US20220061717A1 - Transcutaneous analyte sensor systems and methods - Google Patents

Abstract

Systems for applying a transcutaneous monitor to a person can include a telescoping assembly, a sensor, and a base with adhesive to couple the sensor to skin. The sensor can be located within the telescoping assembly while the base protrudes from a distal end of the system. The system can be configured to couple the sensor to the base by compressing the telescoping assembly.

Description

INCORPORATION BY REFERENCE TO RELATED APPLICATIONS
• Any and all priority claims identified in the Application Data Sheet, or any correction thereto, are hereby incorporated by reference under 37 CFR 1.57. This application is a continuation of U.S. application Ser. No. 17/378,491, filed Jul. 16, 2021, which is a continuation of U.S. application Ser. No. 17/200,620, filed Mar. 12, 2021, now U.S. Pat. No. 11,166,657, issued Nov. 9, 2021, which is a continuation of U.S. application Ser. No. 15/387,088, filed Dec. 21, 2016, which, in turn, claims the benefit of U.S. Provisional Application No. 62/272,983, filed Dec. 30, 2015 and U.S. Provisional Application No. 62/412,100, filed Oct. 24, 2016. Each of the aforementioned applications is incorporated by reference herein in its entirety, and each is hereby expressly made a part of this specification.
FIELD
• Various embodiments disclosed herein relate to measuring an analyte in a person. Certain embodiments relate to systems and methods for applying a transcutaneous analyte measurement system to a person.
BACKGROUND
• Diabetes mellitus is a disorder in which the pancreas cannot create sufficient insulin (Type I or insulin dependent) and/or in which insulin is not effective (Type 2 or non-insulin dependent). In the diabetic state, the victim suffers from high blood sugar, which can cause an array of physiological derangements associated with the deterioration of small blood vessels, for example, kidney failure, skin ulcers, or bleeding into the vitreous of the eye. A hypoglycemic reaction (low blood sugar) can be induced by an inadvertent overdose of insulin, or after a normal dose of insulin or glucose-lowering agent accompanied by extraordinary exercise or insufficient food intake.
• Conventionally, a person with diabetes carries a self-monitoring blood glucose monitor, which typically requires uncomfortable finger pricking methods. Due to the lack of comfort and convenience, a person with diabetes normally only measures his or her glucose levels two to four times per day. Unfortunately, such time intervals are so far spread apart that the person with diabetes likely finds out too late of a hyperglycemic or hypoglycemic condition, sometimes incurring dangerous side effects. Glucose levels may be alternatively monitored continuously by a sensor system including an on-skin sensor assembly. The sensor system may have a wireless transmitter which transmits measurement data to a receiver which can process and display information based on the measurements.
• The process of applying the sensor to the person is important for such a system to be effective and user friendly. The application process can result in the sensor assembly being attached to the person in a state where it is capable of sensing glucose level information, communicating the glucose level information to the transmitter, and transmitting the glucose level information to the receiver.
• The analyte sensor can be placed into subcutaneous tissue. A user can actuate an applicator to insert the analyte sensor into its functional location. This transcutaneous insertion can lead to incomplete sensor insertion, improper sensor insertion, exposed needles, or unnecessary pain. Thus, there is a need for a system that more reliably enables transcutaneous sensor insertion while being easy to use and relatively pain-free.
SUMMARY
• Various systems and methods described herein enable reliable, simple, and pain-minimizing transcutaneous insertion of analyte sensors. Some embodiments are a system for applying an on-skin sensor assembly to skin of a host. Systems can comprise a telescoping assembly having a first portion configured to move distally relative to a second portion from a proximal starting position to a distal position along a path; 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 the base protrudes from a distal end of the system. The base can comprise an adhesive configured to couple the sensor module to the skin. The moving of the first portion to the distal position can couple the sensor module to the base. The sensor can be an analyte sensor; a glucose sensor; any sensor described herein or incorporated by reference; and/or any other suitable sensor.
• In some embodiments (i.e., optional and independently combinable with any of the aspects and embodiments identified herein), the sensor module can include a sensor module housing. The sensor module housing can include a first flex arm.
• In some embodiments (i.e., optional and independently combinable with any of the aspects and embodiments identified herein), the sensor can be located within the second portion while the base protrudes from the distal end of the system such that the system is configured to couple the sensor to the base via moving the first portion distally relative to the second portion.
• In several embodiments (i.e., optional and independently combinable with any of the aspects and embodiments identified herein), the sensor can be coupled to the sensor module while the first portion is located in the proximal starting position.
• In some embodiments, a needle is coupled to the first portion (of the telescoping assembly) such that the sensor and the needle move distally relative to the base and relative to the second portion. The system can comprise a needle release mechanism configured to retract the needle proximally.
• In several embodiments, the base comprises a distal protrusion having a first hole. The distal protrusion can be configured to reduce a resistance of the skin to piercing. The sensor can pass through the first hole of the distal protrusion.
• In some embodiments, a needle having a slot passes through the first hole of the distal protrusion. A portion of the sensor can be located in the slot such that the needle is configured to move distally relative to the base without dislodging the portion of the sensor from the slot.
• In several embodiments, the distal protrusion is convex such that the distal protrusion is configured to tension the skin while the first portion moves distally relative to the second portion to prepare the skin for piercing. The distal protrusion can be shaped like a dome.
• In some embodiments, the adhesive comprises a second hole. The distal protrusion can be located at least partially within the second hole such that the distal protrusion can tension at least a portion of the skin beneath the second hole.
• In several embodiments, the adhesive covers at least a majority of the distal protrusion. The adhesive can cover at zero percent, at least 30 percent, at least 70 percent, and/or less than 80 percent of the distal protrusion. The distal protrusion can protrude at least 0.5 millimeters, less than 3 millimeters, and/or less than 5 millimeters.
• In some embodiments, a sensor module is coupled to the first portion and is located at least 3 millimeters and/or at least 5 millimeters from the base while the first portion is in the proximal starting position. The system can be configured such that moving the first portion to the distal position couples the sensor module to the base.
• In several embodiments, the sensor is already coupled to the sensor module while the first portion is located in the proximal starting position. For example, the sensor can be coupled to the sensor module at the factory (e.g., prior to the user opening a sterile barrier). The sensor can be located within the second portion while the base protrudes from the distal end of the system.
• In some embodiments, the sensor is coupled to a sensor module. During a first portion of the path, the sensor module can be immobile relative to the first portion, and the base can be immobile relative to the second portion. During a second portion of the path, the system can be configured to move the first portion distally relative to the second portion to move the sensor module towards the base, couple the sensor module to the base, and/or enable the coupled sensor module and the base to detach from the telescoping assembly.
• In several embodiments, a sensor module is coupled to the sensor. The system comprises a vertical central axis oriented from a proximal end to the distal end of the system. The sensor module can comprise a first flex arm that is oriented horizontally and is coupled to the base. The first flex arm can extend from an outer perimeter of the sensor module.
• In some embodiments, the base comprises a first proximal protrusion coupled to the first flex arm to couple the sensor module to the base. A first horizontal locking protrusion can be coupled to an end portion of the first flexible arm. A second horizontal locking protrusion can be coupled to the first proximal protrusion of the base. The first horizontal locking protrusion can be located distally under the second horizontal locking protrusion to secure the sensor module to the base. The system can be configured such that moving the first portion of the telescoping assembly to the distal position causes the first flex arm to bend to enable the first horizontal locking protrusion to move distally relative to the second horizontal locking protrusion.
