Apparatus, system and method of controlling sensor deployment

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. These devices, systems, and methods may be used to reduce friction between a sensor and an insertion element and / or to control sensor deployment.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 351,297, filed on June 10, 2022, the entire contents of which are incorporated herein by reference. Background Art Technical Field

[0003] Medical device systems and methods are provided. More specifically, apparatus, systems, and methods are provided for controlling the deployment of a transcutaneous analyte sensor to the skin of a host.

[0004] Related technical notes

[0005] Diabetes is a disease in which the pancreas fails to 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 (hypoglycemia) can be induced by accidental overdoses of insulin, or after normal doses of insulin or glucose-lowering agents with strenuous exercise or inadequate food intake.

[0006] Traditionally, diabetics wear self-monitoring of blood glucose (SMBG) monitors that typically require an uncomfortable finger prick. Due to the lack of comfort and convenience, diabetics typically measure their blood glucose levels only two to four times a day. Unfortunately, such time intervals are so far apart that it may be too late for diabetics to detect hyperglycemia or hypoglycemia, which can sometimes lead to dangerous side effects. Alternatively, glucose levels can be continuously monitored by a measurement system that includes an on-skin sensor assembly. The sensor assembly can have a wireless transmitter that sends the measurement data to a receiver that can process and display information based on the measurement results.

[0007] The process of applying the sensor to the patient is very important for the effectiveness and user-friendliness of such a system. The application process should enable 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 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 for deploying a transcutaneous analyte sensor to the skin of a host are provided. These apparatus, systems and methods can be used to reduce friction between the sensor and an insertion element and / or to control sensor deployment. Various examples of the apparatus, systems and methods of the present invention may have several features, none 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, especially after reading the section entitled "Specific Embodiments", it will be understood how the features of the examples of the present invention provide the advantages described herein.

[0011] In a first aspect, a medical device system includes: a shell configured to be worn on the skin of a host and including a distal surface facing the skin and a proximal surface facing opposite to the distal surface, the shell including an opening for an insertion element to pass through and retract proximally from the skin; an analyte sensor having a first portion connected to the shell and a second portion configured to extend distally from the shell and be guided into the skin of the host by the insertion element; and a plug body configured to prevent the analyte sensor from retracting proximally through the opening when the insertion element is retracted proximally through the opening.

[0012] The implementation of the embodiment may include one or more of the following. The analyte sensor may include a bend between the first portion and the second portion, the bend being aligned axially with the opening. The second portion may be straight and aligned axially with the opening. The plug body may be configured to contact the analyte sensor to prevent the analyte sensor from retracting proximally when the insertion element retracts proximally through the opening. The plug body may be positioned near the opening. The plug body may include a tab extending into the opening. The first portion of the analyte sensor may be positioned in the cavity, and the tab extends from the cavity into the opening. The plug body may be integral with the housing. The plug body may include a plug positioned in the opening. The plug may include a gasket. The plug may have a bevel. The plug may be pierced by the insertion element. The plug body may be positioned proximal to the analyte sensor. The system may also include an insertion element, wherein the insertion element includes a channel for receiving the analyte sensor. The insertion element may include a needle. The needle seat may be positioned at the proximal portion of the needle, and wherein the plug body is positioned between the needle seat and the analyte sensor. The insertion element may be positioned within the opening of the housing and extend parallel to the second portion of the analyte sensor. The plug body may surround the insertion element. The plug body may contact the insertion element. The analyte sensor may include a transcutaneous analyte sensor.

[0013] In a second aspect, a medical device system includes: a shell configured to be worn on the skin of a host and including a distal surface facing the skin and a proximal surface facing opposite to the distal surface; a slender analyte sensor connected to the shell and configured to extend distally from the shell and be positioned in the skin of the host; a slender insertion element, the slender insertion element including an axis configured to extend along a portion of the slender analyte sensor and configured to guide the slender analyte sensor into the skin of the host; and a spacer body configured to be positioned between the portion of the slender analyte sensor and the axis and to separate the portion of the slender analyte sensor from the axis.

[0014] Specific implementations of the embodiments may include one or more of the following. The spacer body may be removed from the portion of the elongated analyte sensor and the shaft. The spacer body may be manually removed from the portion of the elongated analyte sensor and the shaft. The system may also include a tether connected to the spacer body and configured to be pulled to remove the spacer body from the portion of the elongated analyte sensor and the shaft. The tether and the spacer body may be formed from a single piece of material. The tether may include a pull tab for the user to pull. The spacer body may include a sheath surrounding the elongated insertion element. The sheath may include a channel in which the elongated analyte sensor is positioned. The cover may cover the distal surface of the housing and be connected to the spacer body. The system may also include an applicator housing, which is configured to hold the housing and includes a proximal end and a distal opening, the distal opening is used to deploy the housing from the distal opening to the skin, and wherein the cover includes a cap positioned at the distal opening. The system may also include a tether connected to the spacer body and connected to the cap. The removal of the cap-shaped member can pull the tether connected to the spacer body to remove the spacer body from the portion of the elongated analyte sensor and the shaft. The system may also include an adhesive patch positioned at the distal surface of the housing, and wherein the cover includes a lining cover for the adhesive patch. The spacer body may include a thermally expandable metal. The elongated insertion element may have a first thermal expansion coefficient, and the spacer body has a second thermal expansion coefficient different from the first thermal expansion coefficient. The spacer body may be compressible. The elongated insertion element includes a channel for receiving a portion of the elongated analyte sensor. The spacer body may be removable and configured to be removed to place the portion of the elongated analyte sensor in the channel. The elongated insertion element may include a needle. The system may also include a needle seat positioned at the proximal portion of the needle, wherein the spacer body is positioned on the needle seat.

[0015] In a third aspect, a medical device system includes: a shell configured to be worn on the skin of a host and including a distal surface facing the skin and a proximal surface facing opposite to the distal surface; a slender analyte sensor connected to the shell and configured to extend distally from the shell and be positioned in the skin of the host; a slender insertion element, the slender insertion element including a shaft configured to extend along a portion of the slender analyte sensor and be inserted into the skin to guide the slender analyte sensor into the skin of the host and configured to be retracted from the skin; and a displacement mechanism configured to displace the portion of the slender analyte sensor relative to the slender insertion element before the shaft is retracted from the skin to reduce adhesion between the slender analyte sensor and the shaft.

[0016] Specific implementation of the embodiment may include one or more of the following. The displacement mechanism may be configured to slide a portion of the elongated analyte sensor relative to the shaft before the shaft is retracted from the skin to reduce the sticking between the elongated analyte sensor and the shaft. The system may also include a hub positioned at the proximal portion of the elongated insertion element, and wherein the displacement mechanism includes a compressible body positioned between the hub and the proximal surface of the housing. The displacement mechanism may include a compressible body protruding distally from the distal surface of the housing. The displacement mechanism may be configured to vibrate one or more of the portions of the elongated insertion element or the elongated analyte sensor before the shaft is retracted from the skin to reduce the sticking between the elongated analyte sensor and the shaft. The system may include an insertion assembly for inserting the shaft of the elongated insertion element into the skin, wherein the insertion assembly includes a displacement mechanism. The displacement mechanism may include a cover covering the distal surface of the housing. The system may also include an applicator housing, the applicator housing being configured to hold the housing and including a proximal end and a distal opening, the distal opening being used to deploy the housing from the distal opening to the skin, and wherein the cover includes a cap positioned at the distal opening. The cap may include a cam surface for applying a force to the housing to displace a portion of the elongated analyte sensor relative to the elongated insertion element. The system may also include an adhesive patch positioned at the distal surface of the housing, and wherein the cover includes a liner cover for the adhesive patch.

[0017] In a fourth aspect, a medical device system includes: a shell configured to be worn on the skin of a host and including a distal surface facing the skin and a proximal surface facing opposite to the distal surface; a slender analyte sensor connected to the shell and configured to extend distally from the shell and be positioned in the skin of the host; and an elongated insertion element including an axis configured to extend along a portion of the elongated analyte sensor and be inserted into the skin to guide the elongated analyte sensor into the skin of the host, the axis including a surface configured to reduce friction with the portion of the elongated analyte sensor.

[0018] Specific implementations of the embodiments may include one or more of the following. The surface may be configured to reduce sticking with a portion of the elongated analyte sensor. The surface may include a surface texture. The surface may have a surface roughness of 35 root mean square (RMS) micro inches or greater. The surface may include one or more of a bump, a hole, or a groove. The surface may include a coating configured to reduce friction with a portion of the elongated analyte sensor. The coating may include a lubricant. The coating may include one or more of spraying, brushing, electrostatically applying a coating, or more preferably plating, dipping, or deposition. The coating may include a polymer. The coating may include a thermal oxide. The coating may include an inert material. The coating may be bonded to the shaft. The thickness of the coating on the shaft may be less than 1.5 microns. The coating may be cured, i.e., via addition curing, condensation curing, thermal curing, etc. The coating may include silicone. The silicone may include an amino-functionalized dimethylsiloxane copolymer. The surface may be configured to reduce hydrogen bonding with a portion of the elongated analyte sensor. The elongated insertion element may include a needle. The elongate insertion element may include a channel for receiving a portion of the elongate analyte sensor. The channel may have a C-shaped cross-section.

[0019] In a fifth aspect, a medical device system comprises: a shell configured to be worn on the skin of a host and comprising a distal surface facing the skin and a proximal surface facing opposite the distal surface; an elongated analyte sensor connected to the shell and configured to extend distally from the shell and be positioned in the skin of the host; and an elongated insertion element comprising an axis configured to extend along a portion of the elongated analyte sensor and be inserted into the skin to guide the elongated analyte sensor into the skin of the host, the axis having a V-shaped or W-shaped cross-sectional channel for receiving the portion of the elongated analyte sensor.

[0020] Specific implementations of the embodiments may include one or more of the following. The V-shaped cross-sectional channel may have an angle between 60 and 120 degrees. The V-shaped cross-sectional channel may have an angle of 90 degrees. The W-shaped cross-sectional channel may be formed by an elongated protrusion added to the center portion of an elongated insertion element having a C-shaped cross-sectional channel. The outer surface of the elongated analyte sensor may have a circular shape cross-section.

[0021] In a sixth aspect, a medical device system comprises: a shell configured to be worn on the skin of a host and comprising a distal surface facing the skin and a proximal surface facing opposite the distal surface; a slender insertion element comprising an axis configured to be inserted into the skin; and an elongated analyte sensor connected to the shell and configured to extend along the elongated insertion element and be guided into the skin by the elongated insertion element, the elongated analyte sensor comprising a surface configured to reduce friction with the elongated insertion element.

[0022] Implementations of the embodiments may include one or more of the following. The surface may be configured to reduce sticking with the elongated analyte sensor. The surface may be configured to reduce hydrogen bonding with the elongated insertion element. The elongated insertion element may include a needle. The elongated insertion element may include a channel for receiving a portion of the elongated analyte sensor.

[0023] In a seventh aspect, a medical device system comprises: a shell configured to be worn on the skin of a host and comprising a distal surface facing the skin and a proximal surface facing opposite the distal surface; an elongated insertion element comprising an axis configured to be inserted into the skin; and an elongated analyte sensor connected to the shell and configured to extend along the elongated insertion element and be guided into the skin by the elongated insertion element, the elongated analyte sensor having an elliptical cross-section.

[0024] Implementations of the embodiments may include one or more of the following. The outer surface of the elongated analyte sensor may be configured to reduce sticking with the elongated insertion element. The elongated insertion element may include a needle. The elongated insertion element may include a channel for receiving a portion of the elongated analyte sensor. The channel may have a C-shaped cross-section.

[0025] In an eighth aspect, a medical device system comprises: a shell configured to be worn on the skin of a host and comprising a distal surface facing the skin and a proximal surface facing opposite the distal surface; and an analyte sensor having a first portion connected to the shell and a second portion configured to extend distally from the shell and be inserted into the skin of the host, the analyte sensor comprising a bend having at least two kinks that angle the second portion to the first portion.

[0026] Implementations of the embodiments may include one or more of the following. The second portion may extend perpendicularly from the distal surface of the housing. The first portion may extend parallel to the distal surface of the housing. The at least two kinks may angle the second portion to be perpendicular to the first portion. The at least two kinks may include a first kink and a second kink, the first kink having an angle less than ninety degrees and the second kink having an angle less than ninety degrees.

[0027] In a ninth aspect, a medical device system comprises: a shell configured to be worn on the skin of a host and comprising a distal surface facing the skin and a proximal surface facing opposite the distal surface; an analyte sensor connected to the shell and configured to extend distally from the shell and be positioned in the skin of the host; an insertion element configured to extend along the analyte sensor and guide the analyte sensor into the skin of the host; an insertion assembly configured to drive the insertion element into the skin of the host; and a force directing component configured to direct force from the insertion assembly proximate to the insertion element.

[0028] Implementations of the embodiments may include one or more of the following. The insertion assembly may include a plate configured to be positioned proximal to the proximal surface, and the force directing component includes one or more protrusions on the plate configured to direct force proximal to the insertion element. The one or more protrusions may be configured to apply a force to the proximal surface of the housing proximal to the insertion element. The housing may include an opening through which the insertion element is retracted proximally from the skin, and the force directing component is configured to contact the proximal surface of the housing proximal to the opening. The insertion element may include a needle.

[0029] In a tenth aspect, a medical device system comprises: a shell configured to be worn on the skin of a host and comprising a distal surface facing the skin and a proximal surface facing opposite the distal surface; a slender analyte sensor connected to the shell and configured to extend distally from the shell and be positioned in the skin of the host, the slender analyte sensor having a flexural modulus greater than 8 gigapascals; and an elongated insertion element comprising an axis configured to extend along a portion of the elongated analyte sensor and be inserted into the skin to guide the portion of the elongated analyte sensor into the skin of the host.

[0030] Implementations of the embodiments may include one or more of the following. The flexural modulus may be greater than 8.4 gigapascals. The elongated analyte sensor may include a first portion coupled to the housing and a second portion extending distally from a distal surface of the housing, the second portion having a flexural modulus greater than 8 gigapascals. The shaft may include a channel configured to receive a portion of the elongated analyte sensor. The elongated insertion element may include a needle.

[0031] In an eleventh aspect, a medical device system comprises: a shell configured to be worn on the skin of a host and comprising a distal surface facing the skin and a proximal surface facing opposite the distal surface; an elongated analyte sensor connected to the shell and configured to extend distally from the shell and be positioned in the skin of the host; and an elongated insertion element comprising an axis having a channel, a portion of the elongated analyte sensor being positioned in the channel, the axis being configured to be inserted into the skin to guide the portion of the elongated analyte sensor into the skin, and the axis having a diameter gap of at least 0.07 mm with the portion of the elongated analyte sensor.

[0032] Implementations of the embodiments may include one or more of the following. The diameter gap may be at least 0.10 mm. The elongated insertion element may include a needle. The channel may have a C-shaped cross-section. The elongated analyte sensor may have a first portion coupled to the housing and a second portion extending distally from a distal surface of the housing and positioned within the channel.

[0033] In a twelfth aspect, a medical device system comprises: a shell configured to be worn on the skin of a host and comprising a distal surface facing the skin and a proximal surface facing opposite the distal surface; a slender analyte sensor having a first portion connected to the shell and a second portion configured to extend distally from the shell and be positioned in the skin of the host, the second portion having a diameter; and an elongated insertion element comprising a shaft having an opening for a channel, the second portion of the elongated analyte sensor being positioned in the channel, the shaft being configured to be inserted into the skin to guide the second portion into the skin, and the channel having a width at the opening, and wherein a ratio of the diameter to the width is less than 0.9.

[0034] Specific implementations of the embodiments may include one or more of the following. The ratio of diameter to width may be less than 0.8. The ratio of diameter to width may be less than 0.7. The channel may have a C-shaped cross-section. The elongated insertion element may include a needle.

[0035] In a thirteenth aspect, a method includes reducing friction between an analyte sensor and an insertion element during or after a sterilization process of the analyte sensor and the insertion element and before the insertion element is retracted from the host's skin, wherein the insertion element is configured to guide the analyte sensor into the host's skin and retract from the host's skin.

[0036] Implementation of the embodiment may include one or more of the following. The method may also include vibrating the analyte sensor and the insertion element to reduce friction between the analyte sensor and the insertion element. The method may also include raising the ambient temperature or lowering the ambient temperature to reduce friction between the analyte sensor and the insertion element. The method may also include reducing ambient humidity to reduce friction between the analyte sensor and the insertion element. The method may also include packaging the analyte sensor and the insertion element with a desiccant. Friction may include sticking. The insertion element may include an elongated insertion element having an axis configured to be inserted into the skin, and the analyte sensor includes an elongated analyte sensor having a portion extending along the axis of the elongated insertion element. The axis may include a channel and a portion of the elongated analyte sensor is positioned within the channel. The method may also include reducing hydrogen bonding between the analyte sensor and the insertion element. The insertion element may include a needle. The analyte sensor may be coupled to a housing configured to be worn on the skin of the host, the housing including an opening for the insertion element to pass through. The analyte sensor may include a first portion coupled to the housing and a second portion extending distally from a distal surface of the housing. The housing, the analyte sensor, and the insertion element may be positioned within an applicator housing. The sterilization process may include applying a sterilizing gas to the analyte sensor and the insertion element. The sterilization process may include an ethylene oxide sterilization process.

[0037] In a fourteenth aspect, a method includes: coating at least a portion of a shaft of an elongated insertion element with a material, the elongated insertion element being used to guide an elongated analyte sensor into the skin when inserted into the skin of a host, wherein the elongated analyte sensor extends along a portion of the shaft, the material being configured to reduce friction between the insertion element and the elongated analyte sensor.

[0038] Specific implementations of the embodiments may include one or more of the following. The method may include positioning the elongated insertion element adjacent to the elongated analyte sensor. The method may include positioning the elongated analyte sensor within a channel of the elongated insertion element. The elongated analyte sensor may extend distally from a housing configured to be worn on the skin of a host. The material may be configured to reduce sticking to the elongated analyte sensor. The coating may include one or more of plating, dipping, or deposition. The coating may be bonded to the shaft. The thickness of the coating on the shaft may be less than 1.5 microns. The method may include curing the coating on the shaft. The coating may include silicone. The silicone may include an amino-functionalized dimethylsiloxane copolymer. The method may include positioning the shaft in a solution of the material. The solution may include a solvent. The coefficient of friction generated by the material against the portion of the shaft may be less than one-tenth of the coefficient of friction of the surface of the portion of the shaft coated with the material. The elongated insertion element may include a needle.

[0039] In a fifteenth aspect, a medical device system comprises: a shell configured to be worn on the skin of a host and comprising a distal surface facing the skin and a proximal surface facing opposite the distal surface; a slender analyte sensor connected to the shell and configured to extend distally from the shell and be positioned in the skin of the host; and one or more slender insertion elements, each slender insertion element comprising an axis configured to extend along a portion of the slender analyte sensor, each of the one or more slender insertion elements being configured to guide the slender analyte sensor into the skin of the host, wherein the slender analyte sensor is positioned outside the axis of the corresponding slender insertion element.

[0040] Specific implementations of the embodiments may include one or more of the following. The elongated analyte sensor may include a central axis, and each of the one or more elongated insertion elements includes a corresponding central axis, the central axis of the elongated analyte sensor being configured to be parallel to and laterally spaced apart from the corresponding central axis of the one or more elongated insertion elements. At least a portion of each of the one or more elongated insertion elements may include a convex outer surface, which is configured to extend parallel to and adjacent to the outer surface of the elongated analyte sensor. Each of the one or more elongated insertion elements may include an outer surface having a longitudinal extension section, which is configured to extend parallel to and adjacent to the outer surface of the elongated analyte sensor. Each of the one or more elongated insertion elements may not have a channel for holding the elongated analyte sensor. Each of the one or more elongated insertion elements may include an outer surface that is configured to contact the outer surface of the elongated analyte sensor in a deployed configuration. One or more elongated insertion elements may include at least two of the elongated insertion elements. At least two elongated insertion elements may each include an outer surface that is configured to contact the outer surface of the elongated analyte sensor in the deployment configuration. At least two elongated insertion elements may be configured to be positioned on opposite sides of the elongated analyte sensor in the deployment configuration. The elongated analyte sensor may be configured to be positioned between the at least two elongated insertion elements in the deployment configuration. Each of the at least two elongated insertion elements may include a proximal end portion and a top end, and also include a needle seat connected to the corresponding proximal end portion of the at least two elongated insertion elements. The shaft of the corresponding at least two elongated insertion elements may extend from the proximal end portion to the corresponding top end, and the top ends of the at least two elongated insertion elements are not connected to each other. At least two elongated insertion elements may include a first elongated insertion element and a second elongated insertion element, the first elongated insertion element having a first outer surface and the second elongated insertion element having a second outer surface, the second outer surface extending parallel to the first outer surface and laterally spaced apart from the first outer surface. The at least two elongated insertion elements may include a first elongated insertion element having a first outer surface and a second elongated insertion element having a second outer surface extending parallel to and in contact with the first outer surface. The one or more elongated insertion elements may include at least three of the elongated insertion elements.The elongated analyte sensor may be a first elongated analyte sensor and further include a second elongated analyte sensor coupled to the housing and configured to extend distally from the housing and positioned in the skin of the host; and the one or more elongated insertion elements each include an axis configured to extend along a portion of the second elongated analyte sensor, each of the one or more elongated insertion elements being configured to guide the second elongated analyte sensor into the skin of the host, wherein the second elongated analyte sensor is positioned outside the axis of the corresponding elongated insertion element. At least one of the one or more elongated insertion elements may have an elliptical cross-section. The elongated analyte sensor may include a distal tip, and the one or more elongated insertion elements include a distal tip configured to extend radially above at least a portion of the distal tip of the elongated analyte sensor. The distal tip of the one or more elongated insertion elements may have a diameter that is greater than the diameter of the corresponding axis of the one or more elongated insertion elements. The system may include a rotation mechanism for rotating the distal tip of the one or more elongated insertion elements to expose a portion of the distal tip of the elongated analyte sensor.

[0041] Any of the features of the embodiments of any of these aspects (including but not limited to any of the embodiments of any of the first to fifteenth aspects described above) can be applied to all other aspects and embodiments identified herein, including but not limited to any of the embodiments of any of the first to fifteenth aspects described above. In addition, any of the features of the embodiments of each aspect (including but not limited to any of the embodiments of any of the first to fifteenth aspects described 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 of the embodiments of any of the first to fifteenth aspects described 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 a method of another aspect or embodiment (including but not limited to any of the embodiments of any of the first to fifteenth aspects described above).

[0042] 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 be used as an aid in determining the scope of the claimed subject matter. The claimed subject matter is not limited to a specific implementation that solves any or all of the shortcomings mentioned in any part of this disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] 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 denote corresponding features in like examples.

