Apparatuses, systems, and methods for adapters for medical devices

Abstract

Examples of the invention relate generally to apparatuses, systems, and methods for deploying a medical device to the skin of a host. The medical device may include a transdermal analyte sensor applied to the skin of the host. The apparatus, system, and method may include an adapter body for interfacing with at least a portion of an on-skin wearable medical device and an applicator of the on-skin wearable medical device.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 436,527, filed December 31, 2022, the entire contents of which are incorporated herein by reference. Background Art Technical Field

[0003] Medical device apparatus, systems, and methods are provided. More particularly, apparatus, systems, and methods are provided for an adapter for a medical device that may include a transcutaneous analyte sensor for deployment to the skin of a host.

[0004] Related technical notes

[0005] Diabetes mellitus is a disease in which the pancreas does not produce enough insulin (Type 1 or insulin-dependent) and / or is insulin-ineffective (Type 2 or non-insulin-dependent). In the diabetic state, patients suffer from high blood sugar levels, which can cause a range of physiological disturbances associated with the degeneration of small blood vessels, such as kidney failure, skin ulcers, or vitreous hemorrhages in the eyes. Hypoglycemic reactions (low blood sugar) can be induced by an accidental overdose of insulin or after normal doses of insulin or glucose-lowering agents accompanied by strenuous exercise or inadequate food intake.

[0006] Traditionally, people with diabetes wear self-monitoring of blood glucose (SMBG) monitors, which typically require an uncomfortable finger prick. Due to this lack of comfort and convenience, people with diabetes typically only measure their blood glucose levels two to four times a day. Unfortunately, these intervals are so far apart that people with diabetes may not notice hyperglycemia or hypoglycemia until it is too late, sometimes leading to dangerous side effects. Alternatively, glucose levels can be continuously monitored using a measurement system that includes an on-skin sensor assembly. The sensor assembly can have a wireless transmitter that transmits the measurement data to a receiver that can process and display information based on the measurement results.

[0007] The applicator can be used to deploy the on-skin sensor assembly to a person. The application process should cause the on-skin sensor assembly to be attached to the patient in a state capable of sensing analyte (e.g., glucose) level information, transmitting the sensed data to the transmitter, and transmitting the analyte level information to the receiver.

[0008] Exemplary systems are disclosed, for example, in U.S. Patent Publication No. 2014 / 0088389, U.S. Patent Publication No. 2013 / 0267813, and U.S. Patent Publication No. 2018 / 0368771, which are owned by the assignee of the present application and are incorporated herein by reference in their entirety.

[0009] This background technology is provided to introduce a brief context for the following summary and detailed description. This background is not intended to help determine the scope of the claimed subject matter, nor is it to be considered to limit the claimed subject matter to specific implementations that solve any or all of the disadvantages or problems presented above. Summary of the Invention

[0010] The systems and methods of the present invention relate to apparatus, systems, and methods for medical devices. More specifically, apparatus, systems, and methods are provided for an adapter for a medical device that may include a transcutaneous analyte sensor for deployment to the skin of a host. Various examples of the apparatus, systems, and methods of the present invention may have several features, no single one of which is solely responsible for their desired properties. Without limiting the scope of the examples of the present invention as expressed by the appended claims, their more prominent features will now be briefly discussed. After considering this discussion, and particularly after reading the section entitled "Detailed Description of the Invention," it will be understood how the features of the examples of the present invention provide the advantages described herein.

[0011] In a first aspect, an apparatus includes an adapter body configured to interface between at least a portion of a skin-wearable medical device and an applicator of the skin-wearable medical device.

[0012] Specific implementations of the embodiments may include one or more of the following. The adapter body may be configured to interface between at least a portion of the skin-wearable medical device having a first configuration and a portion of the applicator configured to engage at least a portion of the skin-wearable medical device with a second configuration different from the first configuration. The second configuration may differ from the first configuration in one or more of shape or size. The at least portion having the first configuration may be a first skin-wearable medical device, and the skin-wearable medical device having at least a portion with the second configuration may be a second skin-wearable medical device, the first configuration including a configuration of a first wearable shell of the first skin-wearable medical device, and the second configuration including a configuration of a second wearable shell of the second skin-wearable medical device. The skin-wearable medical device having at least a portion with the first configuration may be the same skin-wearable medical device having at least a portion with the second configuration. The skin-wearable medical device may be a first skin-wearable medical device, and the adapter body may be configured to interface between a wearable shell of the first skin-wearable medical device that is smaller than a wearable shell of the second skin-wearable medical device that the applicator is configured to engage. The wearable housing of the first skin-wearable medical device may have a smaller diameter or a smaller height than the wearable housing of the second skin-wearable medical device. The adapter body may be configured to adapt at least a portion of the skin-wearable medical device to mate with the engagement portion of the applicator. The adapter body may include a retaining area for receiving at least a portion of the skin-wearable medical device. The adapter body may include a cavity for receiving at least a portion of the skin-wearable medical device. The adapter body may include one or more walls defining a retaining area for receiving at least a portion of the skin-wearable medical device. The one or more walls may include one or more side walls defining the retaining area. The one or more side walls may include an inner surface and an outer surface, the inner surface configured to face the portion of the skin-wearable medical device and the outer surface configured to face opposite the inner surface. The one or more side walls may have a spacing between the inner surface and the outer surface, the spacing configured to separate the outer surface of the skin-wearable medical device from the outer surface of the one or more side walls. The spacing may be configured to adapt at least a portion of the skin-wearable medical device to mate with the engagement portion of the applicator. The inner surface of the one or more side walls may form an inner perimeter having a different contour than the outer perimeter formed by the outer surface of the one or more side walls. The inner surface of the one or more side walls may form an inner perimeter having a smaller diameter than an outer perimeter formed by the outer surface of the one or more side walls. The one or more walls may include an upper wall defining a retention area. The upper wall may include an inner surface and an outer surface, the inner surface being configured to face the portion of the wearable medical device on the skin, and the outer surface being configured to face opposite the inner surface.The upper wall may have a spacing between the inner and outer surfaces, the spacing configured to separate the outer surface of the skin-wearable medical device from the outer surface of the upper wall. The spacing may be configured to adapt at least a portion of the skin-wearable medical device to mate with an engagement portion of the applicator. One or more stabilizers may be configured to stabilize at least a portion of the skin-wearable medical device within the retention region. The one or more stabilizers may include one or more protrusions configured to contact at least a portion of the skin-wearable medical device. The adapter body may include a ring extending around the retention region for receiving at least a portion of the skin-wearable medical device. The adapter body may include a retainer portion for retaining at least a portion of the skin-wearable medical device to the adapter body. One or more device couplers may be configured to couple the skin-wearable medical device to the adapter body. The one or more device couplers may include an adhesive. The one or more device couplers may include one or more protrusions or recesses configured to engage at least a portion of the skin-wearable medical device. The one or more device couplers may be configured to deflect. The one or more device couplers may include a releasable coupler configured to release the skin-wearable medical device from the adapter body. One or more device couplers may include one or more arms. The one or more arms may define a retaining area for receiving at least a portion of a skin-wearable medical device. The one or more arms may be configured to deflect radially outward from the retaining area for receiving at least a portion of the skin-wearable medical device. The adapter body may include one or more support portions configured to support the one or more device couplers in a coupled configuration with at least a portion of the skin-wearable medical device. The one or more support portions may include one or more contact surfaces of the adapter body. The one or more support portions may include one or more hooks. The one or more applicator couplers may be configured to couple the adapter body to at least a portion of an applicator. The one or more applicator couplers may include one or more protrusions or recesses configured to engage at least a portion of the applicator. The adapter body may include a pop-up portion configured to allow at least a portion of the skin-wearable medical device to be ejected from the adapter body. The pop-up portion may include one or more openings in a surface of the adapter body. The skin-wearable medical device may include a transcutaneous analyte sensor, and the adapter body may be configured to be positioned within a housing of the applicator. The adapter body may include an activation body configured to electrically activate the skin-wearable medical device. The activation body may include a magnet. The adapter body may include one or more walls defining a holding area for receiving at least a portion of the wearable medical device on the skin, and the activation body may be disposed on at least one of the one or more walls. The one or more walls may include an upper wall defining the holding area, and the activation body may be disposed on the upper wall.

[0013] In a second aspect, a system includes: an applicator of an on-skin wearable medical device; and an adapter body configured to interface between at least a portion of the on-skin wearable medical device and the applicator of the on-skin wearable medical device.

[0014] Specific implementations of the embodiments may include one or more of the following. The applicator may include an engagement portion configured to engage an adapter body. The engagement portion may be configured to engage an outer surface of the adapter body. The skin-wearable medical device may be a first skin-wearable medical device, and the engagement portion is configured to engage a second skin-wearable medical device having a different configuration than the first skin-wearable medical device. The first skin-wearable medical device may have a wearable housing having a smaller diameter or a smaller height than the wearable housing of the second skin-wearable medical device. The skin-wearable medical device may be a first skin-wearable medical device having a first wearable housing, and the engagement portion is sized to fit a second wearable housing of the second skin-wearable medical device, the second wearable housing having a larger diameter or a larger height than the first wearable housing. The adapter body may be configured to adapt at least a portion of the skin-wearable medical device to fit the engagement portion of the applicator. The adapter body may include a retaining area for receiving at least a portion of the skin-wearable medical device. The adapter body may include a cavity for receiving at least a portion of the skin-wearable medical device. The adapter body may include one or more walls defining a retaining area for receiving at least a portion of the skin-wearable medical device. The applicator may include an engagement portion configured to engage at least a portion of the one or more walls. The adapter body may include one or more device couplers for coupling the skin-wearable medical device to the adapter body. The one or more device couplers may include a releasable coupler configured to release the skin-wearable medical device from the adapter body. The adapter body may include one or more support portions configured to support the one or more device couplers in a coupled configuration with at least a portion of the skin-wearable medical device; and the applicator may include one or more contact surfaces configured to abut the one or more support portions. The one or more support portions may include one or more hooks. The one or more contact surfaces may include at least one post configured to engage the one or more hooks, the at least one post configured to retract from the one or more hooks to allow the one or more device couplers to be detached from at least a portion of the skin-wearable medical device. The applicator may be configured such that the at least one post retracts during needle retraction to guide the transcutaneous analyte sensor into the skin of the host. The adapter body may include a pop-up portion configured to allow at least a portion of the skin-wearable medical device to be popped out of the adapter body; and the applicator may include a pop-up actuator configured to eject the skin-wearable medical device from the adapter body. The skin-wearable medical device may include a coupling mismatch with the applicator. The skin-wearable medical device may have a wearable housing having a configuration that differs from a configuration of the wearable housing with which the engagement portion of the applicator is configured to mate.The wearable housing of the on-skin wearable medical device may have a smaller diameter or a smaller height than a configuration of the wearable housing with which the engagement portion of the applicator is configured to mate. The on-skin wearable medical device may include a transcutaneous analyte sensor. The adapter body may include an activation body for electrically activating the on-skin wearable medical device. The activation body may include a magnet.

[0015] In a third aspect, a method includes applying a skin-wearable medical device to skin of a host using an applicator, with an adapter body interfacing between at least a portion of the skin-wearable medical device and the applicator.

[0016] Specific implementations of the embodiments may include one or more of the following. The skin-wearable medical device may include a coupling mismatch with the applicator. The adapter body may adapt at least a portion of the skin-wearable medical device to mate with an engagement portion of the applicator. The skin-wearable medical device may be a first skin-wearable medical device, and the applicator may have an engagement portion configured to engage a second skin-wearable medical device having a different configuration than the first skin-wearable medical device. The engagement portion may be configured to engage a wearable housing of the second skin-wearable medical device, the wearable housing having a larger diameter or a greater height than the wearable housing of the first skin-wearable medical device. The method may include releasing the skin-wearable medical device from the adapter body. The method may include releasing the skin-wearable medical device from the adapter body using one or more releasable couplings. The method may include retaining the adapter body to the applicator after releasing the skin-wearable medical device from the adapter body. The skin-wearable medical device may include a transcutaneous analyte sensor. The method may include introducing the transcutaneous analyte sensor into the skin of the host using an insertion element of the applicator. The method may further include electrically activating the on-skin wearable medical device using an activation body disposed on the adapter body. The activation body may include a magnet. Electrically activating the on-skin wearable medical device may include activating the on-skin wearable medical device from a lower power state to a higher power state. Electrically activating the on-skin wearable medical device may include increasing a distance between the on-skin wearable medical device and the activation body. The adapter body may include one or more walls defining a holding area for receiving at least a portion of the on-skin wearable medical device, and the activation body may be disposed on at least one of the one or more walls.

[0017] In other aspects and embodiments, the above methods and features of each aspect are formulated according to a system as in each aspect, the system having an applicator configured to perform the method features. Any of the features of the embodiments of any of these aspects (including but not limited to any embodiment of any of the first to third aspects above) can be applied to all other aspects and embodiments identified herein, including but not limited to any embodiment of any of the first to third aspects above. In addition, any of the features of the embodiments of each aspect (including but not limited to any embodiment of any of the first to third aspects above) can be independently, partially or completely combined with other embodiments described herein in any manner, for example, one, two or three or more embodiments can be combined as a whole or in part. In addition, any of the features of the embodiments of each aspect (including but not limited to any embodiment of any of the first to third aspects above) can be optional for other aspects or embodiments. Any aspect or embodiment of the method can be performed by a system or device of another aspect or embodiment, and any aspect or embodiment of the system or device can be configured to perform the method of another aspect or embodiment (including but not limited to any embodiment of any of the first to third aspects above).

[0018] This summary is intended to introduce a series of concepts in a simplified form. These 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 required. This summary is not intended to identify the key features or essential features of the claimed subject matter, nor is it intended to serve as an aid in determining the scope of the claimed subject matter. The claimed subject matter is not limited to specific implementations that address any or all of the shortcomings mentioned in any part of this disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] These and other features, aspects and advantages are described below with reference to the accompanying drawings, which are intended to illustrate rather than limit the present disclosure. In the drawings, like reference numerals consistently represent corresponding features in like examples.

[0020] Figure 1 A schematic diagram of a continuous analyte sensor system is shown.

[0021] Figure 2A Shown is a top perspective assembled view of the on-skin sensor assembly.

[0022] Figure 2B Shown in assembled state Figure 2A Bottom perspective view of the on-skin sensor assembly.

[0023] Figure 2CShown in assembled state Figure 2A Top perspective view of the on-skin sensor assembly.

[0024] Figure 3 Shown is a perspective assembled view of the on-skin sensor assembly.

[0025] Figure 4 A perspective view of the on-skin sensor assembly is shown.

[0026] Figure 5 A perspective view of an applicator system for an on-skin sensor assembly of an analyte sensor system is shown.

[0027] Figure 6 Shown Figure 5 Exploded perspective view of the applicator system.

[0028] Figures 7 to 9 shows the Figure 5 The section line A-A' is taken Figure 5 and Figure 6 Several cross-sectional views of the applicator system.

[0029] Figures 10 to 12 shows the Figure 5 The section line BB' is taken Figure 5 and Figure 6 Several cross-sectional views of the applicator system.

[0030] Figure 13 and Figure 14 Shown Figure 5 and Figure 6 An enlarged view of some features of the applicator system.

[0031] Figure 15 and Figure 16 Shown Figure 5 and Figure 6 An enlarged view of some features of the applicator system.

[0032] Figure 17 Shown Figure 5 and Figure 6 A perspective, partial cutaway view of the needle carrier assembly, hub, and on-skin sensor assembly of an applicator system of FIG.

[0033] Figure 18 Shown Figure 5 and Figure 6 Cross-sectional view of the hub and on-skin sensor assembly of the applicator system.

[0034] Figure 19 Show Figure 5 and Figure 6 Top view of a portion of the needle carrier assembly and hub.

[0035] Figure 20A and Figure 20B A perspective view of a locking feature of a needle used in an applicator of an analyte sensor system is shown.

[0036] Figures 21 to 23 Several cross-sectional views of yet another applicator for an on-skin sensor assembly of an analyte sensor system are shown, along with various features and operating positions.

[0037] Figure 24 Shown Figures 21 to 23 A perspective view of various features of the applicator system.

[0038] Figure 25 A cross-sectional view of a system according to some examples is shown.

[0039] Figures 26A to 26B Schematic cross-sections of analyte sensors with and without intervening elements are shown.

[0040] Figure 27 A perspective view of the housing of the on-skin sensor assembly is shown.

[0041] Figure 28 A perspective view of the housing of the on-skin sensor assembly is shown.

[0042] Figure 29A An upper perspective view of the adapter is shown.

[0043] Figure 29B Shown Figure 29A A lower perspective view of the adapter is shown.

[0044] Figure 29C Shows positioning of the sensor assembly on the skin Figure 29A A top view of the adapter is shown.

[0045] Figure 30A Shown is a device coupled to an applicator Figure 29A A perspective view of the adapter is shown.

[0046] Figure 30B A sensor assembly coupled to an applicator and to the skin is shown. Figure 29A A perspective view of the adapter is shown.

[0047] Figure 30C A perspective detail view of the device coupling of the adapter is shown.

[0048] Figure 30D Shown Figure 30B A perspective view of the proximal movement of the adapter and on-skin sensor assembly is shown.

[0049] Figure 30E A perspective view showing the retraction of the engagement portion of the applicator.

[0050] Figure 30F Shown Figure 30A A perspective view of the adapter is shown with the on-skin sensor assembly released from the adapter.

[0051] Figure 30G Shown Figure 29A A perspective detail of the applicator coupling of the adapter is shown.

[0052] Figure 31A A top view of the adapter is shown.

[0053] Figure 31B Shows positioning of the sensor assembly on the skin Figure 31A A top view of the adapter is shown.

[0054] Figure 31C Shows positioning of the sensor assembly on the skin Figure 31A Bottom view of the adapter shown.

[0055] Figure 31D Shows positioning of the sensor assembly on the skin Figure 31A A top view of the adapter is shown with the device coupler in the closed position.

[0056] Figure 31E Shows positioning of the sensor assembly on the skin Figure 31A A bottom view of the adapter is shown with the device coupler in the closed position.

[0057] Figure 32A Shown is a sensor assembly positioned on the skin and coupled to an applicator. Figure 31A End view of the adapter shown.

[0058] Figure 32B Shown is a device coupled to an applicator Figure 31A A perspective view of the adapter is shown.

[0059] Figure 32C An end view showing the retraction of the engagement portion of the applicator.

[0060] Figure 32D A perspective detail view showing the release of the device coupler from the on-skin sensor assembly.

[0061] Figure 32E Shows that Figure 31A End view of the on-skin sensor assembly released by the adapter shown.

[0062] Figure 33AShown is a top view of the adapter positioned on the on-skin sensor assembly.

[0063] Figure 33B Shows positioning of the sensor assembly on the skin Figure 33A Bottom view of the adapter shown.

[0064] Figure 33C Shown is the sensor assembly separated from the skin Figure 33A Bottom view of the adapter shown.

[0065] Figure 34A Shown is a device coupled to an applicator Figure 33A A perspective view of the adapter is shown.

[0066] Figure 34B Shown Figure 33B A perspective view of the proximal movement of the adapter and on-skin sensor assembly is shown.

[0067] Figure 34C Shown Figure 33A A perspective view of the adapter is shown with the on-skin sensor assembly released from the adapter.

[0068] Figure 34D Shown is a sensor assembly coupled to the skin and positioned within an applicator. Figure 34A A side cutaway view of the adapter is shown.

[0069] Figure 34E Shown is positioned within the applicator Figure 34A A side cutaway view of the adapter is shown.

[0070] Figure 34F A perspective view of a portion of an applicator is shown.

[0071] Figure 35A A top view of the adapter is shown.

[0072] Figure 35B Shown Figure 35A Bottom perspective view of the adapter shown.

[0073] Figure 35C Shows positioning of the sensor assembly on the skin Figure 35A A top view of the adapter is shown.

[0074] Figure 35D Shows positioning of the sensor assembly on the skin Figure 35A Bottom view of the adapter shown.

[0075] Figure 35E Shown is a sensor assembly positioned on the skin and coupled to an applicator. Figure 35A Bottom view of the adapter shown.

[0076] Figure 35F Shown is a sensor assembly positioned on the skin and coupled to an applicator. Figure 35A A perspective view of the adapter is shown.

[0077] Figure 35G Shows the contact of the applicator Figure 35A A detailed perspective view of the contact surface of the support portion of the adapter is shown.

[0078] Figure 36A A perspective view of the adapter is shown.

[0079] Figure 36B A perspective view of the on-skin sensor assembly is shown.

[0080] Figure 36C Shown Figure 36A The adapter is shown in the holding area Figure 36B A perspective view of the on-skin sensor assembly is shown.

[0081] Figure 37 Shown is the on-skin sensor assembly within the adapter's retention area along Figure 36C Cross-sectional view along line CC'.

[0082] Figure 38 A perspective view of the engagement portion of the applicator is shown.

[0083] Figure 39A Shown is connected to Figure 36A A cross-sectional view of the engagement portion of the applicator of the adapter is shown.

[0084] Figure 39B Shown from Figure 36A A cross-sectional view of the engagement portion of the applicator with the adapter released is shown.

[0085] Figure 39C Shows the release of the sensor assembly from the skin Figure 36A A cross-sectional view of the adapter is shown.

[0086] Figure 40 A perspective view of an adapter body shown with an on-skin sensor assembly is shown.

[0087] Figure 41 Shown Figure 40 The adapter body and on-skin sensor assembly are shown along Figure 40 A side sectional view taken along line D-D'. DETAILED DESCRIPTION

[0088] The following description shows some examples of the present disclosure in detail. Those skilled in the art will recognize that the scope of the present disclosure encompasses many variations and modifications of the present invention. Therefore, the description of specific examples should not be considered to limit the scope of the present disclosure.

[0089] Figure 1 is a diagram depicting an example medical device system according to examples herein. In an example, the medical device system can include a continuous analyte monitoring system 100. The continuous analyte monitoring system 100 can include an analyte sensor system 102 including an on-skin sensor assembly 160 configured to be secured to the skin of a host via a base (not shown).

[0090] In an example, other forms of medical device systems may be utilized, including other forms of monitoring systems, drug delivery systems, or other therapeutic systems. In an example, a skin-wearable medical device may be utilized, which may include an on-skin sensor assembly or a drug delivery medical device, as well as other forms of skin-wearable medical devices.

[0091] like Figure 1As shown, according to certain aspects of the present disclosure, the analyte sensor system 102 can be operably connected to a host and a plurality of display devices 110-114. Example display devices 110-114 may include computers such as smart phones, smart watches, tablet computers, laptop computers and desktop computers. In some examples, the display devices 110-114 may be Apple Watch, iPhone and iPad manufactured by Apple Inc., or iOS, Windows or Android operating system devices. It should be noted that, alternatively or in addition to being a display device, the display device 114 can be a drug delivery device, which can cooperate with the analyte sensor system 102 to deliver the drug to the host. The analyte sensor system 102 may include a sensor electronics module 140 and a continuous analyte sensor 138 associated with the sensor electronics module 140. The sensor electronics module 140 can directly communicate wirelessly with one or more display devices in the plurality of display devices 110-114 via a wireless communication signal. As will be discussed in more detail below, the display devices 110-114 can also communicate with each other and / or with the analyte sensor system 102 through each other. For ease of reference, wireless communication signals from the analyte sensor system 102 to the display devices 110-114 can be referred to as "uplink" signals 128. Wireless communication signals from, for example, the display devices 110-114 to the analyte sensor system 102 can be referred to as "downlink" signals 130. Wireless communication signals between two or more of the display devices 110-114 can be referred to as "crosslink" signals 132. In addition, the wireless communication signals can include data transmitted by one or more of the 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 the remote servers 190.