• In several embodiments, the base comprises a second proximal protrusion coupled to a second flex arm of the sensor module. The first flex arm can be located on an opposite side of the sensor module relative to the second flex arm.
• In some embodiments, a sensor module is coupled to the sensor. The system can comprise a vertical central axis oriented from a proximal end to the distal end of the system. The base can comprise a first flex arm that is oriented horizontally and is coupled to the sensor module. The sensor module can comprise a first distal protrusion coupled to the first flex arm to couple the sensor module to the base.
• In several embodiments, a first horizontal locking protrusion is coupled to an end portion of the first flexible arm, a second horizontal locking protrusion is coupled to the first distal protrusion of the sensor module, and the second horizontal locking protrusion is located distally under the first horizontal locking protrusion to secure the sensor module to the base. The system can be configured such that moving the first portion of the telescoping assembly to the distal position causes the first flex arm to bend to enable the second horizontal locking protrusion to move distally relative to the first horizontal locking protrusion.
• In some embodiments, the sensor module comprises a second distal protrusion coupled to a second flex arm of the base. The first distal protrusion can be located on an opposite side of the sensor module relative to the second distal protrusion.
• In several embodiments, a sensor module is coupled to the sensor. The first portion can comprise a first flex arm and a second flex arm that protrude distally and latch onto the sensor module to releasably secure the sensor module to the first portion while the first portion is in the proximal starting position. The sensor module can be located remotely from the base while the first portion is in the proximal starting position (e.g., such that the sensor module does not touch the base).
• In some embodiments, the sensor module is located within the second portion while the base protrudes from the distal end of the system such that the system is configured to couple the sensor module to the base via moving the first portion distally relative to the second portion.
• In several embodiments, the system comprises a vertical central axis oriented from a proximal end to the distal end of the system. The first and second flex arms of the first portion can 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 can comprise a third flex arm coupled with a first proximal protrusion of the base such that the sensor module is coupled to the base with a second vertical holding strength.
• In some embodiments, the second vertical holding strength is greater than the first vertical holding strength such that continuing to push the first portion distally once the sensor module is coupled to the base overcomes the first and second flex arms of the first portion to detach the sensor module from the first portion. The third flex arm can extend from an outer perimeter of the sensor module.
• In several embodiments, the base protrudes from the distal end of the system while the first portion of the telescoping assembly is located in the proximal starting position and the sensor is located remotely relative to the base such that the system is configured to couple the sensor to the base via moving the first portion distally relative to the second portion. The base can comprise a first radial protrusion releasably coupled with a first vertical holding strength to a second radial protrusion of the second portion of the telescoping assembly.
• In some embodiments, the first radial protrusion protrudes inward and the second radial protrusion protrudes outward. The system can be configured such that moving the first portion to the distal position moves the second radial protrusion relative to the first radial protrusion to detach the base from the telescoping assembly.
• In several embodiments, the first portion of the telescoping assembly comprises a first arm that protrudes distally, the second portion of the telescoping assembly comprises a second flex arm that protrudes distally, and the system is configured such that moving the first portion from the proximal starting position to the distal position along the path causes the first arm to deflect the second flex arm and thereby detach the second flex arm from the base to enable the base to decouple from the telescoping assembly. When the first portion is in the proximal starting position, the first arm of the first portion can be at least partially vertically aligned with the second flex arm of the second portion to enable the first arm to deflect the second flex arm as the first portion is moved to the distal position.
• In some embodiments, when the first portion is in the proximal starting position, at least a section of the first arm is located directly over the second flex arm to enable the first arm to deflect the second flex arm as the first portion is moved to the distal position.
• In several embodiments, the second flex arm comprises a first horizontal protrusion, and the base comprises a second horizontal protrusion latched with the first horizontal protrusion to couple the base to the second portion of the telescoping assembly. The first arm of the first portion can deflect the second flex arm of the second portion to unlatch the base from the second portion of the telescoping assembly.
• In some embodiments, the system is configured to couple the sensor to the base at a first position, and the system is configured to detach the base from the telescoping assembly at a second position that is distal relative to the first position.
• In several embodiments, a third flex arm couples the sensor to the base at a first position, the second flex arm detaches from the base at a second position, and the second position is distal relative to the first position such that the system is configured to secure the base to the telescoping assembly until after the sensor is secured to the base.
• In some embodiments, the base protrudes from the distal end of the system while the first portion of the telescoping assembly is located in the proximal starting position and the sensor is located remotely relative to the base. The system can further comprise a spring configured to retract a needle. The needle can be configured to facilitate inserting the sensor into the skin. When the first portion is in the proximal starting position, the spring can be in a first compressed state. The system can be configured such that moving the first portion distally from the proximal starting position further increases a compression of the spring. The first compressed state places the first and second portions in tension.
• In several embodiments, a system is configured to apply an on-skin sensor assembly to the skin of a host (i.e., a person). The system can include a telescoping assembly having a first portion configured to move distally relative to a second portion from a proximal starting position to a distal position along a path; a sensor coupled to the first portion; and/or a latch configurable to impede a needle from moving proximally relative to the first portion. The sensor can be an analyte sensor; a glucose sensor; any sensor described herein or incorporated by reference; and/or any other suitable sensor.
• In some embodiments, the first portion is releasably secured in the proximal starting position by a securing mechanism that impedes moving the first portion distally relative to the second portion. The system can be configured such that prior to reaching the distal position, moving the first portion distally relative to the second portion releases the latch thereby causing the needle to retract proximally into the system. The system can be configured such that moving the first portion distally 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 securing mechanism can be an interference between the first portion and the second portion of the telescoping assembly.
• In several embodiments, a first force profile is measured along the path. The first force profile can comprise a first magnitude coinciding with overcoming the securing mechanism; a third magnitude coinciding with releasing the latch; and a second magnitude coinciding with an intermediate portion of the path that is distal relative to overcoming the securing mechanism and proximal relative to releasing the latch.
• In some embodiments, the second magnitude is less than the first and third magnitudes such that the system is configured to promote needle acceleration during the intermediate portion of the path to enable a suitable needle speed (e.g., a sufficiently high needle speed) at a time the needle first pierces the skin.
• In several embodiments, the first magnitude is at least 100 percent greater than the second magnitude. The first magnitude can be greater than the third magnitude such that the system is configured to impede initiating a sensor insertion cycle unless a user is applying enough force to release the latch. The first magnitude can be at least 50 percent greater than the third magnitude.
• In some embodiments, an intermediate portion of the path is distal relative to overcoming the securing mechanism and proximal relative to releasing the latch. The system can further comprise a second force profile coinciding with the intermediate portion of the path. A proximal millimeter of the second force profile can comprise a lower average force than a distal millimeter of the second force profile in response to compressing a spring configured to enable the system to retract the needle into the telescoping assembly.
• In several embodiments, a first force profile is measured along the path. The first force profile can comprise a first average magnitude coinciding with moving distally past a proximal half of the securing mechanism and a second average magnitude coinciding with moving distally past a distal half of the securing mechanism. The first average magnitude can be greater than the second average magnitude such that the system is configured to impede initiating a sensor insertion cycle unless a user is applying enough force to complete the sensor insertion cycle (e.g., drive the needle and/or the sensor to the intended insertion depth).