[0044] Figure 1 A schematic diagram of a continuous analyte sensor system is shown.

[0045] Figure 2A A top perspective assembled view of the on-skin sensor assembly is shown.

[0046] Figure 2B Shown in assembled state Figure 2A Bottom perspective view of the on-skin sensor assembly.

[0047] Figure 2C Shown in assembled state Figure 2A Top perspective view of the on-skin sensor assembly.

[0048] Figure 3 A perspective assembled view of the on-skin sensor assembly is shown.

[0049] Figure 4 A perspective view of an on-skin sensor assembly is shown.

[0050] Figure 5 A perspective view of an applicator system for an on-skin sensor assembly of an analyte sensor system is shown.

[0051] Figure 6 Shows Figure 5 Exploded perspective view of the applicator system.

[0052] Figures 7 to 9 shows that during operation along Figure 5 The section line AA' is cut Figure 5 and Figure 6 Several cross-sectional views of the applicator system.

[0053] Figures 10 to 12 shows that during operation along Figure 5 The section line BB' is cut Figure 5 and Figure 6 Several cross-sectional views of the applicator system.

[0054] Fig.13 and Fig.14 Shows Figure 5 and Figure 6 An enlarged view of some features of the applicator system.

[0055] Fig.15 and Fig.16 Shows Figure 5 and Figure 6 An enlarged view of some features of the applicator system.

[0056] Fig.17 Shows 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.

[0057] Fig.18 Shows Figure 5 and Figure 6 Cross-sectional view of the hub and on-skin sensor assembly of the applicator system.

[0058] Fig.19 Show Figure 5 and Figure 6 Top view of a portion of the needle carrier assembly and hub.

[0059] Fig. 20A and Fig. 20B A perspective view of a locking feature of a needle used in an applicator of an analyte sensor system is shown.

[0060] Figure 21 to Figure 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.

[0061] Fig.24 Shows Figure 21 to Figure 23 A perspective view of various features of the applicator system.

[0062] Fig.25 A cross-sectional view of a system according to some examples is shown.

[0063] FIG. 26A to FIG. 26B Schematic cross-sections of analyte sensors with and without intervening elements are shown.

[0064] Fig.27A A cross-sectional view of the housing of the on-skin sensor assembly is shown.

[0065] Fig.27B Shows Fig.27AA cross-sectional view of the housing is shown with the insert element retracted.

[0066] Fig.28 A top cross-sectional view of an analyte sensor positioned within a channel of an insert member is shown.

[0067] Fig.29 A cross-sectional view of the system is shown prior to application to the skin of a host.

[0068] Fig. 30A A cross-sectional view of an analyte sensor positioned within a channel of an insert member is shown.

[0069] Fig. 30B Shows Fig. 30A A cross-sectional view of the analyte sensor and insert member is shown with the spacer body expanded.

[0070] Fig. 30C Shows Fig. 30B A cross-sectional view of an analyte sensor and insert element is shown with the spacer body having reduced dimensions.

[0071] Fig.31 A side view of a spacer body positioned between an analyte sensor and an insert element is shown.

[0072] Fig.32 Shows Fig.31 A front view of the spacer body and a schematic cross-sectional view of the cap are shown.

[0073] Fig.33 A side view of a septum body positioned between an analyte sensor and an insert element is shown, wherein the septum body is coupled to a liner removal component.

[0074] Fig.34A A top perspective cross-sectional view of the spacer body including the sheath is shown.

[0075] Fig.34B Shows Fig.34A A bottom perspective view of the spacer body is shown.

[0076] Fig.34C Shows Fig.34B A bottom view of the spacer body is shown.

[0077] Fig.35A A cross-sectional view of the spacer body and the housing of the on-skin sensor assembly is shown.

[0078] Fig.35B A cross-sectional view of the spacer body and the housing of the on-skin sensor assembly is shown.

[0079] Fig.36A cross-sectional view of the housing of the on-skin sensor assembly is shown positioned within the applicator housing.

[0080] Fig.37A A perspective view of a plug body comprising a flat face is shown.

[0081] Fig.37B A perspective view of a plug body including a protruding face is shown.

[0082] Fig.38 A perspective view of the plug body positioned between the hub and the analyte sensor is shown.

[0083] Fig.39 Shows Fig.36 A bottom view of the plug body is shown.

[0084] Fig.40 A cross-sectional view of the housing of the on-skin sensor assembly is shown.

[0085] Fig.41 A cross-sectional view of the housing of the on-skin sensor assembly is shown.

[0086] Fig.42 A cross-sectional view of the housing of the on-skin sensor assembly is shown.

[0087] Fig.43 A cross-sectional view of the housing of the on-skin sensor assembly is shown.

[0088] Fig.44 A cross-sectional view of the housing of the on-skin sensor assembly is shown.

[0089] Fig.45 A side view of the displacement mechanism between the hub and the housing of the on-skin sensor assembly is shown.

[0090] Fig.46 Shows Fig.45 Top view of the displacement mechanism shown.

[0091] Fig.47 A side view representation of the analyte sensor is shown displaced relative to an insert element.

[0092] Fig.48 A cross-sectional view of the housing of an on-skin sensor assembly including a displacement mechanism is shown.

[0093] Fig.49 Shows Fig.48 A cross-sectional view of the housing of the on-skin sensor assembly is shown.

[0094] Fig.50 A cross-sectional view of the displacement mechanism is shown.

[0095] Fig.51A cross-sectional view of a liner removal component including a displacement mechanism is shown.

[0096] Fig.52 A perspective view of a cap including a displacement mechanism is shown.

[0097] Fig.53 Shows Fig.52 A cross-sectional view of the cap and on-skin sensor assembly is shown.

[0098] Fig.54 Shows Fig.53 The cap shown is from Fig.53 Cross-sectional view of the rotation position shown.

[0099] Fig.55 A bottom perspective view of a force directing component of an insert assembly is shown.

[0100] Fig.56 A cross-sectional view of an analyte sensor positioned within a channel of an insert member is shown.

[0101] Fig.57 An analyte sensor located within a channel of an insert member is shown along Fig.56 Rotated top cross-sectional view of line CC′.

[0102] Fig.58 A cross-sectional view of the housing of the on-skin sensor assembly is shown.

[0103] Fig.59 A cross-sectional view of an analyte sensor positioned within a channel of an insert member is shown.

[0104] Fig.60 A cross-sectional view of an analyte sensor positioned within a channel of an insert member is shown.

[0105] Fig.61 A front view of a channel of an insert element including surface texture is shown.

[0106] Fig.62 A front view of a channel of an insert element including a groove is shown.

[0107] Fig.63 A front view of a channel of an insertion element including a hole is shown.

[0108] Fig.64 A top cross-sectional view of an analyte sensor positioned within a channel of an insert member is shown.

[0109] Fig.65 A top cross-sectional view of an analyte sensor positioned within a channel of an insert member is shown.

[0110] Fig.66A top cross-sectional view of an analyte sensor positioned within a channel of an insert member is shown.

[0111] Fig.67 A schematic side cross-sectional view of an insert element partially withdrawn from a chemical bath is shown.

[0112] Fig.68 A side view of the insert element is shown withdrawn from the chemical bath.

[0113] Fig.69 A side cross-sectional view of a coating on an insert element is shown.

[0114] Fig.70 A top cross-sectional view of a coating on an insert element is shown.

[0115] Fig.71 A side perspective view of a plurality of insert elements adjacent to an analyte sensor is shown.

[0116] Fig.72 Shows that Fig.71 Top cross-sectional view of multiple insert elements adjacent to analyte sensors in position as shown.

[0117] Fig.73 A side perspective view of a plurality of insert elements adjacent to an analyte sensor is shown.

[0118] Fig.74 A side perspective view of multiple insertion elements for introducing an analyte sensor into the skin of a host is shown.

[0119] Fig.75 A side perspective view of a plurality of insertion elements retracted from the skin of a host is shown.

[0120] Fig.76 A top cross-sectional view of a plurality of insert elements adjacent to an analyte sensor is shown.

[0121] Fig.77 A top cross-sectional view of a plurality of insert elements adjacent to an analyte sensor is shown.

[0122] Fig.78 A top cross-sectional view of a plurality of insert elements adjacent to an analyte sensor is shown.

[0123] Fig.79 A top cross-sectional view of a plurality of insert elements adjacent to an analyte sensor is shown.

[0124] Fig.80 A top cross-sectional view of a plurality of insert elements adjacent to an analyte sensor is shown.

[0125] Fig.81A top cross-sectional view of a plurality of insert elements adjacent to a plurality of analyte sensors is shown.

[0126] Fig.82 A top cross-sectional view of a plurality of insert elements adjacent to a plurality of analyte sensors is shown.

[0127] Fig.83 A top cross-sectional view of a plurality of insert elements adjacent to a plurality of analyte sensors is shown.

[0128] Fig.84 A top cross-sectional view of a plurality of insert elements adjacent to a plurality of analyte sensors is shown.

[0129] Fig.85 A top cross-sectional view of a plurality of insert elements adjacent to a plurality of analyte sensors is shown.

[0130] Fig.86 A side partial cross-sectional view of an insert element adjacent to an analyte sensor is shown.

[0131] Fig.87 Shown with Fig.86 A perspective view of an analyte sensor adjacent to an insert element.

[0132] Fig.88 A side view of an insertion element for introducing an analyte sensor into the skin of a host is shown.

[0133] Fig.89 A side view of the insertion element is shown retracted from the host's skin. DETAILED DESCRIPTION

[0134] 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.

[0135] Figure 1 is a diagram depicting an example medical device system according to examples herein. In an example, the medical device system may include a continuous analyte monitoring system 100. The continuous analyte monitoring system 100 may 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).

[0136] 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 a skin-wearable sensor assembly or a drug delivery medical device and other forms of skin-wearable medical devices.

[0137] like Figure 1 As shown, according to certain aspects of the present disclosure, the analyte sensor system 102 can be operably connected to a host and multiple 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 that 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 multiple display devices 110-114 via a wireless communication signal. As will be discussed in more detail below, the display devices 110-114 may also communicate with the analyte sensor system 102 between and / or through each other. For ease of reference, wireless communication signals from the analyte sensor system 102 to the display devices 110-114 may be referred to as "uplink" signals 128. Wireless communication signals from, for example, the display devices 110-114 to the analyte sensor system 102 may be referred to as "downlink" signals 130. Wireless communication signals between two or more of the display devices 110-114 may be referred to as "crosslink" signals 132. In addition, the wireless communication signals may include data transmitted by one or more of the display devices 110-113 via a "long-range" uplink signal 136 (e.g., a cellular signal) to one or more remote servers 190 or network entities (such as a cloud-based server or database), and receive long-range downlink signals 142 transmitted by the remote server 190.

[0138] exist Figure 1In the example shown, one of the multiple display devices may be a custom display device 111 that is 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 multiple display devices may be a handheld device 112 (such as a mobile phone based on an Android operating system, an iOS operating system, or other operating system, a palmtop computer, etc.), 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 data and historical data). Other display devices may include other handheld devices, such as a tablet computer 113, a smart watch 110, a drug delivery device 114, a blood glucose meter, and / or a desktop or laptop computer.

[0139] 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 alarms 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.

[0140] During use, the sensing portion of the sensor 138 can be disposed under the host's skin, and the contact portion of the sensor 138 can be electrically connected to the sensor electronics module 140. The electronics module 140 can be engaged with a housing (e.g., a base) that is attached to a patch that can engage the host's skin. In examples, the patch can be an adhesive patch. In some examples, the electronics module 140 is integrally formed with the housing. In addition, the electronics module 140 can be disposable and directly coupled to the patch.

[0141] The continuous analyte sensor system 100 may include a sensor configuration that provides an output signal indicative of analyte concentration. The output signal including (eg, sensor data, such as a raw data stream, filtered data, smoothed data, and / or otherwise transformed sensor data) is sent to a receiver.

[0142] 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.

[0143] 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 may extend through a housing that may hold the sensor 138 on, in, or under the skin and / or may provide electrical connection of the sensor 138 to the sensor electronics in the sensor electronics module 140.

[0144] In some examples, the descriptions of the base, housing, wearable, and / or transmitter of the on-skin sensor assembly 160 may be interchangeable. In other examples, the base and housing of the on-skin sensor assembly 160 may be distinct in the sense that they are separate components from the sensor electronics module 140 (e.g., from the transmitter or receiver).

[0145] In some examples, the sensor 138 is in the form of a wire. The distal end of the wire may 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.

[0146] The 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, the sensor 138 may be disposed on a substantially planar substrate. For such an electrode, one or two additional conductive layers (e.g., with an intermediate insulating layer provided for electrical isolation) may be added. These conductive layers may be made of any suitable material. In some examples, it may be desirable to use a conductive layer containing conductive particles (i.e., particles of conductive material) in a polymer or other binder.

[0147] 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 hard, and therefore resistant to breakage. For example, in several examples, the ultimate tensile strength of the elongated electrical conductor is greater than 80 kPsi and less than 140 kPsi, and / or the Young's modulus of the elongated electrical conductor is greater than 160 GPa and less than 220 GPa. The yield strength of the elongated electrical conductor can be greater than 58 kPsi and less than 2200 kPsi.

[0148] The electronics module 140 can be releasably or permanently connected to the sensor 138. The electronics module 140 may include an electronic circuit associated with measuring and processing continuous analyte sensor data. The electronics module 140 may be configured to perform 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).

[0149] 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 (such as devices 110-114). The electronic components may be attached to a printed circuit board (PCB), etc., and may take a variety of forms. The electronic components 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 changes in 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 entirety. 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.

[0150] 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 entirety.

[0151] Any sensor shown or described herein may be an analyte sensor; a glucose sensor; and / or any other suitable sensor. The sensor described in the context of any example may be any sensor described herein or incorporated by reference. The sensors shown or described herein may be configured to sense, measure, detect, and / or interact with any analyte.

[0152] As used herein, the term "analyte" is a broad term and will be given its ordinary and customary meaning to those of ordinary skill in the art (and is not limited to a special or customary meaning), and refers to, but is not limited to, substances or chemical components that can be analyzed in biological fluids (e.g., blood, interstitial fluid, cerebrospinal fluid, lymph, urine, sweat, saliva, etc.). Analytes may include naturally occurring substances, artificial substances, metabolites, or reaction products.

[0153] 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 isozyme; 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 beta-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-α-hydroxyprogesterone; hypoxanthine phosphoribosyltransferase; immunoreactive trypsin; lactate; lead; lipoprotein ((a), B / A-1, B); lysozyme; mefloquine; netilmicin; phenobarbital; phenytoin; phytanic acid / noristanic acid; progesterone; prolactin; prolinase; purine nucleoside phosphorylase; quinine; reverse triiodothyronine (rT3); selenium; serum pancreatic lipase; sisomicin; somatomedin C;Specific antibodies (adenovirus, antinuclear antibody, anti-ζ antibody, arbovirus, Aujeskey's disease virus, dengue virus, Guinea worm, Echinococcus granulosus, Entamoeba histolytica, enterovirus, Giardia, 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 stoma virus, Wuchereria bancrofti, Yellow fever virus); Specific antigens (Hepatitis B virus, HIV-1); Acetone (e.g., succinylacetone); Acetoacetic acid; Sulfadoxine; Theophylline; Thyrotropin (TSH); Thyroxine (T4); Thyroxine binding globulin; Trace elements; Transferrin; UDP-galactose-4-epimerase; Urea; Uroporphyrinogen I synthase; Vitamin A; White blood cells; and Zinc protoporphyrin. In some examples, salts, sugars, proteins, fats, vitamins, and hormones naturally present in blood or interstitial fluids may also constitute analytes. Analytes may be naturally present in biological fluids or may be endogenous, such as metabolites, hormones, antigens, antibodies, etc. Alternatively, the analyte may be introduced into the body or be exogenous, such as contrast agents for imaging, radioisotopes, chemical agents, fluorocarbon-based synthetic blood, or drugs or drug compositions, 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, S andrex, Plegine); sedatives (barbiturates, methaqualone, tranquilizers such as diazepam, chlordiazepoxide, meprobamate, sedatives such as chlordiazepoxide, meprobamate, mebutamide, tranxene); hallucinogens (phencyclidine, lysergic acid, mescaline, pyodate, psilocybin); narcotics (heroin, codeine, morphine, opium, pethidine, Percocet, Percodan, Tussionex, fentanyl, Darvon, Talwin, Lomotil); designer drugs (fentanyl, pethidine, amphetamine, methamphetamine, and analogs of phencyclidine, e.g., ecstasy); anabolic steroids;and nicotine. Metabolites of drugs and pharmaceutical compositions are also expected analytes. Analytes produced in the body such as neurochemicals and other chemicals, such as 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 can also be analyzed. ;

[0154] At least Figure 1 Any of the features described in the context of may apply to all aspects and examples identified herein. In addition, any of the features of an example may be combined with other examples described herein independently, partially or completely in any manner, 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 the method may be performed by a system or device of another aspect or example, and any aspect or example of the system may be configured to perform a method of another aspect or example.

[0155] 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 to 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 the 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 for the insertion element to be retracted proximally from the skin through it. A patch 204 such as an adhesive patch may couple the base 202 to the skin 206 of the host. The patch 204 may be positioned on the distal surface of the housing or base 202. In some examples, the adhesive patch 204 may include an engagement surface for engaging the skin and including an adhesive suitable for skin adhesion, such as a pressure-sensitive adhesive (e.g., acrylic, rubber-based, or other suitable types) bonded to a carrier substrate (e.g., spunlace polyester, polyurethane film, or other suitable types) for skin attachment, but any suitable type of adhesive may also be considered. 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 .

[0156] The applicator system may couple the adhesive patch 204 to the skin 206. The glucose sensor module 210 may be secured to the base 202 (e.g., via retaining 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.

[0157] After the on-skin sensor assembly 200 is deployed to 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).

[0158] 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.

[0159] Figure 2B A perspective view of an electronics unit 208 coupled to a base 202 via a retaining element such as a snap fit and / or interference features is shown. 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.

[0160] 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 be attached to the on-skin sensor assembly 200, which when combined may be retained within the applicator.

[0161] Figure 3An example of a skin wearable medical device in the form of a 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 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 305 facing opposite the distal surface. The electronics unit 302 may include one or more tabs 308 that are coupled to a portion of the housing 306 and allow the electronics unit 302 to be held by the housing 306. The housing 306 may include an opening 310 through which an insertion element is retracted proximally from the skin. The opening 310 may allow an insertion element (such as a needle) to pass through to deploy a transcutaneous analyte sensor 312 to the skin. The patch 314 may also include a hole 316 that allows the sensor 312 and the insertion element to pass through. The electronics unit 302 may be coupled to the housing 306 before or after the sensor 312 is deployed to the skin of the host.

[0162] Figure 4 An example of an on-skin wearable medical device in the form of an on-skin sensor assembly 400 is shown, wherein the electronics unit is integral with a housing 402. The housing 402 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 403 facing opposite the distal surface. The on-skin sensor assembly 400 is shown on skin 404, wherein a patch 406 engages the skin 404.

[0163] 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 positioned on the patch, such as on the distal surface of the patch, or in an example, may have another position. 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 to the skin of the host.

[0164] Figure 5 A system for deploying an on-skin wearable medical device to the skin is shown. In an example, the system may include an applicator system. According to some examples, the system may include an applicator for an on-skin sensor assembly of an analyte sensor system. In an example, other forms of systems may be utilized.

[0165] 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, for example, include one or more retaining elements that are used to hold the wearable medical device on the skin and release the wearable medical device on the skin from the applicator housing 501 to the skin. 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.

[0166] 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 deformed 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 at any location, such as at the top, upper side, lower side, or any other location of the applicator 500. The applicator 500 may be large enough for the host to grasp with a hand and push or otherwise activate the activation element 502 with, for example, a thumb or index and / or middle finger.

[0167] 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. In addition, as will be described below in conjunction with Figures 6 to 20B As described in more detail in one or more of the foregoing, the applicator 500 may also be configured such that one or more components therein retract based at least in part on one or more components pushing against the host's skin with a force exceeding a predetermined threshold, rather than based on one or more components translating beyond a predetermined and static distal position. In other words, the applicator 500 may implement a force-based retraction trigger, rather than being limited to a displacement-based retraction trigger.

[0168] Figure 6 According to some examples Figure 5500. 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 in a distal direction by a force applied by the host 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 fire. Further explanation of the alignment process will be explained below.

[0169] 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 be deformed 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 inner housing 506 extends in a proximal direction into the bottom opening of the inner housing 506, beyond a plane defined by the distal surface 510.

[0170] like Figure 7 As shown, the housing 501, in particular the inner housing 506, may include an inner cavity 503 for holding a skin-wearable medical device. The inner cavity 503 may have a distal end portion 505 at the opening for deploying the skin-wearable medical device therefrom. The proximal end portion 507 of the inner cavity 503 may include a skin-wearable medical device coupled to a needle carrier assembly 516.

[0171] Return to reference Figure 6 In some examples, the first barrier layer 512 can be disposed 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 when the applicator 500 is activated. The first barrier layer 512 can include a gas permeable material such as Tyvek, or a non-gas permeable material such as a metal foil, a polymer film, an elastomer, or any other suitable material.

[0172] 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 a 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.

[0173] The applicator 500 may further include a retainer 522 that is releasably coupled to the needle carrier assembly 516 and is 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 the proximal position to the distal insertion position). As will be described in more detail below, 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 522 and / or the needle carrier assembly 516. For example, one or more retaining elements may release the on-skin wearable medical device from the applicator housing 501.

[0174] The applicator 500 may also include an insertion assembly configured to translate the insertion element 520, the needle seat 518, the needle carrier assembly 516, and the sensor assembly 508 on the skin 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 wearable device on the skin into the skin. The 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 a first end contacting or coupled to the internal applicator housing 506 and a second end contacting or coupled to the retainer 522. The first spring 524 is configured to translate the retainer 522, the needle carrier assembly 516, the needle seat 518, the insertion element 520, and the sensor assembly 508 on the skin in a distal direction to a distal insertion position when the insertion assembly is activated. Basically at the distal insertion position, the needle carrier assembly 516 may be disengaged from the retainer 522 and the sensor assembly 508 on the skin.

[0175] 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 seat 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 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 be responsive to the on-skin sensor assembly 508 contacting the host's skin and / or moving at a speed greater than sufficient to cause the first end of the second spring 526 to overcome at least one spring retaining element (e.g., Figures 10 to 14 The force of a predetermined threshold (528a, 528b) of the applicator 500 reaches the stroke limit to translate the needle carrier assembly 516, the needle hub 518, and the insertion element 520 in the proximal direction from the distal insertion position to the proximal retracted position. In some examples, a stop feature (not shown) may be provided at the bottom of the applicator 500, for example, on the distal portion of the inner housing 506. Such a stop feature may be configured to contact one or more of the sensor assembly 508, the needle carrier assembly 516, or the retainer 522 on the skin at the distal insertion position.