[0092] exist Figure 1In the example shown, one of the plurality of display devices may be a customized display device 111 specifically designed to display certain types of displayable sensor information (e.g., numerical values and arrows in some examples) associated with the analyte value received from the sensor electronics module 140. In some examples, one of the plurality of display devices may be a handheld device 112 (such as a mobile phone, a palmtop computer, or the like, based on an Android operating system, an iOS operating system, or other operating systems), wherein the handheld device 112 may have a relatively large display and may be configured to display a graphical representation of continuous sensor data (e.g., including current and historical data). Other display devices may include other handheld devices, such as a tablet computer 113, a smartwatch 110, a drug delivery device 114, a blood glucose meter, and / or a desktop or laptop computer.

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

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

[0095] The continuous analyte sensor system 100 may include a sensor configuration that provides an output signal indicative of analyte concentration. 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 a receiver.

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

[0097] U.S. Patent Publication No. 2005 / 0203360 and U.S. Patent Publication No. 2009 / 0192745 describe various signal processing techniques and glucose monitoring system examples suitable for use with the examples described herein, the contents of which are hereby incorporated by reference in their entirety. The sensor can extend through a housing that can hold the sensor 138 on, in, or under the skin and / or can provide electrical connection between the sensor 138 and the sensor electronics in the sensor electronics module 140.

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

[0099] In some examples, the sensor 138 is in the form of a wire. The distal end of the wire can be formed, for example, to have a tapered shape (to facilitate insertion of the wire into the host's tissue). The sensor 138 may include an elongated analyte sensor and may include an elongated conductive body, such as an elongated conductive core (e.g., a metal wire) or an elongated conductive core coated with one, two, three, four, five or more layers of material, each of which may be conductive or non-conductive. The elongated analyte sensor may be long and thin, but flexible and strong. For example, in some examples, the minimum dimension of the elongated conductive body is less than 0.1 inches, less than 0.075 inches, less than 0.05 inches, less than 0.025 inches, less than 0.01 inches, less than 0.004 inches, less than 0.002 inches, less than 0.001 inches, and / or less than 0.0005 inches.

[0100] Sensor 138 may have a circular cross-section. In some examples, the cross-section of the elongated conductor may be oval, rectangular, triangular, polyhedral, star-shaped, C-shaped, T-shaped, X-shaped, Y-shaped, irregular, etc. In some examples, a conductive wire electrode is used as the core. In other examples, sensor 138 may be disposed on a substantially planar substrate. For such electrodes, one or two additional conductive layers may be added (e.g., with an intervening insulating layer providing electrical isolation). These conductive layers may be composed of any suitable material. In some examples, it may be desirable to employ a conductive layer comprising conductive particles (i.e., particles of a conductive material) in a polymer or other binder.

[0101] In some examples, the material used to form the elongated electrical conductor (e.g., stainless steel, titanium, tantalum, platinum, platinum-iridium, iridium, certain polymers, etc.) can be strong and rigid, and therefore resistant to breakage. For example, in several examples, the elongated electrical conductor has an ultimate tensile strength greater than 80 kPsi and less than 140 kPsi, and / or a Young's modulus greater than 160 GPa and less than 220 GPa. The elongated electrical conductor can have a yield strength greater than 58 kPsi and less than 2200 kPsi.

[0102] The electronics module 140 can be releasably or permanently coupled to the sensor 138. The electronics module 140 may include electronic circuitry associated with measuring and processing continuous analyte sensor data. The electronics module 140 may be configured to execute an algorithm associated with the processing and calibration of sensor data. For example, the electronics module 140 may provide various aspects of the functionality of the 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 herein by reference. The electronics module 140 may include hardware, firmware, and / or software capable of measuring analyte levels via a glucose sensor (such as sensor 138).

[0103] For example, the electronics module 140 may include a voltage regulator, a power supply for providing power to the sensor 138, a signal processing component, a data storage component, and a communication module (e.g., a telemetry module) for unidirectional or bidirectional data communication between the electronics module 140 and one or more receivers, repeaters, and / or display devices (e.g., devices 110-114). The electronics component may be attached to a printed circuit board (PCB), etc., and may take various forms. The electronics component may 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 the time corresponding to the measured analyte values, analyzing the variation of estimated analyte values, etc. Examples of systems and methods for processing sensor analyte data are described in more detail in U.S. Patent No. 7,310,544, U.S. Patent No. 6,931,327, U.S. Patent Publication No. 2005 / 0043598, U.S. Patent Publication No. 2007 / 0032706, U.S. Patent Publication No. 2007 / 0016381, U.S. Patent Publication No. 2008 / 0033254, U.S. Patent Publication No. 2005 / 0203360, U.S. Patent Publication No. 2005 / 0154271, U.S. Patent Publication No. 2005 / 0192557, U.S. Patent Publication No. 2006 / 0222566, U.S. Patent Publication No. 2007 / 0203966, and U.S. Patent Publication No. 2007 / 0208245, the contents of which are hereby incorporated by reference in their entireties. Electronics module 140 may communicate with 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 IEEE 802.11, 802.15, 802.20, 802.22 and other 802 communication protocols; ZigBee; wireless (e.g., cellular) telecommunications; paging network communications; magnetic induction; satellite data communications; proprietary communication protocols, open source communication protocols and / or any suitable wireless communication method.

[0104] Additional sensor information is described in US Patent No. 7,497,827 and US Patent No. 8,828,201. US Patent No. 7,497,827 and US Patent No. 8,828,201 are incorporated herein by reference in their entireties.

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

[0106] As used herein, the term "analyte" is a broad term and is to be given its ordinary and customary meaning to one of ordinary skill in the art (and is not limited to a special or customary meaning), and refers to, but is not limited to, a substance or chemical component that can be analyzed in a biological fluid (e.g., blood, interstitial fluid, cerebrospinal fluid, lymph, urine, sweat, saliva, etc.). Analytes can include naturally occurring substances, man-made substances, metabolites, or reaction products.

[0107] In some examples, the analyte measured by the sensing region, sensing device, sensing system, and sensing method is glucose. However, other analytes are also contemplated, including but not limited to: ketone bodies; acetyl-CoA; carboxyl-free prothrombin; acylcarnitines; adenine phosphoribosyltransferase; adenosine deaminase; albumin; alpha-fetoprotein; amino acid profile (arginine (Krebs cycle), histidine / urocanic acid, homocysteine, phenylalanine / tyrosine, tryptophan); androstenedione; antipyrine; arabinitol enantiomers; arginase; benzoylecgonine (cocaine); biotinidase; biopterin; c-reactive protein; carnitine; carnosinase; CD4; ceruloplasmin; chenodeoxycholic acid; chloroquine; cholesterol; choline Esterase; cortisol; testosterone; choline; creatine kinase; creatine kinase MM isoenzyme; cyclosporin A; d-penicillamine; desethylchloroquine; dehydroepiandrosterone sulfate; DNA (acetylase polymorphism, alcohol dehydrogenase, alpha-1 antitrypsin, cystic fibrosis, Duchenne dystrophy / Becker muscular dystrophy, glucose-6-phosphate dehydrogenase, hemoglobin A, hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F, D-Punjab, beta-thalassemia, hepatitis B virus, HCMV, HIV-1, HTLV-1, Leber hereditary optic neuropathy, MCAD, RNA, PKU, Plasmodium vivax, sexual differentiation, 21-deoxycortisol); desbutyl halofantrine; dihydropteridine reductase; diphtheria / tetanus antitoxin; erythrocyte arginase; erythrocyte protoporphyrin; esterase D; fatty acids / acylglycines; triglycerides; glycerol; free β-human chorionic gonadotropin; free erythrocyte porphyrin; free thyroxine (FT4); free triiodothyronine (FT3); fumaryl acetoacetase; galactose / gal-1-phosphate; galactose-1-phosphate uridyltransferase; gentamicin; glucose-6-phosphate dehydrogenase; glutathione GSH; glutathione peroxidase; glycocholic acid; glycosylated hemoglobin; halofantrine; hemoglobin variants; hexosaminidase A; human erythrocyte carbonic anhydrase I; 17-alpha-hydroxyprogesterone; hypoxanthine phosphoribosyltransferase; immunoreactive trypsin; lactate; lead; lipoprotein ((a), B / A-1, beta); lysozyme; mefloquine; netilmicin; phenobarbital; phenytoin; phytanic acid / pristanic acid; progesterone; prolactin; prolinase; purine nucleoside phosphorylase; quinine; reverse triiodothyronine (rT3); selenium; serum pancreatic lipase; sisomicin; somatomedin C;Specific antibodies (adenovirus, antinuclear antibody, anti-zeta antibody, arbovirus, Aujeszky's disease virus, dengue virus, Guinea worm, Echinococcus granulosus, Entamoeba histolytica, enterovirus, Giardia lamblia, 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, polio virus, Pseudomonas aeruginosa, respiratory syncytial virus, Rickettsia (tsutsugamushi), Schistosoma mansoni, Toxoplasma gondii, Treponema pallidum, Trypanosoma cruzi / T. lamblia, vesicular stomata virus, Wuchereria bancrofti, yellow fever virus); specific antigens (hepatitis B virus, HIV-1); acetone (e.g., succinylacetone); acetoacetic acid; sulfadoxine; theophylline; thyroid-stimulating hormone (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. In some examples, salts, sugars, proteins, fats, vitamins, and hormones naturally present in blood or interstitial fluid can also constitute analytes. Analytes can be naturally present in biological fluids or endogenous, such as metabolites, hormones, antigens, antibodies, etc. Alternatively, the analyte may be introduced into the body or exogenous, such as a contrast agent for imaging, a radioisotope, a chemical reagent, a fluorocarbon-based synthetic blood, or a drug or drug combination, including but not limited to insulin; glucagon; ethanol; cannabis (marijuana, tetrahydrocannabinol, hashish); inhalants (nitrous oxide, amyl nitrite, butyl nitrite, chlorinated hydrocarbons, hydrocarbons); cocaine (crack cocaine); stimulants (amphetamine, methamphetamine, Ritalin, Cylert, Preludin, Didrex, PreState, Voranil, Sanofi, etc.); drex, Plegine); sedatives (barbiturates, methaqualone, tranquilizers such as diazepam, chlordiazepoxide, meprobamate, sulphonate, mebutamide, Tranxene); hallucinogens (phencyclidine, lysergic acid, mescaline, pyodate, psilocybin); narcotics (heroin, codeine, morphine, opium, meperidine, Percocet, Percodan, Tussionex, fentanyl, Darfon, Analgesia, and Cialis); designer drugs (fentanyl, meperidine, amphetamine, methamphetamine, and phencyclidine analogs, such as ecstasy); anabolic steroids;and nicotine. Metabolites of drugs and pharmaceutical compositions are also contemplated analytes. Analytes produced in the body, such as neurochemicals and other chemicals, may also be analyzed, for example, ascorbic acid, uric acid, dopamine, norepinephrine, 3-methoxytyramine (3MT), 3,4-dihydroxyphenylacetic acid (DOPAC), homovanillic acid (HVA), 5-hydroxytryptamine (5HT), 5-hydroxyindoleacetic acid (FHIAA), and intermediates in the citric acid cycle.

[0108] At least Figure 1 Any of the features described in the context of the present invention may apply to all aspects and examples identified herein. In addition, any of the features of an example may be combined in any manner, independently, partially, or in whole, with other examples described herein; for example, one, two, or three or more examples may be combined in whole or in part. In addition, any of the features of an example may be made optional for other aspects or examples. Any aspect or example of a method may be performed by a system or apparatus of another aspect or example, and any aspect or example of a system may be configured to perform a method of another aspect or example.

[0109] Figure 2A A perspective view of an exemplary on-skin wearable medical device in the form of an on-skin sensor assembly 200 is shown, which is configured to be deployed on the skin. The on-skin sensor assembly 200 may include a housing or base 202. The housing or base 202 may be configured to be worn on the skin of a host and may include a distal surface facing the skin and a proximal surface 203 facing opposite the distal surface. The housing or base 202 may include an opening 205 through which an insertion element is retracted proximally from the skin. A patch 204, such as an adhesive patch, may couple the base 202 to the host's skin 206. The patch 204 may be positioned on the distal surface of the housing or base 202. In some examples, the adhesive patch 204 may include an engagement surface for engaging the skin and an adhesive suitable for skin adhesion, such as a pressure-sensitive adhesive (e.g., acrylic, rubber-based, or other suitable type) bonded to a carrier substrate (e.g., spunlace polyester, polyurethane film, or other suitable type) for skin attachment, although any suitable type of adhesive is contemplated. The on-skin sensor assembly 200 may include an electronics unit 208 (eg, a transmitter), which may also include a glucose sensor module 210 coupled to an analyte sensor, such as a transcutaneous analyte sensor (eg, a glucose sensor) 212 , and the base 202 .

[0110] The applicator system can couple the adhesive patch 204 to the skin 206. The glucose sensor module 210 can be secured to the base 202 (e.g., via retention elements such as snap fits and / or interference features, adhesives, welds, etc.) to ensure that the analyte sensor 212 (e.g., a glucose sensor) is coupled to the base 202. In an alternative example, the sensor module 210 and the base 202 are preassembled or manufactured as a single component.

[0111] After the on-skin sensor assembly 200 is deployed on the user's skin, the user (or applicator) can couple the electronics unit 208 (e.g., a transmitter) to the on-skin sensor assembly 200 via retention elements such as snap fits and / or interference features. The electronics unit 208 can measure and / or analyze the glucose indicator sensed by the transcutaneous analyte sensor (e.g., a glucose sensor) 212. The electronics unit 208 can transmit the information (e.g., measurement results, analyte data, glucose data) to a remotely located device (e.g., Figure 1 110-114 shown).

[0112] The on-skin sensor assembly 200 can be attached to the host using an applicator that is adapted to provide convenient and safe application. Such an applicator can also be used to attach the electronics unit 208 to the base 202, insert the sensor 212 through the host's skin, and / or connect the sensor 212 to the electronics unit 208. Once the electronics unit 208 is engaged with the base and the sensor 212 has been inserted into the skin (and connected to the electronics unit 208), the sensor assembly can be detached from the applicator.

[0113] Figure 2B A perspective view of the electronics unit 208 is shown coupled to the base 202 via retaining elements such as snap fits and / or interference features. In some examples, the electronics unit 208 and the base 202 are coupled by adhesive, welding, or other bonding techniques. The patch 204 on the distal surface of the base 202 is configured to couple the sensor assembly 200 to the skin.

[0114] Figure 2C Shown is a perspective view of an on-skin sensor assembly 200. The on-skin sensor assembly 200 may be disposable or reusable. Figure 2C Also shown are an electronics unit 208 coupled to the base 202 and an adhesive patch 204 configured to attach to the on-skin sensor assembly 200, which when combined can be retained within the applicator.

[0115] Figure 3An example of a skin-wearable medical device in the form of an on-skin sensor assembly 300 is shown, wherein an electronics unit 302 is configured to be inserted into a cavity 304 of a base or housing 306. The base or housing 306 can be configured to be worn on the skin of a host and can include a distal surface facing the skin and a proximal surface 305 facing opposite the distal surface. The electronics unit 302 can include one or more tabs 308 that are coupled to a portion of the housing 306 and allow the electronics unit 302 to be retained by the housing 306. The housing 306 can include an opening 310 through which an insertion element can be retracted proximally from the skin. The opening 310 can allow an insertion element (such as a needle) to pass through to deploy a transcutaneous analyte sensor 312 to the skin. The patch 314 can also include a hole 316 that can allow the sensor 312 and the insertion element to pass through. The electronics unit 302 can be coupled to the housing 306 before or after the sensor 312 is deployed on the skin of the host.

[0116] Figure 4 An example of an on-skin wearable medical device is shown in the form of an on-skin sensor assembly 400, wherein the electronics unit is integral with a housing 402. The housing 402 can be configured to be worn on the skin of a host and can include a distal surface facing the skin and a proximal surface 403 facing opposite the distal surface. The on-skin sensor assembly 400 is shown on skin 404, with a patch 406 engaging the skin 404.

[0117] Figures 2A to 4 Examples of the present invention may each include an engagement surface for engaging the skin. In an example, the engagement surface may be located on the patch, for example, on the distal surface of the patch, or in an example, may have another location. In an example, the engagement surface may include an adhesive surface configured to adhere to the skin. The adhesive may be configured to adhere to the skin. Additional adhesive information is described in U.S. Patent No. 11,219,413, filed on August 25, 2015. The entire contents of U.S. Patent No. 11,219,413 are incorporated herein by reference. In an example, the engagement surface may be covered with a liner before being deployed on the host's skin.

[0118] Figure 5 A system for deploying an on-skin wearable medical device to the skin is shown. In some examples, the system can include an applicator system. According to some examples, the system can include an applicator for an on-skin sensor assembly of an analyte sensor system. In some examples, other forms of systems can be utilized.

[0119] In an example, the applicator 500 may include an applicator housing 501, which may include an outer housing 504 and an inner housing 506, as well as other forms of housings. In an example, the applicator housing 501 may be configured to hold a wearable medical device on the skin. The applicator 500 may include a deployment mechanism that may be configured to deploy the wearable medical device on the skin to the skin. In an example, the deployment mechanism may include, for example, an engagement portion for holding the wearable medical device on the skin and releasing the wearable medical device on the skin from the applicator housing 501 to the skin. The engagement portion may include one or more retaining elements. The deployment mechanism may include an insertion assembly for inserting at least a portion of the wearable medical device on the skin into the skin. The insertion assembly may drive a portion of the wearable medical device on the skin (such as an insertion element and a sensor) into the skin of the host. The deployment mechanism may include a retraction assembly, such as an insertion element, for retracting a portion of the wearable medical device on the skin from the skin.

[0120] In an example, the applicator 500 may include an activation element 502 disposed on a side of the applicator 500 (e.g., disposed on a side of a housing 504 of the applicator 500). In some examples, the activation element 502 may be a button, a switch, a toggle, a slider, a trigger, a knob, a rotating member, a deformable and / or curved portion of the applicator 500, or any other suitable mechanism for activating the insertion and / or retraction components of the applicator 500. In some examples, the activation element 502 may be disposed in any location, such as on the top, upper side, lower side, or any other location of the applicator 500. The applicator 500 may be large enough for a user to grasp the applicator 500 with their hand and push or otherwise activate the activation element 502 with, for example, a thumb or index and / or middle finger.

[0121] The applicator 500 may be configured with one or more safety features that prevent the applicator 500 from being activated until the safety features are deactivated. In one example, the one or more safety features prevent the applicator 500 from being activated unless the applicator 500 is pressed against the host's skin with sufficient force. Figures 6 to 20B As described in greater detail in one or more of the foregoing, the applicator 500 can also be configured such that one or more components thereof retract based, at least in part, on the one or more components pushing against the host's skin with a force exceeding a predetermined threshold, rather than based on the one or more components translating beyond a predetermined and static distal position. In other words, the applicator 500 can implement a force-based retraction trigger, rather than being limited to a displacement-based retraction trigger.

[0122] Figure 6 Shown according to some examples Figure 51 is an exploded perspective view of an applicator 500. The applicator 500 may include an outer applicator housing 504 that includes an activation element 502. In an example, the outer applicator housing 504 may be configured to be grasped by a user. The outer applicator housing 504 may be configured to translate distally in response to a force applied by the user to the applicator 500, particularly to the inner housing 506, thereby aligning the activation element 502 in a position that allows the applicator 500 to be fired. Further explanation of the alignment process will be explained below.

[0123] The applicator 500 also includes an inner housing 506 configured to house at least one or more mechanisms for applying the on-skin sensor assembly 508 to the skin of the host. A distal surface 510 of the bottom opening of the inner housing 506 can define a bottom surface of the applicator 500. In some examples, when the applicator 500 is pressed against the skin of the host, the skin can deform into a substantially convex shape at the distal surface 510, such that at least a portion of the skin surface disposed at the bottom opening of the applicator's inner housing 506 extends in a proximal direction into the bottom opening of the inner housing 506, beyond the plane defined by the distal surface 510.

[0124] like Figure 7 As shown, housing 501, particularly inner housing 506, may include an inner cavity 503 for holding a skin-wearable medical device. Inner cavity 503 may have a distal end portion 505 at an opening for deploying the skin-wearable medical device therefrom. Proximal end portion 507 of inner cavity 503 may include a skin-wearable medical device coupled to a needle carrier assembly 516.

[0125] Return Reference Figure 6 In some examples, the first barrier layer 512 can be positioned over one or more apertures (e.g., aperture 514) in the inner housing 506, and at least a portion of the activation element 502 can be configured to extend through the aperture during activation of the applicator 500. In such examples, a portion of the activation element 502 can be configured to pierce or deform the first barrier layer 512 upon activation of the applicator 500. The first barrier layer 512 can include a breathable material such as Tyvek, or a non-breathable material such as a metal foil, a polymer film, an elastomer, or any other suitable material.

[0126] The applicator 500 may also include a needle carrier assembly 516 including a needle hub 518 configured to couple an insertion element 520 to the needle carrier assembly 516. In some other examples, the insertion element 520 may be directly coupled to the needle carrier assembly 516. The insertion element 520 is configured to insert the sensor of the on-skin sensor assembly 508 into the skin of the host. In some examples, the insertion element includes a needle, such as a side-opening 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 other examples, the insertion element 520 may be integrally formed with the sensor and may have sufficient rigidity to be partially inserted into the skin of the host with minimal or no structural support.

[0127] The applicator 500 may further include a retainer 522 that is releasably coupled to the needle carrier assembly 516 and configured to guide the needle carrier assembly 516 and the on-skin sensor assembly 508 while coupled to the needle carrier assembly 516 (e.g., at least during translation from a proximal position to a distal insertion position). As will be described in greater detail below, once the on-skin sensor assembly 508 is positioned on the host's skin, the on-skin sensor assembly 508 may be peeled or released from the retainer 522 and / or the needle carrier assembly 516. For example, an engagement portion or one or more retaining elements may release the on-skin wearable medical device from the applicator housing 501.

[0128] The applicator 500 may also include an insertion assembly configured to translate the insertion element 520, the needle hub 518, the needle carrier assembly 516, and the on-skin sensor assembly 508 in a distal direction from a proximal position to a distal insertion position. Such an insertion assembly may include at least one spring for inserting at least a portion of the on-skin wearable device into the skin. The insertion assembly may include a first spring 524. The first spring 524 may be a compression spring or any other suitable type of spring and may have a first end that contacts or couples to the inner applicator housing 506 and a second end that contacts or couples to the retainer 522. The first spring 524 is configured to translate the retainer 522, the needle carrier assembly 516, the needle hub 518, the insertion element 520, and the on-skin sensor assembly 508 in a distal direction to the distal insertion position upon activation of the insertion assembly. At substantially the distal insertion position, the needle carrier assembly 516 may be disengaged from the retainer 522 and the on-skin sensor assembly 508.