• In some embodiments, a first force peak (coinciding with moving distally past the proximal half of the securing mechanism) is at least 25 percent higher than the second average magnitude.
• In several embodiments, a first force profile is measured along the path. The first force profile can comprise a first magnitude coinciding with overcoming the securing mechanism and a subsequent magnitude coinciding with terminating the securing mechanism. The first magnitude can comprise a proximal vector and the subsequent magnitude can comprise a distal vector.
• In some embodiments, the securing mechanism can comprise a radially outward protrusion extending from the first portion. The radially outward protrusion can be located proximally relative to a proximal end of the second portion while the telescoping assembly is in the proximal starting position. The radially outward protrusion can be configured to cause the second portion to deform elliptically to enable the first portion to move distally relative to the second portion.
• In several embodiments, the securing mechanism comprises a radially outward protrusion of the first portion that interferes with a radially inward protrusion of the second portion such that the securing mechanism is configured to cause the second portion to deform elliptically to enable the first portion to move distally relative to the second portion.
• In some embodiments, the needle is retractably coupled to the first portion by a needle holder configured to resist distal movement of the first portion relative to the second portion. The securing mechanism can comprise a flexible arm of the second portion. The flexible arm can be releasably coupled to the needle holder to releasably secure the first portion to the second portion in the proximal starting position.
• In several embodiments, the securing mechanism comprises a frangible coupling between the first portion and the second portion while the first portion is in the proximal starting position. The system can be configured such that moving the first portion to the distal position breaks the frangible coupling.
• In some embodiments, the securing mechanism comprises a magnet that releasably couples the first portion to the second portion while the first portion is in the proximal starting position. The magnet can be attracted to a metal element coupled to the first portion or the second portion of the telescoping assembly.
• In several embodiments, an electric motor drives the first portion distally relative to the second portion. The electric motor can be configured to move the needle in the skin.
• In some embodiments, an on-skin sensor system is configured for transcutaneous glucose monitoring of a host. The system can comprise a sensor module housing, in which the sensor module housing can include a first flex arm; a sensor having a first section configured for subcutaneous sensing and a second section 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 flex arm of the sensor module housing. The base can have an adhesive configured to couple the base to the skin of the host. The sensor can be an analyte sensor; a glucose sensor; any sensor described herein or incorporated by reference; and/or any other suitable sensor.
• In several embodiments, the electrical interconnect comprises a spring. The spring can comprise a conical portion and/or a helical portion.
• In some embodiments, the sensor module housing comprises at least two proximal protrusions located around a perimeter of the spring. The proximal protrusions can be configured to help orient the spring. A segment of the sensor can be located between the proximal protrusions.
• In several embodiments, the sensor module housing is mechanically coupled to a base having an adhesive configured to couple the base to skin of the host.
• In some embodiments, the proximal protrusions orient the spring such that coupling an electronics unit to the base presses the spring against a first electrical contact of the electronics unit and a second electrical contact of the sensor to electrically couple the sensor to the electronics unit.
• In several embodiments, the sensor module housing comprises a first flex arm that is oriented horizontally and is coupled to the base. The first flex arm can extend from an outer perimeter of the sensor module housing. The base can comprise a first proximal protrusion coupled to the first flex arm to couple the sensor module housing to the base.
• In some embodiments, the electrical interconnect comprises a leaf spring, which can include one metal layer or multiple metal layers. The leaf spring can be a cantilever spring.
• In some embodiments, the sensor module housing comprises a proximal protrusion having a channel in which at least a portion of the second section of the sensor is located. The channel can position a first area of the sensor such that the first area is electrically coupled to the leaf spring.
• In some embodiments, the leaf spring arcs away from the first area and protrudes proximally to electrically couple with an electronics unit. At least a portion of the leaf spring can form a “W” shape. At least a portion of the leaf spring forms a “C” shape.
• In several embodiments, the leaf spring bends around the proximal protrusion. The leaf spring can bend at least 120 degrees and/or at least 160 degrees around the proximal protrusion. The leaf spring can protrude proximally to electrically couple with an electronics unit.
• In some embodiments, a seal is configured to impede fluid ingress to the leaf spring. The sensor module housing can be mechanically coupled to a base. The base can have an adhesive configured to couple the base to skin of the host.
• In several embodiments, the leaf spring is oriented such that coupling an electronics unit to the base presses the leaf spring against a first electrical contact of the electronics unit and against a second electrical contact of the sensor to electrically couple the sensor to the electronics unit. A proximal height of the seal can be greater than a proximal height of the leaf spring such that the electronics unit contacts the seal prior to contacting the leaf spring.
• In some embodiments, the sensor module housing comprises a first flex arm that is oriented horizontally and is coupled to the base. The first flex arm can extend from an outer perimeter of the sensor module housing. The base can comprise a first proximal protrusion coupled to the first flex arm to couple the sensor module housing to the base.
• In several embodiments, the sensor module housing comprises a channel in which at least a portion of the second section of the sensor is located. A distal portion of the leaf spring can be located in the channel such that a proximal portion of the leaf spring protrudes proximally out the channel. The sensor module housing can comprise a groove that intersects the channel. The leaf spring can comprise a tab located in the groove to impede rotation of the leaf spring.
• In some embodiments, the sensor module housing is mechanically coupled to a base that has an adhesive configured to couple the base to skin of the host. The sensor module housing can comprise a first flex arm that is oriented horizontally and is coupled to the base. The first flex arm can extend from an outer perimeter of the sensor module housing. The base can comprises a first proximal protrusion coupled to the first flex arm to couple the sensor module housing to the base.
• In several embodiments, electrical interconnects (such as springs or other types of interconnects) comprises a resistance of less than 100 ohms and/or less than 5 ohms. Electrical interconnects can comprise a compression force of less than one pound over an active compression range.
• In some embodiments, electrical interconnects may require a compression force of less than one pound to compress the spring 20 percent from a relaxed position, which is a substantially uncompressed position. In some embodiments, electrical interconnects may require a compression force of less than one pound to compress the spring 25 percent from a relaxed position, which is a substantially uncompressed position. In some embodiments, electrical interconnects may require a compression force of less than one pound to compress the spring 30 percent from a relaxed position, which is a substantially uncompressed position. In some embodiments, electrical interconnects may require a compression force of less than one pound to compress the spring 50 percent from a relaxed position, which is a substantially uncompressed position.
• In several embodiments, the spring is configured such that compressing the spring 25 percent from a relaxed position requires a force of at least 0.05 pounds and less than 0.5 pounds, and requires moving an end of the spring at least 0.1 millimeter and less than 1.1 millimeter.
• In some embodiments, a system for applying an on-skin sensor assembly to a skin of a host comprises a telescoping assembly having a first portion configured to move distally relative to a second portion from a proximal starting position to a distal position along a path; a sensor coupled to the first portion; and a base comprising adhesive configured to couple the sensor to the skin. The telescoping assembly can further comprise a third portion configured to move distally relative to the second portion.
• In some embodiments, a first spring is positioned between the third portion and the second portion such that moving the third portion distally relative to the second portion compresses the first spring. In the proximal starting position of the telescoping assembly, the first portion can be locked to the second portion. The system can be configured such that moving the third portion distally relative to the second portion unlocks the first portion from the second portion.
