertion carriage 482.

[0156] FIG. 12, for example, illustrates a cross sectional view of the first retraction carriage 470 coupled with the releasable couplers 490 of the cartridge insertion carriage 482. The releasable couplers 490 may be deflected inward to engage with the coupling members 480 of the first retraction carriage 470 by way of the support surfaces 492 backing the releasable couplers 490 to prevent their outward deflection. The driver 474 may be compressed between the cartridge insertion carriage 482 and the coupling members 480 of the first retraction carriage 470. The engagement of the releasable couplers 490 and the coupling members 480 may prevent the release of the driver 474 until the desired time. The assembly of carriages 470, 472, 482 may be held in a raised position (or first position) in such a configuration via the coupler 450 (marked in FIG. 14). Release of the coupler 450 may allow the carriages 470, 472, 482 to descend to a lowered position (or second position) (as shown in FIG. 16) from the raised position to deploy the analyte sensor into the skin. The wearable housing and analyte sensor may similarly descend to the lowered position.

[0157] Referring to FIG. 13, the cartridge insertion carriage 482 may be held within the cartridge 432 such that an interior surface 499 of the cartridge housing 464 may press against the releasable couplers 494 that may be configured to engage the wearable housing 466.- 28 - 4918-3494-8739PATENT - 0955-PCT01Such contact between the interior surface 499 and the releasable couplers 494 may reduce the possibility of the releasable couplers 494 releasing prematurely and producing dislodgement of the wearable housing 466 during transport or otherwise prior to use.

[0158] FIG. 14 illustrates a side cross sectional view of the cartridge 432 inserted into the receiver or interior cavity 430 (marked in FIG. 8) of the applicator 412. The cartridge 432 may be inserted axially, in a direction from a lower portion of the applicator 412 towards an upper portion of the applicator 412.

[0159] The insertion carriage 436 of the applicator 412 may extend through the upper opening 463 of the cartridge 432 to contact internal components of the cartridge 432. For example, the pressing surface 440 of the insertion carriage 436 may contact and press against one of the carriages of the cartridge 432 (for example, the second retraction carriage 472). The pressing surface 448 of the actuator arm 446 may not yet align with the coupler 450 of the cartridge 432. Upon further insertion of the cartridge 432 (which may be via a force applied by the host’s skin to the lower surface of the cartridge 432), the actuator in the form of the actuator arm 446 may align with the coupler 450. FIG. 15, for example, illustrates continued insertion of the cartridge 432 to align the pressing surface 440 of the actuator with the coupler 450. The insertion carriage 436 of the applicator 412 may be in contact with the second retraction carriage 472 to drive the assembly of carriages 470, 472, 482 downward at the desired time.

[0160] The insertion of the cartridge 432 and the analyte sensor into the receiver or interior cavity 430 of the applicator housing 414 may compress and thus provide energy to the driver 438 of the insertion assembly. In an embodiment in which the driver 438 includes a spring, the spring may be compressed by the insertion of the cartridge 432 and the analyte sensor into the interior cavity 430.

[0161] The biasing carriage 452 may be displaced axially to allow the control device 442 to move laterally. Upward pressure against the cartridge 432 by the individual’s skin presses the biasing carriage 452, to move the stop 456 marked in FIG. 7, and allow the control device 442 to move inward to be pressed.

[0162] At a desired time, the control device 442 may be operated. The control device 442 may be pressed laterally such that the actuator in the form of the actuator arm 446 contacts the coupler 450 to release the coupler 450. The actuator arm 446 may press against the first coupling member 484 to release the first coupling member 484 from the second coupling member 485 allow the insertion assembly to drive the assembly of carriages 470, 472, 482 downward.- 29 - 4918-3494-8739PATENT - 0955-PCT01

[0163] FIG. 16 illustrates the assembly of carriages 470, 472, 482 having descended. The insertion carriage 482 may move downward to insert the needle 471 into the host’s skin to insert the analyte sensor into the host’s skin. Further, the patch 468 may be applied to the host’s skin with an adhesive. The on-skin wearable housing 466 is moved relative to the cartridge housing 464 from a raised position to a lowered position. The analyte sensor is moved relative to the cartridge housing 464 from a raised position to a lowered position to be inserted into skin of the host.

[0164] The releasable couplers 494 that may be configured to engage the wearable housing 466 may displace relative to the interior surface 499 shown in FIG. 13 and may be able to deflect outward from the wearable housing 466 at a desired time.

[0165] The cartridge 432 may remain within the receiver or interior cavity of the applicator housing 414 during insertion of the needle 471 and insertion of the analyte sensor into the host’s skin, as well as deployment of the on-skin sensor assembly to the host’s skin.

[0166] The retraction actuator or retraction assembly of the cartridge 432 may be configured to activate based on a force of contact with the host’s skin at a deployment site of the analyte sensor. The retraction actuator or retraction assembly of the cartridge 432 may activate at the point of contact with the host’s skin. For example, as shown in FIG. 16, if the individual’s skin 498 protrudes into the receiver of the cartridge 432 then the retraction actuator may activate at the position of the individual’s skin 498.

[0167] The retraction actuator or retraction assembly may operate utilizing a carriage that over travels with respect to another carriage based on contact with the individual’s skin at a deployment site of the analyte sensor. For example, the second retraction carriage 472 may be configured to over travel with respect to the cartridge insertion carriage 482 upon deployment. Upon deployment, the downward motion of the cartridge insertion carriage 482 may be impeded based on contact with the individual’s skin. The cartridge insertion carriage 482 may thus cease downward movement along with the wearable housing 466 upon the individual’s skin applying a resistive force to the cartridge insertion carriage 482 upon deployment. The second retraction carriage 472, however, may continue to be pressed by the insertion assembly and may continue to travel, or over travel, with respect to the cartridge insertion carriage 482. The cartridge insertion carriage 482 may displace relative to the second retraction carriage 472 based on contact with the individual’s skin to operate the retraction assembly. The over travel may cause a displacement of the second retraction carriage 472 downward with respect to the cartridge insertion carriage 482 and accordingly a displacement of the support surfaces 492 of the second retraction carriage 472 relative to the releasable - 30 - 4918-3494-8739PATENT - 0955-PCT01couplers 490 of the cartridge insertion carriage 482. FIG. 16, for example, illustrates the relative displacement of the support surfaces 492 relative to the releasable couplers 490.

[0168] With the support surfaces 492 of the second retraction carriage 472 released from the releasable couplers 490 of the cartridge insertion carriage 482, the releasable couplers 490 may be able to decouple from the coupling members 480 of the first retraction carriage 470. Referring to FIG. 17, the releasable couplers 490 may deflect outward from the coupling members 480 to allow the driver 474 to expand and retract the needle 471 from the host’s skin.

[0169] FIG. 18 illustrates that upon the over travel of the second retraction carriage 472 with respect to the cartridge insertion carriage 482, the pressing surfaces 493 of the second retraction carriage 472 may press against the releasable couplers 494. The pressing surfaces 493 may deflect the releasable couplers 494 away from the wearable housing 466 and may disengage the releasable couplers 494 from the wearable housing 466 to allow the wearable housing 466 to remain on the host’s skin upon deployment.

[0170] The cartridge 432 may be configured to retain the needle 471 after the cartridge 432 has been separated from the receiver and the needle 471 has been inserted into the host’s skin.

[0171] FIG. 19 illustrates that the locks 486 of the second retraction carriage 472 may engage an interior portion of the cartridge housing 464 to prevent upward or inward pushing of the second retraction carriage 472 following insertion of the needle 471. Such a feature may reduce the possibility of access by a user of the used needle within the cartridge 432.

[0172] In the event that no skin is contacted by the assembly of carriages 470, 472, 482, the retraction actuator or retraction assembly may yet activate. Referring to FIG. 20, the stops 496 of the cartridge insertion carriage 482 may contact an interior portion of the cartridge 432 to impede downward movement of the cartridge insertion carriage 482. Thus, a position or displacement based activation may occur if no skin is contacted. The second retraction carriage 472 may continue to over travel or displace with respect to the cartridge insertion carriage 482 and cause the needle 471 to be retracted from the individual’s skin. Such a feature may reduce the possibility of the needle 471 remaining extended from the cartridge 432 if no skin is contacted upon activation of the insertion assembly.

[0173] With the needle 471 retracted, the cartridge 432 may then be withdrawn from the applicator 412 and discarded, to discard the used needle 471. The applicator may return to the state shown in FIG. 8, for example, for insertion of another cartridge.

[0174] Other forms of cartridges and applicator systems may be utilized in examples herein.- 31 - 4918-3494-8739PATENT - 0955-PCT01

[0175] FIG. 21 illustrates an applicator system for an on-skin wearable medical device. The system may include an applicator 500 for an on-skin sensor assembly. In examples, other forms of systems may be utilized.

[0176] The applicator 500 may include an applicator housing 501, which may include features as disclosed in regard to the applicator housing 414 shown in FIG. 5 unless stated otherwise. The applicator housing 501 may include an outer housing 504 and an inner housing 506, and other forms of housings in examples. The applicator housing 501 may be configured to retain an analyte sensor and other components of an on-skin sensor assembly (e.g., a wearable housing, a patch) in examples.

[0177] 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 may include an insertion assembly for inserting the analyte sensor into the skin of the host. The insertion assembly may move from a raised position to a lowered position to insert the analyte sensor into the skin of the host. The insertion assembly may drive an insertion element (e.g., the needle) and the analyte sensor, into the skin of the host. In examples, the deployment mechanism may include a retraction assembly for retracting the insertion element or needle from the skin.

[0178] The deployment mechanism, for example, may include 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.

[0179] Features of an applicator and applicator system that may be utilized are disclosed in International Application No. PCT / US2022 / 045262, having an international filing date of September 29, 2022, and published on April 6, 2023 as WO / 2023 / 055956 and titled “Apparatuses, Systems, and Methods of Improving Patch Performance for a Medical Device,” the entire contents of which are incorporated by reference for all purposes.

[0180] In examples, the applicator 500 may include a control device 502 disposed on a side of applicator 500, for example, on a side of an outer housing 504 of applicator 500. In some examples, control device 502 may be a button, a switch, a toggle, a slide, a trigger, a knob, a rotating member, a portion of applicator 500 that deforms and / or flexes or any other suitable mechanism for activating an insertion and / or retraction assembly of applicator 500. In some examples, control device 502 may be disposed in any location, e.g., a top, upper side, lower side, or any other location of applicator 500. Applicator 500 may be large enough for a host to grasp with a hand and push, or otherwise activate, control device 502 with, for example, a thumb, or with an index finger and / or a middle finger.- 32 - 4918-3494-8739PATENT - 0955-PCT01

[0181] FIG. 22 illustrates an exploded perspective view of applicator 500 of FIG. 21, according to some examples. Applicator 500 may include outer applicator housing 504 comprising control device 502. The outer applicator housing 504 may be configured to be gripped by a user in examples. Outer applicator housing 504 may be configured to translate in a distal direction by a force applied by a host to applicator 500, specifically to inner housing 506, thereby aligning control device 502 in a position that allows applicator 500 to fire.