[0129] The applicator 500 may also include a retraction assembly for retracting an insertion element (e.g., a needle) from the skin. The retraction assembly may be configured to translate the needle carrier assembly 516, the needle hub 518, and the insertion element 520 in a proximal direction from a distal insertion position to a proximal retraction position. In some examples, the initial proximal position may be the same as the proximal retraction position. In other examples, the initial proximal position may be different from the proximal retraction position. Such a retraction assembly may include at least one spring. The retraction assembly may include a second spring 526. The second spring 526 may be a compression spring or any suitable type of spring and may have a first end that contacts or is coupled to the retainer 522 at least until retracted and contacts or is coupled to at least one spring retaining element (e.g., Figures 10 to 14 The second spring 526 is configured to move in response to the on-skin sensor assembly 508 contacting the host's skin and / or moving at a speed exceeding sufficient to allow the first end of the second spring 526 to overcome at least one spring retaining element (e.g., Figures 10 to 14 The needle carrier assembly 516, the needle hub 518, and the insertion element 520 are translated in the proximal direction from the distal insertion position to the proximal retracted position when a predetermined threshold force (e.g., 528a, 528b) of the needle carrier assembly 516 reaches the travel limit. In some examples, a stop feature (not shown) can be provided at the bottom of the applicator 500, for example, on the distal portion of the inner housing 506. Such a stop feature can be configured to contact one or more of the sensor assembly 508, the needle carrier assembly 516, or the retainer 522 on the skin in the distal insertion position.

[0130] In some examples, a second barrier layer 530 can be disposed over the bottom opening of the inner housing 506. The second barrier layer 530 can include a gas-permeable material, such as Tyvek, or a non-gas-permeable material, such as a metal foil or film. In some examples, the second barrier layer 530 can be removed by the user before using the applicator 500. In examples that include one or both of the first barrier layer 512 and the second barrier layer 530, such layers can provide a sterile environment between the applicator 500 and the external environment and / or can allow gases to enter and exit, such as during sterilization.

[0131] Reference below Figures 7 to 9 Some aspects of the operation of the applicator 500 are briefly described, showing the Figure 5 and Figure 6 Several cross-sectional views of the applicator 500 during operation. For example, Figures 7 to 9 Corresponding to along Figure 5 The applicator 500 is shown cut through along section line AA'.

[0132] Figure 7The applicator 500 is shown in a state prior to activation. The retainer 522 includes an insertion assembly retaining element 532 that is configured to contact the inner housing 506, thereby securing the retainer 522, needle carrier assembly 516, needle hub 518, insertion element 520, and on-skin sensor assembly 508 in a pre-activated state.

[0133] The needle carrier assembly 516 includes an engagement portion of the applicator. The engagement portion may include a plurality of wearable retention and / or alignment elements 534a, 534b configured to extend through the retainer 522 and releasably couple the on-skin sensor assembly 508 to the retainer 522 and / or the needle carrier assembly 516. In examples, the engagement portion may have other configurations. The wearable retention elements 534a, 534b may include, for example, arms, deflection elements, tabs, detents, snaps, or any other features capable of providing a retention function. In some examples, the wearable retention elements 534a, 534b may extend around the retainer 522 rather than extending through it. Although two wearable retention elements are shown, any number of wearable retention elements is contemplated. In some examples, the wearable retention elements 534a, 534b may include a snap fit, a friction fit, an interference feature, an elastomeric grip, and / or an adhesive configured to couple the on-skin sensor assembly 508 with the needle carrier assembly 516 and / or the retainer 522.

[0134] The inner housing 506 may include a spring 536 configured to contact the outer housing 504 and Figure 7 The outer housing 504 and the inner housing 506 are maintained in a predetermined spacing in the pre-activated orientation. The spring 536 can be a compression spring, a leaf spring, a crank spring, a foam or rubber sheet, etc. In some other examples, the outer housing 504 can include the spring 536, and the spring 536 can be configured to Figure 7 The reverse manner shown contacts the inner housing 506 .

[0135] Activation of the applicator 500 can include the host pressing the applicator 500 against their skin with sufficient force to cause the outer housing 504 to translate in the distal direction (as indicated by arrow 538) toward and relative to the inner housing 506 until the activation element 502 is aligned with the aperture 514 of the inner housing 506 and the insertion assembly retaining element 532 of the retainer 522. The insertion assembly retaining element 532 can include, for example, an arm, a deflecting element, a tab, a detent, a snap, or any other feature capable of maintaining functionality. Once such alignment is achieved, the host can activate (e.g., push) the activation element 502, as indicated by arrow 540, thereby sufficiently deflecting the insertion assembly retaining element 532 to release the retainer 522 from the inner housing 506. In some other examples, the applicator 500 can be configured such that the activation element 502 can be activated first, but actual insertion is not triggered until the outer housing 504 has sufficiently translated in the distal direction toward and relative to the inner housing 506. In yet other examples, the activation element 502 may be biased toward the center of the applicator 500 such that the activation element 502 does not need to be explicitly activated by the host, but instead, the activation element 502 may be configured to automatically initiate insertion when the outer housing 504 is sufficiently translated in a distal direction toward and relative to the inner housing 506.

[0136] Such a configuration provides several benefits. First, the translation of the outer housing 504 relative to the inner housing 506 prior to activation provides a measure of drop protection, so that if the applicator 500 is accidentally dropped, it will not fire prematurely. Second, the spring 536 provides a force bias that the host must positively overcome by pressing the applicator 500 into their skin before firing, thereby reducing the likelihood of activating the applicator 500 before it is properly positioned. Furthermore, the host may decide not to fire the applicator 500 and stop pressing the applicator 500 against their skin, in which case the spring 536 will bias against the outer housing 504 and allow the outer housing 504 to return to its initial state.

[0137] The retainer 522, the needle carrier assembly 516, the needle hub 518, the insertion element 520, the on-skin sensor assembly 508, the first spring 524 and the second spring 526 are all in the Figure 7 Shown in the pre-activated position.

[0138] Figure 8 The applicator 500 is shown during insertion of the on-skin sensor assembly 508 but before retraction of the needle carrier assembly 516. The first spring 524 urges the retainer 522, needle carrier assembly 516, needle hub 518, insertion element 520, and on-skin sensor assembly 508 in a distal direction toward a distal insertion position. Figure 8A position is shown in which the on-skin sensor assembly 508 is in contact with the host's skin, but the retainer 522 has not yet been fully driven by the first spring 524 into contact with the on-skin sensor assembly 508 or the host's skin.

[0139] In some examples, the mass of each of the retainer 522, the needle carrier assembly 516, the needle hub 518, the insertion element 520, and the on-skin sensor assembly 508 can be specifically designed to reduce or substantially eliminate the tendency of the needle carrier assembly 516, the needle hub 518, the insertion element 520, and the on-skin sensor assembly 508 to disengage from the retainer 522 due to inertial forces when driven in the distal direction during insertion. In some examples, the force applied by the first spring 524 can be selected to be sufficient for proper operation of the applicator 500 while not being so great as to further exacerbate the above-mentioned inertially triggered disengagement. In some examples, a spring (not shown) can be configured to apply a force against a portion of the needle carrier assembly 516 in the distal direction that is sufficient to prevent the needle carrier assembly 516 from inertially triggered disengagement from the retainer 522 during insertion, for example.

[0140] Figure 9 The applicator 500 is shown during activation as the needle carrier assembly 516, needle hub 518, and insertion element 520 are retracted in the proximal direction by the second spring 526. Figure 9 , the first spring 524 has fully driven the on-skin sensor assembly 508 to the host's skin. In this position, the second spring 526 is released from the spring retaining element (e.g., Figures 10 to 14 528a, 528b) are released and the needle carrier assembly 516, needle hub 518, and insertion element 520 are driven in the proximal direction from the distal insertion position. When the needle carrier assembly 516 reaches the proximal retracted position, the needle carrier retaining element 542 of the retainer 522 engages the needle carrier assembly 516, thereby retaining the needle carrier assembly 516, needle hub 518, and insertion element 520 in a locked retracted position that restricts access to the insertion element 520. The needle carrier retaining element 542 may include, for example, an arm, a deflecting element, a tab, a detent, a snap, or any other feature capable of maintaining functionality. In this retracted position, the needle carrier assembly 516, needle hub 518, and insertion element 520 are prevented from traveling in the distal direction.

[0141] Reference below Figures 10 to 12 Some aspects of the operation of the applicator 500 are further described, showing the Figure 5 and Figure 6 Several cross-sectional views of the applicator 500 during operation. For example, Figures 10 to 12 Corresponding to along Figure 5 The applicator 500 is shown cut through the section line BB'. Figures 10 to 12The needle hub 518 and the insertion element 520 are not shown.

[0142] Figure 10 The applicator 500 is shown before activation. Figure 10 The on-skin sensor assembly 508 is not shown. The retainer 522 includes spring retaining elements 528a, 528b that are configured to contact and retain a first end of a second spring 526 in a pre-activated state, for example, during insertion, while a second end of the spring 526 is in contact with the needle carrier assembly 516. The spring retaining elements 528a, 528b may include, for example, arms, deflection elements, tabs, detents, snaps, or any other features capable of having a retaining function. Although two spring retaining elements 528a, 528b are shown, at least one spring retaining element is contemplated. In some examples, the applicator 500 may include one spring retaining element, such as Figures 21 to 24 As shown. In some examples, the applicator 500 can include three spring retention elements. In some examples, the applicator 500 can include four spring retention elements. In some examples, the spring retention elements 528a, 528b are deflectable arms, rigid arms, deformable features, snaps, catches, or hooks. In some examples, the spring retention elements 528a, 528b can be actively deflected by one or more features within the applicator 500.

[0143] The needle carrier assembly 516 includes stop features 544a, 544b that are configured to, for example, prevent lateral deflection of the spring retaining elements 528a, 528b in the proximal starting position, at least during insertion, thereby supporting the retention of the second spring 526 between the spring retaining elements 528a, 528b and the retainer 522 until retraction. Although two stop features are shown, any number of stop features is contemplated. The number of stop features may be equal to the number of spring retaining elements.

[0144] Figure 13 An enlarged view of the spring retaining element 528b and the stop feature 544b is shown. Figure 13 , the first spring 524 drives the retainer 522, the needle carrier assembly 516, and the on-skin sensor assembly 508 in a distal direction toward the distal insertion position. The stop feature 544b is shown as engaging the spring retaining element 528b, thereby preventing the spring retaining element 528b from deflecting laterally, thereby preventing the second spring 526 from releasing. Figure 13As shown, the proximal end of the spring retaining element 528b can be offset from the distal end of the stop feature 544b by a distance α. In some examples, the distance α is the length required for the spring retaining element 528b to traverse along the stop feature 544b so that the spring retaining element 528b passes over the stop feature 544b. The stop feature 544b can feature a bevel to guide the spring retaining element 528b. The distal end of the needle carrier assembly 516 and the distal end of the retainer 522 can be offset from each other by at least the same distance α to allow the spring retaining element 528b to pass distally over the stop feature 544b.

[0145] It will be appreciated that the frictional force between the corresponding contact surfaces of the stop feature 544b and the spring retaining element 528b may at least partially determine the amount of force required to release the spring retaining element 528b from the stop feature 544b. This force may allow for lateral deflection of the spring retaining element 528b and, therefore, expansion of the second spring 526. In some examples, the force is at least 0.1 lb. In some examples, the force is at least 0.5 lb. In some examples, the force is at least 1 lb. In some examples, the force is at least 2 lb. In some examples, the force is at least 3 lb. In some examples, the force is at least 4 lb. In some examples, the force is at least 5 lb.

[0146] Although the figure shows the stop feature 544b preventing the spring retaining element 528b from deflecting laterally in the radially outward direction, it is contemplated that the opposite structural relationship can be achieved. For example, the inclined surface of the spring retaining element 528b can be reversed to face in the opposite direction, such as Figure 13 In addition, the inclined surface of the spring retaining element 528b can be biased against the stop feature 544b in the radially inward direction by the second spring 526. In such an example, the stop feature 544b can be located radially inward of the spring retaining element 528b.

[0147] Thus, in some examples, the material used to form the retainer 522 and the needle carrier assembly 516 can be selected based on the amount of force desired to release the spring retaining element 528b for lateral deflection. Examples of such materials can include polycarbonate, ABS, PC / ABS, polypropylene, HIPS (high impact polystyrene), polybutylene terephthalate (PBT), polyoxymethylene (POM), acetal, polyacetal, polyoxymethylene, PTFE, high density polyethylene (HDPE), ultra high molecular weight polyethylene (UHMWPE), nylon, polyethylene terephthalate (PET), thermoplastic elastomer (TPE), thermoplastic polyurethane (TPU), TPSiv, cyclic olefin polymer (COP), cyclic olefin copolymer (COC), and / or liquid crystal polymer (LCP).

[0148] The angle θ of the portion of the spring retaining element 528b in contact with the second spring 526 can also influence the amount of frictional force that causes the spring retaining element 528b to laterally deflect and thereby release the force of the second spring 526. Therefore, the angle θ can be selected based on the desired amount of lateral deflection of the spring retaining element 528b to release the force of the second spring 526. In some examples, the angle θ is at least 1 degree relative to the vertical axis of the spring retaining element 528b. In some examples, the angle θ is at least 5 degrees. In some examples, the angle θ is at least 10 degrees. In some examples, the angle θ is at least 15 degrees. In some examples, the angle θ is at least 20 degrees. In some examples, the angle θ is approximately 30 to 45 degrees. Furthermore, the force distribution of the second spring 526 can influence the lateral deflection of the spring retaining element 528b. Thus, in some examples, the force distribution of second spring 526 may be considered when selecting one or both of the materials used to form retainer 522 and needle carrier assembly 516 and the angle θ of the portion of spring retaining element 528b that contacts second spring 526.

[0149] The angle β of the spring retaining element 528b relative to the vertical axis may also affect the amount of frictional force that laterally deflects the spring retaining element 528b and thereby releases the second spring 526. By contacting the spring retaining element 528b, the second spring 526 may exert a force on the spring retaining element 528b at a distance d from the bottom of the spring retaining element 528b that results in a torque sufficient to cause lateral deflection of the spring retaining element 528b.

[0150] Figure 13 Also shown is a needle carrier assembly 516 including a deflection element 546 configured to contact the spring retaining element 528b and maintain the spring retaining element 528b in a laterally deflected orientation once the second spring 526 has initially deflected the spring retaining element 528b and sufficiently driven the needle carrier assembly 516 in a proximal direction, as will be seen in FIG. Figure 14 The deflection element 546 can prevent the spring retaining element 528b from contacting the windings of the second spring 526 when the second spring 526 is extended, thereby smoothing the operation of the applicator 500 and preventing energy released by the second spring 526 and designed to drive the needle carrier assembly 516 in the proximal direction from being absorbed by the spring retaining element 528b during the release of the second spring 526.

[0151] In some examples, the angle θ of the portion of the spring retaining element 528b that contacts the second spring 526 may be substantially 90° (eg, flat), and the deflection element 546 may have a substantially flat angle. Figure 13The position shown is an inclined or angled surface that contacts the spring retaining element 528b. In such an example, in addition to the functions described above, the deflection element 546 can also be configured to move the retainer 522 from the first spring 524 to the second spring 524. Figure 13 The position shown is driven to Figure 14 The position shown has the spring retaining element 528b initially deflected.

[0152] In some examples, the inner housing 506 can include a protrusion 548 extending distally from the inner housing 506. The protrusion 548 can be configured to contact at least one of the spring retaining elements 528a, 528b and the stop features 544a, 544b in the pre-activated state, thereby preventing the spring retaining elements 528a, 528b from lateral deflection until the retainer 522 and the needle carrier assembly 516 have translated in the distal direction at least a predetermined minimum distance. Thus, the protrusion 548 can provide a drop protection measure so that the applicator 500 does not fire prematurely in response to the concussive impact of a drop before intentional activation.

[0153] Return to Figure 10 The inner housing 506 may also include an engagement element 550 configured to engage with a protrusion 552 of the needle carrier assembly 516 when the needle carrier assembly 516 is translated in the distal direction beyond a predetermined threshold, thereby preventing the needle carrier assembly 516 from translating in the distal direction beyond the predetermined threshold. It is contemplated that this can ensure that the needle carrier assembly is retracted in the event of an air or dry fire, in which the applicator 500 is activated in some manner without being held against the host's skin. In some examples, the predetermined threshold may correspond to a point at which the distal end of the needle carrier assembly 516 extends beyond the proximal end of the distal end of the inner housing 506, extends to a point substantially in line with the distal end of the inner housing 506, or extends to a point distal to the distal end of the inner housing 506. In some examples, the engagement element 550 includes a hook, a U-shaped structure, a loop, a protrusion, or any other structure capable of engaging with the protrusion 552, as described above.

[0154] Figure 11 The applicator 500 is shown after activation, at or near the distal insertion position, at the beginning of the force retraction feature process, wherein the on-skin sensor assembly 508 can be in contact with the host's skin. The first spring 524 has urged the retainer 522, the needle carrier assembly 516, the needle hub 518, the insertion element, and the on-skin sensor assembly 508 in a distal direction toward the distal insertion position. During proper operation, the retainer 522 and the on-skin sensor assembly 508 should be pressed against the host's skin. However, Figure 11A dry-fire condition may also be illustrated, in which the applicator 500 is not properly pressed against the host's skin before the applicator 500 is triggered. Thus, when the first spring 524 drives the retainer 522 and the needle carrier assembly 516 in the distal direction beyond a predetermined threshold, the engagement element 550 contacts the protrusion 552, which prevents the needle carrier assembly 516 from further traveling in the distal direction, while the retainer 522 is driven sufficiently further in the distal direction that the stop features 544a, 544b of the needle carrier assembly 516 no longer contact the spring retaining elements 528a, 528b in the distal insertion position, thereby releasing the first end of the second spring 526 and initiating retraction even when the applicator 500 is dry-fired. The insertion force provided by the first spring 524 may be sufficient to additionally overcome the frictional forces between the corresponding contact surfaces of the stop feature 544b and the spring retaining element 528b.

[0155] Steering Figure 14 , the first spring 524 has driven the retainer 522, the needle carrier assembly 516, and the on-skin sensor assembly 508 in the distal direction to the host's skin. When the first spring 524 drives the retainer 522, the needle carrier assembly 516, and the on-skin sensor assembly 508 against the host's skin, the skin provides a reaction force to the force generated by the first spring 524. The skin can resist the force of the first spring 524 and be biased against the distal end of the on-skin sensor assembly 508. Because the distal end of the retainer 522 is offset from the distal end of the on-skin sensor assembly 508, as shown in FIG. Figure 13 As shown, as the first spring 524 continues to drive the retainer 522 toward the skin, the reaction force provided by the skin is transmitted to the retainer 522, while the on-skin sensor assembly 508 is pressed against the skin. The reaction force provided by the skin allows the spring retaining element 528b to shift past the stop feature 544b. Once the spring retaining element 528b has passed the stop feature 544b by a distance α, the second spring 526 can cause the spring retaining element 528b to deflect laterally, thereby releasing the second spring 526, which drives the needle carrier assembly 516 in the proximal direction. Alternatively, as described above in conjunction with Figure 13 As described, when the angle θ of the portion of the spring retaining element 528b that contacts the second spring 526 is substantially 90° (e.g., flat), the inclined or angled surface of the deflection element 546 that contacts the spring retaining element 528b causes the spring retaining element 528b to deflect sufficiently to release the second spring 526, which drives the needle carrier assembly 516 in the proximal direction.

[0156] In some examples, the engagement element 550 can engage the protrusion 552 even when the applicator 500 is pressed against the user's skin. In such examples, the engagement element 550 engages the protrusion 552 as the first spring 524 drives the retainer 522, the needle carrier assembly 516, and the on-skin sensor assembly 508 against the host's skin. As described above, when the engagement element 550 engages the protrusion 552, the engagement element 550 prevents the needle carrier assembly 516 from moving distally. This allows the spring retaining elements 528a, 528b to disengage from the stop features 544a, 544b and allows the second spring 526 to be released. The engagement of the engagement element 550 and the protrusion 552 can add additional force to the reaction force provided by the skin, thereby increasing the energy required to overcome the frictional engagement of the spring retaining elements 528a, 528b and the stop features 544a, 544b. In some cases, the engagement of the engagement element 550 and the protrusion 552 provides an immediate impulse that converts at least some of the initial energy of the first spring 524 into the energy required to overcome the frictional engagement of the spring retaining elements 528a, 528b and the stop features 544a, 544b. It is contemplated that such an example may benefit users with soft skin or a higher body fat percentage.

[0157] Return to Figure 12 , which shows the applicator 500 during activation, with the needle carrier assembly 516 retracted in the proximal direction by the second spring 526, as indicated by arrow 554. Figure 12 In the embodiment of the present invention, with the stop features 544a, 544b no longer securing the spring retaining elements 528a, 528b, when the on-skin sensor assembly 508 contacts the host's skin, the first end of the second spring 526 pushes against the spring retaining elements 528a, 528b with sufficient force to deflect the spring retaining elements 528a, 528b in the distal insertion position, thereby allowing the second spring 526 to pass over the spring retaining elements 528a, 528b and drive the needle carrier assembly 516 in the proximal direction, thereby securing the needle carrier assembly 516, the needle hub 518 (see FIG. 1 ) and the needle hub 518 even in the event of a dry fire. Figures 7 to 9 ) and insert element 520 (see Figures 7 to 9 ) is maintained in the locked retracted position.

[0158] Figure 15 and Figure 16 Shown are enlarged views of some features of an applicator, such as applicator 500 , according to some examples.

[0159] exist Figure 15 In the embodiment, the first spring 524 (see Figures 6 to 12) drives the retainer 522, along with the needle carrier assembly and on-skin sensor assembly 508, in a distal direction indicated by arrow 556 toward the distal insertion position. An engagement portion in the form of a retaining element 534b of the needle carrier assembly is releasably coupled to the on-skin sensor assembly 508. As shown, during insertion and near the distal insertion position, the retainer 522 contacts the spring retaining element 534b, thereby preventing lateral deflection of the spring retaining element 534b and thereby rigidly securing the on-skin sensor assembly 508 to the needle carrier assembly.

[0160] exist Figure 16 In the second spring 526 (see Figures 6 to 12 ) drives needle carrier assembly 516 in the proximal direction from the distal insertion position. Because retainer 522 has been sufficiently driven in the distal direction, retainer 522 is no longer in contact with wearable retaining element 534b at the distal insertion position. As a result, wearable retaining element 534b is free to deflect laterally, thereby releasing on-skin sensor assembly 508 from wearable retaining element 534b and, therefore, from needle carrier assembly 516. Needle carrier assembly 516 is now driven in the proximal direction by second spring 526 while on-skin sensor assembly 508 is secured to the host's skin. Furthermore, in some examples, because retainer 522 is driven to the distal insertion position and is substantially retained in that position by first spring 524, retainer 522 can press against one or both of on-skin sensor assembly 508 or the adhesive patch of on-skin sensor assembly 508, thereby supporting one or both during attachment to the host's skin.

[0161] Figure 17 Shown according to some examples Figure 5 and Figure 6 A perspective, partially cut-away view of the needle carrier assembly 516, needle hub 518, and on-skin sensor assembly 508 of the applicator 500. Figure 18 A cross-sectional view of a needle hub 518 and an on-skin sensor assembly 508 is shown, according to some examples. Figure 19 A top view of a portion of a needle carrier assembly 516 and a needle hub 518 is shown according to some examples. Figures 17 to 19 A description of these characteristics.

[0162] On-skin sensor assembly 508 includes sensor assembly opening 560. Needle hub 518 is configured to couple insertion element 520 to needle carrier assembly 516 and to substantially maintain a desired orientation of insertion element 520 during insertion of the sensor of on-skin sensor assembly 508 into the skin of a host.

