Transdermal analyte sensor systems and methods

Abstract

A system for applying a transdermal monitor to a person may include a retractable assembly, a sensor, and a base having an adhesive for coupling the sensor to the skin. The sensor is positioned within the retractable assembly as the base extends from a distal end of the system. The system may be configured to couple the sensor to the base by compressing the retractable assembly.

Description

[0001] This application is a divisional application of patent application No. 201680051051.4, filed on December 21, 2016, entitled "Transdermal Analyte Sensor System and Method".

[0002] Incorporate the relevant application by reference.

[0003] Any and all priority claims listed in the application data sheet or any correction thereof are hereby incorporated by reference in accordance with 37 CFR 1.57. This application claims the benefits of U.S. Provisional Application No. 62 / 272,983, filed December 30, 2015, and U.S. Provisional Application No. 62 / 412,100, filed October 24, 2016. Each of the foregoing applications is incorporated herein by reference in its entirety, and each thereby expressly forms a part of this specification. Technical Field

[0004] The various embodiments disclosed herein relate to the measurement of analytes in humans. Some embodiments relate to systems and methods for administering transdermal analyte measurement systems to humans. Background Technology

[0005] Diabetes is a condition in which the pancreas cannot produce enough insulin (type 1 or insulin-dependent) and / or where insulin is not effective enough (type 2 or non-insulin-dependent). In diabetes, the patient suffers from hyperglycemia, which can cause a host of physiological disturbances associated with small vessel deterioration, such as kidney failure, skin ulcers, or vitreous hemorrhage. Hypoglycemia can be induced by unintentional overdose of insulin, or by normal doses of insulin or glucose-lowering agents followed by strenuous exercise or insufficient food intake.

[0006] Conventionally, people with diabetes carry self-monitoring blood glucose monitors, which typically require an uncomfortable finger prick method. Due to this lack of comfort and convenience, people with diabetes usually only measure their glucose levels two to four times a day. The disadvantage is that such intervals can be so far apart that people with diabetes may detect high or low blood sugar symptoms too late, sometimes resulting in dangerous side effects. Glucose levels can alternatively be monitored continuously via a sensor system that includes a sensor assembly on the skin. The sensor system may have a wireless transmitter that transmits measurement data to a receiver, which can process and display the information based on the measurements.

[0007] The process of applying sensors to a person is important for the effectiveness and user-friendliness of such systems. The application process involves attaching a sensor assembly to a person in a condition, where the sensor assembly is able to sense glucose level information, communicate this glucose level information to a transmitter, and transmit the glucose level information to a receiver.

[0008] The analyte sensor can be placed in the subcutaneous tissue. The user can actuate the applicator to insert the analyte sensor into its functional position. This percutaneous insertion can lead to incomplete sensor insertion, improper sensor insertion, needle exposure, or unnecessary pain. Therefore, there is a need for a more reliable system that enables percutaneous sensor insertion while being easy to use and relatively painless. Summary of the Invention

[0009] The various systems and methods described herein enable reliable, simple, and pain-minimizing percutaneous insertion of analyte sensors. Some embodiments are systems for applying a sensor assembly to the skin of a subject. The system may include a retractable assembly having a first portion configured to move along a path relative to a second portion from a proximal starting position to a distal position; a sensor module coupled to the first portion, the sensor module including a sensor, electrical contacts, and a seal; and / or a base coupled to the second portion such that a base extends from a distal end of the system. The base may include an adhesive configured to couple the sensor module to the skin. Movement of the first portion to the distal position couples the sensor module to the base. The sensor may be an analyte sensor; a glucose sensor; any sensor described herein or incorporated herein by reference; and / or any other suitable sensor.

[0010] In some embodiments (i.e., optional and in combination independently with any of the aspects and embodiments identified herein), the sensor module may include a sensor module housing. The sensor module housing may include a first curved arm.

[0011] In some embodiments (i.e., optional and can be combined independently with any of the aspects and embodiments identified herein), when the base extends from the distal end of the system, the sensor may be positioned within the second portion such that the system is configured to couple the sensor to the base via a distal movement of the first portion relative to the second portion.

[0012] In several embodiments (i.e., optional and can be combined independently with any of the aspects and embodiments identified herein), when the first portion is positioned at the proximal starting position, the sensor can be coupled to the sensor module.

[0013] In some embodiments, the needle is coupled to a first portion (of the retractable assembly) such that the sensor and the needle move distally relative to the base and relative to the second portion. The system may include a needle release mechanism configured to retract the needle proximally.

[0014] In several embodiments, the base includes a distal protrusion having a first aperture. The distal protrusion may be configured to reduce resistance when piercing the skin. The sensor may pass through the first aperture of the distal protrusion.

[0015] In some embodiments, a needle with a groove passes through a first hole in a distal protrusion. A portion of the sensor may be positioned in the groove such that the needle is configured to move distally relative to the base without removing the portion of the sensor from the groove.

[0016] In several embodiments, the distal protrusion is convex, such that it is configured to stretch the skin as the first portion moves distally relative to the second portion, thus preparing the skin for puncture. The distal protrusion may be shaped like a dome.

[0017] In some embodiments, the adhesive includes a second hole. The distal protrusion may be at least partially positioned within the second hole, such that the distal protrusion can stretch at least a portion of the skin below the second hole.

[0018] In several embodiments, the adhesive covers at least a majority of the distal protrusion. The adhesive may cover 0%, at least 30%, at least 70%, and / or less than 80% of the distal protrusion. The distal protrusion may extend at least 0.5 mm, less than 3 mm, and / or less than 5 mm.

[0019] In some embodiments, when the first portion is in a proximal starting position, the sensor module is coupled to the first portion and positioned at least 3 mm and / or at least 5 mm from the base. The system can be configured such that the first portion is moved to a distal position to couple the sensor module to the base.

[0020] In several embodiments, the sensor is already coupled to the sensor module when the first portion is positioned at the proximal starting position. For example, the sensor may be coupled to the sensor module at the factory (e.g., before the user opens the sterile barrier). The sensor may be positioned within the second portion when the base extends from the distal end of the system.

[0021] In some embodiments, the sensor is coupled to a sensor module. During the first portion of the path, the sensor module may be immobile relative to the first portion, and the base may be immobile relative to the second portion. During the second portion of the path, the system may be configured to move the first portion distally relative to the second portion to move the sensor module toward the base, couple the sensor module to the base, and / or enable the coupled sensor module and base to disengage from the retractable assembly.

[0022] In several embodiments, the sensor module is coupled to the sensor. The system includes a vertical central axis oriented from a proximal end to a distal end of the system. The sensor module may include a first curved arm oriented horizontally and coupled to the base. The first curved arm may extend from the outer periphery of the sensor module.

[0023] In some embodiments, the base includes a first proximal protrusion coupled to a first curved arm to couple a sensor module to the base. A first horizontal locking protrusion may be coupled to an end portion of the first flexible arm. A second horizontal locking protrusion may be coupled to the first proximal protrusion of the base. The first horizontal locking protrusion may be positioned distally below the second horizontal locking protrusion to secure the sensor module to the base. The system may be configured such that a first portion of the retractable assembly moves to a distal position causing the first curved arm to bend, allowing the first horizontal locking protrusion to move distally relative to the second horizontal locking protrusion.

[0024] In several embodiments, the base includes a second proximal projection coupled to a second curved arm of the sensor module. The first curved arm may be positioned on the opposite side of the sensor module relative to the second curved arm.

[0025] In some embodiments, the sensor module is coupled to the sensor. The system may include a vertical central axis oriented from a proximal end to a distal end of the system. The base may include a first curved arm oriented horizontally and coupled to the sensor module. The sensor module may include a first distal projection coupled to the first curved arm to couple the sensor module to the base.

[0026] In several embodiments, a first horizontal locking protrusion is coupled to an end portion of a first flexible arm, and a second horizontal locking protrusion is coupled to a first distal protrusion of a sensor module. The second horizontal locking protrusion is positioned distally below the first horizontal locking protrusion to secure the sensor module to a base. The system can be configured such that a first portion of the retractable assembly moves to a distal position, causing the first bending arm to bend, allowing the second horizontal locking protrusion to move distally relative to the first horizontal locking protrusion.

[0027] In some embodiments, the sensor module includes a second distal projection of a second curved arm coupled to the base. A first distal projection may be positioned on an opposite side of the sensor module relative to the second distal projection.

[0028] In several embodiments, the sensor module is coupled to the sensor. The first portion may include a first curved arm and a second curved arm extending distally and latching onto the sensor module to releasably secure the sensor module to the first portion when the first portion is in a proximal starting position. When the first portion is in the proximal starting position, the sensor module may be positioned distal to the base (e.g., such that the sensor module does not touch the base).

[0029] In some embodiments, when the base extends from the distal end of the system, the sensor module is positioned within the second portion, such that the system is configured to couple the sensor module to the base via a distal movement of the first portion relative to the second portion.

[0030] In several embodiments, the system includes a vertical central axis oriented from a proximal end to a distal end of the system. First and second curved arms of the first portion secure the sensor module to the first portion such that the sensor module is releasably coupled to the first portion with a first vertical holding strength. The sensor module may include a third curved arm coupled to a first proximal protrusion of the base such that the sensor module is coupled to the base with a second vertical holding strength.

[0031] In some embodiments, the second vertical holding strength is greater than the first vertical holding strength, such that once the sensor module is coupled to the base, continued pushing of the first portion distally overcomes the first and second curved arms of the first portion to disengage the sensor module from the first portion. A third curved arm may extend from the outer periphery of the sensor module.

[0032] In several embodiments, when the first portion of the retractable assembly is positioned at a proximal starting position and the sensor is positioned relative to the distal end of the base, the base extends from the distal end of the system, such that the system is configured to couple the sensor to the base via distal movement of the first portion relative to the second portion. The base may include a first radial protrusion that is releasably coupled to a second radial protrusion of the second portion of the retractable assembly with a first vertical holding strength.

[0033] In some embodiments, the first radial protrusion extends inward and the second radial protrusion extends outward. The system can be configured such that moving the first portion to a distal position moves the second radial protrusion relative to the first radial protrusion to disengage the base from the retractable assembly.

[0034] In several embodiments, a first portion of the retractable assembly includes a first arm extending distally, a second portion of the retractable assembly includes a second curved arm extending distally, and the system is configured such that as the first portion moves along a path from a proximal starting position to a distal position, the first arm deflects the second curved arm, thereby disengaging the second curved arm from the base so that the base can be decoupled from the retractable assembly. When the first portion is in the proximal starting position, the first arm of the first portion may be at least partially perpendicularly aligned with the second curved arm of the second portion so that the first arm can deflect the second curved arm when the first portion moves to the distal position.

[0035] In some embodiments, when the first portion is in the proximal starting position, at least a segment of the first arm is positioned directly above the second curved arm to enable the first arm to deflect the second curved arm when the first portion moves to the distal position.

[0036] In several embodiments, the second curved arm includes a first horizontal protrusion, and the base includes a second horizontal protrusion that latches with the first horizontal protrusion to couple the base to a second portion of the retractable assembly. The first arm of the first portion is deflectable to the second curved arm of the second portion to unlatch the base from the second portion of the retractable assembly.

[0037] In some embodiments, the system is configured to couple the sensor to the base at a first position, and the system is configured to disengage the base from the retractable assembly at a second position distal to the first position.

[0038] In several embodiments, a third curved arm couples the sensor to the base at a first position, a second curved arm disengages from the base at a second position, and the second position is distal from the first position, such that the system is configured to secure the base to the retractable assembly until the sensor is secured to the base.

[0039] In some embodiments, when the first portion of the retractable assembly is positioned in a proximal starting position and the sensor is positioned relative to the distal end of the base, the base extends from the distal end of the system. The system may further include a spring configured to retract a needle. The needle may be configured to facilitate sensor insertion into the skin. When the first portion is in the proximal starting position, the spring may be in a first compressed state. The system may be configured such that movement of the first portion from the proximal starting position distally further increases the compression of the spring. The first compressed state puts the first and second portions under tension.

[0040] In several embodiments, the system is configured to apply an on-skin sensor assembly to the skin of a subject (i.e., a person). The system may include a retractable assembly having a first portion configured to move along a path relative to a second portion from a proximal starting position to a distal position; a sensor coupled to the first portion; and / or a latch configured to impede proximal movement of a needle relative to the first portion. The sensor may be an analyte sensor; a glucose sensor; any sensor described herein or incorporated herein by reference; and / or any other suitable sensor.

[0041] In some embodiments, the first portion is releasably secured in a proximal starting position by a fixing mechanism that prevents distal movement of the first portion relative to the second portion. The system can be configured such that distal movement of the first portion relative to the second portion releases the latch before reaching the distal position, thereby causing the needle to retract proximally into the system. The system can also be configured such that distal movement of the first portion relative to the second portion (e.g., moving the first portion to the distal position) releases the latch, thereby causing the needle to retract proximally into the system. The fixing mechanism may be an interference fit between the first and second portions of the retractable assembly.

[0042] In several embodiments, a first force distribution is measured along the path. The first force distribution includes a first magnitude consistent with overcoming the fixing mechanism; a third magnitude consistent with releasing the latch; and a second magnitude consistent with the middle portion of the path located distal to the overcoming fixing mechanism and proximal to the release latch.

[0043] In some embodiments, the second magnitude is smaller than the first and third magnitudes, such that the system is configured to increase needle acceleration during the middle portion of the path to enable an appropriate needle speed (e.g., a sufficiently high needle speed) when the needle first pierces the skin.

[0044] In several embodiments, the first value is at least 100% greater than the second value. The first value may be greater than a third value, such that the system is configured to prevent the initiation of a sensor insertion cycle unless the user applies sufficient force to release the latch. The first value may be at least 50% greater than the third value.

[0045] In some embodiments, the middle portion of the path is located distally relative to the overcoming retaining mechanism and proximal relative to the release latch. The system may further include a second force distribution consistent with the middle portion of the path. In response to compression, a spring configured to allow the system to retract the needle into the retractable assembly may be provided, with the proximal millimeter of the second force distribution containing a lower average force than the distal millimeter of the second force distribution.

[0046] In several embodiments, a first force distribution is measured along the path. The first force distribution may include a first average value consistent with the proximal half of the movement distally through the fixing mechanism and a second average value consistent with the distal half of the movement distally through the fixing mechanism. The first average value may be greater than the second average value, such that the system is configured to prevent the initiation of a sensor insertion cycle unless the user applies sufficient force to complete the sensor insertion cycle (e.g., drive the needle and / or sensor to the desired insertion depth).

[0047] In some embodiments, the first force peak (coinciding with the proximal half of the movement distally through the fixing mechanism) is at least 25% higher than the second average value.

[0048] In several embodiments, a first force distribution is measured along the path. The first force distribution may include a first magnitude consistent with overcoming the fixing mechanism and a subsequent magnitude consistent with terminating the fixing mechanism. The first magnitude may include a proximal vector, and the subsequent magnitude may include a distal vector.

[0049] In some embodiments, the fixing mechanism may include a radially outward protrusion extending from the first portion. When the telescopic assembly is in the proximal starting position, the radially outward protrusion may be positioned proximally relative to the proximal end of the second portion. The radially outward protrusion may be configured to cause the second portion to deform elliptically, thereby enabling the first portion to move distally relative to the second portion.

[0050] In several embodiments, the fixing mechanism includes a radially outward protrusion of the first portion that interferes with the radially inward protrusion of the second portion, such that the fixing mechanism is configured to cause the second portion to deform into an elliptical shape, thereby enabling the first portion to move distally relative to the second portion.

[0051] In some embodiments, the needle is retractably coupled to the first portion via a needle holder configured to resist distal movement of the first portion relative to the second portion. The securing mechanism may include a flexible arm of the second portion. The flexible arm is releasably coupled to the needle holder to releasably secure the first portion to the second portion at a proximal starting position.

[0052] In several embodiments, when the first portion is in the proximal starting position, the fixing mechanism includes a separable coupling between the first and second portions. The system can be configured such that moving the first portion to the distal position breaks the separable coupling.

[0053] In some embodiments, the fixing mechanism includes a magnet that releasably couples the first portion to the second portion when the first portion is in a proximal starting position. The magnet can be attracted to a metal element coupled to either the first or second portion of the retractable assembly.

[0054] In several embodiments, the electric motor drives the first portion distally relative to the second portion. The electric motor may be configured to move a needle within the skin.

[0055] In some embodiments, the skin sensor system is configured for transdermal glucose monitoring of a subject. The system may include a sensor module housing, wherein the sensor module housing may include a first curved arm; a sensor having a first segment configured for subcutaneous sensing and a second segment mechanically coupled to the sensor module housing; an electrical interconnect mechanically coupled to the sensor module housing and electrically coupled to the sensor; and / or a base coupled to the first curved arm of the sensor module housing. The base may have an adhesive configured to couple the base to the skin of the subject. The sensor may be an analyte sensor; a glucose sensor; any sensor described herein or incorporated herein by reference; and / or any other suitable sensor.

[0056] In several embodiments, the electrical interconnect includes a spring. The spring may include a tapered portion and / or a helical portion.

[0057] In some embodiments, the sensor module housing includes at least two proximal protrusions positioned around the periphery of the spring. The proximal protrusions may be configured to assist in the orientation of the spring. A segment of the sensor may be positioned between the proximal protrusions.

[0058] In several embodiments, the sensor module housing is mechanically coupled to a base having an adhesive configured to couple the base to the skin of the body.

[0059] In some embodiments, the proximal protrusion orients the spring such that the electronic unit is coupled to the base against the first electrical contact of the electronic unit and the second electrical contact of the sensor, pressing the spring to electrically couple the sensor to the electronic unit.

[0060] In several embodiments, the sensor module housing includes a first curved arm that is horizontally oriented and coupled to a base. The first curved arm may extend from the outer periphery of the sensor module housing. The base may include a first proximal protrusion coupled to the first curved arm to couple the sensor module housing to the base.

[0061] In some embodiments, the electrical interconnect includes a leaf spring, which may include one or more metal layers. The leaf spring may be a cantilever spring.

[0062] In some embodiments, the sensor module housing includes a proximal protrusion having a channel in which at least a portion of a second segment of the sensor is positioned. The channel accommodates a first region of the sensor such that the first region is electrically coupled to a leaf spring.

[0063] In some embodiments, the leaf spring is arc-shaped away from the first region and extends proximally for electrical coupling with the electronic unit. At least a portion of the leaf spring may be formed in a "W" shape. At least a portion of the leaf spring may be formed in a "C" shape.

[0064] In several embodiments, the leaf spring is bent around a proximal protrusion. The leaf spring may be bent around the proximal protrusion by at least 120 degrees and / or at least 160 degrees. The leaf spring may extend proximally for electrical coupling with the electronic unit.

[0065] In some embodiments, the seal is configured to prevent fluid from entering the leaf spring. The sensor module housing may be mechanically coupled to the base. The base may have an adhesive configured to couple the base to the skin of the body.

[0066] In several embodiments, the leaf spring is oriented such that the electronic unit is coupled to a first electrical contact of the base abutting against the electronic unit and a second electrical contact of the sensor, pressing the spring to electrically couple the sensor to the electronic unit. The proximal height of the seal may be greater than the proximal height of the leaf spring, such that the electronic unit contacts the seal before contacting the leaf spring.

[0067] In some embodiments, the sensor module housing includes a first curved arm that is horizontally oriented and coupled to a base. The first curved arm may extend from the outer periphery of the sensor module housing. The base may include a first proximal protrusion coupled to the first curved arm to couple the sensor module housing to the base.

[0068] In several embodiments, the sensor module housing includes a channel in which at least a portion of a second segment of the sensor is positioned. A distal portion of a leaf spring may be positioned in the channel such that a proximal portion of the leaf spring extends proximally into the channel. The sensor module housing may include a recess intersecting the channel. The leaf spring may include a tab positioned in the recess to impede rotation of the leaf spring.

[0069] In some embodiments, the sensor module housing is mechanically coupled to a base having an adhesive configured to couple a base to the skin of a body. The sensor module housing may include a first curved arm oriented horizontally and coupled to the base. The first curved arm may extend from the outer periphery of the sensor module housing. The base may include a first proximal protrusion coupled to the first curved arm to couple the sensor module housing to the base.

[0070] In several embodiments, the electrical interconnects (such as springs or other types of interconnects) contain resistances of less than 100 ohms and / or less than 5 ohms. The electrical interconnects may contain compressive forces of less than one pound within the effective compression range.

[0071] In some embodiments, the electrical interconnect may require less than one pound of compressive force to compress the spring by 20% from a substantially uncompressed, relaxed position. In some embodiments, the electrical interconnect may require less than one pound of compressive force to compress the spring by 25% from a substantially uncompressed, relaxed position. In some embodiments, the electrical interconnect may require less than one pound of compressive force to compress the spring by 30% from a substantially uncompressed, relaxed position. In some embodiments, the electrical interconnect may require less than one pound of compressive force to compress the spring by 50% from a substantially uncompressed, relaxed position.

[0072] In several embodiments, the spring is configured such that compressing the spring from the relaxed position by 25% requires a force of at least 0.05 lbs and less than 0.5 lbs, and requires moving the end of the spring by at least 0.1 mm and less than 1.1 mm.

[0073] In some embodiments, a system for applying an on-skin sensor assembly to the skin of a subject includes a retractable assembly having a first portion configured to move along a path relative to a second portion from a proximal starting position to a distal position; a sensor coupled to the first portion; and a base including an adhesive configured to couple the sensor to the skin. The retractable assembly may further include a third portion configured to move distally relative to the second portion.

[0074] In some embodiments, a first spring is positioned between the third portion and the second portion such that a distal movement of the third portion relative to the second portion compresses the first spring. At a proximal starting position of the retractable assembly, the first portion is lockable to the second portion. The system can be configured such that a distal movement of the third portion relative to the second portion unlocks the first portion from the second portion.

[0075] In several embodiments, a first proximal protrusion having a first hook passes through a first hole in the second portion to lock the first portion to the second portion. The third portion may include a first distal protrusion. The system may be configured such that the third portion moves distally relative to the second portion to engage a bend in the ramp of the first proximal protrusion to unlock the first portion from the second portion.

[0076] In some embodiments, when the base extends from the distal end of the system, the sensor is positioned within the second portion, such that the system is configured to couple the sensor to the base by moving the first portion distally relative to the second portion.

[0077] In several embodiments, the sensor module is coupled to a distal portion of the first portion, such that the first portion is moved to a distal position to couple the sensor module to the base. When the first portion is positioned at a proximal starting position, the sensor can be coupled to the sensor module.

[0078] In some embodiments, the system is configured such that moving the third part distally relative to the second part unlocks the first part from the second part and locks the third part to the second part.

[0079] In several embodiments, the system includes a first protrusion coupled to a hole of at least one of the second and third portions to lock the third portion to the second portion.

[0080] In some embodiments, the system includes a second protrusion coupled to a hole in at least one of the first portion and the second portion to lock the first portion to the second portion in response to distal movement of the first portion relative to the second portion.

[0081] In several embodiments, a first spring is positioned between a third portion and a second portion such that the third portion moves distally relative to the second portion to compress the first spring and unlock the first portion from the second portion. This allows the compressed first spring to push the first portion distally relative to the second portion, which pushes at least a portion of the sensor away from the distal end of the system and triggers a needle retraction mechanism that allows the second spring to retract the needle.

[0082] In some embodiments, a system is provided for applying an adhesiosynthesis to the skin of a subject. Advantageously, the system includes a sensor insertion assembly having a needle assembly, a sensor module, a base, an actuation member, and a retraction member. The sensor insertion assembly has an initial configuration in which at least the sensor module is positioned in a proximal starting position, and the sensor insertion assembly further has an unfolded configuration in which at least the sensor module and the base are positioned in a distal application position. Preferably, the actuation member is configured to, upon activation, cause the proximal starting position of the needle assembly to move to a distal insertion position, and the retraction member is configured to, upon activation, cause the needle assembly to move from the distal insertion position to a proximal retraction position.

[0083] The sensor module may include a sensor and multiple electrical contacts. In an initial configuration, the sensor may be electrically coupled to at least one of the electrical contacts. Optionally, in the initial configuration, the actuation member is in a de-energized state. In some embodiments, the actuation member may be configured to be energized by the user before being activated. In an alternative embodiment, the actuation member is energized in the initial configuration.

[0084] In several embodiments, the actuating member may include a spring. In an initial configuration, the spring may be in an unstressed state. In an alternative embodiment, the spring is in a compressed state in the initial configuration.

[0085] In some embodiments, the sensor insertion assembly may include a first portion and a second portion, wherein the first portion is fixed about the second portion at least in the axial direction when the sensor insertion assembly is in an initial configuration, and the first portion is movable about the second portion at least in the distal direction after the actuation member is activated. The first portion is operatively coupled to the needle assembly to fix the needle assembly in a proximal starting position before the actuation member is activated and to advance the needle assembly toward a distal insertion position after the actuation member is activated.

[0086] In several embodiments, the retraction member is in a de-energized state when initially configured. Advantageously, the retraction member is configured to be energized by movement of the pin assembly from a proximal starting position to a distal insertion position. In the initial configuration, the retraction member may be energized.

[0087] In another embodiment, the retraction member includes a spring. The spring may be integrally formed with the needle assembly. The spring may be operatively coupled to the needle assembly. In an initial configuration, the spring may be in an unstressed state. In other embodiments, the spring is compressed in the initial configuration.

[0088] In some embodiments, the spring is compressed in the second configuration. In still other embodiments, the spring is stretched in the second configuration.

[0089] In some embodiments, the sensor insertion assembly may further include a third portion operatively coupled to the first portion. In some embodiments, an actuation member may be integrally formed with the third portion. Optionally, the actuation member is operatively coupled to the third portion.

[0090] In some embodiments, the sensor insertion assembly includes an interlocking structure configured to prevent movement of the first portion relative to the second portion in a distal direction until the interlocking structure is decoupled. Advantageously, decoupling of the interlocking structure can activate an actuating member. In other embodiments, the interlocking structure may include a proximal tab of the first portion and a receptacle configured to receive the proximal tab of the second portion. Optionally, the sensor insertion assembly may include a decoupling member configured to decouple the interlocking structure. The decoupling member may have a distal tab of a third portion.

[0091] In other embodiments, the sensor insertion assembly may include interlocking structures configured to prevent movement of the third portion relative to the first portion. These interlocking structures may include a distally extending latch of the third portion and a lug of the first portion configured to engage the distally extending latch.

[0092] In some embodiments, the sensor insertion assembly may include an engaging structure configured to prevent proximal movement of the needle assembly at least when the needle assembly is in a distal insertion position. The engaging structure may have a radially extending release feature of the needle assembly and an inner surface of a first portion configured to compress the release feature. Optionally, the sensor insertion assembly includes a decoupling member configured to disengage the first portion and the engaging structure of the needle assembly. The decoupling member may include an inner surface of a second portion configured to further compress the release feature. Advantageously, the system may further include a trigger member configured to actuate an actuation member. The trigger member may be operatively coupled to a third portion. The trigger member may be integrally formed with the third portion. The trigger member may include a button extending proximally. Alternatively, the trigger member may include a radially extending button. The trigger member may be configured to decouple the engaging structures of the first and third portions.

[0093] In some embodiments, the system may further include a releasable locking member configured to prevent actuation of the actuating member until the locking member is released. The releasable locking member may be configured to prevent proximal movement of the third portion relative to the first portion until the locking member is released. The releasable locking member may include a proximal tab of the first portion and a latching feature of the third portion configured to receive the proximal tab. Advantageously, the releasable locking member is configured to prevent energization of the sensor insertion assembly. In other aspects, the releasable locking member is configured to prevent energization of the actuating member.

[0094] The embodiments may further include a system for applying an on-skin component to the skin of a subject, the system including a sensor insertion assembly having an on-skin component movable in at least a distal direction from a proximal position to a distal position, a first fixation feature configured to releasably fix the on-skin component in a proximal position, a second fixation feature configured to fix the on-skin component in a distal position, and a first resistance configured to prevent movement of the on-skin component in the proximal direction at least when the on-skin component is in the distal position.

[0095] The first resistance feature may be configured to prevent movement of the on-skin assembly in the proximal direction when the on-skin assembly is secured in a distal position. In some embodiments, the first securing feature is configured to releasably secure the on-skin assembly to the needle assembly. The on-skin assembly may have a sensor module. The sensor module may include a sensor and a plurality of electrical contacts. Optionally, at least when the sensor insertion assembly is in a first configuration, the sensor is electrically coupled to at least one of the electrical contacts.

[0096] In some embodiments, the skin-on component includes a base. The skin-on component may include a transmitter. A second fixing feature may be configured to fix the skin-on component to a second skin-on component.

[0097] In other embodiments, the sensor insertion assembly includes at least one distally extending leg, and wherein a first fixing feature includes an adhesive disposed on the distally facing surface of the leg. The sensor insertion assembly may include at least one distally extending member, and wherein the first fixing feature includes a surface of the distally extending member configured to frictionally engage with a corresponding structure of the on-skin assembly. The corresponding structure of the on-skin assembly may include an elastomeric member. Optionally, the distally extending member includes at least one leg of the sensor insertion assembly. The distally extending member may include a needle.

[0098] In some embodiments of the system, the second fixing feature includes an adhesive disposed on the distally facing surface of the skin assembly. The second fixing feature may have an elastomeric member configured to receive the skin assembly.

[0099] In other embodiments, the first resistance feature includes the distal surface of the sensor insertion assembly. The first resistance feature may be distal to an adhesive on the distal surface of the assembly placed on the skin.

[0100] The system may further include an actuator configured to move the on-skin component from a proximal position to a distal position. Optionally, the system may further include a decoupling feature configured to decouple the actuator from the on-skin component at least after the on-skin component is in the distal position. The decoupling feature may have a detachable portion of the actuator. Optionally, the decoupling feature includes a detachable portion of the on-skin component.