[0182] Applicator 500 further comprises inner housing 506, configured to house at least one or more mechanisms utilized to apply on-skin sensor assembly 508 to skin of a host. A distal surface 510 of a bottom opening of inner housing 506 may define a bottom surface of applicator 500. In some examples, upon pressing applicator 500 against skin of the host, skin may deform in a substantially convex shape at distal surface 510 such that at least a portion of a surface of skin disposed at the bottom opening of applicator inner housing 506 extends into the bottom opening of inner housing 506 beyond a plane defined by distal surface 510 in a proximal direction.

[0183] As shown in FIG. 23, the housing 501, and particularly the inner housing 506 may include a receiver or 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 analyte sensor to be deployed from. A proximal end portion 507 of the internal cavity 503 may include the on-skin wearable medical device coupled to a needle carriage 516.

[0184] Referring back to FIG. 22, in some examples, a first barrier layer or sealing layer 512 may be disposed over one or more apertures in inner housing 506, for example, an aperture 514 through which at least a portion of control device 502 may be configured to extend through during activation of applicator 500. In such examples, a portion of control device 502 may be configured to pierce or deform first barrier layer or sealing layer 512 upon activation of applicator 500. First sealing 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.

[0185] Applicator 500 may further comprise a needle carrier assembly, including a needle hub 518 configured to couple an insertion element or needle 520 to needle carriage 516. In some other examples, needle 520 may be directly coupled to needle carriage 516. Needle 520 is configured to guide the analyte sensor of on-skin sensor assembly 508 into skin of the host. In some examples, the needle may comprise 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, needle 520 may be integrally formed - 33 - 4918-3494-8739PATENT - 0955-PCT01with the analyte sensor and may be sufficiently rigid to be inserted partially into skin of the host with minimal or no structural support.

[0186] Applicator 500 may further include a holder carriage 522 releasably coupled to needle carriage 516 and configured to guide needle carriage 516 and on-skin sensor assembly 508 while coupled to needle carriage 516, e.g., at least during translation from a proximal position or raised position to a distal insertion position or lowered position. The on-skin sensor assembly 508 may be stripped or released from the holder 522 and / or needle carriage 516 once on-skin sensor assembly 508 is disposed on skin of the host. For example, one or more retention elements may release the on-skin wearable medical device from the applicator housing 501.

[0187] Applicator 500 may comprise an insertion assembly configured to translate needle 520, needle hub 518, needle carriage 516, and on-skin sensor assembly 508 from a proximal position or raised position, in the distal direction, to a distal insertion position or lowered position. Such an insertion assembly may include at least one driver or spring for inserting at least a portion of the analyte sensor 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 the inner applicator housing 506 and a second end in contact with or coupled to holder carriage 522. First spring 524 is configured to, upon activation of the insertion assembly, translate holder carriage 522, needle carriage 516, needle hub 518, needle 520 and on-skin sensor assembly 508, in the distal direction to the distal insertion position or lowered position. Substantially at the or lowered position, needle carriage 516 may decouple from holder carriage 522 and on-skin sensor assembly 508.

[0188] 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 carriage 516, needle hub 518 and needle 520, in the proximal direction, from the lowered position to a raised position. In some examples the initial raised position may be the same as the retracted raised position. In other examples, the initial raised position may be different from the retracted raised position. Such a retraction assembly may include at least one driver or 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 carriage 522 and a second end in contact with or coupled to at least one spring retention element (e.g., 528a, 528b in FIGS. 26-30), at least until retraction. Second spring 526 is configured to translate needle carriage 516, needle hub 518, and needle - 34 - 4918-3494-8739PATENT - 0955-PCT01520 in the proximal direction from the lowered position to the raised 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. 26-30). 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 carriage 516, or holder carriage 522 in the distal insertion position.

[0189] In some examples, a second barrier layer or sealing layer 530 may be disposed over the bottom opening of inner housing 506. Second sealing 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 sealing layer 530 may be removed by the user or host prior to use of applicator 500. In examples comprising one or both of first and second sealing layer 512, 530, such layers may provide a sterile environment between applicator 500 and the outside environment and / or may allow ingress and egress of gas such as during sterilization.

[0190] A brief description of some aspects of the operation of applicator 500 follows with respect to FIGS. 23-25, which illustrate several cross-sectional views of applicator 500 of FIGS. 21 and 22 during operation. FIGS. 23-25 may correspond to applicator 500 cut along the section line A-A’ shown in FIG. 21, for example.

[0191] FIG. 23 illustrates a state of applicator 500 prior to activation. Holder carriage 522 comprises an insertion assembly retention element 532 configured to contact inner housing 506, thereby immobilizing holder carriage 522, needle carriage 516, needle hub 518, needle 520 and on-skin sensor assembly 508, in the pre-activated state or raised position.

[0192] Needle carriage 516 may include a plurality of wearable retention and / or alignment elements 534a, 534b configured to extend through holder carriage 522 and releasably couple on-skin sensor assembly 508 to holder carriage 522 and / or to needle carriage 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. 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 carriage 516 and / or holder carriage 522.

[0193] 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 - 35 - 4918-3494-8739PATENT - 0955-PCT01housing 506 in the pre-activation orientation or raised position of FIG. 23. 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. 23.

[0194] Activation of applicator 500 may include a user or host pressing applicator 500 against the host’s 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 an activation element of control device 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 user or host may initiate (e.g. pushing) control device 502, as shown by arrow 540, thereby deflecting insertion assembly retention element 532 sufficiently to release holder carriage 522 from inner housing 506.

[0195] FIG. 24 illustrates applicator 500 during insertion of on-skin sensor assembly 508 but before retraction of the needle carriage 516. First spring 524 drives holder carriage 522, needle carriage 516, needle hub 518, needle 520, and on-skin sensor assembly 508, in the distal direction toward the distal insertion position or lowered position. FIG. 24 illustrates a position where on-skin sensor assembly 508 is in contact with skin of the host but where holder carriage 522 is not yet fully driven, by first spring 524, into contact with on-skin sensor assembly 508 or skin of the host.

[0196] FIG. 25 illustrates applicator 500 during activation, as needle carriage 516, needle hub 518 and needle 520 are retracted in the proximal direction by second spring 526. In FIG. 25, 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. 26-30) and drives needle carriage 516, needle hub 518, and needle 520 in the proximal direction from the distal insertion position or lowered position. Upon needle carriage 516 reaching the raised retraction position, a lock feature in the form of needle carrier retention element 542 of holder carriage 522 engages with needle carriage 516, thereby maintaining needle carriage 516, needle hub 518 and needle 520 in a locked, retracted position limiting access to needle 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 locking function. In this retracted position, needle carriage 516, needle hub 518, and needle 520 are prevented from travelling in a distal or lowered direction. Such a feature may prevent a user from- 36 - 4918-3494-8739PATENT - 0955-PCT01inserting his or her fingers into the applicator housing to potentially contact the used needle therein.

[0197] A further description of some aspects of the operation of applicator 500 follows with respect to FIGS. 26-28, which illustrate several cross-sectional views of applicator 500 of FIGS. 21 and 22 during operation, according to some examples. FIGS. 26-28 may correspond to applicator 500 cut along the section line B-B’ shown in FIG. 21, for example. For ease of illustration, needle hub 518 and needle 520 are not shown in FIGS. 26-28.

[0198] FIG. 26 illustrates a state of applicator 500 prior to activation. For ease of illustration, on-skin sensor assembly 508 is not illustrated in FIG. 26. Holder carriage 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 carriage 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 examples. 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, spring retention elements 528a, 528b may be actively deflected by one or more features within applicator 500.

[0199] Needle carriage 516 comprises backstop features 544a, 544b, configured to prevent lateral deflection of spring retention elements 528a, 528b in the proximal starting position or raised position, e.g., at least during insertion, thereby supporting retention of second spring 526 between spring retention elements 528a, 528b and holder carriage 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.

[0200] FIG. 29 illustrates a magnified view of spring retention element 528b and backstop feature 544b. In FIG. 29, first spring 524 is driving holder carriage 522, needle carriage 516 and on-skin sensor assembly 508, in the distal direction toward the distal inserted position or lowered 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. 29, a proximal end of spring retention element 528b may be offset from a distal end of backstop feature 544b by a distance - 37 - 4918-3494-8739PATENT - 0955-PCT01a. 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 carriage 516 and a distal end of holder carriage 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.

[0201] 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. 29. Further, 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.

[0202] 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.

[0203] 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.

[0204] FIG. 29 further illustrates needle carriage 516 comprising a deflecting element 546 configured to contact spring retention element 528b and maintain spring retention element 528b in a laterally deflected orientation once second spring 526 has initially deflected spring retention element 528b and sufficiently driven needle carriage 516 in the proximal direction, as will be shown in more detail in FIG. 30. 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 carriage 516 in the proximal direction from being absorbed by undesired contact with spring retention element 528b during the release of second spring 526.- 38 - 4918-3494-8739PATENT - 0955-PCT01

[0205] 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 or raised position such that spring retention elements 528a, 528b are prevented from laterally deflecting until holder carriage 522 and needle carriage 516 have translated at least a predetermined minimum distance in the distal direction.

[0206] Turning back to FIG. 26, inner housing 506 may further comprise an engagement element 550 configured to engage with a protrusion 552 of needle carriage 516 upon the needle carriage 516 translating in the distal direction beyond a predetermined threshold, thereby preventing needle carriage 516 from translating in the distal direction beyond the predetermined threshold. This may ensure needle carriage retraction in the event of an air firing or dry firing in which applicator 500 is activated when not held against the skin of the host. In some examples, engagement element 550 comprises a hook, a U-shaped structure, a loop, a protrusion, or any other structure capable of engaging with protrusion 552 as described above.

[0207] FIG. 27 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 carriage 522, needle carriage 516, needle hub 518, insertion element (e.g., needle), and on-skin sensor assembly 508, in the distal direction toward the distal insertion position or lowered position. During proper operation, holder carriage 522 and on-skin sensor assembly 508 should be pressing against the skin of the host.

[0208] Turning to FIG. 30, first spring 524 has driven holder carriage 522, needle carriage 516 and on-skin sensor assembly 508 in the distal direction to the skin of the host. As first spring 524 drives holder carriage 522, needle carriage 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 carriage 522 is offset from the distal end of on-skin sensor assembly 508 as shown in FIG. 29, the counter force provided by the skin is transferred to holder carriage 522 as first spring 524 continues to drive holder carriage 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,- 39 - 4918-3494-8739PATENT - 0955-PCT01thereby releasing second spring 526, which drives needle carriage 516 in the proximal direction.

[0209] Turning back to FIG. 28, which illustrates applicator 500 during activation, needle carriage 516 is retracted in the proximal direction by second spring 526, as indicated by arrow 554. In FIG. 28, 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 carriage 516 in the proximal direction, thereby maintaining needle carriage 516, needle hub 518 (see FIGS. 23-25) and needle 520 (see FIGS. 23-25) in a locked, retracted position even in the event of a dry fire.

[0210] FIGS. 31 and 32 illustrate magnified views of some features of an applicator, such as applicator 500, according to some examples.