[0176] In some examples, the 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, a film. In some examples, the second barrier layer 530 can be removed by the host 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 gas to enter and exit, such as during sterilization.

[0177] Reference below Figures 7 to 9 Some aspects of the operation of the applicator 500 are briefly described, and some examples are shown. Figure 5 and Figure 6 Several cross-sectional views of the applicator 500 during operation. For example, Figures 7 to 9 It can correspond to along Figure 5 The applicator 500 is shown cut along section line AA'.

[0178] Figure 7The applicator 500 is shown in a state prior to activation. The retainer 522 includes an insertion assembly retaining element 532 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.

[0179] The needle carrier assembly 516 includes a plurality of wearable retention and / or alignment elements 534a, 534b, which are configured to extend through the retainer 522 and releasably couple the skin sensor assembly 508 to the retainer 522 and / or the needle carrier assembly 516. The wearable retention elements 534a, 534b may include, for example, arms, deflection elements, tabs, pawls, snaps, or any other features capable of having 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 may be envisioned. In some examples, the wearable retention elements 534a, 534b may include snap fits, friction fits, interference features, elastomeric grips, and / or adhesives configured to couple the skin sensor assembly 508 to the needle carrier assembly 516 and / or the retainer 522.

[0180] 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 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 be in contact with the inner housing 506. Figure 7 The reverse manner shown contacts the inner housing 506 .

[0181] Activation of the applicator 500 may 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 hole 514 of the inner housing 506 and the insertion assembly retaining element 532 of the retainer 522. The insertion assembly retaining element 532 may include, for example, an arm, a deflection element, a tab, a detent, a snap, or any other feature capable of maintaining functionality. Once such alignment is achieved, the host may 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 may be configured such that the activation element 502 may 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 yet other examples, the activation element 502 may be biased toward the center of the applicator 500 such that the activation element 502 need not be explicitly activated by the host, but rather, 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.

[0182] 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 prior to firing, thereby reducing the likelihood of activating the applicator 500 before it is properly positioned. In addition, 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.

[0183] 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.

[0184] Figure 8 The applicator 500 is shown during insertion of the on-skin sensor assembly 508 but prior to 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.

[0185] 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, for example, that is sufficient to prevent the needle carrier assembly 516 from inertially triggering disengagement from the retainer 522 during insertion.

[0186] Fig. 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. Fig. 9 , the first spring 524 has fully driven the on-skin sensor assembly 508 into 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) in the holder 522 are released and the needle carrier assembly 516, the needle seat 518 and the 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 with the needle carrier assembly 516, thereby retaining the needle carrier assembly 516, the needle seat 518 and the 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 deflection element, a tab, a pawl, a snap, or any other feature capable of maintaining functionality. In this retracted position, the needle carrier assembly 516, the needle seat 518 and the insertion element 520 are prevented from traveling in the distal direction.

[0187] Reference below Figures 10 to 12 Some aspects of the operation of the applicator 500 are further described, showing that the Figure 5 and Figure 6 Several cross-sectional views of the applicator 500 during operation. For example, Figures 10 to 12 It can correspond to along Figure 5 The applicator 500 is cut through the section line BB' shown. For ease of explanation, Figures 10 to 12The needle hub 518 and the insertion element 520 are not shown.

[0188] Fig.10 The applicator 500 is shown before activation. Fig.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, such as during insertion, while the 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 Figure 21 to Figure 24 As shown. In some examples, the applicator 500 may include three spring retaining elements. In some examples, the applicator 500 may include four spring retaining elements. In some examples, the spring retaining elements 528a, 528b are deflectable arms, rigid arms, deformable features, snaps, catches, or hooks. In some examples, the spring retaining elements 528a, 528b may be actively deflected by one or more features within the applicator 500.

[0189] The needle carrier assembly 516 includes stop features 544a, 544b, which 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 can be envisioned. The number of stop features can be equal to the number of spring retaining elements.

[0190] Fig.13 An enlarged view of the spring retaining element 528b and the stop feature 544b is shown. Fig.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 lateral deflection, thereby preventing the second spring 526 from releasing. Fig.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 be characterized by a ramp 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 through the stop feature 544b distally.

[0191] It will be appreciated that the frictional force between the stop feature 544b and the corresponding contact surface of the spring retaining element 528b may at least partially determine the amount of force that releases the spring retaining element 528b from the stop feature 544b. The force may allow for lateral deflection of the spring retaining element 528b and thus expansion of the second spring 526. In some examples, the magnitude of the force is at least 0.1 pounds. In some examples, the magnitude of the force is at least 0.5 pounds. In some examples, the magnitude of the force is at least 1 pound. In some examples, the magnitude of the force is at least 2 pounds. In some examples, the magnitude of the force is at least 3 pounds. In some examples, the magnitude of the force is at least 4 pounds. In some examples, the magnitude of the force is at least 5 pounds.

[0192] Although the figure shows a stop feature 544b that prevents the spring retaining element 528b from lateral deflection 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 the opposite direction, such as Fig.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.

[0193] 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 expected 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).

[0194] The angle θ of the portion of the spring retaining element 528b in contact with the second spring 526 may also affect the magnitude of the friction force that causes the spring retaining element 528b to deflect laterally and thus release the second spring 526. Therefore, the angle θ may be selected based on the desired amount of force that causes the spring retaining element 528b to deflect laterally sufficiently to release 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 about 30 to 45 degrees. In addition, the force distribution of the second spring 526 may affect the lateral deflection of the spring retaining element 528b spring retaining element b. Thus, in some examples, the force distribution of second spring 526 may be considered when selecting materials used to form retainer 522 and needle carrier assembly 516 and one or both of angle θ of the portion of spring retaining element 528b that contacts second spring 526 .

[0195] The angle β of the spring retaining element 528b relative to the vertical axis may also affect the amount of friction 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 apply a force to the spring retaining element 528b at a distance d from the bottom of the spring retaining element 528b, which results in a torque sufficient to cause lateral deflection of the spring retaining element 528b.

[0196] Fig.13 Also shown is a needle carrier assembly 516 that includes a deflection element 546 that is 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 the proximal direction, as will be seen in FIG. Fig.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 the 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 undesired contact with the spring retaining element 528b during the release of the second spring 526.

[0197] 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. Fig.13The deflection element 546 may also be configured to provide a slanted or angled surface that contacts the spring retaining element 528b in the position shown. In such an example, in addition to the above functions, the deflection element 546 may also be configured to provide a slanted or angled surface that contacts the spring retaining element 528b in the position shown. Fig.13 The position shown is driven to Fig.14 The position shown has the spring retaining element 528b initially deflected.

[0198] In some examples, the inner housing 506 may include a protrusion 548 extending in the distal direction from the inner housing 506. The protrusion 548 may 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 so that the spring retaining elements 528a, 528b are prevented from lateral deflection until the retainer 522 and the needle carrier assembly 516 have translated in the distal direction by at least a predetermined minimum distance. Thus, the protrusion 548 may provide a drop protection measure so that the applicator 500 does not fire prematurely in response to a concussive impact of a drop prior to intentional activation.

[0199] Return to Fig.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 translates 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 when not 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 that is 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.

[0200] Fig.11 The applicator 500 is shown at the beginning of the force retraction feature process after activation, at or near the distal insertion position, where the on-skin sensor assembly 508 can be in contact with the host's skin. The first spring 524 has driven the retainer 522, needle carrier assembly 516, needle hub 518, insertion element, and on-skin sensor assembly 508 in a distal direction toward the distal insertion position. During proper operation, the retainer 522 and on-skin sensor assembly 508 should be pressed against the host's skin. However, Fig.11A dry-fire condition may also be illustrated, wherein the applicator 500 is not properly pressed against the host's skin prior to triggering the applicator 500. 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 beginning to retract 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.

[0201] Steering Fig.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. Fig.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 sensor assembly 508 on the skin 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 away from the 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 Fig.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.

[0202] In some examples, the engagement element 550 may engage the protrusion 552 even when the applicator 500 is pressed against the skin of the user. 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 separate 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 examples may benefit users with soft skin or a higher percentage of body fat.

[0203] Return to Fig.12 , Fig.12 The applicator 500 is shown during activation, with the needle carrier assembly 516 retracted in the proximal direction by the second spring 526, as indicated by arrow 554. Fig.12 In the embodiment of the present invention, when the on-skin sensor assembly 508 contacts the host's skin, with the stop features 544a, 544b no longer securing the spring retaining elements 528a, 528b, 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 seat 518 (see FIG. 1 ) and the proximal direction even in the case of a dry fire. Figures 7 to 9 ) and insert element 520 (see Figures 7 to 9 ) is maintained in the locked retracted position.

[0204] Fig.15 and Fig.16 An enlarged view of some features of an applicator, such as applicator 500 , according to some examples is shown.

[0205] exist Fig.15 In the embodiment, the first spring 524 (see Figures 6 to 12) drives the retainer 522 and the needle carrier assembly and the on-skin sensor assembly 508 in the distal direction indicated by arrow 556 toward the distal insertion position. The 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 wearable retaining element 534b, thereby preventing lateral deflection of the wearable retaining element 534b and thereby rigidly securing the on-skin sensor assembly 508 to the needle carrier assembly.

[0206] exist Fig.16 In the embodiment, the second spring 526 (see Figures 6 to 12 ) drives the needle carrier assembly 516 from the distal insertion position in the proximal direction. Since the retainer 522 has been fully driven in the distal direction, the retainer 522 is no longer in contact with the wearable retaining element 534b at the distal insertion position. Therefore, the wearable retaining element 534b is free to deflect laterally, thereby releasing the sensor assembly 508 on the skin from the wearable retaining element 534b and therefore from the needle carrier assembly 516. The needle carrier assembly 516 is now driven in the proximal direction by the second spring 526, while the sensor assembly 508 on the skin is fixed to the skin of the host. In addition, in some examples, since the retainer 522 is driven to the distal insertion position and is substantially maintained in this position by the first spring 524, the retainer 522 can be pressed against the sensor assembly 508 on the skin or one or both of the adhesive patches of the sensor assembly 508 on the skin, thereby supporting one or both during attachment to the skin of the host.

[0207] Fig.17 According to some examples Figure 5 and Figure 6 A perspective, partial cutaway view of the needle carrier assembly 516, needle hub 518, and on-skin sensor assembly 508 of the applicator 500. Fig.18 A cross-sectional view of a needle hub 518 and an on-skin sensor assembly 508 is shown, according to some examples. Fig.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.

[0208] 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.

[0209] 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 lower arm, are 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 fix 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 bend 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 to the carrier aperture 568, and the lower arms 564a, 564b contact a lower surface of the needle carrier assembly 516 adjacent to 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 be partially or completely relaxed 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.

[0210] 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 to the carrier aperture 568 may include a groove 570 configured to receive the upper arms 562a, 562b when the upper arms 562a, 562b are disposed through the carrier aperture 568 in an orientation complementary to the orientation of the groove 570, such as Fig.19 As shown, the needle hub 518 is thereby fixed relative to the needle carrier assembly 516.

[0211] In some examples, the base 566 also includes a substantially flat surface that is configured to mate with a top surface or a 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 an anti-rotation feature of the base 566 is engaged within the opening 560 of the skin sensor assembly 508.

[0212] 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 preassembling the insertion element 520 onto the on-skin sensor assembly 508, and / or being able to easily engage 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.

[0213] Fig. 20A and Fig. 20B A perspective view of a locking feature of an insertion element in the form of a needle 600a, 600b for use in an applicator for an analyte sensor system according to some examples is shown. For example, needle 600a of FIG. 20 includes a locking feature that includes a ridge 602 that is configured to mate with a complementary shaped feature, such as within needle hub 518. In an alternative embodiment, for example, Fig. 20B Needle 600 b includes a locking feature that includes a groove 604 that is configured to mate with a complementary shaped feature in needle hub 518 .

[0214] 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 located 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.

[0215] During manufacture, the applicator 500 may be assembled in stages. For example, but not limited to, if present, the first barrier layer 512 may be attached to the inner housing 506. The insertion element 520 may be coupled to the needle hub 518, which may then be coupled to the on-skin sensor assembly 508. The second spring 526 may be placed into the holder 522 or the needle carrier assembly 516, which may then be disposed in the holder 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 may be disposed in the holder 522, which may then be mounted into the inner housing 506. The inner housing 506 may be inserted and secured to the outer housing 504. If present, the second barrier layer 530 may be attached to the inner housing 506. If a separate element, the activation element 502 may be disposed into the outer housing 504. Any labeling, sterilization, and / or packaging may then be applied to the applicator 500.

[0216] Figure 21 to Figure 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.

[0217] The applicator 700 may include an outer applicator housing 504 that includes 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 fire, such as Fig.21 As previously described in conjunction with applicator 500, in some examples, activation element 502 can be disposed at any location, such as on the top, upper side, lower side, or any other location of applicator 700.

[0218] 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 be deformed 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 inner housing 506 extends in a proximal direction into the bottom opening of the inner housing 506 beyond a plane defined by the distal surface 510.

[0219] although Figure 21 to Figure 23 506 may include a spring 536 that is configured to contact the outer housing 504 and be in a pre-activated orientation (see 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.

[0220] The applicator 700 may also include a needle carrier assembly 702. The needle carrier assembly 702 includes 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.

[0221] 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 a sensor of the on-skin sensor assembly 508 into the skin of the host. In some examples, the insertion element 520 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, wherein the insertion element 520 may have sufficient rigidity to be partially inserted into the skin of the host with minimal or no structural support.

[0222] The applicator 700 may further include a retainer 704 that is releasably coupled to the needle carrier assembly 702 and is configured to guide the on-skin sensor assembly 508 when coupled to the needle carrier assembly 702 (e.g., at least during translation from the proximal position to the 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.

[0223] 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 contacted or coupled to the inner applicator housing 506 and its second end contacted 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 when the insertion assembly is activated. At substantially the distal insertion position, the needle carrier assembly 702 may be disengaged from the retainer 704 and the on-skin sensor assembly 508.

[0224] 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 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 a second spring 706. The second spring 706 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 704 at least until retraction and a second end of a spring retaining element 710 that contacts or is coupled to the retainer 704, the second end including a tang 708 (e.g., a spring portion or spring end) that is substantially arranged 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 pawl, a snap, or any other feature capable of maintaining functionality. The spring retaining element 710 may 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.

[0225] 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 to be retained between the spring retaining element 710 and the retainer 704 until retracted. Fig.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 .

[0226] 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.

[0227] although Figure 21 to Figure 23 5. Although not shown in the drawings, the inner housing 506 of the applicator 700 may also include the engagement element 550, and the needle carrier assembly 702 may also include the protrusion 552 and may be substantially as previously combined with at least Figures 10 to 12 It works as described.

[0228] although Figure 21 to Figure 23 Although not shown in the drawings, the inner housing 506 of the applicator 700 may also include a protrusion extending from the inner housing 506 in the distal direction, substantially as the protrusion 548 previously described. Fig.13 Similar to that described, 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 so that the spring retaining element 710 is prevented 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 a shock impact of being dropped prior to activation.

[0229] 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 the spring 526 and are configured to contact and retain the coil of the spring 526, the applicator 700 utilizes a spring retaining element 710, which is disposed along the inside of the spring 706 and is configured to contact and retain the tang 708 of the second spring 706 along the diameter of the spring 706. Disposing 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 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.

[0230] Fig.21 The applicator 700 is shown in a state prior to activation according to some examples. The retainer 704, the needle carrier assembly 702, 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 shown in a pre-activated position.

[0231] 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, the needle hub 518, the insertion element 520 and the on-skin sensor assembly 508, in the pre-activated state.

[0232] The stop feature 712 of the needle carrier assembly 702 contacts and prevents the spring retaining element 710 from lateral deflection, 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.

[0233] 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. Fig.21 Once such alignment is achieved, the host may 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 may be configured such that the activation element 502 may 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 may be biased toward the center of the applicator 700, 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 the distal direction toward and relative to the inner housing 506.

[0234] Fig. 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. Fig. 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.

[0235] 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 700 while not being so great as to further exacerbate the above-described 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 702 in the distal direction, for example, that is sufficient to prevent the needle carrier assembly 702 from inertially triggering disengagement from the retainer 704 during insertion.

[0236] Fig.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 Fig.13 , where the angle θ of the portion of the spring retaining element 710 that contacts the tang 708 of the second spring 706 is substantially 90° (e.g., flat), the spring retaining element 710 can be biased to automatically deflect sufficiently to release the second spring 706 when the stop feature 712 is no longer in contact with the spring retaining element 706, thereby releasing the second spring 710 to drive the needle carrier assembly 702 in the proximal direction. Although Figure 21 to Figure 23 506 may further include an engagement element 550 configured to engage with a protrusion 552 of the needle carrier assembly 702 and to substantially engage at least one of the needle carrier assembly 702 as previously described. 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 a distal insertion position.

[0237] Upon release of the second spring 706, the second spring 706 is configured to drive the needle carrier assembly 702, the needle hub 518, and the insertion element 520 in a proximal direction. Fig.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 retaining the needle carrier assembly 702, the needle seat 518 and the insertion element 520 in a locked retracted position, which limits access to the insertion element 520.

[0238] Fig.24 A perspective view of a retainer 704, a first spring 524, and a second spring 706 of an applicator 700 is shown, according to some examples. Fig.24 The spring retaining element 710 is shown along with the orientation of the retaining tang 708 of the second spring 706 within the applicator 700 prior to retraction.

[0239] 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 ) may be attached to the inner housing 506. The insertion element 520 may be coupled to the needle hub 518, which may then be coupled to the on-skin sensor assembly 508. The second spring may be placed into the retainer 704 or the needle carrier assembly 702, which may then be disposed in 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 may be disposed in the retainer 704, which may then be mounted into the inner housing 506. The inner housing 506 may be inserted into and secured to the outer housing 504. If present, the second barrier layer 530 (see Figure 6 ) may be attached to the inner housing 506. If a separate element, the activation element 502 may be provided into the outer housing 504. Any labeling, sterilization and / or packaging may then be applied to the applicator 700.

[0240] In an example, the applicator system may include a cap and / or liner removal component. For example, Fig.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 configuration as described with respect to Figures 5 to 24 The outer housing 904 and the inner housing 906 disclosed in the example of the embodiment of the present invention are shown in FIG. 1 . For example, the outer housing 904 can be configured similarly to the outer housing 504, and the inner housing can be configured similarly to the inner housing 506. In an example, the applicator housing 902 can be configured to be grasped by a user. Various other configurations of the applicator housing can be utilized as desired.

[0241] Applicator housing 902 may include an inner cavity 903 for holding a skin-wearable medical device. Housing 902 may include an opening 905 at an end portion 907 of inner cavity 903 for deploying the skin-wearable medical device from the opening. Inner cavity 903 may include a proximal end portion 909, which may include a skin-wearable medical device coupled to a needle carrier assembly.

[0242] 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 example of . For example, in the example, the deployment mechanism may include one or more retaining elements, which are used to retain the wearable medical device on the skin and release the wearable medical device on the skin from the housing 902 to the skin. 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 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 wearable medical device on the skin to the skin. The deployment mechanism may include a retraction assembly for retracting the insertion element from the skin. In the example, other forms of deployment mechanisms may be utilized as needed.

[0243] 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 seat (e.g., a needle seat 914) that may operate similarly to the needle seat 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 used 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.

[0244] The applicator 900 may include a cap 942 that may be positioned at a distal portion of the applicator housing 902 and may cover a distal opening 905 of the lumen 903. The cap 942 may 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 may include a central portion 948 that covers and spans the distal opening 905 of the lumen. The cap 942 may include an outer cover for the applicator 900 when the applicator 900 is transported and disassembled.

[0245] The central portion 948 of the cap 942 may include one or more openings 950 that may allow sterilizing materials, 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 components in place. The central support 952 may be configured to rotate when the cap 942 is disengaged or unscrewed from the applicator housing 902.

[0246] The engagement portion 946 may include threads or another form of engagement portion 946 for engaging a corresponding engagement portion 954 on an 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.

[0247] 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 wearable medical device on the skin when retracted from the engagement surface of the wearable medical device on the skin. 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.

[0248] 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.

[0249] In an example, a liner 926 may be positioned on 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 to the proximal surface. In an example, the liner may be configured to reduce the possibility that the exposed bonding surface deteriorates or otherwise loses its adhesive properties before deployment. For example, during a sterilization process using a gas or other sterilizing material, the liner may reduce the possibility of degradation of the bonding surface. As needed, the sterilizing gas may include ethylene oxide (EtO) or another form of sterilizing gas. However, before the sensor assembly on the skin is deployed to the skin, the liner will be removed from the bonding surface.

[0250] 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.

[0251] The cap 942 and liner removal component 928 may be removed prior to deploying the on-skin wearable medical device onto the skin.

[0252] Upon activation, an applicator as disclosed herein may insert an analyte sensor into the skin of a host by utilizing an insertion element, such as insertion element 915 .

[0253] refer to Fig.26A , the insertion element 915 can drive the analyte sensor 956 of the on-skin sensor assembly 508 into the host's skin through the analyte sensor 956 extending along the channel 958 of the insertion element 915.

[0254] For example, the analyte sensor 956 may include a first portion 960 or contact portion that may be coupled to a housing 962 of the on-skin sensor assembly 508. For example, the first portion 960 may include electrical contacts 964 that may 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 may 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 may be utilized as desired.

[0255] 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 an opening 978 through which the insertion element 915 passes, such as Fig.26A shown.

[0256] The analyte sensor 956 may include an elongated analyte sensor. The second portion 966 may extend distally to be positioned within the skin layer of the host. 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 utilized 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 utilized as desired.

[0257] 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 Fig.26A The curved portion 970 may be a continuous curvature as shown, or may have another form as desired. The curved portion 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 curved portion 970 may be axially aligned with the opening 978 through which the insertion element 915 passes, such as Fig.26A Other forms of analyte sensor 956 may be utilized as desired.

[0258] The housing 962 of the on-skin sensor assembly 508 can be configured similarly to other forms of housings disclosed herein. The housing 962 can be configured to be worn on the skin of the host. The housing 962 can include a distal surface 968 that can be configured to face the skin of the host. 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 skin of the host. The engagement surface 974 can include an adhesive surface in the example or another form of surface.

[0259] 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.

[0260] 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 may have a variety of forms as needed. For example, the cavity 976 may be configured to hold an adhesive (which may include a liquid adhesive or a curable adhesive), which may 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 may hold an adhesive and may be used to electrically insulate portions of the analyte sensor 956 from each other if necessary. 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 coupling with 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 may be coupled to the housing 962 in other ways.