[0101] The system may further include a sensor assembly configured to couple with an on-skin component, wherein a third fixing feature is configured to releasably fix the sensor assembly in a proximal position, and wherein a fourth fixing feature is configured to fix the sensor assembly to the on-skin component.

[0102] Any feature of each embodiment applies to all aspects and embodiments identified herein. Furthermore, any feature of an embodiment may be independently combined, in part or in whole, with other embodiments described herein in any manner; for example, one, two, or three or more embodiments may be wholly or partially combined. Additionally, any feature of an embodiment may be optional for other aspects or embodiments. Any aspect or embodiment of the method may be performed by a system or apparatus of another aspect or embodiment, and any aspect or embodiment of the system may be configured to perform the method of another aspect or embodiment. Attached Figure Description

[0103] The following description of these and other features, aspects, and advantages is intended to illustrate, but not limit, the invention. In the drawings, similar reference numerals consistently denote corresponding features throughout the similar embodiments.

[0104] Figure 1 A schematic diagram of a continuous analyte sensor system is illustrated based on some embodiments.

[0105] Figure 2 A perspective view of the applicator system is illustrated based on some embodiments.

[0106] Figure 3 According to some embodiments, from Figure 2 A cross-sectional side view of the system.

[0107] Figure 4 A perspective view of a sensor assembly on the skin, illustrated according to some embodiments.

[0108] Figure 5 and 6 A perspective view of a transmitter coupled to a base via mechanical interlocking, illustrated according to some embodiments.

[0109] Figures 7 to 11 According to some embodiments, from Figure 3 A cross-sectional side view of the applicator system.

[0110] Figure 12A According to some embodiments, from Figure 3 A cross-sectional side view of a portion of the applicator system.

[0111] Figure 12B According to some embodiments, it is possible to be in Figure 3The image shows a cross-sectional side view of the base used in conjunction with the applicator system.

[0112] Figure 13 According to some embodiments, from Figure 4 A perspective view of a portion of the adhesive.

[0113] Figure 14 According to some embodiments, from Figure 3 A perspective view of a part of the applicator system.

[0114] Figure 15 and 16 According to some embodiments, in Figure 7 The figure shows a perspective view of a cross-section of a portion of the system.

[0115] Figure 17 According to some embodiments, from Figure 7 A cross-sectional view of the first part of the retractable assembly.

[0116] Figures 18 to 19 According to some embodiments, from Figure 7 A perspective view of a portion of the applicator system.

[0117] Figure 20 and 21 According to some embodiments, from Figure 7 A perspective view of the needle after the retractable assembly has been removed.

[0118] Figure 22 According to some embodiments Figure 7 A perspective view of the cover of the retractable assembly.

[0119] Figure 23 A schematic diagram illustrating force distribution is provided based on some embodiments.

[0120] Figure 24 A cross-sectional side view of a portion of the applicator system is illustrated according to some embodiments.

[0121] Figure 25 A cross-sectional side view of a portion of the fixing mechanism is illustrated according to some embodiments.

[0122] Figure 26 A top view of the ring is illustrated according to some embodiments.

[0123] Figure 27 Perspective views of the fixing mechanism are illustrated according to some embodiments.

[0124] Figure 28 A cross-sectional perspective view of a retractable assembly with a motor is illustrated according to some embodiments.

[0125] Figure 29and 30 A cross-sectional side view of a retractable assembly with a motor is illustrated according to some embodiments.

[0126] Figure 31 A side view of a retractable assembly that causes rotational movement, as illustrated in some embodiments.

[0127] Figure 32 A cross-sectional perspective view of a retractable assembly having a downward locking feature is illustrated according to some embodiments.

[0128] Figure 33 A perspective view of the sensor assembly on the skin just before the electronic unit is coupled to the base, as illustrated in some embodiments.

[0129] Figure 34 and 35 A perspective view of a sensor module with a spring is illustrated according to some embodiments.

[0130] Figure 36 A cross-sectional perspective view of a portion of a sensor module is illustrated according to some embodiments.

[0131] Figure 37 A perspective view of a sensor module with a spring is illustrated according to some embodiments.

[0132] Figure 38 A cross-sectional perspective view of a portion of a sensor module is illustrated according to some embodiments.

[0133] Figure 39 A perspective view of the sensor module is illustrated according to some embodiments.

[0134] Figure 40 A cross-sectional perspective view of an assembly with offset is illustrated according to some embodiments.

[0135] Figure 41 A side view of the sensor is illustrated according to some embodiments.

[0136] Figure 42 A bottom view of the needle is illustrated according to some embodiments.

[0137] Figure 43 A front view of the needle is illustrated according to some embodiments.

[0138] Figure 44 A cross-sectional perspective view of the applicator system is illustrated according to some embodiments.

[0139] Figure 45 A cross-sectional perspective view of a portion of the applicator system is illustrated according to some embodiments.

[0140] Figure 46 A perspective view illustrating a portion of the applicator system according to some embodiments.

[0141] Figure 47 A perspective view of the sensor module is illustrated according to some embodiments.

[0142] Figure 48 A cross-sectional perspective view of the applicator system is illustrated according to some embodiments.

[0143] Figure 49 A cross-sectional perspective view of the proximal portion of a retractable assembly is illustrated according to some embodiments.

[0144] Figure 50 A perspective view of the distal portion of the retractable assembly is illustrated according to some embodiments.

[0145] Figure 51 A perspective view of a needle with adhesive is illustrated according to some embodiments.

[0146] Figure 52 A perspective view of a needle with two separate sides is illustrated according to some embodiments.

[0147] Figure 53 According to some embodiments, in Figure 52 The image shows a top view of the cross-section of the needle.

[0148] Figure 54 A perspective view of a needle with a bevel is illustrated according to some embodiments.

[0149] Figure 55 A top view of the cross-section of four needles is illustrated according to some embodiments.

[0150] Figures 56 to 58 According to some embodiments, it is similar to... Figure 7 The embodiment shown is an exception, which is a cross-sectional side view of a system that does not include needles.

[0151] Figure 59 According to some embodiments, the movement is similar to that in addition to the movement of the starting position and the base. Figure 7 The figure shows a cross-sectional side view of the system of an embodiment.

[0152] Figure 60 A perspective view of a system with a cover is illustrated according to some embodiments.

[0153] Figures 61 to 63 According to some embodiments, it is similar to... Figure 7 The embodiment shown is an exception, which is a cross-sectional perspective view of a system in which the retractable assembly includes additional parts.

[0154] Figure 64 According to some embodiments, in Figures 61 to 63 The figure shows a cross-sectional side view of the system.

[0155] Figure 65 Perspective view illustrating a portion of the sensor module according to some embodiments.

[0156] Figure 66 According to some embodiments, in Figure 65 The image shows a cross-sectional side view of the sensor module.

[0157] Figure 67 Perspective view illustrating a portion of the sensor module according to some embodiments.

[0158] Figure 68 According to some embodiments, in Figure 67 The sensor module is shown in the top view.

[0159] Figure 69 and 70 A perspective view of the electronic unit just before it is coupled to the base, as illustrated in some embodiments.

[0160] Figure 71 A cross-sectional perspective view of the applicator system in a dormant state is illustrated according to some embodiments.

[0161] Figure 72 illustrate Figure 71 A cross-sectional perspective view of the applicator system, in which the actuating component is energized.

[0162] Figure 73 illustrate Figure 72 A rotating cross-sectional perspective view of the applicator system.

[0163] Figure 74 illustrate Figure 71 A cross-sectional perspective view of the applicator system, in which the actuating element is activated and the needle assembly unfolds in the insertion position.

[0164] Figure 75 illustrate Figure 71 A cross-sectional perspective view of the applicator system, showing the components on the skin in the deployed position and the needle assembly retracted.

[0165] Figure 76 A cross-sectional side view of another applicator system in a dormant state is illustrated according to some embodiments.

[0166] Figure 77 illustrate Figure 76 A cross-sectional side view of the applicator system, in which the actuating component is energized.

[0167] Figure 78 illustrate Figure 76 A cross-sectional side view of the applicator system, wherein the actuating member is activated and the needle assembly is deployed in the insertion position.

[0168] Figure 79 illustrate Figure 76 A cross-sectional side view of the applicator system, showing the components on the skin in the deployed position and the needle assembly retracted.

[0169] Figure 80 A cross-sectional side view of another applicator system in a dormant state is illustrated according to some embodiments.

[0170] Figure 81 illustrate Figure 80 A cross-sectional side view of the applicator system, in which the actuating component is energized.

[0171] Figure 82 illustrate Figure 80 A cross-sectional side view of the applicator system, wherein the actuating member is activated and the needle assembly is deployed in the insertion position.

[0172] Figure 83 illustrate Figure 80 A cross-sectional side view of the applicator system, showing the components on the skin in the deployed position and the needle assembly retracted.

[0173] Figure 84 illustrate Figure 80 A perspective view of the applicator system, in which the first and third parts are shown in cross-section to better illustrate certain parts of the system, and in a dormant state.

[0174] Figure 85 illustrate Figure 80 A perspective view of the applicator system, wherein the first and third portions are shown in cross-section to better illustrate certain parts of the system, and wherein the actuating element is energized.

[0175] Figure 86 A cross-sectional side view of another applicator system in a dormant state, where the actuating component is energized, is illustrated according to some embodiments.

[0176] Figure 87 illustrate Figure 86 A cross-sectional side view of the applicator system, wherein the actuating member is activated and the needle assembly is deployed in the insertion position.

[0177] Figure 88 illustrate Figure 86 A cross-sectional side view of the applicator system, showing the components on the skin in the deployed position and the needle assembly retracted.

[0178] Figure 89 A cross-sectional side view of another applicator system in a dormant state, where the actuating component is energized, is illustrated according to some embodiments.

[0179] Figure 90 illustrate Figure 86 A cross-sectional side view of the applicator system, wherein the actuating member is activated and the needle assembly is deployed in the insertion position.

[0180] Figure 91 illustrate Figure 86 A cross-sectional side view of the applicator system, showing the components on the skin in the deployed position and the needle assembly retracted.

[0181] Figure 92 A side view of another applicator system with a top triggering member in a dormant state is illustrated according to some embodiments.

[0182] Figure 93 This means after the object is lifted but before it is triggered. Figure 92 Side view of the applicator system.

[0183] Figure 94 Explanation of the hibernation state Figure 92 A cross-sectional perspective view of the applicator system.

[0184] Figure 95 Explanation when it is tilted Figure 92 A cross-sectional perspective view of the applicator system.

[0185] Figure 96 This means after the object is lifted but before it is triggered. Figure 92 A cross-sectional perspective view of the applicator system.

[0186] Figure 97 illustrate Figure 96 A cross-sectional side view of the applicator system.

[0187] Figure 98 Explanation during the triggering period Figure 92 A cross-sectional side view of the applicator system.

[0188] Figure 99 This indicates that the pin assembly unfolds after triggering and in the insertion position. Figure 92 A cross-sectional side view of the applicator system.

[0189] Figure 100 illustrate Figure 92 A cross-sectional side view of the applicator system, showing the components on the skin in the deployed position and the needle assembly retracted.

[0190] Figure 101 A side view of another applicator system with a side-triggered member is illustrated according to some embodiments.

[0191] Figure 102 illustrate Figure 101 Another side view of the applicator system, in which the first and third parts are shown in cross-section to illustrate the triggering mechanism.

[0192] Figure 103 A side view of another applicator system with an integrated side trigger is illustrated according to some embodiments.

[0193] Figure 104 illustrate Figure 103 Another side view of the applicator system, in which the first and third parts are shown in cross-section and a portion of the second part is removed to illustrate the triggering mechanism.

[0194] Figure 105 A perspective view of another applicator system with a safety feature section is illustrated according to some embodiments.

[0195] Figure 106 illustrate Figure 105 A cross-sectional perspective view of a portion of the applicator system, in which the safety feature is in a locking configuration.

[0196] Figure 107 illustrate Figure 106 An enlarged view of a portion of the applicator system, with the safety features in a locking configuration.

[0197] Figure 108 illustrate Figure 105 A cross-sectional perspective view of a portion of the applicator system, with the safety feature in the release configuration.

[0198] Figure 109 illustrate Figure 105 A cross-sectional perspective view of a portion of the applicator system, wherein the safety feature is in a release configuration and wherein the third portion moves distally relative to the first portion.

[0199] Figure 110 A cross-sectional perspective view of an applicator system in a dormant and locked state is illustrated according to some embodiments, wherein the on-skin component is fixed in a proximal position.

[0200] Figure 111 illustrate Figure 110 A cross-sectional perspective view of the applicator system, in which the safety feature is unlocked.

[0201] Figure 112 illustrate Figure 110 A cross-sectional perspective view of the applicator system, in which the actuating component is energized.

[0202] Figure 113 illustrate Figure 110 A cross-sectional perspective view of the applicator system, in which the actuating element is activated and the needle assembly and the skin assembly are deployed in a distal position.

[0203] Figure 114 illustrate Figure 110A cross-sectional perspective view of the applicator system, showing the skin component in the deployed position and separated from the retractable needle assembly.

[0204] Figure 115 Explanation from Figure 110 A perspective view of the needle assembly of the system, showing the components fixed to the skin during deployment, with the base removed for illustrative purposes.

[0205] Figure 116 illustrate Figure 110 Another perspective view of the needle assembly of the system, showing it separated from the components on the skin, with the base removed for illustrative purposes.

[0206] Figure 117 illustrate Figure 100 A perspective view of a part of the system.

[0207] Figure 118 This indicates that before being coupled to the base Figure 100 A perspective view of the sensor module.

[0208] Figure 119 This indicates that after coupling to the base Figure 100 A perspective view of the sensor module.

[0209] Figure 120 A side view of the skin component and the base before the skin component is coupled to the base, as illustrated in some embodiments.

[0210] Figure 121 This indicates that the component is coupled to the base on the skin before Figure 120 A perspective view of the components and base of the skin.

[0211] Figure 122 This indicates that after the component is coupled to the base on the skin... Figure 120 Side view of the skin components and base.

[0212] Figure 123 A perspective view illustrating a portion of another applicator system according to some embodiments, wherein a component on the skin is coupled to a needle assembly at a proximal location.

[0213] Figure 124 illustrate Figure 123 A perspective view of the skin components and needle assembly.

[0214] Figure 125 Explanation in Figure 123 The image shows a perspective view of a portion of the applicator system, with the skin components separated from the needle assembly.

[0215] Figure 126 This is a perspective view illustrating a portion of the fixing component, showing the assembly fixed to the skin.

[0216] Figure 127 According to some embodiments Figure 126 A perspective view of a portion of the fixing component, in which the sensor module of the component on the skin is shown in cross section, and illustrating the decoupling features of the applicator assembly therein.

[0217] Figure 128 This indicates that after the components on the skin are decoupled from the fixation components... Figure 126 A perspective view of the components on the skin.

[0218] Figure 129 A perspective view illustrating a portion of the applicator assembly according to some embodiments, wherein a second portion is shown in cross-section, and wherein a fixing member is shown to fix the assembly on the skin in a proximal position.

[0219] Figure 130 illustrate Figure 129 A perspective view of a portion of the applicator assembly, showing that a portion of the fixing member has been cut away to better illustrate the configuration of the fixing member.

[0220] Figure 131 This indicates that after the skin components are decoupled from the needle assembly... Figure 129 A perspective view of a portion of the applicator assembly, showing the parts in which components and fixation members are removed from the skin.

[0221] Figure 132 A perspective view illustrating a portion of the applicator assembly according to some embodiments, wherein a second portion is shown in cross-section, and wherein a fixing member is shown to fix the assembly on the skin in a proximal position.

[0222] Figure 133 This indicates that after the skin components are decoupled from the needle assembly... Figure 132 A perspective view of the needle assembly and the components on the skin.

[0223] Figure 134 An exploded perspective view illustrating a portion of an applicator assembly according to some embodiments, wherein a fixing member is configured to releasably couple a component on the skin to a needle assembly.

[0224] Figure 135 illustrate Figure 134 A perspective view of a portion of the applicator assembly, in which the needle assembly is coupled to the skin component.

[0225] Figure 136 illustrate Figure 134 A perspective view of a portion of the applicator assembly, in which the needle assembly is decoupled from the components on the skin.

[0226] Figure 137A perspective view of an applicator assembly is illustrated according to some embodiments, wherein the skin component is releasably secured in a proximal position within the applicator assembly.

[0227] Figure 138 illustrate Figure 137 A perspective view of the applicator assembly, in which components on the skin are released from the fasteners.

[0228] Figure 139 illustrate Figure 137 A perspective view of the components on the skin, where fixed features are in a fixed configuration.

[0229] Figure 140 illustrate Figure 137 A perspective view of the components on the skin, where the fixed features are in the release configuration.

[0230] Figure 141 A cross-sectional perspective view of a portion of the applicator assembly is illustrated according to some embodiments, wherein a second and third portion are shown in the cross-section, and a base coupled to the applicator is shown.

[0231] Figure 142 A perspective view illustrating another applicator assembly according to some embodiments shows a patch coupled to the applicator.

[0232] Figure 143 illustrate Figure 142 A perspective view of the applicator assembly, showing the patch decoupled from the applicator. Detailed Implementation

[0233] While certain embodiments and examples are disclosed below, the subject matter of this invention extends beyond the specific disclosed embodiments to other alternative embodiments and / or uses, and to modifications and equivalents thereof. Therefore, the scope of the appended claims is not limited to any particular embodiment described below. For example, in any method or process disclosed herein, the actions or operations of the method or process can be performed in any suitable order and are not necessarily limited to any particular disclosed order. Various operations may be described in a manner that aids in understanding certain embodiments as a series of sequential, discontinuous operations; however, the order described should not be construed as implying that these operations are sequentially related. Furthermore, the structures, systems, and / or apparatuses described herein may be implemented as integral components or as separate components.

[0234] For the purpose of comparing various embodiments, certain aspects and advantages of these embodiments are described. All such aspects or advantages need not be realized through any specific embodiment. Therefore, for example, various embodiments may be implemented in a manner that achieves or optimizes one or more advantages as taught herein without necessarily achieving other aspects or advantages as may be taught or suggested herein.

[0235] System Introduction

[0236] Interpretation of U.S. Patent Publication No. US-2013-0267811-A1 (the entire contents of which are incorporated herein by reference) Figure 1 A schematic diagram illustrating how a continuous analyte sensor system 100 is attached to a subject (e.g., a person). The analyte sensor system 100 communicates with other devices 110 to 113 (which may be located distal to the subject). The transdermal analyte sensor system 102, including a skin sensor assembly 600, is secured to the subject's skin via a base (not shown) (which may be a disposable housing).

[0237] System 102 includes a transdermal analyte sensor 200 and an electronic unit (interchangeably referred to as a “sensor electronics” or “transmitter”) 500 for wirelessly transmitting analyte information to a receiver. The receiver may be remotely positioned relative to system 102. In some embodiments, the receiver includes a display screen that can display information to a person, such as a subject. Example receivers include computers, such as smartphones, smartwatches, tablets, laptops, and desktop computers. In some embodiments, the receiver may be an Apple Watch, iPhone, or iPad manufactured by Apple Inc. In yet another embodiment, system 102 may be configured to administer a drug delivery device (such as an infusion device) to a patient’s skin. In such embodiments, the system may include a catheter, in lieu of or in addition to the sensor, connected to an infusion pump configured to deliver liquid medications or other fluids into the patient’s body. In embodiments, the catheter may be deployed into the skin in substantially the same manner as the sensor described herein.

[0238] In some embodiments, the receiver is mechanically coupled to the electronic unit 500 so that the receiver can receive data (e.g., analyte data) from the electronic unit 500. To improve user convenience, in several embodiments, the receiver does not need to be mechanically coupled to the electronic unit 500 and can even receive data from the electronic unit 500 over long distances (e.g., when the receiver is many feet or even many miles away from the electronic unit 500).

[0239] During use, the sensing portion of sensor 200 may be located under the skin of the subject, and the contact portion of sensor 200 may be electrically connected to electronic unit 500. Electronic unit 500 may engage with the housing (e.g., base) of an adhesive patch attached to and fastened to the skin of the subject.

[0240] The sensor assembly 600 on the skin can be attached to the body using an applicator suitable for providing convenience and ensuring application. Such an applicator can also be used to attach the electronic unit 500 to the base, insert the sensor 200 through the skin of the body, and / or connect the sensor 200 to the electronic unit 500. Once the electronic unit 500 is engaged with the base and the sensor 200 has been inserted into the skin (and connected to the electronic unit 500), the sensor assembly can be detached from the applicator.

[0241] The continuous analyte sensor system 100 may include a sensor configuration that provides an output signal indicating the concentration of the analyte. The output signal, including (e.g., sensor data such as raw data streams, filtered data, smoothed data, and / or otherwise transformed sensor data), is transmitted to a receiver.

[0242] In some embodiments, the analyte sensor system 100 includes a transdermal glucose sensor, as described in U.S. Patent Application Publication No. US-2011-0027127-A1, the entire contents of which are hereby incorporated by reference. In some embodiments, the sensor system 100 includes a continuous glucose sensor and incorporates a transdermal sensor (e.g., as described in U.S. Patent No. 6,565,509, U.S. Patent No. 6,579,690, and U.S. Patent No. 6,484,046). The entire contents of U.S. Patent Nos. 6,565,509, 6,579,690, and 6,484,046 are hereby incorporated by reference.

[0243] In several embodiments, the sensor system 100 includes a continuous glucose sensor and a refillable subcutaneous sensor (e.g., as described in U.S. Patent No. 6,512,939). In some embodiments, the sensor system 100 includes a continuous glucose sensor and an intravascular sensor (e.g., as described in U.S. Patent No. 6,477,395, and U.S. Patent No. 6,424,847). The entire contents of U.S. Patent Nos. 6,512,939, 6,477,395, and 6,424,847 are hereby incorporated by reference.

[0244] Various signal processing techniques and glucose monitoring system embodiments suitable for use with the embodiments described herein are described in U.S. Patent Publications US-2005-0203360-A1 and US-2009-0192745-A1, the contents of which are incorporated herein by reference in their entirety. A sensor may extend through a housing that holds the sensor to the skin and provides electrical connection between the sensor and sensor electronics available in the electronics unit 500.

[0245] In several embodiments, the sensor is formed of or in the form of a wire. The distal end of the wire may be sharpened to form a cone shape (to facilitate insertion of the wire into the tissue of the body). The sensor may include an elongated conductor, such as a bare elongated conductive core (e.g., a metal wire) or an elongated conductive core coated with one, two, three, four, five, or more layers of material, each layer of material may be conductive or may not be conductive. The elongated sensor may be long and thin, yet flexible and robust. For example, in some embodiments, the minimum size of the elongated conductor is less than 0.1 inches, less than 0.075 inches, less than 0.05 inches, less than 0.025 inches, less than 0.01 inches, less than 0.004 inches, and / or less than 0.002 inches.

[0246] The sensor may have a circular cross-section. In some embodiments, the cross-section of the elongated conductor may be oval, rectangular, triangular, polyhedral, star-shaped, C-shaped, T-shaped, X-shaped, Y-shaped, irregular, etc. In some embodiments, the conductive wire electrode serves as the core. For such electrodes, one or two additional conductive layers may be added (e.g., providing an intervening insulating layer for electrical isolation). The conductive layer may be composed of any suitable material. In some embodiments, it may be necessary to utilize a conductive layer containing conductive particles (i.e., particles of conductive material) in a polymer or other binder.

[0247] In some embodiments, the material used to form the elongated conductor (e.g., stainless steel, titanium, tantalum, platinum, platinum-iridium, iridium, certain polymers, and / or the like) may be strong and rigid, and therefore fracture-resistant. For example, in several embodiments, the final tensile strength of the elongated conductor is greater than 80 kPsi and less than 500 kPsi, and / or the Young's modulus of the elongated conductor is greater than 160 GPa and less than 220 GPa. The yield strength of the elongated conductor may be greater than 60 kPsi and less than 2200 kPsi.

[0248] Electronic unit 500 is releasably coupled to sensor 200. Electronic unit 500 may include electronic circuitry associated with measuring and processing continuous analyte sensor data. Electronic unit 500 may be configured to execute algorithms associated with processing and calibrating sensor data. For example, electronic unit 500 may provide various aspects of the functionality of sensor electronic modules as described in U.S. Patent Publication Nos. US-2009-0240120-A1 and US-2012-0078071-A1, the entire contents of which are incorporated herein by reference. Electronic unit 500 may include hardware, firmware, and / or software enabling the measurement of analyte levels via a glucose sensor such as analyte sensor 200.

[0249] For example, electronic unit 500 may include a potentiostat, a power supply for providing power to sensor 200, signal processing components, data storage components, and a communication module (e.g., a telemetry module) for one-way or two-way data communication between electronic unit 500 and one or more receivers, repeaters, and / or display devices (such as devices 110 to 113). The electronic device may be attached to a printed circuit board (PCB) and may take various forms. The electronic device may take the form of an integrated circuit (IC), such as an application-specific integrated circuit (ASIC), a microcontroller, and / or a processor. Electronic unit 500 may include sensor electronics configured to process sensor information, such as storing data, analyzing data streams, calibrating analyte sensor data, evaluating analyte values, comparing estimated analyte values ​​with analyte values ​​measured over corresponding time periods, and analyzing changes in estimated analyte values. Examples of systems and methods for processing sensor analyte data are described in more detail in U.S. Patent Nos. 7,310,544, 6,931,327, 2005-0043598-A1, 2007-0032706-A1, 2007-0016381-A1, 2008-0033254-A1, and others. The contents of the patents described in U.S. Patent Publication No. 2005-0203360-A1, U.S. Patent Publication No. 2005-0154271-A1, U.S. Patent Publication No. 2005-0192557-A1, U.S. Patent Publication No. 2006-0222566-A1, U.S. Patent Publication No. 2007-0203966-A1, and U.S. Patent Publication No. 2007-0208245-A1 are incorporated herein by reference in their entirety.

[0250] One or more repeaters, receivers, and / or display devices, such as key card repeater 110, medical device receiver 111 (e.g., insulin delivery device and / or dedicated glucose sensor receiver), smartphone 112, portable computer 113, etc., may be communicatively coupled to electronic unit 500 (e.g., to receive data from electronic unit 500). Electronic unit 500 may also be referred to as a transmitter. In some embodiments, devices 110 to 113 transmit data to electronic unit 500. Sensor data may be transmitted from sensor electronic unit 500 to one or more of key card repeater 110, medical device receiver 111, smartphone 112, portable computer 113, etc. In some embodiments, analyzed values ​​are displayed on a display device.

[0251] Electronic unit 500 can communicate with devices 110 to 113 and / or any number of additional devices via any suitable communication protocol. Examples of communication protocols include radio frequency; Bluetooth; Universal Serial Bus; any wireless local area network (WLAN) communication standard, including IEEE 802.11, 802.15, 802.20, 802.22 and other 802 communication protocols; ZigBee; wireless (e.g., cellular) telecommunications; paging network communications; magnetic induction; satellite data communications; and / or proprietary communication protocols.

[0252] Additional sensor information is described in U.S. Patent Nos. 7,497,827 and 8,828,201. The entire contents of U.S. Patent Nos. 7,497,827 and 8,828,201 are incorporated herein by reference.

[0253] Any sensor shown or described herein may be an analyte sensor; a glucose sensor; and / or any other suitable sensor. The sensor described in the context of any embodiment may be any sensor described herein or incorporated herein by reference. Thus, for example in Figure 7 The sensor 138 shown herein may be an analyte sensor; a glucose sensor; any sensor described herein; and any sensor incorporated herein by reference. The sensor shown or described herein may be configured to sense, measure, detect any analyte and / or interact with any analyte.

[0254] As used herein, the term "analyte" is a broad term and is given its general and conventional meaning (and not limited to a particular or specific meaning) to those skilled in the art, and refers without limitation to substances or chemical components in analyzable biological fluids (e.g., blood, interstitial fluid, cerebrospinal fluid, lymph, urine, sweat, saliva, etc.). Analytes may include naturally occurring substances, artificial substances, metabolites, or reactant products.

