Applicator for glucose monitor and method for applying glucose monitor

Abstract

A method for applying a portion of a specimen monitor to a patient using an applicator assembly comprises: adhering the portion of the specimen monitor to the application site while the portion of the specimen monitor is connected to the applicator assembly; and operating the applicator assembly to advance a needle carrying at least the detection area of ​​a sensor member toward the desired application site. The applicator assembly is configured to release the connection with the portion of the specimen monitor from the applicator assembly before the tip of the needle reaches the desired application site. After the tip of the needle has punctured the desired application site, the sensor member is configured to remain connected to and held in the portion of the specimen monitor toward the desired application site, and the needle is configured to retract toward the desired application site.

Description

Technical Field

[0001] Cross - reference to related applications This application claims the priority and benefit of U.S. Provisional Patent Application No. 63 / 505,938, filed on June 2, 2023, the content of which is incorporated in its entirety by reference.

[0002] This disclosure relates to applicators and other devices for facilitating the attachment or other application of a monitor to a subject's body, where the monitor is capable of measuring analytes such as glucose within the subject's body. This disclosure further relates to methods of using an applicator for applying a monitor.

Background Art

[0003] Monitoring different analytes within the human body can be utilized for various diagnostic reasons. In particular, monitoring glucose levels is important for individuals suffering from type 1 or type 2 diabetes. People with type 1 diabetes cannot produce insulin or can produce only very small amounts of insulin, while people with type 2 diabetes show resistance to the action of insulin. Insulin is a hormone produced by the pancreas and helps regulate the flow of blood sugar from the bloodstream into cells that can use it as fuel. Without insulin, blood sugar accumulates in the blood, causing various symptoms and complications such as fatigue, frequent infections, cardiovascular disease, nerve damage, kidney damage, eye damage, and other problems. Individuals with type 1 or type 2 diabetes need to monitor their blood sugar levels to avoid these symptoms and complications.

[0004] Specimen monitors, particularly glucose monitors for monitoring glucose levels in the management of diabetes, are constantly being developed and improved. While several platforms exist for monitoring specimens such as glucose, there remains a need to improve their accuracy, ease of use, and accessibility to end users. Furthermore, there is a desire for robust applicator tools that help facilitate easier, less painful, less error-prone, and / or generally more effective application of glucose monitors to the patient's body, especially continuous glucose monitors that can be attached to the patient's body for longer periods, as well as glucose monitoring functions that can be used in conjunction with such improved applicators and applicator designs.

[0005] Many continuous glucose monitors are intended to be worn on a patient's skin for periods of several days or weeks. Most or all commercially available glucose sensors currently on the market detect glucose in the interstitial fluid (ISF) beneath the skin's surface. Therefore, such detection or monitoring typically involves an initial step of inserting the glucose monitor sensor under the patient's skin. For the most part, this insertion step will involve puncturing the skin surface with a needle to provide access for sensor insertion. Applicators will generally provide means for inserting the sensor under the patient's skin via a needle or other means. Furthermore, continuous glucose monitors may have a device body that remains attached to the patient for extended periods. Applicators may also help facilitate proper placement of the monitor body on the patient in a way that ensures the sensor is properly inserted and remains in place for the duration for which the monitor is intended to function. [Overview of the project]

[0006] One or more embodiments of the present disclosure relate to an applicator assembly for applying at least a portion of a sample monitor, the applicator assembly comprising: a housing having a first end, an opposing second end, and a longitudinal axis extending between the first and second ends; an elastic member having at least a first portion having a first portion at least partially positioned within the housing and fixed to the housing, and a second portion movable relative to the housing in a direction substantially parallel to the longitudinal axis; a needle movable with respect to the second portion of the elastic member; and an actuator. When the actuator is actuated, the second portion of the elastic member and the needle are advanced toward the second end of the housing. When the tip of the needle is advanced to a first position axially located between the first and second tips of the housing, the engaging portion is adjusted from a first configuration in which a portion of the sample monitor connected to the applicator assembly is engaged by the engaging portion and held in place by the applicator assembly, to a second configuration in which the engagement between the engaging portion and the portion of the sample monitor is released. The tip of the needle is configured to be advanced further to a second position located axially past the second tip of the housing after the engaging portion has been adjusted to the second configuration and the portion of the sample monitor has been released.

[0007] The engaging portion may have a latch, which may be configured to engage with a portion of the sample monitor in a first configuration and to release the engagement with a portion of the sample monitor in a second configuration.

[0008] The applicator assembly may further include a plunger member configured to adjust the engagement portion from a first configuration to a second configuration. The plunger member may be movable toward a second end of the housing together with a second portion of the elastic member and a needle. When the plunger member, the second portion of the elastic member and the needle are moved toward the second end of the housing, the plunger member can adjust the engagement portion from the first configuration to the second configuration before the tip of the needle reaches the second end of the housing. The plunger member may be configured to bias the second portion of the elastic member and the needle toward the second end of the housing. When the tip of the needle is advanced to a second position, the second portion of the elastic member and the needle may be configured to retract toward the first end of the housing, while the axial position of the plunger member remains the same.

[0009] At least a portion of the second end of the housing may extend substantially in a plane. The longitudinal axis may be positioned at an angle to the plane. This angle may be between 25° and 35°.

[0010] When the actuator is activated, the tip of the needle may be configured to move continuously forward from a first position to a second position.

[0011] The actuator may have a second portion of the elastic member and a contact portion that prevents the needle from advancing before it is activated.

[0012] When a portion of the sample monitor is connected to the applicator assembly, the portion of the sample monitor can be positioned between the actuator and the desired application site so that the actuator's operation presses the portion of the sample monitor against the desired application site.

[0013] A portion of the sample monitor may have a two-part sample monitor stand or base.

[0014] A second portion of the elastic member may be further configured to connect a sensor member, separated from a portion of the sample monitor, to a portion of the sample monitor when the tip of the needle is advanced to a second position. The sensing portion of the sensor member may be configured to be positionable within the needle, so that when the tip of the needle is advanced to the second position, the needle is configured to puncture the patient's skin, and the sensor member may be configured to be delivered together with the needle to a position below the surface of the patient's skin. The needle may be configured to be withdrawn from the patient's skin after the tip of the needle reaches the second position, but the sensing portion of the sensor member may be configured to separate from the needle and remain below the surface of the patient's skin.

[0015] Aspects of one or more embodiments of the present disclosure relate to a method for applying a portion of a specimen monitor to a patient, the method comprising: adhering a portion of the specimen monitor to a desired application site while the portion of the specimen monitor is connected to an applicator assembly; and operating the applicator assembly to advance a needle carrying at least a sensing area of ​​a sensor member toward the desired application site. The applicator assembly is configured to release the connection with the portion of the specimen monitor from the applicator assembly before the tip of the needle reaches the desired application site. The tip of the needle is configured to puncture the desired application site after the connection between the portion of the specimen monitor and the applicator assembly has been released. The sensor member is configured to remain connected to and held at the desired application site by the portion of the specimen monitor, and is configured to retract so that the needle is pulled away from the desired application site.

[0016] The applicator assembly may have a latch configured to engage with a portion of the sample monitor to connect that portion to the applicator assembly. The latch may be configured to disengage from the portion of the sample monitor when the connection between the portion of the sample monitor and the applicator assembly is released. The applicator assembly may further have a plunger member configured to advance with the needle when in operation. The plunger member may be configured to disengage the latch from the portion of the sample monitor before the tip of the needle reaches the desired application site.

[0017] The applicator assembly may be configured to initiate the release of a portion of the sample monitor's connection from the applicator assembly.

[0018] Further features and advantages of the present invention will become apparent from the description of embodiments with reference to the accompanying drawings. [Brief explanation of the drawing]