[0261] 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 through it. 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. In an example, the insertion element 915 may be positioned within the opening 978 when inserted into the host's skin. Fig.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 Figure 21 to Figure 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.

[0262] Insertion element 915 may include a proximal end portion 980 and a distal end portion 982, the distal end portion including a tip 984 of insertion element 915. Tip 984 may include a sharp tip in the example, and may be configured to pierce the skin of the host and be inserted into the skin of the host.

[0263] 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.

[0264] The insertion element 915 may include an elongated insertion element 915 and may include a shaft 986 that may extend between a proximal end portion 980 and a distal end portion 982. The shaft 986 may be straight or have a linear shape and may be configured to guide the analyte sensor 956 into the skin of the host. For example, the shaft 986 may have a channel 958 that may receive the analyte sensor 956. Fig.28 , shaft 986 has an opening 987 for channel 958, and analyte sensor 956 is configured to be positioned in the opening. A portion of analyte sensor 956 (e.g., second portion 966 or sensing portion) can be positioned within channel 958 and can be inserted into side wall 988 of element 915 (at Fig.28 958). The sidewall 988 may be positioned on the side of the channel 958. The axis 986 may extend along a portion of the analyte sensor 956 (e.g., the second portion 966 or the sensing portion). In an example, the axis 986 may extend parallel to the portion. Therefore, the second portion 966 including the sensing portion of the analyte sensor 956 may extend along the axis 986.

[0265] Analyte sensor 956 can be positioned in channel 958, so that as insertion element 915 is inserted into the skin of the host, analyte sensor 956 can be inserted together with insertion element 915 and can be guided into the skin of the host. Shaft 986 can be inserted into the skin to guide a portion (e.g., second portion 966 or sensing portion) into the skin. Channel 958 can form a space for analyte sensor 956 to be inserted in the skin of the host. When insertion element 915 is retracted, analyte sensor 956 can remain in the skin of the host. In an example, other forms of insertion can be provided, for example, insertion element 915 may not have channel 958 in an example, and analyte sensor 956 can extend along the outer surface of insertion element 915 so as to be inserted into the skin of the host.

[0266] Channel 958 may have a C-shaped cross-section in an example (eg Fig.28 ) or may have another cross-section as desired.

[0267] Fig.26B Insertion element 915 is shown having been retracted by a retraction assembly of the applicator or by another insertion element. Analyte sensor 956 can remain positioned within the host's skin and can continue to sense analytes of the host for days.

[0268] As used throughout this specification and unless otherwise indicated, the term friction may include dynamic friction and / or may include static friction or stiction between the insertion element 915 and the analyte sensor 956. There may be friction between the insertion element 915 and the analyte sensor 956, which may be advantageous. After the analyte sensor 956 is positioned within the channel 958 during manufacturing, the friction between the insertion element 915 and the analyte sensor 956 may help maintain the analyte sensor 956 positioned therein and reduce the likelihood that the analyte sensor 956 will not fall off from the channel 958 during transportation and / or handling prior to insertion. During insertion, as the insertion element 915 pierces the analyte sensor 956 and guides it into the skin of the host, friction may also advantageously maintain the position of the analyte sensor 956 within the channel 958.

[0269] There may be friction between the insert element 915 and the analyte sensor 956 which may have adverse consequences. Fig.27A For example, analyte sensor 956 may be positioned within the channel of insertion element 915 prior to and during insertion into the host's skin. If there is an excessively high level of friction between analyte sensor 956 and insertion element 915, the analyte sensor 956 may be positioned within the channel of insertion element 915 prior to and during insertion into the host's skin. Fig.27B ), the analyte sensor 956 may also be retracted proximally. Specifically, if there is an excessively high level of sticking between the analyte sensor 956 and the insertion element 915, when the insertion element 915 is retracted (as shown in FIG. Fig.27B 956 may be retracted proximally. The analyte sensor 956 may be retracted proximally, thereby possibly being completely retracted from the host's skin or may be partially retracted from the host's skin. The retraction of the analyte sensor 956 may reduce the ability of the analyte sensor 956 to properly sense an analyte in the host's body due to incorrect positioning of the analyte sensor 956, or result in complete retraction of the analyte sensor 956 from the host's skin. In addition, a bend 990, which may include a "U" shaped bend, may be formed in the analyte sensor 956 when the insertion element 915 is retracted. The formation of the bend 990 may interfere with the electrical signals provided by the analyte sensor 956 to the electronics of the on-skin sensor assembly 508 and may be undesirable.

[0270] In an example, the analyte sensor 956 can be retracted along the opening 978 of the housing 962 as the insertion member 915 is retracted along the opening 978. In an example, the analyte sensor 956 can be retracted along the opening 978 of the housing 962. Fig.27B The housing 962 is shown retracted so as to protrude from the proximal surface 972 , or is otherwise undesirably retracted so as not to protrude from the proximal surface 972 .

[0271] The retraction of the analyte sensor 956 may be achieved by the analyte sensor 956 being in contact with the inner surface 992 of the insertion member 915 (at Fig.28 In some embodiments, the inner surface 992 is caused by friction (e.g., dynamic friction or viscosity) between the analyte sensor 956 and the inner surface 992. It has been observed that the viscosity between the analyte sensor 956 and the inner surface 992 tends to be greater than the dynamic friction generated as the insertion element 915 is retracted. Therefore, in many cases, whether the analyte sensor 956 is retracted together with the insertion element 915 depends on the level of viscosity between the analyte sensor 956 and the inner surface 992. The inner surface 992 may include an inner surface of the insertion element 915 that defines the channel 958. In other configurations (e.g., where the insertion element 915 does not include a channel), the inner surface 992 may include an outer surface of the insertion element or include another surface as needed. In an example, the inner surface 992 may have friction with the outer surface 994 or another surface of the analyte sensor 956.

[0272] In the sterilization process applied to the analyte sensor 956 and / or the insertion element 915 and / or other parts of the sensor assembly or applicator on the skin, an undesirable level of friction between the analyte sensor 956 and the insertion element 915 may be generated or increased. For example, the sterilization process may include applying heat to such parts. The sterilization process may include applying greater moisture to such parts. The sterilization process may include applying a sterilizing gas (e.g., ethylene oxide (EtO) or another form of sterilizing gas) to such parts. In an example, a combination of sterilization methods may be utilized in the sterilization process. For example, a sterilization process utilizing ethylene oxide (EtO) may include applying heat, moisture, and EtO to the analyte sensor 956 and the insertion element 915 for a period of time.

[0273] The sterilization process may include applying heat, moisture, and EtO to the applicator 900 with the analyte sensor 956 and the insertion element 915 positioned within the applicator housing 902. The heat, moisture, and EtO may be applied, for example, through Fig.25 The opening 950 is shown and / or may be penetrated through a barrier covering the opening 950. The barrier may be moisture and / or gas permeable to allow moisture and EtO to contact the analyte sensor 956 and the insertion element 915. The other components of the applicator 900 may be sterilized. Other forms of sterilizing gas and other sterilization methods may be used.

[0274] During the sterilization process, the analyte sensor 956 can be positioned within the channel 958 of the insertion member 915. For example, during the sterilization process, the analyte sensor 956 and the insertion member 915 can be positioned such as Fig.27A and / or Fig.28 In examples, other configurations of analyte sensor 956 and insertion member 915 may be utilized as desired.

[0275] The sterilization process applied to the analyte sensor 956 and / or the insertion element 915 can increase the friction between the analyte sensor 956 and the insertion element 915. For example, the stickiness between the analyte sensor 956 and the insertion element 915 may increase during the sterilization process. For example, heat and humidity can swell the membrane of the analyte sensor 956, thereby possibly causing adhesion between the analyte sensor 956 and the insertion element 915. After the drying cycle applied to the analyte sensor 956 and the insertion element 915, the adhesion can remain. Without being bound by any particular theory, the stickiness can be caused by the hydration of the membrane that causes hydrogen bonding between the outer surface 994 of the analyte sensor 956 and the inner surface 992 of the insertion element 915, or by the analyte sensor 956 and the insertion element 915 may be attributed to other forms of bonding caused by charge, chemical interaction and / or mechanical in nature. For example, the sterilization process involving heat, humidity and / or EtO can cause or enhance hydrogen bonding between the analyte sensor 956 and the insertion element 915. Other forms of bonds (whether electrical, chemical or mechanical) may be formed or enhanced as a result of the sterilization process.

[0276] The extended or upgraded sterilization process may increase the possibility of undesirable friction (e.g., stickiness) and undesirable retraction of the analyte sensor 956 after insertion. The larger surface area in contact with the insertion element 915 during the sterilization process and the greater film sensitivity of the analyte sensor 956 to heat and humidity may also increase the possibility of undesirable friction and undesirable retraction of the analyte sensor 956 after insertion. The sterilization process that shortens the duration or reduces the intensity (i.e., lower temperature and lower humidity) may reduce the possibility of friction and undesirable retraction of the analyte sensor 956 after insertion. The smaller surface area in contact with the insertion element 915 during the sterilization process and the lower film sensitivity of the analyte sensor 956 may also reduce the possibility of undesirable friction and undesirable retraction of the analyte sensor 956.

[0277] In an example, an increased elastic modulus or stiffness of the analyte sensor 956 to resist buckling forces applied proximally to the analyte sensor 956 may reduce the likelihood of retraction of the analyte sensor 956. A lower elastic modulus or stiffness of the analyte sensor 956 may increase the likelihood of undesired retraction of the analyte sensor 956.

[0278] In an example, the increase in the retraction spring (e.g., second spring 526) force increases the instantaneous retraction acceleration of the insertion element 915 at the beginning of the retraction step. Given the stiffness and inertial mass of the analyte sensor 956, the force transmitted by the friction (i.e., separation viscosity) between the analyte sensor 956 and the insertion element 915 is insufficient to accelerate the analyte sensor 956 at the same rate as the insertion element 915. Therefore, the insertion element 915 is retracted while the analyte sensor 956 remains inserted into the host's skin.

[0279] The systems, devices and methods disclosed herein can be used after a sterilization process, however, such systems, devices and methods can be used without a sterilization process. For example, the systems, devices and methods are not limited to those used after a sterilization process or those used during or before a sterilization process.

[0280] The systems, devices, and methods disclosed herein may include providing a diametric gap 996 (at 986 mm) from the shaft 986 of the insertion element 915 to the analyte sensor 956 (eg, the second portion 966 or sensing portion). Fig.28 996). The gap 996 can reduce the likelihood of friction (e.g., dynamic friction or stiction) between the insert element 915 and the analyte sensor 956. For example, after the sterilization process, the analyte sensor 956 may swell (e.g., increase in diameter) and / or may form hydrogen bonds (or other forms of bonding) between the insert element 915 and the analyte sensor 956. A diameter gap 996 equal to or greater than a threshold value can reduce the likelihood of such undesirable friction.

[0281] In an example, the diameter gap 996 may be determined before a sterilization process is applied to the analyte sensor 956 and / or the insertion element 915. The diameter gap 996 may be measured before the sterilization process, and if the gap 996 is equal to or greater than a threshold, the analyte sensor 956 and / or the insertion element 915 may continue to be used in the sterilization process. In an example, the diameter gap 996 may be measured without applying a sterilization process, or may be measured after the sterilization process. If the threshold diameter gap is met, the analyte sensor 956 and / or the insertion element 915 may be utilized. The threshold diameter gap 996 may be set to reduce the possibility of undesirable friction between the analyte sensor 956 and / or the insertion element 915.

[0282] In an example, the diameter gap 996 can be set to at least 0.07 millimeters. This can be the distance before the sterilization process or can be the distance after the sterilization process. The diameter gap may be between the shaft 986 of the insertion element 915 and the analyte sensor 956 (e.g., the second part 966 or the sensing part). The distance can reduce the possibility of undesirable friction between the analyte sensor 956 and the insertion element 915. In an example, the diameter gap 996 can be set to at least 0.10 millimeters. In an example, the diameter gap 996 can be set to at least 0.12 millimeters. Other diameter gaps can be utilized and set to reduce the undesirable friction between the analyte sensor 956 and the insertion element 915, and reduce the tendency of undesirably retracting the analyte sensor 956 during the retraction of the insertion element 915.

[0283] In an example, other features of the analyte sensor 956 and / or the insertion element 915 may be utilized or determined to reduce the likelihood of undesired retraction of the analyte sensor 956 when the insertion element 915 is retracted. For example, the diameter 989 of the second portion of the sensing portion of the analyte sensor 956 (at Fig.28 The ratio of the width 991 of the opening 987 for the passage 958 (marked in the middle) to the width 991 of the opening 987 for the passage 958 can be determined before, during, or after the sterilization process. In an example, if the ratio is determined to be equal to or less than a threshold value, the analyte sensor 956 can continue to be used in the sterilization process. In an example, the ratio can be measured without applying a sterilization process or can be measured after the sterilization process. If the threshold ratio is met, the analyte sensor 956 can be utilized.

[0284] In an example, the ratio of diameter 989 to width 991 can be set to less than 0.9. This can be the ratio before the sterilization process or it can be the ratio after the sterilization process. In an example, the ratio can be set to less than 0.8. In an example, the ratio can be set to less than 0.7. Other ratios can be utilized and set to reduce the possibility of retracting the analyte sensor 956 during retraction of the insertion element 915.

[0285] In an example, other features of the analyte sensor 956 may be utilized or determined to reduce the possibility of undesirably retracting the analyte sensor 956 when the insertion element 915 is retracted. For example, the bending modulus of the analyte sensor 956 may be determined before, during, or after the sterilization process. An analyte sensor 956 with a larger bending modulus may have a smaller possibility of retraction during the retraction of the insertion element 915. In an example, if the bending modulus is determined to be equal to or greater than a threshold value, the analyte sensor 956 may continue to be used in the sterilization process. In an example, the bending modulus may be measured without applying a sterilization process or may be measured after the sterilization process. If the threshold bending modulus is met, the analyte sensor 956 may be utilized.

[0286] In an example, the bending modulus can be set to be greater than 8 gigapascals. This can be the bending modulus before the sterilization process or can be the bending modulus after the sterilization process. The bending modulus can reduce the possibility of retracting the analyte sensor 956 during the retraction of the insertion element 915. In an example, the bending modulus can be set to be greater than 8.4 gigapascals. In an example, the bending modulus can be set to be greater than 8.6 gigapascals. Other moduli can be utilized and set to reduce the possibility of retracting the analyte sensor 956 during the retraction of the insertion element 915. In an example, the bending modulus can be the bending modulus of the second part 966 of the sensing portion including the analyte sensor 956.

[0287] The configurations of insertion element 915 and / or analyte sensor 956 may be utilized alone or in combination with other systems, devices, and / or methods disclosed herein.

[0288] In an example, systems, devices, and / or methods may include reducing friction between the analyte sensor 956 and the insertion element 915, for example, via coating, lubrication, and surface roughness modification. In an example, friction may be reduced during or after a sterilization process of the analyte sensor 956 and the insertion element 915 and prior to retracting the insertion element 915 from the host's skin. In an example, friction may be reduced prior to the sterilization process or at another time as desired.

[0289] In an example, friction between the analyte sensor 956 and the insertion element 915 can be reduced by vibrating the analyte sensor 956 and the insertion element 915. In an example, during or after a sterilization process (e.g., an EtO sterilization process), the analyte sensor 956 and the insertion element 915 can be vibrated to reduce friction (e.g., break up stiction) between the analyte sensor 956 and the insertion element 915. The process can include applying pressure to one or more applicators 900 (e.g., using a sterilization process such as Fig.25 The configuration shown in the figure can be sterilized and the applicator 900 can be vibrated to reduce friction. For example, multiple applicators 900 can be sterilized on a surface such as a pallet, and the entire pallet or other surface can be vibrated to vibrate the analyte sensor 956 and the insertion element 915. In an example, direct vibration of the analyte sensor 956 and / or the insertion element 915 can be provided. The method of direct vibration can include the methods disclosed herein or other methods of directly vibrating the analyte sensor 956 and / or the insertion element 915. In other examples, the vibration can occur before the sterilization process or without a sterilization process.

[0290] In an example, the friction between the analyte sensor 956 and the insertion element 915 can be reduced by increasing the ambient temperature or reducing the ambient temperature. For example, during or after the sterilization process, the ambient temperature around the analyte sensor 956 and the insertion element 915 can be reduced for a period of time. The temperature can be reduced to a freezing temperature (e.g., 0 degrees Celsius (°C), -18°C, or -40°C) in the example or reduced to another temperature as needed. The temperature can be maintained for a period of time (e.g., 24 hours or 2 to 3 hours) in a reduced state as needed. In an example, the temperature can be increased to a high temperature (e.g., 50°C) for a period of time (e.g., 24 hours or 2 to 3 hours) as needed. Due to the difference in the coefficient of thermal expansion between the analyte sensor 956 and the insertion element 915 causing movement therebetween, the change in temperature can cause the total friction between the analyte sensor 956 and the insertion element 915 (i.e., by destroying viscosity) to be reduced. In an example, the combination of the increased temperature and the reduced temperature can reduce the friction between the analyte sensor 956 and the insertion element 915. For example, a cycle of temperature reduction after or before temperature increase can be used to reduce friction between the analyte sensor 956 and the insertion element 915. An elevated temperature can be provided for a period of time (e.g., 24 hours or 2 to 3 hours), followed by a reduced temperature for a period of time (e.g., 24 hours or 2 to 3 hours). For the desired number of cycles, the elevated temperature can be alternated with the reduced temperature. In an example, a thermal shock of elevated temperature and reduced temperature can be utilized. In other examples, the change in temperature can occur before or without a sterilization process.

[0291] In an example, the friction between the analyte sensor 956 and the insertion element 915 can be reduced by reducing the ambient humidity. For example, during or after the sterilization process, the ambient humidity around the analyte sensor 956 and the insertion element 915 can be reduced for a period of time. The humidity can be reduced for a period of time to reduce the moisture present in the film of the analyte sensor 956. The humidity can be reduced to dry the space between the analyte sensor 956 and the insertion element 915 or the analyte sensor 956 and the insertion element 915, and the analyte sensor 956 can be shrunk or de-swelled. The humidity can be reduced to produce a dry surrounding environment, and the humidity can be reduced with the increase of temperature to produce a hot dry surrounding environment. The environment can be produced after the sterilization process. In other examples, the change of ambient humidity can occur before the sterilization process or in the absence of a sterilization process.

[0292] The methods disclosed herein may occur with the on-skin sensor assembly (including analyte sensor 956) and insertion element positioned within the housing of an applicator, or may occur external to the housing of an applicator.

[0293] In an example, the desiccant 998 may be packaged or otherwise provided with the analyte sensor 956 and / or the insert element 915. The desiccant 998 may, for example, reduce moisture in the surrounding environment surrounding the analyte sensor 956 and / or the insert element 915 to reduce friction (e.g., sticking) between the analyte sensor 956 and the insert element 915. In an example, the desiccant 998 may be packaged or otherwise provided after or during the sterilization process. For example, the desiccant 998 may be inserted into a cavity, such as a Fig.29 The cavity of the cap 942 is shown with the desiccant 998 positioned to reduce moisture passing through the opening 950. Other positioning of the desiccant 998 may be provided as desired.

[0294] The methods disclosed herein may reduce hydrogen bonding between the analyte sensor 956 and the insert element 915, or may reduce friction (eg, dynamic friction or stiction).

[0295] The methods disclosed herein may be utilized alone or in combination with any system, apparatus, or other method disclosed herein.

[0296] In an example, the spacer body can be configured to be positioned between a portion of the elongated analyte sensor 956 and the insertion element 915 and can space the portion of the elongated analyte sensor 956 from the insertion element 915. The spacer body can space a portion of the elongated analyte sensor 956 (e.g., the second portion 966 including the sensing portion of the analyte sensor 956) from the axis 986 of the insertion element 915.

[0297] Fig. 30A An example is shown in which the spacer body 1000 may include a thermally expandable body positionable between the analyte sensor 956 and the insertion element 915. The spacer body 1000 may be positioned, for example, within the channel 958 between the analyte sensor 956 and the insertion element 915. The spacer body 1000 may be positioned on the inner surface 992 of the insertion element 915. The spacer body 1000 may be an elongated body that may extend along the longitudinal axis of the insertion element 915, or may have another form in examples.

[0298] In an example, the spacer body 1000 may include a thermally expandable metal. In an example, the spacer body 1000 may include another form of thermally expandable material (e.g., a polymer or other form of material). In an example, the spacer body 1000 may have a second thermal expansion coefficient that is different from the first thermal expansion coefficient of the insert element 915. The insert element 915 may be configured to expand at a first rate in response to a temperature change, and the spacer body 1000 may be configured to expand at a second rate that is different from the first rate. The second rate may be greater than the first rate to allow for greater expansion in response to a temperature change.

[0299] refer to Fig. 30A , the analyte sensor 956 may be spaced apart from the insertion element 915 by a distance 1002. Such distance 1002 may be before the thermal expansion of the spacer body 1000. In an example, the temperature of the spacer body 1000 may vary. Such a change may include an increase in the temperature of the spacer body 1000 (which may include a change in the temperature of the insertion element 915). The temperature may change during a sterilization process (e.g., with heat applied) or after a sterilization process. For example, a change in temperature may occur during an EtO process, and the spacer body 1000 may expand when the heat of the EtO process increases or after the EtO process. In other examples, the temperature may change before a sterilization process or in the absence of a sterilization process.

[0300] Changes in temperature may increase the size of the spacer body 1000, such as Fig. 30B The spacer body 1000 can expand toward the analyte sensor 956 and can push the analyte sensor 956 away from the inner surface 992 of the insertion element 915. The diametrical gap of the insertion element 915 from the analyte sensor 956 can increase accordingly.

[0301] The temperature may be further changed (eg, reduced) to reduce the size of the spacer body 1000. For example, Fig. 30C The spacer body 1000 is shown as being reduced in size, while the analyte sensor 956 is maintained at an increased distance 1004 (greater than Fig. 30A The increased distance may thus reduce possible friction (eg, dynamic friction or stiction) between the analyte sensor 956 and the insertion element 915 and may reduce the likelihood of undesired retraction of the analyte sensor 956 when the insertion element 915 is retracted.

[0302] In examples, other forms of spacer bodies may be utilized.

[0303] For example, Fig.31 An example of a spacer body 1010 is shown that is configured to be positioned between a portion of an elongated analyte sensor 956 and an insertion element 915 and to space the portion of the elongated analyte sensor 956 from the insertion element 915. The spacer body 1010 can be positioned to deflect the analyte sensor 956 away from the insertion element 915 such that the analyte sensor 956 is not initially positioned within the channel 958 of the insertion element 915. In an example, the spacer body 1010 can space the analyte sensor 956 from the insertion element 915, wherein the analyte sensor 956 is positioned within the channel 958 but is spaced from the insertion element 915 due to the presence of the spacer body 1010.