[0255] In some embodiments, the analyte used for measurement by the sensing area, device, system, and method is glucose. However, other analytes are also contemplated, including but not limited to ketone bodies; acetyl-CoA; acarboxyprothrombin precursor protein; acylcarnitine; adenine phosphoribosyltransferase; adenosine deaminase; albumin; alpha-fetoprotein; amino acid distribution (arginine (Krebs cycle), histidine / uric acid, homocysteine, phenylalanine / tyrosine, tryptophan); andrenostenedione; antipithione; arabinose enantiomers; arginase; benzoyl succinate (cocaine); biotinylate; biopterin; C-reactive protein; carnitine; carnosine; CD4; copper blue. Protein; chenodeoxycholic acid; chloroquine; cholesterol; cholinesterase; cortisol; testosterone; choline; creatine kinase; creatine kinase MM isoenzyme; cyclosporine A; d-penicillamine; deethylchloroquine; dehydroepiandrosterone sulfate; DNA (acetyltransferase polymorphism, alcohol dehydrogenase, α1-antitrypsin, cystic fibrosis, Duchenne / Becker's muscular dystrophy, glucose-6-phosphate dehydrogenase, hemoglobin A, hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F, D-Punjab hemoglobin, β-thalassemia, hepatitis B virus, HCMV, HIV-1, HTLV-1, Leber hereditary Transmissible optic neuropathy, MCAD, RNA, PKU, Plasmodium vivax, sexual differentiation, 21-deoxycortisol); debutylhalofantrine; dihydropteridine reductase; diphtheria / tetanus antitoxin; erythrocyte arginase; erythrocyte protoporphyrin; esterase D; fatty acids / acylglycine; triglycerides; glycerol; free β-human chorionic gonadotropin; free erythrocyte porphyrin; free thyroxine (FT4); free triiodinated methyladenosine (FT3); fumarate diacetyl; galactose / galactose-1-phosphate; galactose-1-phosphate uridine transferase Gentamicin; glucose-6-phosphate dehydrogenase; glutathione; glutathione catalase; glycocholic acid; glycosylated hemoglobin; halogenated pantyltransferase; hemoglobin variants; hexosamine enzyme A; human erythrocyte carbonic anhydrase I; 17-α-hydroxyprogesterone; hypoxanthine phosphoribosyltransferase; immunoreactive trypsin; lactate; lead; lipoproteins ((a), B / A-1, β); lysozyme; mefloquine; netilmicin; phenobarbital; phenytoin; phytanoic acid / norphytanoic acid; progesterone; prolactin; aminoacylproline dipeptidase; purine nucleoside phosphorylase; quinine; reverse triiodinated methyladenosine (rT3); selenium; serum pancreatic lipase; siclomycin; growth factor C;Specific antibodies (adenovirus, antinuclear antibody, anti-ζ antibody, arbovirus, pseudorabies virus, dengue virus, dracunculia spp., echinococcosis, entamoeba histolytica, enterovirus, Giardia lamblia, Helicobacter pylori, hepatitis B virus, herpesvirus, HIV-1, IgE (atopic disease), influenza virus, Leishmania donovani, Leptospira, measles / mumps / rubella, Mycobacterium leprae, Mycoplasma pneumoniae, myoglobin, filariasis, parainfluenza virus, Plasmodium falciparum, poliovirus, Pseudomonas aeruginosa, respiratory syncytial virus) Viruses, Rickettsiae (jungle typhus), Schizothorax mansoni, Toxoplasma gondii, Treponema pallidum, Trypanosoma japonicum, vesicular stomatitis virus, Wucet's nematode, yellow fever virus); specific antigens (hepatitis B virus, HIV-1); acetone (e.g., succinylated acetone); acetoacetic acid; sulfadoxine; theophylline; thyroid-stimulating hormone (TSH); thyroxine (T4); thyroxine-binding globulin; trace elements; transferrin; UDP-galactose-4-epimerase; urea; uroporphyrinogen I synthase; vitamin A; leukocytes; and zinc protoporphyrin.

[0256] In some embodiments, salts, sugars, proteins, fats, vitamins, and hormones naturally present in blood or interstitial fluid may also constitute the analyte. The analyte may be naturally present in biological fluids or endogenous, such as metabolites, hormones, antigens, antibodies, etc. Alternatively, the analyte may be introduced into the body or be exogenous, such as contrast agents for imaging, radioactive isotopes, chemical reagents, fluorocarbon-based synthetic blood, or pharmaceutical or medical compositions, including (but not limited to): insulin; glucagon; ethanol; cannabinoids (cannabis, tetrahydrocannabinol, hashish); inhalants (nitrous oxide, amyl nitrite, butyl nitrite, chlorinated hydrocarbons, hydrocarbons); cocaine (crack cocaine). Cocaine; Stimulants (amphetamine, methamphetamine, methylphenidate, pemoline, preludin, benzylphenamine hydrochloride, PreState, o-chlorophenamine hydrochloride, Sandrex, benzomorpholine); Depressants (barbiturates, methylquinone, tranquilizers such as diazepam, nitrazepam, methylphenidate, chlorpheniramine, methylphenidate, potassium chlordiazepoxide); Hallucinogens (phencyclohexylpiperidine, lysergic acid, styraxine, peoxyphenide, phytohexidine); Anesthetics (heroin, codeine, morphine, opium, pethidine, percocet, compound oxycodone, hydrocodone antitussive, fentanyl, propoxyphene hydrochloride preparations, analgesics, antidiarrheal drugs); Designer drugs Drugs (analytes of fentanyl, pethidine, amphetamine, methamphetamine, and phencyclohexylpiperidine, e.g., psychedelic drugs); anabolic steroids; and nicotine. Metabolites of drugs and pharmaceutical compositions are also expected analytes. Analytes produced in the human body, such as neurochemicals and other chemicals, such as ascorbic acid, uric acid, dopamine, norepinephrine, 3-methoxytyramine (3MT), 3,4-dihydroxyphenylacetic acid (DOPAC), homovanillic acid (HVA), serotonin (5HT), 5-hydroxyindoleacetic acid (FHIAA), and intermediates in the citric acid cycle, may also be analyzed.

[0257] Many of the embodiments described herein use adhesives (e.g., in...). Figure 7 (Adhesive 126 in the text). One purpose of the adhesive is to couple a base, sensor module, and / or sensor to a body (e.g., to the skin of the body). The adhesive may be configured for adhesion to the skin. The adhesive may include a pad (e.g., positioned between the adhesive and the base). Additional adhesive information, including adhesive pad information, is described in U.S. Patent Application No. 14 / 835,603, filed August 25, 2015. The entire contents of U.S. Patent Application No. 14 / 835,603 are incorporated herein by reference.

[0258] Distal base positioning

[0259] As described above, the system can apply the sensor assembly to the skin of the subject. The system may include a base containing an adhesive that couples a glucose sensor to the skin.

[0260] In some applicators, the base is concealed deep within the applicator until the user moves the needle distally using the base. A challenge with this method is that the insertion site (on the skin of the body) is not ideally prepared for sensor and / or needle insertion. For example, the distal end of the applicator may be a clamp pressed against the skin. The pressure of the applicator on the skin can cause a convex shape to form in the skin area within the clamp. Furthermore, the skin within the clamp may be too easily compressed, lacking sufficient elasticity and firmness. In this state, the sensor and / or needle may press down on the skin without immediately piercing it, which can lead to improper sensor and / or needle insertion.

[0261] In several embodiments, the base is coupled to a retractable assembly such that the base extends from the distal end of the system when the glucose sensor is positioned away from the base and within the retractable assembly. This configuration allows the base to prepare an insertion site in the skin for sensor and / or needle insertion (e.g., by compressing the skin). Therefore, these embodiments can significantly improve the reliability of sensor and / or needle insertion while reducing pain associated with sensor and / or needle insertion.

[0262] The system can accommodate the base at a position distal to the glucose sensor module, such that the glucose sensor is not attached to the base, and allows the glucose sensor to move relative to the base. Moving the glucose sensor module distally toward the base can attach the glucose sensor to the base. This movement can occur due to the compression applicator.

[0263] Figure 2 Description for use with sensor assembly 600 on skin (in) Figure 4 The image shows a perspective view of an applicator system 104, at least partially applied to the skin of a subject (e.g., a human). The system may include a sterile barrier having a shell 120 and a cap 122. The cap 122 may be screwed onto the shell 120 to shield portions of the system 104 from external contaminants.

[0264] Electronic unit 500 (e.g., a transmitter with a battery pack) is detachably coupled to sterile barrier housing 120. The remainder of applicator system 104 can be sterilized, and electronic unit 500 can subsequently be coupled to sterile barrier housing 120 (so that electronic unit 500 is sterilized without the remainder of applicator system 104).

[0265] The user can detach the electronic unit 500 from the sterile barrier shell 120. The user can also couple the electronic unit 500 to the base 128 (e.g., after at least a portion of the sensor has been placed subcutaneously in the applicator system 104 (for analyte sensing)). Figure 6 (as shown in the image).

[0266] Many different sterilization processes can be used with the embodiments described herein. The sterile barrier 120 and / or cap 122 can block gas passage (e.g., it can be airtight). An airtight seal can be formed via threads 140 (in... Figure 3 (As shown in the diagram). The thread 140 may be compliant, allowing it to deform to create a seal. The thread 140 may be positioned between the sterile barrier shell 120 and the cap 122.

[0267] The cap 122 may be made of polypropylene and the shell 120 may be made of polycarbonate (or vice versa), such that one of the cap 122 and shell 120 is harder than the other. This difference in hardness (or flexibility) allows one of the components to deform to produce a threaded seal 140.

[0268] In some embodiments, at least one of the shell 120 and the cap 122 includes a gas-permeable material to allow sterilizing gas to enter the applicator system 104. For example, as in Figure 60 As explained in the context, the system may include a cover 272h.

[0269] For reference Figure 3 The thread 140 can be configured such that the cover 122 is decoupled from the housing 120 by a quarter rotation, at least 15% of full rotation, and / or less than 50% of full rotation. Some embodiments do not include the thread 140. Even in some screw-on embodiments, the cover 122 can be pushed onto the housing 120 (e.g., during assembly).

[0270] The cap 122 can be secured to the housing 120 by an easy-release member 142, which is configured such that removing the cap 122 from the housing 120 disconnects the easy-release member 142. The easy-release member 142 may be configured similarly to the safety ring (with an easy-release portion) of a plastic soda bottle. Unscrewing the cap from the plastic soda bottle disconnects the safety ring from the cap. This method provides evidence of tampering. In the same manner, the applicator system 104 can provide evidence of tampering (because the easy-release member 142 disconnects by removing the cap 122 from the housing 122).

[0271] U.S. Patent Publication No. US-2013-0267811-A1; U.S. Patent Application No. 62 / 165,837, filed May 15, 2015; and U.S. Patent Application No. 62 / 244,520, filed October 21, 2015, include additional details regarding embodiments of the applicator system. The entire contents of U.S. Patent Publication No. US-2013-0267811-A1; U.S. Patent Application No. 62 / 165,837; and U.S. Patent Application No. 62 / 244,520 are incorporated herein by reference.

[0272] Figure 3 A cross-sectional view illustrating system 104 is shown. Glucose sensor module 134 is configured to couple glucose sensor 138 to base 128 (e.g., "housing"). A retractable assembly 132 is positioned at a proximal starting position such that glucose sensor module 134 is positioned proximal and distal to base 128 relative to base 128. Retractable assembly 132 is configured such that retracting retractable assembly 132 connects glucose sensor module 134 to base 128 via one or more mechanical interlocks (e.g., snap-fit ​​assembly, interference fit features).

[0273] The sterile barrier shell 120 is coupled to the retractable assembly 132. After removing the cap 122, the system 104 is configured such that distal compression of the sterile barrier shell 120 (when the distal portion of the system 104 is pressed against the skin) can activate the sensor 138 (in Figure 4 (As shown in the figure) It is inserted into the skin of the body to place the transdermal glucose analyzer sensor 138. In many of the figures shown herein, the sterile barrier shell 120 and the cap 122 are concealed to improve the clarity of other features.

[0274] The retractable assembly 132 further extends at least 2.5 mm of glucose sensor 138 through a hole in the base 128, such that the glucose sensor 138, previously positioned proximally relative to the distal end of the base, extends distally beyond the base 128. Therefore, in some embodiments, the base 128 can remain stable relative to the distal portion of the retractable assembly 132 as the retracting movement of the retractable assembly 132 causes the glucose sensor module 134 to face toward the base 128 and subsequently couples the sensor module 134 to the base 128.

[0275] This relative movement between the sensor module 134 and the base 128 has several benefits, such as allowing the base to prepare an insertion site for the sensor and / or needle (e.g., by compressing the skin). The starting position of the base 128 also allows it to shield the person from the needle, which can be positioned within the applicator system 104. For example, if the base 128 were directly coupled to the sensor module 134 at its proximal starting position in the retractable assembly, the needle could extend distally from the base 128. An exposed needle could pose a potential hazard. In contrast, the distal starting position of the base 128 allows it to protect the person from unintentional needle insertion. Needle protection is particularly important for caregivers (who are not in the area). Figure 4 The intended receiver of the skin sensor assembly 600 shown in the figure is particularly important.

[0276] Figure 4The illustration includes a perspective view of a skin-mounted sensor assembly 600 with base 128. Adhesive 126 couples base 128 to the skin 130 of the body. Adhesive 126 may be a foam adhesive suitable for skin adhesion. A glucose sensor module 134 is configured to couple glucose sensor 138 to base 128.

[0277] Applicator system 104 (in Figure 2 (As shown in the diagram) the adhesive 126 can be coupled to the skin 130. The system 104 can also secure the glucose sensor module 134 (e.g., via mechanical interlocking, such as a snap-fit ​​assembly and / or interference fit) to the base 128 to ensure that the glucose sensor 138 is coupled to the base 128. Thus, the adhesive 126 can couple the glucose sensor 138 to the skin 130 of the body.

[0278] After the glucose sensor module 134 is coupled to the base 128, the user (or applicator) can couple the electronic unit 500 (e.g., a transmitter) to the base 128 via a mechanical interlock (such as a snap-fit ​​assembly and / or an interference fit). The electronic unit 500 can measure and / or analyze the glucose indicator sensed by the glucose sensor 138. The electronic unit 500 can transmit information (e.g., measurement values, analyte data, glucose data) to a remotely located device (e.g., in...). Figure 1 (110 to 113 shown in the figure).

[0279] Figure 5 This is a perspective view illustrating the electronic unit 500 coupled to the base 128 via mechanical interlocking (such as a snap-fit ​​assembly and / or interference fit). An adhesive 126 on the distal side of the base 128 is configured to couple the sensor assembly 600 to the skin. Figure 6 Another perspective view illustrating the electronic unit 500 coupled to the base 128.

[0280] exist Figures 1 to 6 Any features described in the context of this document are applicable to all aspects and embodiments identified herein. For example, many embodiments can be used in… Figure 4 The skin sensor assembly 600 shown in the figure can be used in Figure 2 The sterile barrier shell 120 is shown in the diagram. Furthermore, any feature of the embodiments may be independently combined with other embodiments described herein, in any way, either partially or in whole; for example, one, two, or three or more embodiments may be fully or partially combined. Additionally, any feature of the embodiments may be optional for other aspects or embodiments. Any aspect or embodiment of the method may be performed by a system or apparatus of another aspect or embodiment, and any aspect or embodiment of the system may be configured to perform the method of another aspect or embodiment.

[0281] Figures 7 to 11Explanation from Figure 3 Cross-sectional view of the applicator system 104. Sterile barrier shell 120 and cap 134 are shown. Figures 7 to 11 The scalable assembly 132 is hidden to facilitate viewing.

[0282] The retractable assembly 132 is part of a system for applying the skin sensor assembly 600 to the skin of a subject (in... Figure 4 (As shown in the diagram). The retractable assembly 132 can apply portions of the system to the body. After the applicator system 104 couples the initial portion of the sensor assembly 600 to the body, additional portions of the system can be added to the sensor assembly 600 on the skin. For example, as in... Figure 4 As shown, in the applicator system 104 (in Figure 3 (As shown in the figure) After the base 128, glucose sensor module 134 and / or glucose sensor 138 are coupled to the skin 130 of the body, the electronic unit 500 (e.g., a transmitter) can be coupled to the sensor assembly 600 on the skin.

[0283] In some embodiments, the applicator system 104 (in Figure 3 (As shown in the diagram) At least one, at least two, at least three, at least four, and / or all of the following items are coupled to the skin of the subject: electronic unit 500, glucose sensor module 134, glucose sensor 138, base 128, and adhesive 126. Electronic unit 500 may be located within applicator system 104 such that applicator system 104 is configured to couple electronic unit 500 to the skin of the subject.

[0284] Figure 7 The description describes a retractable assembly 132 having a first portion 150 (e.g., a "pusher") configured to move along path 154 from a proximal starting position relative to a second portion 152 (e.g., a "needle sheath") to a distal position. Figure 7 Description of the retractable assembly 132 at the proximal starting position. Figure 8 This describes a retractable assembly 132 that moves between a proximal starting position and a distal position. Figure 11 Description of the retractable assembly 132 at the distal position. Path 154 (in Figure 7 (As shown in the image) indicates the movement between the proximal starting position and the distal position.

[0285] The first group of items can not be moved relative to the first part 150, and the second group of items can not be moved relative to the second part 152 when the first group of items moves relative to the second group of items.

[0286] For reference Figure 7The glucose sensor 138 and sensor module 134 are coupled to a first portion 150 (e.g., such that they cannot move relative to the first portion 150 during the proximal portion of path 154). A base 128 is coupled to a second portion 152 such that the base 128 extends from the distal end of the system (e.g., the base extends from the distal end of the retractable assembly 132). The base 128 includes an adhesive 126 configured to ultimately couple the glucose sensor 138 to the skin (e.g., after at least a portion of the glucose sensor 138 is rigidly coupled to the base 128).

[0287] exist Figure 7 In this configuration, as the base 128 extends from the distal end of the system (e.g., from the distal end of the retractable assembly 132), the glucose sensor 138 and sensor module 134 are positioned within the second portion 152, such that the system is configured to couple the glucose sensor 138 to the base 128 via distal movement of the first portion 150 relative to the second portion 152. Figures 7 to 11 The progress shown illustrates that the first part 150 moves distally relative to the second part 152.

[0288] Sensor module 138 is coupled to the distal portion of first portion 150 such that moving first portion 150 to a distal position (as described above) couples sensor module 134 to base 128. When first portion 150 is positioned in a proximal starting position, glucose sensor 138 is coupled to sensor module 134 (e.g., cannot move relative to sensor module 134). Glucose sensor 138 may include a distally extending portion and a proximal portion. The proximal portion may be rigidly coupled to sensor module 134 such that even if the distally extending portion may be bent relative to sensor module 134, the proximal portion cannot move relative to sensor module 134.

[0289] A needle 156 (e.g., a "C-shaped" needle) is coupled to the first portion 150 such that the glucose sensor 138 and the needle 156 are moved distally relative to the base 128 and relative to the second portion 152. The system may further include a needle release mechanism 158 configured to retract the needle 156 proximally.

[0290] Needle 156 can come in many different forms. Many different types of needle 156 can be used with the embodiments described herein. Figures 51 to 55 Various pin embodiments that can be used with any of the embodiments described herein are explained.

[0291] The needle 156 can guide the sensor 138 into the skin of the subject. The distal portion of the sensor 138 can be positioned within the channel of the needle 156 (e.g., in...). Figure 42(As shown in the diagram). Sometimes, the distal end of the sensor 138 protrudes from the needle 156 and hooks into the tissue of the body when the sensor 138 and needle 156 are inserted into the body. Therefore, the sensor 138 can bend and cannot be inserted deep enough into the subcutaneous tissue. In other words, in some embodiments, the sensor wire must be placed within the channel of the C-shaped needle 156 to be guided into the tissue and must remain in the channel 330 during deployment.

[0292] The danger of sensor 138 probing channel 330 (and thus failing to detect the feature of insertion into the body) can be detected by... Figure 51 The embodiment shown is significantly simplified. In this embodiment, adhesive 376 bonds the distal portion of glucose sensor 138 to the channel 330 of needle 156. Retracting needle 156 breaks the bond of adhesive 376 so that the distal portion of sensor 138 can remain subcutaneously positioned when needle 156 is retracted (and even after needle 156 is retracted).

[0293] The danger of sensor 138 probing channel 330 (and thus failing to detect the feature of insertion into the body) can be detected by... Figure 52 and 53 The embodiment shown is significantly reduced. In this embodiment, the needle 156a includes two sides that can be separated by a slot 378. The sensor 138 may have a width greater than the width of the slot 378, such that the sensor 138 cannot leave the channel 330a until the two sides of the needle 156a move apart (to widen the slot 378).

[0294] exist Figure 54 The embodiments shown can be used with any other embodiments described herein. The needle 156b includes a bevel 380 at the distal end of the channel 330b. The distal end of the needle 156b may include a tapered tip 382. The bevel 380 can be configured to retract when the needle 156b is retracted into the retractable assembly 132 (in... Figure 7 (As shown in the diagram) When the sensor 138 is pushed away from the channel 330b of the needle 156b, it is pushed away from the channel 330b.

[0295] Figure 55 The description can be used in Figure 7Cross-sectional views of different needles 156c, 156d, 156e, 156f of needle 156 in any other embodiment described herein. Needle 156c includes an enclosed channel 330c. While needles 156d, 156e, 156f are C-needles, many other C-needle shapes may be used in several embodiments. The ends of needle 156d may be angled relative to each other. In some embodiments, the ends of the needles may be angled away from each other as shown by 156d. In some embodiments, the ends of the needles may have flared edges, wherein the flared edges are rounded to prevent sensor contact with sharp edges. The ends of needle 156e may be parallel and / or flat relative to each other. The outer portion of channel 330f may be formed by straight and / or parallel walls (rather than by curved walls, as is the case for other needles 156d, 156e). Some needles 156d can be manufactured by laser cutting, some needles 156e can be manufactured by wire electrical discharge machining (“EDM”), and some needles 156f can be manufactured by stamping.

[0296] As in Figure 7 As shown, needle hub 162 is coupled to needle 156. The needle hub includes an outwardly extending release feature 160. In some embodiments, the release feature may include one, two, or more flexible arms. The outwardly extending end 164 of the release feature 160 hooks onto the inwardly facing protruding end 166 (e.g., undercut, pawl) of the first portion 150, causing distal movement of the first portion 150 relative to the second portion 152, resulting in distal movement of the needle retraction mechanism 158 until the release point.

[0297] At the release point, the proximal protrusion 170 of the second part 152 engages with the release feature 160 (in... Figure 9 (as shown in the diagram), this forces the release feature 160 to bend inward until the release feature 160 no longer hooks onto the protruding end 166 of the first portion 150 (in...). Figure 10 (As shown in the diagram). Once the release feature 160 no longer hooks onto the protruding end 166 of the first portion 150, the spring 234 of the needle retraction mechanism 158 pushes the needle 156 and needle seat 162 proximally relative to the first portion 150 and relative to the second portion 152 until the needle no longer extends distally from the base 128 and is completely concealed within the retractable assembly 132 (in the diagram). Figure 11 (as shown in the image).

[0298] Needle 156 can be obtained from Figure 7 The embodiments shown are removed to prepare needle-free embodiments. Therefore, in some embodiments, needle 156 is not used. For example, the distal end of glucose sensor 138 may be formed into a conical shape so that glucose sensor 138 can be inserted into the skin without the need for needle 156. Unless otherwise indicated, the embodiments described herein may be formed with or without needle 156.

[0299] In several embodiments, a needle may assist in guiding the glucose sensor 138 (e.g., at least the distal portion of the glucose sensor) into the skin. In some embodiments, the needle is not part of the system and is not used to assist in guiding the glucose sensor 138 into the skin. In both needle-based and needle-free embodiments, skin puncture is an important consideration. Failure to properly puncture the skin can lead to improper placement of the glucose sensor 138.

[0300] Tightening the skin before puncturing it with the glucose sensor 138 and / or the needle 156 can significantly improve the consistency of achieving proper placement of the glucose sensor 138. Tightening the skin can be accomplished by compressing the skin with a distally extending shape (e.g., a convex shape) before puncturing the skin with the glucose sensor 138 and / or the needle 156 and at the moment of puncture.

[0301] Figure 12A Explanation in Figure 7 A portion of the cross-section is shown. Base 128 includes an optional distally facing protrusion 174 positioned distally relative to the second portion 152 (and relative to the remainder of the retractable assembly 132). The distal protrusion 174 is convex and shaped as a dome. In some embodiments, the distal protrusion 174 has a block shape, a star shape, and a cylindrical shape. Several embodiments of base 128 do not include the protrusion 174.

[0302] The distal protrusion 174 may be positioned further distally than any other portion of the base 128. The distal protrusion 174 may extend through a hole 176 in the adhesive 126 (also as in...). Figure 5 (As shown in the figure). When the proximal portion of the protrusion 174 of the convex surface is positioned proximally relative to the adhesive 126, the distal portion of the protrusion 174 of the convex surface can be positioned distally relative to the adhesive 126.

[0303] The distal protrusion 174 has an aperture 180 through which a needle 156 and / or a glucose sensor 138 can pass. The distal protrusion 174 is compressible to the skin, such that the distal protrusion 174 is configured to reduce resistance when piercing the skin.

[0304] Figure 12B Explanation and in Figure 7 and 12B The base 128 shown is the same as the base 128b except for the following features: base 128b does not include the protrusion 174. Base 128b includes a funnel 186 (e.g., radius) on the distal side of the hole 180b.

[0305] Similar to Figure 12A In the embodiment shown, sensor 138 (e.g., analyte sensor) and / or needle 156 (in...) Figure 12A (As shown in the image) can pass through hole 180b (in) Figure 12B (As shown in the diagram). Funnels 182 and 186 may be mirror images of each other or may be of different shapes. Base 128b may be used with any of the embodiments described herein.

[0306] Figure 13 A perspective view illustrating a portion of adhesive 126. Needle 156 may have many different shapes and cross-sections. In some embodiments, needle 156 includes a groove 184 into which at least a portion of glucose sensor 138 can be placed (e.g., in…). Figure 42 and 43 Channel 330 shown in the figure.

[0307] A needle 156 with a groove 184 passes through a hole 180 of a distal protrusion and through a hole 176 of an adhesive 126. A portion of a glucose sensor 138 is positioned in the groove 184 such that the needle 156 is configured relative to the base 128 (in Figure 12A (As shown in the diagram) the portion that moves distally without removing the glucose sensor 138 from the slot 184. The distal protrusion 174 is convex, such that the distal protrusion 174 is configured such that the first portion 150 is relative to the second portion 152 of the retractable assembly 132 (in... Figure 7 (As shown in the image) Stretch the skin as you move it distally to prepare it for puncture.

[0308] As described above, the adhesive 126 includes a hole 176 through which at least a portion of the distal protrusion 174 of the base 128 can pass. The distal protrusion 174 is positioned within the hole 176 of the adhesive 126 such that the distal protrusion 174 can stretch over at least a portion of the skin within the second hole (e.g., positioned below the hole 176). The hole 176 may be circular or any other suitable shape. The hole 176 may be sized such that at least a majority of the distal protrusion 174 extends through the hole 176. The periphery of the hole 176 may be positioned outside the distal protrusion 174 such that the periphery of the hole 176 is radially outward relative to the periphery of the protrusion 174, wherein the protrusion 174 is connected to the remainder of the base 128.

[0309] In some embodiments, the orifice 176 of the adhesive 126 is large enough that the adhesive 126 does not cover any distal protrusion 174. In some embodiments, the adhesive 126 covers at least a portion or even most of the distal protrusion 174. Therefore, the adhesive 126 need not be flat and may protrude distally in the area above the distal protrusion 174.

[0310] In several embodiments, the adhesive 126 has a non-uniform thickness, such that the thickness of the adhesive 126 in the region surrounding the needle departure area is greater than its thickness in other areas radially outward from the needle departure area. Therefore, the distal protrusion 174 may be part of the adhesive 126 rather than part of the base 128. However, in several embodiments, the base 128 comprises the adhesive 126, and the distal protrusion 174 may be formed of plastic from the base 128 or of the foam adhesive 126 of the base 128.

[0311] Needle 156 includes a distal end 198 and a heel 194. The heel 194 is the proximal end of an angled portion of the needle tip. The angled portion is intended to form a sharp tip to facilitate tissue penetration. Sensor 138 has a distal end 208.

[0312] During the insertion of needle 156 and sensor 138 into the tissue; as needle 156 and sensor 138 initially extend distally from the system; and / or when needle 156 and sensor 138 are positioned within the retractable assembly, the end portion 208 of sensor 138 may be positioned at least 0.1 mm proximal to the heel 194, less than 1 mm proximal to the heel 194, less than 3 mm proximal to the heel 194, and / or within plus or minus 0.5 mm of the heel 194; and / or the end portion 208 of sensor 138 may be positioned at least 0.3 mm proximal to the distal end portion 198 of needle 156 and / or less than 2 mm proximal to the distal end portion 198.

[0313] For reference Figure 12A The distal protrusion 174 may extend from the distal surface of the adhesive 126 by at least 0.5 mm and less than 5 mm. In embodiments where the adhesive 126 has a non-planar distal surface, the distal protrusion 174 may extend from the average distal location of the adhesive 126 by at least 0.5 mm and less than 5 mm.

[0314] As described above, in some embodiments, the base is coupled to the retractable assembly such that when the glucose sensor is positioned away from the base and within the retractable assembly, the base extends from the distal end of the system. However, in other embodiments, the base is coupled to the retractable assembly such that the base is completely positioned within the retractable assembly, and the base moves distally with the sensor as the first portion moves distally relative to the second portion of the retractable assembly.

[0315] For example, Figure 59The description describes how the first portion 150 of the retractable assembly 132f is coupled to the sensor module 134 and the base 128 of the sensor 138 when the first portion 150 is positioned in the proximal starting position. As the first portion 150 moves distally relative to the second portion 152, the base 128 moves distally. When the first portion 150 is positioned in the proximal starting position, the base 128 is coupled to the distal end portion of the first portion 150. All features and embodiments described herein can be configured and... Figure 59 The base 128 described in the context is used together.

[0316] All embodiments described herein can be used with a base coupled to a retractable assembly such that the base is fully positioned within the retractable assembly, and the base moves distally with the sensor as the first portion moves distally relative to the second portion of the retractable assembly. All embodiments described herein can be used with a base coupled to a retractable assembly such that the base extends from the distal end of the system when the glucose sensor is positioned distally from the base and within the retractable assembly.

[0317] Sensor module docking and base separation

[0318] As explained above, maintaining the base against the skin during sensor and / or needle insertion enables substantial medical benefits. However, maintaining the base against the skin requires moving the sensor relative to the base during the insertion process. Once inserted, the sensor needs to be coupled to the base to prevent it from accidentally moving away. Therefore, a system is needed that allows the sensor to move relative to the base while also locking it to the base (without being overly burdensome for the user).