[0163] The needle hub 518 includes 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 shown, any number of arms, including a single upper arm and a single lower arm, is contemplated. In some examples, the upper arms 562a, 562b and the lower arms 564a, 564b can be flexible so that when the needle hub 518 is coupled to the needle carrier assembly 516, the upper arms 562a, 562b and the lower arms 564a, 564b secure the needle hub 518 in a desired orientation relative to the needle carrier assembly 516. For example, the upper arms 562a, 562b can be configured to flex radially inwardly so that, when disposed through the carrier aperture 568 in the needle carrier assembly 516, the upper arms 562a, 562b contact an upper surface of the needle carrier assembly 516 adjacent the carrier aperture 568, and the lower arms 564a, 564b contact a lower surface of the needle carrier assembly 516 adjacent the carrier aperture 568. This arrangement allows for a compliant fit between the needle carrier assembly 516 and the needle hub 518, wherein the lower arms 564a, 564b deflect to allow the upper arms 562a, 562b to expand after passing over the surface of the carrier aperture 568. The lower arms 564a, 564b can partially or completely relax to bias the needle hub in a distal direction and reduce a gap between the needle hub and the needle carrier that would otherwise exist with a non-compliant fit. Additionally, the upper arms 562a, 562b and the lower arms 564a, 564b also help maintain contact between the base 566 and the top surface of the on-skin sensor assembly 508.

[0164] The base 566 includes an anti-rotation feature. The anti-rotation feature may include a key having a shape complementary to at least a portion of the sensor assembly opening 560 of the on-skin sensor assembly 508 and may be configured to substantially prevent the needle hub 518 from rotating relative to the on-skin sensor assembly 508 about an axis 567 parallel to the insertion element 520, for example, to prevent the base 566 from rotating within the sensor assembly opening 560. Additionally or alternatively, an upper surface of the needle carrier assembly 516 adjacent the carrier aperture 568 may include a groove 570 configured to receive the upper arms 562a, 562b when the upper arms 562a, 562b are positioned through the carrier aperture 568 in an orientation complementary to the orientation of the groove 570, as shown. Figure 19 As shown, the needle hub 518 is thereby fixed relative to the needle carrier assembly 516.

[0165] In some examples, the base 566 also includes a substantially flat surface that is configured to mate with a top surface, upper surface, or proximal surface of the skin sensor assembly 508 and, in some cases, maintain the insertion element 520 in an orientation substantially perpendicular to the top surface of the skin sensor assembly 508 when the anti-rotation feature of the base 566 is engaged within the opening 560 of the skin sensor assembly 508.

[0166] Based at least on the above-described features of the needle hub 518, the on-skin sensor assembly 508, and / or the needle carrier assembly 516, the base 566 allows for easy assembly during manufacturing, including but not limited to properly aligning and pre-assembling the insertion element 520 onto the on-skin sensor assembly 508, and / or being able to easily join the components of the needle hub 518, the insertion element 520, the sensor, and the on-skin sensor assembly 508 to other portions of the assembled applicator 500.

[0167] Figure 20A and Figure 20B A perspective view of a locking feature of an insertion element in the form of needles 600a, 600b for use in an applicator for an analyte sensor system according to some examples is shown. For example, Figure 20A The needle 600a includes a locking feature comprising a ridge 602 configured to mate with a complementary shaped feature within, for example, the needle hub 518. In an alternative embodiment, for example, Figure 20B Needle 600b includes a locking feature comprising a groove 604 configured to mate with a complementary shaped feature within needle hub 518 .

[0168] In yet another alternative, any of the insert elements described in the present disclosure may include, for example, a locking feature that heat rivets the selected insert element to the needle hub 518. In yet another alternative, any of the insert elements described in the present disclosure may include, for example, a locking feature that includes one or more friction fit or snap fit elements that secure the selected insert element to the needle hub 518. In yet another alternative, any of the insert elements described in the present disclosure may include, for example, a locking feature that includes complementary flip-top elements on the selected insert element and the needle hub 518 that are configured to mate with each other. In yet another alternative, any of the insert elements described in the present disclosure may include, for example, a locking element that includes one or more inserted molded elements that are configured to couple the selected insert element to the needle hub 518.

[0169] During manufacturing, the applicator 500 can be assembled in stages. For example, but not limited to, if present, the first barrier layer 512 can be attached to the inner housing 506. The insertion element 520 can be coupled to the needle hub 518, which can then be coupled to the on-skin sensor assembly 508. The second spring 526 can be placed in the retainer 522 or the needle carrier assembly 516, which can then be positioned in the retainer 522 and attached to the needle hub 518 and the on-skin sensor assembly 508 via the wearable retaining elements 534a, 534b. The first spring 524 can be positioned in the retainer 522, which can then be mounted in the inner housing 506. The inner housing 506 can be inserted into and secured to the outer housing 504. If present, the second barrier layer 530 can be attached to the inner housing 506. If a separate element, the activation element 502 can be positioned in the outer housing 504. Any labeling, sterilization, and / or packaging can then be applied to the applicator 500.

[0170] Figures 21 to 23 Several cross-sectional views of yet another applicator 700 for an on-skin sensor assembly of an analyte sensor system are shown, along with various features and operating positions, according to some examples.

[0171] The applicator 700 may include an outer applicator housing 504 including an activation element 502. The outer applicator housing 504 may be configured to translate in a distal direction under the action of a force applied by a host of the applicator 700, thereby aligning the activation element 502 in a position that allows the applicator 700 to be fired, such as Figure 21 As previously described in conjunction with applicator 500, in some examples, activation element 502 can be positioned anywhere, such as on the top, upper side, lower side, or any other location of applicator 700.

[0172] The applicator 700 also includes an inner housing 506 configured to house one or more mechanisms for applying the on-skin sensor assembly 508 to the skin of the host. A distal surface 510 of the bottom opening of the inner housing 506 can define a bottom surface of the applicator 700. In some examples, when the applicator 700 is pressed against the skin of the host, the skin can deform into a substantially convex shape at the distal surface 510, such that at least a portion of the surface of the skin disposed at the bottom opening of the applicator housing 506 extends in a proximal direction into the bottom opening of the inner housing 506, beyond the plane defined by the distal surface 510.

[0173] although Figures 21 to 23 506 may include a spring 536 configured to contact the outer housing 504 and to be in a pre-activated orientation (see FIG. Figure 7) maintains a predetermined spacing between the outer housing 504 and the inner housing 506. The spring 536 may be a compression spring, a leaf spring, a crank spring, a foam or rubber sheet, etc. In some other examples, the outer housing 504 may include the spring 536, and the spring 536 may be configured to contact the inner housing 506.

[0174] The applicator 700 may also include a needle carrier assembly 702. The needle carrier assembly 702 includes an engagement portion, which may be in the form of wearable retention and / or alignment elements 534a, 534b configured to pass through the holder 704 and releasably couple the on-skin sensor assembly 508 to the holder 704 and / or the needle carrier assembly 702. Although two wearable retention and / or alignment elements are shown, any number of wearable retention and / or alignment elements are contemplated.

[0175] The applicator 700 also includes a needle hub 518 configured to couple an insertion element 520 to the needle carrier assembly 702. The insertion element 520 is configured to insert the sensor of the on-skin sensor assembly 508 into the skin of the host. In some examples, the insertion element 520 comprises a needle, such as a side-opening 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 other examples, the insertion element 520 can be integrally formed with the sensor, wherein the insertion element 520 can have sufficient rigidity to be partially inserted into the skin of the host with minimal or no structural support.

[0176] The applicator 700 may further include a retainer 704 that is releasably coupled to the needle carrier assembly 702 and configured to guide the on-skin sensor assembly 508 while coupled to the needle carrier assembly 702 (e.g., at least during translation from a proximal position to a distal insertion position). As previously described in conjunction with the applicator 500, once the on-skin sensor assembly 508 is disposed on the host's skin, the on-skin sensor assembly 508 may be peeled or released from the retainer 704 and / or the needle carrier assembly 702.

[0177] The applicator 700 may also include an insertion assembly configured to translate the insertion element 520, the needle hub 518, and the needle carrier assembly 702 in a distal direction from a proximal position to a distal insertion position. Such an insertion assembly may include a first spring 524. The first spring 524 may be a compression spring or any suitable type of spring and may have its first end contacting or coupled to the inner applicator housing 506 and its second end contacting or coupled to the retainer 704. The first spring 524 is configured to translate the retainer 704, the needle carrier assembly 702, the needle hub 518, the insertion element 520, and the on-skin sensor assembly 508 in a distal direction to the distal insertion position upon activation of the insertion assembly. Essentially at the distal insertion position, the needle carrier assembly 702 may be disengaged from the retainer 704 and the on-skin sensor assembly 508.

[0178] The applicator 700 may also include a retraction assembly configured to translate the needle carrier assembly 702, the needle hub 518, and the insertion element 520 in a proximal direction from a distal insertion position to a proximal retracted position. In some examples, the initial proximal position may be the same as the proximal retracted position. In other examples, the initial proximal position may be different from the proximal retracted position. Such a retraction assembly may include a second spring 706. The second spring 706 may be a compression spring or any other suitable type of spring and may have a first end that contacts or couples to the retainer 704 at least until retraction and a second end that contacts or couples to the retainer 704, the second end including a tang 708 (e.g., a spring portion or spring end) that is disposed substantially along the diameter of the second spring 706. The spring retaining element 710 may include, for example, an arm, a deflection element, a tab, a detent, a snap, or any other feature capable of maintaining functionality. The spring retaining element 710 can have substantially the same form and function as the spring retaining elements 528a, 528b of the applicator 500, except as described below. The second spring 706 is configured to translate the needle carrier assembly 702, the needle hub 518, and the insertion element 520 in a proximal direction from the distal insertion position to the proximal retracted position. When the spring retaining element 710 is not supported by the stop element 712, and in response to the tang 708 of the second spring 706 pushing against the spring retaining element 710 with a force exceeding a predetermined threshold sufficient to overcome and deflect the spring retaining element 710, the tang 708 of the second spring 706 is released from the spring retaining element 710 in the distal insertion position.

[0179] The needle carrier assembly 702 also includes a stop feature 712 configured to prevent lateral movement of the spring retaining element 710 of the retainer 704 in at least the proximal pre-activated position, thereby supporting the second spring 706 between the spring retaining element 710 and the retainer 704 until retracted. Figure 21In the orientation shown, the second spring 706 applies a force to the spring retaining element 710 , but the stop feature 712 prevents lateral deflection of the retaining element 710 .

[0180] The retainer 704 also includes a needle carrier retaining element 542, which may include a deflectable arm, a rigid arm, a deformable feature, a snap, a catch, or a hook. When the needle carrier assembly 702 reaches the proximal retracted position after activation, the needle carrier retaining element 542 is configured to engage with the needle carrier assembly 702, thereby retaining the needle carrier assembly 702, the needle hub 518, and the insertion element 520 in the locked retracted position, thereby restricting access to the insertion element 520.

[0181] although Figures 21 to 23 550, and the needle carrier assembly 702 may also include a protrusion 552 and may be substantially as previously combined with at least Figures 10 to 12 The above works.

[0182] although Figures 21 to 23 Although not shown, the inner housing 506 of the applicator 700 may also include a protrusion extending in the distal direction from the inner housing 506, substantially as the protrusion 548 previously described. Figure 13 Similar to the description, the protrusion can be configured to contact at least one of the spring retaining element 710 and the stop feature 712 in the pre-activated state, thereby preventing the spring retaining element 710 from lateral deflection until the retainer 704 and the needle carrier assembly 702 have translated in the distal direction at least a predetermined minimum distance. Thus, the protrusion can provide a drop protection measure so that the applicator 700 does not fire prematurely in response to the shock of being dropped before activation.

[0183] The applicator 700 functions substantially similarly to the applicator 500, except that, instead of utilizing spring retaining elements 528a, 528b (which are disposed along the outside of the second coil of spring 526 and are configured to contact and retain the coil of spring 526), the applicator 700 utilizes a spring retaining element 710 (which is disposed along the inside of spring 706 and is configured to contact and retain the tang 708 of the second spring 706 along a diameter of the spring 706). Positioning the spring retaining element 710 within the second spring 706 and substantially along the center of the second spring 706, as opposed to along the outside of the second spring 706, further ensures that the spring retaining element 710 does not contact the coil of the second spring 706 when the second spring 706 is extended during retraction, thereby smoothing the operation of the applicator 700. Additionally, as opposed to the spring retaining elements 528a, 528b, the arrangement including the spring retaining element 710 mitigates the risk and difficulty of substantially simultaneously triggering or overcoming multiple spring retaining elements.

[0184] Figure 21 The applicator 700 is shown in a state prior to activation according to some examples. The retainer 704, needle carrier assembly 702, needle hub 518, insertion element 520, on-skin sensor assembly 508, first spring 524, and second spring 526 are all shown in a pre-activated position.

[0185] The retaining element 532 of the retainer 704 contacts the inner housing 506, thereby securing the retainer 704, and therefore also the needle carrier assembly 702, needle hub 518, insertion element 520, and on-skin sensor assembly 508, in the pre-activated state.

[0186] The stop feature 712 of the needle carrier assembly 702 contacts and prevents the spring retaining element 710 from deflecting laterally, thereby ensuring that the spring retaining element 710 retains the tang 708 of the second spring 706 in the loaded or pre-activated position as shown.

[0187] Activation of the applicator 700 may include the host pressing the applicator 700 against their skin with sufficient force to cause the outer housing 504 to translate in a distal direction toward and relative to the inner housing 506 until the activation element 502 is aligned with the insertion assembly retaining element 532 of the retainer 704, as shown. Figure 21 Once this alignment is achieved, the host can activate the activation element 502, thereby sufficiently deflecting the insertion assembly retaining element 532 to release the retainer 704 from the inner housing 506. In some other examples, the applicator 700 can be configured such that the activation element 502 can be activated first, but the actual insertion is not triggered until the outer housing 504 is sufficiently translated in the distal direction toward and relative to the inner housing 506. In still other examples, the activation element 502 can be biased toward the center of the applicator 700 so that the activation element 502 does not need to be explicitly activated by the host, but instead, the activation element 502 can be configured to automatically initiate insertion when the outer housing 504 is sufficiently translated in the distal direction toward and relative to the inner housing 506.

[0188] Figure 22 The applicator 700 is shown after activation and during insertion according to some examples. The first spring 524 drives the retainer 704, and thus the needle carrier assembly 702, the needle hub 518, the insertion element 520, and the on-skin sensor assembly 508, in a distal direction toward a distal insertion position. Figure 22 The on-skin sensor assembly 508 is shown in contact with the host's skin, but wherein the retainer 704 has not yet been fully driven by the first spring 524 into contact with the on-skin sensor assembly 508 or the host's skin.

[0189] In some examples, the mass of each of the retainer 704, the needle carrier assembly 702, the needle hub 518, the insertion element 520, and the on-skin sensor assembly 508 can be specifically designed to reduce or substantially eliminate the tendency of the needle carrier assembly 702, the needle hub 518, the insertion element 520, and the on-skin sensor assembly 508 to disengage from the retainer 704 when driven in the distal direction during insertion. In some examples, the force applied by the first spring 524 can also be selected to be sufficient for proper operation of the applicator 500 while not being so great as to further exacerbate the inertially triggered disengagement described above. In some examples, a spring (not shown) can be configured to apply a force against a portion of the needle carrier assembly 702 in the distal direction that is sufficient to prevent the needle carrier assembly 516 from inertially triggered disengagement from the retainer 704 during insertion, for example.

[0190] Figure 23 The applicator 700 is shown after activation and at or near the distal insertion position according to some examples. The first spring 524 has driven the retainer 704, the needle carrier assembly 702, and the on-skin sensor assembly 508 in the distal direction to the distal insertion position. Because the first spring 524 has driven the retainer 704 a short distance further in the distal direction than the needle carrier assembly 702, the stop feature 712 is no longer in contact with the spring retaining element 710, thereby allowing the second spring 706 (e.g., the tang 708) to laterally deflect the spring retaining element 710, thereby releasing the second spring 706, which drives the needle carrier assembly 702 in the proximal direction. Alternatively, in combination with the above Figure 13 , wherein the angle θ of the portion of the spring retaining element 710 that contacts the tang 708 of the second spring 526 is substantially 90° (e.g., flat), the spring retaining element 710 can be biased to automatically deflect sufficiently to release the second spring 526 when the stop feature 712 is no longer in contact with the spring retaining element 710, thereby releasing the second spring 706 to drive the needle carrier assembly 702 in the proximal direction. Although Figures 21 to 23 5. Not shown, but the inner housing 506 may further include an engagement element 550 configured to engage with the protrusion 552 of the needle carrier assembly 702 and substantially as previously combined with at least Figures 10 to 12 In some examples, a stop feature (not shown) can be provided at the bottom of the applicator 700, for example, on a distal portion of the inner housing 506. Such a stop feature can be configured to contact one or more of the on-skin sensor assembly 508, the needle carrier assembly 702, or the retainer 704 in the distal insertion position.

[0191] Upon release of the second spring 706, the second spring 706 is configured to urge the needle carrier assembly 702, the needle hub 518, and the insertion element 520 in a proximal direction. Figure 23Not shown, but when the needle carrier assembly 702 moves to the proximal retracted position, the needle carrier retaining element 542 can engage with the needle carrier assembly 702, thereby maintaining the needle carrier assembly 702, the needle seat 518 and the insertion element 520 in a locked retracted position that limits access to the insertion element 520.

[0192] Figure 24 A perspective view of the retainer 704 , the first spring 524 , and the second spring 706 of the applicator 700 is shown, according to some examples. Figure 24 The spring retaining element 710 is shown with the retaining tang 708 of the second spring 706 in a certain orientation within the applicator 700 prior to retraction.

[0193] During manufacture, the applicator 700 may be assembled in stages. For example, but not limited to, if present, the first barrier layer 512 (see Figure 6 ) can be attached to the inner housing 506. The insertion element 520 can be coupled to the needle hub 518, which can then be coupled to the on-skin sensor assembly 508. The second spring can be placed into the retainer 704 or the needle carrier assembly 702, which can then be positioned into the retainer 704 and attached to the needle hub 518 and the on-skin sensor assembly via the wearable retaining elements 534a, 534b. The first spring 524 can be positioned in the retainer 704, which can then be mounted into the inner housing 506. The inner housing 506 can be inserted into and secured to the outer housing 504. If present, the second barrier layer 530 (see Figure 6 ) can be attached to the inner housing 506. If a separate element, the activation element 502 can be provided in the outer housing 504. Any labeling, sterilization and / or packaging can then be applied to the applicator 700.

[0194] In an example, the applicator system may include a cap and / or liner removal component. For example, Figure 25 An example of an applicator 900 is shown having an applicator housing 902 configured to hold an on-skin wearable medical device and a deployment mechanism configured to deploy the on-skin wearable medical device to the skin. The applicator housing 902 can be configured similarly to the examples of applicators disclosed herein, including having a housing 902 as described with respect to Figures 5 to 24 904 and inner housing 906 are disclosed in the example of FIG. For example, outer housing 904 can be configured similarly to outer housing 504, and inner housing can be configured similarly to inner housing 506. In an example, applicator housing 902 can be configured to be grasped by a user. Various other configurations of applicator housings can be utilized as desired.

[0195] Applicator housing 902 may include an interior cavity 903 for holding a skin-wearable medical device. Housing 902 may include an opening 905 at an end portion 907 of interior cavity 903 for deploying the skin-wearable medical device from the opening. Interior cavity 903 may include a proximal end portion 909 that may include the skin-wearable medical device coupled to a needle carrier assembly.

[0196] The deployment mechanism can be configured similarly to other forms of deployment mechanisms disclosed herein. Figures 5 to 24 The deployment mechanism may be configured similarly to the deployment mechanism disclosed in the examples of . For example, in the examples, the deployment mechanism may include an engagement portion in the form of one or more retaining elements that are used to retain the skin wearable medical device and release the skin wearable medical device from the housing 902 to the skin. The deployment mechanism may include an insertion assembly for inserting at least a portion of the skin wearable medical device into the skin. The insertion assembly may insert an insertion element (e.g., a needle) into the skin. The deployment mechanism may drive the insertion element to the skin when the deployment mechanism deploys the skin wearable medical device to the skin. The deployment mechanism may include a retraction assembly for retracting the insertion element from the skin. In the examples, other forms of deployment mechanisms may be utilized as needed.

[0197] The applicator 900 may include an activation element 908 that may operate similarly to the activation element 502. The applicator 900 may include a needle carrier assembly 910 that may operate similarly to the needle carrier assembly 516. The applicator 900 may include a retainer 912 that may operate similarly to the retainer 522. The applicator 900 may include a hub (e.g., a needle hub 914) that may operate similarly to the needle hub 518. The applicator 900 may include an insertion element 915 (e.g., a needle) that may operate similarly to the insertion element 520. The applicator 900 may include springs 916, 918 that may operate similarly to the springs 524, 526, respectively. The applicator 900 may include retaining elements 920a, 920b that may operate similarly to the retaining elements 534a, 534b, respectively. Figures 5 to 24 Additional components of the applicator shown may be utilized with the applicator 900. The applicator 900 may be used with Figures 5 to 24 The applicators shown operate in a similar manner and provide similar functionality.

[0198] The applicator 900 can include a cap 942 that can be positioned at a distal portion of the applicator housing 902 and can cover the distal opening 905 of the lumen 903. The cap 942 can include a gripping portion 944 on an outer surface of the cap 942 and an engagement portion 946 on an inner surface of the cap 942. The cap 942 can include a central portion 948 that covers and spans the distal opening 905 of the lumen. The cap 942 can include an outer cover for the applicator 900 when the applicator 900 is being transported and disassembled.

[0199] The central portion 948 of the cap 942 may include one or more openings 950 that may allow sterilizing material, such as sterilizing gas, to pass through to sterilize the internal components of the applicator 900. The central portion 948 may include a central support 952 that may be configured to press against the liner removal component 928 to hold the liner removal component 928 in place. The central support 952 may be configured to rotate when the cap 942 is disengaged or unscrewed from the applicator housing 902.

[0200] The engagement portion 946 of the cap 942 may include threads or another form of engagement portion 946 for engaging a corresponding engagement portion 954 on the outer surface of the housing 902. The engagement portion 946 may be configured to rotate relative to the applicator housing 902 to unscrew from the housing 902 and allow the liner removal component 928 to be released from the applicator housing 902.

[0201] The applicator 900 may include a liner removal component 928. The liner removal component 928 may be configured to engage a liner 926 positioned on an engagement surface of the patch 922 and remove the liner 926 from the engagement surface of the skin wearable medical device when retracted from the engagement surface of the skin wearable medical device. The liner removal component 928 may include an engagement surface 930 for engaging the liner 926. The engagement surface 930 may be a flat surface that may extend parallel to the liner 926. The engagement surface 930 may include an opening 927 configured to allow the insertion element 915 to pass therethrough. The liner removal component 928 may also include a sheath 939 configured to cover the insertion element 915. The liner removal component 928 may also include a raised portion 936 that may extend from a distal portion 932 of the liner removal component 928. The raised portion 936 may extend axially within the lumen 903.

[0202] The distal portion 932 of the liner removal member 928 may include a flange 933 for a user to grasp to remove the liner removal member 928 from the inner cavity 903 and thereby remove the liner 926 from the engaging surface of the wearable medical device on the skin. In an example, the flange 933 may not be used.

[0203] In an example, a liner 926 may be positioned over the bonding surface of the patch. The liner may cover the bonding surface and may protect the bonding surface from damage, degradation, or other adverse effects. For example, the liner may include a sheet of material covering the bonding surface of the patch. The liner may have a proximal surface that contacts the bonding surface of the patch and a distal surface that faces opposite the proximal surface. In an example, the liner may be configured to reduce the likelihood that the exposed bonding surface will deteriorate or otherwise lose its adhesive properties prior to deployment. For example, during a sterilization process using a gas or other sterilizing material, the liner may reduce the likelihood of degradation of the bonding surface. As desired, the sterilizing gas may include ethylene oxide (EtO) or another form of sterilizing gas. However, the liner will be removed from the bonding surface before the on-skin sensor assembly is deployed to the skin.