[0211] In FIG. 31, first spring 524 (see FIGS. 22-28) is driving holder carriage 522, as well as the needle carriage and on-skin sensor assembly 508 in the distal direction, illustrated by arrow 556, toward the distal insertion position or lowered position. The retention element 534b of the needle carrier assembly is releasably coupled to on-skin sensor assembly 508. As illustrated, during insertion and near the distal inserted position, holder carriage 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 carriage.

[0212] In FIG. 32, second spring 526 (see FIGS. 22-28) is driving needle carriage 516 in the proximal direction from the distal insertion position or lowered position. Because holder carriage 522 has been driven sufficiently in the distal direction, at the distal insertion position or lowered position, holder carriage 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 carriage 516. Needle carriage 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 carriage 522 is driven to the distal inserted position and substantially held in that position by first spring 524, holder carriage 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.- 40 - 4918-3494-8739PATENT - 0955-PCT01

[0213] FIG. 33 illustrates a perspective partial cutaway view of needle carriage 516, needle hub 518, and on-skin sensor assembly 508 of applicator 500 of FIGS. 21 and 22. FIG.34 illustrates a cross-sectional view of needle hub 518 and on-skin sensor assembly 508, according to some examples. FIG. 35 illustrates a top view of a portion of needle carriage 516 and needle hub 518, according to some examples. The following is a description of these features with reference to FIGS. 33-35.

[0214] On-skin sensor assembly 508 includes a sensor assembly opening or through hole 560. Needle hub 518 is configured to couple needle 520 to the needle carriage 516 and to substantially maintain a desired orientation of needle 520 during insertion of the analyte sensor of on-skin sensor assembly 508 into the skin of the host.

[0215] Needle hub 518 may comprise 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 carriage 516, upper arms 562a, 562b and lower arms 564a, 564b secure needle hub 518 in a desired orientation with respect to the needle carriage 516. For example, upper arms 562a, 562b may be configured to flex radially inward, such that when disposed through an engagement portion of the needle carriage 516 in the form of a carrier aperture 568, upper arms 562a, 562b are in contact with an upper surface of needle carriage 516 adjacent to carrier aperture 568 and lower arms 564a, 564b are in contact with a lower surface of needle carriage 516 adjacent to carrier aperture 568. Such an arrangement allows a compliant fit between needle carriage 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.

[0216] Base 566 may comprise an anti-rotation feature. The anti-rotation feature may comprise a key having a shape complementary to at least a portion of through hole 560 of on-skin sensor assembly 508 and may be configured to substantially prevent needle hub 518 from rotating about a longitudinal axis 567 of the needle 520 with respect to on-skin sensor assembly 508, e.g., to prevent rotation of base 566 within the through hole 560. In addition, or the alternative, the upper surface of needle carriage 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. 35, thereby immobilizing needle hub 518 with respect to needle carriage 516.- 41 - 4918-3494-8739PATENT - 0955-PCT01

[0217] FIGS. 36A and 36B illustrate perspective views of locking features for insertion elements in the form of needles 600a, 600b for use in an applicator for an analyte sensor system, according to some examples. For example, needle 600a of FIG. 36A comprises 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. 36B comprises a locking feature comprising a groove 604 configured to mate with a complementary-shaped feature within needle hub 518, for example. The examples of needles 600a, 600b that may be utilized in examples herein may each include respective elongate channels 604a, b for receiving an analyte sensor. An analyte sensor may be positioned within a respective one of the elongate channels 604a, b for the needle 600a, 600b to guide the analyte sensor into the skin of the host. The features of FIGS. 21-36B may be utilized solely or in combination with any example herein.

[0218] Features of an applicator and applicator system that may be utilized are disclosed in International Application No. PCT / US2022 / 045262, the entire contents of which are incorporated by reference herein.

[0219] In examples, the configuration of the applicator 500 may vary such that the applicator may comprise a reusable or multiple-use applicator. For example, the applicator 500 may comprise a single-use or disposable applicator. The on-skin sensor assembly 508 shown in FIG. 22 may be deployed to the skin of the host, and the remaining components shown in FIG. 22 (e.g., the applicator) may be discarded after use. Variations in a configuration of the applicator 500 may be utilized in examples. The variations may comprise reusable or multiple-use applicators, although features disclosed herein may be utilized with single-use or disposable applicators as desired.

[0220] FIG. 37, for example, illustrates a schematic side cross sectional view of an applicator 700 that may be utilized in examples herein. The applicator 700 may comprise a variation of the applicator 500 discussed in regard to FIGS. 21-35, and may include the features of the applicator 500 unless stated otherwise. The applicator 700 may include an applicator housing 702 and may include a deployment assembly for deploying an analyte sensor and other components of an on-skin sensor assembly to skin of a host.

[0221] The applicator housing 702 may be configured similarly as the applicator housing 501 (although shown in a schematic view in FIG. 37) and may include the features of the applicator housing 501. The applicator housing 702 may include a lower surface 704 that may be configured to contact skin of a host upon application of an analyte sensor. The- 42 - 4918-3494-8739PATENT - 0955-PCT01applicator housing 702 may include an upper surface as represented in FIGS. 21 and 22 and may include multiple housings as shown in FIG. 22.

[0222] The applicator housing 702 may surround a receiver or interior cavity 706, which may be configured similarly as the receiver or internal cavity 503 of the applicator 500. The receiver or interior cavity 706 is configured for retaining the on-skin wearable medical device. The applicator 700 is configured to deploy the analyte sensor from the interior cavity 706. The applicator 700 deploys the analyte sensor from the interior cavity 706 in an axial direction, in a similar manner as the applicator 500.

[0223] The applicator 700 includes a deployment mechanism for deploying the analyte sensor and other components of the on-skin sensor assembly to the skin of the host. The deployment mechanism may include an insertion assembly configured to move from a raised position (or first position) to a lowered position (or second position) to insert the analyte sensor into the skin of the host, in a similar manner as with the applicator 500. The applicator 700 may include a retraction assembly for retracting an insertion element or needle from the skin of the host following deployment. Features of the deployment mechanism described in regard to the applicator 500 may be utilized with the applicator 700 unless stated otherwise.

[0224] The applicator 700 includes one or more carriages configured to move from a raised position to a lowered position to deploy the analyte sensor into the skin of the host. The carriages may include the features of the carriages 516, 522 of the applicator 500 and may operate in a similar manner unless stated otherwise. The applicator 700, for example, may include a needle carriage 708 that may include the features of the needle carriage 516 unless stated otherwise. The applicator 700 may include a holder carriage 710 that may include the features of the holder carriage 522 unless stated otherwise. The carriages 708, 710 may deploy and release the analyte sensor into the skin of the host in a similar manner as the respective carriages 516, 522. In examples, drivers similar to the drivers or springs 524, 526 of the applicator 500 may be utilized to drive the carriages 708, 710 in a similar manner as the springs 524, 526.

[0225] In examples, the applicator 700 may utilize a control device that may operate in a similar manner as the control device 502 of the applicator 500. Other features of the applicator 500 may be incorporated with the applicator 700 as desired.

[0226] The needle carriage 708 of the applicator 700 may include a variation of the engagement portion of the needle carriage 516 represented in FIGS. 33 and 35 for example. The needle carriage 708 may include an engagement portion 712 that is configured to be rotationally coupled with a needle hub 714 (marked in FIG. 38) of a needle 716 about the - 43 - 4918-3494-8739PATENT - 0955-PCT01longitudinal axis 718 of the needle 716. The engagement portion 712, for example, may comprise a slot or groove 720 configured for rotational coupling with the needle hub 714. The engagement portion 712 may include a sheath 722 or shroud that may extend axially and may have the groove 720 positioned thereon. Other configurations of engagement portions 712 may be utilized in examples that may provide for rotational coupling (e.g., threading, plugs, snap connectors, spirals, hooks, among others). In examples, the engagement portion 712 and needle hub 714 (e.g., the engagement feature 792 of the needle hub 714) may comprise a bayonet mechanism. Other mechanisms may be utilized in examples.

[0227] In examples, the groove 720 may comprise an angled cam groove. The relative rotation of the groove 720 with respect to the needle hub 714 may produce a rotational motion and a longitudinal motion along the groove 720. FIG. 41, for example, illustrates a close up perspective view of the engagement portion 712. The groove 720 extends circumferentially about the sheath 722 and displaces longitudinally such that the needle hub 714 is retracted longitudinally proximally and is rotated simultaneously upon engagement with the groove 720. In examples, the engagement portion 712 may include a lock feature 724 for locking the needle hub 714 to the engagement portion 712. The lock feature 724 may comprise a notch in the groove 720 that the needle hub 714 may enter. Other forms of lock features 724 may be utilized in examples (e.g., snaps, jaws, ridged surfaces, among others).

[0228] In examples, the applicator 700 may include a lock feature 726 for locking the insertion assembly in the lowered position following insertion of the analyte sensor into the skin of the host. The lock feature 726 may operate in a similar manner as the lock feature in the form of needle carrier retention element 542 of the applicator 500. The lock feature 726, for example, may lock the needle carriage 708 in an axially displaced position relative to the holder carriage 710 to lock the insertion assembly in the lowered position. The holder carriage 710 may be held in a lowered position by the lock feature 726, with the needle carriage 708 in a raised position, as shown in FIG. 50. Such a feature may reduce the possibility of a user inserting his or her fingers into the interior cavity 706 to contact a used needle. The lock feature 726 may abut the holder carriage 710 to provide such functionality in examples. In examples, alternatively, the lock feature 726 may abut the needle carriage 708 to lock the needle carriage 708 in the axially displaced position relative to the holder carriage 710. A configuration as shown in FIG. 25 may be utilized in examples.

[0229] In examples, the lock feature 726 may comprise a post or arm having a contact surface 730, although other configurations may be utilized in examples.- 44 - 4918-3494-8739PATENT - 0955-PCT01

[0230] FIG. 38 illustrates a cross sectional view of a cartridge 740 that may be utilized in examples herein. The cartridge 740 may include a cartridge housing 742 that may be configured to retain contents of the cartridge 740 therein. The cartridge housing 742 may include one or more walls 744 surrounding an interior cavity 746 for retaining components of the on-skin sensor assembly therein. The one or more walls 744 may comprise a shaped layer that may be shaped to accommodate the contents of the on-skin sensor assembly therein. For example, a lower wall or bottom wall of the walls 744 may include a protrusion 748 for accommodating a longitudinal shape of the needle 716.

[0231] In examples, the cartridge housing 742 may include an upper opening 752 for access to the contents of the cartridge housing 742. In examples, a barrier layer or sealing layer 754 may be provided that may cover the upper opening 752 and the interior cavity 746 of the cartridge housing 742. The sealing layer 754 may be configured to provide a sterile or hermetic seal of the interior cavity 746. The sealing layer 754 is configured to be removed for access to the contents of the cartridge housing 742.

[0232] FIG. 39 illustrates a perspective view of the sealed cartridge 740.