[0319] In several embodiments, a unique coupling system enables the base to remain in contact with the skin during distal movement of the sensor and / or needle. This is achieved by securing the sensor (and sensor module) to a first portion of the retractable assembly and the base to a second portion of the retractable assembly. Moving the first portion toward the second portion of the retractable assembly aligns the sensor with the base while temporarily holding the sensor in place. The system can then couple the sensor to the base. Finally, the system can detach the base and sensor from the retractable assembly (which may be disposable or reusable with different sensors).

[0320] As in Figure 4 As shown, sensor module 134 and glucose sensor 138 are not initially coupled to base 128. Coupling sensor module 134 and glucose sensor 138 to base 128 via compression retractable assembly 132 and before disengaging base 128 from retractable assembly 132 can be a substantial challenge, but is also enabled by many of the embodiments described herein.

[0321] As in Figure 7 and 14 As shown, even though sensor module 134 (and glucose sensor 138) are indirectly coupled via retractable assembly 132, they can be positioned distal to base 128. In other words, when base 128 is coupled to the second portion 152 of retractable assembly 132, sensor module 134 (and glucose sensor 138) can be coupled to the first portion 150 of retractable assembly 132. In this state, sensor module 134 and glucose sensor 138 can move relative to base 128 (e.g., when sensor module 134 and glucose sensor 138 move along a path from a proximal starting position to a distal position to “dock” sensor module 134 and glucose sensor 138 to base 128).

[0322] After the sensor module 134 and glucose sensor 138 are "docked" with the base 128, the system can detach the base 128 from the retractable assembly 132 so that the sensor module 134, glucose sensor 138 and base 128 can be coupled to the skin via adhesive 126 when the retractable assembly 132 and other parts of the system are discarded.

[0323] As in Figure 7 As shown, when the first portion 150 is in the proximal starting position, the sensor module 134 is coupled to the first portion 150 and positioned at least 5 mm from the base 128. The system is configured such that the first portion 150 is moved to a distal position to couple the sensor module 134 to the base 128 (as shown in...). Figure 11 (As shown in the diagram). When the first portion 150 is positioned at the proximal starting position, the glucose sensor 138 is coupled to the sensor module 134. When the base 128 extends from the distal end of the system, the glucose sensor 138 is positioned within the second portion 152.

[0324] Arrow 188 indicates that... Figure 7 The proximal direction. Arrow 190 indicates in... Figure 7 The direction distal to the center. Line 172 indicates the horizontal orientation. As used in this text, horizontal means within plus or minus 20 degrees perpendicular to the central axis 196.

[0325] Figure 15 Explanation in Figure 7 The diagram shows a cross-sectional perspective view of a portion of the system. The cross-section passes through a hole 180 in the base 128. The visible portion includes a sensor module 134, a sensor 138, a seal 192, a needle 156, the base 128, and an adhesive 126. The sensor module 134 is in a proximal starting position. The seal 192 is configured to block fluid (e.g., bodily fluid) from entering the glucose sensor module 134.

[0326] The glucose sensor 138 is mechanically coupled to the sensor module 134. The glucose sensor 138 operates within an internal portion of the sensor module 134 and is electrically coupled to interconnects within the internal portion of the sensor module 134. The interconnects are located within... Figure 15 The glucose sensor 138 is concealed to facilitate viewing the proximal portion of the glucose sensor 138 within the internal portion of the sensor module 134. Many other parts of the system are also located there. Figure 15 Hides it in the middle so that the visible part can be clearly seen.

[0327] In many embodiments, sensor module 134 is derived from... Figure 15 The position shown is moved until the sensor module 134 is fastened to the base 128 via a latch assembly described in more detail below. Figure 11 This describes the sensor module 134 that latches onto the base 128. This movement from the proximal starting position to the "docking" position can be achieved along path 154 (in... Figure 7 As shown in and through Figures 7 to 11 (Progress description) Movement complete. (The arrow indicating path 154 may not be drawn to scale.)

[0328] For reference Figure 7 and 15 During the first portion of path 154, sensor module 134 is immobile relative to first portion 150, and base 128 is immobile relative to second portion 152 of retractable assembly 132. During the second portion of path 154, the system is configured to move first portion 150 distally relative to second portion 152; move sensor module 134 toward base 128; move at least a portion of sensor 138 through a hole 180 in base 128; couple sensor module 134 to base 128; and enable the coupled sensor module 134 and base 128 to disengage from retractable assembly 132.

[0329] Figure 7 This describes the vertical central axis 196 oriented from the proximal end to the distal end of the system. (A portion of the central axis 196 is located in...) Figure 7 (Hide the arrow representing path 154 to avoid obscuring it and avoid obscuring pin 156.)

[0330] Figure 15 The bent arm 202 of the sensor module 134 is described. The bent arm 202 is horizontally oriented and configured to secure the sensor module 134 to a protrusion of the base 128. In some embodiments, the bent arm 202 is an alignment arm to prevent and / or impede rotation of the sensor module 134 relative to the base 128.

[0331] Figure 16The illustration shows a perspective view of a cross-section in which the sensor module 134 is coupled to the base 128 via a curved arm 202. An interconnect 204 extends proximally to connect the sensor module 134 to an electronics unit 500 (e.g., a transmitter).

[0332] For reference Figure 15 and 16 The curved arm 202 extends from the outer periphery of the sensor module 134. The base 128 includes a protrusion 206 extending proximally from a flat, horizontal portion of the base 128.

[0333] For reference Figure 16 Each of the proximal protrusions 206 of the base 128 is coupled to the curved arm 202 of the sensor module 134. Thus, the proximal protrusions 206 coupled to the curved arm 202 couple the sensor module 134 to the base 128.

[0334] Each proximal protrusion 206 may include a locking protrusion 212 extending at an angle of at least 45 degrees to the central axis of each proximal protrusion 206. In some embodiments, the locking protrusion 212 extends horizontally (e.g., as in...). Figure 15 (As shown in the diagram). Each horizontal locking protrusion 212 is coupled to the end portion 210 of the flexible arm 202.

[0335] The end portion 210 of each flexible arm 202 may extend at an angle greater than 45 degrees and less than 135 degrees relative to the central axis of most of the flexible arms 202. The end portion 210 of each flexible arm 202 may include a horizontal locking protrusion (e.g., as shown in...). Figure 15 (as shown in the image).

[0336] exist Figure 15 and 16 In the middle, a first horizontal locking protrusion is coupled to the end portion 210 of the first flexible arm 202. A second horizontal locking protrusion 212 is coupled to the first proximal protrusion 206 of the base 128. Figure 16 In the middle, the first horizontal locking protrusion is positioned distally below the second horizontal locking protrusion 212 to secure the sensor module 134 to the base 128. The system is configured such that the first portion 150 of the retractable assembly 132 is moved to the distal position (in Figure 11 (As shown in the figure) this causes the first curved arm 202 to bend so that the first horizontal locking protrusion of the curved arm 202 can move distally relative to the second horizontal locking protrusion 212. Thus, the curved arm 202 is fixed between the locking protrusion 212 of the base 128 and the distal side.

[0337] At least a portion of the curved arm 202 (e.g., end portion 210) is positioned distally under a horizontal locking protrusion 212 of the base 128 to secure the sensor module 134 to the base 128. The system is configured such that a first portion 150 of the retractable assembly 132 is moved to a distal position causing the curved arm 202 (e.g., end portion 210) to bend away from (e.g., outward) the remainder of the sensor module 134, allowing the horizontal locking protrusion of the curved arm 202 to surround the locking protrusion 212 of the proximal protrusion 206. Thus, at least a portion of the curved arm 202 is movable distally relative to the horizontal locking protrusion 212 of the proximal protrusion 206 of the base 128.

[0338] The sensor module 134 may have a plurality of curved arms 202, and the base may have a plurality of proximal protrusions 206 configured to couple the sensor module 134 to the base 128. In some embodiments, a first curved arm 202 is positioned on the opposite side of the sensor module 134 relative to a second curved arm 202 (e.g., as in...). Figure 15 and 16 (as shown in the image).

[0339] In some embodiments, the base 128 includes a curved arm (e.g., similar to a curved arm in a curved arm). Figure 15 and 16 The bent arm 202 shown is illustrated, and the sensor module 134 includes a protrusion of the bent arm coupled to the base 128. The protrusion of the sensor module 134 may be similar to that in... Figure 15 and 16 The protrusion 206 shown is an exception in some embodiments, where the protrusion extends distally toward the curved arm of the base 128. Thus, the base 128 can be coupled to the sensor module 134 via the curved arm and the mating protrusion, regardless of whether the base 128 or the sensor module 134 includes the curved arm.

[0340] In several embodiments, a sensor module is coupled to a glucose sensor. The system includes a vertical central axis oriented from a proximal end to a distal end of the system. A base includes a first curved arm oriented horizontally and coupled to the sensor module. The sensor module includes a first distal projection coupled to the first curved arm to couple the sensor module to the base. A first horizontal locking projection is coupled to an end portion of the first flexible arm. A second horizontal locking projection is coupled to the first distal projection of the sensor module. The second horizontal locking projection is distally positioned below the first horizontal locking projection to secure the sensor module to the base. The system is configured such that a first portion of the retractable assembly moves to a distal position causing the first curved arm to bend, allowing the second horizontal locking projection to move distally relative to the first horizontal locking projection. The sensor module includes a second distal projection of a second curved arm coupled to the base. The first distal projection is positioned on the opposite side of the sensor module relative to the second distal projection.

[0341] As the sensor module 134 moves toward the base 128 from the first portion 150, the docking of the sensor module 134 with the base 128 may include securing the sensor module 134 to the first portion 150 of the retractable assembly 132. This securing of the sensor module 134 to the first portion 150 of the retractable assembly 132 needs to be reliable but temporary, so that the sensor module 134 can be detached from the first portion 150 at appropriate stages. The structure for securing the sensor module 134 to the first portion 150 of the retractable assembly 132 generally needs to avoid obtaining it through a docking process.

[0342] Figure 17 This describes a cross-sectional view of the first portion 150 of the retractable assembly 132. Figure 17 The glucose sensor module 134 and needle 156 are shown. Some embodiments do not include needle 156. Many items in Figure 17 The middle is hidden to provide a clear view of the curved arms 214, 216 of the first part 150.

[0343] The first portion 150 includes a first curved arm 214 and a second curved arm 216 extending distally and latching onto the sensor module 134, so that the first portion 150 is in a proximal starting position (in Figure 7 (As shown in the diagram) the sensor module 134 is releasably secured to the first portion 150. Bending arms 214, 216 are coupled to the outer periphery of the sensor module 134 such that the distal ends of the bending arms 214, 216 surround the distal side of the sensor module 134. In some embodiments, when the first portion 150 is in the proximal starting position, the distal ends of the bending arms 214, 216 are positioned distally to the sensor module 134.

[0344] Base 128 Figure 17 Hidden in, but in Figure 17 In the configuration shown, the sensor module 134 is positioned distal to the base 128 to provide a distance of at least 3 mm from the sensor module 134 to the base 128 when the first portion 150 is in the proximal starting position. This distance is important for allowing the base to rest on the skin during percutaneous insertion as the needle 156 and / or the glucose sensor 138 pierce and advance into the skin.

[0345] For reference Figure 7 and 17When the base 128 extends from the distal end of the system, the sensor module 134 is positioned within the second portion 152, such that the system is configured to couple the sensor module 134 to the base 128 via a distal movement of the first portion 150 relative to the second portion 152. Even though the sensor module 134 is movable relative to the second portion 152 of the retractable assembly 132, the sensor module 134 is positioned within the second portion 152 when the base 128 extends from the distal end of the system. Therefore, the first portion 150 moves the sensor module 134 through the interior region of the second portion 152 of the retractable assembly 132 without moving the base 128 through the interior region of the second portion 152.

[0346] The system includes a vertical central axis 196 oriented from the proximal end to the distal end of the system. A first curved arm 214 and a second curved arm 216 of the first portion 150 secure the sensor module 134 to the first portion 150 such that the sensor module 134 is releasably coupled to the first portion 150 with a first vertical holding strength (measured along the vertical central axis 196).

[0347] As in Figure 15 and 16 As shown, sensor module 134 is coupled to base 128 via at least one curved arm 202, such that sensor module 134 is coupled to base 128 with a second vertical holding strength. Curved arm 202 may extend from the outer periphery of sensor module 134. Curved arm 202 may be part of base 128.

[0348] For reference Figure 17 In some embodiments, the second vertical holding strength is greater than the first vertical holding strength, such that once the sensor module 134 is coupled to the base 128, the first portion 150 continues to be pushed distally to overcome the first and second curved arms 214, 216 of the first portion 150 to disengage the sensor module 134 from the first portion 150.

[0349] In some embodiments, the second vertical holding strength is at least 50% greater than the first vertical holding strength. In several embodiments, the second vertical holding strength is at least 100% greater than the first vertical holding strength. In some embodiments, the second vertical holding strength is greater than 400% greater than the first vertical holding strength.

[0350] Figure 6 This describes the skin sensor assembly 600 in a state where it is attached to the main body. The skin sensor assembly 600 may include a glucose sensor 138 and / or a sensor module 134 (in...). Figure 7 (as shown in the figure). In some embodiments, the skin sensor assembly 600 includes a needle 156. However, in several embodiments, the skin sensor assembly 600 does not include a needle 156.

[0351] As explained above, maintaining the base against the skin during sensor and / or needle insertion enables substantial medical benefits. However, maintaining the base against the skin can complicate disengagement from the base to the applicator. For example, in some prior art systems, the base disengages after it has moved distally and downward with the needle. This relatively long journey allows for several base disengagement mechanisms. In contrast, releasing the base can be problematic when it remains stationary as the needle moves toward it.

[0352] Many embodiments described herein enable the base 128 to remain in contact with the skin during insertion of the sensor 138 and / or the needle 156. As described above... Figures 7 to 11 In the context of the sensor module 134 being coupled to the base 128, the sensor module 134 and the base 128 need to be disengaged from the retractable assembly 132 in order to secure the glucose sensor 138 to the body and to allow the retractable assembly to be discarded, recycled, or reused.

[0353] As in Figures 7 to 11 As shown, in several embodiments, as the sensor module 134 moves toward the base 128, the base 128 is held in a stationary position relative to the second portion 152 of the retractable assembly 132. Referring now to... Figure 18 Once the sensor module 134 is attached to the base 128, the system can release the base 128 by bending it to couple the base 128 to the bending arm 220 of the second part 152. Figure 18 The system is shown in the state before the sensor module 134 is docked with the base 128 to illustrate that the distal protrusion 222 of the first portion 150 is aligned with the curved arm 220 such that the distal protrusion 222 is configured to bend the curved arm 220 (via the distal protrusion 222 of the contacting curved arm 220).

[0354] The distal protrusion 222 bends the curved arm 220 to couple the sensor module 134 to the base 128 (as in...). Figure 11 and 16 (as shown in the diagram) After that, the base 128 is connected to the retractable assembly 132 (in Figure 7 (As shown in the diagram) Disengagement. The bent arm 220 may include a ramp 224. The distal end of the distal protrusion 222 may contact the ramp 224 and may subsequently continue to move distally as shown in the diagram. Figure 18 Arrow 228 indicates the bending of the curved arm 220. This bending decouples the curved arm 220 from the locking feature 230 of the base 128. This unlocking is accomplished by moving the first portion 150 distally relative to the second portion 152, causing the distal protrusion 222 to move as indicated by arrow 226.

[0355] exist Figure 18The advantage of the system shown is that the unlocking movement (within plus or minus 20 degrees) of the arm 220 (as indicated by arrow 228) is perpendicular to the input force (e.g., as indicated by arrow 226). Therefore, the system is designed such that the maximum holding capacity (e.g., of the locking feature 230) is many times greater than the force required to unlock the arm 220 from the base 128. Consequently, the system is extremely reliable and insensitive to manufacturing variability and changes in normal use.

[0356] In contrast, if the holding force and unlocking force are oriented along the same axis (e.g., within plus or minus 20 degrees), then the holding force will typically be equal to or less than the unlocking force. However, in Figure 18 The unique structure shown allows the holding force to be at least twice as great as the unlocking force (and in some cases, at least four times as great). Therefore, the system prevents unintentional unlocking of the base 128 when the unlocking force is low enough to be easily provided by the user or by another part of the system (e.g., a motor).

[0357] Another advantage of this system lies in the locking and unlocking sequence of its control operations. In other words, the structure prevents premature locking and unlocking. This control is extremely valuable in a medical context because reliability is paramount. For example, in several embodiments, the process follows this sequence: sensor module 134 is coupled to base 128. Subsequently, first portion 150 releases sensor module 134. Subsequently, second portion 152 releases base 128. In several embodiments, the vertical positioning of various locking and unlocking structures is optimized to ensure that this sequence is unique, which is possible as first portion 150 moves from a proximal starting position to a distal position along the previously described path. (Some embodiments use different locking and unlocking sequences of operation.)

[0358] Figure 7 The description describes a base 128 extending from the distal end of the system when the first portion 150 of the retractable assembly 132 is positioned in a proximal starting position. The sensor module 134 and at least a majority of the glucose sensor 138 are positioned distally relative to the base 128. The system is configured to couple the sensor module 134 and the glucose sensor 138 to the base 128 via distal movement of the first portion 150 relative to the second portion 152.

[0359] For reference Figure 18 and 19 The base 128 includes a second radial protrusion 232 (e.g., a locking feature) that is releasably coupled to the second portion 152 of the retractable assembly 132 with a first vertical holding strength. Figure 7A first radial protrusion 230 (e.g., a locking feature) is shown in the diagram. The first radial protrusion 230 extends inward and a second radial protrusion extends outward 232. The system is configured such that the first portion 150 moves to a distal position to move the second radial protrusion 232 relative to the first radial protrusion 230 to disengage the base 128 from the retractable assembly 132.

[0360] The first portion 150 of the telescopic assembly 132 includes a first arm 222 extending distally. The second portion 152 of the telescopic assembly 132 includes a second curved arm 220 extending distally. The first arm 222 and the second curved arm 220 are oriented within 25 degrees of each other (as measured between their central axes). The system is configured such that the first portion 150 extends along path 154 (in... Figure 7 (As shown in the diagram) Moving from the proximal starting position to the distal position causes the first arm 222 to deflect the second curved arm 220, thereby disengaging the second curved arm 220 from the base 128 so that the base 128 can engage with the telescopic assembly 132 (in... Figure 7 (As shown in the diagram) decoupling. Therefore, the curved arm 220 is configured to releasably couple the second portion 152 to the base 128.

[0361] When the first portion 150 is in the proximal starting position, the first arm 222 of the first portion 150 may be at least partially vertically aligned with the second curved arm 220 of the second portion 152 so that the first arm 222 can deflect the second curved arm 220 when the first portion moves to the distal position.

[0362] The first arm 222 and the second arm 220 may be oriented distally such that at least a portion of the first arm 222 is positioned proximally on a protrusion (e.g., ramp 224) of the second arm 220. This protrusion may be configured such that a collision between the first arm 222 and the protrusion can cause the second arm 220 to deflect (to disengage the base 128 from the second portion 152).

[0363] exist Figure 18 In the embodiment described herein, when the first portion 150 is in the proximal starting position, at least a segment of the first arm 222 is positioned directly above at least a portion of the second curved arm 220 such that the first arm 222 can deflect the second curved arm 220 when the first portion 150 moves to the distal position described above. The second curved arm 220 includes a first horizontal protrusion (e.g., locking feature 232). The base 128 includes a second horizontal protrusion (e.g., locking feature 230) that latches with the first horizontal protrusion to couple the base 128 to the second portion 152 of the retractable assembly 132. The first arm 222 of the first portion 150 deflects the second curved arm 220 of the second portion 152 to unlatch the base 128 from the second portion 152, which in turn unlatches the base 128 from the retractable assembly 132.

[0364] For reference Figure 7 The system is configured to couple glucose sensor 138 to base 128 at a first position. The system is configured to disengage base 128 from retractable assembly 132 at a second position distal to the first position.

[0365] The third curved arm (e.g. in) Figure 15 The curved arm 202 in the middle couples the glucose sensor 138 to the base 128 at a first position. The second curved arm (e.g. in the middle) couples the glucose sensor 138 to the base 128 at a first position. Figure 18 The curved arm 220 in the middle is disengaged from the base in the second position. The second position is on the far side relative to the first position, such that the system is configured to secure the base 128 to the retractable assembly 132 until after the glucose sensor 138 is secured to the base 128.

[0366] Spring compression

[0367] The needle used in glucose sensor inserters can be harmful. For example, an unintentional prick can divert the disease. Using a spring-loaded retractable needle can reduce the risk of needle injury.

[0368] For reference Figure 7 A spring 234 (e.g., a coil spring) can be used to retract the needle holder 162 that supports the C-shaped needle 156. The needle holder 162 can be released at the bottom of the insertion depth (so that the needle 156 can be retracted). For example, when the needle 156 reaches its maximum distal position, the latch 236 can be released so that the spring 234 can push the needle 156 proximally into a protective housing (e.g., into the first portion 150, which may be a protective housing).

[0369] Many applicators use pre-compressed springs. Many applicators use essentially uncompressed springs, which are compressed by the user as the applicator is compressed. One disadvantage of pre-compressed springs is that the spring force can cause component creep (e.g., change shape over time), which can compromise design reliability. One disadvantage of uncompressed springs is that the first and second parts of the telescopic assembly can move slightly freely relative to each other (when the assembly is in the proximal starting position). This "chatter" of the first and second parts can make the assembly appear fragile and vulnerable.

[0370] Many of the components described herein can be molded from plastic (although springs are typically metal). Preventing creep in plastic components helps ensure that the applicator functions the same when the plastic component is manufactured and after a long period of time. One way to reduce the risk of creep is to avoid placing components under loads large enough to cause plastic deformation during storage (e.g., in storage).

[0371] The retraction energy is generated by storing energy in the spring during deployment, limiting the duration of the load on the system. For example, the retraction force of the spring can be at least partially generated by contracting the retractable assembly (effectively storing the large retraction force of a fully pre-compressed spring in the system).

[0372] Percutaneous and implantable sensors are affected by their in vivo properties and physiological responses in surrounding tissues. For example, a decrease in sensor accuracy after implantation is a common phenomenon observed. This phenomenon is sometimes referred to as the "impregnation and recovery" process. Impregnation and recovery are thought to be triggered by the trauma of implantation of the implantable sensor and may be caused by stimulation of nerve bundles near the implantation site, leading to a reduction in blood flow to the implantation site.

[0373] Alternatively, maceration and recovery can be associated with damage to nearby blood vessels, leading to vasospasm events. Any local cessation of blood flow in the implantation area for a period of time results in a decrease in the amount of glucose in the sensor's area. During this time, the sensor has reduced sensitivity and is unable to accurately track glucose. Therefore, maceration and recovery manifest as suppressed glucose signals. Suppressive signals from maceration and recovery typically appear within the first day after implantation, most commonly within the first 12 hours post-implantation. Maceration and recovery usually resolve within 6 to 8 hours.

[0374] Immersion and recovery identification can inform patients, doctors or other users that the sensor is only temporarily affected by short-term physiological responses and does not require implant removal, as normal function will likely return within hours.

[0375] Minimizing the time a needle spends in the body can reduce the chance of tissue trauma, such as maceration and retraction. Rapid needle retraction helps limit the time the needle spends in the body. A large spring retraction force allows for rapid needle retraction.

[0376] exist Figure 7 The embodiments described herein address the "flutter" problem, prevent substantial creep, and enable rapid needle retraction. The embodiments place spring 234 with a slight preload between the first portion 150 and the second portion 152 of the retractable assembly 132. In other words, when the first portion 150 is in the proximal starting position, spring 234 is in a slightly compressed state because the relaxed length of spring 234 is longer than the length of the chamber in which spring 234 resides within the retractable assembly 132.

[0377] In some embodiments, the relaxation length of the spring 234 is at least 4% longer than the length of the chamber. In several embodiments, the relaxation length of the spring 234 is at least 9% longer than the length of the chamber. In some embodiments, the relaxation length of the spring 234 is less than 18% longer than the length of the chamber. In several embodiments, the relaxation length of the spring 234 is less than 30% longer than the length of the chamber.

[0378] As the first portion 150 moves distally relative to the second portion 152, the spring 234 is compressed further. In some embodiments, this slight preload has a compression length much shorter than that of a normally fully pre-compressed spring. In several embodiments, the preload causes the compression length of the spring 234 to be less than 25% of the compression length of a fully compressed spring 234. In some embodiments, the preload causes the compression length of the spring 234 to be greater than 3% of the compression length of a fully compressed spring 234. The slight preload eliminates "chatter" when there are forces that cause substantial creep of non-spring components in the system to be too small.

[0379] Spring 234 can be inserted into first portion 150 via hole 238 in the proximal end of first portion 150. Subsequently, needle seat 162 (and attached C-shaped needle 156) can be loaded through the proximal side of first portion 150 of telescopic assembly (e.g. via hole 238 in the proximal end of first portion 150).

[0380] The needle seat 162 slides through the first portion 150 until a radial latch (e.g., the release feature 160 of the needle seat 162) engages a segment of the first portion 150 (see latch 236). Thus, the spring 234 is positioned with a slight preload between the needle seat 162 and the distal portion of the first portion 150 of the retractable assembly 132.

[0381] During applicator activation and retraction (e.g., retracting the first section 150 into the second section 152), the spring 234 is compressed further. During bottom travel (e.g., at the distal end position), the radial latch of the needle seat 162 forces radially inward (as by) a feature (e.g., protrusion 170) in the retractable assembly 132. Figures 7 to 11 (As shown in the progress). This releases the needle seat 162 and allows the spring 234 to expand to drive the needle 156 proximally away from the body (and into the first part 150 and / or the second part 152).

[0382] As in Figure 7As shown, with the first portion 150 of the retractable assembly 132 positioned in the proximal starting position and the glucose sensor 138 positioned distally relative to the base 128, the base 128 extends from the distal end of the system. The glucose sensor 138 is movably coupled to the base 128 via the retractable assembly 132, because the glucose sensor 138 is coupled to the first portion 150 and the base 128 is coupled to the second portion 152 of the retractable assembly 132.

[0383] The system includes a spring 234 configured to retract a needle 156. The needle 156 is configured to facilitate insertion of a glucose sensor 138 into the skin. In some embodiments, the system does not include a needle 156.

[0384] When the first portion 150 is in the proximal starting position, the spring 234 is in a first compressed state. The system is configured such that the first portion 150 moves distally from the proximal starting position, increasing the compression of the spring 234. The first compressed state puts the first portion 150 and the second portion 152 into tension. The latching feature holds the first portion 150 and the second portion 152 in tension. In other words, in the proximal starting position, the latching feature is configured to prevent the spring 234 from pushing the first portion 150 proximally relative to the second portion 152. The latching feature resists the first compressed state.

[0385] In several embodiments, the potential energy of the first compressed state is less than the amount of potential energy required for the retraction needle 156. This low potential energy of the partially pre-compressed spring 234 is generally insufficient to cause creep, but is generally sufficient to eliminate the “chatter” described above.

[0386] The redundancy system helps ensure that the needle 156 (and in some cases, the sensor 138) can always be removed from the body after it has been inserted into the body. If, in extreme cases, the required needle removal force is greater than the spring return force, the user can pull the entire retractable assembly 132 proximally to remove the needle 156 and / or sensor 138 from the body.

[0387] Some embodiments include a two-stage retraction spring. In other words, in some embodiments, in... Figure 7 Spring 234 is actually two concentric springs. (In some embodiments, spring 234 is actually only one spring.) The secondary spring may be shorter than the primary retraction spring. The secondary retraction spring can provide additional needle retraction force and allows for additional adjustment of the force distribution.

[0388] Many users want to minimize the amount of material they discard (such as trash). Moving needle 156 to the back of the deployed applicator makes it easily accessible for removal of the deployed needle 156.

[0389] Figure 20The illustration shows a perspective view of the needle 156, needle seat 162, and spring 234 after they have been removed from the proximal end of the first portion 150 of the retractable assembly 132 through the hole 238.

[0390] Hole 238 is an opening at the proximal end of the applicator. Hole 238 is configured to enable the removal of needle 156, needle seat 162, and / or spring 234. This opening may be covered by a removable cover (e.g., adhesive sheet, hinged cap).

[0391] Figure 21 and 22 The illustration shows a perspective view in which a removable cover 272 is coupled to the first portion 150 to cover the hole 238, through which the pin 156 can be removed from the retractable assembly 132. A hinge 274 couples the cover 272 to the first portion 150, allowing the cover 272 to rotate to close the hole 238 (as shown in...). Figure 22 (as shown in the diagram) and rotate to open hole 238 (as shown in the diagram). Figure 21 (as shown in the image).

[0392] Removing the cover 272 allows the user to remove the needle 156 from the applicator (e.g., the retractable assembly 132), enabling the user to insert the needle 156 into the sharps container and reuse the applicator with a new needle. Removing the needle 156 from the applicator also allows the user to insert the rest of the applicator into a regular waste collector, reducing the amount of waste that needs to be held in the sharps container.

[0393] exist Figures 20 to 22 The features described in the context of 60 can be combined with any of the embodiments described herein.

[0394] Figure 60 A perspective view illustrating another retractable assembly embodiment 132h. A cover 272h is bonded to the proximal end of the retractable assembly 132h to cover a hole configured to retrieve the needle after needle retraction (e.g., as in...). Figure 21 and 22 (Described in the context of...) The peeling of the cover 272h from the retractable assembly 132h allows the user to insert the needle 156 (in...) Figure 7 (As shown in the image) Pour it into the sharps container.

[0395] In this embodiment, the cover 272h is a flexible diaphragm, such as a Tyvek label manufactured by DuPont de Nemoursand Company (“DuPont”). The cover 272h may include an adhesive to bond the cover 272h to the proximal end of the retractable assembly 132h.