• 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 can comprise a first distal protrusion. The system can be configured such that moving the third portion distally relative to the second portion engages a ramp to bend the first proximal protrusion to unlock the first portion from the second portion.
• In some embodiments, the sensor is located within the second portion while the base protrudes from the distal end of the system such that the system is configured to couple the sensor to the base by moving the first portion distally relative to the second portion.
• In several embodiments, a sensor module is coupled to a distal portion of the first portion such that moving the first portion to the distal position couples the sensor module to the base. The sensor can be coupled to the sensor module while the first portion is located in the proximal starting position.
• In some embodiments, the system is configured such that moving the third portion distally relative to the second portion unlocks the first portion from the second portion and locks the third portion to the second portion.
• In several embodiments, the system comprises a first protrusion that couples with a hole of at least one of the second portion and the third portion to lock the third portion to the second portion.
• In some embodiments, the system comprises a second protrusion that couples with a hole of at least one of the first portion and the second portion to lock the first portion to the second portion in response to moving the first portion distally relative to the second portion.
• In several embodiments, a first spring is positioned between the third portion and the second portion such that moving the third portion distally relative to the second portion compresses the first spring and unlocks the first portion from the second portion, which enables the compressed first spring to push the first portion distally relative to the second portion, which pushes at least a portion of the sensor out of the distal end of the system and triggers a needle retraction mechanism to enable a second spring to retract a needle.
• In some embodiments, a system for applying an on-skin assembly to a skin of a host is provided. Advantageously, the system includes a sensor inserter assembly having a needle assembly, a sensor module, a base, an actuation member, and a retraction member, the sensor inserter assembly having an initial configuration in which at least the sensor module is disposed in a proximal starting position, the sensor inserter assembly further having a deployed configuration in which at least the sensor module and the base are disposed at a distal applied position. Preferably, the actuation member is configured to, once activated, cause the needle assembly to move a proximal starting position to a distal insertion position, and the retraction member is configured to, once activated, cause the needle assembly to move from the distal insertion position to a proximal retracted position.
• The sensor module may comprise a sensor and a plurality of electrical contacts. In the initial configuration, the sensor can be electrically coupled to at least one of the electrical contacts. Optionally, in the initial configuration, the actuation member is in an unenergized state. In some embodiments, the actuation member can be configured to be energized by a user before being activated. In alternative embodiments, in the initial configuration, the actuation member is in an energized state.
• In several embodiments the actuation member can include a spring. In an initial configuration, the spring can be in an unstressed state. In alternative embodiments, in the initial configuration, the spring is in a compressed state.
• In some embodiments, the sensor inserter assembly may include a first portion and a second portion, the first portion being fixed, at least in an axial direction, with respect to the second portion at least when the sensor inserter assembly is in the initial configuration, the first portion being movable in at least a distal direction with respect to the second portion after activation of the actuation member. The first portion may be operatively coupled to the needle assembly so as to secure the needle assembly in the proximal starting position before activation of the actuation member and to urge the needle assembly toward the distal insertion position after activation of the actuation member.
• In several embodiments, the retraction member is in an unenergized state when in the initial configuration. Advantageously, the retraction member is configured to be energized by the movement of the needle assembly from the proximal starting position to the distal insertion position. In the initial configuration, the retraction member may be in an energized state.
• In still other embodiments, the retraction member comprises a spring. The spring may be integrally formed with the needle assembly. The spring may be operatively coupled to the needle assembly. In the initial configuration, the spring may be in an unstressed state. In other embodiments, in the initial configuration, the spring is in compression.
• In some aspects, in the second configuration, the spring is in compression. In still other embodiments, in the second configuration, the spring is in tension.
• In some embodiments, the sensor inserter assembly can further include a third portion, the third portion being operatively coupled to the first portion. The actuation member may be integrally formed with the third portion in certain embodiments. Optionally, the actuation member is operatively coupled to the third portion.
• In some embodiments, the sensor inserter assembly includes interengaging structures configured to prevent movement of the first portion in the distal direction relative to the second portion until the interengaging structures are decoupled. Advantageously, the decoupling of the interengaging structures may activate the actuation member. In other embodiments, the interengaging structures may include a proximally extending tab of the first portion and a receptacle of the second portion configured to receive the proximally extending tab. Optionally, the sensor inserter assembly can include a decoupling member configured to decouple the interengaging structures. The decoupling member may have a distally extending tab of the third portion.
• In yet other embodiments, the sensor inserter assembly can include interengaging structures configured to prevent proximal movement of the third portion with respect to the first portion. These interengaging structures may include a distally-extending latch of the third portion and a ledge of the first portion configured to engage the distally-extending latch.
• In certain embodiments, the sensor inserter assembly can include interengaging structures configured to prevent proximal movement of the needle assembly at least when the needle assembly is in the distal insertion position. The interengaging structures can have radially-extending release features of the needle assembly and an inner surface of the first portion configured to compress the release features. Optionally, the sensor inserter assembly includes a decoupling member configured to disengage the interengaging structures of the first portion and the needle assembly. The decoupling member may include an inner surface of the second portion configured to further compress the release features. Advantageously, the system may further include a trigger member configured to activate the actuation member. The trigger member may be operatively coupled to the third portion. The trigger member may be integrally formed with the third portion. The trigger member may include a proximally-extending button. Alternatively, the trigger member may include a radially-extending button. The trigger member may be configured to decouple the interengaging structure of the first portion and the third portion.
• In some embodiments, the system may further include a releasable locking member configured to prevent activation of the actuation member until the locking member is released. The releasable locking member may be configured to prevent proximal movement of the third portion with respect to the first portion until the locking member is released. The releasable locking member may include a proximally-extending tab of the first portion and a latch feature of the third portion configured to receive the proximally-extending tab. Advantageously, the releasable locking member is configured to prevent energizing of the sensor inserter assembly. In other aspects, the releasable locking member is configured to prevent energizing of the actuation member.
• Embodiments may further include a system for applying an on-skin component to a skin of a host, the system may include a sensor inserter assembly having an on-skin component being movable in at least a distal direction from a proximal position to a distal position, a first securing feature configured to releasably secure the on-skin component in the proximal position, a second securing feature configured to secure the on-skin component in the distal position, and a first resistance configured to prevent movement of the on-skin component in a proximal direction at least when the on-skin component is in the distal position.
• The first resistance feature can be configured to prevent movement of the on-skin component in a proximal direction when the on-skin component is secured in the distal position. In some embodiments, the first securing feature is configured to releasably secure the on-skin component to a needle assembly. The on-skin component may have a sensor module. The sensor module may include a sensor and a plurality of electrical contacts. Optionally, the sensor is electrically coupled to at least one of the electrical contacts, at least when the sensor inserter assembly is in the first configuration.
• In some embodiments, the on-skin component comprises a base. The on-skin component may include a transmitter. The second securing feature can be configured to secure the on-skin component to a second on-skin component.
• In other embodiments, the sensor inserter assembly includes at least one distally-extending leg, and wherein the first securing feature comprises an adhesive disposed on a distally-facing surface of the leg. The sensor inserter assembly may include at least one distally-extending member, and wherein the first securing feature comprises a surface of the distally-extending member configured to frictionally engage with a corresponding structure of the on-skin component. The corresponding structure of the on-skin component may include an elastomeric member. Optionally, the distally-extending member includes at least one leg of the sensor inserter assembly. The distally-extending member may include a needle.