[0019] [Figure 1A] Figure 1A schematically shows a human body equipped with a monitor containing a sample sensor according to an embodiment of the present invention. The monitor can be mounted at different positions on the body. [Figure 1B] Figure 1B schematically shows a human body equipped with a monitor containing a sample sensor according to an embodiment of the present invention. The monitor can be mounted at different positions on the body. [Figure 2] Figure 2 shows an overhead perspective view of an exemplary monitor equipped with a sample sensor according to an embodiment of the present invention. [Figure 3] Figure 3 is a perspective view of the monitor shown in Figure 2, viewed from below. [Figure 4A] Figure 4A shows an exemplary monitor, for example, a perspective view from above the stand of the monitors in Figures 2 and 3. [Figure 4B] Figure 4B shows an exemplary monitor, for example, a top-down perspective view of the transmitter of the monitors in Figures 2 and 3. [Figure 5] Figure 5 shows a side view of another exemplary monitor equipped with a sample sensor according to an embodiment of the present invention. [Figure 6A] FIG. 6A shows a perspective view from above the base of another exemplary monitor including a specimen sensor, according to an embodiment of the present invention. [Figure 6B] FIG. 6B shows a front view of the base of FIG. 6A. [Figure 6C] FIG. 6C shows a side view of the base of FIGS. 6A and 6B. [Figure 6D] FIG. 6D shows a top view of the base of FIGS. 6A - 6C. [Figure 6E] FIG. 6E shows a cross - sectional view of the base of FIGS. 6A - 6D, the cross - section being taken along the plane A - A shown in FIG. 6D. [Figure 7] FIG. 7 shows a perspective view of an applicator assembly according to a first embodiment in a pre - use transport or similar state by an end - user. [Figure 8A] FIG. 8A shows a cross - sectional view of the applicator assembly of FIG. 7 in a transport state. [Figure 8B] FIG. 8B shows a close - up of a portion of the applicator assembly shown in FIG. 8A. [Figure 9A] FIG. 9A shows a side view of a striker or plunger of an applicator assembly in a non - biased state according to a first embodiment. [Figure 9B] FIG. 9B shows the striker or plunger of FIG. 9A in a biased state. [Figure 10] FIG. 10 shows a needle carrier of an applicator assembly according to a first embodiment. [Figure 11] FIG. 11 shows a cap of an applicator assembly according to a first embodiment. [Figure 12] FIG. 12 shows a cross - sectional view of an applicator assembly according to a first embodiment after the step of cocking or otherwise biasing a striker or plunger. [Figure 13] FIG. 13 shows a cross - sectional view of an applicator assembly according to a first embodiment with the striker or plunger in a biased state and the cap removed. [Figure 14A]Figure 14A shows a cross-sectional view of the applicator assembly according to the first embodiment, with the striker or plunger in a biased state and the button on the applicator assembly pressed. [Figure 14B] Figure 14B shows a cross-sectional view of the applicator assembly according to the first embodiment in the state shown in Figure 14A, which has a cross-sectional view obtained by relatively rotating the cross-sectional view shown in Figure 14A. [Figure 14C] Figure 14C shows a close-up of a portion of the applicator assembly shown in Figure 14B. [Figure 15] Figure 15 shows a cross-sectional view of the applicator assembly according to the first embodiment after the button is pressed, the striker or plunger is released, and the needle of the needle carrier of the applicator assembly is advanced and deployed for insertion into the patient's body. [Figure 16A] Figure 16A shows a cross-sectional view of the applicator assembly according to the first embodiment after the needle has been deployed. The striker or plunger is further advanced to conceal the needle from the outside of the applicator assembly. [Figure 16B] Figure 16B shows a cross-sectional view of the applicator assembly according to the first embodiment in the state shown in Figure 16A. This cross-sectional view is rotated relative to the cross-sectional view shown in Figure 16A. [Figure 17] Figure 17 shows a perspective view of the applicator assembly according to the second embodiment. [Figure 18A] Figure 18A shows a perspective view of an applicator assembly according to a third embodiment, which is in a state of pre-use transport or similar condition by the end user, with the outer housing of the applicator assembly removed to expose the internal components. [Figure 18B] Figure 18B shows a cutaway of the applicator assembly in Figure 18A in its transport state, where the cutout is taken vertically through the applicator assembly. [Figure 18C] Figure 18C shows a cutaway view of the applicator assembly in the transport state as shown in Figures 18A and 18B, with the cut being taken horizontally through the applicator assembly. [Figure 19A]Figure 19A shows a top view of the needle carrier of the applicator assembly shown in Figures 18A-18C, which holds the sensor member for the sample sensor base shown in Figures 6A-6E. [Figure 19B] Figure 19B shows a side view of the needle carrier shown in Figure 19A. [Figure 19C] Figure 19C shows a cross-sectional view of the needle carrier shown in Figures 19A and 19B, where the cross-section is taken along the plane BB shown in Figure 19A. [Figure 19D] Figure 19D shows a magnified view of a portion of the needle carrier having the attached sensor member identified in Figure 19A. [Figure 19E] Figure 19E shows a perspective view of the needle carrier portion to which the sensor component shown in Figure 19D is attached. [Figure 20A] Figure 20A shows an exemplary top view of the needle carrier of the applicator assembly in an unbiased state. [Figure 20B] Figure 20B shows a top view of the needle carrier in the biased state shown in Figure 20A. [Figure 21A] Figure 21A shows a perspective view of the applicator assembly according to the third embodiment in operation, after the mounted base has been released from the applicator assembly, but before the needle carrier of the applicator assembly is inserted into the patient's body. [Figure 21B] Figure 21B shows a cutaway of the applicator assembly in the state shown in Figure 21A, where the cutout is taken vertically through the applicator assembly. [Figure 21C] Figure 21C shows a cutaway view of the applicator assembly in the state shown in Figures 21A and 21B, where the cut was taken horizontally through the applicator assembly. [Figure 22A] Figure 22A shows a perspective view of the applicator assembly according to the third embodiment in operation, after the needle of the needle carrier of the applicator assembly has been inserted into the patient's body. [Figure 22B] Figure 22B shows a cutaway of the applicator assembly in the state shown in Figure 22A, where the cut is taken horizontally through the applicator assembly. [Figure 23A]Figure 23A shows a perspective view of the applicator assembly according to the third embodiment, with the needle at least partially retracted after deployment. [Figure 23B] Figure 23B shows a cutout of the applicator assembly in the state shown in Figure 23A, where the cut is taken horizontally through the applicator assembly. [Figure 24A] Figure 24A shows a perspective view of the applicator assembly according to the third embodiment after the applicator assembly has been detached from the base, with the base attached to the patient's skin and the sensor member inserted into the patient's skin. [Figure 24B] Figure 24B shows a cutaway of the applicator assembly in the state shown in Figure 24A, where the cut is taken perpendicularly through the applicator assembly. [Figure 25A] Figure 25A shows a perspective view of the applicator assembly according to the fourth embodiment, which is in a state of pre-use transport or similar condition by the end user, with the outer housing of the applicator assembly removed to expose the internal components. [Figure 25B] Figure 25B shows a side view of the applicator assembly shown in Figure 25A in its transport state. [Figure 25C] Figure 25C shows a front view of the applicator assembly shown in Figures 25A and 25B in its transport state. [Figure 25D] Figure 25D shows a cross-sectional view of the applicator assembly shown in Figures 25A to 25C in the transport state, with the cross-section taken along the plane CC shown in Figure 25C. [Figure 26] Figure 26 shows a cross-sectional view of the applicator assembly according to the fourth embodiment after the actuator button has been pressed. [Figure 27] Figure 27 shows a cross-sectional view of the applicator assembly according to the fourth embodiment in operation, after the attached base has been released from the applicator assembly, but before the needle carrier of the applicator assembly has been inserted into the patient's body. [Figure 28] Figure 28 shows a cross-sectional view of the applicator assembly according to the fourth embodiment in operation, after the needle of the needle carrier of the applicator assembly has been inserted into the patient's body. [Figure 29] Figure 29 shows a cross-sectional view of the applicator assembly according to the fourth embodiment, with the needle retracted at least partially after deployment. [Figure 30] Figure 30 shows a cross-sectional view of the applicator assembly according to the fourth embodiment after the applicator assembly has been detached from the base. The base is attached to the patient's skin, and the sensor member is inserted into the patient's skin. [Modes for carrying out the invention]

[0020] In the following detailed description, only specific embodiments of the subject matter of this disclosure will be described for illustrative purposes. As will be apparent to those skilled in the art, the subject matter of this disclosure can be embodied in many different forms and should not be construed as being limited to the embodiments described herein.

[0021] Sample sensors, such as glucose monitors, and monitors, including continuous glucose monitors in particular, can be attached to the patient's body in different locations, for example, to improve glucose monitoring and / or patient comfort, because continuous glucose monitors must sometimes remain attached to the patient's skin for several days or more. Figure 1A shows a first exemplary sample monitor 2000 attached to the patient's abdomen, while Figure 1B shows an exemplary sample monitor 2000 attached to the patient's arm instead. These are merely exemplary attachment sites, and in other circumstances, this or a similar sample monitor may be attached to other parts of the patient's body or attached in other ways instead.

[0022] Figures 2 and 3 show various schematic diagrams of an exemplary sample monitor 2000 that can be used as a continuous glucose monitor according to one embodiment of the present invention. The continuous glucose monitor 2000 has a base or stand 2010 which may have an adhesive layer for adhering to the patient's skin, a transmitter 2020 for transmitting data to a location away from the patient, and a sensor member 2030 which may have an integrated sample detection area such as a glucose sensor.

[0023] Figure 4A shows the base or stand 2010 of the monitor 2000. In the illustrated embodiment, the base or stand 2010 is connectable to and detachable from the transmitter 2020, but in other embodiments, the monitor may be a single, integrated, and connected unit. The stand 2010 comprises an adhesive or similar layer 2011 for attaching the stand to the patient's skin. The adhesive layer may have a larger contact area or dimensions compared to the rest of the stand to facilitate a stronger connection to the patient or to last for a longer period, for example, several days or weeks. Other methods of attachment to the patient's skin are also conceivable in the spirit and scope of the invention.

[0024] The base 2010 further comprises a main body 2012 configured to facilitate mounting to the transmitter 2020. In the illustrated example, the base body 2012 is wedge-shaped to match the similar wedge shape of the transmitter 2020, but in other embodiments, both the body and the transmitter may have other shapes. In one area of ​​the body, the base 2010 may further have contacts 2013 to facilitate electrical connection to the transmitter 2020. In the illustrated embodiment, the contacts 2013 are located on one side of the base 2010, but in other embodiments, depending on the specific design and connection characteristics of a particular monitor, the contacts may be located in other areas of the base. The base 2010 may also be provided with a snap-fit ​​or other locking mechanism 2014 to facilitate a robust connection to the transmitter 2020 and reduce or eliminate the occurrence of accidental disconnection.

[0025] Although not shown in Figure 4A due to the angle of the perspective view, the base 2010 may further have a sensor member 2030 as an integrated component. For example, in at least some of the embodiments of the applicator assembly described later, the applicator assembly is configured to attach the base together with the integrated sensor, so that the operation of the applicator assembly not only deploys and properly positions the sensor member under the patient's skin in a single user step, but also adheres the base to the outside of the patient's skin.

[0026] The base or platform may further have at least a portion of electronic circuitry that enables interconnection with other components, such as a transmitter and / or battery.