[0304] The spacer body 1010 can space the analyte sensor 956 from the insertion element 915 before, during, or after the sterilization process. Thus, in examples where the spacer body 1010 is positioned before or during a sterilization process, the spacer body 1010 can reduce the likelihood of friction (e.g., sticking) forming between the analyte sensor 956 and the insertion element 915 during such a sterilization process. For example, the distance between the analyte sensor 956 and the insertion element 915 can reduce the likelihood of hydrogen bonding or other forms of bonding occurring during the sterilization process. Thus, in examples such as Fig.31 In the illustrated configuration, the analyte sensor 956 and the insertion element 915 are sterilized. In an example, the spacer body 1010 can be inserted during the loading process of the analyte sensor 956 and the insertion element 915, wherein the insertion element 915 is inserted to extend along the analyte sensor 956, and the spacer body 1010 separates the analyte sensor 956 from the insertion element 915.

[0305] The spacer body 1010 may have a variety of forms and may include, for example, Fig.31 and Fig.32 The rod may include a crossbar 1012 (at Fig.32 ), and may include a larger diameter end 1014 of the cross bar 1012 that prevents the cross bar 1012 from sliding laterally out of the analyte sensor 956.

[0306] The spacer body 1010 can be removed from between a portion of the analyte sensor 956 and the insertion element 915 (e.g., the shaft 986 of the insertion element 915). The spacer body 1010 can be configured to be removed to position a portion of the analyte sensor (e.g., the second portion 966 or the sensing portion) in the channel 958 (e.g., Fig.28 shown).

[0307] In an example, the spacer body 1010 can be manually removed from between the analyte sensor 956 and the insertion element 915. For example, the spacer body 1010 can be coupled to a tether 1016 that can be configured to be pulled to remove the spacer body 1010 from between a portion of the analyte sensor 956 and the insertion element 915. The tether 1016 can be coupled to the crossbar 1012 or another portion of the spacer body 1010.

[0308] In an example, the tether 1016 may include a pull tab for the user to pull. For example, before the insertion element 915 and the analyte sensor 956 are inserted into the skin of the host, the tether 1016 may be pulled by the user. The spacer body 1010 may be removed to allow the analyte sensor 956 to be placed in the channel 958 of the insertion element 915. The analyte sensor 956 may then be inserted into the skin of the host using the insertion element 915. By placing the analyte sensor 956 in the channel 958 of the insertion element 915 just before the user applies it, any friction that increases due to the sterilization process and / or over time is eliminated. This benefit also applies to other embodiments in which the analyte sensor 956 is spaced apart from the channel 958 until just before the user applies it.

[0309] In an example, the tether 1016 may be in the form of a cap (eg, Fig.25 The cap 942 may cover the distal surface of the housing of the on-skin sensor assembly. The cap 942 may be positioned at the distal opening of the applicator housing (e.g., as shown in FIG. Fig.25 When the cap 942 is removed, the user can access the tether 1016, which the user can pull to displace the septum body 1010 away from its position between the analyte sensor 956 and the insertion element 915.

[0310] The tether 1016 and the spacer body 1010 may be formed from a single piece of material, although other multi-material configurations may be utilized as desired.

[0311] In an example, the spacer body 1010 can be coupled to the cap 942 via a tether 1016 or in another manner. Fig.32 , the tether 1016 can be coupled to the cap 942, thereby coupling the spacer body 1010 to the cap 942. Removal of the cap 942 can pull the tether 1016 coupled to the spacer body 1010 to remove the spacer body 1010 from between the portion of the analyte sensor 956 and the insertion element 915.

[0312] In an example, the spacer body 1020 can be configured as a pin positionable between the insertion element 915 and the analyte sensor 956. For example, Fig.33 Such a configuration is shown for a spacer body 1020. The spacer body 1020 can operate in a similar manner to the spacer body 1010 and can space the insertion element 915 from the analyte sensor 956.

[0313] like Fig.33As shown, the spacer body 1020 can be coupled to a post 1022 that is coupled to a liner removal member 928 or other removable member. The liner removal member 928 can include a cover (e.g., a liner cover) that can cover the distal surface of the housing of the on-skin sensor assembly. The liner removal member 928 can include a liner cover for a patch of the on-skin sensor assembly. When the liner removal member 928 is removed, the spacer body 1020 can be removed from between the insertion element 915 and the analyte sensor 956. In an example, the spacer body 1020 can be coupled to a tether in the form of a pull tab or a tether coupled to the cap 942, such as Fig.32 In the example, Fig.31 and Fig.32 The illustrated spacer body 1010 may be coupled to the liner removal component 928 as desired.

[0314] In an example, the spacer body 1030 may include a sheath. For example, see Fig.34A , a spacer body 1030 in the form of a sheath can space the analyte sensor 956 from the insertion element 915. The sheath can surround the insertion element 915 and can include a portion 1032 positioned between the analyte sensor 956 and the insertion element 915 and a portion 1034 extending around the outer surface of the insertion element 915. The sheath can include a channel 1035 in which the analyte sensor 956 is positioned.

[0315] For example, Fig.34B A perspective view of the spacer body 1030 surrounding the insert element 915 is shown. Fig.34C An end view of the analyte sensor 956 and the insertion element 915 separated by the spacer body 1030 is shown.

[0316] The septum body 1030 can be positioned between the analyte sensor 956 and the insertion element 915 prior to the sterilization process. In other examples, the septum body 1030 is put in place after the sterilization process.

[0317] At a desired time prior to application, the spacer body 1030 can be withdrawn from between the analyte sensor 956 and the insertion element 915 to allow the analyte sensor to be seated in the channel 958 of the insertion element 915. For example, a user can manually remove the spacer body 1030. In an example, the spacer body 1030 can be coupled to the cap 942 or the liner removal component 928 or to another device for removal when desired. The spacer body 1030 can be coupled to a tether, for example, for removal when desired.

[0318] In an example, the spacer body 1040 can be positioned between a portion of the elongated analyte sensor 956 and the insertion element 915 and space the portion of the elongated analyte sensor 956 from the insertion element 915. The spacer body 1040 can be compressible and configured to compress to allow the analyte sensor 956 to be placed in the insertion element 915. The spacer body 1040 can, for example, include a compressible body configured to compress over a period of time. The spacer body 1040 can, for example, include a collapsible body configured to collapse after exposure to a sterilization process. For example, Fig.35A The spacer body 1040 is shown in an uncompressed or expanded configuration and spacing the analyte sensor 956 from the insertion element 915 .

[0319] In the example, Fig.35A The configuration shown may include a configuration of the analyte sensor 956 and the insertion element 915 positioned during or prior to sterilization. In an example, Fig.35B The configuration may include the configuration after sterilization.

[0320] The spacer body 1040 may be positioned on the needle hub 914 or may be positioned on another component of the applicator or on-skin sensor assembly. For example, the spacer body 1040 may be positioned on the housing 1042 of the on-skin sensor assembly or on another component as desired.

[0321] The spacer body 1040 can be configured to compress, collapse, and / or reduce in size over time. The spacer body 1040 can compress to allow the analyte sensor 956 to be positioned within the insertion element 915, for example, as Fig.35B The reduced size of the spacer body 1040 can reduce the spacing between the analyte sensor 956 and the insert element 915 and allow the analyte sensor 956 to move into the channel 958 (e.g., as Fig.28 shown).

[0322] In an example, the spacer body 1040 may compress simply due to a time span, or may collapse based on the sterilization process. For example, thermal cycling, humidity cycling, and / or exposure to a sterilizing gas (e.g., EtO) may trigger the collapse of the spacer body 1040. Thus, after sterilization, the spacer body 1040 may gradually collapse and position the analyte sensor 956 in the insertion element 915. In an example, the compression of the spacer body 1040 may occur over a span of several days or over a longer or shorter duration.

[0323] The features of the spacer body disclosed herein can reduce friction between the analyte sensor and the insertion element, and can reduce the possibility of undesirably retracting the analyte sensor 956 when the insertion element 915 is retracted. In an example, the spacer body can prevent friction (e.g., sticking) between the analyte sensor 956 and the insertion element 915. The spacer body can be used before or during the sterilization process, and / or can be used after the sterilization process. In an example, the spacer body can be used during packaging and / or distribution of the applicator and the sensor assembly on the skin as needed. The use of the spacer body can be used alone or in combination with any system, device or method disclosed herein.

[0324] In an example, the stopper body can be configured to prevent the analyte sensor 956 from being proximally retracted through the opening 978 through which the insertion element 915 extends when the insertion element 915 is proximally retracted through the opening 978 .

[0325] For example, Fig.36 The plug body 1050 is shown positioned proximate to the opening 978. The plug body 1050 can be positioned within the opening 978 and can protrude into the opening 978. The plug body 1050 can include a tab extending into the opening 978. In an example, the plug body 1050 can be positioned proximal to the analyte sensor 956. The plug body 1050 can be positioned within the opening 978 or can be positioned proximal to the opening 978 (e.g., positioned on or above a proximal surface of the housing 1052, among other locations).

[0326] Fig.36 and Fig.38 A plug body 1050 is shown having an angled surface and extending into the opening 978 . Fig.37A A close-up perspective view of a plug body 1050 having a flat face and extending into the opening 978 is shown. Fig.37B A close-up perspective view of a plug body 1050 having a protruding face and extending into the opening 978 is shown. The face portion of the plug body 1050 can be spaced apart from the analyte sensor 956, or initially contact the analyte sensor prior to insertion. The face portion of the plug body 1050 is designed to contact the analyte sensor 956 when the friction between the analyte sensor 956 and the insertion element 915 begins to remove the analyte sensor 956 from the host's skin when the insertion element 915 is retracted. By supporting the analyte sensor 956 at a point closer to the insertion element 915, the plug body 1050 reduces the bending moment applied to the analyte sensor 956 by the insertion element 915 when retracted.

[0327] In an example, the plug body 1050 may include an insert that is inserted into the housing 1052 of the on-skin sensor assembly, or may include a molded portion of the housing 1052. For example, Fig.38 A perspective view of a stopper body 1050 is shown, which includes an insert in the form of a ring that can be inserted into the opening 978. The ring can be positioned distal to the needle hub 914, but proximal to the analyte sensor 956. The stopper body 1050 can thus be positioned between the needle hub 914 and the analyte sensor 956.

[0328] Fig.39 A distal view of the plug body 1050 is shown protruding into the opening 978 .

[0329] refer to Fig.36 , as the insertion element 915 is retracted from the host's skin and the opening 978, the plug body 1050 can contact the analyte sensor 956 to prevent the analyte sensor 956 from retracting proximally as the insertion element 915 is retracted proximally through the opening 978. Thus, a reduced likelihood of the analyte sensor 956 being retracted from the skin and a reduced likelihood of the analyte sensor 956 being retracted proximally can result. Fig.27B The reduced possibility of the bend 990 is shown.

[0330] In examples, the plug body may have other forms. Fig.40 An example is shown in which the plug body 1060 can protrude from a cavity 1062 configured to receive the first portion 960 of the analyte sensor 956. 1062 can be connected to Fig.26A The cavity 976 shown is similarly configured. Cavity 1062 can be configured to receive a liquid form of adhesive (which can be curable), for example. Cavity 1062 can include one or more fixed dams for retaining an adhesive or other form of curable liquid. Plug body 1060 can include a tab extending from cavity 1062 into opening 978.

[0331] In an example, the plug body 1070 can be integral with the housing 1072. The plug body 1070 can include a portion of the housing 1072.

[0332] In an example, the plug body may surround the insertion element 915 and may fit tightly against the insertion element 915. For example, Fig.41 A plug body 1070 is shown including a surface of a housing 1072 having a fit around the insertion element 915 that prevents the analyte sensor 956 from being retracted proximally through the opening 978. In addition, the fit of the plug body 1070 with the insertion element 915 can allow the insertion element 915 to extend perpendicularly relative to the distal surface 1074 of the housing 1072 and relative to the host's skin. The perpendicular angle 1076 of insertion into and retraction from the host's skin can further reduce the likelihood of the analyte sensor 956 being retracted from the host's skin.

[0333] The systems, methods, and devices disclosed herein may include providing a perpendicular insertion angle into the host's skin, as well as a perpendicular angle of the insertion element to the distal surface of the housing of the sensor assembly on the skin. The opening 978 in the housing through which the insertion element 915 passes may be sized and arranged to provide such perpendicularity.

[0334] In an example, the plug body may include a plug positioned within the opening 978. Fig.42 , the plug 1080 may have a beveled surface that may be angled to contact the analyte sensor 956. The plug 1080 may, for example, include an annular shape (e.g., a gasket) positioned within the opening 978 and having a beveled surface. The plug 1080 may be inserted into the opening 978 before or after the analyte sensor 956 is assembled to the housing 1052. The angled surface of the plug 1080 may contact the analyte sensor 956 when the insertion element 915 is retracted to prevent the analyte sensor 956 from retracting.

[0335] In an example, the plug may include a washer 1090. Fig.43 , the gasket 1090 can be inserted into the opening 978 and can fit the insertion element 915. In an example, the gasket 1090 can include a self-healing gasket and can conform to the shape of the insertion element 915. The gasket 1090 can contact the analyte sensor 956 to prevent the analyte sensor 956 from retracting when the insertion element 915 is retracted. In an example, the gasket 1090 can be overmolded as part of the housing 1052.

[0336] In an example, the plug 1100 can be pierced by the insertion element 915. Fig.44 , the plug 1100 can be pierceable so that during assembly of the on-skin sensor assembly, the insertion element 915 can pierce the plug 1100 so that the plug 1100 conforms to the shape of the insertion element 915. The plug body in the form of the plug 1100 can thus contact the analyte sensor 956 and prevent the analyte sensor 956 from retracting when the insertion element 915 is retracted. In examples, the plug body can be selected to include a biocompatible and / or compliant material.

[0337] The use of the plug body can be utilized alone or in combination with any system, device or method disclosed herein. The plug body can be provided during, after or before a sterilization process or provided without a sterilization process. During distribution, the plug body can be packaged with components of the insertion element, analyte sensor and / or applicator system. The plug body can be used when the insertion element and analyte sensor are deployed. The plug body can increase the resistance of the analyte sensor to the flexing force applied to the analyte sensor proximally when inserted into the skin of the host and when the insertion element is retracted.

[0338] In an example, the plug body can be added after the process of loading the analyte sensor into the insertion element. For example, the plug body can be added on the proximal side of the analyte sensor. For example, the plug can be inserted into the opening of the housing, or another method of providing the plug body can be used. The plug body can be a press fit or a snap fit, or another form of insertion can be used to remain in the housing when the insertion element 915 is retracted. In an example, the plug body can be injection molded to extend into the opening of the housing. Other forms of forming or inserting the plug body can be used as needed.

[0339] In an example, a displacement mechanism can be utilized that can be configured to displace a portion of the analyte sensor 956 relative to the insertion element 915 before the insertion element 915 is retracted from the host's skin. The displacement mechanism can displace the analyte sensor 956 relative to the insertion element 915 to reduce sticking between the analyte sensor 956 and the insertion element 915.

[0340] In an example, the displacement mechanism can be configured to slide a portion of the analyte sensor 956 (e.g., the second portion 966 or the sensing portion) relative to the shaft 986 of the insertion member 915. The displacement mechanism can slide the portion of the analyte sensor 956 before the shaft 986 is retracted from the skin to reduce friction between the analyte sensor 956 and the shaft 986 (e.g., break stiction).

[0341] refer to Fig.45 , the displacement mechanism may include a compressible body 1082 positionable between the needle seat 914 and the proximal surface 972 of the housing 962 of the on-skin sensor assembly. Fig.46 A top view of the housing 962 is shown with the compressible body 1082 positioned on the proximal surface 972. The compressible body 1082 can surround the opening 978 in the housing 962.

[0342] The compressible body 1082 can be configured to compress when distal pressure from the needle hub 914 is applied to the compressible body 1082. Fig.25 , the needle carrier assembly 910 or other components of the insertion assembly may apply a distal force to the needle hub 914 when deployed. In this way, the compressible body 1082 may compress when the insertion element 915 and the analyte sensor 956 are inserted into the host's skin. The compression of the compressible body 1082 may allow the needle hub 914 to move distally relative to the housing 962 and the analyte sensor 956 and continue to move distally relative to the housing 962 and the analyte sensor 956. The insertion element 915 may be inserted farther than the analyte sensor 956. For example, Fig.47 Shows Fig.47 The insertion element 915 in the rightmost portion is relative to Fig.47956. The insertion element 915 may be advanced independently of the analyte sensor 956 after reaching full or maximum depth. The displacement of the insertion element 915 relative to the analyte sensor 956 may reduce friction between the insertion element 915 and the analyte sensor 956 (e.g., break up adhesion). This may result in a reduced likelihood of the analyte sensor 956 being retracted from the skin as the insertion element 915 is retracted, as well as a reduced likelihood of the analyte sensor 956 being retracted from the skin. Fig.27B The reduced possibility of the bend 990 is shown.

[0343] Additionally, the displacement mechanism may include a second compressible body 1084 ( Fig.46 ), the needle carrier assembly 910 can further apply force thereto. The second compressible body 1084 can operate in a similar manner to the first compressible body 1082.

[0344] Fig.48 and Fig.49 Another form of a displacement mechanism is shown, where the displacement mechanism can be configured to slide a portion of the analyte sensor 956 (e.g., the second portion 966 including the sensing portion) relative to the shaft 986 of the insertion element 915. The analyte sensor 956 can be displaced relative to the housing 962. The displacement mechanism can include a compressible body 1092 that can protrude distally from the distal surface 968 of the housing 962 and is configured to apply a proximal force when in contact with the host's skin. The compressible body 1092 can have a distal end 1093 configured to contact the host's skin and a proximal end 1094 configured to contact the analyte sensor 956.

[0345] refer to Fig.49 As the insertion element 915 and the housing 962 advance distally to contact the host's skin 1096 during deployment or insertion, the distal end 1093 of the compressible body 1092 may contact the skin 1096, thereby driving the proximal end 1094 to contact the analyte sensor 956. After the insertion element 915 reaches full or maximum depth, the analyte sensor 956 may move proximally independently of the insertion element 915. The analyte sensor 956 may be displaced proximally relative to the housing 962 and the insertion element 915, thereby reducing friction (e.g., sticking) between the insertion element 915 and the analyte sensor 956. This may result in a reduced likelihood of the analyte sensor 956 being retracted from the skin as the insertion element 915 is retracted, as well as Fig.27B The reduced possibility of the bend 990 is shown.

[0346] Fig.50An example of a displacement mechanism is shown that is configured to actuate one or more of the insertion element 915 (e.g., shaft 986) or analyte sensor 956 (e.g., second portion 966 or sensing portion) before the insertion element 915 is retracted from the skin to break the sticking between the analyte sensor 956 and the insertion element 915. The displacement mechanism can be configured to generate vibrations when the analyte sensor 956 is deployed distally into the skin of the host. In an example, the insertion assembly can include a displacement mechanism.

[0347] The displacement mechanism may include, for example, one or more ridges 1105 for contacting a portion of the insertion assembly to cause the insertion assembly to vibrate during deployment. The ridges 1105 may, for example, be Fig.25 The ridge 1105 is shown positioned on the inner housing 906, and / or may be positioned on the retainer 912, the needle carrier assembly 910, and / or other components of the applicator as desired. The ridge 1105 may be used to vibrate the sensor assembly on the skin and / or the needle holder 914 or other components during insertion to reduce friction (e.g., break up stiction) between the insertion element 915 and the analyte sensor 956. This may result in a reduced likelihood of the analyte sensor 956 being retracted from the skin as the insertion element 915 is retracted, and as Fig.27B The reduced possibility of the bend 990 is shown.

[0348] Fig.51 An example of a displacement mechanism is shown that includes a cover positioned on a distal surface covering a housing 962. The cover may include an optional liner removal component 928 that may include a liner cover for a patch of a sensor assembly on the skin. The displacement mechanism may be configured to vibrate one or more of the insertion element 915 or the analyte sensor 956 when the liner removal component 928 is retracted from the housing 962 and the patch 922. The liner removal component 928 may include one or more ridges 1110 that may contact the insertion element 915 and / or the analyte sensor 956 when the liner removal component 928 is removed. The vibration caused by the ridges 1110 may reduce friction between the insertion element 915 and the analyte sensor 956 (e.g., break up adhesion). This may result in a reduced likelihood of the analyte sensor 956 being retracted from the skin as the insertion element 915 is retracted, as well as a reduced likelihood of the analyte sensor 956 being retracted from the skin. Fig.27B The reduced possibility of the bend 990 is shown.

[0349] Figure 52 to Figure 54 An example of a displacement mechanism positioned on a cover covering the distal surface of housing 962 is shown. The cover may include a cap 1120 having a displacement mechanism. Cap 1120 may be provided with Fig.25The cap 942 shown is similarly configured, which can be positioned at the distal opening of the applicator housing, and can also include a displacement mechanism in the form of a cam surface 1122. The cam surface 1122 can be configured to apply a force to the housing 962 to displace a portion of the analyte sensor 956 (e.g., the second portion 966 or the sensing portion) relative to the insertion element 915. The cam surface 1122 can cause one or more of the analyte sensor 956 or the insertion element 915 to vibrate.

[0350] The cam surface 1122 can be positioned on a central support 1124 of the cap 942, which can extend proximally from the central portion 948 of the cap 1120. The cam surface 1122 can be configured to be positioned within a cavity of the housing 962 that can receive the cam surface 1122. When the cap 1120 is rotated (in a disengaging, unscrewing, or uncapping motion), the cam surface 1122 can rotate its position to contact the distal surface of the housing 962 or patch 922. For example, Fig.53 A schematic cross-sectional view is shown in which the cam surface 1122 is positioned within the cavity of the housing 962. Fig.54 The cap 1120 is shown rotated so that the cam surface 1122 leaves the cavity of the housing 962 and contacts the distal surface or patch 922 of the housing 962. The housing 962 is accordingly rotated. Fig.54 The displacement of the housing 962 due to the cam surface 1122 can cause the analyte sensor 956 to vibrate and displace relative to the insertion element 915, and can reduce the friction between the insertion element 915 and the analyte sensor 956 (e.g., break the viscosity). Therefore, during the opening operation, the friction between the insertion element 915 and the analyte sensor 956 can be reduced. The continued rotation of the cap 1120 can cause the housing 962 to continue to vibrate via the cam surface 1122 to continue to reduce the friction between the insertion element 915 and the analyte sensor 956. When the insertion element 915 is retracted, it can result in a reduced possibility of the analyte sensor 956 being retracted from the skin, as well as Fig.27B The reduced possibility of the bend 990 is shown.