• In some embodiments of the system, the second securing feature includes an adhesive disposed on a distally-facing surface of the on-skin component. The second securing feature may have an elastomeric member configured to receive the on-skin component.
• In other embodiments, the first resistance feature includes a distally-facing surface of the sensor inserter assembly. The first resistance feature may be distal to an adhesive disposed on a distally-facing surface of the on-skin component.
• The system may further include a pusher configured to move the on-skin component from the proximal position to the distal position. Optionally, the system can further include a decoupling feature configured to decouple the pusher from the on-skin component at least after the on-skin component is in the distal position. The decoupling feature may have a frangible portion of the pusher. Optionally, the decoupling feature comprises a frangible portion of the on-skin component.
• The system may further comprise a sensor assembly configured to couple with the on-skin component, wherein a third securing feature is configured to releasably secure the sensor assembly in a proximal position, and wherein a fourth securing feature is configured to secure the sensor assembly to the on-skin component.
• Any of the features of each embodiment is applicable to all aspects and embodiments identified herein. Moreover, any of the features of an embodiment is independently combinable, partly or wholly with other embodiments described herein in any way, e.g., one, two, or three or more embodiments may be combinable in whole or in part. Further, any of the features of an embodiment may be made optional to other aspects or embodiments. Any aspect or embodiment of a method can be performed by a system or apparatus of another aspect or embodiment, and any aspect or embodiment of a system can be configured to perform a method of another aspect or embodiment.
BRIEF DESCRIPTION OF THE DRAWINGS
• These and other features, aspects, and advantages are described below with reference to the drawings, which are intended to illustrate, but not to limit, the invention. In the drawings, like reference characters denote corresponding features consistently throughout similar embodiments.
• FIG. 1 illustrates a schematic view of a continuous analyte sensor system, according to some embodiments.
• FIG. 2 illustrates a perspective view of an applicator system, according to some embodiments.
• FIG. 3 illustrates a cross-sectional side view of the system fromFIG. 2, according to some embodiments.
• FIG. 4 illustrates a perspective view of an on-skin sensor assembly, according to some embodiments.
• FIGS. 5 and 6 illustrate perspective views of a transmitter coupled to a base via mechanical interlocks, according to some embodiments.
• FIGS. 7-11 illustrate cross-sectional side views of the applicator system fromFIG. 3, according to some embodiments.
• FIG. 12A illustrates a cross-sectional side view of a portion of the applicator system fromFIG. 3, according to some embodiments.
• FIG. 12B illustrates a cross-sectional side view of a base that can be used with the applicator system shown inFIG. 3, according to some embodiments.
• FIG. 13 illustrates a perspective view of a portion of the adhesive fromFIG. 4, according to some embodiments.
• FIG. 14 illustrates a perspective view of a portion of the applicator system fromFIG. 3, according to some embodiments.
• FIGS. 15 and 16 illustrate perspective views of cross sections of portions of the system shown inFIG. 7, according to some embodiments.
• FIG. 17 illustrates a cross-sectional view of the first portion of the telescoping assembly fromFIG. 7, according to some embodiments.
• FIGS. 18 and 19 illustrate perspective views of portions of the applicator system fromFIG. 7, according to some embodiments.
• FIGS. 20 and 21 illustrate perspective views of the needle after being removed from the telescoping assembly ofFIG. 7, according to some embodiments.
• FIG. 22 illustrates a perspective view of a cover of the telescoping assembly ofFIG. 7, according to some embodiments.
• FIG. 23 illustrates a schematic view of force profiles, according to some embodiments.
• FIG. 24 illustrates a cross-sectional side view of a portion of an applicator system, according to some embodiments.
• FIG. 25 illustrates a cross-sectional side view of a portion of a securing mechanism, according to some embodiments.
• FIG. 26 illustrates a top view of a ring, according to some embodiments.
• FIG. 27 illustrates a perspective view of a securing mechanism, according to some embodiments.
• FIG. 28 illustrates a cross-sectional perspective view of telescoping assembly with a motor, according to some embodiments.
• FIGS. 29 and 30 illustrate cross-sectional side views of telescoping assemblies with a motor, according to some embodiments.
• FIG. 31 illustrates a side view of a telescoping assembly that causes rotational movement, according to some embodiments.
• FIG. 32 illustrates a cross-sectional perspective view of a telescoping assembly with a downward locking feature, according to some embodiments.
• FIG. 33 illustrates a perspective view of an on-skin senor assembly just before the electronics unit is coupled to the base, according to some embodiments.
• FIGS. 34 and 35 illustrate perspective views of sensor modules that have springs, according to some embodiments.
• FIG. 36 illustrates a cross-sectional perspective view of a portion of a sensor module, according to some embodiments.
• FIG. 37 illustrates a perspective view of a sensor module that has springs, according to some embodiments.
• FIG. 38 illustrates a cross-sectional perspective view of a portion of a sensor module, according to some embodiments.
• FIG. 39 illustrates a perspective view of a sensor module, according to some embodiments.
• FIG. 40 illustrates a cross-sectional perspective view of assembly that has an offset, according to some embodiments.
• FIG. 41 illustrates a side view of a sensor, according to some embodiments.
• FIG. 42 illustrates a bottom view of a needle, according to some embodiments.
• FIG. 43 illustrates a front view of a needle, according to some embodiments.
• FIG. 44 illustrates a cross-sectional perspective view of an applicator system, according to some embodiments.
• FIG. 45 illustrates a cross-sectional perspective view of a portion of an applicator system, according to some embodiments.
• FIG. 46 illustrates a perspective view of a portion of an applicator system, according to some embodiments.
• FIG. 47 illustrates a perspective view of a sensor module, according to some embodiments.
• FIG. 48 illustrates a cross-sectional perspective view of an applicator system, according to some embodiments.
• FIG. 49 illustrates a cross-sectional perspective view of a proximal portion of a telescoping assembly, according to some embodiments.
• FIG. 50 illustrates a perspective view of a distal portion of a telescoping assembly, according to some embodiments.
• FIG. 51 illustrates a perspective view of a needle with adhesive, according to some embodiments.
• FIG. 52 illustrates a perspective view of a needle that has two separate sides, according to some embodiments.
• FIG. 53 illustrates a cross-sectional top view of the needle shown inFIG. 52, according to some embodiments.
• FIG. 54 illustrates a perspective view of a needle that has a ramp, according to some embodiments.
• FIG. 55 illustrates a cross-sectional top view of four needles, according to some embodiments.
• FIGS. 56-58 illustrate cross-sectional side views of a system that is similar to the embodiment shown inFIG. 7 except that the system does not include a needle, according to some embodiments.
• FIG. 59 illustrates a cross-sectional side view of a system that is similar to the embodiment shown inFIG. 7 except for the starting position and the movement of the base, according to some embodiments.
• FIG. 60 illustrates a perspective view of a system having a cover, according to some embodiments.
• FIGS. 61-63 illustrate cross-sectional perspectives views of a system that is similar to the embodiment shown inFIG. 7 except that the telescoping assembly includes an extra portion, according to some embodiments.
• FIG. 64 illustrates a cross-sectional side view of the system shown inFIGS. 61-63, according to some embodiments.
• FIG. 65 illustrates a perspective view of portions of a sensor module, according to some embodiments.