[0204] The applicator 900 can be used to deploy a skin-wearable medical device to the skin. The skin-wearable medical device may include, for example, Figure 6 The on-skin sensor assembly 508 shown may include a housing, an analyte sensor coupled to the housing, an electronics unit, and a patch 922. The on-skin sensor assembly may have, for example, Figures 2A to 4 The form shown, or other forms as required.

[0205] The cap 942 and liner removal component 928 may be removed prior to deploying the on-skin wearable medical device to the skin.

[0206] Upon activation, an applicator as disclosed herein may insert the analyte sensor into the skin of a host by utilizing an insertion element, such as insertion element 915 .

[0207] refer to Figure 26A , the insertion element 915 can drive the analyte sensor 956 of the on-skin sensor assembly 508 into the host's skin with the analyte sensor 956 extending along the channel 958 of the insertion element 915.

[0208] For example, the analyte sensor 956 may include a first portion 960 or contact portion that can be coupled to the housing 962 of the on-skin sensor assembly 508. For example, the first portion 960 may include electrical contacts 964 that can be electrically connected to electrical terminals of the on-skin sensor assembly 508 or another component of the on-skin sensor assembly 508. The electrical terminals can be located on an interface board or circuit board, or on another component of the on-skin sensor assembly 508 as desired. Other coupling methods between the first portion 960 and the housing 962 can be utilized as desired.

[0209] The analyte sensor 956 may include a second portion 966 including a sensing portion that may be configured to be inserted into or through the host's skin and positioned in or under the skin. In an example, the second portion 966 may extend distally from a distal surface 968 of the housing 962 and may be guided into the host's skin by the insertion element 915. The second portion 966 may be straight and may be axially aligned with the opening 978 through which the insertion element 915 passes, as shown. Figure 26A shown.

[0210] The analyte sensor 956 may include an elongated analyte sensor. The second portion 966 may extend distally for positioning within the host's skin layer. In an example, the second portion 966 of the analyte sensor 956 may extend perpendicularly relative to the distal surface 968 of the housing 962. In an example, other angles may be used as desired. The second portion 966 may extend perpendicularly relative to the first portion 960 of the analyte sensor 956. In an example, other angles may be used as desired.

[0211] The bend 970 can angle the second portion 966 of the analyte sensor 956 relative to the first portion 960 of the analyte sensor 956. For example, the bend 970 can be positioned between the second portion 966 and the first portion 960 and can have a shape such as: Figure 26A The curvature shown may be continuous, or may have another form as desired. The bend 970 may cause the second portion 966 to be at a right angle relative to the first portion 960 or at another angle as desired. The bend 970 may be axially aligned with the opening 978 through which the insertion element 915 passes, as shown. Figure 26A Other forms of analyte sensor 956 may be utilized as desired.

[0212] The housing 962 of the on-skin sensor assembly 508 can be configured similarly to other forms of housing disclosed herein. The housing 962 can include a wearable housing. The housing 962 can be configured to be worn on the host's skin. The housing 962 can include a distal surface 968 that can be configured to face the host's skin. The patch 922 can be positioned on the distal surface 968 of the housing 962. The patch 922 can include an engagement surface 974 for engaging the host's skin. The engagement surface 974 can include an adhesive surface, as shown, or another type of surface.

[0213] The housing 962 can include a proximal surface 972 that faces opposite the distal surface 968. The proximal surface 972 can extend parallel to the distal surface 968, or can have another configuration as desired.

[0214] In an example, the housing 962 may include a cavity 976 that can receive the first portion 960 of the analyte sensor 956. The cavity 976 can have various forms as needed. For example, the cavity 976 can be configured to hold an adhesive (which may include a liquid adhesive or a curable adhesive), which can couple the first portion 960 of the analyte sensor 956 to the housing 962 in an example. The cavity 976 may include one or more dams or other features that can hold an adhesive and, if necessary, can be used to electrically insulate the parts of the analyte sensor 956 from each other. In an example, the cavity 976 may include a recessed portion into which the first portion 960 of the analyte sensor 956 is inserted, thereby being coupled to the housing 962 in other ways. In an example, the cavity 976 may not be used, and the first portion 960 of the analyte sensor 956 can be coupled to the housing 962 in other ways.

[0215] The housing 962 may include an opening 978 through which the insertion element 915 passes. The opening 978 may extend through the proximal surface 972 of the housing 962 and may extend to the distal surface 968 of the housing 962. The opening 978 may be configured to allow the insertion element 915 to be retracted proximally from the skin therethrough. The insertion element 915 may be retracted after penetrating the host's skin. In examples, the insertion element 915 may be positioned within the opening 978 when inserted into the host's skin, or may be passed distally relative to the opening 978 when inserted into the host's skin. Figure 26A In the example shown, the insertion element 915 can be positioned within the opening 978 and can be stationary relative to the opening 978 when inserted into the host's skin. Figures 7 and 8 and Figures 21 to 23 As shown, the insertion element 915 can move distally with the housing 962 of the on-skin sensor assembly 508 and can remain stationary relative to the housing 962 when inserted into the host's skin. In examples, other forms of insertion can be utilized.

[0216] Insertion element 915 may include a proximal end portion 980 and a distal end portion 982 including a tip 984 of insertion element 915. Tip 984 may include a sharp tip in examples and may be configured to pierce and be inserted into the skin of a host.

[0217] The needle hub 914 can be positioned at the proximal end portion 980 of the insertion element 915. The needle hub 914 can be in contact with the proximal surface 972 of the housing 962, or can be spaced apart from the proximal surface 972 as desired.

[0218] Figure 27 A perspective view of an on-skin wearable medical device in the form of an on-skin sensor assembly 508 is shown. A wearable housing 509 of the on-skin sensor assembly 508 is shown with the patch 922 (in the figure) excluded from view for clarity. Figure 25 (marked in the middle).

[0219] The wearable housing 509 has a diameter 511 and a height 513 (in Figure 27 ). The wearable housing 509 may also include one or more outer surfaces 515 having a contour defining the shape of the wearable housing 509. The wearable housing 509 includes a shape (e.g., Figure 27 The wearable housing 509 includes an outer upper, top, or proximal surface 517 having a flat shape (as shown). The wearable housing 509 includes an outer lower, bottom, or distal surface 519 having a certain shape. The distance from the outer upper surface 517 to the outer lower surface 519 of the housing 509 may include the height 513 of the housing 509.

[0220] The wearable housing 509 may also include one or more coupling features 521 that may be configured to engage an engagement portion of the applicator. The coupling features 521 may have various forms and may include, for example, Figure 27 The recess shown. Other forms of coupling features (e.g., protrusions, adhesives) may be utilized in examples as desired. The coupling feature 521 may be located on one or more exterior surfaces 515 of the housing 509, or may have other locations in examples as desired. The coupling feature 521 may be configured to engage an engagement portion of an applicator, which may be in the form of wearable retention and / or alignment elements 534a, 534b, such as, for example, Figure 15 and Figure 16 shown.

[0221] In an example, a stabilizing feature 523 can be provided that can stabilize the wearable housing 509 within the applicator. The stabilizing feature 523 can include, for example, a recess in one or more of the outer surfaces 515 that can mate with a stabilizer of the applicator. The stabilizer can contact the stabilizing feature 523 to prevent displacement or other movement of the on-skin sensor assembly 508 within the applicator.

[0222] The configuration of the on-skin sensor assembly 508 can be adapted to an applicator (e.g., the applicators disclosed herein, including applicators 500, 700). For example, the size of the on-skin sensor assembly 508 (e.g., the diameter 511 and / or height 513 of the wearable housing 509) can be adapted to the applicator and to the engagement portion of the applicator. Figure 15 and Figure 16 The illustrated engagement portions in the form of wearable retention and / or alignment elements 534a , 534b may be sized and otherwise configured to engage with the wearable housing 509 of the on-skin sensor assembly 508 .

[0223] The position and shape of the coupling feature 521 can be further configured to engage an engagement portion of an applicator. For example, the coupling feature 521 can be positioned, shaped, or otherwise configured for wearable retention and / or alignment elements 534a, 534b to enter, such as Figure 15 and Figure 16 Stabilizing feature 523 may further be positioned, shaped, or otherwise configured to cooperate with a stabilizer of an applicator.

[0224] An applicator (eg, an applicator disclosed herein, including applicators 500, 700) may thus be configured to engage and deploy Figure 27 The on-skin sensor assembly 508 is shown. The engaging portion of the applicator (e.g., as e.g. Figure 15 and Figure 16 The wearable retention and / or alignment elements 534a, 534b) shown may be adapted to fit the on-skin sensor assembly 508.

[0225] However, other forms of skin-wearable medical devices may be utilized in examples. For example, Figure 28 Shown with Figure 27 Perspective views of an on-skin wearable medical device showing different configurations of the on-skin wearable medical device are shown. Figure 28 A skin-wearable medical device is shown in the form of an on-skin sensor assembly 1000. A wearable housing 1002 of the on-skin sensor assembly 1000 is shown (with the patch excluded from view for clarity). The patch can have a configuration similar to other configurations of patches disclosed herein, or can have other configurations as desired.

[0226] The wearable housing 1002 may have a diameter 1004 and a height 1006. The wearable housing 1002 may also include one or more outer surfaces 1008 having a contour defining the shape of the wearable housing 1002. The wearable housing 1002 may include a housing having a certain shape (e.g., Figure 28 The wearable housing 1002 includes an outer upper, top, or proximal surface 1010 (a flat shape as shown). The wearable housing 1002 includes an outer lower, bottom, or distal surface 1012 having a certain shape. The distance from the outer upper surface 1010 to the outer lower surface 1012 of the housing 1002 may include the height 1006 of the housing 1002.

[0227] The wearable housing 1002 may also include one or more coupling features 1014. The coupling features 1014 may have various forms and may include, for example, Figure 28The recess shown. Other forms of coupling features (e.g., protrusions, adhesives) may be utilized in examples as needed. The coupling features 1014 may be located on one or more exterior surfaces 1008 of the housing 1002, or may have other locations in examples as needed.

[0228] Figure 28 The configuration of the on-skin sensor assembly 1000 shown is different from Figure 27 The configuration of the on-skin sensor assembly 508 is shown. For example, the size of the on-skin sensor assembly 1000 is different from Figure 27 The size of the on-skin sensor assembly 508 is shown. For example, the diameter 1004 of the housing 1002 is smaller than the diameter 511 of the housing 509. For example, the height 1006 of the housing 1002 is smaller than the height 513 of the housing 509. Figure 27 and Figure 28 are shown as being different, but in examples, one or more of the height or diameter may be different.

[0229] Figure 28 The shape of the on-skin sensor assembly 1000 shown is different from Figure 27 The shape of the on-skin sensor assembly 508 is shown. Figure 27 The on-skin sensor assembly 508 is shown, for example, having a wider end portion and a narrower end portion, and Figure 28 The on-skin sensor assembly 1000 is shown to have end portions of uniform width. The on-skin sensor assembly 1000 may have an oval shape or an elliptical shape, and Figure 27 The on-skin sensor assembly 508 can have an oval shape with one end portion wider than the other end portion.

[0230] Figure 28 The configuration of the on-skin sensor assembly 1000 shown may vary. Figure 27 The configuration of the on-skin sensor assembly 508 shown may vary in size, location, or other configuration of the coupling features. For example, Figure 27 The illustrated coupling feature 521 may be positioned at an end portion of the wearable shell 509 . Figure 28 The illustrated coupling feature 1014 may be positioned at a mid-portion of the wearable housing 1002 . Figure 28 The configuration of the on-skin sensor assembly 1000 shown may be configured differently as desired. Figure 27 The configuration of the on-skin sensor assembly 508 is shown.

[0231] Thus, the on-skin sensor assembly 1000 may include a coupling mismatch with an applicator (e.g., an applicator disclosed herein, including applicators 500, 700). The applicator may be configured to mate Figure 27The on-skin sensor assembly 508 shown, however, due to Figure 28 As a variation of the configuration of the on-skin sensor assembly 1000 shown, the applicator may not be fitted with the on-skin sensor assembly 1000. For example, see Figure 15 and Figure 16 , the engagement portion in the form of the wearable retention and / or alignment elements 534a, 534b may not be configured to engage with the on-skin sensor assembly 1000.

[0232] See also Figure 29A In an example, an adapter body 1020 may be utilized. The adapter body 1020 may be configured to interface between at least a portion of the on-skin wearable medical device and the applicator. The adapter body 1020 may, for example, adapt at least a portion of the on-skin wearable medical device to mate with an engaging portion of the applicator. For example, see Figure 27 and Figure 28 , the adapter body 1020 can allow the on-skin sensor assembly 1000 to mate with an engagement portion of an applicator that is configured to mate with the on-skin sensor assembly 508. The engagement portion can be configured to engage the adapter body 1020.

[0233] In examples, the adapter body 1020 can be configured to interface in various ways. For example, the adapter body 1020 can interface with the portion of the sensor assembly 1000 having the first configuration (e.g., Figure 28 ) and a second configuration of the applicator configured to engage the sensor assembly 508 on the skin, different from the first configuration (as shown in FIG. Figure 27 ) (e.g., as shown in Figure 15 and Figure 16 The configurations may differ from one another in one or more of shape, size, or other configurations (e.g., the location or shape of the coupling features). The configurations may be configurations of the respective wearable housings 509, 1002 or other portions of the assemblies 508, 1000.

[0234] In an example, on-skin sensor assembly 1000 can be smaller than on-skin sensor assembly 508. The size difference can be a size difference between housings 509, 1002 of on-skin sensor assemblies 508, 1000. For example, housing 1002 can be provided with a smaller diameter or a smaller height. Adapter body 1020 can therefore include a spacer body configured to space the size difference between on-skin sensor assemblies 508, 1000. In an example, other forms of interfaces can be provided.

[0235] In an example, the adapter body 1020 can be configured to adapt a skin-wearable medical device that can be modified or adjusted from a first configuration to a second configuration. For example, the skin-wearable medical device can have components or modules added or removed, or other variations in the skin-wearable medical device, that can change the configuration of the skin-wearable medical device for engagement with an applicator. The added or removed components or modules can include electrical components or modules (e.g., communication components, a power source such as a battery, sensing components, a processor, etc.) or other configurations of components or modules. Variations of the skin-wearable medical device can change the shape, size, or other configuration of the skin-wearable medical device (e.g., the location or shape of coupling features) from a first configuration to a second configuration. Thus, a skin-wearable medical device with a first configuration can be the same skin-wearable medical device with a second configuration. The adapter body 1020 can be configured to interface between the skin-wearable device with the second configuration and the applicator (while the applicator can be configured to engage the same skin-wearable device with the first configuration without the use of the adapter body 1020). Other uses of the adapter body 1020 can result.

[0236] See also Figure 29A and Figure 29B , the adapter body 1020 can include a retaining area 1022 for receiving at least a portion of the on-skin wearable medical device. For example, the retaining area 1022 can include a cavity for receiving at least a portion of the on-skin wearable medical device.

[0237] The adapter body 1020 may include one or more walls that may define a retention area 1022. The one or more walls may include one or more side walls 1024 that may define the retention area 1022. The side walls 1024 may be configured to cover the corresponding side surfaces 1008 (at Figure 28 (marked in the middle).

[0238] Sidewall 1024 may include an inner surface 1026 (at Figure 29B ) and outer surface 1028. Inner surface 1026 can be configured to face the portion of the skin-wearable medical device that can be positioned within retention region 1022. Outer surface 1028 can be configured to face opposite inner surface 1026 and can face radially outward from the skin-wearable medical device.

[0239] The one or more side walls 1024 can have a spacing between the inner surface 1026 and the outer surface 1028, which can be configured to separate the outer surface 1008 of the wearable medical device on the skin (at Figure 281024 is spaced apart from an outer surface 1028 of the one or more side walls 1024. For example, the outer surface 1008 of the skin wearable medical device may include the outer side surface 1008 of the housing 1002. The thickness of the one or more side walls 1024 may form the spacing, or the spacing may be provided in other ways.

[0240] The inner surface 1026 can be configured to contact the outer surface 1008 of the on-skin wearable medical device. The inner surface 1026 can be contoured to the shape of the outer surface 1008 of the on-skin wearable medical device to provide a contoured fit with the shape of the outer surface 1008. In an example, the outer surface 1028 of the adapter body 1020 can have a different contour than the inner surface 1026 of the adapter body 1020.

[0241] For example, inner surface 1026 may form an inner perimeter 1030 of adapter body 1020. Outer surface 1028 may form an outer perimeter 1032 of adapter body 1020. Inner perimeter 1030 may have a different contour than outer perimeter 1032. Such a feature may account for the difference in shape between outer side surface 1008 of on-skin sensor assembly 1000 and the shape of the adapter body 1020 to which the on-skin sensor assembly 1000 is adapted. For example, if the engagement portion of the applicator is configured to fit a square shape, and outer side surface 1008 of on-skin sensor assembly 1000 has an oval shape, outer perimeter 1032 may be contoured to a square shape. However, inner perimeter 1030 may maintain an oval shape to accommodate the shape of outer side surface 1008 of on-skin sensor assembly 1000. In an example, inner perimeter 1030 may have a smaller diameter than outer perimeter 1032. The engagement portion may be configured to engage at least a portion of one or more walls of the adapter body. The engagement portion may be configured to engage an outer surface of the adapter body.

[0242] The spacing between inner surface 1026 and outer surface 1028 can adapt the on-skin wearable medical device to fit the engagement portion of the applicator. For example, the engagement portion of the applicator can be configured to engage an on-skin sensor assembly having a larger diameter than on-skin sensor assembly 1000. The spacing can compensate for differences in diameter. Alternatively, or in combination, the spacing can compensate for differences in shape between on-skin sensor assemblies.

[0243] The one or more walls may include an upper wall 1034 that may define the retention area 1022. The upper wall 1034 may be configured to cover a corresponding outer upper surface, top surface, or proximal surface 1010 (at Figure 28 ). The upper wall 1034 may include an inner surface 1036 (at Figure 29B) and outer surface 1038. Inner surface 1036 can be configured to face the portion of the skin wearable medical device that can be positioned within retention region 1022. Outer surface 1038 can be configured to face opposite inner surface 1036 and can face radially outward from the skin wearable medical device.

[0244] The upper wall 1034 can have a spacing between the inner surface 1036 and the outer surface 1038, which can be configured to separate the outer upper surface, top surface, or proximal surface 1010 (at Figure 28 1034 is spaced apart from the outer surface 1038 of the upper wall 1034. For example, the outer surface 1010 of the skin wearable medical device may include the outer upper surface 1010 of the housing 1002. The thickness of the upper wall 1034 may form the spacing, or the spacing may be provided in other ways. The upper wall 1034 may include an opening 1035 that may allow for the insertion or retraction of an insertion element (such as a needle).

[0245] The inner surface 1036 can be configured to contact the outer surface 1010 of the on-skin wearable medical device. The inner surface 1036 can be contoured to the shape of the outer surface 1010 of the on-skin wearable medical device to provide a contoured fit with the shape of the outer surface 1010. In an example, the outer upper surface 1038 of the adapter body 1020 can have a different contour than the inner surface 1036 of the adapter body 1020.

[0246] The spacing between the inner surface 1036 and the outer surface 1038 can adapt the on-skin wearable medical device to fit the engagement portion of the applicator. For example, the engagement portion of the applicator can be configured to engage an on-skin sensor assembly having a greater height than the on-skin sensor assembly 1000. The spacing can compensate for differences in height. Alternatively, or in combination, the spacing can compensate for differences in shape between on-skin sensor assemblies.

[0247] In an example, the sidewall 1024 can extend distally from the upper wall 1034. In an example, the sidewall 1024 can extend distally from an outer edge or perimeter of the upper wall 1034. In an example, other configurations can be provided.

[0248] One or more stabilizers 1040 may be provided to stabilize the skin-wearable medical device within the holding region 1022. For example, the stabilizer may include a Figure 29B The stabilizer 1040 may comprise a portion of one or more of the sidewalls 1024, including an inner surface 1026 of the sidewall 1024.

[0249] See also Figure 29A and Figure 29B , the outer surface 1028 of the side wall 1024 may include a stabilizing feature 1042 that may be configured to stabilize the adapter body 1020 within the applicator. The stabilizing feature 1042 may include a recessed portion of the outer surface 1028 of the side wall 1024. The stabilizing feature 1042 may have a shape similar to, for example, Figure 27 The profile and location of the stabilizing feature 523 are shown. Thus, the stabilizing feature 1042 can be used to stabilize the adapter body 1020 in a manner similar to how the stabilizing feature 523 stabilizes the on-skin sensor assembly 508 within the applicator. Other configurations of stabilizing features can be utilized as desired.

[0250] The adapter body 1020 can include a retainer portion 1044 for retaining the on-skin wearable medical device to the adapter body 1020. The retainer portion 1044 can have various forms. In an example, the retainer portion 1044 can include one or more device couplers 1046 that can couple the on-skin wearable medical device to the adapter body 1020.

[0251] In examples, the device coupler 1046 can have various forms. Figure 29B , the device coupler 1046 may include a protrusion 1048 that may be configured to engage the on-skin sensor assembly 1000. The protrusion 1048 may be configured to engage the coupling feature 1014 (e.g., such as Figure 30C ). Protrusion 1048 can enter into coupling feature 1014 in the form of a recess in wearable housing 1002. In examples, device coupler 1046 can have other forms. For example, the device coupler can include a protrusion or a recess, or one or more of the protrusion or recess. The device coupler can include an adhesive or can have another form.

[0252] In an example, the device coupler 1046 can be positioned at an edge portion of the upper wall 1034 and can include a portion of the side wall 1024 of the adapter body 1020. In an example, the device coupler 1046 can have other locations.

[0253] The device coupler 1046 may include a releasable coupler configured to release the skin-wearable medical device from the adapter body 1020. For example, the device coupler 1046 may be configured to deflect to release the skin-wearable medical device from the adapter body 1020. The deflection may be in a radially outward direction to allow the device coupler 1046 to disengage from the skin-wearable medical device.

[0254] In an example, the device coupler 1046 may include an arm. For example, the arm 1050 may extend in a distal direction from the upper wall 1034. The end portion of the arm 1050 may include a protrusion 1048. The arm 1050 may be coupled to the upper wall 1034 using a hinge portion 1052. For example, see Figure 30C , the hinge portion 1052 can allow the arm 1050 to deflect radially outward from the wearable housing 1002. The hinge portion 1052 can be configured to pivot about an axis extending parallel to a plane of the adapter body 1020 (e.g., the plane of the upper wall 1034).

[0255] In an example, the arms 1050 can define a retention region 1022. The arms 1050 can deflect the retention region 1022 radially outward to allow the on-skin wearable medical device to be released from the retention region 1022 of the adapter body 1020.

[0256] In an example, the adapter body 1020 may include one or more support portions 1054. The support portion 1054 may be configured to support the device coupler 1046 in a coupled configuration with a wearable medical device on the skin. The support portion 1054 may have various forms and may include a contact surface of the adapter body 1020. The contact surface may be configured to contact a contact surface 1056 of the applicator (in Figure 30A ) to press the device coupler 1046 toward the skin-wearable medical device. The contact surface 1056 can abut the contact surface of the support portion 1054. Thus, the device coupler 1046 can be maintained in a coupled configuration with the skin-wearable medical device. In examples, the support portion 1054 can have other configurations.