[0233] Referring to FIG. 38, the cartridge 740 may retain the on-skin sensor assembly and the insertion element or needle 716 for guiding the analyte sensor 756 into the skin of the host. The on-skin sensor assembly, for example, may include a wearable housing 758 or on-skin wearable housing, a patch 760, and the analyte sensor 756. The on-skin sensor assembly and needle hub may comprise a needle assembly in examples (with a needle coupled to the needle hub). The analyte sensor 756 may be coupled to the wearable housing 758 in examples, or may be separate from the wearable housing 758 and configured for later coupling to the wearable housing 758 in examples.

[0234] The patch 760 may include an upper surface 762 for facing towards the wearable housing 758 and coupling to a lower surface of the wearable housing 758. The patch 760 may include a lower surface 764 facing opposite the upper surface 762 and configured to attach to skin of the host. The lower surface 764 may comprise an engagement surface and may include an adhesive or other manner of attachment to the skin of the host.

[0235] In examples, a liner 766 may be provided that may cover the lower surface 764 of the patch 760. The liner 766 may extend along a lower surface of the cartridge housing 742 in examples. The liner 766 may be coupled to the cartridge housing 742 such that a withdrawal movement of the wearable housing 758 from the cartridge 740 at least partially removes the liner 766 from the patch 760. FIG. 48, for example, illustrates the wearable housing 758 being- 45 - 4918-3494-8739PATENT - 0955-PCT01withdrawn from the cartridge 740 with the liner 766 remaining coupled to the cartridge housing 742.

[0236] The wearable housing 758 may include features similar to other wearable housings disclosed herein (e.g., the wearable housing of the on-skin sensor assembly 508) unless stated otherwise. The wearable housing 758 may couple to the analyte sensor 756. The wearable housing 758 may include an opening or through-hole 768 for the insertion device or needle 716 to pass through. The through-hole 768 may extend from an upper surface of the wearable housing 758 to a lower surface or bottom surface of the wearable housing 758. The patch 760 and liner 766 may include similar openings or through-holes aligned with the through-hole 768 for the insertion element or needle 716 to pass through.

[0237] In examples, the wearable housing 758 may include a retention feature for retaining the needle 716 to the wearable housing 758. The retention feature may comprise a cavity 770 extending radially outward of the through-hole 768 for receiving a locking member 772 coupled to the needle 716. The retention feature may include contact surfaces 774 (marked in FIG. 42) (which may comprise upper contact surfaces 774) for contacting the locking member 772 to impede release of the needle 716 from the wearable housing 758.

[0238] The through-hole 768 may have a shape of an elongate slot 780 (marked in FIG.43). FIG. 43 illustrates a top view of the through-hole 768 at the upper surface 782 of the wearable housing 758 showing the shape of the elongate slot 780. The elongate shape of the slot 780 may extend transverse to the longitudinal extent of the through-hole 768. The elongate slot 780 may be configured such that as the locking member 772 is rotated to extend into the cavity 770 (as represented in FIGS. 42 and 43) (in a locked position), the contact surfaces 774 of the cavity 770 impede release of the locking member 772 from the cavity 770. As the locking member 772 is rotated within the through-hole 768 (as marked in FIG. 47) to align with the elongate shape of the slot 780 (in an unlocked position), the alignment of the shape of the locking member 772 and the slot 780 allows for removal of the needle 716 from the wearable housing 758. As such, the locking member 772 may rotate from a locked position (as represented in FIGS. 42 and 43) to a rotationally offset unlocked position (as represented in FIG. 47) by rotating about the longitudinal axis 718 of the needle 716.

[0239] Other configurations of retention features for retaining the needle 716 to the wearable housing 758 may be utilized in examples.

[0240] FIG. 40 illustrates a perspective isolated view of the needle 716. The needle 716 may extend from an upper or proximal end to a lower or distal end or tip 784 along a longitudinal axis 718 (marked in FIG. 42). The needle 716 is configured to guide the analyte - 46 - 4918-3494-8739PATENT - 0955-PCT01sensor 756 into the skin of the host. The needle 716 may include an elongate channel 786 for receiving the analyte sensor 756. The elongate channel 786 may be configured similarly as either of the elongate channels 604a, b illustrated in FIGS. 36A, B. The analyte sensor 756 may be positioned within the elongate channel 786 at the time of insertion into the skin of the host.

[0241] The locking member 772 may be coupled to the needle 716. The locking member 772 may be positioned at a mid-section of the needle 716 or in examples may be positioned at the upper or proximal end of the needle 716 or at another position as desired. The locking member 772 may comprise an elongate body that may be shaped to align with the shape of the slot 780 as shown in the upper view of FIG. 47. The locking member 772 may include one or more protrusions configured to enter the cavity 770 in a locked position and contact the contact surfaces 774 of the cavity 770 in examples. The locking member 772 may have a triangular shape as shown in FIG. 40, or may have another shape in examples as desired.

[0242] The locking member 772 may be configured to rotate with a rotation of the needle 716 about the longitudinal axis 718. The locking member 772 may be configured to rotate from a locked position as represented in FIGS. 42 and 43 to an unlocked position as represented in FIG. 47. The needle 716 is locked to the wearable housing 758 with the locking member 772 in the locked position and is removable from the wearable housing 758 when the locking member 772 is in the unlocked position.

[0243] FIG. 40 illustrates the needle hub 714 coupled to the needle 716. The needle hub 714 may be positioned at the upper or proximal end of the needle 716 or may have other positions in examples. The needle hub 714 may include a central body 790 and one or more engagement features 792.

[0244] The needle hub 714 may be configured to be rotationally coupled about the longitudinal axis 718 of the needle 716 with the engagement portion 712 of the applicator 700. The needle hub 714 may rotate about the longitudinal axis 718 of the needle 716 to rotationally couple with the engagement portion 712 of the applicator 700. The engagement features 792 of the needle hub 714, for example, may be configured to rotationally engage and couple with the engagement portion 712 of the applicator 700. The engagement features 792 may comprise protrusions configured to enter and slide along a groove 720 of the engagement portion 712. The protrusions may rotationally engage the groove 720. The protrusions may fit within the lock feature 724 of the engagement portion 712. Other configurations of engagement features 792 of the needle hub 714 may be utilized. The engagement portion 712 of the applicator 700 may be varied accordingly to rotationally couple with the needle 716.- 47 - 4918-3494-8739PATENT - 0955-PCT01

[0245] In examples, the needle hub 714 may be configured to rotate, with the engagement portion 712 of the applicator 700 remaining static. In examples however, the engagement portion 712 of the applicator 700 may be configured to rotate with the needle hub 714 remaining static for rotational coupling about the longitudinal axis 718 of the needle 716. For example, the engagement portion 712 of the applicator 700 may be pivotal or able to rotate, with the needle hub 714 remaining static. In examples, variations in the engagement features 792 of the needle hub 714 may be provided. The engagement features 792 may comprise a groove and the engagement portion 712 of the applicator 700 may include protrusions, although other configurations may be utilized as desired. In examples, the needle hub 714 and / or locking member 772 may be configured to rotate relative to the needle 716 (e.g., a pivotal or rotational coupling).

[0246] In examples, the needle hub 714 may have a diameter that is less than a diameter of the spring or driver that retracts the needle carriage 708 (similar to the spring 526 shown in FIG. 22).

[0247] In examples, the rotation of the needle hub 714 may correspondingly rotate the needle 716 and the locking member 772. The rotation of the needle hub 714 during engagement with the engagement portion 712 of the applicator 700 may rotate the locking member 772 about the longitudinal axis 718 from the locked position (as represented in FIGS. 42 and 43) to the unlocked position (as represented in FIG. 47).

[0248] FIGS. 44-50 illustrate an exemplary use and deployment sequence utilizing the applicator 700 and the cartridge 740. In FIG. 44, the barrier layer or sealing layer 754 for the cartridge 740 has been removed. The cartridge housing 742 approaches the interior cavity 746 of the applicator 700 and may enter the interior cavity 746 in examples. The cartridge housing 742 may approach the interior cavity 746 such that the needle hub 714 is moved into proximity to the engagement portion 712 of the applicator 700.

[0249] The cartridge housing 742 may continue to be inserted towards the applicator 700 until the needle hub 714 engages with the engagement portion 712 of the applicator 700 and rotationally couples about the longitudinal axis 718 with the engagement portion 712 of the applicator 700. FIG. 45, for example, illustrates a side view of an engagement feature 792 entering the groove 720. The needle hub 714 may continue to be advanced axially towards the engagement portion 712 such that the engagement feature 792 slides to engage with the lock feature 724. During such movement, the needle hub 714 rotates about the longitudinal axis of the needle 716. FIG. 46 illustrates the rotated position of the needle hub 714. The engagement between the needle hub 714 and engagement portion 712 may be automatic in examples.- 48 - 4918-3494-8739PATENT - 0955-PCT01

[0250] Retention elements 800a, b that may be configured similarly as the retention elements 534b (shown in FIGS. 31 and 32) may engage the wearable housing 758 in a similar manner as discussed regarding the retention elements 534b. The retention elements 800a, b may be coupled to the needle carriage 708 in examples.

[0251] The rotation of the needle hub 714 rotates the needle 716 and the locking member 772 in examples. The needle 716 may rotate about the longitudinal axis 718 within the through-hole 768. The needle 716 may rotate relative to the analyte sensor 756 (with the analyte sensor being positioned within the channel 786). The locking member 772 may rotate to the unlocked position as represented in FIG. 47. As such, the needle 716 may be released from the wearable housing 758 and able to retract from the wearable housing 758. The retention elements 800a, b coupled to the needle carriage 708 may retain an axial position of the wearable housing 758 relative to the needle 716 until a time of retraction of the needle 716 (e.g., operation of the retraction assembly).

[0252] With the retention elements 800a, b engaging the wearable housing 758, the cartridge housing 742 may be withdrawn from the applicator 700 as represented in FIG. 48. The liner 766 may be removed from the patch 760 via the connection between the liner 766 and the cartridge housing 742.

[0253] FIG. 49 illustrates an operation of the insertion assembly to insert the analyte sensor 756 into the skin of the host. The insertion assembly may operate in a similar manner as disclosed with regard to the insertion assembly of the applicator 500. The insertion element or needle 716 may insert into the skin to guide the analyte sensor 756 into the skin. Both carriages 708, 710 may descend to a lowered position from a raised position, as discussed regarding the applicator 500. The retention elements 800a, b may release from the wearable housing 758 in a similar manner as discussed regarding the retention elements 534b.

[0254] The retraction assembly may retract the needle carriage 708 relative to the holder carriage 710 to retract the needle 716 from the skin as shown in FIG. 50. The needle 716 is in the unlocked position and able to retract relative to the wearable housing 758. The wearable housing 758 may remain coupled to the skin of the host via the patch 760. Variations in the configuration of the applicator 700 or cartridge 740 may be provided in examples.