• FIG. 66 illustrates a cross-sectional side view of the sensor module shown inFIG. 65, according to some embodiments.
• FIG. 67 illustrates a perspective view of portions of a sensor module, according to some embodiments.
• FIG. 68 illustrates a top view of the sensor module shown inFIG. 67, according to some embodiments.
• FIGS. 69 and 70 illustrate perspective views of an electronics unit just before the electronics unit is coupled to a base, according to some embodiments.
• FIG. 71 illustrates a cross-sectional perspective view of an applicator system, according to some embodiments, in a resting state.
• FIG. 72 illustrates a cross-sectional perspective view of the applicator system ofFIG. 71, with the actuation member energized.
• FIG. 73 illustrates a rotated cross-sectional perspective view of the applicator system ofFIG. 72.
• FIG. 74 illustrates a cross-sectional perspective view of the applicator system ofFIG. 71, with the actuation member activated and with the needle assembly deployed in an insertion position.
• FIG. 75 illustrates a cross-sectional perspective view of the applicator system ofFIG. 71, with the on-skin component in a deployed position and the needle assembly retracted.
• FIG. 76 illustrates a cross-sectional side view of another applicator system, according to some embodiments, in a resting state.
• FIG. 77 illustrates a cross-sectional side view of the applicator system ofFIG. 76, with the actuation member energized.
• FIG. 78 illustrates a cross-sectional side view of the applicator system ofFIG. 76, with the actuation member activated and with the needle assembly deployed in an insertion position.
• FIG. 79 illustrates a cross-sectional side view of the applicator system ofFIG. 76, with the on-skin component in a deployed position and the needle assembly retracted.
• FIG. 80 illustrates a cross-sectional side view of another applicator system, according to some embodiments, in a resting state.
• FIG. 81 illustrates a cross-sectional side view of the applicator system ofFIG. 80, with the actuation member energized.
• FIG. 82 illustrates a cross-sectional side view of the applicator system ofFIG. 80, with the actuation member activated and with the needle assembly deployed in an insertion position.
• FIG. 83 illustrates a cross-sectional side view of the applicator system ofFIG. 80, with the on-skin component in a deployed position and the needle assembly retracted.
• FIG. 84 illustrates a perspective view of the applicator system ofFIG. 80, with the first and third portions shown in cross section to better illustrate certain portions of the system, and in a resting state.
• FIG. 85 illustrates a perspective view of the applicator system ofFIG. 80, with the first and third portions shown in cross section to better illustrate certain portions of the system, and with the actuation member energized.
• FIG. 86 illustrates a cross-sectional side view of another applicator system, according to some embodiments, in a resting state in which the actuation member is already energized.
• FIG. 87 illustrates a cross-sectional side view of the applicator system ofFIG. 86, with the actuation member activated and with the needle assembly deployed in an insertion position.
• FIG. 88 illustrates a cross-sectional side view of the applicator system ofFIG. 86, with the on-skin component in a deployed position and the needle assembly retracted.
• FIG. 89 illustrates a cross-sectional side view of another applicator system, according to some embodiments, in a resting state in which the actuation member is already energized.
• FIG. 90 illustrates a cross-sectional side view of the applicator system ofFIG. 86, with the actuation member activated and with the needle assembly deployed in an insertion position.
• FIG. 91 illustrates a cross-sectional side view of the applicator system ofFIG. 86, with the on-skin component in a deployed position and the needle assembly retracted.
• FIG. 92 illustrates a side view of another applicator system, according to some embodiments, with a top trigger member, in a resting state.
• FIG. 93 illustrates a side view of the applicator system ofFIG. 92, after being cocked but before being triggered.
• FIG. 94 illustrates a cross-sectional perspective view of the applicator system ofFIG. 92, in a resting state.
• FIG. 95 illustrates a cross-sectional perspective view of the applicator system ofFIG. 92 while being cocked.
• FIG. 96 illustrates a cross-sectional perspective view of the applicator system ofFIG. 92, after being cocked but before being triggered.
• FIG. 97 illustrates a cross-sectional side view of the applicator system ofFIG. 96.
• FIG. 98 illustrates a cross-sectional side view of the applicator system ofFIG. 92, during triggering.
• FIG. 99 illustrates a cross-sectional side view of the applicator system ofFIG. 92, after being triggered and with the needle assembly deployed in an insertion position.
• FIG. 100 illustrates a cross-sectional side view of the applicator system ofFIG. 92, with the on-skin component in a deployed position and the needle assembly retracted.
• FIG. 101 illustrates a side view of another applicator system, according to some embodiments, with a side trigger member.
• FIG. 102 illustrates another side view of the applicator system ofFIG. 101, with the first and third portions shown in cross-section to illustrate the trigger mechanism.
• FIG. 103 illustrates a side view of another applicator system, according to some embodiments, with an integrated side trigger.
• FIG. 104 illustrates another side view of the applicator system ofFIG. 103, with the first and third portions shown in cross-section and with a portion of the second portion removed to illustrate the trigger mechanism.
• FIG. 105 illustrates a perspective view of another applicator system, according to some embodiments, with a safety feature.
• FIG. 106 illustrates a cross-sectional perspective view of a portion of the applicator system ofFIG. 105, with the safety feature in a locked configuration.
• FIG. 107 illustrates an enlarged view of the portion of the applicator system ofFIG. 106, with the safety feature in a locked configuration.
• FIG. 108 illustrates a cross-sectional perspective view of a portion of the applicator system ofFIG. 105, with the safety feature in a released configuration.
• FIG. 109 illustrates a cross-sectional perspective view of a portion of the applicator system ofFIG. 105, with the safety feature in a released configuration and with the third portion moved distally relative to the first portion.
• FIG. 110 illustrates a cross-sectional perspective view of an applicator system, according to some embodiments, in a resting and locked state, with the on-skin component secured in a proximal position.
• FIG. 111 illustrates a cross-sectional perspective view of the applicator system ofFIG. 110, with the safety feature unlocked.
• FIG. 112 illustrates a cross-sectional perspective view of the applicator system ofFIG. 110, with the actuation member energized.
• FIG. 113 illustrates a cross-sectional perspective view of the applicator system ofFIG. 110, with the actuation member activated and with the needle assembly and on-skin component deployed in a distal position.
• FIG. 114 illustrates a cross-sectional perspective view of the applicator system ofFIG. 110, with the on-skin component in a deployed position and separated from the retracted needle assembly.
• FIG. 115 illustrates a perspective view of the needle assembly from the system ofFIG. 110, shown securing the on-skin component during deployment, with the base removed for purposes of illustration.
• FIG. 116 illustrates another perspective view of the needle assembly from the system ofFIG. 110, shown separated from the on-skin component, with the base removed for purposes of illustration.
• FIG. 117 illustrates a perspective view of a portion of the system ofFIG. 100.
• FIG. 118 illustrates a perspective view of the sensor module ofFIG. 100, before being coupled to the base.
• FIG. 119 illustrates a perspective view of the sensor module ofFIG. 100, after being coupled to the base.
• FIG. 120 illustrates a side view of an on-skin component and base, according to some embodiments, prior to coupling of the on-skin component to the base.
• FIG. 121 illustrates a perspective view of the on-skin component and base ofFIG. 120, prior to coupling of the on-skin component to the base.