[0027] Transmitter 2020 may have a main transmitter body 2021. The transmitter body 2021 comprises at least a transmitter and may further have other components such as a circuit board, a memory device, or other components necessary for the transmitter to function properly. Transmitter 2020 may further have a contact 2022 configured to engage with a contact 2013 on a base 2010 to create a closed circuit for monitor 2000 to start up and function properly.

[0028] Like the stand, the transmitter may also have other components, such as batteries. It will be recognized that the specific design of the monitor dictates the placement of different components and determines whether they are found on the stand or on the transmitter. For example, if the batteries are housed in the stand, there is no need to house a second battery in the transmitter.

[0029] As described above, sample monitors of other embodiments may be integrated single-piece monitors. As an example, Figure 5 shows a side view of another exemplary monitor 2100 equipped with a sample sensor according to an embodiment of the present invention. Monitor 2100 is an integrated monitor and has a base 2110 which may have an integrated adhesive layer, a body 2120 which may have some or all of the components described above with respect to the 2000, and a sensor member 2030. More or fewer parts may be required for the proper functioning of the above integrated monitor. For example, an integrated monitor design may not require separate contacts.

[0030] Furthermore, yet another embodiment of the sample monitor may have a different shape and a different configuration of components than those described above. Figures 6A to 6E show a stand 2210 of yet another sample monitor according to an embodiment of the present invention. Although a separate transmitter for the sample monitor is not shown, those skilled in the art will recognize that, correspondingly, any transmitter having contacts shaped to be received within the stand 2210 and configured to be electronically coupled to the contacts described herein may be suitable for use with the stand 2210.

[0031] Similar to the base or platform 2010, the base or platform 2210 has an adhesive or similar layer 2211 for attaching the platform to the patient's skin. The adhesive layer may have a larger contact area or dimensions compared to other parts of the platform for a larger surface area, which facilitates a stronger connection to the patient or lasts for a longer period, for example, several days or weeks. Other methods of attachment to the patient's skin are also conceivable within the spirit and scope of the present invention.

[0032] The base 2210 further comprises a main body 2212 configured to facilitate mounting to a separate transmitter. In this embodiment, the body 2212 is round or circular in shape to accommodate a similar round or circular shape to be transmitted, but in other embodiments, both the body and the transmitter may be other shapes. In some cases, an asymmetrical shape may be preferred over a round or circular shape to facilitate blind connection with the transmitter by the user afterwards (for example, after the base has been attached to the patient's skin on a part of the body that is not visible to the patient or is only partially visible, such as the back of the arm). The body 2212 may have a side wall 2213 and / or other mechanism configured to at least partially accommodate the transmitter when connected, and may further have one or more mounting mechanisms to facilitate holding the transmitter and base together after the components have been connected together. The above-mentioned connection mechanisms may be formed on the side wall 2213, on another part of the body 2212, on another part of the base 2210, or on any combination thereof.

[0033] In this embodiment, the base 2210 further comprises a sensor housing 2214 for housing a separate sensor member 2230. The shapes of the housing 2214 and the sensor member 2230, respectively, may be complementary to provide at least a partial form-fit connection between the parts when assembled. In an exemplary embodiment of the present invention, the applicator assembly can automatically connect the base 2210 with the sensor member 2230 when the base is applied to the patient's skin, at which point the specimen sensor 2231 of the sensor member is positioned beneath the surface of the patient's skin. In this case, as will be described in detail below, the base 2210 retains the proper position of the specimen sensor 2231 after deployment. As best seen in Figures 6A, 6D, and 6E, in this embodiment, the housing 2214 may have a rear opening large enough to facilitate the insertion of the sensor member 2230 through therein, a front opening configured to expose the contacts 2232 of the sensor member 2230 when the sensor member is fully inserted into the housing 2214, and a bottom opening configured to facilitate the passage of the specimen sensor 2231 through therein into the patient's skin. The housing 2214 may further have a latch 2216 or other retaining mechanism (as best seen in Figure 6E) which engages with a corresponding recess or other engaging surface 2234 on the sensor member 2230 to hold the sensor member 2230 in place after insertion and to prevent the sensor member 2230 from separating from the base 2210 through the rear opening of the housing 2214. In some embodiments, two or more of the several openings described may communicate with each other, in other words, may be formed as two parts of a continuous opening, or otherwise may be arranged to facilitate the functions described herein. In some embodiments, the outer, side, and / or inner surfaces of the housing 2214 may be shaped to facilitate mounting with at least a portion of the applicator assembly in order to provide further stability during transport and / or deployment of the platform onto the wearer's skin.

[0034] The base 2210 may further have a shelf 2215 or other protrusions, recesses, or other mounting mechanisms configured to hold the base 2210 to the applicator assembly before deployment. In this embodiment, the shelf 2215 defines a recess beneath it, facilitating a latching connection to the applicator assembly, as will be described in more detail below. However, any other mounting mechanism is feasible as long as proper attachment to the applicator assembly is achievable and can be released via the mechanisms and methods described below.

[0035] As described above, the sensor member 2230 comprises a specimen sensor 2231 and one or more communicating electrical contacts 2232 configured to facilitate signal delivery from the sensor 2231 to a processor housed in a separate component, for example, a separate transmitter configured to be connected to a base 2210. As seen in Figures 6A-6E, the connection between the base 2210 and the sensor member 2230 is made by advancing the sensor member 2230 diagonally into the rear opening of the housing 2214, and the sensor member 2230 is then snapped into place in the housing 2214. This allows for angled delivery of the specimen sensor 2231 into the patient, and in the illustrated embodiment, the angle can be between 25° and 35°, or more broadly between 20° and 40°. However, in other embodiments, the specimen sensor may be delivered subcutaneously in a linear or perpendicular orientation to the surface of the patient's skin and / or at an angle smaller or larger than the angles shown in the described embodiment or embodiment.

[0036] In some embodiments, either the base 2210 or the sensor member 2230 may house an additional battery (not shown), in which case a separate battery may be unnecessary within the transmitter configured to connect to the base. Wherever the main battery is housed in the sample sensor, the electrical connections between the components can be configured to facilitate the supply of power to all electrical components after the components are connected to each other. The battery location can be selected to be most beneficial based on the design of each embodiment and its respective purpose.

[0037] As described above, in some embodiments, an applicator assembly is provided for attaching either the base or the entire monitor to the patient's skin, and the applicator assembly can properly insert and position the sensor member under the patient's skin, and properly and securely adhere the base or monitor body to the outer surface of the patient's skin. Preferably, the placement of both the sensor member and the base or monitor body can be achieved together through a single action by the user, for example, by operating a button on the applicator assembly.

[0038] Generally, an applicator assembly having a needle deployment section for facilitating placement of a sensor component under the skin includes an integrated sharpness protection mechanism, which further shields the needle from the outside of the applicator assembly to avoid injury caused by the needle being exposed to the outside of the applicator assembly when the needle is retracted or otherwise deployed.

[0039] Applicator assemblies of the first embodiment are shown in Figures 7 to 16B. The applicator assembly 100 according to the first embodiment may be a molded spring applicator, and the internal spring mechanism and / or other parts of the applicator assembly may be injection molded or otherwise molded. The applicator assembly comprises a body or frame 110, a button 120, a cap 130, a plunger or striker 140, and a needle carrier 150. More or fewer parts may be included in other embodiments, depending on their particular design. Figures 7 to 8B show the applicator assembly 100 in its initial transport or storage state. Here, the applicator assembly is generally transported as a sterile assembly, and elastomers or other sterile barriers, which may be found on the cap or frame, help to facilitate keeping the assembly sterile. In some examples, plastic-on-plastic engagement or engagements other than elastomer engagement can be used to save costs, but may be slower or more difficult to manufacture. Other types of barriers may also be used. The applicator assembly 100 can be transported further in its initial transport condition in sterile packaging.

[0040] In the illustrated embodiment, the applicator assembly 100 in its initial transport state has a length of approximately 6 cm and an outer diameter of approximately 6 cm with the cap attached. In other embodiments, the dimensions and shape of the applicator assembly may be larger or smaller and / or have a different shape, at least in part, based on the dimensions and shape of the attachment device (e.g., a stand or integrated monitor) to be applied to the patient.

[0041] Figures 9A and 9B show the striker or plunger 140 of the applicator assembly 100 according to the first embodiment. The plunger 140 forms the main elastic member for the applicator assembly. The plunger 140 has a central section 141 which may be sized and shaped to house the needle carrier 150 in an axially movable state. For example, if the needle carrier has a substantially cylindrical or similar shape with a circular cross-section, the central section 141 of the plunger 140 may similarly be substantially cylindrical or conical, for example. The plunger 140 may further have at least one elastic part, such as a spring 142, to facilitate the movement of the plunger 140 within the frame 110. In this embodiment, the spring 142 is integrally formed with the rest of the plunger 140 and extends circumferentially around the plunger 140 to a free end 143 which has mounting means configured to attach to the frame 110. In the illustrated embodiment, the spring is formed, for example, by injection molding, but may be formed by any other preferred method. Furthermore, the spring 142 is formed integrally with the rest of the plunger 140, but in other embodiments, it may be a separate part connectable to the rest of the plunger 140. Here, the embodiment comprises three springs, each extending slightly to less than 120° around the circumference of the plunger 140, so that together the three springs extend around substantially the entire circumference of the plunger 140. In other embodiments, more or fewer springs may be included, based on the desired strength and movement of the plunger 140 relative to the frame 110, in order to effectively deploy the needle and / or other components for delivering the mounting device. In yet another embodiment, other forwarding mechanisms other than springs may also be used. At the end of the spring 142 opposite the free end 143, the plunger 140 includes an engaging portion 144 configured to move along the inclined surface of the cap 130 to bias the spring, as will be described in more detail below.