[0396] In some embodiments, the second cover 272 is bonded to the distal end of the retractable assembly 132h to cover the sensor 138 (in Figure 7(As shown in the diagram) The end of the retractable assembly 132h passes through. The distal end of the retractable assembly 132h may also be covered by a plastic cap 122h.

[0397] The hood 272h can be configured to allow the sterilization process to pass through its material to facilitate sterilization inside the retractable assembly 132h. For example, sterilizing gases can pass through the hood 272h.

[0398] exist Figure 60 Any features described in the context of this document are applicable to all aspects and embodiments identified herein. For example, in Figure 60 The embodiments described in the context can be compared with those in Figures 1 to 59 Combined with the embodiments described in the context of 61 to 70.

[0399] The retractable assembly 132h can be used in Figure 7 The same internal features and components are described in the context of the first part 150h sliding on the outer surface of the second part 152 (instead of sliding on the outer surface of the second part 152). Figure 7 The inner side of a portion of the second part 152 shown slides. Additionally, the retractable assembly 132h does not use the sterile barrier shell 120 (as shown). Figure 2 (As shown).

[0400] exist Figures 7 to 22 Any features described in the context of this document are applicable to all aspects and embodiments identified herein. For example, in Figures 7 to 22 The embodiments described in the context can be compared with those in Figures 23 to 70 The embodiments described in the context of this document are combined. Furthermore, any feature of an embodiment may be independently combined with other embodiments described herein, in any way, either partially or in whole; for example, one, two, or three or more embodiments may be fully or partially combined. Additionally, any feature of an embodiment may be optional for other aspects or embodiments. Any aspect or embodiment of the method may be performed by a system or apparatus of another aspect or embodiment, and any aspect or embodiment of the system may be configured to perform the method of another aspect or embodiment.

[0401] Force distribution

[0402] For reference Figure 7 In some embodiments, the first portion 150 of the retractable assembly 132, which is distally movable relative to the second portion 152, typically involves abutting the distal end of the skin placement system of the body and subsequently applying a distal force to the proximal end of the system. This distal force can cause the first portion 150 to move distally relative to the second portion 152 to deploy the needle 156 and / or glucose sensor 138 into the skin.

[0403] The ideal user force generated axially in the direction of deployment is a balance between preventing accidental premature deployment and facilitating insertion. The ideal force at one part of the distal actuation can be much smaller than the ideal force at another part of the distal actuation.

[0404] The user places the applicator (e.g., the retractable assembly 132) against the skin surface and applies a force distally to the applicator (e.g., by pushing downwards on the proximal end of the applicator). When the force applied by the user exceeds a threshold, the applicator retracts (e.g., extends distally) and the user drives the sensor into the body.

[0405] Several embodiments include a unique force distribution that reduces accidental premature deployment; significantly increases the likelihood of complete and proper deployment; and reduces patient discomfort. Specific structures enable these unique force distributions. For example, the following structures enable the unique force distributions described herein: a structure for holding the retractable assembly 132 in a proximal starting position; a structure for attaching the sensor module 134 to the base 128; a structure for releasing the sensor module 134 from the first portion 150; a structure for preventing premature retraction of the needle 156; a structure for retracting the needle 156; a structure for releasing the base 128 from the second portion 152; a structure for cushioning collisions in the distal position; and a structure for holding the retractable assembly 132 in a distal ending position. These structures are described in various sections herein.

[0406] Several embodiments include a system for applying the on-skin sensor assembly 600 to the skin 130 of a subject (in... Figure 4 (As shown in the image). Now refer to... Figure 7 The system may include a retractable assembly 132 having a first portion 150 configured to move along path 154 relative to the second portion 152 from a proximal starting position to a distal position; a glucose sensor 138 coupled to the first portion 150; and a latch 236 configured to prevent the needle 156 from moving proximally relative to the first portion.

[0407] The first part 150 is secured by a fixing mechanism (e.g., in) that prevents the first part 150 from moving distally relative to the second part 152. Figure 7 The combination of parts 240 and 242 is releasably secured in the proximal starting position. The system is configured such that before and / or upon reaching the distal position, the first part 150 moves distally relative to the second part 152 to release latch 236, thereby causing the needle 156 to retract proximally back into the system.

[0408] In several embodiments, the fixing mechanism is formed by an interference fit between the first portion 150 and the second portion 152. The interference fit may be configured to prevent the first portion 150 from moving distally relative to the second portion 152. For example, a radially outwardly projecting protrusion 240 of the first portion 150 may collide with a proximal end 242 of the second portion 152 such that distal movement of the first portion 150 requires overcoming a force threshold such that the first portion 150 and / or the second portion 152 deform to allow the radially outwardly projecting protrusion 240 to move distally relative to the proximal end 242 of the second portion 152.

[0409] The system may include a first force distribution measured along path 154. (As in...) Figure 23 As shown, force distribution 244 may include force on the Y-axis and travel distance on the X-axis. Now refer to Figure 7 and 23 The force distribution 244 can be measured along the central axis 196.

[0410] One method of measuring force distribution 244 is to place the retractable assembly 132 against the skin; place a force gauge, such as a load cell, on the proximal end of the retractable assembly 132; calibrate the measuring system to account for the weight of the force gauge; and then press on the proximal side of the force gauge to drive the retractable assembly 132 along path 154 from the proximal starting position to the distal position. Figure 23 This describes the distance of the force pair from the proximal starting position based on this type of test procedure.

[0411] The first force distribution 244 may include a first magnitude 246 consistent with the overcoming fixing mechanism (e.g., 240 and 242), a third magnitude 250 consistent with the release latch 236 (e.g., the release pin retraction mechanism), and a second magnitude 248 consistent with the middle portion of the path 154 located distal to the overcoming fixing mechanism and proximal to the release latch 236.

[0412] In several embodiments, the second value 248 is the same as the compression needle retraction spring before the latch 236 begins to release (e.g., in...). Figure 7 The peak force associated with the spring 234 in the spring. This peak force may be at least 0.5 lbs, at least 1.5 lbs, less than 4 lbs, and / or less than 6 lbs.

[0413] In several embodiments, the third value 250 is the peak force associated with the release needle retraction mechanism. This peak force may be at least 1 pound, at least 2 pounds, less than 4 pounds, and / or less than 6 pounds.

[0414] In some embodiments, the second magnitude 248 is less than the first magnitude 246 and the third magnitude 250, such that the system is configured to increase needle acceleration during the middle portion of the path 154 to enable an appropriate needle speed when the needle 156 (or glucose sensor 138) first punctures the skin.

[0415] The first magnitude 246 may be the peak force required to overcome the fixing mechanisms (e.g., 240 and 242). This peak force may be at least 5 psi, at least 6 psi, less than 10 psi, and / or less than 12 psi. The first magnitude 246 may be at least 100% greater than the second magnitude 248. The first magnitude 246 may be at least 200% greater than the second magnitude 248. The second magnitude 248 may be reached precisely before the needle 156 begins to retract proximally during a period in which the compression of the spring 234 is at least 50% of the maximum spring compression of the force distribution 244. For at least 1 mm during the period of measuring the second magnitude 248, the slope of the force distribution 244 may be positive (due to the increased spring force as the spring compression increases).

[0416] The first value 246 may be greater than the third value 250 (and / or greater than the second value 248), such that the system is configured to prevent the initiation of a glucose sensor insertion cycle unless the user applies sufficient force to release the latch 236. For example, the force required for the distal movement of the protrusion 240 relative to the proximal end 242 may be intentionally designed to be greater than the force required for the retraction needle 156.

[0417] To provide a sufficient safety limit, the first value 246 may be at least 50% larger than the third value 250. In some embodiments, the first value 246 is at least 75% larger than the third value 250. To avoid a system in which the first value 246 is unnecessarily high relative to the force required along path 154 distally, the first value 246 may be 250% larger than the third value 250.

[0418] The second force distribution 252 may coincide with the middle portion of path 154. For example, the second magnitude 248 may be a part of the second force distribution 252. This second force distribution 252 may include periods in which the slope is at least 1 mm, at least 2.5 mm, less than 8 mm, and / or less than 15 mm (due to the increase in spring force when the spring is compressed).

[0419] In response to compression, the system is configured to retract the needle 156 into the spring 234 in the retractable assembly 132, wherein the proximal millimeter of the second force distribution 252 contains a lower average force than the distal millimeter of the second force distribution 252.

[0420] The system also includes a first force distribution 254 (measured along path 154). The first force distribution 254 includes a first average value consistent with the proximal half of the movement distally through the fixing mechanism and a second average value consistent with the distal half of the movement distally through the fixing mechanism. The first average value is greater than the second average value, such that the system is configured to prevent the initiation of a glucose sensor insertion cycle unless the user applies sufficient force to complete the glucose sensor insertion cycle.

[0421] The first force peak 256 coincides with the proximal half of the path that moves distally through the fixed mechanism. The first force peak 256 is at least 25% higher than the second average value.

[0422] The first force distribution 254 includes a first magnitude 246 consistent with overcoming the fixed mechanism and a subsequent magnitude consistent with terminating the fixed mechanism (e.g., moving through the distal portion of the fixed mechanism). The first magnitude 246 includes a proximal vector, and the subsequent magnitude includes a distal vector. Figure 23 To truncate at zero force, the far-side vector appears to have... Figure 23 The value is zero, but the actual value is negative (e.g., negative 2 pounds).

[0423] The proximal vector refers to the system resisting distal movement of the first portion 150 relative to the second portion 152. The distal vector refers to the second half of the fixation mechanism assisting in advancing the needle 156 and sensor 138 toward and / or into the skin. In other words, the distal vector assists in distal movement of the first portion 150 relative to the second portion 152.

[0424] The third force distribution 260 may include a number of peaks and values ​​due to the following events: sensor module 134 docking with base 128; base disengaging from second portion 152 (and thus from retractable assembly 132); release feature 160 of needle seat 162 being inwardly defected due to proximal protrusion 170 of second portion 152; latch 236 being released; needle 156 retracting into the inner cavity of first portion 150; and / or first portion 150 striking a distal position (e.g., the traveling end).

[0425] As in Figure 7 As shown, the fixing mechanism may be a radially outward protrusion 240 of the first portion 150 configured to collide with the proximal end 242 of the second portion 152, such that distal movement of the first portion 150 requires overcoming a force threshold to deform the first portion 150 and / or the second portion 152 so that the radially outward protrusion 240 can move distally relative to the proximal end 242 of the second portion 152. The radially outward protrusion 240 is configured to cause the second portion 152 to deform elliptically so that the first portion 150 can move distally relative to the second portion 152.

[0426] Figure 24Another fixing mechanism is described. At least one segment of the first portion 150 is interference-fitted with the proximal end 242 of the second portion 152, such that pushing the first portion 150 distally relative to the second portion 152 requires a force greater than a force threshold. The force threshold is the minimum force necessary to overcome the interference 266 and deform at least one of the first portion 150 and the second portion 152, which is... Figure 24 The inside of the dashed circle is shown.

[0427] Many different interference geometry shapes and types are used in various embodiments. The interference may be between the first portion 150 and the second portion 152. The interference may also be between the needle seat 162 and the second portion 152. For example, the interference may resist distal movement of the needle seat 162.

[0428] In some embodiments, the first portion 150 includes a taper 262. Once the interference section of the first portion 150 moves distally past the interference region 266, the taper 262 creates a system such that the interference 266 no longer impedes the distal movement of the first portion 150.

[0429] The second part 152 may also have a taper 263. The taper 263 may be on the inner surface of the second part 152 such that the internal size becomes larger when measured from the proximal to the distal side along the taper 263.

[0430] The interference portion 242 of the second part 152 may include a ramp (as in...). Figure 24 (As shown in the diagram) to aid the deformation described above. The interference section of the first part 150 is positioned proximally relative to the interference section of the second part 152.

[0431] The fixing mechanism may include a radially inwardly projecting interference fit with the second part 152 (e.g., as in...). Figure 24 The radially outward protrusion of the first portion 150 (as shown in the interference fit 266) (e.g., in) Figure 7 (240) such that the fixing mechanism is configured to cause the second part 152 to deform into an ellipse so that the first part 150 can move distally relative to the second part 152.

[0432] exist Figures 24 to 32 Any features described in the context of this document are applicable to all aspects and embodiments identified herein. For example, in Figures 24 to 32 The embodiments described in the context can be compared with those in Figures 1 to 23The embodiments described in the context of 33 to 70 are combined. Furthermore, any feature of the embodiments may be independently combined with other embodiments described herein, in any way, either partially or in whole; for example, one, two, or three or more embodiments may be wholly or partially combined. Additionally, any feature of the embodiments may be optional for other aspects or embodiments. Any aspect or embodiment of the method may be performed by a system or apparatus of another aspect or embodiment, and any aspect or embodiment of the system may be configured to perform the method of another aspect or embodiment.

[0433] Figure 25 This is a cross-sectional view illustrating a portion of an embodiment in which the needle holder (e.g., needle hub 162) is configured to resist distal movement of the first portion 150 relative to the second portion 152b. The second portion 152b is similar to other second portions 150 described herein (e.g., as in...). Figure 7 (as shown in the diagram), except that the second part 152b includes a bent arm 276, which is at least a portion of the fixing mechanism. The bent arm 276 is releasably coupled to the needle holder to releasably secure the first part 150 to the second part 152b at the proximal starting position (as shown in the diagram). Figure 7 (as shown in the image).

[0434] Needle 156 (in) Figure 7 (As shown in the diagram) it is retractably coupled to the first portion 150 via a needle holder 162. The needle holder 162 is configured to resist distal movement of the first portion 150 relative to the second portion 152b due to the chamfer and / or ramp 278 interfering with the bent arm 276. Pushing the first portion 150 distally requires overcoming the force necessary to deflect the bent arm 276 outwards, causing the bent arm 276 to move away from the path of the ramp 278.

[0435] Figure 27 This illustrates another type of fixing mechanism, a perspective view showing easy separation and release of 280°. Figure 26 A top view illustrating the separable ring 282 is shown. The ring 282 includes two radially inwardly extending separable tabs 284. In some embodiments, the tabs 284 are radially inwardly projecting on opposite sides of the ring 282 relative to each other. The separable member (e.g., ring 282) may be part of a first portion 150, a second portion 152, or any other portion of the system. For example, the separable member may be a molded feature of the second portion 152.

[0436] The ring 282 may be made of a brittle material configured such that the tab 284 can break when the first portion 150 is pushed distally relative to the second portion 152. For example, when the first portion 150 is in the proximal starting position, a segment of the first portion 150 may be positioned proximally on the tab 284 (as in...). Figure 27(As shown in the diagram 280, which is easily detachable). Moving the first portion 150 distally may cause the segment of the first portion 150 to bend and / or break the tab 284.

[0437] In some embodiments, the radially outward projection 286 of the first portion 150 is configured to bend and / or disconnect the tab 284. The ring 282, tab 284, and other components described herein may be molded from plastics such as acrylonitrile butadiene styrene, polyethylene, and polyetheretherketone. (Springs, interconnects, and pins may be made of steel.) In some embodiments, the ring 282 is at least 0.2 mm thick, at least 0.3 mm thick, less than 0.9 mm thick, and / or less than 1.5 mm thick.

[0438] The ring 282 can be secured between the first portion 150 and the second portion 152 of the telescopic assembly 132. The ring 282 can surround the periphery of the first portion 150 and can be positioned proximally relative to the second portion 152 such that the ring 282 rests against the proximal end of the second portion 152.

[0439] When the first portion 150 is in the proximal starting position, ring 282 enables easily separable coupling between the first portion 150 and the second portion 152. Figure 27 In this configuration, the system is set such that the first part 150 moves to a remote position to disconnect the easily separable coupling (e.g., easily separable release 280).

[0440] In some embodiments, tab 284 is not part of ring 282. Tab 284 may be part of second portion 152 or part of first portion 150.

[0441] Figure 27 It also includes a magnet system 290. The magnet system 290 includes a magnet and a metal element that is sufficiently close to be attracted to a metal element (e.g., a metal disk). For example, a second portion 152 may include a magnet, and a first portion 150 may include a metal element. In several embodiments, the second portion 152 may include a metal element, and the first portion 150 may include a magnet.

[0442] Magnets and metal components can be positioned such that they are oriented along a straight line radially outward from the central axis 196 (in Figure 7 (As shown in the diagram). This configuration allows the magnets to exert a sufficient attractive force on the metal element to resist movement of the first portion 150. For example, when the first portion 150 is in the proximal starting position, the magnetic force of the magnet system 290 can resist distal movement of the first portion. Therefore, when the first portion 150 is in the proximal starting position, the magnets releasably couple the first portion 150 to the second portion 152.

[0443] In several embodiments, the internal spring is user-compressible or the spring may be pre-compressed (e.g., fully compressed at the factory). The retractable assembly may include a button 291 configured to release the spring force to move the needle and / or sensor into the skin.

[0444] exist Figure 60 The hood 272h described in the context can be adhered to in Figure 27 The proximal end of the first portion 150 is shown in the diagram. The cover 272h can be used with any of the embodiments described herein.

[0445] Figure 31 This illustration shows a side view of a retractable assembly 132e having a first portion 150e and a second portion 152e. The first portion 150e includes a radially outward projection 286e configured to engage a radially inwardly inclined surface 296 positioned on the inner wall of the second portion 152e. When a user applies a distal axial force to the first portion 150e, the projection 286e collides with the inclined surface 296. The angle of the inclined surface causes the first portion 150e to rotate relative to the second portion 152e. This rotation resists the distal force and acts as a fixing mechanism. Once the projection 286e has moved beyond the distal end of the inclined surface 296, the inclined surface 296 no longer causes rotation and therefore no longer acts as a fixing mechanism.

[0446] Many of the embodiments described herein rely on human compressive force. Numerous unique structures enable the force distribution described herein. These structures help ensure reliable performance of the compressive force generated by a person pushing a portion of the system distally. One challenge of relying on a person pushing the system downwards to generate appropriate force is that the input force can be substantially varied by the user. Even a single user can apply different input forces at different times.

[0447] One solution to this variability is to replace the user-generated input force with the force generated by a motor. A motor can provide a reliable input force. Furthermore, a motor enables variations in force at different segments of the path from the proximal starting position to the distal position.

[0448] Figures 28 to 30 The description includes embodiments of retractable assemblies 132c, 132d, including motors 290c, 290d to drive needle 156 and / or glucose sensor 138 into the skin. Motors 290c, 290d may be linear actuators that use an internal magnetic system to push the rod distally and proximally. Linear actuators may also convert rotational input into linear motion to push the rod distally and proximally. Rod movement is movable across various parts of the system, including needle 156, needle holder 162c, first portions 150c, 150d of the retractable assemblies 132c, 132d, sensor module 134, and / or sensor 138. Motors 290c, 290d may include an internal battery pack to supply power to motors 290c, 290d.

[0449] Figure 28 This is a perspective cross-sectional view illustrating an embodiment in which motor 290c pushes needle holder 162c distally relative to motor 290c and relative to second portion 152c. Needle holder 162c may include a bar that slides within and away from the housing of motor 292c. Distal movement of needle holder 162c may displace at least a portion of needle 156 and / or sensor 138 (in...) Figure 7 (As shown in the diagram) it is pushed into the skin. Distal movement of the needle hub 162c can move the sensor module 134 distally, causing the sensor module 134 to dock with the base 128. This coupling can disengage from the retractable assembly 132c before the base 128.

[0450] Figure 29 and 30 A side cross-sectional view illustrating another embodiment of the motor is shown. In this embodiment, the rod 294 of the motor 292d is coupled to and is immobile relative to the second portion 152d of the retractable assembly 132d. The motor 292d is coupled to and is immobile relative to the first portion 150d of the retractable assembly 132d. Therefore, pulling the rod 294 into the housing of the motor 292d causes the first portion 150d to move distally relative to the second portion 152d. The glucose module 134 is coupled to the distal portion of the first portion 150d (as described herein). Therefore, the glucose sensor 138 moves distally into the skin of the body, and the glucose module 134 is coupled to the base 128. Figure 29 and 30 As shown, the embodiment does not include a needle. Similar embodiments may include a needle.

[0451] Figure 32 This illustrates a perspective cross-sectional view of the retractable assembly 132. In some embodiments, a protrusion 302 of the first portion 150 is coupled to a hole 304 of the second portion 152. The protrusion 302 may be oriented distally to latch the first portion 150 with the hole 304 in response to reaching a distal position.

[0452] In several embodiments, the protrusion 302 of the second portion 152 is coupled to the aperture 304 of the first portion 150. The protrusion 302 may be oriented proximally to latch the first portion 150 with the aperture 304 in response to reaching a distal position.

[0453] The protrusion 302 may be a curved arm at least 10 mm long, at least 15 mm long, and / or less than 50 mm long. The protrusion 302 may include an end portion that extends at an angle relative to the central axis of most of the protrusion 302. This angle may be at least 45 degrees, at least 75 degrees, less than 110 degrees, and / or less than 135 degrees.

[0454] When the needle 156 is in the retracted state, the protrusion 302, coupled to the hole 304, can be permanently locked in the first portion 150 of the downward position (which is distal to the proximal starting position and within 3 mm of the distal position). This locking prevents the system from being reused and prevents needle damage.

[0455] exist Figure 23 Any features described in the context of this document are applicable to all aspects and embodiments identified herein. For example, in Figure 23 The embodiments described in the context can be compared with those in Figures 1 to 22 The embodiments described in the context of 24 to 70 are combined. Furthermore, any feature of the embodiments may be independently combined with other embodiments described herein, in any way, either partially or in whole; for example, one, two, or three or more embodiments may be fully or partially combined. Additionally, any feature of the embodiments may be optional for other aspects or embodiments. Any aspect or embodiment of the method may be performed by a system or apparatus of another aspect or embodiment, and any aspect or embodiment of the system may be configured to perform the method of another aspect or embodiment.

[0456] interconnects

[0457] For reference Figure 4 In many embodiments, the electronic unit 500 drives a voltage bias through the sensor 138 to enable a measurable current. Therefore, the system is able to analyze glucose levels in the body. The reliability of the electrical connection between the sensor 138 and the electronic unit 500 is crucial for accurate sensor data measurement.

[0458] In many embodiments, the subject or caregiver establishes an electrical connection between sensor 138 and electronics 500. When electronics 500 is pressed against glucose sensor module 134, seal 192 prevents fluid ingress. Oxidation and corrosion can alter the system's resistance and are sources of errors and noise in the signal.

[0459] Electrical connections should be mechanically stable. Relative movement between components of the power system can cause signal noise, which can hinder the acquisition of accurate glucose data.

[0460] Low-resistance electrical connections save more energy. Power efficiency helps maximize the battery life of the 500 electronic unit.

[0461] In embodiments where the user or caregiver must compress the electrical interconnects and / or seals 192, minimizing the required force improves user satisfaction. Reducing the force applied by the user makes the transmitter easier to install. If the required force is too high, the user and caregiver may inadvertently fail to apply sufficient force, which can jeopardize the reliability and performance of the system. The force that the user needs to apply to couple the electronics 500 to the base 128 and sensor module 134 is strongly influenced by the force required to compress the interconnects. Therefore, electrical interconnects with lower compressive forces are required.

[0462] When the sensor assembly 600 is used on the skin, manufacturing variability, body movement, and temperature changes necessitate robust electrical connections throughout the entire effective compression range (which covers reasonably likely minimum and maximum compression states). Therefore, electrical connections that withstand compression variations within the effective compression range are required.

[0463] A metal spring (such as a disc spring or leaf spring) can be compressed between the sensor 138 and the electronics unit 500 to provide a robust, reliable electrical connection with low compressive force required to couple the electronics unit 500 to the base 128.

[0464] Figure 33 The illustration shows a perspective view of the sensor assembly on the skin just before the electronic unit 500 (e.g., a transmitter) is snapped onto the base 128. The electronic unit 500 is coupled to the base 128 via a compressible seal 192 to prevent fluid ingress, and a compressible interconnect (e.g., a spring 306) to create an electrical connection 310 between the glucose sensor 138 and the electronic unit 500.

[0465] Creating an electrical connection 310 and / or coupling the electronic unit 500 to the base 128 can cause the electronic unit 500 (e.g., a transmitter) to exit sleep mode. For example, a conductive member (e.g., of the sensor module 134 and / or the base 128) can touch an electrical contact of the electronic unit 500 (e.g., an electrical contact of the battery pack of the electronic unit 500), which can cause the electronic unit 500 to exit sleep mode. The conductive member of the sensor module 134 and / or the base 128 can be a battery pack jumper that shuts off a circuit so that power from the battery pack can flow into other parts of the electronic unit 500.

[0466] Therefore, creating electrical connection 310 and / or coupling electronic unit 500 to base 128 can "activate" electronic unit 500, enabling and / or preparing electronic unit 500 to wirelessly transmit information to other devices 110 to 113 (in Figure 1 (As shown in the image). U.S. Patent Publication No. US-2012-0078071-A1 includes additional information regarding transmitter startup. The entire contents of U.S. Patent Publication No. US-2012-0078071-A1 are incorporated herein by reference.

[0467] The distal side of the electronic unit 500 may include a flat electrical contact that touches the proximal end portion of the spring 306. The distal end portion of the spring 306 may contact various conductive elements of the glucose sensor 138. Therefore, the spring 306 can electrically couple the electronic unit 500 to the various conductive elements of the glucose sensor 138. In the illustrated embodiment, two metal springs 306 are electrically connected to the glucose sensor 138 and the electronic unit 500. Some embodiments use one spring 306. Other embodiments use three, four, five, ten, or more springs 306.

[0468] A metal spring 306 (e.g., a gold-plated spring) is positioned above the sensor wire 138 in the sensor module 134. The sensor 138 is positioned between the rigid polymer base 128 and the bottom surface of the spring 306. The top surface of the spring 306 contacts a palladium electrode positioned in the bottom of the electronics module 500. The rigid electronics module 500 and the rigid polymer base 128 are placed together to create a compression sandwich with the sensor 138 and the spring 306.

[0469] Spring 306 is oriented such that its central axis is within 25 degrees of the central axis 196 of the telescopic assembly 132 (in Figure 7 (As shown in the figure). Spring 306 may have a helical shape. Spring 306 may be a disc spring or a leaf spring.

[0470] Spring 306 may have ends that are flat, ground, square, square and ground, or any other suitable configuration. Gold, copper, titanium, and bronze may be used to manufacture spring 306. Spring 306 may be made of spring steel. In several embodiments, the steel used to manufacture spring 306 may be low-alloy, medium-carbon, or high-carbon steel with very high yield strength. Spring 306 may be a compression spring, torsion spring, constant-force spring, variable-force spring, helical spring, plate spring, machine-made spring, cantilever spring, spiral spring, balance spring, leaf spring, V-spring, and / or washer spring.

[0471] Some embodiments use a spring-loaded pin system. The spring system may include a receptacle. The pin may be partially positioned inside the receptacle, allowing it to partially slide and slide away from the receptacle. The spring may be positioned inside the receptacle, biasing the pin outward toward the electronics unit 500. The receptacle may be electrically coupled to the sensor 138, such that the electronics unit 500 presses against the spring-loaded pin system, electrically coupling the electronics unit 500 and the sensor 138.

[0472] Mill-Max Manufacturing Co., Ltd. of Oyster Bay, New York, USA (“Mill-Max”) manufactures spring-loaded pin systems using a brass alloy shell plated with gold on nickel. A Mill-Max spring-loaded pin system features a stainless steel spring and an order code of 0926-1-15-20-75-14-11-0.

[0473] In several embodiments, the electronic unit 500 includes a battery pack to provide electrical power to various electrical components (e.g., transmitters) of the electronic unit 500.

[0474] In some embodiments, the base 128 may include a battery pack 314 positioned outside the electronics unit 500. The battery pack 314 may be electrically coupled to an electrical connection 310, such that the electronics unit 500 is coupled to the base 128, which couples the battery pack 314 to the electronics unit 500. (See U.S. Patent Publication No. US-2009-0076360-A1). Figure 22 B and 22C describe battery pack 444, which in some embodiments may be part of a base (which may have included herein) Figure 33 (Many forms of the base 128 shown). The entire contents of U.S. Patent Publication No. US-2009-0076360-A1 are incorporated herein by reference.

[0475] Figure 34 This is a perspective view illustrating sensor module 134. Protrusion 308 secures spring 306 to sensor module 134. (Not all protrusions 308 are labeled for ease of reference.) Figure 34 (The clarity of the image.) Protrusion 308 can extend distally.

[0476] At least three, at least four, and / or fewer than ten protrusions 308 may be configured to contact the periphery of the spring 306. The protrusions 308 may be separated by a gap. The gap allows the protrusions 308 to bend outwards when the spring 306 is inserted between the protrusions 308. A downward force coupled to the base 128 by the electronic unit 500 may push the spring 306 against the sensor 138 to electrically couple the spring 306 to the sensor 138. The sensor 138 may operate between at least two of the protrusions 308.

[0477] Figure 33 This describes a skin sensor system 600 configured for transdermal glucose monitoring in a host device. The skin sensor system 600 can be used with... Figure 7 It is used in conjunction with the other components shown. Sensor module 134 can be used in... Figure 35 and 37 The sensor modules 134d and 134e shown are replaced. Therefore, in Figure 35 and37 The sensor modules 134d and 134e shown can be used with... Figure 7 Use it together with the other components shown.

[0478] For reference Figure 33 and 34 System 600 may include a sensor module housing 312; glucose sensors 138a, 138b having a first segment 138a configured for subcutaneous sensing and a second segment 138b mechanically coupled to the sensor module housing 312; and electrical interconnects (e.g., spring 306) mechanically coupled to the sensor module housing 312 and electrically coupled to the glucose sensors 138a, 138b. The spring may be a conical spring, a helical spring, or any other type of spring mentioned herein or suitable for electrical connection.