[0255] The configuration of the cartridge 740 and / or applicator 700 disclosed in regard to FIGS. 38-50 may be utilized with a single-use or disposable applicator system in examples. For example, the applicator 700 and needle 716 in the configuration shown in FIG. 50 may be discarded after use in such a configuration. In examples, however, the cartridge 740 and / or applicator 700 may be utilized in a reusable applicator system.- 49 - 4918-3494-8739PATENT - 0955-PCT01

[0256] The applicator 700, for example, may be reusable and configured to be reset or otherwise reloaded for use to deploy another analyte sensor or other components of an on-skin sensor assembly. Thus, the applicator 700 may not be discarded after first use but may be reused to deploy one or more subsequent analyte sensors. This feature may be beneficial to reduce waste and expense associated with discarding an applicator 700 after single use.

[0257] The cartridge 740 may retain the on-skin sensor assembly and needle 716 for use with the reusable applicator 700. Each cartridge 740 may comprise a single-use or disposable cartridge for use with the reusable applicator 700. Multiple successive cartridges may be used with the applicator 700 in a similar manner as disclosed regarding the cartridge 740. The cartridge 740 may contain a relatively low number of components therein (as compared to a cartridge 432 as represented in FIG. 10). As such, a reduced number of total discarded components per cartridge 740 may be produced, which may also beneficially reduce waste and expense associated with use of the cartridge 740.

[0258] In examples, systems, apparatuses, and methods may be provided to reset or reload the applicator 700 for subsequent use (e.g., a reusable applicator). FIG. 51, for example, illustrates a perspective view of a needle removal device 810 that may be utilized in examples herein. The needle removal device 810 may include a sheath 812 for covering the used needle 716 and may include engagement features 814 for engaging and retaining with the needle locking member 772 to protect the user from harm from the used needle 716.

[0259] The sheath 812 may surround an interior cavity 816 (marked in FIG. 52 A) for the used needle 716 to be positioned within. The sheath 812 may comprise an elongate tube for extending to the used needle 716 that is coupled to the engagement portion 712 of the applicator 700. The needle removal device 810 may be configured to engage the used needle 716 and remove the used needle 716 from the engagement portion 712 of the applicator 700.

[0260] The engagement features 814 may have a variety of configurations in examples. FIG. 51 illustrates a configuration in which the engagement features 814 comprise a plurality of flanges or hooks extending radially inward from the sheath 812. The engagement features 814 may be configured to engage with the locking member 772 in examples. The engagement features 814 may be angled in a downward direction, such that the sheath 812 may be inserted upward axially along the needle 716 to extend over the upper contact surfaces of the locking member 772. The engagement features 814 may engage with the locking member 772 as represented in FIG. 52A. FIG. 52B illustrates a top view of the engagement between the engagement features 814 and the locking member 772. In such a configuration, the engagement features 814 may be able to apply a force to the needle 716 to rotate the needle - 50 - 4918-3494-8739PATENT - 0955-PCT01716 in an opposite direction of rotation, to release the needle 716 from the engagement portion 712 of the applicator 700 (e.g., release the engagement features 792 from the groove 720).

[0261] Variations in the configuration of the engagement features 814 may be provided in examples. FIG. 53, for example, illustrates a variation in which the engagement features 820 comprise screw threading configured to engage with the needle hub 714. The needle hub 714 may include corresponding screw threading for engaging with the engagement features 820. The needle removal device 822 may be rotated to engage with the needle hub 714 and then further rotated to disengage the needle hub 714 from the engagement portion 712 of the applicator 700 (e.g., release the engagement features 792 from the groove 720).

[0262] FIG. 54 illustrates a variation in which the engagement features 830 comprises a groove that seats with the engagement features 792 of the needle hub 714. The needle removal device 832 may be rotated in a reverse direction to disengage the needle hub 714 from the engagement portion 712 of the applicator 700 (e.g., release the engagement features 792 from the groove 720).

[0263] In examples, the holder carriage 710 may be configured to accommodate insertion of a needle removal device through the holder carriage 710. FIG. 55, for example, illustrates a bottom view of a lower surface of the holder carriage 710, illustrating an opening 839 for a needle removal device to pass through to engage with the needle 716 and remove the needle 716 from the engagement portion 712 of the applicator 700.

[0264] FIGS. 57 and 58 illustrate an exemplary operation of the needle removal device 810. The needle removal device 810 may be inserted axially into the interior cavity 746 to engage with the used needle 716. FIG. 58 illustrates a release and removal of the used needle 716. The needle removal device 810 may be discarded with the used needle 716 after use. In examples, reusable needle removal devices may be utilized.

[0265] Beneficially, a needle removal device 810 may provide for safe handling and disposal of a used needle, with a reduced number of overall components discarded with the application system.

[0266] FIG. 56 illustrates a perspective view of a reset device 840 that may be utilized in examples herein. The reset device 840 may be utilized to reset or reload the applicator 700 back to a configuration as represented in FIG. 37 from a configuration as represented in FIG.50. The reset device 840 may comprise a body that is configured to apply a force to a portion of the applicator 700 to reset the applicator 700. The reset device 840 may reset the insertion assembly by pressing against at least a portion of the insertion assembly. The reset device 840 may be configured to be pressed against one or more of the carriages 710, 708 to move the - 51 - 4918-3494-8739PATENT - 0955-PCT01carriages 710, 708 back to the raised position (or first position) from the lowered position (or second position) after the carriages 710, 708 have moved from the raised position to the lowered position to deploy the analyte sensor into the skin. The reset device 840, for example, may include a pressing surface 842 configured to press against one or more of the carriages 710, 708 of the applicator 700 to return the carriages 710, 708 to a raised or initial position. The pressing surface 842 may be configured to be inserted axially into the interior cavity 746 to press against one or more of the carriages 710, 708. The reset device 840 may be inserted into the interior cavity 746 in a direction opposite the direction of deployment of the analyte sensor. The portion of the reset device 840 comprising the pressing surface 842 may be configured to fit within the interior cavity 746 of the applicator 700.

[0267] In examples, the reset device 840 may include an unlock feature 844 that is configured to unlock the lock feature 726 of the applicator 700. The unlock feature 844 may allow the insertion assembly to move to the raised position from the lowered position following insertion of the analyte sensor into the skin of the host. The unlock feature 844, for example, may comprise a body for applying a force to the lock feature 726 to unlock the lock feature 726. The unlock feature 844 may be configured to deflect or displace the lock feature 726 to unlock the lock feature 726. In examples, the unlock feature 844 may comprise an elongate arm or post configured to protrude axially from the pressing surface 842. Other configurations of unlock features 844 may be utilized in examples (which may correspond to a configuration of the lock feature 726).

[0268] In examples, the holder carriage 710 may include an opening 841 (marked in FIG. 55) for the unlock feature 844 to pass through to unlock the lock feature 726.

[0269] The reset device 840 may include one or more openings 846 for portions of the carriages 710, 708 to extend through. For example, the openings 846 may be configured for the retention elements 800a, b to pass through as the reset device 840 is pressed against the carriages 710, 708. The openings 846 may be positioned on the pressing surface 842 in examples.

[0270] The reset device 840 may include an opening 848 for the needle removal device 810 to pass through. The needle removal device 810 may releasably couple to the reset device 840 and may be inserted axially into the interior cavity 746 with the reset device 840, or may be passed through the reset device 840 after insertion of the reset device 840 (or before insertion of the reset device 840). The opening 848 in the reset device 840 may serve to stabilize the needle removal device 810 upon its use and align the needle removal device 810 with the used needle 716 as desired.- 52 - 4918-3494-8739PATENT - 0955-PCT01

[0271] FIGS. 57-59 illustrate an exemplary use of the reset device 840. In FIG. 57, the reset device 840 has been inserted into the interior cavity 746 to contact and press against the holder carriage 710. The unlock feature 844 extends to contact the lock feature 726 of the applicator 700. The needle removal device 810 may extend through the opening 848 and engage with the used needle 716.

[0272] In FIG. 58, the needle removal device 810 has been withdrawn. The unlock feature 844 moves or deflects the lock feature 726 to allow the holder carriage 710 to displace axially relative to the needle carriage 708. The pressing surface 842 of the reset device 840 presses axially against the holder carriage 710 to slide the holder carriage 710 in a proximal direction (e.g., to a raised position).

[0273] FIG. 59 illustrates the continued pressure applied by the reset device 840 to move the holder carriage 710 to the initial raised position. Upon the carriages 710, 708 reaching such a position, the reset device 840 may be withdrawn. FIG. 60 illustrates a resulting position of the carriages 710, 708, with the applicator 700 in a configuration for use with a new cartridge 740.

[0274] The reset device 840, in examples, may comprise a reusable reset device that may be utilized multiple times to reset the applicator 700 (or other applicators). The reset device 840 may be a body that is separate from the cartridge 740 (which may be a single-use or disposable cartridge). In examples, the reset device 840 may be configured to be positioned upon a support surface such as a table or floor, or other form of support surface. The reset device 840 may be configured for a user or host to move the applicator 700 onto the reset device 840 to reset the applicator 700. The reset device 840, in examples, may comprise a pedestal that the applicator 700 is positioned upon to reset the applicator 700. In examples, the reset device 840 may remain static and in position to repeatedly reset the applicator 700. The reusable applicator 700 and reusable reset device 840 may be provided to the user or host as a system for repeated application of analyte sensors.

[0275] In examples, a plurality of needle removal devices 810 may be provided to the user or host as part of the system. The needle removal device 810 may be single-use or disposable, for use with the reusable reset device 840. In examples, the reusable reset device 840 may include a bin or receptacle (such as a receptacle 866 as shown in FIG. 61) for retaining the used or expended needle removal devices 810.

[0276] Other configurations may be utilized in examples. FIG. 61, for example, illustrates a variation in which the reset device 850 includes one or more motors 852 for automatically displacing and pressing the pressing surface 854 against the applicator 700 to - 53 - 4918-3494-8739PATENT - 0955-PCT01reset the applicator 700. The motors 852 may comprise piston actuators or gear actuators or other mechanisms to automatically displace the pressing surface 854 and apply force to the applicator 700 as discussed in regard to the reset device 840. A user may operate a control device 856 to provide a signal to operate the motors 852.

[0277] In examples, electronics 858 may be provided to receive a control signal and provide a signal to the motors 852 to operate. The electronics 858 may be configured to operate based on the signal received from the control device 856. In examples, a power source 860 (e.g., a battery or mains electrical plug, among other forms of power sources) may be utilized to provide power to the components of the reset device 850.

[0278] In examples, a sensor 862 may be utilized to sense when the applicator 700 is positioned on the reset device 850. The sensor 862 may operate to produce a control signal to automatically cause the motors 852 to operate. In examples the sensor 862 may serve as a safety mechanism to allow the control device 856 to only operate the motors 852 when the applicator 700 is present upon the reset device 850. In examples, the sensor 862 may comprise the control device, such that the motors 852 operate automatically upon a signal provided by the sensor 862. Various forms of sensors 862 may be utilized, including proximity sensors, pressure sensors, contact sensors, electromagnetic responsive sensors, among others.

[0279] The reset device 850 may include one or more indicators 864 for indicating when the reset device 850 is in a configuration to be operated (e.g., when the sensor 862 indicates that the applicator 700 is present). The indicators 864 may further be utilized to provide other signals on the status of the reset device 850 or applicator 700, including indicating that the applicator 700 is reset and ready to use, or that the reset device 850 is ready to use, or that the receptacle 866 is full, among other indications.