• FIG. 122 illustrates a side view of the on-skin component and base ofFIG. 120, after coupling of the on-skin component to the base.
• FIG. 123 illustrates a perspective view of a portion of another applicator system, according to some embodiments, with an on-skin component coupled to a needle assembly in a proximal position.
• FIG. 124 illustrates a perspective view of the on-skin component and the needle assembly ofFIG. 123.
• FIG. 125 illustrates a perspective view of a portion of the applicator system shown inFIG. 123, with the on-skin component separated from the needle assembly.
• FIG. 126 illustrates a perspective view of a portion of a securing member, shown securing an on-skin component.
• FIG. 127 illustrates a perspective view of a portion of the securing member ofFIG. 126, with the sensor module of the on-skin component shown in cross section, and illustrated with a decoupling feature of an applicator assembly, according to some embodiments.
• FIG. 128 illustrates a perspective view of the on-skin component ofFIG. 126, after decoupling of the on-skin component from the securing member.
• FIG. 129 illustrates a perspective view of a portion of an applicator assembly, according to some embodiments, with the second portion shown in cross section, and with a securing member shown securing an on-skin component in a proximal position.
• FIG. 130 illustrates a perspective view of a portion of the applicator assembly ofFIG. 129, shown with a portion of the securing member cut away to better illustrate the configuration of the securing member.
• FIG. 131 illustrates a perspective view of a portion of the applicator assembly ofFIG. 129, after decoupling of the on-skin component from the needle assembly, shown with portions of the on-skin component and the securing member cut away.
• FIG. 132 illustrates a perspective view of a portion of an applicator assembly, according to some embodiments, with the second portion shown in cross section, and with a securing member shown securing an on-skin component in a proximal position.
• FIG. 133 illustrates a perspective view of the needle assembly and on-skin component ofFIG. 132, after decoupling of the on-skin component from the needle assembly.
• FIG. 134 illustrates an exploded perspective view of a portion of an applicator assembly, according to some embodiments, with a securing member configured to releasably couple an on-skin component to a needle assembly.
• FIG. 135 illustrates a perspective view of a portion of the applicator assembly ofFIG. 134, with the needle assembly coupled to the on-skin component.
• FIG. 136 illustrates a perspective view of a portion of the applicator assembly ofFIG. 134, with the needle assembly decoupled from the on-skin component.
• FIG. 137 illustrates a perspective view of an applicator assembly, according to some embodiments, with an on-skin component releasably secured in a proximal position within the applicator assembly.
• FIG. 138 illustrates a perspective view of the applicator assembly ofFIG. 137, with the on-skin component released from securement.
• FIG. 139 illustrates a perspective view of the on-skin component ofFIG. 137, with the securing feature in a secured configuration.
• FIG. 140 illustrates a perspective view of the on-skin component ofFIG. 137, with the securing feature in a released configuration.
• FIG. 141 illustrates a cross-sectional perspective view of a portion of an applicator assembly, according to some embodiments, with the second and third portions shown in cross section, and showing a base coupled to an applicator.
• FIG. 142 illustrates a perspective view of another applicator assembly, according to some embodiments, showing a patch coupled to an applicator.
• FIG. 143 illustrates a perspective view of the applicator assembly ofFIG. 142, the patch decoupled from the applicator.
DETAILED DESCRIPTION OF CERTAIN INVENTIVE EMBODIMENTS
• Although certain embodiments and examples are disclosed below, inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses, and to modifications and equivalents thereof. Thus, the scope of the claims appended hereto is not limited by any of the particular embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding certain embodiments; however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures, systems, and/or devices described herein may be embodied as integrated components or as separate components.
• For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, for example, various embodiments may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.
System Introduction
• U.S. Patent Publication No. US-2013-0267811-A1, the entire contents of which are incorporated by reference herein, explains howFIG. 1 is a schematic of a continuousanalyte sensor system100 attached to a host (e.g., a person). Theanalyte sensor system100 communicates with other devices110-113 (which can be located remotely from the host). A transcutaneousanalyte sensor system102 comprising an on-skin sensor assembly600 is fastened to the skin of a host via a base (not shown), which can be a disposable housing.
• Thesystem102 includes atranscutaneous analyte sensor200 and an electronics unit (referred to interchangeably as “sensor electronics” or “transmitter”)500 for wirelessly transmitting analyte information to a receiver. The receiver can be located remotely relative to thesystem102. In some embodiments, the receiver includes a display screen, which can display information to a person such as the host. Example receivers include computers such as smartphones, smartwatches, tablet computers, laptop computers, and desktop computers. In some embodiments, receivers can be Apple Watches, iPhones, and iPads made by Apple Inc. In still further embodiments, thesystem102 can be configured for use in applying a drug delivery device, such an infusion device, to the skin of a patient. In such embodiments, the system can include a catheter instead of, or in addition to, a sensor, the catheter being connected to an infusion pump configured to deliver liquid medicines or other fluids into the patient's body. In embodiments, the catheter can be deployed into the skin in much the same manner as a sensor would be, for example as described herein.
• In some embodiments, the receiver is mechanically coupled to theelectronics unit500 to enable the receiver to receive data (e.g., analyte data) from theelectronics unit500. To increase the convenience to users, in several embodiments, the receiver does not need to be mechanically coupled to theelectronics unit500 and can even receive data from theelectronics unit500 over great distances (e.g., when the receiver is many feet or even many miles from the electronics unit500).
• During use, a sensing portion of thesensor200 can be under the host's skin and a contact portion of thesensor200 can be electrically connected to theelectronics unit500. Theelectronics unit500 can be engaged with a housing (e.g., a base) which is attached to an adhesive patch fastened to the skin of the host.
• The on-skin sensor assembly600 may be attached to the host with use of an applicator adapted to provide convenient and secure application. Such an applicator may also be used for attaching theelectronics unit500 to a base, inserting thesensor200 through the host's skin, and/or connecting thesensor200 to theelectronics unit500. Once theelectronics unit500 is engaged with the base and thesensor200 has been inserted into the skin (and is connected to the electronics unit500), the sensor assembly can detach from the applicator.
• The continuousanalyte sensor system100 can include a sensor configuration that provides an output signal indicative of a concentration of an analyte. The output signal including (e.g., sensor data, such as a raw data stream, filtered data, smoothed data, and/or otherwise transformed sensor data) is sent to the receiver.
• In some embodiments, theanalyte sensor system100 includes a transcutaneous glucose sensor, such as is described in U.S. Patent Publication No. US-2011-0027127-A1, the entire contents of which are hereby incorporated by reference. In some embodiments, thesensor system100 includes a continuous glucose sensor and comprises a transcutaneous sensor (e.g., as described in U.S. Pat. No. 6,565,509, as described in U.S. Pat. No. 6,579,690, as described in U.S. Pat. No. 6,484,046). The contents of U.S. Pat. Nos. 6,565,509, 6,579,690, and 6,484,046 are hereby incorporated by reference in their entirety.
• In several embodiments, thesensor system100 includes a continuous glucose sensor and comprises a refillable subcutaneous sensor (e.g., as described in U.S. Pat. No. 6,512,939). In some embodiments, thesensor system100 includes a continuous glucose sensor and comprises an intravascular sensor (e.g., as described in U.S. Pat. No. 6,477,395, as described in U.S. Pat. No. 6,424,847). The contents of U.S. Pat. Nos. 6,512,939, 6,477,395, and 6,424,847 are hereby incorporated by reference in their entirety.