[0042] Figure 9A shows the plunger 140 in an unbiased state, where the spring 142 is not biased. Figure 9B shows the plunger 140 in a biased or fully cocked state, where a preload is applied, for example, to the body of the plunger 140, and the end 143 of the spring 142 is held in a predetermined position, resulting in the spring 142 being biased axially.

[0043] A latch 145 may be provided at or near the upper end of the plunger 140, and this latch may be flexible, for example, to flex radially inward. Furthermore, as labeled in Figure 8A, the bottom surface 146 of the plunger 140 may be sized and shaped to effectively receive and hold a mounting device, such as a stand for a continuous glucose monitor, and the downward advance of the plunger 140 similarly results in the downward advance of the mounting device until the mounting device contacts the patient's skin. In the case of a mounting device with adhesive, the adhesive will attach and retain the mounting device on the patient's skin, but the applicator assembly can be detached and removed from the mounting device. As best shown in Figure 13, the bottom of the plunger 140 may also form an inner shelf 147, which restricts the downward or distal movement of the needle carrier 150 relative to the plunger 140 so that when the needle carrier 150 contacts the shelf 147, the needle 151 can extend over a desired distance from the bottom of the rest of the applicator assembly 100. In some embodiments, the plunger 140 may further have additional mechanisms such as a latch 148 (see, e.g., Figure 8B) and a post 149 (see, e.g., Figure 14C), which help to facilitate the operation of the applicator assembly 100 and are described in more detail below.

[0044] A needle carrier 150 of an applicator assembly 100 according to a first embodiment is shown in Figure 10. The needle carrier 150 comprises a needle 151 that can be attached to a body 152. The carrier body in this embodiment may have a substantially circular shape, with a stop or contact portion 153 formed on one side of an axially extending wall at its end. The wall of the needle carrier may further be flexible, for example, radially inward and / or outward, so that the stop 153 is radially movable depending on the stroke position. The needle carrier should not be limited to the disclosed embodiment, and other needle carrier configurations may be used instead, depending on the overall design of the applicator assembly.

[0045] A cap 130 of the applicator assembly 100 according to the first embodiment is shown in Figure 11. The cap 130 has a circular track extending around the internal chamber of the cap. The circular track may have a shelf portion 131 and an inclined surface 132, the shelf portion 131 extending parallel to the bottom surface of the cap 130, and the inclined surface 132 extending inclined from the shelf portion 131 toward the opening of the cap. In this embodiment, there are three shelf portions 131 and three inclined surfaces 132 corresponding to the three springs 142 of the plunger 140. However, in other embodiments, depending on the design of the applicator assembly, in particular based on the arrangement of the springs included in the applicator assembly, more or fewer shelf portions and / or inclined surfaces may be included. The cap 130 may further have a projection 133 or other form of engagement mechanism configured to engage with a corresponding engagement mechanism (not shown) on the frame. For example, in this embodiment, the projection 133 on the cap 130 is rectangular in shape, and the cap 130 may have three similar projections 133 equidistant around the cap, for example, at 120° intervals. The frame may have a suspended thread or raceway, for example, a raceway extending at an angle slightly less than 120°, thereby allowing the cap 130 to disengage from the frame 110 by rotating the cap 130 relative to the frame 110 over the length of the raceway. In other embodiments, the suspended thread or raceway may be provided on the cap, and projections similar to those shown on the cap in this embodiment may be provided on the frame instead. In other embodiments, the raceway may be inclined to facilitate rotations greater than 120°, even if the three projections require a 150° rotation to disengage, or otherwise arranged. Alternatively, any other arrangement may be used that allows the cap to disengage from the frame with a rotation of less than 360° of the cap. By allowing the cap to be removed from the frame with less than a full 360° rotation, relative movement between parts is minimized or reduced, which is beneficial in simplifying removal for the end user.In addition, as detailed below, the design of the inclined surface 132 may require separation without excessive rotation, which could make a complete 360° rotation of the cap difficult.

[0046] During manufacturing, the cap 130 may be designed as a push-to-connect part, for example, so that the cap 130 and / or the frame 110 are slightly flexible and / or so that several parts can be easily connected together via a unidirectional inclined surface incorporated into the structure of the part. However, axial disconnection of parts may be undesirable in order to ensure proper operation of the device and, for example, to prevent user error. Therefore, in this embodiment, the cap 130 should only be able to be detached from the frame 110 by rotation of the cap 130 relative to the frame 110. In another assembly method, these parts may simply be assembled in the same way that they are intended to be disassembled. For example, in an embodiment where the removal of this cap requires a rotation of the cap 130 of about 120° relative to the frame 110, the assembly may simply require a simple bayonet action, where the assembly is completed by rapid engagement and rotation between the parts. In yet another embodiment, other connection mechanisms may be utilized.

[0047] Referring again to Figures 7-8B, in the initial transport or storage state, the spring 142 may not be fully biased, or may be only slightly biased. A slight preload from the time of manufacture may be desirable unless there is a load sufficient to cause creep in the part. In addition, referring specifically to Figure 8B, a slight preload on the spring 142 may ensure that the plunger 140 is positioned slightly higher axially relative to the frame 110, which may prevent the latch 148 from unintentionally engaging with the shelf 116 on the frame 110. The latch 148 is intended to engage with the shelf 116 after the applicator assembly is launched in order to act as a lock to prevent the plunger 140 from retracting back into the frame 110, and the plunger 140 may be used as a sharpness guard, as will be described in detail below. In some embodiments, an undercut may be included to house the latch 148 in the transport state in order to prevent preload from acting on the latch 148. In other embodiments, the spring can be biased or preloaded more heavily during manufacturing so that it is fully biased, for example, in a "ready to fire" state.

[0048] As mentioned above, a sterile barrier may be formed between the cap and the frame to seal and keep the inside of the applicator assembly sterile. Furthermore, a similar seal may be formed between the button and the frame for the same purpose. In addition, the cap or another part of the assembly may have a safety mechanism to prevent the button from being accidentally fired before the attachment device is ready to be deployed.

[0049] Figures 12 and 13 show the applicator assembly 100 in a ready-to-fire state. As is best seen in Figures 8A and 8B, before cocking the applicator assembly, the engaging portion 144 of the plunger 140 rests on the shelf portion 131 of the cap 130. Next, referring to Figures 11 and 12, by unscrewing or otherwise rotating the cap 130 relative to the frame 110, the engaging portion 144 of the plunger moves upward on the inclined surface 132, for example, in the proximal direction toward the button 120, while the end 143 of the spring 142 is held in the same axial position relative to the frame 110 by the engaging portion 113 (see, for example, Figure 14B). This biases the spring 142 in the manner shown in Figure 9B, resulting in the base of the plunger 140 being held in a higher position as shown in Figure 11. The plunger 140 is moved upward until the latch 145 snaps into place on the shelf 111 of the frame 110, or engages in another way, holding the body of the plunger 140 in this high cocked position. Simultaneously, the needle carrier 150 is also moved upward along with the body of the plunger 140 via engagement on the shelf 147. In the fully cocked position shown in Figures 12 and 13, the free end of the needle is recessed axially from the lower or distal end of the frame 110 so that the needle does not extend axially from the applicator assembly 100 until the button 120 is pressed. The rotation of the cap until the plunger 140 is in the fully cocked position can coincide with the projection 133 of the cap 130 that aligns with the opening on the track of the frame 110, allowing the cap 130 to be removed from the rest of the applicator assembly 100 only when the plunger 140 is fully cocked and the latch 145 is snapped into place. After the removal of the cap 130, the applicator assembly becomes ready for application of the attached mounting device (not shown), as shown in Figure 13.

[0050] Loading (applying a load to) the applicator assembly 100 via rotary cocking offers several advantages to the pre-loaded spring. For example, prolonged storage of a plastic spring in a cocked state can degrade it, as cold flow and creep can negatively affect its performance. By having the user cock the spring while removing the sterile barrier cap, the risk of cold flow is eliminated, as the plastic firing spring is only cocked at the time of use. Furthermore, integrating the spring cocking into the partition removal step makes the cocking process invisible to the user and may also provide mechanical advantages in achieving a higher cocking force for faster needle insertion.

[0051] The steps for launching the applicator assembly 100 are shown in Figures 14A to 16B. The operation or launch of the applicator assembly 100 is designed as a single-step process for the end user, for example, by pressing a button 120 on the frame 110. In practice, after removing the cap 130, the user places the applicator assembly 100 in the desired mounting position on the base or other attachment device, with its open end facing the skin. Once the desired deployment position is selected, the button 120 is pressed down toward the skin, resulting in both the launch of the applicator assembly 100 to position the attachment device on the skin, the launch to position the sensor below the surface of the skin, and subsequently the deployment of the sharp edge guard to retract the needle 151 and / or otherwise conceal it for safety purposes.

[0052] Referring first to Figures 14A-14C, when button 120 is pressed, the post 122 of button 120 is moved downward relative to the frame 110 until it engages with the latch 145 of plunger 140. The bottom surface of post 122 can push the latch 145 radially inward, causing the latch 145 to disengage from the shelf 111 of frame 110. One or both of the top of the latch 145 and / or the bottom of post 122 can be tapered or inclined to facilitate the radially inward movement of the latch 145. Button 120 itself can move downward by a small fixed axial distance, and another latch, for example, latch 121 on button 120, can engage with the shelf 112 of frame 110 to hold button 120 in its lower, depressed position, ensuring the deployment of plunger 140. In some embodiments, the engagement of a latch(s) 121 with the shelf 112 may produce an audible or tactile clicking sound to indicate to the user that the button has been successfully pressed. In some embodiments, the latches 121 may be longer or shorter, and their number and dimensions may differ from, for example, those shown in the figure, depending on the specific design of the applicator assembly.