[0479] The sensor module housing 312 includes at least two proximal protrusions 308 positioned around the periphery of the spring 306. The proximal protrusions 308 are configured to assist in the orientation of the spring 306. A segment of the glucose sensor 138b is positioned between the proximal protrusions 308 (distal to the spring 306).

[0480] The sensor module housing 312 is mechanically coupled to the base 128. The base 128 includes an adhesive 126 configured to couple the base 128 to the skin of the body.

[0481] The proximal protrusion 308 orients the spring 306 so that the electronic unit 500 is coupled to the base 128, which presses the spring 306 against the first electrical contact of the electronic unit 500 and the second electrical contact of the glucose sensor 138b to electrically couple the glucose sensors 138a, 138b to the electronic unit 500.

[0482] For reference Figure 33 and 35 Up to 38, system 600 may include sensor module housings 312d, 312e; glucose sensors 138a, 138b having a first segment 138a configured for subcutaneous sensing and a second segment 138b mechanically coupled to the sensor module housings 312d, 312e; and electrical interconnects (e.g., leaf springs 306d, 306e) mechanically coupled to the sensor module housings 312d, 312e and electrically coupled to the glucose sensors 138a, 138b. Sensor modules 134d, 134e can be used to place... Figure 7 The sensor module 134 is shown in the figure. The leaf springs 306d and 306e can be configured to bend in response to the coupling of the electronic unit 500 with the base 128.

[0483] As used herein, a cantilever spring is a type of leaf spring. As used herein, a leaf spring can be made of multiple curved metal strips, one held together above the other. As used herein, in many embodiments, a leaf spring comprises only one strip of curved metal (e.g., a single layer) (rather than multiple layers of curved metal). For example, in Figure 35 The leaf spring 306d can be made of a single layer of metal or multiple layers of metal. In some embodiments, the leaf spring includes a single layer of flat metal fixed to one end (making the leaf spring a cantilever spring).

[0484] As in Figure 35 and 36 As shown, the sensor module housing 312d includes a proximal protrusion 320d having a channel 322d in which at least a portion of a second segment of a glucose sensor 138b is positioned. The channel 322d houses a first region of the glucose sensor 138b such that the region is electrically coupled to a leaf spring 306d.

[0485] As in Figure 36 As shown in the cross-sectional perspective view, the leaf spring 306d is arc-shaped away from the first region and extends proximally to be electrically coupled to the electronic unit 500 (in Figure 33 (As shown in the diagram). At least a portion of the leaf spring 306d forms a "W" shape. At least a portion of the leaf spring 306d forms a "C" shape. The leaf spring 306d bends around the proximal protrusion 320d. The leaf spring 306d extends proximally to be electrically coupled to the electronic unit 500 (in... Figure 33 (As shown in the diagram). The seal 192 is configured to prevent fluid from entering the leaf spring 306d.

[0486] The leaf spring 306d is oriented such that the electronic unit 500 is coupled to the base 128 (in Figure 33 (As shown in the diagram) The first electrical contact of the electronic unit 500 and the second electrical contact of the glucose sensor 138b press the leaf spring 306d to electrically couple the glucose sensors 138a and 138b to the electronic unit 500. The proximal height of the seal 192 is greater than the proximal height of the leaf spring 306d, such that the electronic unit 500 contacts the seal 192 before contacting the leaf spring 306d.

[0487] For reference Figure 33 and 37 Up to 38, the sensor module housing 312e includes a channel 322e in which at least a portion of the second segment of the glucose sensor 138b is positioned. A distal portion of the leaf spring 306e is positioned in the channel 322e such that a proximal portion of the leaf spring 306e extends proximally into the channel 322e.

[0488] The sensor module housing 312e includes a recess 326e with a laterally cut channel 322e (e.g., intersecting with the channel 322e). The leaf spring 306e includes a tab 328 positioned in the recess to impede rotation of the leaf spring. At least a portion of the leaf spring 306e forms a "C" shape.

[0489] Figure 36 and 38 This illustrates the shapes of two leaf springs. Other embodiments use other types of leaf springs. They can be combined in... Figures 33 to 38 The components shown in the figure.

[0490] For reference Figures 33 to 38 Interconnects 306, 306d, and 306e may include palladium contacts, alloys, coating materials, conductive plating materials, gold-plated portions, silver materials, and / or any suitable conductor. Interconnects 306, 306d, and 306e described herein may have a resistance of less than 5 ohms, less than 20 ohms, and / or less than 100 ohms. Many interconnect embodiments enable a resistance of approximately 2.7 ohms or less, which can significantly improve battery life compared to higher resistance alternatives.

[0491] Reducing the force required to compress interconnects 306, 306d, and 306e (e.g., when coupling electronic unit 500 to base 128) can reduce coupling errors and difficulties. For example, if the required force is high, the probability is essentially that the user will unintentionally fail to securely couple electronic unit 500 to base 128. In some cases, if the required force is too high, some users will be unable to couple electronic unit 500 to base 128. Therefore, systems requiring lower forces to couple electronic unit 500 to base 128 are necessary.

[0492] Many of the embodiments described herein (e.g., spring embodiments) significantly reduce the force required to couple the electronic unit 500 to the base 128. Interconnects 306, 306d, 306e may have a compressive force of at least 0.05 psi; less than 0.5 psi, less than 1 psi, less than 3 psi; and / or less than 4.5 psi within an effective compression range.

[0493] In some embodiments, electrical interconnects 306, 306d, 306e may require less than one pound of compressive force to compress the spring by 20% from a substantially uncompressed, relaxed position. In some embodiments, electrical interconnects 306, 306d, 306e may require less than one pound of compressive force to compress the spring by 25% from a substantially uncompressed, relaxed position. In some embodiments, electrical interconnects 306, 306d, 306e may require less than one pound of compressive force to compress the spring by 30% from a substantially uncompressed, relaxed position. In some embodiments, interconnects 306, 306d, 306e (changing dependence on the independent claim) may require less than one pound of compressive force to compress the spring by 50% from a substantially uncompressed, relaxed position.

[0494] Springs 306, 306d, and 306e may have a height of 2.6 mm, at least 0.5 mm, and / or less than 4 mm. Seal 192 may have a height of 2.0 mm, at least 1 mm, and / or less than 3 mm. In some embodiments, in their relaxed state (i.e., substantially uncompressed), springs 306, 306d, and 306e extend from the top of seal 192 (e.g., distally) by at least 0.2 mm and / or less than 1.2 mm.

[0495] When the electronic unit 500 is coupled to the base 128, the compression of springs 306, 306d, and 306e can be 0.62 mm, at least 0.2 mm, less than 1 mm, and / or less than 2 mm, having a compression percentage of 24%, at least 10%, and / or less than 50%. The effective compression range of springs 306, 306d, and 306e can be 16% to 40%, 8% to 32%, 40% to 57%, 29% to 47%, at least 5%, at least 10%, and / or less than 66%.

[0496] In some embodiments, the electrical connection between sensor 138 and electronics unit 500 is manufactured at the factory. This electrical connection may be sealed at the factory to prevent fluid ingress, which could compromise the integrity of the electrical connection.

[0497] Electrical connections can be made by any of the following methods: electrodes can pierce a conductive elastomer (making vertical deformation unnecessary); sensors can be "clamped" (e.g., compressed) between adjacent coils of a coil spring; conductive epoxy resin; brazing; laser welding; and resistance welding.

[0498] For reference Figure 4 , 6Connections 7 and 33 are critical electrical connections between electronics unit 500 (e.g., a transmitter) and sensor module 134. Another critical electrical connection is between sensor module 134 and glucose sensor 138. Both connections should be robust enough to enable connection of sensor module 134 to base 128, and subsequently, connection of base 128 and sensor module 134 to electronics unit 500 (e.g., a transmitter). Stabilizing sensor module 134 allows it to couple to base 128 without causing signal noise in the future.

[0499] These two critical electrical connections can be fabricated in the factory (e.g., before the receiving system is installed by the user or caregiver). These electrical connections can also be fabricated by the user when the electronics unit 500 is attached to the base 128 and / or the sensor module 134.

[0500] In some embodiments, the connection between the glucose sensor 138 and the sensor module 134 may be fabricated at the factory (e.g., prior to the user receiving system), and the user may subsequently couple the electronics unit 500 to the sensor module 134 and / or the base 128. In several embodiments, the electronics unit 500 may be coupled to the sensor module 134 and / or the base 128 at the factory (e.g., prior to the user receiving system), and the user may subsequently couple this assembly to the glucose sensor 138.

[0501] exist Figures 33 to 38 Any features described in the context of this document are applicable to all aspects and embodiments identified herein. For example, in Figures 33 to 38 The embodiments described in the context can be compared with those in Figures 1 to 32 The embodiments described in the context of 39 to 70 are combined. Furthermore, any feature of the embodiments may be independently combined with other embodiments described herein, in any way, either partially or in whole; for example, one, two, or three or more embodiments may be fully or partially combined. Additionally, any feature of the embodiments may be optional for other aspects or embodiments. Any aspect or embodiment of the method may be performed by a system or apparatus of another aspect or embodiment, and any aspect or embodiment of the system may be configured to perform the method of another aspect or embodiment.

[0502] For reference Figure 33 The battery pack 314 may be located inside the electronic unit 500 or may be part of the base 128. Maximizing the lifespan of the battery pack 314 is important for many reasons. For example, the electronic unit 500 may be stored for months or even years before use. If the battery pack 413 is substantially depleted during this storage period, the number of days the subject can use the electronic unit (e.g., to measure analytes) can be significantly reduced.

[0503] In some embodiments, during storage (e.g., before being received by the subject), the electronic unit 500 is in a low-power consumption state (e.g., a "sleep" mode). This low-power consumption state can deplete the battery pack 314. Therefore, there is a need for a system that reduces or even eliminates battery pack power consumption during storage and / or before the electronic unit 500 is coupled to the base 128.

[0504] As in Figure 33 As described in the context, creating electrical connection 310 and / or coupling electronic unit 500 to base 128 can cause electronic unit 500 (e.g., a transmitter) to exit sleep mode. For example, conductive members (e.g., sensor module 134 and / or base 128) can touch electrical contacts of electronic unit 500 (e.g., battery contacts of electronic unit 500), which can cause electronic unit 500 to exit sleep mode and / or allow the flow of electrical power from the battery pack to begin. Conductive members of sensor module 134 and / or base 128 can be battery pack jumpers that shut off circuitry to allow power from the battery pack to flow into other parts of electronic unit 500.

[0505] Therefore, creating electrical connection 310 and / or coupling electronic unit 500 to base 128 can "activate" electronic unit 500, enabling and / or preparing electronic unit 500 to wirelessly transmit information to other devices 110 to 113 (in Figure 1 (As shown in the figure). U.S. Patent Publication No. US-2012-0078071-A1 includes additional information regarding the activation of the electronic unit 500 (e.g., transmitter activation). The entire contents of U.S. Patent Publication No. US-2012-0078071-A1 are incorporated herein by reference.

[0506] Figure 65 This is a perspective view illustrating parts of sensor module 134j. Some components (such as springs and sensors) are shown. Figure 65 The hidden information clarifies that sensor module 134j can use any spring or sensor described herein. Sensor module 134j can use any spring 306, 306d, 306e described herein; sensor 138, 138a, 138b; protrusion 308; channel 322d, 322e; and recess 326e (e.g., as in...). Figures 34 to 40 (As shown in the diagram). Sensor module 134j can be used to replace any other sensor module described herein. Sensor module 134j can be used in... Figure 7 The embodiments described in the context of this document can be used with any of the scalable assemblies described herein.

[0507] Figure 66 Explanation in Figure 65 The image shows a cross-sectional side view of the sensor module. Now refer to... Figures 65 to 70The sensor module 134j includes a conductive jumper 420f (e.g., a conductive connection that may contain metal). The conductive jumper 420f is configured to couple two electrical contacts 428a, 428b of the electronic unit 500 to the sensor module 134j and / or to the base 128 in response to the electronic unit 500 (e.g., a transmitter).

[0508] Conductive jumper 420f may be at least partially positioned at two electrical connections 426 (e.g., in...) Figures 34 to 38 The springs 306, 306d, and 306e shown are connected. A conductive jumper 306f may include two springs 306f coupled via a conductive link 422f. The first spring 306f of jumper 420f may be coupled to a first contact 428a, and the second spring 306f of jumper 420f may be coupled to a second contact 428b, which completes the circuitry to enable the battery pack to supply power to the electronic unit 500. The springs 306f may be leaf springs, disc springs, conical springs, and / or any other suitable type of spring. In some embodiments, the springs 306f are proximal protrusions coupled to contacts 428a and 428b.

[0509] As in Figure 66 As shown, the conductive link 422f can be arched, allowing the sensor 138b (in) Figure 34 (As shown in the diagram) Passes under and / or through the arched portion of the conductive link 422f. In some embodiments, the conductive link 422f is oriented within plus or minus 35 degrees perpendicular to the sensor 138b, such that the conductive link 422f crosses over a portion of the sensor 138b, which is positioned inside the sealed area (e.g., inside the seal 192).

[0510] Figure 67 The description is similar to that in Figure 65 and 66 The image shows a perspective view of a portion of the sensor module 134k of the sensor module 134j. Figure 68 Explanation in Figure 67 The image shows a top view of the sensor module 134k.

[0511] For reference Figure 67 and 68 The sensor module 134k includes conductive jumpers 420g of different types, each jumper 420g including two helical springs 306g electrically coupled via a conductive link 422g. The conductive link 422g is configured to cross above or below the sensor 138b. Figure 34 (As shown in the image). Figure 67 and 68As shown, spring 306g is a conical spring; however, some embodiments do not use conical springs. Spring 306g is configured to electrically couple the two electrical contacts 428a, 428b of electronic unit 500 to initiate current flow within electronic unit 500. Therefore, conductive jumper 420g can "start" electronic unit 500. Conductive jumper 420g can be used with any sensor module described herein.

[0512] Figure 69 and 70 This illustration shows a perspective view of the electronic unit 500 just before it is coupled to the base 128. (See also...) Figure 70 As shown, the electronic unit 500 may have been configured to be electrically coupled to the conductive jumper 420f (in Figure 65 and 66 (as shown in the image), 420g (in) Figure 67 and 68 Two electrical contacts 428a and 428b are shown in the diagram. The electronic unit 500 may also have two contacts 428a and 428b configured to be electrically coupled to springs 306, 306d and 306e (in...). Figures 34 to 38 (as shown in) and / or to sensor 138 (in Figure 39 (as shown in the diagram) and the two electrical contacts 428c, 428d of any other type of electrical connection 426 between the electronic unit 500 and the electronic unit 500.

[0513] Electronic unit 500 is coupled to sensor module 134k and / or to base 128, which can electrically and / or mechanically couple electrical contacts 428a, 428b to conductive jumper 420f (in Figure 65 (as shown in the image), 420g (in) Figure 67 (as shown in the image).

[0514] Electronic unit 500 is coupled to sensor module 134k and / or to base 128, which can electrically and / or mechanically couple electrical contacts 428c, 428d to springs 306, 306d, 306e (in Figures 34 to 38 (as shown in the diagram) and / or coupled to sensor 138 (in Figure 39 Any other type of electrical connection 426 between (as shown in) and electronic unit 500 (e.g., as shown in) Figure 67 (as shown in the image).

[0515] exist Figures 65 to 70 Any features described in the context of this document are applicable to all aspects and embodiments identified herein. For example, in Figures 65 to 70 The embodiments described in the context can be compared with those in Figures 1 to 64The embodiments described in the context of this document are combined. Furthermore, any feature of an embodiment may be independently combined with other embodiments described herein, in any way, either partially or in whole; for example, one, two, or three or more embodiments may be fully or partially combined. Additionally, any feature of an embodiment may be optional for other aspects or embodiments. Any aspect or embodiment of the method may be performed by a system or apparatus of another aspect or embodiment, and any aspect or embodiment of the system may be configured to perform the method of another aspect or embodiment.

[0516] Needle angle and offset

[0517] Figure 43 The front view of the "C-shaped" needle 156 is shown. Figure 42 A bottom view illustrating the C-shaped needle 156. Needle 156 includes a channel 330. A glucose sensor 138 is configured for subcutaneous sensing (in...). Figure 7 Segment 138a (in the middle) Figure 34 (as shown in the diagram) can be placed in channel 330 (as shown in the diagram). Figure 40 (as shown in the image).

[0518] The needle 156 guides the sensor 138 into the skin of the subject. The distal portion of the sensor 138 can be positioned within the channel 330 of the needle 156. Sometimes, the distal end of the sensor 138 protrudes from the needle 156 and hooks into the tissue of the subject when the sensor 138 and needle 156 are inserted. Therefore, the sensor 138 may bend and cannot be inserted deep enough into the subcutaneous tissue. In other words, in some embodiments, the sensor wire must be placed within the channel 330 of the C-shaped needle 156 to be guided into the tissue and must remain within the channel 330 during deployment.

[0519] The danger of sensor 138 protruding from channel 330 (and thus failing to provide the characteristic of being inserted into the body) can be mitigated by positioning sensor 138 at a specific angle 338 (in Figure 41 (shown in) and offset 336 (in) Figure 40 The image shows a significant reduction in the channel 330 placed in needle 156. Figure 42 Position B 334 indicates the sensor protruding from channel 330.

[0520] Angle 338 and offset 336 cause elastic deformation of sensor 138, generating a force that pushes sensor 138 to the bottom of channel 300 (as per the force exerted by the angle 338 and offset 336). Figure 42 (As shown in position A 332) This avoids the potential adverse effects of improper angles 338 and offsets 336. Angles 338 and offsets 336 can also cause plastic deformation of sensor 138 to help shape sensor 138 in a manner that minimizes the risk of sensor 138 being dislodged from channel 330 during insertion into the skin.

[0521] In several embodiments, angle 338 and offset 336 shape portions of sensor 138 for optimal insertion performance. For example, angle 338 may bend sensor 138 before placing portions of sensor 138 into the channel 330 of needle 156.

[0522] As in Figure 39 As shown, a portion of the glucose sensor 138b (also in Figure 34 The glucose sensor 138b (as indicated by the center marker) can be placed in the distal-facing channel 342 (in some embodiments, this is a tunnel). This channel 342 helps the glucose sensor 138b align with the channel 330 of the needle 156 (in...). Figure 43 (As shown in the image) orientation.

[0523] As in Figure 41 As described, glucose sensor 138 may be included in sensor module housing 312 (in Figure 34 An angle 338 is shown between a portion of the glucose sensor 138 (as illustrated) and a portion of the glucose sensor configured to be inserted into the body. In some embodiments, this angle 338 may be between the sensor 138 and the sensor module housing 312 (as shown in the figure). Figure 34 (as shown in the diagram) before and / or when a portion of the sensor 138 is placed in channel 330 of the needle 156 (in Figure 43 (As shown in the image) was formed before.

[0524] For reference Figure 41 An angle 338 less than 110 degrees can cause deployment failure (e.g., with an offset of 0.06 inches plus 0.06 inches and / or minus 0.03 inches). In some embodiments, an angle 338 less than 125 degrees can cause deployment failure (e.g., with an offset of 0.06 inches plus 0.06 inches and / or minus 0.03 inches). An angle 338 of 145 degrees (plus 5 degrees and / or minus 10 degrees) can reduce the probability of deployment failure. In some embodiments, angle 338 is at least 120 degrees and / or less than 155 degrees.

[0525] In some embodiments, the manufacturing method includes bending the sensor 138 before placing a portion of the sensor 138 into the channel 330 of the needle 156. In this manufacturing method, from coupling to the sensor module housing 312 (in...) Figure 34A portion of a glucose sensor 138 (shown in the diagram) and a portion of a glucose sensor configured to be inserted into a needle measure the angle of its central axis. According to this angle measurement, angles greater than 70 degrees can cause deployment failure (e.g., at offsets of 0.06 inches plus 0.06 inches and / or minus 0.03 inches). In some embodiments, angles greater than 55 degrees can cause deployment failure (e.g., at offsets of 0.06 inches plus 0.06 inches and / or minus 0.03 inches). An angle of 35 degrees (plus 10 degrees and / or minus 5 degrees) can reduce the probability of deployment failure. In some embodiments, the angle is at least 25 degrees and / or less than 60 degrees.

[0526] Too large an offset of 336 (in) Figure 40 (As shown in the diagram) This can cause sensor 138 to be unreliably held in channel 330 (in Figure 42 (as shown in the diagram). In other words, a large offset 336 may cause sensor 138 to be positioned at location B 334 instead of being firmly positioned at location A 332. Too small an offset 336 may place too much stress on sensor 138, which could disconnect sensor 138. In view of these factors, in several embodiments, offset 336 is at least 0.02 inches, at least 0.04 inches, less than 0.08 inches, and / or less than 0.13 inches. In some embodiments, offset 336 is equal to or greater than 0.06 inches and / or less than or equal to 0.10 inches. Offset 336 is as shown in the diagram. Figure 40 The measurement is shown at the base of needle 156.

[0527] In some embodiments, at least a portion of the bend in sensor 138 may include strain relief. For example, the bend in sensor 138 may be encapsulated in a polymeric tube or an elastomeric tube to provide strain relief for sensor 138. In some examples, the entire bend in sensor 138 may be encapsulated in a polymeric tube or an elastomeric tube. In some embodiments, the tube is made of a soft polymer. The polymeric tube or elastomeric tube may encapsulate sensor 138 via a heat-shrink process. In some embodiments, a siloxane gel may be used in channel 342 (in... Figure 39 (as shown in the image) at or near the proximal protrusion 320d (in the image) Figure 35 At least a portion of the lower side of the sensor (as shown in the diagram) is applied to the sensor.

[0528] Needle channel width 344 (in Figure 42 (As shown in the figure) can be 0.012 inches. In some embodiments, the width 344 is equal to or greater than 0.010 inches and / or less than or equal to 0.015 inches. The width 344 of the channel 330 is measured at the narrowest span in which the glucose sensor 138 can be positioned.

[0529] For reference Figure 40The funnel 182 in the base 128 helps guide the needle 156 and / or glucose sensor 138 into the orifice 180. The funnel 182 and orifice 180 help hold the sensor 138 in the C-shaped needle 156 during storage and deployment. For example, the orifice 180 can be so small that there is no channel 330 for the sensor 138 to exit the needle 156 (in... Figure 42 Additional space (within hole 180) as shown in the figure.

[0530] Another function of the funnel 182 and the hole 180 is to support the needle 156 and / or sensor 138 against the bending force during insertion into the body.

[0531] The funnel 182 and the hole 180 also prevent accidental needle prick injuries (because they are so small that, for example, a finger can reach the needle 156 before the needle is spread out).

[0532] Sensor module 134 cannot pass through funnel 182 and hole 180 (e.g., due to the geometry of sensor module 134 and funnel 182). Preventing sensor module 134 from passing through base 128 ensures that sensor module 134 is removed from the body when base 128 is detached from the body. Angle 338 prevents all sensors 138 from passing through hole 180 to ensure that sensors 138 are removed from the body when base 128 is detached from the body.

[0533] exist Figures 39 to 43 Any features described in the context of this document are applicable to all aspects and embodiments identified herein. For example, in Figures 39 to 43 The embodiments described in the context can be compared with those in Figures 1 to 38 The embodiments described in the context of 44 to 70 are combined. Furthermore, any feature of the embodiments may be independently combined with other embodiments described herein, in any way, either partially or in whole; for example, one, two, or three or more embodiments may be fully or partially combined. Additionally, any feature of the embodiments may be optional for other aspects or embodiments. Any aspect or embodiment of the method may be performed by a system or apparatus of another aspect or embodiment, and any aspect or embodiment of the system may be configured to perform the method of another aspect or embodiment.

[0534] Needle-free

[0535] Some implementations use needles to help insert the glucose sensor into the subcutaneous tissue. However, some people are afraid of needles. Furthermore, needle disposal may require the use of a sharps container, which may not be readily available.

[0536] Many embodiments do not use a needle to insert the sensor, which helps people feel more comfortable inserting the sensor and eliminates the need to use a sharps box to hold the applicator or its parts.

[0537] Several needle-free embodiments are described in U.S. Patent Publications US-2011-0077490-A1, US-2014-0107450-A1, and US-2014-0213866-A1. The entire contents of U.S. Patent Publications US-2011-0077490-A1, US-2014-0107450-A1, and US-2014-0213866-A1 are incorporated herein by reference.

[0538] Any of the embodiments described herein can be used with or without needles. For example, in Figures 1 to 50 The embodiments described in the context can be used with or without needles. For example, in Figure 7 The embodiment shown can be used in a very similar manner without the needle 156. In this needle-free embodiment, the first portion 150 moves distally to drive the distal portion of the glucose sensor 138 into the skin (without using the needle 156). In the needle-free embodiment, the sensor 138 may have sufficient flexural resistance so that (when supported by the aperture 180) the sensor 138 does not buckle. Sharpening the distal tip of the sensor 138 may also facilitate needle-free insertion into the body.

[0539] Figure 56 The description is very similar to that in Figure 7 The exceptions shown in the embodiments are Figure 56 The embodiments do not include needle-based embodiments. The retractable assembly 132b pushes the sensor 138 (which can be any type of analyte sensor) into the body of the subject. Figure 56 The embodiments shown do not include the needle holder 162, spring 234, or needle retraction mechanism 158 (as in...). Figure 7 (as shown in the examples) but may include any items and features described in the context of other embodiments herein.

[0540] Figure 57 The first part 150 is moved distally relative to the second part 152 of the retractable assembly 132b to move the sensor module 134 and sensor 138 toward the base 128 in preparation, so as to couple the sensor module 134 and sensor 138 to the base 128.

[0541] Figure 58 This describes the first portion 150 at its distal end position relative to the second portion 152. Sensor module 134 and sensor 138 are coupled to base 128. Base 128 is no longer coupled to retractable assembly 132b, allowing retractable assembly 132b to be discarded while leaving adhesive 126 coupled to the skin of the body (as in...). Figures 4 to 6(as described in the context).

[0542] exist Figures 56 to 58 The embodiments described herein can be integrated into Figure 2 and 3 The applicator system 104 shown in the figure.

[0543] exist Figures 12A to 50 The items and features described in the context can also be related to... Figures 56 to 58 The embodiments described herein are used together. Articles and features are described in the context of some embodiments to reduce redundancy. However, the articles and features shown in all the figures are combinable. The embodiments described herein have been designed to illustrate the interchangeability of the articles and features described herein.

[0544] Figure 44 and 45 Another embodiment of the retractable assembly 132g is described. This embodiment includes a first portion 150g that moves distally relative to the second portion 152g to push the glucose sensor 138g through a hole in the base 128g and into the body.

[0545] The first portion 150g of the retractable assembly 132g (e.g., a pusher) may include a distal protrusion 352 supporting a substantially horizontal segment of the glucose sensor 138g (e.g., when the glucose sensor 138g extends from the sensor module 134g). The end of the distal protrusion 352 may include a recess 354 in which at least a portion of the glucose sensor 138g is positioned. The recess 354 helps retain the glucose sensor 138g. The distal protrusion 352 may provide axial support for the glucose sensor 138g (e.g., to push the glucose sensor 138g distally into the tissue of the body).

[0546] The base 128g may include a proximal-facing funnel 182g to help guide the distal end of the glucose sensor 138g into a hole 180g in the base 128g. The hole 180g may radially support the sensor 138g when it is inserted into the tissue of the body.

[0547] When the first portion 150g of the retractable assembly 132g is in the proximal starting position, the distal end of the glucose sensor 138g can be positioned in the hole 180g to help guide the glucose sensor 138g in the proper distal direction.

[0548] The hole 180g can retract the distal convex protrusion 174g in the base 128g. The distal convex protrusion 174g can help stretch the skin before the sensor is inserted. As described more fully in other embodiments, the base 128g can rest against the skin of the body as the sensor module 134g moves distally toward and is subsequently coupled to the base 128g.

[0549] The retractable assembly 132g (e.g., the applicator) does not include a needle. Therefore, there are no sharp objects in the applicator, eliminating any need for sharps protection after use. This design feature prevents the need for a retraction spring or needle holder. The distal end of the sensor wire 138g can be sharpened to indicate a reduced need for needle insertion.

[0550] The retractable assembly 132g (e.g., an applicator) may include a first portion 150g and a second portion 152g. A base 128g may be coupled to the distal end of the first portion 150g. A glucose sensor 138g and a sensor module 134g may be coupled to the distal end of the first portion 150g, such that the applicator does not require a spring, needle, or needle hub; the first portion 150g is secured in a proximal starting position by an interference fit between the first portion 150g and the second portion 152g of the retractable assembly 132g; and / or by applying a distal force greater than a disconnection threshold of the interference fit, causing the first portion 150g to move distally relative to the second portion 152g (e.g., until the sensor 138g is inserted into the tissue and the sensor module 134g is coupled to the base 128g).

[0551] Figure 46 and 47 This describes a similar needle-free embodiment. This embodiment is not used in... Figure 45 The distal protrusion 352 is shown in the diagram. Conversely, the sensor module 134h includes a distally oriented channel 358 that guides the sensor 138h distally, such that the glucose sensor 138h includes a bend of at least 45 degrees and / or less than 135 degrees. A channel cover 362 secures the glucose sensor 138h within the distally oriented channel 358.

[0552] exist Figures 44 to 47 The embodiments described herein can be integrated into Figure 2 and 3 The applicator system 104 is shown in the diagram. Now refer to... Figure 2 The electronic unit 500 (e.g., a transmitter with a battery pack) is detachably coupled to the sterile barrier housing 120. The rest of the applicator system 104 can be sterilized, and the electronic unit 500 can then be coupled to the sterile barrier housing 120 (so that the electronic unit 500 is sterilized without the rest of the applicator system 104).