[0280] In examples, a receptacle 866 may be provided for retaining used needles 716. The used needles may be retained within a needle removal device 810 or may be dispensed from the needle removal device 810 to the receptacle 866. The user or host may empty the receptacle 866 at a desired time. The receptacle 866 may be provided as a unit with the reset device 850 in examples. In examples, a separate receptacle 866 may be utilized as part of a system herein.

[0281] The reset device 850 may be configured for reuse with the applicator 700. The reset device 850 may comprise a pedestal or table-top system that may be provided for the user for multiple uses with the reusable applicator 700.

[0282] The features of FIGS. 21-61 may be utilized solely or in combination with any example herein.- 54 - 4918-3494-8739PATENT - 0955-PCT01

[0283] Other configurations of cartridges and applicator systems may be utilized in examples.

[0284] Improvements to pre-release securement features of a cartridge 432 as shown in FIG. 9, for example, may be provided. FIG. 62 illustrates a cross sectional view of the cartridge 432 (shown in FIG. 9) in a state prior to deployment of the analyte sensor and other components of the on-skin sensor assembly (e.g., the wearable housing 466 and patch 468). The insertion element or needle 471 is shown extending through a through-hole 441 of the wearable housing 466. The assembly of carriages 470, 472, 482 are in a raised position (or first position) within the cartridge housing 464.

[0285] The upper removable cover or upper sealing layer 460 is illustrated covering the upper opening 463 of the cartridge housing 464 or upper surface of the cartridge housing 464. The lower removable cover or lower sealing layer 462 (marked in FIG. 10) covers a bottom or lower opening 465 of the cartridge 432. An interior cavity 443 of the cartridge housing 464 may be sealed (e.g., a sterile or hermetic seal) by the upper sealing layer 460 and the lower sealing layer 462 in examples.

[0286] The cartridge 432, in a configuration shown in FIG. 62, may be configured for transport or storage. For example, the cartridge 432 may comprise a sealed unit that may be shipped, transported, or otherwise distributed to a user. The cartridge 432 may be distributed with the applicator 412 in examples, or may be distributed separately in examples. The cartridge 432 may be received by a user (with the applicator 412 or separately) for use with the applicator 412. The user may remove the sealing layers 460, 462 and use the cartridge 432 with the applicator 412. The user may then dispose of the cartridge 432 after use.

[0287] As described herein, the coupler 450 may include coupling members 484, 485, and may form a latch. The coupling members 484, 485 of the coupler 450 may be in an engaged configuration (as shown in FIG. 62) during the shipping, transport, or other distribution of the cartridge 432. The coupling member 484, 485 may have a variety of forms, and may have a configuration in which the first coupling member 484 is a deflectable arm. The deflectable arm may include a support surface 445 that may rest upon the second coupling member 485. The deflectable arm may have an opening 447 that the second coupling member 485 may protrude through. For example, the deflectable arm may have a loop or closed hook configuration, with an opening 447 that the second coupling member 485 extends through.

[0288] In examples, the second coupling member 485 may comprise a ledge for engaging with the first coupling member 484. The ledge may include a support surface 449 that the first coupling member 484 contacts and rests upon. A support surface 445 of the first - 55 - 4918-3494-8739PATENT - 0955-PCT01coupling member 484 may rest upon the support surface 449 of the second coupling member 485. The second coupling member 485 may extend through the opening 447 of the first coupling member 484. Other configurations of the first coupling member 484 and second coupling member 485 may be utilized in examples.

[0289] The first coupling member 484 is in an engaged configuration with the second coupling member 485 to retain the analyte sensor in the raised position. Similarly, as represented in FIG. 15, the first coupling member 484 in the engaged configuration with the second coupling member 485 retains the insertion assembly of the applicator 412 in the raised position. For example, the first coupling member 484 in the engaged configuration with the second coupling member 485 resists a force of the driver 438 and the pressing surface 440 (marked in FIG. 8). In an example in which the driver 438 is a spring, the force may be a spring-bias force of the driver 438. The first coupling member 484 in the engaged configuration with the second coupling member 485 resists a pressing force of the insertion assembly of the applicator 412 to insert the analyte sensor into the skin of the host.

[0290] The first coupling member 484 is releasable from the second coupling member 485 to allow the analyte sensor to move to a lowered position (as represented in FIG. 16). Similarly, the first coupling member 484 is releasable from the second coupling member 485 to allow the insertion assembly to move to a lowered position (as represented in FIG. 16). The analyte sensor may be inserted into the skin of the host via the downward movement of the insertion element (e.g., needle).

[0291] The first coupling member 484 is thus preferably retained in the engaged configuration with the second coupling member 485 during shipping, transportation, or other forms of distribution (or movement) of the cartridge 432. Such a feature allows the coupler 450 to release and function at a desired time. Shocks, drop events, or other forms of accelerations or forces upon the cartridge 432 however, may occur, whether through distribution of the cartridge 432 or upon a user dropping or hitting the cartridge 432 prior to use. It is undesirable for the coupler 450 to release prior to a desired time (a premature release of the coupler 450) whether due to shocks, drops, or other forms of accelerations or forces upon the cartridge 432 or through other methods.

[0292] FIG. 63, for example, illustrates the second coupling member 485 having deformed due to forces (e.g., shocks) upon the cartridge 432. The first coupling member 484 has shifted in position relative to the second coupling member 485 and thus functionality of the coupler 450 may be reduced (or eliminated).- 56 - 4918-3494-8739PATENT - 0955-PCT01

[0293] FIG. 64 illustrates a variation in which a securement feature 451 is provided that is configured to impede movement of the first coupling member 484 relative to the second coupling member 485 to retain the first coupling member 484 in the engaged configuration with the second coupling member 485. The securement feature 451 may be provided with the cartridge 432. The securement feature 451 is configured to attach to the first coupling member 484 to retain the first coupling member 484 in the engaged configuration with the second coupling member 485. The securement feature 451 is configured to be released from the first coupling member 484 to allow the first coupling member 484 to release from the second coupling member 485.

[0294] The securement feature 451, for example, may comprise a bonding material that bonds the upper sealing layer 460 directly to the first coupling member 484. The bonding material may have a variety of forms in examples and may comprise a welding (e.g., a heat welding) of the upper sealing layer 460 to the first coupling member 484. Heat and pressure may be applied to form the welding. The upper sealing layer 460 may similarly have a bonding 453 or welding around a periphery of the sealing layer 460 to an upper surface of the cartridge housing 464. In examples, the bonding material may comprise an adhesive utilized to adhere the first coupling member 484 to the upper sealing layer 460. The bonding 453 may similarly comprise an adhesive or other form of bonding with the cartridge housing 464.

[0295] In examples, the bonding material comprising the securement feature 451 may be formed at a time that the upper sealing layer 460 is attached or laminated to the cartridge housing 464. The material of the bonding 453 may similarly be attached or laminated to the cartridge housing 464.

[0296] The bonding material comprising the securement feature 451 may be releasable, to release from the first coupling member 484 at a desired time. For example, the user may remove the upper sealing layer 460 from the cartridge housing 464 prior to use, which may release the securement feature 451 from the first coupling member 484. The first coupling member 484 accordingly may be allowed to move and release from the second coupling member 485 at a desired time via operation of the actuator in the form of actuator arm 446 (marked in FIG. 7). The actuator arm 446 may press against the first coupling member 484 to release the first coupling member 484 from the second coupling member 485 to allow the insertion assembly to move to the lowered position.

[0297] Other forms of securement features may be utilized in examples. FIGS. 65A-B illustrate a variation in which the securement feature comprises at least one body 455 configured to abut a portion of the first coupling member 484 to retain the first coupling - 57 - 4918-3494-8739PATENT - 0955-PCT01member 484 in the engaged configuration with the second coupling member 485. The at least one body 455 is configured to be moved away from the portion of the first coupling member 484 to allow the first coupling member 484 to release from the second coupling member 485.

[0298] The body 455 may comprise a wall or support surface that is configured to abut the first coupling member 484. The body 455 may be configured to be positioned on a side of the first coupling member 484 that is the side corresponding to the direction of movement of the first coupling member 484 for release of the coupler 450. As such, the body 455 impedes movement of the first coupling member 484 to release from the second coupling member 485.

[0299] In examples, the body 455 may be attached to the upper sealing layer 460. The body 455 may be attached to a surface of the sealing layer 460 that faces towards the interior cavity 443 of the cartridge housing 464. The body 455 may be positioned adjacent to the first coupling member 484 at a time that the sealing layer 460 is attached to the cartridge housing 464. The body 455 may be moved away from the first coupling member 484 at the time that the sealing layer 460 is removed from the cartridge housing 464. Other configurations of bodies may be utilized in examples.

[0300] FIG. 66, for example, illustrates a variation in which the body 457 is configured to be positioned on opposed sides of the first coupling member 484. The body 457, for example, may include a first wall 459 for being positioned on a first side of the first coupling member 484, and a second wall 461 for being positioned on a second opposite side of the first coupling member 484. The body 457 may contact at least two sides of the first coupling member 484. The body 457 may include a channel or recess 467 for the first coupling member 484 to insert into. In examples, the body 457 may have a configuration of a U-shaped cup or other shape that wraps around the first coupling member 484 on opposing sides of the first coupling member 484. The body 457 may comprise a U-shaped body configured to surround at least a portion of the first coupling member 484. The first coupling member 484 may be retained within the channel or recess 467 and impeded from release from the second coupling member 485. The body 457 may be released upon removal of the sealing layer 460, in a similar manner as the body 455. The body 457 may be positioned between the first coupling member 484 and the sealing layer 460. Other configurations of bodies may be utilized in examples. For example, the body 457 may be disconnected or free from the sealing layer 460 and precoupled to the first coupling member 484 (e.g., hung on the first coupling member 484). The body 457 may be manually removed at a desired time.- 58 - 4918-3494-8739PATENT - 0955-PCT01

[0301] In examples, the bodies of FIGS. 65A-66 may be attached to a sealing layer, or may be free from a sealing layer in examples. The sealing layer may maintain a position of the body in contact with the first coupling member.

[0302] FIGS. 67-71 illustrate a variation in which the bodies of the securement feature comprise one or more flexures or deflectable tabs 469a, b configured to abut a portion of the first coupling member 484 to retain the first coupling member 484 in the engaged configuration with the second coupling member 485. The deflectable tabs 469a, b are configured to be moved away from the first coupling member 484 to allow the first coupling member 484 to release from the second coupling member 485.

[0303] The deflectable tabs 469a, b may comprise a portion of the cartridge housing 464 or may comprise another form of component in examples. The deflectable tabs 469a, b may angle in a downward direction and towards each other to be positioned adjacent to the first coupling member 484 as shown in FIG. 67 for example. A gap 473 may be positioned between the deflectable tabs 469a, b or the deflectable tabs 469a, b may be in contact with each other in examples. The angle of the deflectable tabs 469a, b may allow for ease of movement and release of the deflectable tabs 469a, b at a desired time. FIG. 68 illustrates a position of the tab 469a relative to the first coupling member 484.