[0053] When the latch 145 of the plunger 140 is biased inward and disengaged from the shelf 111 of the frame 110, the body of the plunger 140 is no longer held in the upper position, and the biasing of the spring 142 plays a role in biasing the body of the plunger 140 downward. Furthermore, the downward movement of the plunger 140 will result in downward movement of the mounting device or other measuring instrument connected to the bottom surface 146 of the plunger 140 toward the user's skin. As is best seen in Figures 14B and 14C, the needle carrier 150 with the needle 151 is also biased downward along with the plunger 140. The wall of the needle carrier 150 with the latch 153 is prevented from flexing radially inward by the post 114 on the frame 110 and an additional post 149 on the plunger pushing down the top of the latch 153, and as a result, the plunger 140 and the needle carrier 150 are translated downward together toward the user's skin. Because of the presence of post 114, even if the upper surface of latch 153 is inclined, post 114 prevents the inward movement of latch 153 to escape the downward force of post 149, so the downward pressure applied by post 149 of plunger 140 will result in the downward movement of needle carrier 150.

[0054] In Figure 15, the needle carrier 150 has reached its lowest position during the deployment process. At this position, the bottom surface 146 of the plunger 140 biases the attachment device or other measuring instrument against the user's skin, while the needle 151 and any loaded sensor member are pushed through the skin to a desired position below the surface of the skin. The length of the needle 151 varies depending on the dimensions and configuration of the applicator assembly, the desired depth and positioning of the sensor member, and the dimensions and shape of the attachment device or other measuring instrument, such as the shape of the stand on which the sensor member is delivered, and how the measuring instrument is loaded and held by the applicator assembly. In the illustrated embodiment, the needle is inserted into the skin perpendicular to the user's skin surface. In some other embodiments described later, the needle may be inserted into the user's skin at an angle to the surface of the skin. Here, the engagement of the latch 153 on the needle carrier 150 with the shelf portion 115 of the frame 110 prevents the needle carrier from moving further downward. At this height, the walls of the needle carrier 150 can also be clear in the axial direction of the post 114, which would allow the walls to flex slightly inward to allow the posts 149 of the plunger 140 to pass through them. This would allow the plunger 140 to continue moving downward relative to the frame 110 while the axial position of the needle carrier 150 relative to the frame 110 remains the same.

[0055] After the downward movement of the needle carrier 150 relative to the frame 110 ceases, the biasing force of the spring 142 will continue to apply a downward force to the plunger 140 relative to the frame 110 and needle 151, even without further user input. Since the bottom surface 146 of the plunger 140 is already pressed against the user's skin or a measuring instrument held against the user's skin, further movement of the plunger 140 relative to the frame 110 will cause the frame 110 and needle 151 to be pushed away from the user's skin, effectively withdrawing the needle from the user's body. Furthermore, as the needle 151 is retracted axially relative to the plunger 140, when the plunger 140 is fully advanced relative to the frame 110 and needle 151, as shown in Figures 16A and 16B, the body of the plunger 140 acts as a sharp edge guard covering or surrounding the needle 151. In this position, the needle 151 is safely housed within the plunger 140 after deployment. Here, the spring 142 can return to or near their unbiased state so that the plunger 140 does not move back into the frame 110, and the latch 148 snaps into place under the shelf 116 at or near the lower end of the frame 116, or engages in other ways. Since the positions of both the plunger 140 and the needle 151 are fixed relative to the frame 110 in this final position, the needle 151 is prevented from being exposed to the outside of the applicator assembly. Here, the cap 130 can be replaced to cover the bottom of the applicator assembly for further protection and disposal.

[0056] A second embodiment of the applicator assembly is shown in Figure 17. The parts, components, and operations of the second embodiment of the applicator assembly are similar to those of the first embodiment and are not repeated.

[0057] Rather than deploying the needle perpendicular to the surface of the patient's skin, the applicator assembly 200 of the second embodiment is configured to deploy the needle at an angle to the patient's skin. The applicator assembly 200 in the second embodiment may have an engagement surface 201 with one or more connecting mechanisms or means for connecting and holding a sample monitor or a portion of a sample monitor, such as a stand 2210, which is discussed in relation to Figures 6A to 6E, before deployment. The applicator assembly 200 may further have an angled main housing 202 that houses various parts for deploying the needle and various parts for removing the stand 2210 from there. Similarly, as described above, preferred angle arrangements of the housing may allow needle deployment at an angle of 25° to 35° relative to the surface of the skin, more broadly at an angle of 20° to 40° relative to the surface of the skin, or at any of various other angles based on the requirements of the sensor to be deployed, among other factors.

[0058] To facilitate angled deployment, the internal components of the applicator assembly 200 can be arranged at a certain angle, and the applicator assembly 100 according to the first embodiment may have all or part of the mechanisms described above, and may have further internal components and mechanisms to facilitate angled movement.

[0059] Although not depicted in this embodiment, the applicator assembly further includes a button or other actuator for initiating deployment. Upon activation of the actuator, the needle assembly launches to facilitate the implantation of the specimen sensor at the desired depth and angle, and in some embodiments, further retracts in a single step to remove the needle from the patient while the base and specimen sensor remain in place relative to the patient.

[0060] Furthermore, the applicator assembly 200 may also have a bottom engagement surface 203 configured to rest on the patient's skin. The bottom engagement surface 203 can be positioned at a desired deployment angle relative to the main housing 202, which helps to facilitate positioning the applicator assembly 200 at the appropriate angle during operation or deployment, for example, when the entire engagement surface 203 or at least a large portion of the engagement surface 203 is properly pressed against the user's skin before deployment. To achieve this effect, it is preferable that the engagement surface 203 be formed relatively large relative to the rest of the applicator assembly 200, as shown in the figure. In other embodiments, the engagement surface may be formed larger or smaller than shown, or may be omitted entirely to facilitate proper angleing of the applicator assembly by the patient, if another mechanism is included.

[0061] The bottom engagement surface 203 may further have one or more high-friction elements 204, such as added textures or beads made of high-friction material, to ensure that the applicator assembly 200 is held more stably in place and does not slip around, once it is firmly held against the user's skin. This may improve the usability of applicator assemblies with angled or steep insertion angles, and the force from the launch may otherwise help to shift the applicator assembly during the application of a given measuring instrument. Other friction elements and / or mechanisms may also be implemented in other embodiments having similar results. In one embodiment, the high-friction surface 204 may further assist in pulling the skin at the insertion site or gathering the skin upward as the user slides the applicator assembly as part of the applicator processing or workflow. In another embodiment, the user may slide the applicator and create surface tension on the high-friction surface, which can overcome the spring force that releases the actuator and deploys the sensor, for example, instead of a button as discussed in the above embodiments. In further embodiments, other implementations of high-friction surfaces can also be utilized.

[0062] The applicator assembly of the third embodiment is shown in Figures 18A to 24B. The parts, components, and operations of the third embodiment of the applicator assembly are similar to those of the first and second embodiments and are not repeated. Here, the applicator assembly 300 according to the third embodiment is presented with the housing of the applicator assembly removed or omitted in order to more clearly visualize and discuss the internal components of the applicator assembly. As can be seen from the drawings, the applicator assembly 300 according to the third embodiment is configured to deploy a needle and insert a specimen sensor into the patient's skin at an angle of, for example, 25° to 35° to the surface of the skin, or at any other angle as appropriate. The internal components of the applicator assembly 300 can be housed in a housing 210, for example, with respect to the applicator assembly 200 of the second embodiment, but can be housed in the housing of another applicator assembly, as long as the selected housing is configured to match the deployment angle of the internal components. In addition to the omission of the housing, actuators or triggers for initiating and starting the deployment of the applicator assembly 300 are not shown. It should be understood that, without departing from the spirit or scope of the present invention, buttons or triggers, or any other type of actuator, can be integrated into the design as described above. One of the above actuators is further illustrated in Figures 25A-30 and in the applicator assembly of the fourth embodiment, which will be described in detail later.

[0063] Figures 18A-18C show the internal components of the actuator assembly 300 in its initial state, for example, in transport or when the actuator assembly is cocked and ready for firing / deployment. As can be seen from the figures, the body or stand 2210 of the specimen monitor, or any other suitable stand or entire specimen monitor, as discussed with reference to Figures 6A-6E, can be packaged together with the actuator assembly 300, or, for example in some cases, can be manually attached by the user before deployment.

[0064] Referring to Figures 18A to 18C, the actuator assembly 300 has a first distal fixing portion 310 whose position is fixed to the housing, and a second proximal fixing portion 320 whose position is fixed to the housing. In some embodiments where the first fixing portion 310 and the second fixing portion 320 are spaced apart from each other, an additional support post 330 can extend between the first fixing portion 310 and the second fixing portion 320 to help maintain a constant structure of the applicator assembly 300.