[0553] exist Figures 12A to 43The items and features described in the context of 48 to 70 can also be related to... Figures 44 to 47 The embodiments described herein are used together. Articles and features are described in the context of some embodiments to reduce redundancy. However, the articles and features shown in all the figures are combinable. The embodiments described herein have been designed to illustrate the interchangeability of the articles and features described herein.

[0554] exist Figures 44 to 47 Any features described in the context of this document are applicable to all aspects and embodiments identified herein. For example, in Figures 44 to 47 The embodiments described in the context can be compared with those in Figures 1 to 43 The embodiments described in the context of 48 to 70 are combined. Furthermore, any feature of the embodiments may be independently combined with other embodiments described herein, in any way, either partially or in whole; for example, one, two, or three or more embodiments may be fully or partially combined. Additionally, any feature of the embodiments may be optional for other aspects or embodiments. Any aspect or embodiment of the method may be performed by a system or apparatus of another aspect or embodiment, and any aspect or embodiment of the system may be configured to perform the method of another aspect or embodiment.

[0555] In some embodiments, sensor 138 may be coupled to base 128 and deployed (e.g., into the skin of the body) in response to electronic unit 500 (e.g., a transmitter). Sensor 138 may be any type of analyte sensor (e.g., a glucose sensor).

[0556] Premature deployment of sensor 138 can result in its insertion into the wrong person and / or insufficient insertion depth. Premature deployment can also damage sensor 138, which may be fragile in some embodiments. Therefore, it is necessary to reduce the likelihood of premature sensor deployment.

[0557] One way to reduce the likelihood of premature sensor deployment is to include initial resistance in the system (e.g., to couple the electronics unit 500 to the base 128). This initial resistance may require the accumulation of force before it can be overcome. When the initial resistance is overcome, the sensor 138 typically deploys faster than if there were no initial resistance (e.g., due to force accumulation, which may be at least 0.5 lbs, 1 lb, and / or less than 5 lbs). This rapid deployment reduces pain associated with the sensor insertion process.

[0558] In some embodiments, after overcoming initial resistance, the resistance to which the electronic unit 500 couples to the base 128 is less than 10%, less than 40%, and / or at least 5% of the initial resistance. This low resistance to the electronic unit 500 coupling to the base 128 after overcoming initial resistance enables rapid sensor insertion, which can reduce pain associated with the sensor insertion process.

[0559] Figures 56 to 58 The first portion 150 extends the sensor 138 into the skin of the subject. In some embodiments, the first portion 150 is used in... Figure 4 The electronic unit 500 shown is replaced such that the electronic unit 500 is coupled to the base 128 to push the sensor 138 into the skin of the body. Now refer to Figure 4 and 56 At point 58, the protrusion 240 (as explained in other embodiments) may be part of the electronic unit 500, such that the electronic unit moves distally relative to the second portion 152 and / or the electronic unit 500 couples to the base 128, requiring the overcoming of the initial resistance of the protrusion 240.

[0560] In some embodiments, the sensor 138 is configured to deploy (e.g., into the skin of the body) in response to the electronics 500 being coupled to the base 128, without using the retractable assembly 132b. Instead, features of the base 128 provide initial resistance to couple the electronics 500 to the base 128. Although in some other embodiments, it is used for different purposes Figure 33 The locking feature 230 in the base 128 can be coupled to a corresponding feature of the electronic unit 500. This coupling may require overcoming initial resistance.

[0561] exist Figures 1 to 70 Any features and embodiments described in the context are applicable to all aspects and embodiments in which the sensor 138 is coupled to the base 128 in response to the electronic unit 500 (e.g., a transmitter) unfolding (e.g., into the skin of the body).

[0562] Vertical Locking

[0563] After a retractable assembly (such as an applicator) has been used to insert a glucose sensor, the needle used to insert the glucose sensor could inadvertently pierce another person. To prevent this danger, the retractable assembly protects the person from subsequent needle prick injury by preventing the first part of the retractable assembly from moving distally relative to the second part after the sensor has been inserted into the body.

[0564] Figure 48 The description includes a perspective cross-sectional view of the retractable assembly 132i, comprising the first part 150i and the second part 152i. (See reference below.) Figures 48 to 50 The first portion 150i is configured to extend distally relative to the second portion 152i. The second portion 152i of the retractable assembly 132i may include a proximal protrusion 364 that slides through the locking feature 366 of the first portion 150i of the retractable assembly 132i when the first portion 150i moves distally.

[0565] The proximal protrusion 364 can be biased such that the elastic deformation of the proximal protrusion 364 generates a force configured such that once the proximal protrusion 364 engages the locking feature 366, the proximal protrusion 364 presses into the bottom of the locking feature 366.

[0566] When the first part 150i moves distally for the first time, the proximal protrusion 364 does not engage the locking feature 366. Once the first part 150i is in the distal end position, the spring can push the first part 150i to the second proximal position. Instead of returning to the starting proximal position, the proximal protrusion 364 engages the locking feature 366 (due to the offset of the proximal protrusion 364 of the locking feature 366 and the distal notch 368).

[0567] Once the proximal end of the proximal protrusion 364 is captured in the locking feature 366, the rigidity of the proximal protrusion 364 prevents the first portion 150i of the retractable assembly 132i from moving distally for the second time.

[0568] As the first portion 150i moves distally relative to the second portion 152i, the inclined surface 370 of the first portion 150i pushes the proximal protrusion 364 outward (towards the locking feature 366). The proximal protrusion 364 can be positioned between the two distal protrusions 372 of the first portion 150i. The distal protrusions 372 can guide the proximal protrusion 364 along the inclined surface 370.

[0569] As a portion of the proximal protrusion 364 slides along the inclined plane 370 (as the first portion 150i moves distally), the inclined plane bends the proximal protrusion 364 until a portion of the proximal protrusion 364, previously between the two distal protrusions 372, is no longer between the distal protrusions 372. Once a portion of the proximal protrusion 364 is no longer between the two distal protrusions 372, the proximal protrusion 364 is in a state of hooking the notch 368. The notch 368 may be a portion of the distal protrusion 372.

[0570] The second portion 152i of the retractable assembly 132i may include a proximal protrusion 364, which may be oriented at an angle between zero and 45 degrees relative to the central axis. The first portion 150i of the retractable assembly 132i may include a feature that causes the proximal protrusion 364 to follow a first path when the first portion 150i moves distally and subsequently follows a second path when the first portion 150i moves proximally. The second path includes a locking feature 366 that prevents the first portion 150i from moving distally a second time.

[0571] The first portion 150i may include a ramp 370 that guides the proximal protrusion 364 along a first path. A distal protrusion (e.g., ramp 370) of the first portion 150i may bias the proximal protrusion 364 such that the proximal protrusion 364 enters a second path as the first portion 150i moves proximally. The proximal protrusion 364 may be a curved arm. A lock 366 may include a distally facing notch 368 that hooks onto the proximal end of the proximal protrusion 364.

[0572] As in Figure 48 and 50 As shown, the retractable assembly 132i may include a sensor module 134i. The sensor module 134i may be any sensor module described herein.

[0573] exist Figures 48 to 50 Any features described in the context of this document are applicable to all aspects and embodiments identified herein. For example, in Figures 48 to 50 The embodiments described in the context can be compared with those in Figures 1 to 47 The embodiments described in the context of 51 to 70 are combined. Furthermore, any feature of the embodiments may be independently combined with other embodiments described herein, in any way, either partially or in whole; for example, one, two, or three or more embodiments may be fully or partially combined. Additionally, any feature of the embodiments may be optional for other aspects or embodiments. Any aspect or embodiment of the method may be performed by a system or apparatus of another aspect or embodiment, and any aspect or embodiment of the system may be configured to perform the method of another aspect or embodiment.

[0574] Double spring assembly

[0575] Partial sensor insertion can lead to suboptimal sensing. In some cases, partial sensor insertion can cause pinprick damage (because the needle does not retract into the protective housing). Therefore, a system that ensures complete sensor insertion is required.

[0576] exist Figures 61 to 64 The embodiment described herein significantly reduces the probability of partial sensor insertion by preventing sensor insertion until sufficient potential energy is stored in the system. The potential energy is stored in the first spring 402.

[0577] The system includes data from... Figure 7 Many items (e.g., base 128 and sensor module 134) are described in the embodiments. The system includes optional needle 156 and needle holder 162. Figures 61 to 64 The embodiments described herein can also be configured to be needle-free by removing the needle 156, the second spring 234, the needle seat 162, and the needle retraction mechanism 158.

[0578] The retractable assembly 132k has three parts 150k, 152k, and 392. The third part 392 moves distally relative to the second part 152k, storing energy in a first spring 402 (by compressing the first spring 402). Once the first part 150k unlocks from the second part 152k, the energy stored in the compressed first spring 402 is used to push the first part 150k distally relative to the second part 152k to engage the sensor 138 (in...). Figure 7 (As shown in the image) Driven into the skin of the body.

[0579] To ensure that the first portion 150k does not move distally relative to the second portion 152k until the first spring 402 is sufficiently compressed (and therefore has sufficient stored energy), the first portion 150k is locked to the second portion 152k. Once the first spring 402 is sufficiently compressed (and therefore has sufficient stored energy), the system unlocks the first portion 150k from the second portion 152k so that the stored energy can move the sensor 138 (and in some embodiments the needle 156) into the skin of the body.

[0580] The retractable assembly 132k can lock the third part 392 to the second part 152k in response to the third part 392 reaching a sufficiently distal position relative to the second part 152k. The protrusion 408 can be coupled with the hole 410 to lock the third part 392 to the second part 152k.

[0581] Some embodiments do not include the locking protrusion 408 and do not lock the third portion 392 to the second portion 152k in response to the third portion 392 reaching a sufficiently distal position relative to the second portion 152k.

[0582] In several embodiments, a sufficiently distal position is at least 3 mm, at least 5 mm, and / or less than 30 mm distal to the proximal starting position.

[0583] The retractable assembly 132k can lock the first portion 150k to the second portion 152k in response to the first portion 150k reaching a sufficiently distal position relative to the second portion 152k. The protrusion 412 (e.g., the distal protrusion) can be coupled to the hole 414 (e.g., in a surface within plus or minus 30 degrees perpendicular to the central axis of the retractable assembly 132k) to lock the first portion 150k to the second portion 152k.

[0584] Some embodiments include a needle 156 to assist in the insertion of the sensor into the skin of the body. In embodiments including the needle 156, the retractable assembly 132k may be included. Figure 7The needle retraction mechanism 158 is described in the context of the above. The first part 150k is moved to a sufficiently distal position relative to the second part 152k to trigger the needle retraction mechanism 158 (e.g., to release the latch) so that the second spring 234 can retract the needle 156.

[0585] Figure 61 Description for use with sensor assembly 600 on skin (in) Figures 4 to 6 (As shown in the diagram) a system applied to the skin of the subject. The system includes a position configured to begin proximally along a path relative to the second portion 152k (e.g., at...). Figure 61 The position shown in the image) is moved to the distal position (e.g., in the position shown in the image) to the distal position. Figure 64 The first part 150k of the retractable assembly 132k (as shown in the diagram) comprises a retractable assembly 132k; and a sensor 138 coupled to the first part 150k (in... Figure 64 (as shown in the figure); and a base 128 comprising an adhesive 126 configured to couple sensor 138 to skin. The retractable assembly 132k may further comprise a third portion 392 configured to move distally relative to the second portion 152k.

[0586] In some embodiments, the first portion 150k is positioned inside the second portion 152k such that the second portion 152k surrounds the first portion 150k in a cross-section taken perpendicular to the central axis of the retractable assembly 132k.

[0587] In some embodiments, a first spring 402 is positioned between a third portion 392 and a second portion 152k, such that the third portion 392 moves distally relative to the second portion 152k to compress the first spring 402. The first spring 402 may be a metal helical spring and / or a metal conical spring. In several embodiments, the first spring 402 is a molded feature that is part of the third portion 392, part of the second portion 152k, or part of the first portion 150k. The first spring 402 may be molded plastic.

[0588] The retractable assembly 132k may be configured such that the first spring 402 is not compressed in the proximal starting position and / or is not compressed during storage. In several embodiments, the retractable assembly 132k may be configured such that the first spring 402 is not compressed by more than 15% in the proximal starting position and / or during storage (e.g., to avoid unfavorable spring relaxation and / or creep of at least one of the third part 392, the second part 152k, and the first part 150k).

[0589] Some embodiments including needle 156 do not include needle holder 162. In these embodiments, a second spring 234 may be positioned between a second portion 152k and a first portion 150k such that the first portion 150k is moved distally relative to the second portion 152k to compress the second spring 234 so that the second spring 234 can push the first portion 150k proximally relative to the second portion 152k to retract needle 156 (e.g., after sensor insertion).

[0590] In several embodiments, the second spring 234 is compressed when the retractable assembly 132k is in the proximal start position. For example, the second spring 234 may be compressed at the factory during assembly of the retractable assembly 132k such that when the user receives the retractable assembly 132k, the second spring 234 has already been compressed (e.g., compressed enough to retract the pin 156).

[0591] The second spring 234 may have the same context as other embodiments herein (e.g., ...). Figure 7 (In the context of the embodiments described) Any properties and features associated with the spring 234.

[0592] In some embodiments, the movement of sensor module 134 (e.g., analyte sensor module) and sensor 138 (e.g., analyte sensor) relative to base 128 may be as described in the context of other embodiments (e.g., by means of...). Figures 7 to 11 (As illustrated in the description of the progress).

[0593] At the proximal starting position of the retractable assembly 132k, the first part 150k can be locked to the second part 152k. The system can be configured such that the third part 392 moves distally relative to the second part 152k to unlock the first part 150k from the second part 152k.

[0594] In several embodiments, a first proximal protrusion 394 having a first hook 396 passes through a first hole 398 in the second portion 152k to lock the first portion 150k to the second portion 152k. The third portion 392 may include a first distal protrusion 404. The system may be configured such that the third portion 392 moves distally relative to the second portion 152k, and the engaging ramp 406 bends the first proximal protrusion 394 to unlock the first portion 150k from the second portion 152k.

[0595] In some embodiments, when the base 128 extends from the distal end of the system, the sensor 138 is positioned within the second portion 152k, such that the system is configured to couple the sensor 138 to the base 128 by moving the first portion 150k distally relative to the second portion 152k.

[0596] In several embodiments, sensor module 134 is coupled to a distal portion of first portion 150k such that the first portion 150k is moved to a distal position to couple sensor module 134 to base 128. This coupling may be described in the context of other embodiments herein. When the first portion 150k is positioned at a proximal starting position, sensor 138 may be coupled to sensor module 134.

[0597] The system can be configured such that a third portion 392 moves distally relative to the second portion 152k before the first portion 150k moves distally relative to the first portion 152k. The system can also be configured such that the distal movement of the third portion 392 relative to the second portion 152k unlocks the first portion 150k from the second portion 150k and locks the third portion 392 to the second portion 152k.

[0598] The first protrusion 408 is coupled to a hole 410 of at least one of the second portion 152k and the third portion 392 to lock the third portion 392 to the second portion 152k.

[0599] In some embodiments, the system includes a second protrusion 412 coupled to a hole 414 of at least one of the first portion 150k and the second portion 152k to lock the first portion 150k to the second portion 152k in response to distal movement of the first portion 150k relative to the second portion 152k.

[0600] In several embodiments, a first spring 402 is positioned between a third portion 392 and a second portion 152k such that the third portion 392 moves distally relative to the second portion 152k, compressing the first spring 402 and unlocking the first portion 150k from the second portion 152k. This allows the compressed first spring 402 to push the first portion 150k distally relative to the second portion 152k, which pushes at least a portion of the sensor 138 away from the distal end of the system and triggers the needle retraction mechanism 158 so that the second spring 234 can retract the needle 156.

[0601] In another aspect, this document discloses a dual-spring type sensor insertion device (i.e., an analyte sensor electrically coupled to at least one electrical contact before the sensor is deployed) with a pre-connected sensor assembly. This type of sensor insertion device provides convenient and reliable insertion of the sensor into the user's skin via a needle and reliable retraction of the needle after sensor insertion, providing user convenience as well as predictability and reliability of the insertion mechanism. The reliability and convenience of dual-spring type sensor insertion devices with automatic insertion and automatic retraction represent a significant advancement in the field of sensor insertion devices. Furthermore, this type of device offers both safety and storage stability.

[0602] In several embodiments, the insertion device may include a first spring and a second spring. In such embodiments, either or both of the first and second springs may be integrally formed with a portion of the retractable assembly (such as a first portion and a second portion of the retractable assembly). In several embodiments, either or both of the first and second springs may be separately formed with respect to a portion of the retractable assembly and operatively coupled to that portion. For example, in some embodiments, the insertion spring may be integrally formed with a portion of the retractable assembly when the retraction spring is a separate component operatively coupled to that portion of the retractable assembly.

[0603] In some embodiments, instead of being configured to undergo compression during activation, either or both of the first and second springs may be configured to undergo stretching during activation. In these embodiments, coupling between the springs and portions of the retractable assembly, as well as coupling between moving portions of the assembly (e.g., in a dormant state and during activation, deployment, and retraction), may be adjusted to drive and / or facilitate desired action and response within the system. For example, in embodiments employing a stretched retraction spring to drive the insertion process, the retraction spring may be coupled to or integrally formed with a second portion of the retractable assembly. In such embodiments, the retraction spring may be pre-stretched in a dormant state. In other such embodiments, the retraction spring may be unstretched in a dormant state and stretched during the sensor insertion process.

[0604] In several embodiments, when the system is in a dormant state, either or both of the first and second springs may be substantially unenergized and / or unstressed. In several embodiments, when the system is in a dormant state, either or both of the first and second springs may be energized and / or stressed. As used herein, the term "energized" means sufficient potential energy stored in the spring to perform the desired action and response within the system. In some embodiments, the first spring may be partially energized in the dormant state, allowing the user to supply a small amount of force to fully energize the first spring. In some embodiments, the second spring may be partially energized in the dormant state, such that the energy stored in the first spring (either in the dormant state or after being energized by the user) provides the force to energize the second spring. In some embodiments, the energy stored in the first spring provides sufficient force to energize the second spring to at least retract the needle from the skin. In some embodiments, either or both of the first and second springs may be compressed or stretched by 50% or more, 60% or more, 70% or more, 80% or more, 90% or more, or 100% in the dormant state. In other embodiments, either or both of the first and second springs may be compressed or stretched by 50% or less, 40% or less, 30% or less, 20% or less, 15% or less, 10% or less, 5% or less, or 0% in the dormant state.

[0605] In embodiments where both the first and second springs are substantially unenergized in a dormant state, they may be subjected to the same, similar, or completely different amounts of stress. In embodiments where both the first and second springs are effectivelyenergized in a dormant state, they may be subjected to the same, similar, or completely different amounts of stress. In embodiments where the second spring is substantially unenergized in a dormant state, the first spring may be configured to store sufficient energy to drive the desired movement of both springs in the system (e.g., movement of a first portion in a distal direction) and to energize the second spring.

[0606] For reference Figures 71 to 75 This illustrates another embodiment of a system 104m for applying a sensor assembly to the skin of a subject. Figures 71 to 75 The embodiments described herein reduce the likelihood of incomplete sensor insertion by preventing sensor insertion until sufficient potential energy is stored in the system. The potential energy for sensor insertion can be stored in an actuator, such as a first spring 402m. The embodiments may offer other advantages, such as control speed, control force, and an improved user experience.

[0607] System 104m may include from Figure 7 Many features of the embodiments described herein (e.g., needle 156, base 128, and sensor module 134). System 104m may include alternative elements such as (but not limited to) needle holder 162m, second spring 234m, and needle retraction mechanism 158m. Figures 71 to 75 The embodiments described herein can also be configured as needleless by removing the needle 156, the second spring 234m, the needle holder 162m, and the needle retraction mechanism 158m. In such embodiments, the sensor may be a self-inserting sensor.

[0608] System 104m may include similar to Figures 61 to 64The embodiments described herein include many features (e.g., retractable assembly 132m), including a first portion 150m, a second portion 152m, and a third portion 392m; wherein locking features 396m and 398m are configured to releasably lock the first portion 150m to the second portion 152m until the third portion 392m has reached a sufficiently distal position relative to the second portion 152m to compress the first spring 402m and store sufficient energy in the spring 402m to drive the sensor 138 (and in some embodiments, the needle 156) into the skin of the body; locking features 408m and 410m are configured to lock the third portion 392m to the second portion 152m in response to the third portion 392m reaching a sufficiently distal position relative to the second portion 152m (e.g., to prevent the third portion 392m from being positioned relative to the second portion 152m). (2m proximal movement); unlocking features 404m and 406m are configured to unlock locking features 396m and 398m at least after the third part 392m is locked to the second part 152m and / or the first spring 402m is sufficiently compressed; locking features 412m and 414m are configured to lock the first part 150m to the second part 152m in response to the first part 150m reaching a sufficiently distal position relative to the second part 152m to drive the sensor 138 (and in some embodiments the needle 156) into the skin of the body; and needle retraction mechanism 158m is configured to unlock the needle seat 162m from the first part 150m at least once the needle seat 162m has reached a sufficiently distal position and thereby allows the second spring 234m to retract the needle 156 (e.g. to allow proximal movement of the needle seat 162m with respect to the first part 150m).

[0609] Figure 71 The illustration shows a cross-sectional perspective view of the applicator system 104m in a dormant state (e.g., when provided to a consumer, before user activation and applicator system deployment). As illustrated, the first spring 402m may be neither stretched nor compressed, such that the first spring is substantially unenergized. In some embodiments, the first spring 402m may be slightly stretched or slightly compressed in the dormant state (e.g., neither stretched nor compressed more than 15%), such that the first spring is substantially or almost unenergized in the dormant state. In some embodiments, the first spring may be effectively unenergized, for example, minimally energized in the dormant state but not to the extent that it would cause any kind of cascading effect in the system.

[0610] exist Figures 71 to 75 In the embodiments described herein, the first spring 402m is integrally formed as part of the third portion 392m. In some embodiments, the first spring 402m may be integrally formed as part of other components of the system 104m, such as (but not limited to) the first portion 150m, the second portion 152m, etc. Integrally formed springs (such as in...) Figures 71 to 75 The spring described herein offers advantages including reducing the number of parts in the system and reducing the amount of assembly process. The first spring 402m can be molded plastic. (As described in...) Figure 71 As described, in the dormant state, the second spring 234m is also substantially unenergized (e.g., neither stretched nor compressed more than 15%). The second spring 234m is integrally formed as part of the pin seat 162m. In some embodiments, the second spring 234m may be integrally formed as part of other components of the system 104m, such as (but not limited to) the first portion 150m, the second portion 152m, the base 128, etc. The second spring 234m may be molded plastic. This configuration simplifies the manufacture and assembly of the system 104m while avoiding undesirable relaxation and / or creep of the first spring 402m, the second spring 234m, or other components of the system 104m during storage and / or before deployment. It is also contemplated in other embodiments that the first spring 402m and / or the second spring 234m may comprise metal.

[0611] In some embodiments, the first spring 402m and / or the second spring 234m may comprise molded plastics such as (but not limited to): polycarbonate (PC), acrylonitrile butadiene styrene (ABS), PC / ABS blends, nylon, polyethylene (PE), polypropylene (PP), and acetal. In some embodiments, the spring constant of the first spring 402m and / or the second spring 234m is less than 10 psi.

[0612] The applicator system 104 can be energized by the movement of one component relative to another. For example, when the second part 152m is placed against the skin of the body or another surface, the third part 392m can store energy in the first spring 402m when it is compressed against the first part 150m, moving distally relative to the second part 152m. The third part 392m can move distally until locking features 408m and 410m (see...) Figure 73The first portion 150m is engaged with the second portion 396m. In some embodiments, the third portion 392m may be further moved distally until the unlocking feature 404m engages the locking feature 396m. The unlocking feature 404m may engage and release the locking feature 396m and allow the first portion 150m to move distally. In some embodiments, the locking features 408m and 410m are coupled together before the locking feature 396m is released from the locking feature 398m. In other embodiments, the unlocking feature 404m engages the locking feature 396m and causes the locking feature 396m to be released from the locking feature 398m, and the locking features 408m and 410m may be coupled together. In some embodiments, the locking feature 408m is a protrusion characterized by a hook portion, the locking feature 410m is a hole characterized by an angled surface, the unlocking feature 404m is a distal protrusion characterized by an angled surface, the locking feature 396m is a hook characterized by a bevel 406m, and the locking feature 398m is a hole. When the first spring 402m is energized, the sensor module 134 remains in the proximal starting position.

[0613] Figure 72 The diagram illustrates a cross-sectional perspective view of the applicator system 104m, wherein a first spring 402m is compressed and unlocking features 404m and 406m engage to unlock the first portion 150m from the second portion 152m. Until the first portion 150m is unlocked from the second portion 152m, the sensor module 134 remains in its proximal starting position, and the second spring 234m remains substantially uncharged. Figure 73 A rotating cross-sectional perspective view of the applicator system 104m is shown, illustrating the engagement of locking features 408m and 410m to prevent proximal movement of the third portion 392m relative to the second portion 152m. In some embodiments, such as in Figure 73 As described herein, the system may include a secondary locking feature 409m, which is configured to cooperate with the opening 410m to prevent the third part 392 from falling off or otherwise separating from the remainder of the system 104m before deployment.

[0614] Figure 74 This illustrates a cross-sectional perspective view of the applicator system 104m, where system 104m has been activated by disassembling the first part 150m with respect to the second part 152m. (As shown in...) Figure 74As can be seen, once the first part 150m and the second part 152m are disengaged or released, the potential energy stored in the first spring 402m drives the first part 150m, along with the needle holder 162m and the sensor module 134, in the distal direction. This movement compresses the second spring 234m and extends the needle 156 and the sensor module 134 distally to the distal insertion position, wherein the sensor module 134 is coupled to the base 128 and the needle 156 extends distally to the base 128. Once the needle 156 and the sensor module 134 reach the distal insertion position, the locking features 412m and 414m (see...) Figure 73 The first portion 150m engages to prevent proximal movement of the second portion 152m, and the unlocking feature of the needle retraction mechanism 158m (e.g., proximal protrusion 170m, release feature 160m, and latch 236m including end 164m of release feature 160m and protruding end 166m of the first portion 150m) cooperates to release latch 236m. Optionally, after the second spring 243m is activated, the user can hear a click, which indicates that the cap is locked in the proper position.

[0615] Once the latch 236m is released, while the first portion 150m, along with the sensor module 134, remains in the distal deployed position, the potential energy stored in the compressed second spring 234m drives the needle holder 162m back in the proximal direction. The stored potential energy can be between 0.25 psi and 4 psi. In a preferred embodiment, the stored potential energy is between approximately 1 psi and 2 psi. Figure 75 The diagram illustrates a cross-sectional perspective view of the applicator system 104m, wherein the sensor module 134 is in a distal unfolded position, coupled to the base 128, and wherein the needle holder 162m is retracted to a proximal retracted position.

[0616] The system configured according to the embodiment provides inherent safety and storage stability for sensor insertion. Unloaded (i.e., substantially uncompressed and substantially unactivated) springs do not need to be prematurely fired. In practice, such systems are primarily designed to prevent unintentional firing without direct user interaction, as the first and / or second springs are substantially unenergized during storage. Furthermore, systems with springs that are substantially uncompressed before activation are expected to offer storage stability because, compared to pre-energized insertion devices, the system components are not exposed to forces or time-varying phase changes (such as creep, environmental factors, defects from time-dependent load conditions, etc.). The substantially uncompressed first and second springs provide the system in which the substantially unenergized first spring 404m is configured to load sufficient energy to drive the sensor from a proximal position to a distal position and also transfer energy to the second spring 234m to drive the needle to a fully retracted position.

[0617] Other embodiments may also be configured to achieve these benefits. For example, Figures 76 to 79This describes another embodiment of a system 104n for applying a sensor assembly to the skin of a subject. System 104n includes components similar to those in... Figures 71 to 75 Many features of those embodiments described herein (e.g., a retractable assembly 132n including a first portion 150n, a second portion 152n, and a third portion 392n; a pin holder 162n; a first spring 402n; and a second spring 234n). In Figures 76 to 79 In the embodiments described herein, the first spring 402n is formed separately from and operatively coupled to the third portion 392n. The second spring 234n is formed separately from and operatively coupled to the needle seat 162n. The first spring and / or the second spring may each comprise a helical spring having a circular cross-section. In some embodiments, the first spring and / or the second spring may each comprise a helical spring having a square or non-circular cross-section. The first spring and / or the second spring may comprise a metal, such as (but not limited to) stainless steel, steel, or other types of metal. Alternatively, in some embodiments, one or both of the first spring and the second spring may be integrally formed with a portion of the applicator assembly. For example, and without limitation, in some embodiments, the first spring may be integrally formed with the first portion. In some embodiments, the second spring may be integrally formed with the needle seat. In several embodiments, the first spring and / or the second spring may be molded plastic, such as (but not limited to) PC or ABS.

[0618] Figure 76 The diagram illustrates a cross-sectional side view of the system 104n in a dormant state, wherein both the first spring 402n and the second spring 234n are unstressed and unenergized. In the dormant state, the first portion 150n is fixed at least axially with respect to the second portion 152n, while the third portion 392n is movable at least distally with respect to the first portion 150n. The first portion 150n and the second portion 152n can be fixed with respect to each other in any suitable manner, for example, by making a releasable locking feature coupled to or forming a portion of the first portion 150n and the second portion 152n (e.g., as shown in...). Figures 71 to 75 The system 104n includes a skin-mounted assembly 134n releasably coupled to a needle hub 162n. The skin-mounted assembly may contain a sensor module, such as... Figure 3 Combined with the described sensor module 134, or a combined sensor module and base assembly, or an integrated sensor module / base / transmitter assembly, or any other component intended to be applied to the skin of the subject, whether directly or indirectly, for example, via an adhesive patch.