[0304] In examples, pressing surfaces of the applicator 412 or another component may be utilized to press against the deflectable tabs 469a, b to deflect and move the tabs 469a, b out of position. The cartridge housing 464 may include one or more openings 477 for receiving the pressing surfaces for applying the force to the deflectable tabs 469a, b to move the deflectable tabs 469a, b. FIG. 69 illustrates pressing surfaces 475 of the applicator 412 comprising arms configured to extend towards the upper surface of the cartridge 432. The pressing surfaces 475 may approach the tabs 469a, b as the cartridge 432 is inserted axially into the interior cavity 430 of the applicator housing 414 as shown in FIG. 70. The pressing surfaces 475 may press against the deflectable tabs 469a, b to move them to a deflected or displaced position as represented with dashed lines in FIG. 71. The pressing surfaces 475 may move the deflectable tabs 469a, b out of position to allow the first coupling member 484 to release from the second coupling member 485. In examples, other configurations of securement features may be utilized.

[0305] In examples, the pressing surfaces 475 may comprise a portion of the insertion carriage 436 utilized to press the assembly of carriages 470, 472, 482 to the lowered position, or may have another position as desired.- 59 - 4918-3494-8739PATENT - 0955-PCT01

[0306] Beneficially, the securement features may mechanically retain the coupling members in position without a need to increase a stiffness or size of the coupling members. Increasing a size of the coupling members may reduce the amount of space available within the cartridge housing. As such, improved mechanical properties and shock or acceleration resistance may result without varying the force required to release the coupling members.

[0307] The features of FIGS. 64-71 may be utilized solely or in combination with any other example herein.

[0308] Features of examples disclosed herein may be utilized solely or in combination with any other system, apparatus, or method disclosed herein.

[0309] 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, concise, 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.

[0310] 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.

[0311] 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,’- 60 - 4918-3494-8739PATENT - 0955-PCT01‘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, essential, 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. 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.

[0312] 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.

[0313] 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.

[0314] 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 - 61 - 4918-3494-8739PATENT - 0955-PCT01‘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, typically 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.’

[0315] 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.- 62 - 4918-3494-8739PATENT - 0955-PCT01

[0316] 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 described herein, but rather to also cover all modification and alternatives coming with the true scope and spirit of the invention.- 63 - 4918-3494-8739

Claims

PATENT - 0955-PCT01WHAT IS CLAIMED IS:

1. An applicator system for an on-skin wearable medical device, the system comprising: an insertion assembly configured to move from a first position to a second position to insert an analyte sensor into skin of a host;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 first position, the first coupling member being releasable from the second coupling member to allow the insertion assembly to move to the second position; anda securement feature configured to impede movement of the first coupling member relative to the second coupling member to retain the first coupling member in the engaged configuration with the second coupling member.

2. The system of claim 1, wherein the insertion assembly includes a driver configured to drive the insertion assembly from the first position to the second position.

3. The system of claim 2, wherein the driver comprises one or more springs.

4. The system of claim 2 or claim 3, wherein the first coupling member in the engaged configuration with the second coupling member resists a force of the driver.

5. The system of claim 4, wherein the force is a spring-bias force.

6. The system of any of claims 1-5, wherein the insertion assembly is configured to insert a needle into the skin of the host to insert the analyte sensor into the skin of the host.

7. The system of claim 6, further comprising a retraction assembly configured to retract the needle from the skin of the host.

8. The system of claim 7, wherein the retraction assembly is configured to automatically retract the needle from the skin of the host after insertion of the analyte sensor into the skin of the host.- 64 - 4918-3494-8739PATENT - 0955-PCT019. The system of any of claims 1-8, wherein the securement feature is configured to attach to the first coupling member to retain the first coupling member in the engaged configuration with the second coupling member, and is configured to be released from the first coupling member to allow the first coupling member to release from the second coupling member.

10. The system of any of claims 1-9, wherein the securement feature comprises at least one body configured to abut a portion of the first coupling member to retain the first coupling member in the engaged configuration with the second coupling member.

11. The system of claim 10, wherein the at least one body is configured to be moved away from the portion of the first coupling member to allow the first coupling member to release from the second coupling member.

12. The system of any of claims 1-11, further comprising an applicator housing and a cartridge configured to engage with the applicator housing, wherein the cartridge includes the securement feature.

13. The system of claim 12, further comprising the analyte sensor positioned within the cartridge.

14. The system of claim 13, further comprising an on-skin wearable housing positioned within the cartridge and being coupled to the analyte sensor, the on-skin wearable housing configured to be positioned on the skin of the host.

15. The system of any of claims 12-14, wherein the securement feature includes one or more deflectable tabs positioned on the cartridge and configured to abut a portion of the first coupling member to retain the first coupling member in the engaged configuration with the second coupling member.

16. The system of any of claims 12-15, further comprising a sealing layer coupled to the cartridge, wherein the securement feature is a bonding material that bonds the sealing layer directly to the first coupling member.

17. The system of claim 16, wherein the bonding material is an adhesive.- 65 - 4918-3494-8739PATENT - 0955-PCT0118. The system of claim 17, wherein the sealing layer is removed prior to the first coupling member being released from the second coupling member to allow the insertion assembly to move to the second position for inserting the analyte sensor.

19. The system of any of claims 12-17, further comprising a sealing layer coupled to the cartridge, wherein the securement feature is a body attached to the sealing layer and configured to abut a portion of the first coupling member to retain the first coupling member in the engaged configuration with the second coupling member.

20. The system of claim 19, wherein the sealing layer is removed prior to the first coupling member being released from the second coupling member, and wherein removal of the sealing layer removes the body to allow the insertion assembly to move to the second position for inserting the analyte sensor.

21. The system of any of claims 12-20, further comprising a sealing layer coupled to the cartridge, wherein the securement feature is a body positioned between a portion of the first coupling member and the sealing layer to retain the first coupling member in the engaged configuration with the second coupling member.

22. The system of claim 21, wherein the body is configured to contact at least two sides of the first coupling member.

23. The system of claim 21 or claim 22, wherein the body is a U-shaped body configured to surround at least a portion of the first coupling member.

24. The system of claim 23, wherein the sealing layer maintains a position of the body in contact with the first coupling member.

25. The system of claim 24, wherein the sealing layer is removed prior to the first coupling member being released from the second coupling member, and wherein removal of the sealing layer removes the body to allow the insertion assembly to move to the second position for inserting the analyte sensor.- 66 - 4918-3494-8739PATENT - 0955-PCT0126. The system of any of claims 1-25, wherein the first coupling member is a deflectable arm and the second coupling member is a ledge.

27. The system of claim 26, further comprising an actuator for pressing against the deflectable arm to release the deflectable arm from the ledge to allow the insertion assembly to move to the second position.

28. A cartridge for use with an applicator for an on-skin wearable medical device, the cartridge comprising:a cartridge housing;an analyte sensor retained by the cartridge housing, the analyte sensor configured to be moved relative to the cartridge housing from a first position to a second position to be inserted into skin of a host;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 analyte sensor in the first position, the first coupling member being releasable from the second coupling member to allow the analyte sensor to move to the second position; anda securement feature configured to impede movement of the first coupling member relative to the second coupling member to retain the first coupling member in the engaged configuration with the second coupling member.

29. The cartridge of claim 28, wherein the cartridge housing includes an opening for the analyte sensor to be deployed through.

30. The cartridge of claim 29, wherein the opening is a lower opening, and the cartridge housing includes an upper opening for receiving a portion of an insertion assembly for insertion of the analyte sensor into the skin of the host.

31. The cartridge of claim 30, wherein the first coupling member in the engaged configuration with the second coupling member is configured to resist a pressing force of the insertion assembly to insert the analyte sensor into the skin of the host.- 67 - 4918-3494-8739PATENT - 0955-PCT0132. The cartridge of any of claims 28-31, wherein the securement feature is configured to attach to the first coupling member to retain the first coupling member in the engaged configuration with the second coupling member, and is configured to be released from the first coupling member to allow the first coupling member to release from the second coupling member.

33. The cartridge of any of claims 28-32, wherein the securement feature comprises at least one body configured to abut a portion of the first coupling member to retain the first coupling member in the engaged configuration with the second coupling member.

34. The cartridge of claim 33, wherein the at least one body is configured to be moved away from the portion of the first coupling member to allow the first coupling member to release from the second coupling member.

35. The cartridge of any of claims 28-34, further comprising an on-skin wearable housing positioned within the cartridge housing and being coupled to the analyte sensor, the on-skin wearable housing configured to be positioned on the skin of the host.

36. The cartridge of claim 35, wherein the on-skin wearable housing is configured to be moved relative to the cartridge housing from the first position to the second position.

37. The cartridge of any of claims 28-36, wherein the securement feature includes one or more deflectable tabs configured to abut a portion of the first coupling member to retain the first coupling member in the engaged configuration with the second coupling member.

38. The cartridge of claim 37, wherein the cartridge housing includes one or more openings for receiving a pressing surface for applying a force to the one or more deflectable tabs to move the one or more deflectable tabs to allow the first coupling member to release from the second coupling member.

39. The cartridge of any of claims 28-38, further comprising a sealing layer coupled to the cartridge housing, wherein the securement feature is a bonding material that bonds the sealing layer to the first coupling member.- 68 - 4918-3494-8739PATENT - 0955-PCT0140. The cartridge of claim 39, wherein the bonding material is an adhesive.

41. The cartridge of claim 40, wherein the sealing layer is removed prior to the first coupling member being released from the second coupling member to allow the analyte sensor to move to the second position.

42. The cartridge of any of claims 28-41, further comprising a sealing layer coupled to the cartridge housing, wherein the securement feature is a body attached to the sealing layer and configured to abut a portion of the first coupling member to retain the first coupling member in the engaged configuration with the second coupling member.

43. The cartridge of claim 42, wherein the sealing layer is removed prior to the first coupling member being released from the second coupling member to allow the analyte sensor to move to the second position.

44. The cartridge of any of claims 28-43, further comprising a sealing layer coupled to the cartridge housing, wherein the securement feature is a body positioned between a portion of the first coupling member and the sealing layer to retain the first coupling member in the engaged configuration with the second coupling member.

45. The cartridge of claim 44, wherein the body is configured to contact at least two sides of the first coupling member.

46. The cartridge of claim 44 or claim 45, wherein the body is a U-shaped body configured to surround at least a portion of the first coupling member.

47. The cartridge of claim 46, wherein the sealing layer maintains a position of the body in contact with the first coupling member.

48. The cartridge of claim 47, wherein the sealing layer is removed prior to the first coupling member being released from the second coupling member, and wherein removal of the sealing layer removes the body to allow the analyte sensor to move to the second position.- 69 - 4918-3494-8739PATENT - 0955-PCT0149. The cartridge of any of claims 28-48, wherein the first coupling member is a deflectable arm and the second coupling member is a ledge.

50. An on-skin wearable system comprising:an analyte sensor configured to be inserted into skin of a host;a wearable housing coupled to the analyte sensor and configured to be worn on the skin of the host, the wearable housing including a through-hole;a needle extending through the through-hole of the wearable housing and configured to guide the analyte sensor into the skin of the host, the needle extending along a longitudinal axis; anda needle hub coupled to the needle, the needle hub configured to be rotationally coupled about the longitudinal axis of the needle with an engagement portion of an applicator for the analyte sensor.