[0065] A more detailed examination of the first distal fixation portion 310 reveals that the first fixation portion has a first engagement portion 311 configured to engage with the base 2210, another suitable base, or the entire specimen monitor intended to be applied to the patient's skin. In the illustrated embodiment, the first engagement portion 311 comprises at least a rounded area configured to occupy at least a portion of the internal space of the base 2210 to minimize or eliminate movement between the parts when connected. The first engagement portion 311 may further have one or more connecting means to connect to the frame of the base 2210, or more specifically, to a portion of the housing 2214 for the sensor member 2230, for example, its outer surface. The first engagement portion 311 may further be attached to or stabilized against the base 2210 by any of a variety of other methods. The first fixing portion 310 may further have a recess or other portion 312 configured to connect to a latch 370 or a spring 374 or other biasing mechanism of another connecting member, which is configured to removably hold the base 2210 to the applicator assembly 300. In the illustrated embodiment, the connector 312 is formed by a bore into which the spring 374 extends and is fixed. In embodiments having a support post 330, the first fixing portion 310 may further have a region 313 for connection to the support post 330. In the illustrated embodiment, this region is a series of recesses into which the support post extends. The first fixing portion 310 and the support post may be fixed to each other by means of, for example, glue or other adhesive, threading, interference fit, or any other suitable method. Furthermore, an angled bore 314 extends through the first fixing portion. This angled bore is sized and configured to facilitate passage between the sensor member 2230 and at least a portion of the delivery component, for example, the distal portion 354 of the needle carrier 350 configured to hold the sensor member 2230 and deliver it to the base 2210.

[0066] The second proximal fixing portion 320 can be positioned as a proximal end plate, or in some embodiments may have further mechanisms. The second fixing portion 320 can act as a sealing or other closing function that engages with the housing to prevent access to the internal components of the applicator assembly 300. In the illustrated embodiment, the second proximal fixing portion 320 has at least a contact surface 321 to which the support post 330, the spring 345 of the plunger member 340, or both, and / or further components can abut. The second fixing portion 320 may further have mounting means for fixing, for example, the proximal end of the support post 330, the proximal end of the spring 345, or both, as will be described in more detail below, thereby providing a fixing point that facilitates structural stability with the support post 330 and / or extends the spring 345. The second fixing portion 320 may further have a mounting mechanism, such as a shelf portion 322, for engaging with and holding the proximal end 351 of the needle carrier 350 fixed to the housing of the applicator assembly 300. In other embodiments, attachment of a portion of the needle carrier 350 to the second fixing portion 320 or to another portion of the applicator assembly 300 may be achieved by other means.

[0067] The applicator assembly may further include a plunger member 340. The plunger member 340 is movable relative to the housing and the fixed portion of the applicator assembly 340, and in particular, is axially movable along the deployment axis of the needle 360. In this embodiment, the plunger member 340 is a solid member, but in other embodiments it may be flexible and / or otherwise operable. The plunger member 340 includes a plunger or post 341, several wing portions 342 configured to engage with the needle carrier 350, and a spring 345 or other biasing member configured to launch the plunger member 340 distal to the fixed portion of the applicator assembly 300, or otherwise deploy it. The post 341 may be an elongated member extending substantially parallel to the deployment axis of the needle 360 ​​and axially aligned along the extension axis with respect to the latch 370. These wing portions 342 are configured to engage with and push at least a portion of the needle carrier 350, as will be described in more detail below. These wing portions 342 define a central bore 343 between them and can accommodate at least a portion of the needle carrier 350, for example, a portion of the proximal end 351 so that the proximal end 351 can engage with a second fixed portion 320, and may further include a contact surface 344 configured to contact an outer tab 353 on the needle carrier 350 and push and / or advance a portion of the needle carrier 350 in other ways, as will be described in more detail below. The spring 345 may be biased and compressed during transport so that energy is stored in the spring 345 before operation, and the spring 345 may play a role in launching or firing the plunger member 340 in a generally distal direction when the catch is released via the operation of a button, trigger, or other actuation mechanism. The proximal end of the spring 345 can be fixed to the second fixed portion 320, and as a result, the distal end of the spring 345 is configured to push the plunger member 340 distally when the spring 345 expands from its compressed state. Other embodiments may have other forward mechanisms instead of a spring, such as a push rod, and such embodiments may operate similarly.

[0068] The needle hub or needle carrier 350 will now be described in more detail with reference to Figures 18A to 20B. The needle carrier 350 comprises a fixed or fixed proximal portion 351, the proximal portion having a tab or other engaging means for engaging with a fixed second portion 320 or another fixed portion of the applicator assembly 300. In the illustrated embodiment, the tab of the proximal portion 351 extends into the second portion 320 and snaps into place, thereby configuring the needle carrier 350 to extend axially as the distal portion of the needle carrier 350 moves distally, and the axial length of the needle carrier 350 increases accordingly. The needle carrier further comprises an elastic arm 352, one end of which is connected to the proximal portion 351 and the other end of which is movable and connected to a distal main body 354. The elastic arm 352 is positioned to bias the axial ends 351 and 354 of the needle carrier 350 back together if they are pulled apart by, for example, an external force. In other words, when the body 354 of the needle carrier 350 is pulled axially away from the proximal end 351, the elastic arm 352 is configured to be pulled axially, biased radially inward, and then return to its original shape so as to effectively bias the body 354 toward the proximal end 351 (see, for example, Figures 20A and 20B). In this way, the needle carrier 350 can be considered to be configured similarly to a rivet member. To further facilitate snapback, the needle carrier 350 may further have an integrated spring 356 or other biasing member to pull the main body 354 toward the proximal end 351 after deployment. In the illustrated embodiment, the spring 356 is directly connected between the portion 351 and the portion 354, and when stretched axially, it pulls the two portions toward each other more effectively. A solid tab 353 is positioned at a radially outward position on the elastic arm 352, substantially flattened in shape, and configured to extend radially outward and engage with the wing portion 342 of the plunger member 340.

[0069] The main body 354 of the needle carrier 350 is configured to engage with and hold the sensor member 2230 in a releasable manner and may have, for example, a snap-fit ​​or latch 355 or other fastening means configured to engage with a corresponding protrusion or recess 2233 on the sensor member 2230. The main body 354 of the needle carrier 350 is further connected thereto to a needle 360 ​​extending distally therefrom. The needle 360 ​​is substantially hollow to facilitate holding the specimen sensor 2231 inside when the sensor member 2230 is attached to the needle carrier 350. The needle 360 ​​is further long enough to completely penetrate the sensor member 2230 and extend outward from its distal end, so that the distal tip of the needle 360 ​​can puncture the patient's skin and implant the specimen sensor 2231 at a desired location under the patient's skin. The sensor member 2230 may have a passage extending therethrough to facilitate the passage of the needle 360. The needle 360 ​​may further have a compressible or other flexible pad or other member 361, which may be, for example, sponge-like, that is positionable between the needle carrier 350 and the sensor member 2230 at the proximal end where the needle 360 ​​connects to the needle carrier 350. The flexible member 361 can be used to buffer or otherwise soften the delivery of the sensor member 2230 into the base 2210, which reduces the possibility of damaging each component, for example, when the base assembly is assembled during the deployment of the applicator assembly 300. In some embodiments, the flexible member 361 may, when the pad 361 is compressed, activate a mechanism that breaks the needle 360 ​​from the sensor member 2230 or separates it in another way, and / or ensures that the sample sensor 2231 of the sensor member 2230 advances to a desired depth before the needle 360 ​​begins to retract from the sensor member 2230.

[0070] The latch 370 may be a rotatable latch that rotates around a pivot point, such as a pivot 371. The pivot 371 may be attached to the housing, for example, a first fixed part 310, or to another fixed or stationary part of the applicator assembly 300. As shown in Figures 18A and 18B, the latch 370 in transport or other initial state may have a projection 372 configured to engage with the base 2210 to provide a releaseable hold on the base so as not to separate from the applicator assembly 300. At the opposite end of the latch 370, the engaging portion is configured to engage with a post 341 of the plunger member 340 and may have an inclined surface 373 or other surface that facilitates rotation of the latch 370 relative to the pivot 371 when, for example, the post 341 engages with the inclined surface 373. When the inclined surface 373 engages with the post 341, the latch 370 may rotate in such a manner that the projection 372 moves away from the base 2210 to release the hold. A catch spring or other biasing member 374 can be attached to the first fixed portion 310 before the post 341 engages and pushes down on the inclined surface 373 of the latch 370, releasing it from being held on the base 2210, and can serve to hold the latch 370 in the latch position where it engages with the base 2210.

[0071] Next, the operation of the applicator assembly 300 according to the third embodiment will be described with reference to Figures 18A to 24B. As mentioned above, Figures 18A to 18C show the applicator assembly 300 in its initial or transport state. If the base 2210 is not pre-attached to the applicator assembly 300, the patient can manually attach the base 2210 to the applicator assembly 300 before operation of the applicator assembly 300. If an adhesive patch is present under the base of the base 2210, the patient can remove the cover of the adhesive patch and adhere the base 2210 to the patient's skin at a desired position on the patient's body.

[0072] As shown in Figures 21A-21C, after the trigger is activated and releases the blocking member or other type of retainer on the plunger member 340 (not shown), the energy stored in the spring 345 is released, causing the spring 345 to begin expanding and pushing the plunger member 340 distally relative to the fixed portion of the applicator assembly 300. The distal movement of the wings 342 of the plunger member 340, particularly the contact portion 343, also pushes the body 354 of the needle carrier 350 distally (e.g., via the arms 352 and tab 353), then accelerating the needle 360 ​​and sensor member 2230, biasing them distally toward the base 2210 and the patient's skin. Additionally, the axial extension of the arms 352 of the needle carrier 350 causes the arms 352 to begin collapsing radially inward, and the tab 353 moves radially inward, as is best seen in Figure 21C. In addition, as is most commonly seen in Figures 21B and 21C, the tension spring 356 of the needle carrier 350 also begins to extend. Generally, the elasticity of both the arm 352 of the needle carrier 350 and the tension spring 356 may be weaker than that of the launch spring 345, and therefore, in some embodiments, the tension of the tension spring 356 will have no effect on the distal advance of the plunger member 340, or will only slow it to a minimal degree.