[0619] exist Figure 76In the dormant state described herein, the skin assembly 134n is positioned at a proximal starting position between the proximal and distal ends of the system 104n. The distal end of the needle 156 may also be positioned between the proximal and distal ends of the system 104n. In the dormant state, the distal end of the first spring 402n abuts against the proximal-facing surface of the first portion 150n. A force is applied against the proximal-facing surface of the third portion 392n, causing the third portion 392n to move distally relative to the first portion 150n, compressing and thus energizing the first spring 402n. In some embodiments, this process may be similar to... Figure 71 Combined with the described spring energizing process.

[0620] Figure 77 illustrate Figure 76 A cross-sectional side view of the applicator system, wherein the first spring 402n is energized. When the third portion 392n has moved sufficiently distally to energize the first spring 402n, the third portion 392n becomes fixed at least axially with respect to the second portion 152n. At the same time or about the same time (e.g., simultaneously or subsequently), the first portion 150n becomes movable at least distally with respect to the second portion 152n. The third portion 392n and the second portion 150n can be fixed with respect to each other in any suitable manner, for example by making a locking feature coupled to or forming therewith a portion of the third portion 392n and the second portion 152n (e.g., in...) Figures 71 to 75 The locking feature (or similar feature) described herein cooperates, and a portion of the third part 392n and the second part 152n are configured to engage each other once the third part 392n has reached a sufficiently distal position. The first part 150n and the second part 152n can be released by being configured to... Figure 76 The structure of one or more locking features coupled together in the hibernation configuration described in the text (in) Figures 76 to 79 (Not shown) are movable relative to each other. The first part 150n includes a protruding end (sometimes referred to as a pawl, undercut, and / or needle seat engagement feature) 166n, which cooperates with the release feature 160n of the needle seat 162n to fix the needle seat 162n relative to the first part 150n, both when the system is in a dormant state and during the activation of the spring 392n.

[0621] Figure 78The diagram illustrates a cross-sectional side view of system 104n, in which the first portion 150n and the second portion 152n are unlocked, activating the first spring 402n and storing energy therein to drive the first portion 150n in the distal direction. The movement of the first portion 150n further propels the needle hub 162n (and the skin assembly 134n coupled to the needle hub 162n) against the proximal surface of the second portion 152n, compressing the second spring 234n, coupling the skin assembly 134n to the base 128n, and driving the needle 156 to... Figure 78 In the distal insertion position described herein, when the needle hub 162n has reached a sufficiently distal position to achieve these functions, the end of the release feature 160n contacts the bevel 170n of the second portion 152n, causing the release feature 160n to compress inward (towards the central axis of the system 104n), releasing the end of the release feature 160n from the protruding end 166n. In some embodiments, this process may be similar to that described above. Figure 74 Referring to the described spring compression process, in some embodiments, the inclined plane 170n is a proximal inclined plane. In other embodiments, the inclined plane 170n is a distal inclined plane (not shown). In some embodiments, the release feature or multiple features may be configured to compress inward (or otherwise release) by relative rotational movement of certain components of the system, such as by torsion or other rotational movement of the first part about the second part. In some embodiments, the release feature or multiple features may extend in a direction perpendicular to the axis of the system, and / or may extend circumferentially about the axis of the system, instead of being typically parallel to the axis as described above. Figure 78 The axial extensions (or other than) of the system described herein.

[0622] Figure 79 The diagram illustrates a cross-sectional side view of system 104n, in which needle hub 162n releases from engagement with protrusion 166, activating second spring 234n and causing energy stored therein to drive needle hub 162n in the proximal direction. When needle hub 162n retracts to the proximal position, skin assembly 134n decouples from needle hub 162n to remain in the deployed position and couples to base 128n.

[0623] Figures 80 to 85 This describes another embodiment of a system 104p for applying a sensor assembly to the skin of a subject. The sensor insertion system, as described in... Figures 80 to 85The sensor insertion system described herein provides enhanced predictability of spring displacement of the second energized spring 234p because the second spring 234p has been compressed. This configuration appropriately assists in ensuring that the needle retracts at a sufficient distance from the skin. In some embodiments, a system incorporating a pre-energized retraction spring provides effective and reliable insertion and retraction when a smaller amount of user supply force is required compared to, for example, a system in which both the insertion and retraction springs are substantially unenergized before deployment, making this configuration more convenient for at least some users. Additionally, in some embodiments, a system incorporating one or more metal springs provides effective and reliable insertion and retraction when a smaller amount of force is required compared to a system in which both the insertion and retraction springs are made of plastic. System 104p includes components similar to those in… Figures 76 to 79 Many features of those embodiments described herein (e.g., the retractable assembly 132p including first portion 150p, second portion 152p, and third portion 392p; needle holder 162p; first spring 402p; second spring 234p; skin assembly 134n; and base 128p). In Figures 80 to 85 In the embodiments described herein, the first spring 402p is formed separately from and operatively coupled to the third portion 392p. The second spring 234p is formed separately from and operatively coupled to the needle seat 162p. The first spring and / or the second spring may comprise metal. Alternatively, in some embodiments, one or both of the first and second springs may be integrally formed with a portion of the applicator assembly. For example, and without limitation, in some embodiments, the first spring may be integrally formed with the first portion. In some embodiments, the second spring may be integrally formed with the needle seat. In several embodiments, the first spring and / or the second spring may be molded plastic.

[0624] Figure 80 This illustrates a cross-sectional side view of system 104p in a dormant state, where the first spring 402p is substantially unstressed and unenergized, but the second spring 234n is pre-energized (e.g., compressed). Figure 80 In the dormant state described herein, the first portion 150p is locked to the second portion 152p to prevent movement of the first portion 150p proximal or distal to the second portion 152p. The first portion 150p and the second portion 152p can be locked together in any suitable manner, for example by making a portion of the first portion 150p and the second portion 152p coupled to or forming therewith releasable locking features 396p and 398p (see [link to documentation]). Figure 84 and 85Collaboration. The needle seat 162n can also be releasably secured to the first portion 150p. The needle seat 162n can be secured to the first portion 150p in any suitable manner, for example, by means of a feature of the first portion 150p configured to engage or compress the release feature (sometimes referred to as the needle seat resistance feature) 160p of the needle seat 162n.

[0625] exist Figure 80 In the dormant state described herein, the skin assembly 134p is positioned at a proximal starting position, such that the distal end of the needle 156 is positioned between the proximal and distal ends of the system 104p. In the dormant state, the distal end of the first spring 402p abuts the proximal-facing surface of the first portion 150p. A force is applied against the proximal-facing surface of the third portion 392p, causing the third portion 392p to move distally relative to the first portion 150p, compressing the first spring 402n and thus energizing the first spring 402p. In some embodiments, this process may be similar to... Figure 76 Combined with the described spring energizing process.

[0626] Figure 81 This describes the process after the third part 392n has been moved sufficiently to the distal position to engage the first spring 402p and optionally the third part 392p is locked to the second part 152p. Figure 80 A cross-sectional side view of system 104p. The third part 392n and the second part 150n can be locked together in any suitable manner, for example, by coupling a portion of the third part 392p and the second part 152p or forming a locking feature therewith (e.g., in...). Figures 76 to 79 The locking feature (or similar feature) described herein cooperates. At the same time or approximately the same time as the third part 392p locking to the second part 152p (e.g., simultaneously or subsequently), the unlocking features 404p and 406p (see [reference]) are engaged. Figure 84 and 85 Collaborate to release the lock between Part 150p and Part 152p.

[0627] Figure 82 The diagram illustrates a cross-sectional side view of system 104p, wherein a first spring 402p is activated to drive a first portion 150p in a distal direction. The movement of the first portion 150p further advances the needle hub 162p (and the supra-skin assembly 134p coupled to the needle hub 162p) in the distal direction, couples the supra-skin assembly 134p to the base 128p, and also drives the needle 156 through the distal end of system 104p in the distal direction. Upon reaching the needle hub 162p... Figure 82At or approximately the time of the distal insertion position described herein (e.g., immediately before, simultaneously with, or subsequently thereafter), the end of the release feature 160p contacts the bevel 170p of the second portion 152p, causing the release feature 160p to compress inward (towards the central axis of system 104p), unlocking the needle holder 162p from the first portion 150p and releasing or activating the second spring 234p. In some embodiments, the bevel 170p is a proximal bevel. In other embodiments, the bevel 170p is a distal bevel (not shown). Activation of the second spring 234p advances the needle holder 162p in the proximal direction.

[0628] Figure 83 The diagram illustrates a cross-sectional side view of system 104p, in which needle hub 162p is unlocked from first portion 150p and retracted to a proximal position. When needle hub 162p retracts to the proximal position, skin assembly 134p is decoupled from needle hub 162p to remain in the deployed position and coupled to base 128p.

[0629] Figure 84 A perspective view illustrating the system 104p in a dormant state is shown, in which the first part 150p and the third part 392p are shown in cross-section to better illustrate certain parts of the system 104p, such as locking features 396p, 398p and unlocking features 404p, 406p. Figure 85 Another perspective view of system 104p is shown, in which the first part 150p and the third part 392p are shown in cross-section, and the first spring 402p is energized but not activated.

[0630] Figures 86 to 88 Another embodiment of a system 104q for applying a sensor assembly to the skin of a subject is described, wherein the insertion spring is pre-compressed and the retraction spring is substantially uncompressed. Such systems allow a user to initiate needle insertion and retraction with fewer steps. Anticipated advantages may include a relatively small applicator size and more predictable spring displacement of the first spring, as the first spring is already compressed, thereby aiding in ensuring proper needle insertion into the user's skin. In some embodiments, systems incorporating a pre-energized insertion spring provide efficient and reliable insertion and retraction when a smaller amount of user supply force is required compared to systems, for example, where both the insertion and retraction springs are substantially unenergized before unfolding, making such configurations more convenient for at least some users. System 104q includes similar features to those in… Figures 76 to 79Many items of those embodiments described herein (e.g., a retractable assembly 132q including a first portion 150q, a second portion 152q, and a third portion 392q; a needle holder 162q; a first spring 402q; a second spring 234q; an on-skin assembly 134q; and a base 128q). In system 104q, the first spring 402q is formed separately from and operatively coupled to the third portion 392q. The second spring 234q is formed separately from and operatively coupled to the needle holder 162q. The first spring and / or the second spring may comprise metal. Alternatively, in some embodiments, one or both of the first and second springs may be integrally formed with a portion of the applicator assembly.

[0631] Figure 86 This illustrates a cross-sectional side view of system 104q in a dormant state, where the first spring 402q is energized, but the second spring 234q is substantially unenergized (e.g., primarily uncompressed or unstressed; partially energized). Figure 86 In the dormant state described herein, the first portion 150q is locked to the second portion 152q to prevent movement of the first portion 150q proximal or distal to the second portion 152q. The first portion 150q and the second portion 152q can be locked together in any suitable manner, for example by coupling a portion of the first portion 150q and the second portion 152q or forming a releasable locking feature thereon (e.g., in…). Figures 76 to 79 The locking feature described herein, or other suitable locking features, cooperates. The needle seat 162q can also be releasably locked to the first portion 150q. The needle seat 162q can be locked to the first portion 150q in any suitable manner, for example, by means of a feature of the first portion 150q configured to engage or compress the release feature 160q of the needle seat 162q. The third portion 392q and the second portion 152q are also locked together to prevent relative movement of the third portion 392q and the second portion 152q in the axial direction. The third portion 392q and the second portion 152q can be locked together in any suitable manner, for example, by means of a locking feature (in the form of) that can be coupled to a portion of the third portion 392q and the second portion 152q. Figures 86 to 89 (Not shown in the image) Collaboration. In Figure 80 In the dormant state described herein, the skin component 134q is positioned at the proximal starting position, such that the distal end of the needle 156 is positioned between the proximal and distal ends of the system 104q.

[0632] To trigger the deployment of system 104q, the locking feature coupling the first part 150q to the second part 152q can be unlocked, decoupling the two parts and thereby releasing or activating the first spring 402q. The locking feature can be unlocked by a user-activated trigger mechanism, such as a button located on or within the top or side surface of system 104q, or configured to disengage a torsion-release feature when the third part 392q rotates relative to the first part 150q and / or the second part 152q about an axis of the system. Some examples of trigger mechanisms are related to... Figures 92 to 104 Based on the description.

[0633] Figure 87 This illustrates a cross-sectional side view of system 104q after the first part 150q and the second part 152q have been unlocked. (See also...) Figure 87 As can be seen, when the first spring 402q expands, it drives the first portion 150q in the distal direction. The movement of the first portion 150q also propels the needle hub 162q (and the skin assembly 134q coupled to the needle hub 162q) in the distal direction, coupling the skin assembly 134q to the base 128q, compressing the second spring 234q, and driving the needle 156 through the distal end of the system 104q in the distal direction. When the needle hub 162q reaches the... Figure 87 At or approximately the time of the distal insertion position described (e.g., immediately before, simultaneously with, or subsequently thereafter), the end of the release feature 160q contacts the interference feature 170q of the second portion 152q, causing the release feature 160q to compress inward (towards the central axis of the system 104q), unlocking the needle seat 162q from the first portion 150q and activating the now-energized second spring 234q. In some embodiments, the interference feature 170q is a proximal interference feature. In other embodiments, the interference feature 170q is a distal interference feature (not shown).

[0634] While the skin assembly 134q, already coupled to the base 128q, remains in the extended distal position, the second spring 234q advances the needle hub 162q in the proximal direction upon activation by the user or mechanism. Figure 88 The diagram illustrates a cross-sectional side view of system 104q, with skin component 134q in the extended position and needle hub 162q retracted to the proximal position.

[0635] Figures 89 to 91 Another embodiment of a system 104r for applying a sensor assembly to the skin of a subject is described. As is expected with reference to... Figures 89 to 91The described system 104r provides predictable spring displacement of the first spring 402r as it is compressed, thereby assisting in proper needle insertion into the user's skin. Furthermore, the anticipated compression of the second spring 234r provides predictable spring displacement and assists in ensuring proper retraction of the needle from the user's skin. In some embodiments, systems incorporating pre-energized insertion and retraction springs can provide effective and reliable insertion and retraction when a smaller amount of user supply force is required compared to systems where one or both insertion and retraction springs are substantially unenergized before deployment, making such configurations more convenient for at least some users. System 104r includes features similar to those in… Figures 76 to 79 Many items of those described in the embodiments (e.g., a retractable assembly 132r including a first portion 150r, a second portion 152r, and a third portion 392r; a needle holder 162r; a first spring 402r; a second spring 234r; a skin assembly 134r; and a base 128r). As in Figures 89 to 91 As described, both the first spring 402r and the second spring 234r are pre-compressed. In system 104r, the first spring 402r is formed separately from and operatively coupled to the third portion 392r. The second spring 234r is formed separately from and operatively coupled to the needle holder 162r. The first spring and / or the second spring may comprise metal. Alternatively, in some embodiments, one or both of the first and second springs may be integrally formed with a portion of the applicator assembly.

[0636] Figure 89 This illustrates a cross-sectional side view of system 104r in a dormant state, where both the first spring 402r and the second spring 234r are pre-energized (e.g., sufficiently compressed to drive the needle insertion and retraction process). Figure 89 In the dormant state described herein, the first portion 150r is locked to the second portion 152r to prevent movement of the first portion 150r proximally or distally with respect to the second portion 152r. The first portion 150r and the second portion 152r can be locked together in any suitable manner, for example by coupling a portion of the first portion 150r and the second portion 152r or forming a releasable locking feature therewith (e.g., with...). Figures 80 to 83The locking feature 162r, in conjunction with the described locking feature (or other suitable locking feature), cooperates. The needle seat 162r can also be releasably locked to the first portion 150r. The needle seat 162r can be locked to the first portion 150r in any suitable manner, for example, by means of a feature of the first portion 150r configured to engage or compress the release feature 160r of the needle seat 162r. The third portion 392r and the second portion 152r are also locked together to prevent relative movement of the third portion 392r and the second portion 152r in at least the axial direction. The third portion 392r and the second portion 152r can be locked together in any suitable manner, for example, by means of a locking feature (in the form of) that can be coupled to a portion of the third portion 392r and the second portion 152r. Figures 89 to 91 (Not shown in the image) Collaboration. In Figure 89 In the dormant state described herein, the skin component 134r is positioned at the proximal starting position, such that the distal end of the needle 156 is positioned between the proximal and distal ends of the system 104r.

[0637] In order to trigger the deployment of system 104r, the locking feature that couples the first part 150r to the second part 152r can be unlocked, decoupling the two parts and thereby releasing or activating the first spring 402r. Figure 90 This describes a cross-sectional side view of system 104r after the first part 150r and the second part 152r have been unlocked. (See also...) Figure 90 As can be seen, when the first spring 402r expands or decompresses, the first spring 402r drives the first portion 150r in the distal direction. The movement of the first portion 150r also advances the needle hub 162r (and the skin assembly 134r coupled to the needle hub 162r) in the distal direction until the skin assembly 134r is coupled to the base 128r, and until the needle 156 reaches the distal insertion position beyond the distal end of the system 104r. When the needle hub 162r reaches the... Figure 87 At the time or approximately the time of the distal insertion position described in the text (e.g., immediately before, simultaneously with, or subsequently thereafter), the end of the release feature 160r contacts the corresponding interference feature 170r of the second part 152r, causing the release feature 160r to compress inward (towards the central axis of the system 104r), unlocking the needle seat 162r from the first part 150r and releasing or activating the second spring 234r.

[0638] When the skin assembly 134r, which has been coupled to the base 128r, is held in the extended distal position, the activation of the second spring 234r drives the needle seat 162r in the proximal direction. Figure 91The diagram illustrates a cross-sectional side view of system 104r, with the skin assembly 134r in the deployed position and the needle hub 162r retracted to the proximal position. According to this configuration, system 104r can be removed and separated from the deployed skin assembly 134r and the base 128r.

[0639] Figures 92 to 100 Another embodiment of a system 104s for applying a sensor assembly to the skin of a subject is described, which includes a safety feature to prevent accidental firing of the sensor insertion device. System 104s includes features similar to those in… Figures 76 to 79 Many items of those embodiments described herein (e.g., a retractable assembly 132s including a first portion 150s, a second portion 152s, and a third portion 392s; a needle holder 162s; a first spring 402s; a second spring 234s; an on-skin assembly 134s; and a base 128s). In system 104s, the first spring 402s may be formed separately from and operatively coupled to the third portion 392s. The second spring 234s may be formed separately from and operatively coupled to the needle holder 162s. The first spring and / or the second spring may comprise metal. Alternatively, in some embodiments, either or both of the first and second springs may be integrally formed with a portion of the applicator assembly.

[0640] Figure 92 The diagram illustrates a side view of system 104s in a dormant state, where the first spring 402s is unstressed and unenergized, but the second spring 234s is energized (e.g., compressed). System 104s includes a tilting mechanism 702, through which the first spring 402s can be energized (e.g., compressed) without automatically triggering the unfolding of the first portion 150s or the activation of the first spring 402s. System 104s also includes a trigger button 720 configured to activate the first spring 402s after the system tilts up. Figure 93 This describes a side view of the applicator system 104s after it is lifted but before it is triggered.

[0641] Figure 94 A cross-sectional perspective view of the system 104s in a dormant state shows the first spring 402s substantially uncompressed. The tilting mechanism 702 includes a pair of lever arms 704 extending proximally, each having a radially angled tab 706. In some embodiments, the lever arms 704 may be integrally formed with the second portion 152s, as shown in... Figure 94 As shown, in other embodiments, lever arm 704 can be detached from and operably coupled to the second portion 152s. Figure 94In the dormant state described herein, the angled tab 706 extends through the distal aperture 708 in the third portion 392s to prevent proximal movement of the third portion 392s with respect to the second portion 152s. The angled tab 706 is also configured to inhibit distal movement of the third portion 392s with respect to the second portion 152s unless and until a sufficient amount of force is applied to the third portion 392s to deflect the angled tab 706 and the lever arm 704 inward, as described in Figure 95 As explained in the text.

[0642] When sufficient force is applied to the third portion 392s in the distal direction (e.g., via the user's hand or thumb), the angled tab 706 deflects inward and releases from engagement with the distal aperture 708, causing the third portion 392s to move distally with respect to the second portion 152s. This allows the user to compress and energize the first spring 402s. When the third portion 392s has reached a sufficiently distal position to compress the first spring 402s to drive the sensor into the skin of the body, the angled tab 706 engages with the proximal aperture 710 of the third portion 392s to lock the position of the third portion 392s with respect to the second portion 152s, as in Figure 96 As described herein, the angled tab 706 can be configured to produce a "click" sound when engaged with the proximal aperture 710 to prevent proximal movement of the third part 392s about 152s, so that the user can feel and / or hear it when these parts are engaged. Figure 96 In the configuration described, system 104s is powered on, with the third part 392 in the tilted position. System 104s is ready to deploy the sensor, but it does not deploy until the user takes further action.

[0643] Figure 97 The illustration shows a cross-sectional side view of system 104s in a tilted but untriggered state. In this state, the first portion 150s is locked to the second portion 152s to prevent movement of the first portion 150s proximal or distal to the second portion 152s. The first portion 150s and the second portion 152s can be locked together in any suitable manner, for example by cooperating with releasable locking features 396s and 398s operably coupled to or forming with a portion of the first portion 150s and the second portion 152s. Trigger button 720 includes a distally extending protrusion 722, which, once pressed by the user to a sufficiently distal position, is configured to cooperate with the unlocking feature 406s of locking feature 396s to decouple the first portion 150s from the second portion 152s. Trigger button 720 is operably coupled to a third portion 392s, as shown in... Figures 92 to 100As described herein, it may be integrally formed with the third part, for example, when the lever arm is formed within the proximal or lateral surface of the third part. In some embodiments, the trigger button may be located at the top of the system (such that applying a force in the distal direction triggers system activation), or on one side of the system (such that applying a force in the radially inward direction perpendicular to the direction of needle deployment triggers system activation).

[0644] Figure 98 This describes a cross-sectional side view of the empowerment system 104s when the trigger button 720 has been sufficiently pressed to cause the protrusion 722 to bend radially inward, locking the feature 396s, releasing it from the opening 398s, and unlocking the first part 150s from the second part 152s. Pressing the trigger button 720 thus activates the first spring 402, pushing the first part 150s and the needle seat 162s in the distal direction, along with the skin assembly 134s coupled thereto, until the skin assembly is coupled to the base 128s, as shown in... Figure 99 As explained in the text. The needle reaches its position at 162 seconds. Figure 99 At the time of the distal insertion position described herein, or approximately the time described thereafter (e.g., immediately before, simultaneously with, or subsequently thereafter), the corresponding release feature of the needle hub 162s and the first portion 150s can engage (via, for example, in) Figures 76 to 91 The needle holder 162s is released from the first part 150s (or any other suitable release feature described in the text) and the second spring 234s is released or activated. Activation of the second spring 234s propels the needle holder 162s in the proximal direction.

[0645] Figure 100 illustrate Figure 92 A cross-sectional side view of the applicator system, wherein the skin assembly 134s is in the deployed position and the needle hub 162s is retracted to the proximal position. When the needle hub 162s is retracted to the proximal position, the skin assembly 134s is decoupled from the needle hub 162s to remain in the deployed position and coupled to the base 128s. According to this configuration, the remainder of the system 104s can be removed and separated from the deployed skin assembly 134s and the base 128s.

[0646] exist Figures 61 to 99 Any feature described in the context of any of these contexts is applicable to all aspects and embodiments identified herein. For example, in Figures 61 to 64 The embodiments described in the context can be compared with those in Figures 1 to 60 Combined with the embodiments described in the context of 65 to 70. As another example, in Figures 92 to 109 Any embodiment described in the context of [the preceding text] may be related to [the following text] Figures 1 to 60This can be combined with any of the embodiments described in the context of 65 to 91 and 110 to 143. Furthermore, any feature of the embodiments may be independently combined with other embodiments described herein, in any way, either partially or in whole; for example, one, two, or three or more embodiments may be wholly or partially combined. Additionally, any feature of the embodiments may be optional for other aspects or embodiments. Any aspect or embodiment of the method may be performed by a system or apparatus of another aspect or embodiment, and any aspect or embodiment of the system may be configured to perform the method of another aspect or embodiment.

[0647] Triggering mechanism and security lock

[0648] In some embodiments, sufficient force to apply enough energy to the first spring to drive the insertion of the sensor can also be used to activate the first spring. In other embodiments, the activation of the first spring can be decoupled from its activation, requiring a separate action by a part of the user to activate (e.g., compress) the first spring and trigger the deployment of the system.

[0649] For example, in Figures 92 to 100 The embodiments described herein include a trigger mechanism in the context of a user-activated actuator. In such embodiments, the user first lifts system 104s to activate the first spring 402s, and then triggers the activation of the first spring 402s with a separate action using trigger button 720. The locking feature is easily released by the user and, when combined with the trigger mechanism, allows for one-handed operation.

[0650] In some embodiments, the actuator or insert spring is already activated when the system is in a dormant state. In these embodiments, the triggering mechanism, such as in Figures 92 to 100 The triggering mechanism described in the context can be used to activate an already energized insertion spring without any action by the user to energize the spring.

[0651] Figure 101 This illustration shows a side view of an applicator system 104t with a side-triggered button 730. The system 104t can be configured substantially similar to those shown in the illustration. Figures 86 to 88 The system 104q or system 104r described in the context of 89 to 91, where similar reference numerals indicate similar parts. (As in...) Figure 101 As can be seen, the trigger button 730 is operably coupled to the third component 392t.

[0652] Figure 102 Another side view of system 104t is shown, in which the first part 150t and the third part 392t are shown in cross-section to illustrate the triggering mechanism. (As shown in...) Figure 102As can be seen, the trigger button 730 includes a protrusion 732 extending radially inward toward the central axis of the system 104t. The protrusion 732 is radially aligned with the locking feature 396t of the first portion 150t. When a user applies a lateral (e.g., radially inward) force to the trigger button 730, the protrusion 732 pushes the locking feature 396t radially inward, disengaging it from the lug feature 398t in the second portion 152t (which can be configured similarly, for example, in…). Figure 84 and 85 The engagement of the lug locking feature 398p described herein releases and actuates the first spring 402t. In other embodiments, the locking features 396, 398 may include a structural cooperation of a key / keyway mechanism configured to release when the features 396, 398 are brought into contact with each other in a certain direction (e.g., using radially applied force, axially applied force to twist or rotate, or other types of actuation).

[0653] Figure 103 A side view illustrating another applicator system 104u with an integrated side-triggered button 730. System 104u can be configured substantially similar to [the applicator system 104u with an integrated side-triggered button 730]. Figures 86 to 88 The system 104q or system 104r described in the context of 89 to 91, where similar reference...

Claims

1. A skin sensor system configured for transdermal glucose monitoring in a subject, the system comprising: A sensor module housing, the sensor module housing including a channel and a groove intersecting the channel; A glucose sensor having a first segment configured for subcutaneous sensing and a second segment mechanically coupled to a sensor module housing; and At least one leaf spring, said at least one leaf spring being mechanically coupled to the sensor module housing and electrically coupled to the glucose sensor; The at least one leaf spring includes a tab positioned in the groove to impede rotation of the at least one leaf spring, and At least a portion of the second segment of the glucose sensor is positioned in the channel, and a portion of the sheet spring is positioned in the channel.

2. The system of claim 1, wherein the at least one leaf spring comprises a palladium contact, an alloy, a coating material, a conductive plating material, a gold-plated portion, and / or a silver material.

3. The system according to claim 1, wherein the at least one leaf spring comprises a conductor.

4. The system according to claim 1, further comprising a base.

5. The system of claim 4, wherein the sensor module housing is mechanically coupled to the base, the base having an adhesive configured to couple the base to the skin of the body.

6. The system of claim 4, wherein the sensor module housing is mechanically coupled to the base.

7. The system according to any one of claims 1-6, wherein at least a portion of the at least one leaf spring is formed in a "C" shape.

8. The system according to any one of claims 1-6, the system further comprising a seal to prevent fluid from entering the at least one leaf spring.

9. The system according to any one of claims 1-6, further comprising an electronic unit.

10. The system of claim 9, wherein the electrical connection between the glucose sensor and the electronic unit is manufactured at the factory.

11. The system of claim 10, wherein the electrical connection is sealed at the plant to prevent fluid ingress.

12. The system according to any one of claims 1-6, wherein the at least one leaf spring has a resistance of less than 5 ohms.

13. The system according to any one of claims 1-6, wherein the at least one leaf spring has a resistance of less than 20 ohms.

14. The system according to any one of claims 1-6, wherein the at least one leaf spring has a resistance of less than 100 ohms.

15. The system according to any one of claims 1-6, wherein the at least one leaf spring has a resistance of about 2.7 ohms or less.

16. The system according to any one of claims 1-6, wherein the at least one leaf spring has a compressive force of at least 0.05 pounds within the effective compression range.

17. The system according to any one of claims 1-6, wherein the at least one leaf spring has a compressive force of less than 0.5 pounds within its effective compression range.

18. The system according to any one of claims 1-6, wherein the at least one leaf spring has a compressive force of less than 1 pound within the effective compression range.

19. The system according to any one of claims 1-6, wherein the at least one leaf spring has a compressive force of less than 3 pounds within the effective compression range.

20. The system according to any one of claims 1-6, wherein the at least one leaf spring has a compressive force of less than 4.5 pounds within its effective compression range.

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