[0351] The use of a displacement mechanism may be utilized alone or in combination with any system, device, or method disclosed herein. The use of a displacement mechanism may occur after a sterilization process, or in an example, may occur before or during a sterilization process. In an example, the use of a displacement mechanism may occur without a prior sterilization process.

[0352] In an example, a force directing component can be utilized, which can be configured to direct force from the insertion assembly proximate the insertion element 915. The force directing component can reduce friction (eg, stiction) between the analyte sensor 956 and the insertion element 915.

[0353] refer to Fig.55 , a component of the insertion assembly, such as a retainer 1130, may include a force directing component 1132. The retainer 1130 may be Fig.25 The illustrated retainer 912 is similarly configured. A portion of the insertion assembly, such as retainer 1130, may include a plate 1134 that may be configured to be positioned proximal to the proximal surface 972 of the housing 962. The plate 1134 may include an opening 1136 through which the needle hub 914 passes.

[0354] The force directing component 1132 may include one or more protrusions 1138 that may be configured to direct force of the insertion assembly proximate the needle hub 914 and the insertion element 915. The one or more protrusions 1138 may be positioned on the plate 1134. The one or more protrusions 1138 may be configured to contact the proximal surface 972 of the housing 962 and apply a force to the proximal surface 972 proximate the insertion element 915. The one or more protrusions 1138 may contact the proximal surface 972 proximate the opening 978 of the housing 962 for the insertion element 915 to pass through.

[0355] One or more protrusions 1138 can direct deployment forces proximate the needle hub 914 and the insertion element 915. The force from the force directing component 1132 can displace the analyte sensor 956 relative to the insertion element 915 and can reduce friction between the insertion element 915 and the analyte sensor 956 (e.g., break up stiction). The force from the force directing component 1132 can vibrate the analyte sensor 956 relative to the insertion element 915 or transmit vibrations to the analyte sensor. This can result in a reduced likelihood of the analyte sensor 956 being retracted from the skin as the insertion element 915 is retracted, as well as a reduced likelihood of the analyte sensor 956 being retracted from the skin. Fig.27B The reduced likelihood of the bend 990 is shown. In an example, the force directing member can contact the proximal surface 972 of the housing 962 after the insertion element 915 penetrates the skin.

[0356] The use of force directing components may be utilized alone or in combination with any system, apparatus, or method disclosed herein.

[0357] In an example, the analyte sensor may be configured to reduce friction (eg, viscous or dynamic friction) with the insertion element 915 . Fig.56 An example of an analyte sensor 1140 having an oval cross-section is shown. Fig.57 Shown along Fig.5698 ' of the analyte sensor 1140 and the insert element 915. The outer surface 1141 of the analyte sensor 1140 can be configured to reduce friction (e.g., stiction) with the insert element 915. The elliptical shape of the cross section can reduce the distance or gap between the analyte sensor 1140 and the sidewall 988 of the insert element 915, and thus can reduce friction with the insert element 915. For example, the channel 958 of the insert element 915 can have a C-shaped cross section that can increase the diameter gap from the sidewall 988 to the elliptical analyte sensor 1140. In addition, it can result in a reduced contact point or contact surface area between the elliptical analyte sensor 1140 and the insert element 915.

[0358] Fig.56 and Fig.57 The features of may be utilized alone or in combination with any system, apparatus, or method disclosed herein.

[0359] In an example, the analyte sensor may have a surface configured to reduce friction with the insertion element 915. For example, the surface of the analyte sensor may include an outer surface that can be configured to reduce sticking with the insertion element 915. The surface can be configured, for example, to reduce hydrogen bonding with the insertion element 915. In an example, the membrane comprising the outer surface of the analyte sensor may have properties that prevent hydrophilic permeability and / or membrane swelling. For example, the ratio of polyvinyl pyrrolidone (PVP) can be changed (e.g., reduced) to prevent hydrophilic permeability and / or membrane swelling. The surface features of the insertion element disclosed herein can also be utilized together with the surface of the analyte sensor.

[0360] In an example, the analyte sensor may be oriented to increase resistance to flexion forces of the analyte sensor and thereby provide a reduced likelihood of the analyte sensor being retracted from the skin and, as such, provide a reduced likelihood of the analyte sensor being retracted from the skin. Fig.27B The reduced possibility of the bend 990 shown. For example, referring to Fig.58 , the analyte sensor 1143 may include a first portion 1144 or contact portion and a second portion 1145 or sensing portion. The first portion 1144 may be coupled to the housing 962, and the second portion 1145 may be configured to extend distally from the housing 962 and be inserted into the skin of the host.

[0361] The bend 1146 of the analyte sensor 1143 can have at least two kinks 1147, 11481 that can angle the second portion 1145 with respect to the first portion 1144. The first kink 1147 can be positioned between the first portion 1144 and the middle portion 1149 of the analyte sensor 1143. The second kink 1148 can be positioned between the middle portion 1149 and the second portion 1145.

[0362] The first kink 1147 may have an angle less than ninety degrees. For example, the first kink 1147 may have an angle between thirty degrees and sixty degrees, which may be an angle of forty-five degrees, or another angle may be utilized as needed. Similarly, the second kink 1148 may have an angle between thirty degrees and sixty degrees, which may be an angle of forty-five degrees, or another angle may be utilized as needed. In an example, at least two kinks 1147, 1148 may angle the second portion 1145 to be perpendicular to the first portion 1144. The second portion 1145 may extend vertically from the distal surface 968 of the housing 962 or extend at another angle as needed. In an example, the first portion 1144 may extend parallel to the distal surface 968 of the housing 962. Other varying angles may be utilized as needed.

[0363] The middle portion 1149 of the analyte sensor 1143 may be straight or linear. In an example, the middle portion 1149 may have a curvature as desired.

[0364] The use of kinks 1147, 1148 can enhance the ability of the analyte sensor 1143 to respond to a flexing or retracting force (along the Fig.58 The increased strength of the analyte sensor 1143 in response to the flexion force can reduce the likelihood of the analyte sensor 956 being retracted from the skin and can result in the following: Fig.27B The reduced possibility of the bend 990 is shown.

[0365] Fig.58 The features of may be utilized alone or in combination with any system, apparatus, or method disclosed herein.

[0366] In examples, other configurations of the analyte sensor may be utilized to increase the strength of the analyte sensor in response to a buckling force. For example, the stiffness of the analyte sensor may be increased. A sensor of a harder alloy may be utilized as desired.

[0367] In an example, the insert element 915 can be configured to reduce friction (eg, viscous or dynamic friction) with the analyte sensor 956. Fig.59 For example, a surface 1152 of the insertion element 915 (e.g., a surface 1152 of a shaft of the insertion element 915) can be configured to reduce friction with a portion of the analyte sensor (e.g., the second portion 966 or the sensing portion). In an example, a metal or alloy that can reduce friction with the analyte sensor 956 can be selected for the insertion element 915.

[0368] In an example, the surface 1152 may include a coating that may be configured to reduce friction with a portion of the analyte sensor 956. The coating may be, for example, a lubricant that may be positioned on a portion of the insertion element. The lubricant may include a biocompatible lubricant. In an example, petroleum jelly (petroleum jelly), as well as other forms of lubricants, may be used. In an example, the coating may include a polymer. For example, a plastic coating, such as a thin plastic coating, may be used. A polymer such as polytetrafluoroethylene (PTFE), polyparaphenylene dimethyl ether, or another form of polymer may be coated on the insertion element. The polymer may be applied to the insertion element 915 using vapor deposition.

[0369] In an example, the coating may include thermal oxide.For example, thermal oxide may be formed on an insert element 915 including aluminum or titanium.

[0370] In an example, the coating of the insert element 915 may include an inert material. For example, an inert material having a low surface energy may be used to reduce the possibility of hydrogen bonding or other forms of electrical bonding with the analyte sensor. For example, an inert material such as silane (SiH 4 ).

[0371] In an example, the coating of the insert element 915 may include one or more of spraying, brushing, electrostatically applied coating, anodizing, or more preferably plating, dipping, or deposition. In an example, vapor deposition may be used, including chemical vapor deposition and physical vapor deposition. For example, vapor deposition of chromium nitride, titanium nitride, and titanium carbonitride may be applied to the insert element 915. In certain embodiments, the thickness of the nitride coating is between 10 nanometers and 5000 nanometers (nm), and preferably between 100 nm and 1000 nm. Plating may include plating such as titanium, nickel, gold, other forms of plating, and alloys thereof.

[0372] In an example, a coating may be provided that may be bonded to the shaft of the insert element 915. In an example, the coating may be chemically bonded. The coating may be provided by plating, dipping, or deposition (which may be spray coating, chemical vapor deposition, or physical vapor deposition), among other processes. The coating material may be a silicone-based material, a silicone-based material, a fluorinated compound-based material, or a parylene-based material, among other materials.

[0373] In an example, the coating can be cured. The coating can be cured by addition curing, condensation curing, thermal curing, and other curing methods. The cured coating can be applied in a variety of ways disclosed herein. Curing can produce crosslinks that can improve the adhesion and cohesion of the coating and the robustness of the coating on the insert element 915. Examples of coatings herein can be heated, evaporated, or other processes performed on them to promote curing. In an example, curing can be performed at room temperature.

[0374] In an example, the coating may include silicone. The coating may be derived from silane (SiH 4 ) compound. In an example, the silicone may include an amino-functional dimethylsiloxane copolymer. The material may be provided as a compound of about 50% active silicone component (e.g., amino-functional dimethylsiloxane copolymer) mixed with one or more solvents. In an example, the solvent may include an aliphatic hydrocarbon and an isopropyl alcohol solvent. In an example, other proportions of components comprising the material may be provided (e.g., about 45% to 55% active silicone component, about 40% to 60% active silicone component, etc.). In an example, other forms of solvents may be utilized. In an example, other forms of coating materials may be utilized.

[0375] Fig.67 Exemplary steps in a method of coating at least a portion of shaft 986 of elongated insertion element 915 are shown. The coating may be a material configured to reduce stiction and friction between elongated insertion element 915 and elongated analyte sensor 956. In examples, other forms of application of materials (e.g., spray coating or other forms of deposition) may be utilized as disclosed herein.

[0376] Fig.67 The shaft 986 of the elongated insertion element 915 is shown positioned within the bath 1162. The bath 1162 may include a material. A solution of the material may be provided. For example, in an example where the material comprises a compound of an active silicone component mixed with one or more solvents (e.g., an amino-functionalized dimethylsiloxane copolymer), the material may be combined with or diluted with an additional solvent. The material may be added to the additional solvent to form a mixture of about 0.1% of the material (e.g., an amino-functionalized dimethylsiloxane copolymer mixed with a solvent) in the additional solvent bath. The ratio of the material to the additional solvent may vary as desired. For example, the material may be provided at a concentration of about 0.05%, 0.2%, 0.3%, 1.0%, or more as desired. The additional solvent may comprise hexane or other forms of solvent.

[0377] The shaft 986 of the elongated insertion element 915 can be positioned within the bath 1162 for a desired duration (e.g., less than 30 minutes, or another duration as desired). The thickness of the material on the shaft 986 of the elongated insertion element 915 can be determined by the duration within the bath 1162. The loose silicone molecules can chemically bond to the surface of the shaft 986 of the elongated insertion element 915. The polar ends of any amino-functional groups can adhere to the metal shaft 986 to form a dense packing layer on the surface. The shaft 986 can be withdrawn from the bath 1162 ( Fig.67 986 to form a layer of material 1164, as shown in FIG. Fig.67 shown.

[0378] Layer 1164 may be cured on shaft 986. For example, Fig.68 The shaft 986 is shown outside the bath 1162. The material can be cured at room temperature, or other curing methods (e.g., heating or evaporation, etc.) can be used. Air or other gases can be blown over the material during the curing process. Ambient (room) relative humidity can be used. Curing can be carried out for a desired duration (e.g., about 1 week, less than 24 hours, less than 30 minutes, or longer or shorter durations as desired). Curing can produce crosslinks that can improve the adhesion and cohesion of the coating and the robustness of the coating on the insert element 915. Permanent chemical bonding can be obtained.

[0379] Fig.69 The resulting layer 1164 is shown on the outer surface of the shaft 986 of the insert element 915. Based on the selected coating material, the duration in the tank bath, and the curing process and duration used, the layer 1164 can have a certain thickness as desired. In an example, the layer 1164 can have a thickness 1166 of less than 1 micron on the shaft 986. In an example, the layer 1164 can have a thickness 1166 of less than 1.5 microns on the shaft 986. In an example, the layer 1164 can have a thickness 1166 of less than 2 microns on the shaft 986. In an example, the layer 1164 can have a thickness 1166 in a range between 0.1 microns and 1 micron, 1.5 microns, or 2 microns. In an example, the layer 1164 can have a thickness 1166 in a range between 0.5 microns and 1 micron, 1.5 microns, or 2 microns. Greater or lesser thicknesses can be provided as desired.

[0380] In an example, the channel 958 of the insert element 915 may include a layer of material. For example, Fig.70 The inner surface of the insert element 915 forming the channel 958 is shown provided with a layer of material. The layer may have a thickness dimension as disclosed herein.

[0381] The material layer can be advantageously stable and durable. The material layer can have very low extractables and leachables and can therefore be safely used in medical insertion applications. The material layer can reduce the sticking and frictional forces of the insertion element 915 with the analyte sensor 956 and the local tissue. The material can reduce friction (e.g., sticking or dynamic friction) with the elongated analyte sensor 956. Improved deployment reliability and accuracy can be obtained. Reduced insertion tissue damage can be provided.

[0382] In an example, the coefficient of friction generated by the material against the shaft 986 may be the surface 1171 of the portion of the shaft 986 coated with the material (at Fig.69 In the examples, a greater or lesser variation in the coefficient of friction may be provided.

[0383] After the coating process, additional assembly steps can be provided using the insertion element 915. For example, the elongated insertion element 915 can be positioned adjacent to the elongated analyte sensor 956. The elongated analyte sensor 956 can be positioned within the channel 958 of the elongated insertion element 915, as disclosed herein. The elongated analyte sensor 956 can be configured similarly to other forms of analyte sensors disclosed herein. For example, the elongated analyte sensor 956 can extend distally from a housing 962 configured to be worn on the skin of a host. Other assembly steps can be provided after or before the coating process.

[0384] The methods disclosed herein can be used with other forms of materials. The steps of these methods can be replaced, excluded, added or modified as needed.

[0385] In an example, the surface of the insert element 915 may have a surface roughness. Fig.60 , surface 1154 may include multiple bumps as needed. The raised portion of the bump may contact the analyte sensor 956 and may reduce the contact surface area and thus reduce friction with the analyte sensor 956. In an example, the height of the bump may vary as needed. For example, in an example, the surface roughness may be 35 root mean square (RMS) micro inches or greater. In an example, the surface roughness may be 40RMS micro inches or greater. In an example, the surface roughness may be 45RMS micro inches or greater. A larger or smaller surface roughness may be provided as needed.

[0386] The surface 1154 of the insert member 915 can be an inner surface facing the analyte sensor 956. The inner surface can be positioned within the channel 1155 of the insert member 915.

[0387] The surface of the insert element may have a surface texture. The texture may include one or more patterns of raised portions of the surface. For example, Fig.61 A front view of the channel 1157 of the insert member is shown, showing an inner surface 1159 having a surface texture. The insert member 915 can have sidewalls 1161 defining the channel 1157. The texture reduces the total surface area in contact between the analyte sensor 956 and the insert member 915, thereby reducing friction.

[0388] For example, the surface of the insert element 915 may include grooves. Fig.62 A front view of the channel 1163 of the insertion element 915 is shown, showing the inner surface 1165 having the groove 1158. The groove 1158 can extend along the longitudinal axis of the channel 1163 and can be straight or can be angled or curved as desired. For example, Fig.62As shown, the grooves 1158 can intersect in a repeating curved pattern. The grooves 1158 can be configured as a spiral or helical shape or other configuration as desired. The grooves can be laser, mechanical, chemically etched or can be formed in another way. The grooves 1158 reduce the total surface area of ​​contact between the analyte sensor 956 and the insertion element 915, thereby reducing friction.

[0389] For example, the surface of the insert element 915 may include holes. For example, Fig.63 A front view of a channel 1167 of an insert element 915 is shown, showing an inner surface 1156 having holes 1160. The holes 1160 can be arranged in a pattern, and the pattern can extend along the longitudinal axis of the channel 1167. For example, a repeating pattern of longitudinally aligned holes 1160 can be utilized, or another pattern can be provided as desired. The holes 1160 reduce the total surface area of ​​contact between the analyte sensor 956 and the insert element 915, thereby reducing friction.

[0390] In an example, the surface of the insert element may include one or more of bumps, holes, or grooves. These surfaces may be configured to reduce friction (e.g., viscous or dynamic friction) with a portion of the analyte sensor 956. For example, these surfaces may reduce hydrogen bonding sites between the analyte sensor 956 and the insert element 915 as well as other forms of friction reduction (e.g., electrical or mechanical).

[0391] Figure 59 to Figure 63 The channel of the illustrated insert element 915 may have a C-shaped cross-section. In examples, other cross-sectional shapes may be provided.

[0392] For example, Fig.64 A top cross-sectional view is shown showing an insertion member 1170 having a V-shaped cross-sectional channel 1172 for receiving a portion of the analyte sensor 956. The shaft 1174 of the insertion member 1170 can include the V-shaped cross-sectional channel 1172.

[0393] The V-shape of the channel 1172 can be formed by the side walls 1176 of the insert element 1170 that are angled relative to each other. Therefore, the inner surface 1178 of the side walls 1176 can be angled relative to each other. In an example, the V-shaped cross-sectional channel 1172 can have an angle between 60 degrees and 120 degrees. In an example, the V-shaped cross-sectional channel 1172 can have an angle of 90 degrees. In an example, a larger or smaller angle can be provided as needed. The inner surface 1178 may include a flat wall that can be positioned to contact the circular analyte sensor 956 only at two contact points. A reduced surface area can be obtained, and therefore reduced friction (e.g., viscous or dynamic friction) can be caused.

[0394] Fig.65A top cross-sectional view is shown showing an insertion element 1180 having a W-shaped cross-sectional channel 1182 for receiving a portion of the analyte sensor 956. The shaft 1184 of the insertion element 1180 can include the W-shaped cross-sectional channel 1182.

[0395] The W-shape of the channel 1182 can be formed by an elongated protrusion 1186 added to the central portion 1188 of the elongated insertion element 1180 having a C-shaped cross-sectional channel. Thus, by adding the protrusion 1186, the C-shaped cross-sectional channel can be modified to form a W-shaped cross-sectional channel 1182. This can result in a reduction in the number of possible contact points between the insertion element 1180 and the analyte sensor 956. For example, the outer surface of the analyte sensor 956 can have a circular cross-section. Thus, reduced friction (e.g., viscous or dynamic friction) can result.

[0396] Fig.66 A top cross-sectional view is shown showing an insertion element 1190 having a W-shaped cross-sectional channel 1192 for receiving a portion of the analyte sensor 956. A shaft 1194 of the insertion element 1190 can include the W-shaped cross-sectional channel 1192.

[0397] The W-shape of the channel 1192 may be formed by shaping (e.g., stamping) the shaft 1194 into a W-shape. This may result in a reduced number of contact points or surface areas between the insert element 1190 and the analyte sensor 956, and thus may result in reduced friction (e.g., viscous or dynamic friction).

[0398] Fig.71 One or more elongated insertion elements 1200 (in Fig.71 Each of the elongated insertion elements 1200 may include a respective axis 1202a, 1202b that may be configured to extend along a portion of the elongated analyte sensor 956.

[0399] Each of the elongated insertion elements 1200 can be configured to guide the elongated analyte sensor 956 into the skin of the host, wherein the elongated analyte sensor 956 is positioned outside of the shaft 1202a, 1202b of the respective elongated insertion element 1200a, 1200b. Thus, the elongated insertion elements 1200a, 1200b can be free of a channel for holding the elongated analyte sensor 956, such as Fig.28 In contrast, the elongated analyte sensor 956 may Fig.72The arrangement shown in the cross-sectional view of FIG. 1 is positioned outside of shafts 1202a, 1202b. In examples, the elongated insertion element 1200 may have a solid center or interior. In examples, the elongated insertion element 1200 may include a pin or pin-shaped needle. In examples, the elongated insertion element 1200 may be hollow or have a channel, and the elongated analyte sensor 956 is positioned outside the shaft of such an elongated insertion element.

[0400] Each of the elongated insertion elements 1200 may extend along a respective central axis 1204a, 1204b. The elongated analyte sensor 956 may include a central axis 1206. The central axis 1206 of the elongated analyte sensor 956 may be configured to be positioned parallel to and laterally spaced apart from the respective central axes 1204a, 1204b of the elongated insertion element 1200 (e.g., as shown in FIG. 1 ). Fig.72 In an example, the second portion 966, sensing portion or distal portion of the elongated analyte sensor 956 can include a central axis 1206 extending parallel to and laterally spaced apart from the respective central axes 1204a, 1204b of the elongated insertion element 1200.

[0401] In an example, each of the elongated insertion elements 1200 may include a respective outer surface 1208a, 1208b. The outer surfaces 1208a, 1208b of the elongated insertion elements 1200a, 1200b may extend parallel to each other. The elongated analyte sensor 956 may be positioned outside of the respective outer surfaces 1208a, 1208b. The elongated analyte sensor 956 may include an outer surface 1210.

[0402] Fig.72 Shows Fig.71 1204a, 1204b, 1206. The outer surface 1208a of the elongated insertion element 1200a may include a longitudinal extension section 1212a configured to extend parallel to and adjacent to the outer surface 1210 of the elongated analyte sensor 956. The longitudinal extension section 1212a may include the entire circumference of the outer surface 1208a or only a portion of the circumference. In an example, the longitudinal extension section 1212a may extend the entire length of the insertion element 1200a or only a portion of the length. The outer surface 1208b of the elongated insertion element 1200b may include a similarly configured longitudinal extension section 1212b. In an example, the longitudinal extension sections 1212a, 1212b may face each other.

[0403] The longitudinally extending segments 1212a, 1212b that include a portion of the entire circumference or outer circumference of the respective outer surface 1208a, 1208b can provide a longitudinally extending contact surface 1214a, 1214b for the respective elongated insertion element 1200a, 1200b. The longitudinally extending contact surface 1214a, 1214b can include only a portion of the entire circumference or outer circumference of the respective outer surface 1208a, 1208b, thereby providing a relatively narrow or thin line contact area between the outer surface 1208a, 1208b and the elongated analyte sensor 956. Thus, reduced stiction, friction, and contact surface area between the elongated insertion element 1200a, 1200b and the elongated analyte sensor 956 can result.