[0073] When the plunger member 340 is moved distally by a sufficient distance, the plunger member 340 presses down on the inclined surface 373, causing contact with the post 341 and activating the latch 370, which in turn rotates around the pivot portion 371 and projection 372, disengaging from the base member 2210, thereby releasing the hold between the applicator assembly 300 and the base member 2210. In this embodiment, the disengagement of the applicator assembly 300 from the base member 2210 or other measuring instrument occurs before the needle 360 ​​reaches the patient's skin. In other words, the base 2210 is released from the applicator assembly 300 before the specimen sensor 22310 is inserted into the patient's skin or before the base 2210 is fully assembled. This configuration can be beneficial in various ways. For example, current applicators often present a problem where patients have difficulty disengaging the applicator from the fully embedded platform or monitor due to insufficient separation mechanisms in the current design. Releasing the platform earlier can mitigate or eliminate this situation, and the earlier release of the connection may allow for more slight wiggle during deployment, potentially further enhancing patient comfort.

[0074] As seen in Figures 22A and 22B, by further advancing the plunger member 340 and then the body 354 of the needle carrier 350, the needle 360 ​​and the specimen sensor 2231 housed therein are fully advanced, extending outward from the distal end of the applicator assembly 300 to puncture the patient's skin. When the sensor member 2230 is advanced to a desired position relative to the base 2210, for example, to a fully assembled position between the base 2210 and the sensor member 2230, the engaging latch 2216 or other mechanism on the base 2210 engages with the corresponding engaging surface 2234 on the sensor member 2230, allowing the respective parts to be held together (see, for example, Figures 6E and 24B). Such engagement ensures proper positioning of the sensor member 2230 relative to the base 2210, and consequently, proper positioning of the specimen sensor 2231 relative to the patient at a desired depth and / or a specific orientation of the sensor, with the sensor chemistry facing upward toward the skin surface. The snap-fit ​​or other engagement portion 2216, 2234 between the base 2210 and the sensor member 2230 can be more rigid, or otherwise stronger, than the snap mechanism formed by the latch 355 of the needle carrier 350 on the sensor member 2230, and as a result, when the sensor member 2230 is finally assembled to the base, the stronger connection will disengage and release the needle carrier 350 from the sensor member 2230. Almost simultaneously, the axial extension of the needle carrier 350 will cause the arm 352 of the needle carrier 350 to collapse or constrict to some extent radially inward, so that the tab 353 will no longer contact the contact portion 343 of the wing portion 342 of the plunger member 340 and can slide over them. In this way, while the spring 345 holds the plunger member 340 in the appropriate distal position, the tab 353 of the needle carrier 350 is made able to move proximal to the contact portion 343 of the plunger member 340, and thereafter the arm 352 of the needle carrier is made able to retract axially and expand radially again, thereby pulling the body 354 of the needle carrier proximal to the rest of the applicator assembly 300.

[0075] Figures 23A and 23B show the retraction of the main body 354 of the needle carrier 350 relative to the other parts of the applicator assembly 300 described above. While the plunger member 340 is held distally by, for example, the spring 345, the tab 353 of the needle carrier 350 is allowed to slide radially inward and proximal beyond the contact portion 343 on the plunger member 340. This allows the initial stiffness or elasticity of the arm 352, as well as the tension spring 356, to pull the body 354 of the needle carrier 350 back proximal relative to the other parts of the applicator assembly 300. The proximal retraction of the main body similarly retracts the needle 360 ​​further proximal, drawing it out of the patient's body and returning it to the housing of the applicator assembly 300, which can serve as a sharp edge guard for the needle 360 ​​after operation and deployment. As best illustrated in Figure 23B, while the needle 360 ​​is retracting, the engagement between the base 2210 and the sensor member 2230 holds the sensor member 2230 in place relative to the base 2210, and the specimen sensor 2231 remains positioned in the desired location beneath the surface of the patient's skin. This can be facilitated by the fact that the hold between the base 2210 and the sensor member 2230 is stronger than the hold between the sensor member 2230 and the needle carrier 350, as described above.

[0076] In the final step of the applicator assembly 300 shown in Figures 24A and 24B, the applicator assembly 300 is separated from the assembly comprising the base 2210 and the connected sensor member 2230. The base 2210 is held in place on the patient's skin, for example, via adhesive on its bottom side, while the specimen sensor 2231 is firmly held in a desired position below the surface of the patient's skin. Subsequently, if the base is applied by the applicator assembly, a separate transmitter or other durable or reusable part may then be attached to the base both mechanically and electrically to complete the specimen monitor assembly.

[0077] The applicator assembly of the fourth embodiment is shown in Figures 25A to 30. The parts, components, and operations of the fourth embodiment of the applicator assembly are similar to those of the first, second, and third embodiments and are not repeated. Similar to the third embodiment, the applicator assembly 400 according to the fourth embodiment is presented with the housing of the applicator assembly removed or omitted in order to more clearly visualize and discuss the internal components of the applicator assembly. As can be seen from the figures, the applicator assembly 400 according to the fourth embodiment is configured to deploy a needle and insert the specimen sensor into the patient's skin at an angle of, for example, 25° to 35° to the surface of the skin, or at any other angle as appropriate.

[0078] In general, the applicator assembly 400 according to the fourth embodiment is very similar to the applicator assembly 300 according to the third embodiment, and while identical or similar parts will not be repeated, we will focus on the differences between the two embodiments. To achieve this effect, the second proximal fixing portion 420 is the same as the second proximal fixing portion 320 of the third embodiment, the support post 430 is the same as the support post 330 of the third embodiment, the plunger member 440 is the same as the plunger member 340 of the third embodiment, the needle 460 is the same as the needle assembly 360 of the third embodiment, and the latch 470 is the same as the latch 370 of the third embodiment.

[0079] Most notably, the applicator assembly 400 of the fourth embodiment differs from the applicator assembly 300 of the third embodiment in that the operation of the applicator assembly 400 is facilitated and thereby initiated by the addition of a button or other actuator 480. The button 480 has a main button body 481 which may have two halves on either side of the applicator assembly 400. In some embodiments, the main button body 481 may instead be a single, integrated piece, or it may consist of three or more pieces. On the inner surface of the main button body 481, a block rib 482 is formed, as is best seen in Figure 25D, which prevents the forward movement of the post 441 of the plunger member 440. In this embodiment, the block rib 482 is vertical and extends laterally by a sufficient amount to form a contact portion that abuts against the distal end of the post 441. The button 480 may further include a spring 483 or other elastic member or component that holds the button 480 in a blocked position until the user presses or otherwise activates the button 480. In this embodiment, the spring 483 is located at the lower end of the button 480 and extends downward from there. The lower end of the spring 483 may be attached, for example, to an engaging portion 411 of the first distal fixing portion 410 and extend between the engaging portion 411 and the button 480.

[0080] Furthermore, the first fixed portion 410 may further differ from the first fixed portion 310 in the third embodiment by the addition of a stopping mechanism 415 that prevents the latch 455 on the body 454 of the needle carrier 450 from bending when it is in an initial position or transport position (see, for example, Figure 25D). In this embodiment, the stopping mechanism 415 is formed by an enlarged inner surface that reduces the dimensions of the passage through the first fixed portion 410, so that the enlarged inner surface abuts against the latch 455 and restricts the movement of the latch 455 away from the sensor member 2230 when the sensor member 2230 is attached to the main body 454 of the needle carrier 450. In this way, the latch 455 can be reliably held by the main body 454 of the needle carrier 450 during transport and / or before the applicator assembly 400 is activated in any other way.

[0081] Furthermore, the needle carrier 450 according to the fourth embodiment may differ slightly from the needle carrier 350 according to the third embodiment. Although not shown, the needle carrier 450 may further have a snap-fit ​​or other engagement mechanism that can engage when retracted and hold the needle carrier 450 in the retracted position after deployment. This can be connected to a smaller distal opening of the first fixed portion 410 to more reliably guard the needle 460 after retraction. Here, the distal opening of the first fixed portion 410 can be small enough that no finger can be inserted into it, and the catch, snap-fit ​​or other mechanism on the needle carrier 450 can hold the needle fully retracted from the distal opening of the first fixed portion 410, thereby potentially preventing the patient from inadvertently pricking themselves with a biologically harmful needle after the applicator assembly 400 has been activated.

[0082] The operation of the applicator assembly 400 according to the fourth embodiment is generally similar to that of the applicator assembly 300 according to the third embodiment. First, as shown in the initial or transport state in Figures 25A-25D, the block rib 482 of the button 480 prevents distal forward movement of the support 441 of the plunger member 440, while the spring 483 holds or biases the button 480 in a predetermined position in the upper blocking position. When the plunger member 440 is in the cocked or retracted position, the spring 445 is compressed to store energy for the subsequent firing of the plunger member 440. Here again, the needle carrier 450 is in the retracted position due to the rigidity of the arm 452 and the tension spring 456. Meanwhile, the base 2210 is fixed to the applicator assembly 400 via the projection 472 of the latch 470. In embodiments where the base 2210 is not pre-assembled to the applicator assembly 400, the patient can manually attach the base 2210 to the applicator assembly 400 when ready to apply the base 2210 to their skin.