51. The system of claim 50, further comprising a cartridge retaining the analyte sensor, the wearable housing, the needle, and the needle hub.

52. The system of claim 51, wherein the cartridge includes an opening covered with a sealing layer for the cartridge.

53. The system of claim 51 or claim 52, wherein the wearable housing includes a lower surface, and wherein the system further comprises a patch and a liner, the patch having an upper surface coupled to the lower surface of the wearable housing and the patch having a lower surface configured to attach to the skin of the host, and the liner covering the lower surface of the patch.

54. The system of claim 53, wherein the cartridge is coupled to the liner such that a withdrawal movement of the wearable housing from the cartridge at least partially removes the liner from the patch.

55. The system of any of claims 50-54, wherein the needle hub is configured to rotate about the longitudinal axis of the needle to rotationally couple with the engagement portion of the applicator.- 70 - 4918-3494-8739PATENT - 0955-PCT0156. The system of any of claims 50-55, wherein the needle is configured to rotate about the longitudinal axis of the needle within the through-hole.

57. The system of any of claims 50-56, further comprising a locking member configured to rotate about the longitudinal axis of the needle from a locked position to an unlocked position, the needle being locked to the wearable housing when the locking member is in the locked position and being removable from the wearable housing when the locking member is in the unlocked position.

58. The system of claim 57, wherein the locking member comprises an elongate body, wherein the wearable housing includes an elongate slot, and wherein the elongate body is aligned with the elongate slot in the unlocked position and is rotationally offset from the elongate slot in the locked position.

59. The system of claim 57 or claim 58, wherein the needle hub is configured to rotate the locking member about the longitudinal axis from the locked position to the unlocked position when the needle hub rotates about the longitudinal axis.

60. The system of any of claims 50-59, wherein the needle hub includes one or more engagement features for rotational engagement with a groove in the engagement portion of the applicator.

61. The system of claim 60, wherein the engagement features include one or more protrusions.

62. The system of claim 60 or claim 61, wherein the groove is an angled cam groove.

63. The system of any of claims 50-62, wherein the engagement portion includes a lock feature for locking the needle hub to the engagement portion.

64. The system of claim 63, wherein the lock feature includes a notch in the engagement portion of the applicator.- 71 - 4918-3494-8739PATENT - 0955-PCT0165. The system of any of claims 50-64, wherein the needle includes an elongate channel for receiving the analyte sensor, and wherein the needle is configured to rotate about the longitudinal axis relative to the analyte sensor.

66. The system of any of claims 50-65, further comprising the applicator.

67. The system of claim 66, wherein the applicator is a reusable applicator.

68. The system of claim 66 or claim 67, wherein the applicator includes one or more carriages configured to move from a raised position to a lowered position to deploy the analyte sensor into the skin of the host, and wherein the system further comprises a reset device configured to be pressed against the one or more carriages to move the one or more carriages back to the raised position from the lowered position after the one or more carriages have moved from the raised position to the lowered position to deploy the analyte sensor into the skin.

69. The system of claim 68, wherein the applicator includes an interior cavity for the analyte sensor to be deployed from, and the reset device is configured to be inserted into the interior cavity in a direction opposite a direction of deployment of the analyte sensor.

70. The system of any of claims 50-69, further comprising a needle removal device configured to engage the needle after it has been used for at least partial insertion into the skin of the host and to remove the used needle from the engagement portion of the applicator.

71. The system of claim 70, wherein the needle removal device is configured to mount to a reset device configured to be pressed against a portion of the applicator to reset an insertion assembly of the applicator.

72. An applicator system for an on-skin wearable medical device, the system comprising: a cartridge retaining an analyte sensor for insertion into skin of a host;an applicator for the analyte sensor, the applicator including an insertion assembly configured to move from a raised position to a lowered position to insert the analyte sensor into the skin of the host; and- 72 - 4918-3494-8739PATENT - 0955-PCT01a reusable reset device configured to apply a force against at least a portion of the applicator to reset the insertion assembly to the raised position from the lowered position following insertion of the analyte sensor into the skin of the host.

73. The applicator system of claim 72, wherein the applicator includes an interior cavity for the analyte sensor to be positioned within, and the reusable reset device is configured to be inserted into the interior cavity to reset the insertion assembly to the raised position from the lowered position.

74. The applicator system of claim 73, wherein the applicator is configured to deploy the analyte sensor from the interior cavity to the skin of the host in a first direction, and the reusable reset device is configured to insert into the interior cavity in a second direction that is opposite the first direction to reset the insertion assembly.

75. The applicator system of any of claims 72-74, wherein the reusable reset device includes a pressing surface for pressing against at least a portion of the insertion assembly to reset the insertion assembly.

76. The applicator system of any of claims 72-75, wherein the applicator includes a lock feature for locking the insertion assembly in the lowered position following insertion of the analyte sensor into the skin of the host, and the reusable reset device includes an unlock feature for unlocking the lock feature to allow the insertion assembly to move to the raised position from the lowered position following insertion of the analyte sensor into the skin of the host.

77. The applicator system of claim 76, wherein the unlock feature includes a body for applying a force to the lock feature to unlock the lock feature.

78. The applicator system of any of claims 72-77, further comprising a needle, and wherein the applicator is configured to insert the needle into the skin of the host to guide the analyte sensor into the skin of the host, and the applicator system further comprises a needle removal device configured to engage with the used needle to withdraw the used needle from the applicator.- 73 - 4918-3494-8739PATENT - 0955-PCT0179. The applicator system of claim 78, wherein the needle removal device includes a sheath for covering the used needle.

80. The applicator system of claim 78 or claim 79, wherein the applicator includes an interior cavity for the analyte sensor to be positioned within, and the needle removal device is configured to be inserted into the interior cavity to engage with the used needle.

81. The applicator system of any of claims 78-80, wherein the needle removal device is configured to releasably couple with the reusable reset device.

82. The applicator system of any of claims 72-81, wherein the insertion assembly includes at least one carriage for moving from the raised position from the lowered position to insert the analyte sensor into the skin of the host.

83. The applicator system of any of claims 72-82, further comprising a needle, and wherein the applicator is configured to insert the needle into the skin of the host to guide the analyte sensor into the skin of the host, and wherein the applicator includes a retraction assembly configured to retract the needle from the skin of the host.

84. The applicator system of any of claims 72-83, wherein the reusable reset device includes a body that is separate from the cartridge.

85. The applicator system of any of claims 72-84, wherein the cartridge retains a needle and an on-skin wearable housing, the needle being configured to guide the analyte sensor into the skin of the host, and the on-skin wearable housing being coupled to the analyte sensor.

86. The applicator system of claim 85, wherein the needle extends along a longitudinal axis, and the cartridge retains a needle hub coupled to the needle, the needle hub configured to be rotationally coupled about the longitudinal axis of the needle with an engagement portion of the applicator.

87. A needle hub and an on-skin sensor assembly, wherein the needle hub is configured to apply the on-skin sensor assembly to a skin of a host, the needle hub comprising:a central body; and- 74 - 4918-3494-8739PATENT - 0955-PCT01one or more engagement features for rotational engagement with a groove in an engagement portion of an applicator for applying the on-skin sensor assembly.

88. The needle hub and on-skin sensor assembly of claim 87, wherein the engagement portion includes a lock feature for locking the needle hub to the engagement portion.

89. The needle hub and on-skin sensor assembly of claim 87 or claim 88, wherein the groove is an angled cam groove.

90. The needle hub and on-skin sensor assembly of any one of claims 87-89, wherein the needle hub is configured to be rotationally coupled about a longitudinal axis of a needle with the engagement portion of the applicator.

91. The needle hub and on-skin sensor assembly of any one of claims 87-90, wherein the needle hub is configured to rotate a locking member about the longitudinal axis from the locked position to the unlocked position when the needle hub rotates about the longitudinal axis.

92. A needle assembly comprising the needle hub and on-skin sensor assembly of any one of claims 87-91; and a needle coupled to the needle hub.

93. The needle assembly of claim 92, wherein the needle extends through a through-hole of a housing of the on-skin sensor assembly and is configured to guide an analyte sensor into the skin of the host, and wherein the needle extends along a longitudinal axis.

94. The needle assembly of claim 93, further comprising a locking member.

95. The needle assembly of claim 94, wherein the locking member is coupled to the needle.

96. The needle assembly of claim 94 or claim 95, wherein the locking member comprises an elongate body shaped to align with a shape of a through-hole of a housing of the on-skin sensor assembly.

97. A reusable reset device for an applicator of an analyte sensor, comprising:- 75 - 4918-3494-8739PATENT - 0955-PCT01a pressing surface for pressing against at least a portion of an insertion assembly of the applicator to reset the insertion assembly.

98. The reusable reset device of claim 97, further comprising: an unlock feature for unlocking a lock feature of the applicator to allow the insertion assembly to move to a raised position from a lowered position following insertion of the analyte sensor into skin of a host.

99. The reusable reset device of claim 97 or claim 98, wherein the reusable reset device is configured to apply a force against at least a portion of the applicator to reset the insertion assembly to a raised position from a lowered position following insertion of the analyte sensor into skin of a host.

100. The reusable reset device of any one of claims 97-99, wherein the reusable reset device is configured to be inserted into an interior cavity of the applicator to reset the insertion assembly to a raised position from a lowered position.

101. The reusable reset device of claim 100, wherein the reusable reset device is configured to insert into the interior cavity in a direction that is opposite an insertion direction to reset the insertion assembly.

102. A reusable applicator system for an analyte sensor, comprising:a reusable applicator for insertion of the analyte sensor into skin of a host; and a disposable cartridge configured to be coupled to the reusable applicator for use in insertion of the analyte sensor into the skin of the host, wherein the disposable cartridge is configured to be removed from the reusable applicator after insertion of the analyte sensor into the skin of the host, and wherein the disposable cartridge is configured to retain within an interior of the disposable cartridge: the analyte sensor; a wearable housing coupled to the analyte sensor and configured to be worn on the skin of the host, a needle extending through a through-hole of the wearable housing and configured to guide the analyte sensor into the skin of the host, and a needle hub coupled to the needle.

103. The reusable applicator system of claim 102, further comprising: a sealing layer covering an opening into the interior of the disposable cartridge.- 76 - 4918-3494-8739PATENT - 0955-PCT01104. The reusable applicator system of claim 102 or claim 103, wherein the reusable applicator comprises one or more carriages configured to move from a raised position to a lowered position to deploy the analyte sensor into the skin of the host.

105. The reusable applicator system of claim 104, further comprising: a reset device configured to be pressed against the one or more carriages to move the one or more carriages back to the raised position from the lowered position after the one or more carriages have moved from the raised position to the lowered position to deploy the analyte sensor into the skin of the host.

106. The reusable applicator system of claim 104 or claim 105, wherein the one or more carriages comprises a needle carriage configured to be coupled with the needle hub of the disposable cartridge.- 77 - 4918-3494-8739

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