[0404] In an example, the respective outer surfaces 1208a, 1208b and the longitudinally extending segments 1212a, 1212b may include a convex outer surface. The convex outer surface may be curved radially outward and may further reduce the size of the longitudinally extending contact surfaces 1214a, 1214b that may contact the outer surface 1210 of the elongated analyte sensor 956. In an example, other shapes of the outer surfaces 1208a, 1208b or the longitudinally extending segments 1212a, 1212b may be utilized (e.g., flat, triangular, rectangular, pentagonal, hexagonal, etc.).

[0405] Fig.71 A configuration is shown in which multiple insertion elements 1200a, 1200b may be utilized. Each insertion element 1200a, 1200b may include a respective proximal end portion 1216a, 1216b and a distal end portion 1218a, 1218b. A respective shaft 1202a, 1202b may extend between the proximal end portion 1216a, 1216b and the distal end portion 1218a, 1218b. The distal end portion 1218a, 1218b may include a respective top end 1220a, 1220b of the insertion element 1200a, 1200b.

[0406] Needle hub 1222 can couple two proximal end portions 1216a, 1216b to each other. The shafts 1202a, 1202b of the respective insertion elements 1200a, 1200b can extend from the proximal ends 1216a, 1216b to the respective top ends 1220a, 1220b. The shafts 1202a, 1202b can be separated from each other along the length of the shafts 1202a, 1202b and are not connected to each other by the material comprising the shafts 1202a, 1202b. The shafts 1202a, 1202b can therefore include independent columns or columns extending parallel to each other and connected at the needle hub 1222. The shafts 1202a, 1202b can be overmolded at the needle hub 1222. The respective top ends 1220a, 1220b can be not connected to each other. The shafts 1202a, 1202b can include free shafts that are free to deflect independently of each other.

[0407] The axes 1202a, 1202b of the respective insertion elements 1200a, 1200b can be positioned to define the sides of the elongated analyte sensor 956. For example, see Fig.72 , each shaft 1202a, 1202b can be positioned on respective opposite sides 1224a, 1224b of the elongated analyte sensor 956. The shafts 1202a, 1202b and the elongated analyte sensor 956 can be arranged in a triangular configuration, although other configurations can be utilized as desired. The elongated analyte sensor 956 can be positioned between the shafts 1202a, 1202b of the respective insertion elements 1200a, 1200b, such as Fig.72 As shown, the central axis 1206 is laterally offset from a plane or line extending between the central axes 1204a, 1204b. Other configurations may be utilized as desired (e.g., the central axis 1206 may be aligned with a plane or line extending between the central axes 1204a, 1204b in a co-linear arrangement as well as other configurations).

[0408] The shafts 1202a, 1202b of the respective insertion elements 1200a, 1200b can be configured to support the elongated analyte sensor 956 when inserted into the skin of the host. The shafts 1202a, 1202b of the respective insertion elements 1200a, 1200b can be configured to support the elongated analyte sensor 956 when inserted into the skin of the host. Fig.71 The deployment configuration shown supports the elongated analyte sensor 956. The deployment configuration may include a configuration in which the elongated analyte sensor 956 is positioned for deployment to the skin of the host. The elongated analyte sensor 956 may be positioned in the deployment configuration just prior to insertion into the skin of the host and / or at another time prior to insertion (e.g., when sterilizing the insertion elements 1200a, 1200b and / or the elongated analyte sensor 956 as needed).

[0409] The outer surfaces 1208a, 1208b of the shafts 1202a, 1202b may contact the outer surface 1210 of the elongated analyte sensor 956. For example, during a sterilization process or prior to insertion, the outer surfaces 1208a, 1208b may be, for example, Fig.71 and Fig.72 The arrangement shown contacts the outer surface 1210 of the elongated analyte sensor 956. In an example, the outer surfaces 1208a, 1208b may be spaced apart from the outer surface 1210 of the elongated analyte sensor 956 in the deployed configuration. In an example, one or more of the insertion elements 1200a, 1200b or the elongated analyte sensor 956 may pass through the septum 1225, which may support the position of the elongated analyte sensor 956 relative to the insertion elements 1200a, 1200b. For example, Fig.73A configuration is shown in which the insertion elements 1200a, 1200b and the elongated analyte sensor 956 axially pass through a diaphragm 1225 that laterally stabilizes the elongated analyte sensor 956 relative to the insertion elements 1200a, 1200b. The diaphragm 1225 may be coupled to the housing from which the elongated analyte sensor 956 extends, or may have another location (e.g., located on a patch for the housing or a liner for the patch as desired). In examples, the diaphragm 1225 may not be used.

[0410] Positioning the elongated analyte sensor 956 outside of the shaft 1202a, 1202b of the respective insert element 1200a, 1200b may provide a number of benefits. For example, during sterilization, the reduced contact area between the elongated analyte sensor 956 and the shaft 1202a, 1202b may reduce the strength of any sticking that may form between the elongated analyte sensor 956 and the shaft 1202a, 1202b. This may be sticking due to swelling of the elongated analyte sensor 956 that promotes hydrogen bonding during sterilization, or sticking due to other reasons. Additionally, the interior of the insert element (e.g., such as Fig.28 The swelling of the elongated analyte sensor 956 (within the channel shown) may create a large contact surface area between the outer surface of the elongated analyte sensor 956 and the inner surface of the insertion element due to the positioning of the elongated analyte sensor 956 within the insertion element. The large contact surface area may create greater friction (both viscous and dynamic friction) between the insertion element and the analyte sensor 956. Positioning the analyte sensor 956 on the exterior of the shaft may reduce the surface area and friction (viscous and dynamic friction). For example, the longitudinal extensions 1212a, 1212b may include a smaller contact surface area than the inner surface of the channel of the insertion element. Reduced friction may occur regardless of whether a sterilization process occurs.

[0411] Insertion elements 1200a, 1200b may also provide a smaller penetration profile for insertion into the skin than an insertion element that retains analyte sensor 956 therein. Reduced wound size and impact may result.

[0412] The elongated insertion elements 1200a, 1200b may be as follows Fig.71 The configuration shown guides the elongated analyte sensor 956 into the host's skin. The insertion elements 1200a, 1200b and the elongated analyte sensor 956 together can be inserted distally into the skin. For example, Fig.74 Insertion elements 1200a, 1200b and elongated analyte sensor 956 are shown together axially penetrating into skin 1227. Insertion elements 1200a, 1200b may be retracted from the insertion site to insert elongated analyte sensor 956 into skin 1227, e.g. Fig.75The proportions and sizes of the relevant parts may vary from Fig.74 and Fig.75 Representation.

[0413] In the example, the space 1226 between the elongated insertion elements 1200a, 1200b (in Fig.72 ) may include a tearing region in which the skin 1227 is torn by the insertion elements 1220a, 1220b to facilitate insertion of the elongated analyte sensor 956. The outer surfaces 1208a, 1208b of the shafts 1202a, 1202b may be laterally spaced apart from each other to form a space 1226 as desired. In an example, variations may be provided. For example, Fig.76 A variation is shown in which the outer surfaces 1208a, 1208b contact each other. In an example, the elongated insertion members 1200a, 1200b may be formed to tear, allowing the elongated analyte sensor 956 to slide therein.

[0414] Various other intervals may be utilized. For example, Fig.77 Shows the available ratio Fig.72 An example of a smaller spacing 1228 is shown. Fig.78 Shows the available ratio Fig.77 An example of a larger spacing 1230 is shown. In an example, the spacing can be set to form a desired tear area size.

[0415] In examples, the number of insertion elements utilized may vary. In examples, one or more insertion elements may be utilized. For example, Fig.79 A configuration is shown in which three elongated insertion elements 1232a, 1232b, 1232c may be utilized. The insertion elements 1232a, 1232b, 1232c may be positioned in a triangular arrangement with the elongated analyte sensor 956 defined by the insertion elements 1232a, 1232b, 1232c. In an example, only one insertion element may be utilized. In an example, two or more insertion elements may be utilized.

[0416] In an example, the size or diameter of the insertion element utilized may vary. For example, the insertion elements 1232a, 1232b, 1232c may each have a smaller diameter than a corresponding one of the insertion elements 1200a, 1200b. The insertion elements 1232a, 1232b, 1232c may each have a smaller diameter than the elongated analyte sensor 956. The insertion elements 1232a, 1232b, 1232c may be configured similarly to the insertion elements 1200a, 1200b in other respects.

[0417] In examples, the shape of the insert element may vary. For example, Fig.80956. The configuration of the insertion elements 1234a, 1234b is shown as each having an elliptical cross-section. The elliptical cross-section can change the size or shape of the corresponding longitudinal extension of the corresponding insertion element 1234a, 1234b that can face the elongated analyte sensor 956. The insertion elements 1234a, 1234b can be configured similarly to the insertion elements 1200a, 1200b in other respects. In an example, the insertion element can have a circular cross-section (e.g., Fig.72 ). In examples, other shapes may be utilized. The shape of the elongated sensor 956 may be varied to form, for example, Figures 76 to 80 In the example, a circular shape (such as Fig.72 ) and other shapes.

[0418] In examples, more than one analyte sensor may be utilized. Figure 81 to Figure 85 An example is shown in which multiple analyte sensors may be utilized. Figures 71 to 80 or any other example herein may be used with Figure 81 to Figure 85 Use together with the examples.

[0419] Fig.81 An example is shown in which a second analyte sensor 956b can be utilized in combination with a first analyte sensor 956a. The second analyte sensor 956b can be positioned on the side of the elongated insertion elements 1200a, 1200b opposite to the first analyte sensor 956a. The analyte sensors 956a, b and the elongated insertion elements 1200a, 1200b can be positioned in a diamond configuration. In examples, other configurations (e.g., rectangular or co-linear) can be utilized.

[0420] The elongated insertion elements 1200a, 1200b can separate and isolate the first analyte sensor 956a from the second analyte sensor 956b. Thus, during the sterilization process, a reduced likelihood of the first analyte sensor 956a contacting and having sticking with the second analyte sensor 956b can be obtained. Such a configuration is different from a configuration in which multiple analyte sensors can be inserted into a single channel (having Fig.28 ). The sterilization process may cause sticking between multiple analyte sensors in a single channel. The elongated insertion elements 1200a, 1200b may separate and isolate the first analyte sensor 956a from the second analyte sensor 956b to reduce the possibility of such sticking. The elongated insertion elements 1200a, 1200b may be used to communicate with the analyte sensor 956a. Figures 71 to 80 Analyte sensor 956a is introduced into the skin of the host in a manner similar to that discussed above.

[0421] In an example, the lateral spacing between the elongated insertion elements 1200a, 1200b may be varied to change the size or shape of the space 1236 between the elongated insertion elements 1200a, 1200b. Fig.83 As shown, the lateral spacing 1238 between the elongated insertion elements 1200a, 1200b is greater than Fig.82 Space 1236 is shown, which can reduce the lateral distance between analyte sensors 956a, b. The size or shape of space 1236 can vary as desired.

[0422] The number of analyte sensors can vary as desired. For example, Fig.84 Four analyte sensors 956a, 956b, 956c, 956d are shown being used. The elongated insertion element 1200a may include a central elongated insertion element 1200a between the elongated insertion elements 1200b, 1200c and the four analyte sensors 956a, 956b, 956c, 956d. The elongated insertion element 1200a may separate and isolate the four analyte sensors 956a, 956b, 956c, 956d from each other.

[0423] Elongated insertion elements 1200a, 1200b, 1200c may be positioned co-linearly with one another, wherein each analyte sensor 956a, 956b, 956c, 956d is defined by two of the elongated insertion elements (analyte sensor 956a is defined by elongated insertion elements 1200a, 1200b; analyte sensor 956b is defined by elongated insertion elements 1200a, 1200b on a side opposite to analyte sensor 956a; analyte sensor 956c is defined by elongated insertion elements 1200a, 1200c; and analyte sensor 956d is defined by elongated insertion elements 1200a, 1200c on a side opposite to analyte sensor 956c). Insertion element 1200c may otherwise be configured similarly to insertion elements 1200a, 1200b, and analyte sensors 956a, 956b, 956c, 956d may otherwise be configured similarly to analyte sensor 956.

[0424] In examples, a greater or lesser number of analyte sensors and elongated insertion elements may be utilized. In examples, the shape or size of the analyte sensors and elongated insertion elements may vary. The positioning of one or more analyte sensors or elongated insertion elements may vary relative to each other.

[0425] For example, Fig.85Five elongated insertion elements 1240a, 1240b, 1240c, 1240d, 1240e are shown for separating and separating three analyte sensors 956e, 956f, 956g. Each insertion element 1240a, 1240b, 1240c, 1240d, 1240e may have an outer diameter smaller than each of the analyte sensors 956e, 956f, 956g. Insertion elements 1240a, 1240b, 1240c, 1240d, 1240e may be arranged in a staggered orientation. Analyte sensors 956e, 956f, 956g may be arranged in a staggered orientation. Analyte sensor 956e may be defined by insertion elements 1240a, 1240b, 1240c. Analyte sensor 956f may be defined by insertion elements 1240b, 1240c, 1240d. Analyte sensor 956g may be defined by insert elements 1240c, 1240d, 1240e. Various other configurations may be used as desired. Insert elements 1240a, 1240b, 1240c, 1240d, 1240e may be configured similarly to insert elements 1200a, 1200b in other respects, and analyte sensors 956e, 956f, 956g may be configured similarly to analyte sensor 956 in other respects.

[0426] Fig.86 An example is shown in which the elongated insertion element 1242 includes a distal tip 1244 that is configured to extend radially over at least a portion of the distal tip 1246 of the elongated analyte sensor 956 (e.g., in the example Fig.86 in the lateral direction as shown). Fig.87 A perspective view of the distal tip 1244 or a proximal surface 1248 of the distal tip 1244 extending above the distal tip 1246 of the elongated analyte sensor 956 is shown.

[0427] The distal tip 1244 can protrude radially outward to have a diameter 1250 that is larger than the diameter 1252 of the shaft 1254 of the elongated insertion element 1242. The distal tip 1244 can extend radially over at least a portion of the distal tip 1246 of the elongated analyte sensor 956 to shield the distal tip 1246 of the elongated analyte sensor when the elongated analyte sensor 956 penetrates into the skin of the host. Thus, the distal tip 1244 can form a tear region distal to the elongated analyte sensor 956 into which the elongated analyte sensor 956 can be inserted.

[0428] Elongated insertion element 1242 can be configured to rotate to displace distal tip 1244 of elongated insertion element 1242 from distal tip 1246 of elongated analyte sensor 956 when elongated insertion element 1242 is retracted. For example, a rotation mechanism 1256 can be provided that can rotate elongated insertion element 1242 and distal tip 1244 to expose a portion of distal tip 1246 of elongated analyte sensor 956.

[0429] In examples, the rotation mechanism 1256 can have a variety of configurations. For example, Fig.86 A helical thread 1258 is shown that can be engaged by a protrusion 1260. The helical thread 1258 can be located on the needle hub 1262 or at another location as desired. The protrusion 1260 can be located on an applicator system for a wearable medical device on the skin or at another location as desired. As the elongated insertion element 1242 is retracted, the rotation mechanism 1256 can produce a rotation of the distal tip 1244 of the elongated insertion element 1242 to expose a portion of the distal tip 1246. Other configurations of the rotation mechanism 1256 (e.g., gears, cams, levers, electrical actuation, etc.) can be utilized as desired.

[0430] Rotation of distal tip 1244 may occur within skin 1227. For example, Fig.88 Elongated insertion element 1242 is shown having penetrated skin 1227 and rotated within skin 1227. Distal tip 1244 is rotated (e.g., 180 degrees or another amount) to expose distal tip 1246 of elongated analyte sensor 956. Distal tip 1244 and elongated insertion element 1242 may then be retracted from skin 1227 while elongated analyte sensor 956 remains in place.

[0431] The elongated insertion element 1242 may otherwise be configured similarly to the insertion element 1200a or any other form of insertion element disclosed herein.

[0432] The elongate insertion element may comprise a needle or may have any other form as desired.

[0433] Features of the examples disclosed herein may be utilized alone or in combination with any system, apparatus, or method disclosed herein.

[0434] The above description presents the best way to implement the present invention, as well as the manner and process of making and using the present invention in full, clear, concise and accurate terms, so that any technician in the field can make and use the present invention. However, the present invention can be modified and alternative constructions that are completely equivalent to the above-mentioned 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 essence and scope of the present invention as generally expressed by the attached claims, and the attached claims specifically 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 will be considered illustrative or exemplary rather than restrictive.

[0435] 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 the specification, the specification is intended to supersede and / or take precedence over any such conflicting material.

[0436] Unless otherwise defined, all terms (including technical and scientific terms) will be given their ordinary and customary meanings to those of ordinary skill in the art and will not 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 redefined herein to be limited to include any specific characteristics of the feature or aspect of the present disclosure associated with the term. Unless expressly stated otherwise, the terms and phrases used in this application and their variations, especially those used in the appended claims, should be interpreted as open-ended and non-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", "having" 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 an illustrative example 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 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 understood to imply 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 specific example of the invention. Likewise, a group of items linked with the conjunction "and" should not be read as requiring each of those items to 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.

[0437] Where a range of values ​​is provided, it should be understood that the upper and lower limits and every intermediate value between the upper and lower limits of that range is encompassed within those examples.

[0438] With regard to the use of substantially any plural term and / or singular term herein, those skilled in the art may appropriately convert from the plural to the singular and / or from the singular to the plural, 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 "a kind" does not exclude a plurality / multiple. A single processor or other unit may implement 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 advantageously used. Any figure marks in the claims should not be understood as limiting the scope.

[0439] 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 a 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 statements. However, the use of such phrases should not be construed to imply that a claim statement introduced by the indefinite article "a" or "an" will include any particular claim of such introduced claim statement to include only one such statement, even when the same claim includes the introductory phrases "one or more" or "at least one" and an indefinite article, such as "a" or "a kind" (e.g., "a" and / or "an" should generally be interpreted as meaning "at least one" or "one or more"); the same is true for the use of definite articles used to introduce claim statements. In addition, even if a specific number of introduced claim statements is explicitly recited, those skilled in the art will recognize that such recitation should generally be interpreted as meaning at least the recited number (e.g., the unmodified recitation "two statements" in the absence of other modifiers generally means at least two statements, or two or more statements). Furthermore, in those cases 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 of the convention as would be understood by one skilled in the art (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 cases 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 of the convention as would be understood by one skilled in the art (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.). One skilled in the art would 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 of the terms, either of the terms, or both of the terms. For example, the phrase "A or B" will be understood to include the possibilities of "A" or "B" or "A and B."

[0440] All numbers used in this specification that represent 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 digits and ordinary rounding methods, rather than attempting to limit the application of the doctrine of equivalents to the scope of any claim.

[0441] In addition, although the foregoing has been described in considerable detail by way of illustration and example for the purposes of clarity and understanding, it is apparent to those skilled in the art that certain changes and modifications may be implemented. Therefore, this specification and examples should not be interpreted as limiting the scope of the present invention to the specific examples described herein, but also encompass all modifications and substitutions that are consistent with the true scope and essence of the present invention.

Claims

1. A medical device system, comprising: a housing configured to be worn on the skin of a host and comprising a distal surface facing the skin and a proximal surface facing opposite the distal surface, the housing comprising an opening through which an insertion element is proximally retracted from the skin; an analyte sensor having a first portion coupled to the housing and a second portion configured to extend distally from the housing and be guided by the insertion element into the skin of the host; as well as A stopper body is configured to prevent the analyte sensor from being proximally retracted through the opening when the insertion member is proximally retracted through the opening. 2 . The medical device system of claim 1 , wherein the analyte sensor includes a bend between the first portion and the second portion, the bend being axially aligned with the opening.

3. The medical device system of claim 1 or claim 2, wherein the second portion is straight and axially aligned with the opening.

4. The medical device system of any one of claims 1 to 3, wherein the plug body is configured to contact the analyte sensor to prevent proximal retraction of the analyte sensor when the insertion element is proximally retracted through the opening.

5. The medical device system of any one of claims 1 to 4, wherein the plug body is positioned proximate to the opening.

6. The medical device system of any one of claims 1 to 5, wherein the plug body includes a tab extending into the opening.

7. The medical device system of claim 6, wherein the first portion of the analyte sensor is positioned within a cavity and the tab extends from the cavity into the opening.

8. The medical device system of any one of claims 1 to 7, wherein the plug body is integral with the housing.

9. The medical device system of any one of claims 1 to 8, wherein the plug body comprises a plug positioned within the opening.

10. The medical device system of claim 9, wherein the plug comprises a gasket.

11. The medical device system of claim 9 or claim 10, wherein the plug has a beveled surface.

12. The medical device system of any one of claims 9 to 11, wherein the plug is pierceable by the insertion element.

13. The medical device system of any one of claims 1 to 12, wherein the plug body is positioned proximal to the analyte sensor.

14. The medical device system of any one of claims 1 to 13, further comprising the insertion element, wherein the insertion element comprises a channel for receiving the analyte sensor.

15. The medical device system of claim 14, wherein the insertion element comprises a needle.

16. The medical device system of claim 15, further comprising a needle hub positioned at a proximal portion of the needle, and wherein the stopper body is positioned between the needle hub and the analyte sensor.

17. The medical device system of any one of claims 14 to 16, wherein the insertion element is positioned within the opening of the housing and extends parallel to the second portion of the analyte sensor.

18. The medical device system of claim 17, wherein the plug body surrounds the insertion element.

19. The medical device system of claim 17 or claim 18, wherein the plug body is in contact with the insertion element.

20. The medical device system of any one of claims 1 to 19, wherein the analyte sensor comprises a transcutaneous analyte sensor.

21. A medical device system, comprising: a housing configured to be worn on the skin of a host and comprising a distal surface facing toward the skin and a proximal surface facing opposite the distal surface; an elongated analyte sensor coupled to the housing and configured to extend distally from the housing and to be positioned in the skin of the host; an elongated insertion element comprising a shaft configured to extend along a portion of the elongated analyte sensor and configured to guide the elongated analyte sensor into the skin of the host; as well as A spacer body is configured to be positioned between and space the portion of the elongated analyte sensor from the shaft.

22. The medical device system of claim 21, wherein the spacer body is removable from between the portion of the elongated analyte sensor and the shaft.

23. The medical device system of claim 22, wherein the spacer body is manually removable from between the portion of the elongated analyte sensor and the shaft.

24. The medical device system of claim 22 or claim 23, further comprising a tether coupled to the spacer body and configured to be pulled to remove the spacer body from between the portion of the elongated analyte sensor and the shaft.

25. The medical device system of claim 24, wherein the tether and the spacer body are formed from a single piece of material.

26. The medical device system of claim 24 or claim 25, wherein the tether comprises a pull tab for a user to pull.

27. The medical device system of any one of claims 21 to 26, wherein the spacer body comprises a sheath surrounding the elongate insertion element.