[0257] See also Figure 29A and Figure 29B , the applicator coupler 1060 can be used to couple the adapter body 1020 to at least a portion of the applicator. The applicator coupler 1060 can include a protrusion that can engage the applicator. The applicator coupler 1060 can have other forms, such as a recess or an adhesive. In examples, one or more of a protrusion or a recess can be provided. Figure 29A and Figure 29B As shown, the applicator coupler 1060 can protrude radially outward from the outer surface 1028 of one or more sidewalls 1024 .

[0258] Figure 29C A top view of the adapter body 1020 is shown positioned on the on-skin sensor assembly 1000. The spacing of the outer surface 1028 of the sidewall 1024 from the outer side surface 1008 of the wearable housing 1002 is visible.

[0259] Figure 30AThe adapter body 1020 is shown coupled to the applicator. The engaging portion of the applicator (e.g., the wearable retaining elements 534a-534d) can engage the sidewall 1024 of the adapter body 1020. The contact surface of the sidewall 1024 can be positioned with respect to the Figure 27 The coupling feature 521 shown will engage the same location of the wearable retention elements 534a-534d. The applicator includes a stabilizer 1070 that mates with the stabilizing feature 1042 of the adapter body 1020. The stabilizer 1070 may include, for example Figure 6 Portions of needle carrier assembly 516 are shown. In examples, stabilizer 1070 may include one or more posts, or may have another form.

[0260] The applicator may further include a stabilizer 1072 having a contact surface 1056 for contacting the support portion 1054 of the adapter body 1020. The stabilizer 1072 may also include, for example Figure 6 Portions of needle carrier assembly 516 are shown. In examples, stabilizer 1072 may include one or more posts, or may have another form.

[0261] An insertion element in the form of a needle may extend through an opening 1035 in the upper surface of the adapter body 1020 .

[0262] In such Figure 30A In the configuration shown, the applicator coupler 1060 may not yet be coupled to the applicator. This is because the deployment mechanism may be in a distal position before being applied to the host's skin. The deployment mechanism may move proximally when in contact with the host's skin during deployment.

[0263] Figure 30B The wearable housing 1002 of the on-skin sensor assembly 1000 is shown coupled to an adapter body 1020. A device coupler 1046 may couple the wearable housing 1002 to the adapter body 1020. Figure 30C A detailed view of the device connector 1046 coupled to the wearable housing 1002 is shown.

[0264] Figure 30D Exemplary steps for deploying the on-skin sensor assembly 1000 onto the skin of a host are shown. The applicator can be pressed against the skin surface, causing the deployment mechanism to retract proximally. The needle carrier assembly 516 can be retracted proximally relative to the holder 522, for example. This movement can allow the applicator coupler 1060 to couple to the applicator. For example, the applicator coupler 1060 can enter a recess or channel 1073 in the holder 522 to couple to the holder 522.

[0265] Needle carrier assembly 516 may be retracted during deployment according to the methods disclosed herein. Figure 30EThe resulting configuration is shown in which the needle carrier assembly 516 has been retracted. Thus, the engagement portion in the form of the wearable retention elements 534a-534d can be released from the adapter body 1020 in a manner similar to that disclosed herein with respect to the on-skin sensor assembly 508 (e.g., Figure 15 and Figure 16 An exemplary release is shown. The insertion element in the form of a needle can be retracted. The applicator coupler 1060 can retain the adapter body 1020 to the applicator.

[0266] The stabilizer 1072 has a contact surface 1056 for contacting the support portion 1054 of the adapter body 1020 (at Figure 30A 1056, and the on-skin sensor assembly 1000 can be deployed to the host's skin via an adhesive or other form of engagement with the skin, and thus can remain deployed to the skin when the applicator is removed from the skin.

[0267] For example, Figure 30F The resulting configuration of the applicator and a portion of the adapter body 1020 is shown with the on-skin sensor assembly 1000 released from the adapter body 1020. The adapter body 1020 can be coupled to an applicator (e.g., Figure 30G (as shown in the detailed figure).

[0268] In examples, other configurations of the adapter body may be utilized. Figure 31A An example of an adapter body 1080 is shown. Adapter body 1080 may include features of adapter body 1020 unless otherwise noted.

[0269] For example, see Figures 31A to 31C , the adapter body 1080 can include a retaining area 1082 for receiving at least a portion of the on-skin wearable medical device. For example, the retaining area 1082 can include a cavity for receiving at least a portion of the on-skin wearable medical device.

[0270] The adapter body 1080 may include one or more walls that may define a retention area 1082. The one or more walls may include one or more side walls 1084 that may define the retention area 1082. The side walls 1084 may be configured to cover the corresponding side surfaces 1008 of the on-skin sensor assembly 1000 (at Figure 28 (marked in the middle).

[0271] Sidewall 1084 may include an inner surface 1086 (at Figure 32B Marked in) and outer surface 1088 (in Figure 31C ). Inner surface 1086 can be configured to face the portion of the skin-wearable medical device that can be positioned within retention region 1082. Outer surface 1088 can be configured to face opposite inner surface 1086 and can face radially outward from the skin-wearable medical device.

[0272] The one or more side walls 1084 can have a spacing between the inner surface 1086 and the outer surface 1088, which can be configured to separate the outer surface 1008 of the wearable medical device on the skin (at Figure 28 ) is spaced apart from the outer surface 1088 of the one or more side walls 1084. The thickness of the one or more side walls 1084 can form the spacing, or the spacing can be provided in other ways.

[0273] The inner surface 1086 can be configured to contact the outer surface 1008 of the on-skin wearable medical device. The inner surface 1086 can be contoured to the shape of the outer surface 1008 of the on-skin wearable medical device to provide a contoured fit with the shape of the outer surface 1008. In an example, the outer surface 1088 of the adapter body 1080 can have a different contour than the inner surface 1086 of the adapter body 1080.

[0274] For example, the inner surface 1086 may form an inner periphery 1090 of the adapter body 1080 (at Figure 31C ). The outer surface 1088 can form an outer perimeter 1092 of the adapter body 1080. The inner perimeter 1090 can have a different profile than the outer perimeter 1092. Such a feature can account for the difference in shape between the outer side surface 1008 of the on-skin sensor assembly 1000 and the shape of the adapter body 1080 to which the on-skin sensor assembly 1000 is adapted. In an example, the inner perimeter 1090 can have a smaller diameter than the outer perimeter 1092.

[0275] The spacing between inner surface 1086 and outer surface 1088 can adapt the on-skin wearable medical device to mate with the engagement portion of the applicator. For example, the engagement portion of the applicator can be configured to engage an on-skin sensor assembly having a larger diameter than the on-skin sensor assembly 1000. The spacing can compensate for differences in diameter. Alternatively, or in combination, the spacing can compensate for differences in shape between on-skin sensor assemblies.

[0276] The one or more walls may include an upper wall 1094 (at Figure 31A The upper wall 1094 can be configured to cover a corresponding outer upper surface, top surface, or proximal surface 1010 (at Figure 28). Upper wall 1094 may include inner surface 1096 (at Figure 31C ) and outer surface 1098. Inner surface 1096 can be configured to face the portion of the on-skin wearable medical device that can be positioned within retention region 1082. Outer surface 1098 can be configured to face opposite inner surface 1096 and can face radially outward from the on-skin wearable medical device.

[0277] The upper wall 1094 can have a spacing between the inner surface 1096 and the outer surface 1098, which can be configured to separate the outer upper surface, top surface, or proximal surface 1010 (at the top of the skin) of the wearable medical device from the outer surface 1096 and the outer surface 1098. Figure 28 1094 is spaced apart from the outer surface 1098 of the upper wall 1094. For example, the outer surface 1010 of the skin wearable medical device may include the outer upper surface 1010 of the housing 1002. The thickness of the upper wall 1094 may form the spacing, or the spacing may be provided in other ways. The upper wall 1094 may include an opening 1095 that may allow for the insertion or retraction of an insertion element (such as a needle).

[0278] The inner surface 1096 can be configured to contact the outer surface 1010 of the on-skin wearable medical device. The inner surface 1096 can be contoured to the shape of the outer surface 1010 of the on-skin wearable medical device to provide a contoured fit with the shape of the outer surface 1010. In an example, the outer upper surface 1098 of the adapter body 1020 can have a different contour than the inner surface 1096 of the adapter body 1020.

[0279] The spacing between inner surface 1096 and outer surface 1098 can adapt the on-skin wearable medical device to mate with the engagement portion of the applicator. For example, the engagement portion of the applicator can be configured to engage an on-skin sensor assembly having a greater height than the on-skin sensor assembly 1000. The spacing can compensate for differences in height. Alternatively, or in combination, the spacing can compensate for differences in shape between on-skin sensor assemblies.

[0280] In an example, the sidewall 1084 can extend distally from the upper wall 1094. In an example, the sidewall 1084 can extend distally from an outer edge or perimeter of the upper wall 1094. In an example, other configurations can be provided.

[0281] The adapter body 1080 can include a retainer portion 1104 for retaining the on-skin wearable medical device to the adapter body 1080. The retainer portion 1104 can have various forms. In an example, the retainer portion 1104 can include one or more device couplers 1106 that can couple the on-skin wearable medical device to the adapter body 1080.

[0282] In examples, the device coupler 1106 can have various forms. Figure 31C , the device coupler 1106 may include a protrusion 1108 that may be configured to engage the on-skin sensor assembly 1000. The protrusion 1108 may be configured to engage a coupling feature 1110 of the wearable housing 1002 of the on-skin sensor assembly 1000, which may have a similar configuration to, for example, Figure 28 The coupling features shown may be configured differently. For example, coupling feature 1110 may be positioned at an end portion of wearable housing 1002. Other locations may be utilized as desired. Protrusion 1108 may enter coupling feature 1110, which may be in the form of a recess in wearable housing 1002. In examples, device coupler 1106 may have other forms. For example, the device coupler may include a protrusion or a recess, or one or more of the protrusion or recess. The device coupler may include an adhesive or may have another form.

[0283] In an example, the device coupler 1106 may include arms. For example, the arms 1120 may extend circumferentially around the outer periphery of the adapter body 1080. The arms 1120 may extend circumferentially from respective hinge portions 1122 to respective end portions 1124 of the arms 1120. Each arm 1120 may extend circumferentially around a side surface of the wearable housing 1002. Each arm 1120 may include a protrusion 1108.

[0284] The hinge portion 1122 can allow the arm 1120 to deflect radially outward from the wearable housing 1002. The hinge portion 1122 can be configured to pivot about an axis extending transverse to or perpendicular to the plane of the adapter body 1080 (e.g., the plane of the upper wall 1094).

[0285] In an example, the arms 1120 can define a retention region 1082. The arms 1120 can deflect radially outward from the retention region 1082 to allow the on-skin wearable medical device to be released from the retention region 1082 of the adapter body 1080.

[0286] In an example, the device coupler 1106 can be positioned at an edge portion of the upper wall 1094 and can include a portion of the side wall 1084 of the adapter body 1080. In an example, the device coupler 1106 can have other locations.

[0287] The device coupler 1106 may include a releasable coupler configured to release the skin-wearable medical device from the adapter body 1080. For example, the device coupler 1106 may be configured to deflect to release the skin-wearable medical device from the adapter body 1080. The deflection may be in a radially outward direction to allow the device coupler 1106 to disengage from the skin-wearable medical device.

[0288] In an example, the adapter body 1080 may include one or more support portions 1126. The support portion 1126 may be configured to support the device coupler 1106 in a coupled configuration with a wearable medical device on the skin. The support portion 1126 may have various forms and may include a contact surface of the adapter body 1080. The contact surface may be configured to contact a contact surface 1127 of the applicator (in Figure 32B ) to press the device coupler 1106 toward the skin-wearable medical device. In examples, the support portion 1126 may include a recess in the arm 1120 or may have another configuration. Thus, the device coupler 1106 may be maintained in a coupled configuration with the skin-wearable medical device. In examples, the support portion 1126 may have other configurations.

[0289] The support portion 1126 may also include a stabilizing feature that may be configured to stabilize the adapter body 1080 within the applicator. The stabilizing feature may operate in a similar manner to other forms of stabilizing features disclosed herein.

[0290] See also Figure 31A and Figure 31B , the applicator coupler 1128 can be used to couple the adapter body 1080 to at least a portion of the applicator. The applicator coupler 1128 can include a protrusion that can engage the applicator. The applicator coupler 1128 can have other forms, such as a recess or an adhesive. In examples, one or more of a protrusion or a recess can be provided. Figure 31A and Figure 31B As shown, the applicator coupler 1128 can project radially outward from an outer surface 1088 of one or more sidewalls 1084. The applicator coupler 1128 can be positioned on the device coupler 1106 and can be positioned on the end portion 1124 of the arm 1120. In examples, other locations can be utilized.

[0291] In an example, the device coupler 1106 can be biased to extend radially outward from the retention region 1082. For example, Figure 31A A top view of the adapter body 1080 is shown showing the device coupler 1106 in a free state, with the device coupler 1106 extending radially outward (ie, an open configuration). Figure 31B A top view of the adapter body 1080 positioned on the wearable housing 1002 is shown. Figure 31C A bottom view of the adapter body 1080 on the wearable housing 1002 is shown with the device coupler 1106 in an open configuration.

[0292] Figure 31D A top view of the adapter body 1080 is shown positioned on the wearable housing 1002 with the device coupler 1106 in a closed configuration. Figure 31E A bottom view of the adapter body 1080 is shown positioned on the wearable housing 1002 with the device coupler 1106 in a closed configuration.

[0293] Figure 32A An adapter body 1080 is shown coupled to an applicator. An engaging portion of the applicator (e.g., wearable retention elements 534a-534d) may engage a sidewall 1084 of the adapter body 1080. The contact surface of the sidewall 1084 may be positioned to contact the applicator. Figure 27 The coupling feature 521 shown will engage the same location on the wearable retention elements 534a-534d. The applicator includes a stabilizer 1070 that mates with the support portion 1126 of the adapter body 1080. Figure 32B , , and . The contact between the stabilizer 1070 and the support portion 1126 of the adapter body 1080 is shown in FIG. This contact can hold the device coupler 1106 in the closed configuration.

[0294] In such Figure 32A and Figure 32B In the configuration shown, the applicator coupler 1128 may not yet be coupled to the applicator. This is because the deployment mechanism may be in a distal position before being applied to the host's skin. The deployment mechanism may move proximally when in contact with the host's skin during deployment.

[0295] See also Figure 32C , the needle carrier assembly 516 can be retracted during deployment according to the methods disclosed herein. Figure 32C The resulting configuration is shown in which the needle carrier assembly 516 has been retracted. Thus, the engagement portion in the form of the wearable retention elements 534a-534d can be released from the adapter body 1080 in a manner similar to that disclosed herein with respect to the on-skin sensor assembly 508 (e.g., Figure 15 and Figure 16 Example release shown.) Retraction of the needle carrier assembly 516 may retract the insertion element in the form of a needle.

[0296] The stabilizer 1070 has a contact surface for contacting the support portion 1126 of the adapter body 1080 (at Figure 30A ) can be retracted. Thus, the support portion 1126 can be unsupported by the contact surface, and the device coupler 1106 can be configured to deflect radially outward. The outward deflection of the device coupler 1106 can allow the on-skin sensor assembly 1000 to be released from the adapter body 1080. The on-skin sensor assembly 1000 can be deployed to the host's skin via an adhesive or other form of engagement with the skin, and thus can remain deployed to the skin when the applicator is removed from the skin.

[0297] The outward deflection of the device coupler 1106 may further allow the applicator coupler 1128 to couple to the recess or channel 1130 of the applicator (at Figure 32D ). Thus, the applicator coupler 1128 can retain the adapter body 1080 to the applicator.

[0298] For example, Figure 32E The resulting configuration of the applicator and a portion of the adapter body 1080 is shown, with the on-skin sensor assembly 1000 released from the adapter body 1080. The adapter body 1080 can be coupled to an applicator (e.g., Figure 32D (as shown in the detailed figure).

[0299] In examples, other configurations of the adapter body may be utilized. Figure 33A An example of an adapter body 1140 is shown. Unless otherwise specified, the adapter body 1140 may include features of other forms of adapter bodies disclosed herein.

[0300] See also Figures 33A to 33C , the adapter body 1140 can include a retaining area 1142 for receiving at least a portion of the on-skin wearable medical device. For example, the retaining area 1142 can include a cavity for receiving at least a portion of the on-skin wearable medical device.

[0301] The adapter body 1140 may include one or more walls that may define a retention area 1142. The one or more walls may include one or more side walls 1144 that may define the retention area 1142. The side walls 1144 may be configured to cover the corresponding side surfaces 1008 (at Figure 28 (marked in the middle).

[0302] Sidewall 1144 may include an inner surface 1146 (at Figure 33C ) and outer surface 1148. Inner surface 1146 can be configured to face the portion of the skin wearable medical device that can be positioned within retention region 1142. Outer surface 1148 can be configured to face opposite inner surface 1146 and can face radially outward from the skin wearable medical device.

[0303] The one or more side walls 1144 can have a spacing between the inner surface 1146 and the outer surface 1148, which can be configured to separate the outer surface 1008 of the wearable medical device on the skin (at Figure 28 ) is spaced apart from the outer surface 1148 of one or more side walls 1144. For example, the outer surface 1008 of the skin wearable medical device may include the outer side surface 1008 of the housing 1002. The spacing may be determined by the inner side wall 1144a (e.g., Figure 33Cshown) is provided relative to the distance of the outer side wall 1144b.

[0304] The inner surface 1146 can be configured to contact the outer surface 1008 of the on-skin wearable medical device. The inner surface 1146 can be contoured to the shape of the outer surface 1008 of the on-skin wearable medical device to provide a contoured fit with the shape of the outer surface 1008. In an example, the outer surface 1148 of the adapter body 1140 can have a different contour than the inner surface 1146 of the adapter body 1140.

[0305] For example, the inner surface 1146 can form an inner perimeter 1150 of the adapter body 1140. The outer surface 1148 can form an outer perimeter 1152 of the adapter body 1140. The inner perimeter 1150 can have a different profile than the outer perimeter 1152. Such a feature can account for the difference in shape between the outer side surface 1008 of the on-skin sensor assembly 1000 and the shape of the adapter body 1140 to which the on-skin sensor assembly 1000 is adapted. In an example, the inner perimeter 1150 can have a smaller diameter than the outer perimeter 1152.

[0306] The spacing between inner surface 1146 and outer surface 1148 can adapt the on-skin wearable medical device to mate with the engagement portion of the applicator. For example, the engagement portion of the applicator can be configured to engage an on-skin sensor assembly having a larger diameter than on-skin sensor assembly 1000. The spacing can compensate for differences in diameter. Alternatively, or in combination, the spacing can compensate for differences in shape between on-skin sensor assemblies.

[0307] The one or more walls may include an upper wall 1154 that may define the retention area 1142. The upper wall 1154 may be configured to cover a corresponding outer upper surface, top surface, or proximal surface 1010 (at Figure 28 ). Upper wall 1154 may include inner surface 1156 (at Figure 33C and outer surface 1158 (marked in Figure 33A ). Inner surface 1156 can be configured to face the portion of the skin-wearable medical device that can be positioned within retention region 1142. Outer surface 1158 can be configured to face opposite inner surface 1156 and can face radially outward from the skin-wearable medical device.

[0308] The upper wall 1154 can have a spacing between the inner surface 1156 and the outer surface 1158, which can be configured to separate the outer upper surface, top surface, or proximal surface 1010 (at Figure 281002 ). The outer surface 1158 of the upper wall 1154 is spaced apart. For example, the outer surface 1010 of the skin wearable medical device may include the outer upper surface 1010 of the housing 1002. The thickness of the upper wall 1154 may form the spacing, or the spacing may be provided in other ways. The upper wall 1154 may include an opening 1155 that may allow for the insertion or retraction of an insertion element (such as a needle).

[0309] The inner surface 1156 can be configured to contact the outer surface 1010 of the on-skin wearable medical device. The inner surface 1156 can be contoured to the shape of the outer surface 1010 of the on-skin wearable medical device to provide a contoured fit with the shape of the outer surface 1010. In an example, the outer upper surface 1158 of the adapter body 1140 can have a different contour than the inner surface 1156 of the adapter body 1140.

[0310] The spacing between inner surface 1156 and outer surface 1158 can adapt the on-skin wearable medical device to mate with the engagement portion of the applicator. For example, the engagement portion of the applicator can be configured to engage an on-skin sensor assembly having a greater height than the on-skin sensor assembly 1000. The spacing can compensate for differences in height. Alternatively, or in combination, the spacing can compensate for differences in shape between on-skin sensor assemblies.

[0311] In an example, the sidewall 1144 can extend distally from the upper wall 1154. In an example, the sidewall 1144 can extend distally from an outer edge or perimeter of the upper wall 1154. In an example, other configurations can be provided.

[0312] In an example, the adapter body 1140 can include a pop-up portion 1160 that can be configured to allow the on-skin wearable medical device to be popped out of the adapter body 1140. The pop-up portion 1160 can include one or more openings 1162 in the upper wall 1154 of the adapter body 1140. The openings 1162 can be configured to allow an pop-up assembly of an applicator to pass through to contact the on-skin wearable device and eject it from the adapter body 1140. The pop-up assembly can, for example, include one or more protrusions configured to pass through the openings 1162.

[0313] One or more stabilizers 1170 may be provided (at Figure 33C ) for stabilizing the wearable medical device on the skin within the holding area 1142. For example, the stabilizer may include Figure 33C The stabilizer 1170 may include a protrusion as shown. In some examples, the stabilizer may have other forms. The stabilizer may be configured to contact the skin-wearable medical device to prevent movement of the skin-wearable device within the retention region 1142. For example, lateral movement may be resisted. The stabilizer 1170 may include a portion of one or more of the sidewalls 1144, including the inner surface 1146 of the sidewall 1144.

[0314] See also Figure 33A and Figure 33B , the outer surface 1148 of the side wall 1144 may include a stabilizing feature 1164 that may be configured to stabilize the adapter body 1140 within the applicator. The stabilizing feature 1164 may include a recessed portion of the outer surface 1148 of the side wall 1144. The stabilizing feature 1164 may have a shape similar to, for example Figure 27 The profile and location of the stabilizing feature 523 are shown. Thus, the stabilizing feature 1164 can be used to stabilize the adapter body 1140 in a manner similar to how the stabilizing feature 523 stabilizes the on-skin sensor assembly 508 within the applicator. Other configurations of stabilizing features can be utilized as desired.

[0315] The adapter body 1140 can include a retainer portion 1166 for retaining the on-skin wearable medical device to the adapter body 1140. The retainer portion 1166 can have various forms. In an example, the retainer portion 1166 can include one or more device couplers 1168 that can couple the on-skin wearable medical device to the adapter body 1140.

[0316] See also Figure 33C , the device coupler 1168 may include an adhesive that can couple the skin-wearable medical device to the adapter body 1140. The adhesive may include an adhesive layer that includes the inner surface 1156 of the upper wall 1154. The adhesive may include a releasable coupler in the form of a releasable adhesive that is configured to release the skin-wearable medical device from the adapter body 1140.

[0317] See also Figure 33A and Figure 33B , the applicator coupler 1180 can be used to couple the adapter body 1140 to at least a portion of the applicator. The applicator coupler 1180 can include a protrusion that can engage the applicator. The applicator coupler 1180 can be used with respect to Figure 29A and Figure 29B The discussed applicator coupler 1060 is similarly configured.

[0318] Figure 33A A top view of the adapter body 1140 is shown positioned on the on-skin sensor assembly 1000. The spacing of the outer surface 1148 of the sidewall 1144 from the outer side surface 1008 of the wearable housing 1002 is visible.