[0083] In the first step, the base 2210 with the attached applicator assembly 400 is adhered to the desired position on the patient's skin, as described above with respect to the third embodiment. The user then presses down the main body 481 of the button 480, as shown in Figure 26, thereby moving the block rib 482 downward to a position where the post 441 of the plunger member 440 is no longer obstructed by the block rib 482, and thus allowing it to advance freely distally relative to the rest of the applicator assembly 400. In this embodiment, by positioning the button 480 directly above the base 2210, further downward pressure can be applied to the base 2210, which can further ensure and enhance the adhesion of the base 2210 to the patient's skin surface and / or the force applied by the patient can act as a stabilizing pressure during deployment, contributing to firmly holding the assembly in place during the activation of the applicator assembly 400 and the deployment of the base 2210 therefrom.

[0084] In Figure 27, with no obstruction formed by the block rib 482 of the button 480, the plunger member 440 moves freely distally, propelled by the force generated by the launch spring 445. The distal advance of the plunger member 440 causes the wing portion 442 of the plunger member to similarly bias the arm 452 and tab 453 of the needle carrier 450 distally, thereby further advancing the body 454 of the needle carrier 450 together with the needle 460 and the sensor member 2230. Similar to the third embodiment, the distal movement of the main body 454 of the needle carrier 450 causes the arm 452 to extend axially while compressing or retracting radially.

[0085] Returning to Figure 27, before the needle 460 reaches the patient's skin, the post 441 of the plunger member 440 strikes and engages with the inclined surface 473 of the latch 470, thereby releasing the projection 472 from the base 2210, thereby releasing the applicator assembly 400 from its hold on the base 2210 before the needle 460 punctures the patient's skin and the specimen sensor 2231 is embedded beneath the surface of the patient's skin, and before the sensor member 2230 is finally assembled with the base 2210.

[0086] Next, referring to Figure 28, the plunger member 440 is further advanced distally by the launch spring 445 until the needle 460 penetrates the patient's skin. At this point, the sensor member 2230 is latched to the base 2210, and the latch 455 has been advanced distally by a sufficient amount to move away from the stop mechanism 415, so that after the sensor member 2230 is latched to the base 2210, the latch 455 is automatically released from the sensor member 2230. At this point, as in the third embodiment, the tab 453 on the arm 452 of the needle carrier 450 has been moved radially inward by a sufficient amount to slide inward and proximal to the wing portion 442 of the plunger member 440, so that the body 454 of the needle carrier 450 can begin to retract relative to the rest of the applicator assembly 400. The elasticity of the arm 452 and the extension direction of the spring 456 act to begin biasing the main body 454 of the needle carrier 450 proximal together with the needle 460, while the delivered sensor member 2230 remains attached to the base 2210. This can be seen in Figure 29. Furthermore, as described above, the needle holder 450 may further have a separate snap-fit ​​or latching mechanism that holds the body 454 of the needle holder 450 and the attached needle 460 in a sufficiently retracted position, thereby eliminating the probability of the tip of the needle 460 extending from the distal end of the applicator assembly 400, and providing the applicator assembly 440 with an effective sharp edge guard for the biologically harmful needle after the applicator assembly 440 has been used.

[0087] Finally, in Figure 30, the patient can remove the applicator assembly 400 from the assembled base 2210 and sensor member 2230, and then discard the applicator assembly 400. In some embodiments, the applicator assembly 400 can be removed perpendicularly away from the surface of the patient's skin, or in the opposite direction to the insertion direction, or both, or at a different angle. The base 2210 is held in place on the patient's skin, for example, via adhesive on its bottom side, while the specimen sensor 2231 is held firmly in place at a desired position below the surface of the patient's skin. If the base is then applied by the applicator assembly, a separate transmitter or other durable or reusable part may then be attached to the base both mechanically and electrically to complete the specimen monitor assembly.

[0088] Without departing from the spirit or scope of the present invention, it is also possible to provide further variations of the applicator assembly and / or monitor by combining, for example, different mechanisms from those described in the various embodiments, in addition to the embodiments already described. Furthermore, the present invention should not be limited to the structures and / or shapes described in the above embodiments.

[0089] Unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as those generally understood by a person skilled in the art in which this disclosure pertains. Furthermore, it should be understood that terms as defined in commonly used dictionaries should be interpreted to have the same meaning as their meanings in the context of the relevant art and / or this disclosure, and should not be interpreted in an idealized or overly formal sense unless explicitly defined herein.

[0090] While the subject matter of this disclosure has been described in relation to specific embodiments, it should be understood that the subject matter of this disclosure is not limited to the disclosed embodiments, but rather is intended to extend to the various modifications and equivalents contained within the spirit and scope of the attached claims, as well as their equivalents.

Claims

1. In an applicator assembly for applying at least a portion of a sample monitor, The aforementioned applicator assembly is A housing having a first end, an opposing second end, and a longitudinal axis extending between the first end and the second end, The engagement portion at the second end is configured to engage with at least a portion of the sample monitor in a releasable manner, An elastic member having at least a first portion that is at least partially positioned within the housing and fixed to the housing, and a second portion that is movable relative to the housing in a direction substantially parallel to the longitudinal axis, A needle that is movable together with the second portion of the elastic member, Equipped with an actuator, When the actuator is activated, the second portion of the elastic member and the needle are advanced toward the second end of the housing. Applicator assembly wherein, when the tip of the needle is advanced to a first position located axially between the first and second ends of the housing, the engaging portion is adjusted from a first configuration in which a portion of the sample monitor connected to the applicator assembly is engaged by the engaging portion and holds the portion of the sample monitor to the applicator assembly, to a second configuration in which the engagement between the engaging portion and the portion of the sample monitor is released, and the tip of the needle is configured to be further advanced to a second position located axially through the second end of the housing after the engaging portion has been adjusted to the second configuration and the portion of the sample monitor has been released.

2. The applicator assembly according to claim 1, wherein the engaging portion comprises a latch, the latch is configured to engage with the portion of the sample monitor in the first configuration and to release the engagement with the portion of the sample monitor in the second configuration.

3. The applicator assembly according to claim 1, further comprising a plunger member configured to adjust the engaging portion from the first configuration to the second configuration.

4. The applicator assembly according to claim 3, wherein the plunger member is movable toward the second end of the housing together with the second portion of the elastic member and the needle.

5. The applicator assembly according to claim 4, wherein when the plunger member, the second portion of the elastic member, and the needle are moved toward the second end of the housing, the plunger member adjusts the engagement portion from the first configuration to the second configuration before the tip of the needle reaches the second end of the housing.

6. The applicator assembly according to claim 4, wherein the plunger member is configured to bias the second portion of the elastic member and the needle toward the second end of the housing.

7. The applicator assembly according to claim 6, wherein when the tip of the needle is advanced to the second position, the second portion of the elastic member and the needle are configured to return toward the first end of the housing, and the axial position of the plunger member remains the same.

8. The applicator assembly according to claim 1, wherein at least a portion of the second end of the housing extends substantially in a plane, and the longitudinal axis is positioned at an angle to the plane.

9. The applicator assembly according to claim 8, wherein the angle is 25° to 35°.

10. The applicator assembly according to claim 1, wherein when the actuator is activated, the tip of the needle is configured to advance continuously from the first position to the second position.

11. The applicator assembly according to claim 1, wherein the actuator comprises, before operation, the second portion of the elastic member and a contact portion that prevents the forward movement of the needle.

12. The applicator assembly according to claim 1, wherein when the portion of the sample monitor is connected to the applicator assembly, the portion of the sample monitor is positionable between the actuator and the desired application site such that the operation of the actuator presses the portion of the sample monitor against the desired application site.

13. The applicator assembly according to claim 1, wherein the portion of the sample monitor comprises a stand or base for the sample monitor consisting of two parts.

14. The applicator assembly according to claim 1, wherein the second portion of the elastic member is further configured to connect a sensor member, which is separated from the portion of the sample monitor, to the portion of the sample monitor when the tip of the needle is advanced to the second position.

15. The applicator assembly according to claim 14, wherein the detection portion of the sensor member is configured to be positionable within the needle, so that when the tip of the needle is advanced to the second position, the needle punctures the patient's skin, and the sensor member is configured to be delivered together with the needle to a position below the surface of the patient's skin.

16. The applicator assembly according to claim 15, wherein the needle is configured to retract so as to be pulled away from the patient's skin after the tip of the needle reaches the second position, and the sensing portion of the sensor member is configured to separate from the needle and remain below the surface of the patient's skin.

17. In a method of applying a portion of the specimen monitoring to a patient, The aforementioned method, The process involves adhering a portion of the sample monitor to a desired application site while a portion of the sample monitor is connected to the applicator assembly, The applicator assembly is operated to advance a needle that carries at least the detection area of ​​the sensor member toward a desired application site. The applicator assembly is configured to disconnect from the portion of the sample monitor before the tip of the needle reaches the desired application site. The tip of the needle is configured to puncture the desired application site after the connection between the sample monitor and the applicator assembly is released. A method wherein the sensor member is connected by the portion of the sample monitor and remains held in the desired application site, and the needle is configured to retract so as to be pulled away from the desired application site.

18. The applicator assembly includes a latch configured to engage with the portion of the sample monitor for connecting the portion of the sample monitor to the applicator assembly. The method according to claim 17, wherein the latch is configured to disengage from the portion of the sample monitor when the connection between the portion of the sample monitor and the applicator assembly is released.

19. The applicator assembly further comprises a plunger member configured to be advanced together with the needle during operation, The method according to claim 18, wherein the plunger member is configured to disengage the latch from the portion of the sample monitor before the tip of the needle reaches the desired application site.

20. The method according to claim 17, wherein the operation of the applicator assembly is configured to initiate the release of a portion of the connection of the sample monitor from the applicator assembly.

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