28. The medical device system of claim 27, wherein the sheath includes a channel in which the elongated analyte sensor is positioned.

29. The medical device system of any one of claims 21 to 28, further comprising a cover covering the distal surface of the housing and coupled to the spacer body.

30. The medical device system of claim 29, further comprising: An applicator housing configured to hold the housing and comprising a proximal end and a distal opening for deploying the housing from the distal opening to the skin, and wherein the covering comprises a cap positioned at the distal opening.

31. The medical device system of claim 30, further comprising a tether coupled to the spacer body and to the cap.

32. The medical device system of claim 31 , wherein removal of the cap pulls on the tether coupled to the spacer body to remove the spacer body from between the portion of the elongated analyte sensor and the shaft.

33. The medical device system according to any one of claims 29 to 32, further comprising: an adhesive patch positioned at the distal surface of the housing, and Wherein the covering comprises a liner covering for the adhesive patch.

34. The medical device system of any one of claims 21 to 33, wherein the spacer body comprises a thermally expandable metal.

35. The medical device system of any one of claims 21 to 34, wherein the elongated insertion element has a first coefficient of thermal expansion and the spacer body has a second coefficient of thermal expansion different than the first coefficient of thermal expansion.

36. The medical device system of any one of claims 21 to 35, wherein the spacer body is compressible.

37. The medical device system of any one of claims 21 to 36, wherein the elongate insertion element comprises a channel for receiving the portion of the elongate analyte sensor.

38. The medical device system of claim 37, wherein the spacer body is removable and configured to be removed to position the portion of the elongated analyte sensor in the channel.

39. The medical device system of any one of claims 21 to 38, wherein the elongate insertion element comprises a needle.

40. The medical device system of claim 39, further comprising a needle hub positioned at a proximal portion of the needle, wherein the septum body is positioned on the needle hub.

41. A medical device system, comprising: a housing configured to be worn on the skin of a host and comprising a distal surface facing toward the skin and a proximal surface facing opposite the distal surface; an elongated analyte sensor coupled to the housing and configured to extend distally from the housing and to be positioned in the skin of the host; an elongated insertion element comprising a shaft configured to extend along a portion of the elongated analyte sensor and to be inserted into the skin to guide the elongated analyte sensor into the skin of the host and configured to be retracted from the skin; as well as A displacement mechanism is configured to displace the portion of the elongate analyte sensor relative to the elongate insertion element to reduce stiction between the elongate analyte sensor and the shaft prior to retraction of the shaft from the skin.

42. The medical device system of claim 41 wherein the displacement mechanism is configured to slide the portion of the elongated analyte sensor relative to the shaft prior to retraction of the shaft from the skin to reduce stiction between the elongated analyte sensor and the shaft.

43. The medical device system of claim 41 or claim 42, further comprising a hub positioned at a proximal portion of the elongated insertion element, and wherein the displacement mechanism comprises a compressible body positioned between the hub and the proximal surface of the housing.

44. The medical device system of any one of claims 41 to 43, wherein the displacement mechanism comprises a compressible body protruding distally from the distal surface of the housing.

45. A medical device system according to any one of claims 41 to 44, wherein the displacement mechanism is configured to vibrate one or more of the portions of the elongated insertion element or the elongated analyte sensor before the shaft is retracted from the skin to reduce viscosity between the elongated analyte sensor and the shaft.

46. ​​The medical device system of any one of claims 41 to 45, further comprising an insertion assembly for inserting the shaft of the elongate insertion element into the skin, wherein the insertion assembly comprises the displacement mechanism.

47. The medical device system of any one of claims 41 to 46, wherein the displacement mechanism comprises a cover covering the distal surface of the housing.

48. The medical device system of claim 47, further comprising: An applicator housing configured to hold the housing and comprising a proximal end and a distal opening for deploying the housing from the distal opening to the skin, and wherein the covering comprises a cap positioned at the distal opening.

49. The medical device system of claim 48 wherein the cap includes a cam surface for applying a force to the housing to displace the portion of the elongated analyte sensor relative to the elongated insertion element.

50. The medical device system of any one of claims 47 to 49, further comprising: an adhesive patch positioned at the distal surface of the housing, and Wherein the covering comprises a liner covering for the adhesive patch.

51. A medical device system, comprising: a housing configured to be worn on the skin of a host and comprising a distal surface facing toward the skin and a proximal surface facing opposite the distal surface; an elongated analyte sensor coupled to the housing and configured to extend distally from the housing and to be positioned in the skin of the host; as well as An elongated insertion element comprising a shaft configured to extend along a portion of the elongated analyte sensor and be inserted into the skin to guide the elongated analyte sensor into the skin of the host, the shaft comprising a surface configured to reduce friction with the portion of the elongated analyte sensor.

52. The medical device system of claim 51 wherein the surface is configured to reduce sticking with the portion of the elongated analyte sensor.

53. The medical device system of claim 51 or claim 52, wherein the surface comprises a surface texture.

54. The medical device system of any one of claims 51 to 53, wherein the surface comprises a surface roughness of 35 root mean square (RMS) micro-inches or greater.

55. The medical device system of any one of claims 51 to 54, wherein the surface comprises one or more of bumps, holes, or grooves.

56. The medical device system of any one of claims 51 to 55, wherein the surface comprises a coating configured to reduce friction with the portion of the elongated analyte sensor.

57. The medical device system of claim 56, wherein the coating comprises a lubricant.

58. The medical device system of claim 56 or claim 57, wherein the coating comprises one or more of plating, dipping, or deposition.

59. The medical device system of any one of claims 56 to 58, wherein the coating comprises a polymer.

60. The medical device system of any one of claims 56-59, wherein the coating comprises a thermal oxide.

61. The medical device system of any one of claims 56-60, wherein the coating comprises an inert material.

62. The medical device system of any one of claims 56-61, wherein the coating is bonded to the shaft.

63. The medical device system of any one of claims 56-62, wherein the coating has a thickness on the shaft of less than 1.5 microns.

64. The medical device system of any one of claims 56 to 63, wherein the coating is cured.

65. The medical device system of any one of claims 56-64, wherein the coating comprises silicone.

66. The medical device system of claim 65, wherein the silicone comprises an amino-functional dimethylsiloxane copolymer.

67. The medical device system of any one of claims 51 to 66, wherein the surface is configured to reduce hydrogen bonding with the portion of the elongated analyte sensor.

68. The medical device system of any one of claims 51 to 67, wherein the elongate insertion element comprises a needle.

69. The medical device system of any one of claims 51 to 68, wherein the elongate insertion element comprises a channel for receiving the portion of the elongate analyte sensor.

70. The medical device system of claim 69, wherein the channel has a C-shaped cross-section.

71. A medical device system, comprising: a housing configured to be worn on the skin of a host and comprising a distal surface facing toward the skin and a proximal surface facing opposite the distal surface; an elongated analyte sensor coupled to the housing and configured to extend distally from the housing and to be positioned in the skin of the host; as well as An elongated insertion element comprising a shaft configured to extend along a portion of the elongated analyte sensor and be inserted into the skin to guide the elongated analyte sensor into the skin of the host, the shaft having a V-shaped or W-shaped cross-sectional channel for receiving the portion of the elongated analyte sensor.

72. The medical device system of claim 71, wherein the V-shaped cross-sectional channel has an angle between 60 degrees and 120 degrees.

73. The medical device system of claim 72, wherein the V-shaped cross-sectional channel has an angle of 90 degrees.

74. The medical device system of any one of claims 71 to 73, wherein the W-shaped cross-sectional channel is formed by an elongated protrusion added to a central portion of an elongated insertion element having a C-shaped cross-sectional channel.

75. The medical device system of any one of claims 71 to 74, wherein an outer surface of the elongated analyte sensor has a circular cross-section.

76. A medical device system, comprising: a housing configured to be worn on the skin of a host and comprising a distal surface facing toward the skin and a proximal surface facing opposite the distal surface; an elongated insertion element comprising a shaft configured to be inserted into the skin; as well as An elongated analyte sensor is coupled to the housing and configured to extend along and be guided into the skin by the elongated insertion element, the elongated analyte sensor including a surface configured to reduce friction with the elongated insertion element.

77. The medical device system of claim 76, wherein the surface is configured to reduce sticking with the elongated analyte sensor.

78. The medical device system of claim 76 or claim 77, wherein the surface is configured to reduce hydrogen bonding with the elongate insertion element.

79. The medical device system of any one of claims 76 to 78, wherein the elongate insertion element comprises a needle.

80. The medical device system of any one of claims 76-79, wherein the elongate insertion element comprises a channel for receiving a portion of the elongate analyte sensor.

81. A medical device system, comprising: a housing configured to be worn on the skin of a host and comprising a distal surface facing toward the skin and a proximal surface facing opposite the distal surface; an elongated insertion element comprising a shaft configured to be inserted into the skin; as well as An elongated analyte sensor is coupled to the housing and is configured to extend along and be guided into the skin by the elongated insertion element, the elongated analyte sensor having an elliptical cross-section.

82. The medical device system of claim 81, wherein an outer surface of the elongate analyte sensor is configured to reduce sticking with the elongate insertion element.

83. The medical device system of claim 81 or claim 82, wherein the elongate insertion element comprises a needle.

84. The medical device system of any one of claims 81 to 83, wherein the elongate insertion element comprises a channel for receiving a portion of the elongate analyte sensor.

85. The medical device system of claim 84, wherein the channel has a C-shaped cross-section.

86. A medical device system, comprising: a housing configured to be worn on the skin of a host and comprising a distal surface facing toward the skin and a proximal surface facing opposite the distal surface; as well as An analyte sensor having a first portion coupled to the housing and a second portion configured to extend distally from the housing and be inserted into the skin of the host, the analyte sensor including a bend having at least two kinks that angle the second portion to the first portion.

87. The medical device system of claim 86, wherein the second portion extends perpendicularly from the distal surface of the housing.

88. The medical device system of claim 86 or claim 87, wherein the first portion extends parallel to the distal surface of the housing.

89. The medical device system of any one of claims 86 to 88, wherein the at least two kinks angle the second portion to be perpendicular to the first portion.

90. The medical device system of any one of claims 86 to 89, wherein the at least two kinks include a first kink and a second kink, the first kink having an angle less than ninety degrees and the second kink having an angle less than ninety degrees.

91. A medical device system, comprising: a housing configured to be worn on the skin of a host and comprising a distal surface facing toward the skin and a proximal surface facing opposite the distal surface; an analyte sensor coupled to the housing and configured to extend distally from the housing and to be positioned in the skin of the host; an insertion element configured to extend along the analyte sensor and guide the analyte sensor into the skin of the host; an insertion assembly configured to drive the insertion element into the skin of the host; as well as A force directing component is configured to direct forces from the insert assembly proximate the insert element.

92. A medical device system according to claim 91, wherein the insertion assembly includes a plate configured to be positioned proximal to the proximal surface, and the force directing component includes one or more protrusions located on the plate configured to direct the force proximate the insertion element.

93. The medical device system of claim 92, wherein the one or more protrusions are configured to apply a force to the proximal surface of the housing proximate the insertion element.

94. A medical device system according to any one of claims 91 to 93, wherein the shell includes an opening for the insertion element to be retracted proximally from the skin through it, and the force directing component is configured to contact the proximal surface of the shell near the opening.

95. The medical device system of any one of claims 91 to 94, wherein the insertion element comprises a needle.

96. A medical device system, comprising: a housing configured to be worn on the skin of a host and comprising a distal surface facing toward the skin and a proximal surface facing opposite the distal surface; an elongated analyte sensor coupled to the housing and configured to extend distally from the housing and to be positioned in the skin of the host, the elongated analyte sensor having a flexural modulus greater than 8 Gigapascals; as well as An elongated insertion member includes a shaft configured to extend along a portion of the elongated analyte sensor and to be inserted into the skin to guide the portion of the elongated analyte sensor into the skin of the host.

97. The medical device system of claim 96, wherein the flexural modulus is greater than 8.4 GPa.

98. A medical device system according to claim 96 or claim 97, wherein the slender analyte sensor includes a first portion connected to the shell and a second portion extending distally from the distal surface of the shell, the second portion having the bending modulus greater than 8 GPa.

99. The medical device system of any one of claims 96-98, wherein the shaft comprises a channel configured to receive the portion of the elongated analyte sensor.

100. The medical device system of any one of claims 96-99, wherein the elongate insertion element comprises a needle.

101. A medical device system, the medical device system comprising: a housing configured to be worn on the skin of a host and comprising a distal surface facing toward the skin and a proximal surface facing opposite the distal surface; an elongated analyte sensor coupled to the housing and configured to extend distally from the housing and to be positioned in the skin of the host; as well as A slender insertion element, the slender insertion element includes a shaft having a channel, a portion of the slender analyte sensor is positioned in the channel, the shaft is configured to be inserted into the skin to guide the portion of the slender analyte sensor into the skin, and the shaft has a diameter gap of at least 0.07 mm with the portion of the slender analyte sensor.

102. The medical device system of claim 101, wherein the diameter gap is at least 0.10 mm.

103. The medical device system of claim 101 or claim 102, wherein the elongated insertion element comprises a needle.

104. The medical device system of any one of claims 101 to 103, wherein the channel has a C-shaped cross-section.

105. The medical device system of any one of claims 101 to 104, wherein the elongated analyte sensor has a first portion coupled to the housing and a second portion extending distally from the distal surface of the housing and positioned within the channel.

106. A medical device system, the medical device system comprising: a housing configured to be worn on the skin of a host and comprising a distal surface facing toward the skin and a proximal surface facing opposite the distal surface; an elongated analyte sensor having a first portion coupled to the housing and a second portion configured to extend distally from the housing and to be positioned in the skin of the host, the second portion having a diameter; as well as an elongated insertion element comprising a shaft having an opening for a channel, the second portion of the elongated analyte sensor being positioned in the channel, the shaft being configured to be inserted into the skin to introduce the second portion into the skin, and the channel having a width at the opening, and wherein a ratio of the diameter to the width is less than 0.

9.

107. A medical device system according to claim 106, wherein the ratio of the diameter to the width is less than 0.

8.

108. A medical device system according to claim 106 or claim 107, wherein the ratio of the diameter to the width is less than 0.

7.

109. The medical device system of any one of claims 106 to 108, wherein the channel has a C-shaped cross-section.

110. A medical device system according to any one of claims 106 to 109, wherein the slender insertion element comprises a needle.

111. A method comprising: Reducing friction between the analyte sensor and the insertion element during or after a sterilization process is performed on the analyte sensor and the insertion element and before the insertion element is retracted from the skin of the host, wherein the insertion element is configured to guide the analyte sensor into the skin of the host and to retract from the skin of the host.

112. The method of claim 111, further comprising vibrating the analyte sensor and the insert element to reduce the friction between the analyte sensor and the insert element.

113. The method of claim 111 or claim 112, further comprising increasing the ambient temperature or decreasing the ambient temperature to reduce the friction between the analyte sensor and the insertion element.

114. The method of any one of claims 111 to 113, further comprising reducing ambient humidity to reduce the friction between the analyte sensor and the insertion element.

115. The method of any one of claims 111 to 114, further comprising packaging the analyte sensor and the insert element with a desiccant.

116. The method of any one of claims 111 to 115, wherein the friction comprises viscosity.

117. A method according to any one of claims 111 to 116, wherein the insertion element comprises an elongated insertion element having an axis configured to be inserted into the skin, and the analyte sensor comprises an elongated analyte sensor having a portion extending along the axis of the elongated insertion element.

118. The method of claim 117, wherein the shaft includes a channel and the portion of the elongated analyte sensor is positioned within the channel.

119. The method of any one of claims 111 to 118, further comprising reducing hydrogen bonding between the analyte sensor and the insertion element.

120. The method of any one of claims 111 to 119, wherein the insertion element comprises a needle.

121. The method of any one of claims 111 to 120, wherein the analyte sensor is coupled to a housing configured to be worn on the skin of a host, the housing comprising an opening through which the insertion element passes.

122. The method of claim 121, wherein the analyte sensor comprises a first portion coupled to the housing and a second portion extending distally from a distal surface of the housing.

123. The method of claim 121 or claim 122, wherein the housing, the analyte sensor, and the insertion element are positioned within an applicator housing.

124. The method of any one of claims 111 to 123, wherein the sterilization process comprises applying a sterilizing gas to the analyte sensor and the insertion element.

125. The method according to any one of claims 111 to 124, wherein the sterilization process comprises an ethylene oxide sterilization process.

126. A method comprising: At least a portion of the shaft of an elongated insertion element is coated with a material, wherein the elongated insertion element is used to guide an elongated analyte sensor into the skin of a host when inserted into the skin, wherein the elongated analyte sensor extends along a portion of the shaft, and the material is configured to reduce friction between the insertion element and the elongated analyte sensor.

127. The method of claim 126, further comprising positioning the elongate insertion element adjacent to the elongate analyte sensor.

128. The method of claim 126 or claim 127, further comprising positioning the elongated analyte sensor within a channel of the elongated insertion element.

129. The method of any one of claims 126 to 128, wherein the elongated analyte sensor extends distally from a housing configured to be worn on the skin of the host.

130. The method of any one of claims 126 to 129, wherein the material is configured to reduce adhesion to the elongated analyte sensor.

131. The method of any one of claims 126 to 130, wherein the coating comprises one or more of plating, dipping, or deposition.

132. The method of any one of claims 126 to 131, wherein the coating is bonded to the shaft.

133. The method of any one of claims 126 to 132, wherein the coating has a thickness on the shaft of less than 1.5 microns.

134. The method of any one of claims 126 to 133, further comprising curing the coating on the shaft.

135. A method according to any one of claims 126 to 134, wherein the coating comprises silicone.

136. The method of claim 135, wherein the silicone comprises an amino-functional dimethylsiloxane copolymer.

137. The method of any one of claims 126 to 136, further comprising positioning the shaft within a solution of the material.

138. The method of claim 137, wherein the solution comprises a solvent.

139. A method according to any one of claims 126 to 138, wherein the coefficient of friction produced by the material on the portion of the shaft is less than one-tenth of the coefficient of friction of the surface of the portion of the shaft coated with the material.

140. The method of any one of claims 126 to 139, wherein the elongate insertion element comprises a needle.

141. A medical device system, the medical device system comprising: a housing configured to be worn on the skin of a host and comprising a distal surface facing toward the skin and a proximal surface facing opposite the distal surface; an elongated analyte sensor coupled to the housing and configured to extend distally from the housing and to be positioned in the skin of the host; as well as One or more elongated insertion elements, each elongated insertion element comprising an axis configured to extend along a portion of the elongated analyte sensor, each of the one or more elongated insertion elements being configured to guide the elongated analyte sensor into the skin of the host, wherein the elongated analyte sensor is positioned outside of the axis of the corresponding elongated insertion element.

142. The medical device system of claim 141, wherein the elongated analyte sensor comprises a central axis, and each of the one or more elongated insertion elements comprises a corresponding central axis, the central axis of the elongated analyte sensor being configured to be parallel to and laterally spaced apart from the corresponding central axis of the one or more elongated insertion elements.

143. A medical device system according to claim 141 or claim 142, wherein at least a portion of each of the one or more slender insertion elements includes a convex outer surface, which is configured to extend parallel to and adjacent to the outer surface of the slender analyte sensor.

144. A medical device system according to any one of claims 141 to 143, wherein each of the one or more slender insertion elements includes an outer surface having a longitudinal extension segment, and the longitudinal extension segment is configured to extend parallel to and adjacent to the outer surface of the slender analyte sensor.

145. The medical device system of any one of claims 141-144, wherein each of the one or more elongated insertion elements is devoid of a channel for retaining an elongated analyte sensor.

146. The medical device system of any one of claims 141 to 145, wherein each of the one or more elongated insertion elements comprises an outer surface configured to contact an outer surface of the elongated analyte sensor in a deployed configuration.

147. The medical device system of any one of claims 141-146, wherein the one or more elongated insertion elements comprises at least two of the elongated insertion elements.

148. The medical device system of claim 147, wherein the at least two elongated insertion elements each comprise an outer surface configured to contact an outer surface of the elongated analyte sensor in a deployed configuration.

149. The medical device system of claim 147 or claim 148, wherein the at least two elongated insertion elements are configured to be positioned on opposite sides of the elongated analyte sensor in a deployed configuration.

150. The medical device system of any one of claims 147-149, wherein the elongate analyte sensor is configured to be positioned between the at least two elongate insertion elements in a deployed configuration.

151. A medical device system according to any one of claims 147 to 150, wherein each of the at least two slender insertion elements includes a proximal end portion and a top end, and further includes a needle seat connected to the corresponding proximal end portion of the at least two slender insertion elements.

152. The medical device system of claim 151, wherein the axes of the corresponding at least two slender insertion elements extend from the proximal end portions to the corresponding top ends, and the top ends of the at least two slender insertion elements are not connected to each other.

153. A medical device system according to any one of claims 147 to 152, wherein the at least two elongated insertion elements include a first elongated insertion element and a second elongated insertion element, the first elongated insertion element having a first outer surface and the second elongated insertion element having a second outer surface, the second outer surface extending parallel to the first outer surface and laterally spaced apart from the first outer surface.

154. A medical device system according to any one of claims 147 to 153, wherein the at least two elongated insertion elements include a first elongated insertion element and a second elongated insertion element, the first elongated insertion element having a first outer surface and the second elongated insertion element having a second outer surface, the second outer surface extending parallel to the first outer surface and in contact with the first outer surface.

155. The medical device system of any one of claims 141-154, wherein the one or more elongated insertion elements comprises at least three of the elongated insertion elements.

156. The medical device system according to any one of claims 141 to 155, wherein the elongated analyte sensor is a first elongated analyte sensor, and further comprising a second elongated analyte sensor coupled to the housing and configured to extend distally from the housing and to be positioned in the skin of the host; and The one or more elongated insertion elements each include an axis configured to extend along a portion of the second elongated analyte sensor, and each of the one or more elongated insertion elements is configured to guide the second elongated analyte sensor into the skin of the host, wherein the second elongated analyte sensor is positioned outside of the axis of the corresponding elongated insertion element.

157. The medical device system of any one of claims 141-156, wherein at least one of the one or more elongated insertion elements has an elliptical cross-section.

158. A medical device system according to any one of claims 141 to 157, wherein the slender analyte sensor includes a distal tip, and the one or more slender insertion elements include a distal tip configured to extend radially above at least a portion of the distal tip of the slender analyte sensor.

159. The medical device system of claim 158, wherein the distal tip of the one or more elongated insertion elements has a diameter that is greater than a diameter of a corresponding shaft of the one or more elongated insertion elements.

160. The medical device system of claim 158 or claim 159, further comprising a rotation mechanism for rotating the distal tip of the one or more elongated insertion elements to expose the portion of the distal tip of the elongated analyte sensor.

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