[0319] Figure 33B A bottom view of the adapter body 1140 positioned on the on-skin sensor assembly 1000 is shown. Figure 33CA bottom view of the adapter body 1140 is shown without the on-skin sensor assembly 1000 .

[0320] Figure 34A An adapter body 1140 is shown coupled to an applicator. An engaging portion of the applicator (e.g., wearable retaining elements 534a-534d) may engage a sidewall 1144 of the adapter body 1140. The contact surface of the sidewall 1144 may be positioned to contact the applicator. Figure 27 The coupling feature 521 shown will engage the same location on the wearable retention elements 534a-534d. The applicator includes a stabilizer 1070 that mates with the stabilizing feature 1164 of the adapter body 1140. The stabilizer 1070 may include, for example Figure 6 Portions of needle carrier assembly 516 are shown.

[0321] In such Figure 34A In the configuration shown, the applicator coupler 1180 may not yet be coupled to the applicator. This is because the deployment mechanism may be in a distal position before being applied to the host's skin. The deployment mechanism may move proximally when in contact with the host's skin during deployment.

[0322] Figure 34B Exemplary steps for deploying the on-skin sensor assembly 1000 onto the skin of a host are shown. The applicator can be pressed against the skin surface, causing the deployment mechanism to retract proximally. The needle carrier assembly 516 can be retracted proximally relative to the holder 522, for example. This movement can allow the applicator coupler 1180 to couple to the applicator. For example, the applicator coupler 1180 can enter a recess or channel 1182 in the holder 522 to couple to the holder 522. Figure 34C The configuration of the on-skin sensor assembly 1000 is shown without illustration for clarity.After the on-skin wearable medical device is released from the adapter body 1140, the applicator coupler 1180 can retain the adapter body 1140 to the applicator.

[0323] After the on-skin sensor assembly 1000 is deployed on the host's skin, the retainer 522 can be advanced distally according to the methods disclosed herein. For example, the ejection assembly of the applicator can operate when the retainer 522 is advanced distally relative to the adapter body 1140.

[0324] For example, Figure 34DAn ejection assembly including an ejection actuator in the form of a protrusion 1190 is shown. The ejection actuator can be configured to eject the on-skin wearable medical device from the adapter body 1140. The protrusion 1190 of the ejection actuator can extend through an opening in the adapter body 1140. The protrusion 1190 can be pushed distally to disengage the on-skin sensor assembly 1000 from the device coupler 1168 by pressing distally with the protrusion 1190. For example, Figure 34F A distal perspective view of the retainer 522 is shown without the adapter body 1140. A protrusion 1190 extends distally from a surface of the retainer 522.

[0325] The ejection assembly can be depressed distally with the needle carrier assembly 516 retracted, e.g., Figure 34E The on-skin sensor assembly 1000 can be released from the adapter body 1140. The adapter body 1140 can be coupled to the applicator using an applicator coupler 1180 positioned within a recess or channel 1182 of the applicator.

[0326] In examples, other configurations of the adapter body may be utilized. Figure 35A An example of an adapter body 1200 is shown. Unless otherwise noted, the adapter body 1200 may include features of other adapter bodies disclosed herein.

[0327] For example, see Figures 35A to 35D , the adapter body 1200 can include a retaining area 1202 for receiving at least a portion of a skin-wearable medical device. For example, the retaining area 1202 can include a cavity for receiving at least a portion of a skin-wearable medical device.

[0328] The adapter body 1200 may include one or more walls that may define a holding area 1202. The one or more walls may include one or more side walls 1204 that may define the holding area 1202. The side walls 1204 may be configured to cover corresponding side surfaces 1008 (at Figure 28 (marked in the middle).

[0329] Sidewall 1204 may include an inner surface 1206 (at Figure 35B ) and outer surface 1208. Inner surface 1206 can be configured to face the portion of the skin-wearable medical device that can be positioned within retention region 1202. Outer surface 1208 can be configured to face opposite inner surface 1206 and can face radially outward from the skin-wearable medical device.

[0330] The one or more side walls 1204 can have a spacing between the inner surface 1206 and the outer surface 1208, which can be configured to separate the outer surface 1008 of the wearable medical device on the skin (at Figure 28) is spaced apart from the outer surface 1208 of the one or more side walls 1204. The thickness of the one or more side walls 1204 can form the spacing, or the spacing can be provided in other ways.

[0331] The inner surface 1206 can be configured to contact the outer surface 1008 of the on-skin wearable medical device. The inner surface 1206 can be contoured to the shape of the outer surface 1008 of the on-skin wearable medical device to provide a contoured fit with the shape of the outer surface 1008. In an example, the outer surface 1208 of the adapter body 1200 can have a different contour than the inner surface 1206 of the adapter body 1200.

[0332] For example, the inner surface 1206 may form an inner periphery 1210 of the adapter body 1200 (at Figure 35B ). The outer surface 1208 can form an outer perimeter 1212 of the adapter body 1200. The inner perimeter 1210 can have a different profile than the outer perimeter 1212. Such a feature can account for the difference in shape between the outer side surface 1008 of the on-skin sensor assembly 1000 and the shape of the adapter body 1200 to which the on-skin sensor assembly 1000 is adapted. In an example, the inner perimeter 1210 can have a smaller diameter than the outer perimeter 1212.

[0333] The spacing between inner surface 1206 and outer surface 1208 can adapt the on-skin wearable medical device to fit the engagement portion of the applicator. For example, the engagement portion of the applicator can be configured to engage an on-skin sensor assembly having a larger diameter than on-skin sensor assembly 1000. The spacing can compensate for differences in diameter. Alternatively, or in combination, the spacing can compensate for differences in shape between on-skin sensor assemblies.

[0334] The outer surface 1208 of the side wall 1204 may include a stabilizing feature 1240 that may be configured to stabilize the adapter body 1200 within the applicator. The stabilizing feature 1240 may include a recessed portion of the outer surface 1208 of the side wall 1204. The stabilizing feature 1240 may have a shape similar to, for example, Figure 27 The profile and location of the stabilizing feature 523 are shown. Thus, the stabilizing feature 1240 can be used to stabilize the adapter body 1200 in a manner similar to how the stabilizing feature 523 stabilizes the on-skin sensor assembly 508 within the applicator. Other configurations of stabilizing features can be utilized as desired.

[0335] The one or more walls may include an upper wall 1214 (at the Figure 35A The upper wall 1214 can be configured to cover a corresponding outer upper surface, top surface, or proximal surface 1010 (at Figure 28 ). Upper wall 1214 may include inner surface 1216 (at Figure 35B ) and outer surface 1218. Inner surface 1216 can be configured to face the portion of the skin wearable medical device that can be positioned within retention region 1202. Outer surface 1218 can be configured to face opposite inner surface 1216 and can face radially outward from the skin wearable medical device.

[0336] The upper wall 1214 can have a spacing between the inner surface 1216 and the outer surface 1218, which can be configured to separate the outer upper surface, top surface, or proximal surface 1010 (at Figure 28 1002 ). The outer surface 1218 of the upper wall 1214 is spaced apart. For example, the outer surface 1010 of the skin-wearable medical device may include the outer upper surface 1010 of the housing 1002. The thickness of the upper wall 1214 may form the spacing, or the spacing may be provided in other ways. The upper wall 1214 may include an opening 1215 that may allow for the insertion or retraction of an insertion element (such as a needle).

[0337] The inner surface 1216 can be configured to contact the outer surface 1010 of the on-skin wearable medical device. The inner surface 1216 can be contoured to the shape of the outer surface 1010 of the on-skin wearable medical device to provide a contoured fit with the shape of the outer surface 1010. In an example, the outer upper surface 1218 of the adapter body 1200 can have a different contour than the inner surface 1216 of the adapter body 1200.

[0338] The spacing between inner surface 1216 and outer surface 1218 can adapt the on-skin wearable medical device to mate with the engagement portion of the applicator. For example, the engagement portion of the applicator can be configured to engage an on-skin sensor assembly having a greater height than the on-skin sensor assembly 1000. The spacing can compensate for differences in height. Alternatively, or in combination, the spacing can compensate for differences in shape between on-skin sensor assemblies.

[0339] In an example, the sidewall 1204 can extend distally from the upper wall 1214. In an example, the sidewall 1204 can extend distally from an outer edge or perimeter of the upper wall 1214. In an example, other configurations can be provided.

[0340] The adapter body 1200 can include a retainer portion 1220 for retaining a skin-wearable medical device to the adapter body 1200. The retainer portion 1220 can have various forms. In an example, the retainer portion 1220 can include one or more device couplers 1222 that can couple the skin-wearable medical device to the adapter body 1080.

[0341] In examples, the device coupler 1222 can have various forms. Figure 35B, the device coupler 1222 may include a protrusion 1224 that may be configured to engage the on-skin sensor assembly 1000. The protrusion 1224 may be configured to engage a coupling feature of the wearable housing 1002 of the on-skin sensor assembly 1000, which may have similar characteristics to, for example, Figure 28 The coupling features shown may be configured differently. For example, the coupling features may be positioned at an end portion of the wearable housing 1002. Other locations may be utilized as desired. The protrusion 1224 may enter a coupling feature in the form of a recess in the wearable housing 1002. In examples, the device coupler 1222 may have other forms. For example, the device coupler may include a protrusion or a recess, or one or more of the protrusion or recess. The device coupler may include an adhesive or may have another form.

[0342] In an example, the device coupler 1222 may include an arm. For example, the arm 1226 may extend circumferentially around the outer periphery of the adapter body 1200. The arm 1226 may extend circumferentially from the hinge portion 1228 to a corresponding end portion 1230 of the arm 1226. Each arm 1226 may extend circumferentially around a side surface of the wearable housing 1002. Each arm 1226 may include a protrusion 1224.

[0343] The respective hinge portions 1228 can allow the respective arms 1226 to deflect radially outward from the wearable housing 1002. The hinge portions 1228 can be configured to pivot about an axis extending transverse to or perpendicular to the plane of the adapter body 1200 (e.g., the plane of the upper wall 1214).

[0344] In an example, arms 1226 can define the retention region 1202. The arms 1226 can deflect radially outward from the retention region 1202 to allow the on-skin wearable medical device to be released from the retention region 1202 of the adapter body 1200.

[0345] The arm 1226 of the device coupler 1222 can comprise a majority of the outer perimeter 1212 of the adapter body 1200. In an example, the arm 1226 can comprise at least 60%, or 70%, or 80% of the outer perimeter 1212.

[0346] The device coupler 1222 may include a releasable coupler configured to release the skin-wearable medical device from the adapter body 1200. For example, the device coupler 1222 may be configured to deflect to release the skin-wearable medical device from the adapter body 1200. The deflection may be in a radially outward direction to allow the device coupler 1222 to disengage from the skin-wearable medical device.

[0347] In an example, the adapter body 1200 may include one or more support portions 1232. The support portion 1232 may be configured to support the device coupler 1222 in a coupled configuration with the on-skin wearable medical device. The support portion 1232 may have various forms and may include a contact surface of the adapter body 1200. The support portion 1232 may include, for example, Figure 35B The hook can be configured to surround the contact surface 1234 of the applicator (at Figure 35G ) extends to press the device coupler 1222 toward the skin-wearable medical device. The contact surface 1234 of the applicator may include at least one post that can engage the hook. Thus, the device coupler 1222 can be maintained in a coupled configuration with the skin-wearable medical device. The post can be configured to retract from the hook to allow the device coupler 1222 to be partially disengaged from the skin-wearable medical device. As disclosed herein, the post can be retracted during retraction of an insertion element or needle used to guide the transcutaneous analyte sensor into the skin of the host. In examples, the support portion 1232 may have other configurations.

[0348] In an example, the device coupler 1222 can be biased to extend radially outward from the retention region 1202. In this way, when the support portion 1232 is released, the device coupler 1222 can be released from the skin wearable medical device.

[0349] Figure 35C A top view of the adapter body 1200 is shown positioned on an on-skin wearable medical device. Figure 35D A bottom view of the adapter body 1200 is shown positioned on an on-skin wearable medical device.

[0350] Figure 35E The adapter body 1200 is shown coupled to the applicator. The engaging portion of the applicator (e.g., the wearable retaining elements 534a-534d) can engage the sidewall 1204 of the adapter body 1200. The contact surface of the sidewall 1204 can be positioned with respect to the Figure 27 The coupling feature 521 shown will engage the same location of the wearable retaining elements 534a-534d. The applicator includes at least one stabilizer 1235 having a contact surface 1234 that mates with the support portion 1232 of the adapter body 1200. The stabilizer 1235 may include a post that engages with the hook of the support portion 1232. The hook may be wrapped around the post. Figure 35G , , and . The contact between the stabilizer 1235 and the support portion 1232 of the adapter body 1200 is shown in FIG. This contact can hold the device coupler 1222 in the closed configuration.

[0351] Figure 35FThe assembly is shown prior to retraction of the needle carrier assembly 516. The needle carrier assembly 516 may be retracted during deployment according to the methods disclosed herein. The engaging portion of the applicator in the form of wearable retention elements 534a-534d may be released from the adapter body 1200 in a manner similar to that disclosed herein with respect to the on-skin sensor assembly 508 (e.g., Figure 15 and Figure 16 Example release shown).

[0352] The stabilizer 1235 having a contact surface for contacting the support portion 1232 of the adapter body 1200 can be retracted. The post can be retracted from its position between the hooks of the support portion 1232. As a result, the post can no longer be located between the hooks of the support portion 1232. As a result, the support portion 1232 can be unsupported by the contact surface, and the device coupler 1222 can be configured to deflect radially outward. The hooks can be released in opposite directions to allow the device coupler 1222 to deflect radially outward and disengage from the on-skin wearable medical device. The outward deflection of the device coupler 1222 can allow the on-skin sensor assembly 1000 to be released from the adapter body 1200. The on-skin sensor assembly 1000 can be deployed to the host's skin via an adhesive or other form of engagement with the skin, and thus can remain deployed to the skin when the applicator is removed from the skin.

[0353] In examples, other configurations of the adapter body may be utilized. Figure 36A An example of an adapter body 1250 is shown. Unless otherwise noted, the adapter body 1250 may include features of other examples of adapter bodies.

[0354] See also Figure 36A , the adapter body 1250 can include a retaining area 1252 for receiving at least a portion of a skin-wearable medical device. For example, the retaining area 1252 can include a cavity for receiving at least a portion of a skin-wearable medical device.

[0355] The adapter body 1250 may include one or more walls that may define a retention area 1252. The one or more walls may include one or more side walls 1254 that may define the retention area 1252. The side walls 1254 may be configured to cover the corresponding side surfaces 1008 (at Figure 28 (marked in the middle).

[0356] Sidewall 1254 can include an inner surface 1256 and an outer surface 1258. Inner surface 1256 can be configured to face the portion of the skin-wearable medical device that can be positioned within retention region 1252. Outer surface 1258 can be configured to face opposite inner surface 1256 and can face radially outward from the skin-wearable medical device.

[0357] The one or more side walls 1254 can have a spacing between the inner surface 1256 and the outer surface 1258, which can be configured to provide an outer surface 1260 (at the Figure 36B 1254 is spaced apart from an outer surface 1258 of the one or more side walls 1254. For example, the outer surface 1260 of the on-skin wearable medical device can include the outer side surface 1260 of the housing 1272 of the on-skin wearable medical device. The thickness of the one or more side walls 1254 can form the spacing, or the spacing can be provided in other ways.

[0358] The inner surface 1256 can be configured to contact an outer surface 1260 of the on-skin wearable medical device. The inner surface 1256 can be contoured to the shape of the outer surface 1260 of the on-skin wearable medical device to provide a contoured fit with the shape of the outer surface 1260. In an example, the outer surface 1258 of the adapter body 1250 can have a different contour than the inner surface 1256 of the adapter body 1250.

[0359] For example, the inner surface 1256 can form an inner perimeter 1262 of the adapter body 1250. The outer surface 1258 can form an outer perimeter 1264 of the adapter body 1250. The inner perimeter 1262 can have a different profile than the outer perimeter 1264. Such a feature can account for the difference in shape between the outer side surface 1260 of the on-skin sensor assembly 1259 and the shape of the adapter body 1250 to which the on-skin sensor assembly 1259 is adapted.

[0360] The spacing between inner surface 1256 and outer surface 1258 can adapt the on-skin wearable medical device to mate with the engagement portion of the applicator. For example, the engagement portion of the applicator can be configured to engage an on-skin sensor assembly having a larger diameter than on-skin sensor assembly 1259. The spacing can compensate for differences in diameter. Alternatively, or in combination, the spacing can compensate for differences in shape between on-skin sensor assemblies.

[0361] Adapter body 1250 may include a ring extending around retention area 1252 .

[0362] The adapter body 1250 can include a retainer portion 1266 for retaining the on-skin wearable medical device to the adapter body 1250. The retainer portion 1266 can have various forms. In an example, the retainer portion 1266 can include one or more device couplers 1268 that can couple the on-skin wearable medical device to the adapter body 1250.

[0363] In examples, the device coupler 1268 can have various forms. Figure 36A, the device coupler 1268 may include a protrusion that may be configured to engage the on-skin sensor assembly 1259. The protrusion may be configured to engage the coupling feature 1270 (at Figure 36B ). The protrusion can enter a coupling feature 1270 in the form of a recess in the wearable housing 1272. In examples, the device coupler 1268 can have other forms. For example, the device coupler can include a protrusion or a recess, or one or more of the protrusion or recess. The device coupler can include an adhesive or can have another form. A ball and groove arrangement can be utilized (e.g., with a coupling feature 1270 including a groove).

[0364] The device coupler 1268 can be positioned on the inner surface 1256 of the sidewall 1254 and can be configured to extend radially inward toward the retention area 1252. In examples, the device coupler 1268 can have other locations.

[0365] The device coupler 1268 may include a releasable coupler configured to release the skin-wearable medical device from the adapter body 1250. The device coupler 1268 may be configured to release from the skin-wearable medical device when sufficient force is applied to the device coupler 1268. The protrusion may disengage from the coupling feature 1270. In examples where the device coupler 1268 includes a recess, the protrusion of the wearable housing 1272 may disengage from the recess of the adapter body 1250 to provide release of the adapter body 1250.

[0366] The applicator coupler 1274 can be used to couple the adapter body 1250 to at least a portion of the applicator. The applicator coupler 1274 can include a recessed portion that can engage a protrusion of the applicator. The applicator coupler 1274 can have other forms, such as protrusions or adhesive. In examples, one or more of a protrusion or a recessed portion can be provided. Figure 36A As shown, the applicator coupler 1274 can be positioned on the outer surface 1258 of the side wall 1254 or at another location as desired.

[0367] Figure 36B Shown is a perspective view of an exemplary on-skin sensor assembly 1259 that can be utilized with the adapter body 1250. The adapter body 1250 can enclose a wearable housing 1272 of the on-skin sensor assembly 1259.

[0368] For example, Figure 36C The adapter body 1250 is shown positioned around the wearable housing 1272. The device coupler 1268 can be coupled to the coupling feature 1270. For example, Figure 37 Shown along Figure 36CCross-sectional view along line CC'.

[0369] The engagement portion of the applicator can be configured to engage the adapter body 1250. The engagement portion can include a wearable retention and / or alignment element as disclosed herein, or can have other forms. For example, Figure 38 A configuration of an engagement portion 1280 including a retaining element in the form of a protrusion 1282 is shown. The protrusion 1282 may be positioned on an arm of a wearable retaining and / or alignment element as disclosed herein, or may have other forms. Other forms (e.g., recesses, adhesives) may be utilized as desired. The wearable retaining and / or alignment element may include a portion of a needle carrier assembly as disclosed herein. The engagement portion 1280 may be configured to engage an applicator coupler 1274, as disclosed herein. Figure 39A The protrusion 1282 can engage the applicator coupler 1274, or can create another coupling configuration.

[0370] The adapter body 1250 can be adapted to fit the on-skin sensor assembly 1259 to mate with the engagement portion 1280 .

[0371] In an example, the engagement portion 1280 can be configured to release from the adapter body 1250. For example, see Figure 39B , the engaging portion 1280 of the applicator can be released after being retracted from the adapter body 1250. Under the action of the force pulling the protrusion 1282 from the applicator coupler 1274, the protrusion 1282 can be disengaged from the applicator coupler 1274. For example, the engaging portion 1280 can be deflected out of the applicator coupler 1274 for release. For example, the arms of the wearable retention and / or alignment element can be deflected outward to allow the protrusion 1282 to be released from the applicator coupler 1274. Other forms of release can be utilized as desired. In an example, if desired, the adapter body 1250 can be removed from the wearable housing 1272. The skin wearable medical device can be released from the adapter body 1250. For example, Figure 39C The resulting configuration is shown. The device coupler 1268 can be disengaged from the coupling feature 1270.

[0372] In an example, the adapter body 1250 can remain engaged with the engagement portion 1280 when the wearable housing 1272 is deployed. For example, the wearable housing 1272 can be disengaged from the adapter body 1250 and can remain on the host's skin. The adapter body 1250 can remain engaged with the engagement portion 1280 and can be retracted from the host's skin along with the engagement portion 1280 of the applicator. The wearable housing 1272 can remain positioned on the host's skin, such as, for example Figure 39C Indicated.

[0373] In an example, the adapter body 1250 can interface between the on-skin wearable medical device and the applicator, while the applicator cannot engage other configurations of the on-skin wearable medical device. Figures 36A to 39C In the configuration shown, the engagement portion 1280 may not engage any other form of skin-wearable medical device. The adapter body 1250 may also interface with the engagement portion 1280 by allowing the skin-wearable medical device to mate with the engagement portion 1280. Such a configuration may be beneficial in allowing multiple skin-wearable medical devices of different sizes or other configurations to mate with a single form of engagement portion. For example, see Figures 36A to 39C , multiple different adapter bodies can be used to mate multiple differently configured skin-wearable medical devices to the engagement portion 1280. Adapter bodies of different diameters or shapes can be utilized to enable multiple adapter bodies of different diameters or shapes to fit with the same engagement portion 1280. Other configurations of engagement portions and skin-wearable medical devices are contemplated by the use of adapter bodies.

[0374] An applicator as disclosed herein (e.g., an applicator disclosed herein, including applicators 500, 700, 900) may include an activation body 1300 (e.g., Figure 30B Activation body 1300 is a device that electrically activates an on-skin wearable medical device or on-skin sensor assembly 1000. Features and operation of activation body 1300 are disclosed in U.S. Patent Application No. 16 / 400,974, filed May 1, 2019, and published as U.S. Publication No. 2019 / 0342637 on November 7, 2019, the entire contents of which are incorporated by reference for all purposes. Activation body 1300 is operable to activate sensor electronics module 140 of on-skin sensor assembly 1000 through remote sensing by sensor electronics module 140. Sensor electronics module 140 may, for example, include a proximity sensor that can detect proximity of activation body 1300. The proximity sensor may have a form disclosed in U.S. Publication No. 2019 / 0342637, such as a Hall effect sensor, a reed switch, or other form of proximity sensor. The proximity sensor may be a magnetic field sensor for sensing the magnetic field of activation body 1300. For example, activation body 1300 may include a magnet that generates a magnetic field. Variations in the proximity of the proximity sensor to the activation body 1300 (eg, variations in the strength of the magnetic field generated by the activation body 1300 due to distance) can be sensed and used to activate the on-skin sensor assembly 1000 .

[0375] Electrical activation can be performed from a lower power state to a higher power state in the manner disclosed in U.S. Publication No. 2019 / 0342637. The on-skin sensor assembly 1000 and sensor electronics module 140 can remain in a low power state or quiescent state when coupled to an applicator (e.g., the applicators disclosed herein, including applicators 500, 700, and 900). This is because the on-skin sensor assembly 1000 is not in use in this configuration. The on-skin sensor assembly 1000 can conserve battery power in this configuration. The on-skin sensor assembly 1000 is intended for use when deployed and can therefore be activated to a higher power state for operation of the on-skin sensor assembly 1000 on the host's skin. When the applicator is removed from the on-skin sensor assembly 1000 positioned on the host's skin, the distance between the on-skin sensor assembly 1000 and the activation body 1300 increases when the on-skin sensor assembly 1000 is applied. This increase in distance is detected by the proximity sensor, and the on-skin sensor assembly 1000 is activated to a higher power state for use.

[0376] See also Figure 30B , the location of the activation body 1300 on the applicator may require a large activation body 1300 (e.g., a large magnet) to generate a sufficient magnetic field to be sensed by the sensor electronics module 140 of the on-skin sensor assembly 1000. Furthermore, if the size of the on-skin sensor assembly 1000 is reduced, or if the presence of additional structure, such as an adapter or other configuration change, increases the distance between the activation body 1300 and the sensor electronics module 140 of the applicator, then an even larger activation body 1300 (e.g., a larger magnet) may be required due to the increased distance between the activation body 1300 and the on-skin sensor assembly 1000.

[0377] Figure 40 An example is shown in which an adapter body 1302 includes an activation body 1304. The activation body 1304 operates in the same manner as the activation body 1300. The activation body 1304 may include a magnet.

[0378] The adapter body 1302 is configured similarly to other examples of adapter bodies disclosed herein. The adapter body 1302 includes one or more walls 1306, 1308 that define a holding area 1310 for receiving the on-skin sensor assembly 1000. The one or more walls include one or more side walls 1306 and an upper wall 1308. The adapter body 1302 may include one or more device couplers 1312 that may couple the on-skin sensor assembly 1000 to the adapter body 1302. The device coupler 1312 may include arms that extend along side surfaces of the on-skin sensor assembly 1000 and may be arranged to be attached to, for example, the on-skin sensor assembly 1000. Figures 31A to 31CThe device coupler 1106 operates in a similar manner. Other configurations of device couplers as disclosed herein may be utilized.

[0379] The activation body 1304 can be positioned in or on one or more walls 1306 , 1308 . Figure 40 The activation body 1304 is positioned on the upper wall 1308. The activation body 1304 is positioned in a receiver 1314 in the outer surface 1316 of the upper wall 1308, or may be positioned on another surface (e.g., Figure 41 13). The receiver 1314 may include a cavity or may have another configuration. In an example, the activation body 1304 may be positioned on the sidewall 1306. In an example, the receiver 1314 or other portion of the adapter body 1302 may include one or more securing features (e.g., snap-fit features, retention tabs, or adhesive) to retain the activation body 1304 in the receiver.

[0380] When the assembly 1000 is received within the adapter body 1302, the activation body 1304 can be positioned proximate to the proximity sensor of the on-skin sensor assembly 1000. For example, Figure 41 Shown along line D-D' Figure 40 1, which shows an activation body 1304 positioned above and near the sensor electronics 140 of the on-skin sensor assembly 1000, which may include a proximity sensor. The location of the activation body 1304 on the adapter body 1302 can beneficially increase the proximity of the activation body 1304 to the proximity sensor of the on-skin sensor assembly 1000. This can provide a larger magnetic field for the proximity sensor to detect. An activation body 1304 that is smaller than the activation body 1300 can be used to provide a field or other signal for the proximity sensor to detect.

[0381] Any of the adapter bodies disclosed herein can be combined with an activation body 1304 as disclosed herein. The activation body 1304 can include a magnet, or can have other forms, depending on the form of proximity sensor used (e.g., a magnetically responsive material can be used in examples where the proximity sensor includes a magnet; an electric field generator (e.g., a charged body) can be utilized; an optical indicator can be used for optical sensing, etc.).

[0382] In operation, activation body 1304 can operate in a similar manner to activation body 1300. When on-skin sensor assembly 1000 is deployed on the skin of a host, the distance between activation body 1304 and on-skin sensor assembly 1000 increases. The proximity sensor senses the removal of activation body 1304 and electrically activates on-skin sensor assembly 1000 from a lower power state to a higher power state. In examples, variations in the method of operation can be provided.

[0383] Features of the adapter body can allow different configurations of on-skin wearable medical devices to interface with various configurations of applicators. In an example, the applicator can include a universal applicator, wherein the adapter body interfaces to allow the on-skin wearable medical device to engage the universal applicator.

[0384] The features of the examples disclosed herein may be utilized alone or in combination with any system, apparatus, or method disclosed herein.

[0385] The above description presents the best mode of implementing the present invention, as well as the manner and process of making and using the present invention, in sufficient, clear, concise and accurate terms to enable any person skilled in the art to make and use the present invention. However, the present invention can be modified and alternative constructions that are completely equivalent to the above-described structures can be adopted. Therefore, the present invention is not limited to the specific examples disclosed. On the contrary, the present invention covers all modifications and alternative constructions that fall within the spirit and scope of the present invention as generally expressed by the appended claims, which particularly point out and clearly claim the subject matter of the present invention. Although the present disclosure has been shown and described in detail in the drawings and the foregoing description, such illustrations and descriptions are to be considered illustrative or exemplary rather than restrictive.

[0386] All references cited herein are incorporated herein by reference in their entirety. To the extent publications and patents or patent applications incorporated by reference conflict with the disclosure contained in this specification, the specification is intended to supersede and / or take precedence over any such conflicting material.

[0387] Unless otherwise defined, all terms (including technical and scientific terms) are to be given their ordinary and customary meanings to those of ordinary skill in the art and are not to be limited to specific or customized meanings unless expressly so defined herein. It should be noted that when describing certain features or aspects of the present disclosure, the use of a particular term should not be taken as implying that the term is to be redefined herein to be limited to include any specific characteristics of the feature or aspect of the disclosure with which the term is associated. Unless expressly stated otherwise, the terms and phrases used in this application, and variations thereof, particularly those used in the appended claims, should be interpreted as open ended and not restrictive. As an example of the foregoing, the term "including" should be understood to mean "including but not limited to", "including without limitation", etc.; as used herein, the term "comprising" 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 "including" should be interpreted as "including but not limited to"; the term "example" is used to provide illustrative examples of the items discussed, rather than an exhaustive or limiting list thereof; adjectives such as "known", "normal", "standard" and terms of similar meaning should not be interpreted as limiting the items described to a given time period or to items available at a given time, but should be understood to cover known, normal or standard technologies that are available or known at any time now or in the future; and the use of terms such as "preferred" or "desired" and words of similar meaning should not be interpreted as implying that certain features are critical, necessary or even important to the structure or function of the invention, but are merely intended to highlight alternative or additional features that may or may not be utilized in a particular example of the invention. Likewise, a group of items linked with the conjunction "and" should not be read as requiring that each and every one of those items be present in the grouping, but rather should be read as "and / or" unless expressly stated otherwise. Similarly, a group of items linked with the conjunction "or" should not be read as requiring mutual exclusivity in the grouping, but rather should be read as "and / or" unless expressly stated otherwise.

[0388] Where a range of values is provided, it is understood that the upper and lower limits and every intervening value between the upper and lower limits of that range is encompassed within those examples.

[0389] With respect to the use of substantially any plural and / or singular terms herein, a person skilled in the art may convert from the plural to the singular and / or from the singular to the plural, as appropriate, depending on the context and / or application. For the sake of clarity, various singular / plural permutations may be explicitly set forth herein. The indefinite article "a" or "an" does not exclude a plurality. A single processor or other unit may perform the functions of several items recited in a claim. The fact that certain measures are recited in mutually different dependent claims does not in itself indicate that a combination of these measures cannot be used to advantage. Any figure marks in the claims should not be construed as limiting the scope.

[0390] Those skilled in the art will further understand that if a specific number of an introduced claim recitation is intended, such intent will be explicitly recited in the claim, and in the absence of such recitation, no such intent is present. For example, to aid understanding, the following appended claims may contain the use of the introductory phrases "at least one" and "one or more" to introduce claim recitations. However, the use of such phrases should not be construed to imply that a claim recitation introduced by the indefinite article "a" or "an" will include any particular claim of such introduced claim recitation to include only one such recitation, even when the same claim includes the introductory phrases "one or more" or "at least one" and an indefinite article, such as "a" or "an" (e.g., "a" and / or "an" should generally be interpreted to mean "at least one" or "one or more"); the same is true for the use of definite articles used to introduce claim recitations. Furthermore, even if a specific number of introduced claim recitations is explicitly recited, those skilled in the art will recognize that such recitation should generally be interpreted to mean at least the recited number (e.g., the unmodified recitation "two recitations" in the absence of other modifiers generally means at least two recitations, or two or more recitations). Furthermore, in those instances where a convention similar to “at least one of A, B, and C, etc.” is used, generally speaking, such construction is intended to have the meaning that one skilled in the art would understand the convention to mean (e.g., “a system having at least one of A, B, and C” would include, but is not limited to, systems having 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 similar to “at least one of A, B, or C, etc.” is used, generally speaking, such construction is intended to have the meaning that one skilled in the art would understand the convention to mean (e.g., “a system having at least one of A, B, or C” would include, but is not limited to, systems having 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.). Those skilled in the art will further understand that any disjunctive conjunctions and / or phrases that actually present two or more alternative terms, whether in the specification, claims, or drawings, should be understood to contemplate the possibility of including one, either, or both of these terms. For example, the phrase "A or B" will be understood to include the possibilities of "A" or "B" or "A and B."

[0391] All numbers used in this specification indicating the amount of ingredients, reaction conditions, etc. should be understood to be modified by the term "about" in all cases. Therefore, unless otherwise indicated, the numerical parameters described herein are approximate values that may vary depending on the desired properties sought to be obtained. In any application claiming priority to the present application, each numerical parameter should be interpreted based on the number of significant figures and ordinary rounding methods, rather than attempting to limit the application of the doctrine of equivalents to the scope of any claim.

[0392] Furthermore, although the foregoing has been described in considerable detail by way of illustration and example for purposes of clarity and understanding, it will be apparent to those skilled in the art that certain changes and modifications may be implemented. Therefore, this description and examples should not be construed as limiting the scope of the invention to the specific examples described herein, but rather to encompass all modifications and alternatives that fall within the true scope and spirit of the invention.

Claims

1. A device, comprising: An adapter body is configured to interface between at least a portion of a skin-wearable medical device and an applicator of the skin-wearable medical device.

2. An apparatus according to claim 1, wherein the adapter body is configured to interface between at least the portion of the wearable medical device on the skin having a first configuration and a portion of the applicator having a second configuration different from the first configuration and configured to engage at least a portion of the wearable medical device on the skin.

3. The apparatus of claim 2, wherein the second configuration differs from the first configuration in one or more of shape or size.

4. The apparatus according to claim 2 or claim 3, wherein: the on-skin wearable medical device having at least the portion with the first configuration is a first on-skin wearable medical device, and the on-skin wearable medical device having at least the portion with the second configuration is a second on-skin wearable medical device, The first configuration includes a configuration of a first wearable housing of the first on-skin wearable medical device, and The second configuration includes a configuration of a second wearable housing of the second on-skin wearable medical device.

5. The apparatus of claim 2 or claim 3, wherein the on-skin wearable medical device having at least the portion with the first configuration is the same on-skin wearable medical device having at least the portion with the second configuration.

6. The apparatus according to any one of claims 1 to 5, wherein: The on-skin wearable medical device is a first on-skin wearable medical device, and The adapter body is configured to interface between a wearable housing of the first on-skin wearable medical device that is smaller than a wearable housing of a second on-skin wearable medical device that the applicator is configured to engage. 7 . The apparatus of claim 6 , wherein the wearable housing of the first on-skin wearable medical device has a smaller diameter or a smaller height than the wearable housing of the second on-skin wearable medical device.

8. The apparatus according to any one of claims 1 to 7, wherein the adapter body is configured to adapt at least the portion of the on-skin wearable medical device to mate with an engagement portion of the applicator.

9. The apparatus of any one of claims 1 to 8, wherein the adapter body comprises a holding area for receiving at least the portion of the on-skin wearable medical device.

10. The apparatus of any one of claims 1 to 9, wherein the adapter body comprises a cavity for receiving at least the portion of the on-skin wearable medical device.

11. The apparatus of any one of claims 1 to 10, wherein the adapter body comprises one or more walls defining a retaining area for receiving at least the portion of the on-skin wearable medical device.

12. The apparatus of claim 11, wherein the one or more walls include one or more side walls defining the holding area.

13. The apparatus of claim 12, wherein the one or more side walls comprise an inner surface and an outer surface, the inner surface being configured to face the portion of the on-skin wearable medical device, and the outer surface being configured to face opposite the inner surface.

14. The apparatus of claim 13, wherein the one or more side walls have a spacing between the inner surface and the outer surface, the spacing being configured to space the outer surface of the skin wearable medical device apart from the outer surfaces of the one or more side walls.

15. The apparatus of claim 14, wherein the spacing is configured to adapt at least the portion of the on-skin wearable medical device to mate with an engagement portion of the applicator.

16. The apparatus of any one of claims 13 to 15, wherein the inner surface of the one or more side walls forms an inner perimeter having a different profile than an outer perimeter formed by the outer surface of the one or more side walls.

17. The apparatus of any one of claims 13 to 16, wherein the inner surface of the one or more side walls forms an inner periphery having a smaller diameter than an outer periphery formed by the outer surface of the one or more side walls.

18. Apparatus according to any one of claims 11 to 17, wherein the one or more walls comprises an upper wall defining the holding area.

19. The apparatus of claim 18, wherein the upper wall comprises an inner surface and an outer surface, the inner surface being configured to face the portion of the on-skin wearable medical device, and the outer surface being configured to face opposite the inner surface.

20. The apparatus of claim 19, wherein the upper wall has a spacing between the inner surface and the outer surface, the spacing configured to space an outer surface of the on-skin wearable medical device apart from the outer surface of the upper wall.

21. The apparatus of claim 20, wherein the spacing is configured to adapt at least the portion of the skin wearable medical device to mate with an engagement portion of the applicator.

22. The apparatus of any one of claims 9 to 21, further comprising one or more stabilizers for stabilizing at least the portion of the on-skin wearable medical device within the holding area.

23. The apparatus of claim 22, wherein the one or more stabilizers comprise one or more protrusions for contacting at least the portion of the wearable medical device on the skin.

24. The apparatus of any one of claims 1 to 23, wherein the adapter body comprises a ring extending around a retaining area for receiving at least the portion of the on-skin wearable medical device.

25. The apparatus of any one of claims 1 to 24, wherein the adapter body comprises a retainer portion for retaining at least the portion of the on-skin wearable medical device to the adapter body.

26. The apparatus of any one of claims 1 to 25, further comprising one or more device couplers for coupling the on-skin wearable medical device to the adapter body.

27. The apparatus of claim 26, wherein the one or more device couplers comprise an adhesive.

28. An apparatus according to claim 26 or claim 27, wherein the one or more device couplers comprise one or more of a protrusion or a recess configured to engage at least the portion of the skin-wearable medical device.

29. The apparatus of any one of claims 26 to 28, wherein the one or more device couplers are configured to deflect.

30. The apparatus of any one of claims 26 to 29, wherein the one or more device couplers comprise a releasable coupler configured to release the skin-wearable medical device from the adapter body.

31. The apparatus of any one of claims 26 to 30, wherein the one or more device couplers comprise one or more arms.

32. The apparatus of claim 31 , wherein the one or more arms define a holding area for receiving at least the portion of the on-skin wearable medical device.

33. An apparatus according to claim 31 or claim 32, wherein the one or more arms are configured to deflect radially outwardly from a retaining area for receiving at least the portion of the on-skin wearable medical device.

34. An apparatus according to any one of claims 26 to 33, wherein the adapter body includes one or more support portions, and the one or more support portions are configured to support the one or more device connectors in a coupling configuration with at least the portion of the wearable medical device on the skin.

35. The apparatus of claim 34, wherein the one or more support portions comprise one or more contact surfaces of the adapter body.

36. Apparatus according to claim 34 or claim 35, wherein the one or more support portions comprise one or more hooks.

37. The apparatus of any one of claims 1 to 36, further comprising one or more applicator couplers for coupling the adapter body to at least a portion of the applicator.

38. The apparatus of claim 37, wherein the one or more applicator couplers comprise one or more of a protrusion or a recess configured to engage at least the portion of the applicator.

39. The apparatus of any one of claims 1 to 38, wherein the adapter body comprises a pop-up portion configured to allow at least the portion of the skin wearable medical device to be ejected from the adapter body.

40. The apparatus of claim 39, wherein the pop-up portion comprises one or more openings in a surface of the adapter body.

41. The apparatus of any one of claims 1 to 40, wherein the on-skin wearable medical device comprises a transcutaneous analyte sensor and the adapter body is configured to be positioned within a housing of the applicator.

42. The apparatus according to any one of claims 1 to 41, wherein the adapter body comprises an activation body configured to electrically activate the on-skin wearable medical device.

43. The apparatus of claim 42, wherein the activation body comprises a magnet.

44. An apparatus according to claim 42 or claim 43, wherein the adapter body includes one or more walls defining a retaining area for receiving at least the portion of the wearable medical device on the skin, and the activation body is disposed on at least one of the one or more walls.

45. The apparatus of claim 44, wherein the one or more walls include an upper wall defining the retention area, and the activation body is disposed on the upper wall.

46. A system comprising: Applicators for wearable medical devices on the skin; as well as An adapter body is configured to interface between at least a portion of the on-skin wearable medical device and the applicator of the on-skin wearable medical device.

47. The system of claim 46, wherein the applicator includes an engagement portion configured to engage the adapter body.

48. The system of claim 47, wherein the engagement portion is configured to engage an outer surface of the adapter body.

49. A system according to claim 47 or claim 48, wherein the skin-wearable medical device is a first skin-wearable medical device and the engaging portion is configured to engage a second skin-wearable medical device having a different configuration than the first skin-wearable medical device.

50. The system of claim 49, wherein the first on-skin wearable medical device has a wearable housing that is smaller in diameter or smaller in height than a wearable housing of the second on-skin wearable medical device.

51. A system according to any one of claims 47 to 50, wherein the skin-wearable medical device is a first skin-wearable medical device having a first wearable shell, and the size of the coupling portion is designed to mate with a second wearable shell of a second skin-wearable medical device, the second wearable shell having a larger diameter or a larger height than the first wearable shell.

52. The system of any one of claims 47 to 51, wherein the adapter body is configured to adapt at least the portion of the on-skin wearable medical device to mate with the engagement portion of the applicator.

53. The system of any one of claims 46 to 52, wherein the adapter body comprises a retaining area for receiving at least the portion of the on-skin wearable medical device.

54. The system of any one of claims 46 to 53, wherein the adapter body comprises a cavity for receiving at least the portion of the on-skin wearable medical device.

55. The system of any one of claims 46 to 54, wherein the adapter body comprises one or more walls defining a retaining area for receiving at least the portion of the on-skin wearable medical device.

56. The system of claim 55, wherein the applicator comprises an engagement portion configured to engage at least a portion of the one or more walls.

57. The system of any one of claims 46 to 56, wherein the adapter body comprises one or more device couplers for coupling the on-skin wearable medical device to the adapter body.

58. The system of claim 57, wherein the one or more device couplers comprise a releasable coupler configured to release the skin-wearable medical device from the adapter body.

59. The system of claim 57 or 58, wherein: the adapter body comprising one or more support portions configured to support the one or more device couplers in a coupled configuration with at least the portion of the on-skin wearable medical device; and The applicator includes one or more contact surfaces configured to abut the one or more support portions.

60. The system of claim 59, wherein the one or more support portions comprise one or more hooks.

61. A system according to claim 60, wherein the one or more contact surfaces include at least one post configured to engage the one or more hooks, the at least one post being configured to retract from the one or more hooks to allow the one or more device connectors to be disengaged from at least the portion of the wearable medical device on the skin.

62. The system of claim 61, wherein the applicator is configured such that the at least one post is retracted during retraction of the needle for introducing the transcutaneous analyte sensor into the skin of the host.

63. The system of any one of claims 46 to 62, wherein: the adapter body comprising a pop-up portion configured to allow at least the portion of the on-skin wearable medical device to be popped out of the adapter body; and The applicator includes an ejection actuator configured to eject the on-skin wearable medical device from the adapter body.

64. The system of any one of claims 46 to 63, further comprising the skin-wearable medical device.

65. The system of claim 64, wherein the on-skin wearable medical device comprises a coupling mismatch with the applicator.

66. The system of claim 64 or claim 65, wherein the on-skin wearable medical device has a wearable housing having a configuration that is different from a configuration of the wearable housing that the engagement portion of the applicator is configured to mate with.

67. The system of claim 66, wherein the wearable housing of the on-skin wearable medical device has a smaller diameter or a smaller height than the configuration of the wearable housing that the engagement portion of the applicator is configured to mate with.

68. The system of any one of claims 64 to 67, wherein the skin-wearable medical device comprises a transcutaneous analyte sensor.

69. The system of any one of claims 46 to 68, wherein the adapter body comprises an activation body for electrically activating the on-skin wearable medical device.

70. The apparatus of claim 69, wherein the activation body comprises a magnet.

71. A method comprising: The on-skin wearable medical device is applied to the skin of the host using an applicator, with an adapter body interfacing between at least a portion of the on-skin wearable medical device and the applicator.

72. The method of claim 71 , wherein the on-skin wearable medical device comprises a coupling mismatch with the applicator.

73. The method of claim 71 or claim 72, wherein the adapter body adapts at least the portion of the skin wearable medical device to mate with an engagement portion of the applicator.

74. A method according to any one of claims 71 to 73, wherein the skin-wearable medical device is a first skin-wearable medical device and the applicator has a coupling portion configured to couple a second skin-wearable medical device having a different configuration than the first skin-wearable medical device.

75. The method of claim 74, wherein the engaging portion is configured to engage a wearable housing of the second skin-wearable medical device, the wearable housing having a larger diameter or a larger height than the wearable housing of the first skin-wearable medical device.

76. The method of any one of claims 71 to 75, further comprising releasing the on-skin wearable medical device from the adapter body.

77. The method of claim 76, further comprising releasing the skin-wearable medical device from the adapter body using one or more releasable couplings.

78. The method of claim 76 or claim 77, further comprising retaining the adapter body to the applicator after releasing the on-skin wearable medical device from the adapter body.

79. The method of any one of claims 71 to 78, wherein the skin-wearable medical device comprises a transcutaneous analyte sensor.

80. The method of claim 79, further comprising introducing the transcutaneous analyte sensor into the skin of the host using an insertion element of the applicator.

81. The method according to any one of claims 71 to 80, further comprising electrically activating the skin wearable medical device using an activation body provided on the adapter body.

82. The method of claim 81 , wherein the activation body comprises a magnet.

83. The method of claim 81 or claim 82, wherein electrically activating the on-skin wearable medical device comprises activating the on-skin wearable medical device from a lower power state to a higher power state.

84. The method of any one of claims 81 to 83, wherein electrically activating the on-skin wearable medical device comprises increasing a distance between the on-skin wearable medical device and the activating subject.

85. A method according to any one of claims 71 to 84, wherein the adapter body includes one or more walls defining a retaining area for receiving at least the portion of the wearable medical device on the skin, and the activation body is disposed on at least one of the one or more walls.

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