• Various signal processing techniques and glucose monitoring system embodiments suitable for use with the embodiments described herein are described in U.S. Patent Publication No. US-2005-0203360-A1 and U.S. Patent Publication No. US-2009-0192745-A1, the contents of which are hereby incorporated by reference in their entirety. The sensor can extend through a housing, which can maintain the sensor on the skin and can provide for electrical connection of the sensor to sensor electronics, which can be provided in theelectronics unit500.
• In several embodiments, the sensor is formed from a wire or is in a form of a wire. A distal end of the wire can be sharpened to form a conical shape (to facilitate inserting the wire into the tissue of the host). The sensor can include an elongated conductive body, 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 of which may or may not be conductive. The elongated sensor may be long and thin, yet flexible and strong. For example, in some embodiments, the smallest dimension of the elongated conductive body is less than 0.1 inches, less than 0.075 inches, less than 0.05 inches, less than 0.025 inches, less than 0.01 inches, less than 0.004 inches, and/or less than 0.002 inches.
• The sensor may have a circular cross section. In some embodiments, the cross section of the elongated conductive body can be ovoid, rectangular, triangular, polyhedral, star-shaped, C-shaped, T-shaped, X-shaped, Y-shaped, irregular, or the like. In some embodiments, a conductive wire electrode is employed as a core. To such an electrode, one or two additional conducting layers may be added (e.g., with intervening insulating layers provided for electrical isolation). The conductive layers can be comprised of any suitable material. In certain embodiments, it may be desirable to employ a conductive layer comprising conductive particles (i.e., particles of a conductive material) in a polymer or other binder.
• In some embodiments, the materials used to form the elongated conductive body (e.g., stainless steel, titanium, tantalum, platinum, platinum-iridium, iridium, certain polymers, and/or the like) can be strong and hard, and therefore can be resistant to breakage. For example, in several embodiments, the ultimate tensile strength of the elongated conductive body is greater than 80 kPsi and less than 500 kPsi, and/or the Young's modulus of the elongated conductive body is greater than 160 GPa and less than 220 GPa. The yield strength of the elongated conductive body can be greater than 60 kPsi and less than 2200 kPsi.
• Theelectronics unit500 can be releasably coupled to thesensor200. Theelectronics unit500 can include electronic circuitry associated with measuring and processing the continuous analyte sensor data. Theelectronics unit500 can be configured to perform algorithms associated with processing and calibration of the sensor data. For example, theelectronics unit500 can provide various aspects of the functionality of a sensor electronics module as described in U.S. Patent Publication No. US-2009-0240120-A1 and U.S. Patent Publication No. US-2012-0078071-A1, the entire contents of which are incorporated by reference herein. Theelectronics unit500 may include hardware, firmware, and/or software that enable measurement of levels of the analyte via a glucose sensor, such as ananalyte sensor200.
• For example, theelectronics unit500 can include a potentiostat, a power source for providing power to thesensor200, signal processing components, data storage components, and a communication module (e.g., a telemetry module) for one-way or two-way data communication between theelectronics unit500 and one or more receivers, repeaters, and/or display devices, such as devices110-113. Electronics can be affixed to a printed circuit board (PCB), or the like, and can take a variety of forms. The electronics can take the form of an integrated circuit (IC), such as an Application-Specific Integrated Circuit (ASIC), a microcontroller, and/or a processor. Theelectronics unit500 may include sensor electronics that are configured to process sensor information, such as storing data, analyzing data streams, calibrating analyte sensor data, estimating analyte values, comparing estimated analyte values with time-corresponding measured analyte values, analyzing a variation of estimated analyte values, and the like. Examples of systems and methods for processing sensor analyte data are described in more detail in U.S. Pat. Nos. 7,310,544, 6,931,327, U.S. Patent Publication No. 2005-0043598-A1, U.S. Patent Publication No. 2007-0032706-A1, U.S. Patent Publication No. 2007-0016381-A1, U.S. Patent Publication No. 2008-0033254-A1, 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, the contents of which are hereby incorporated by reference in their entirety.
• One or more repeaters, receivers and/or display devices, such as akey fob repeater110, a medical device receiver111 (e.g., an insulin delivery device and/or a dedicated glucose sensor receiver), asmartphone112, aportable computer113, and the like can be communicatively coupled to the electronics unit500 (e.g., to receive data from the electronics unit500). Theelectronics unit500 can also be referred to as a transmitter. In some embodiments, the devices110-113 transmit data to theelectronics unit500. The sensor data can be transmitted from thesensor electronics unit500 to one or more of thekey fob repeater110, themedical device receiver111, thesmartphone112, theportable computer113, and the like. In some embodiments, analyte values are displayed on a display device.
• Theelectronics unit500 may communicate with the devices110-113, and/or any number of additional devices, via any suitable communication protocol. Example communication protocols include radio frequency; Bluetooth; universal serial bus; any of the wireless local area network (WLAN) communication standards, including the IEEE 802.11, 802.15, 802.20, 802.22 and other 802 communication protocols; ZigBee; wireless (e.g., cellular) telecommunication; paging network communication; magnetic induction; satellite data communication; and/or a proprietary communication protocol.
• Additional sensor information is described in U.S. Pat. Nos. 7,497,827 and 8,828,201. The entire contents of U.S. Pat. Nos. 7,497,827 and 8,828,201 are incorporated by reference herein.
• Any sensor shown or described herein can be an analyte sensor; a glucose sensor; and/or any other suitable sensor. A sensor described in the context of any embodiment can be any sensor described herein or incorporated by reference. Thus, for example, thesensor138 shown inFIG. 7 can be an analyte sensor; a glucose sensor; any sensor described herein; and any sensor incorporated by reference. Sensors shown or described herein can be configured to sense, measure, detect, and/or interact with any analyte.
• As used herein, the term “analyte” is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a substance or chemical constituent in a biological fluid (for example, blood, interstitial fluid, cerebral spinal fluid, lymph fluid, urine, sweat, saliva, etc.) that can be analyzed. Analytes can include naturally occurring substances, artificial substances, metabolites, or reaction products.
• In some embodiments, the analyte for measurement by the sensing regions, devices, systems, and methods is glucose. However, other analytes are contemplated as well, including, but not limited to ketone bodies; Acetyl Co A; acarboxyprothrombin; acylcarnitine; adenine phosphoribosyl transferase; adenosine deaminase; albumin; alpha-fetoprotein; amino acid profiles (arginine (Krebs cycle), histidine/urocanic acid, homocysteine, phenylalanine/tyrosine, tryptophan); andrenostenedione; antipyrine; arabinitol enantiomers; arginase; benzoylecgonine (cocaine); biotinidase; biopterin; c-reactive protein; carnitine; carnosinase; CD4; ceruloplasmin; chenodeoxycholic acid; chloroquine; cholesterol; cholinesterase; cortisol; testosterone; choline; creatine kinase; creatine kinase MM isoenzyme; cyclosporin A; d-penicillamine; de-ethylchloroquine; dehydroepiandrosterone sulfate; DNA (acetylator polymorphism, alcohol dehydrogenase, alpha 1-antitrypsin, cystic fibrosis, Duchenne/Becker muscular dystrophy, glucose-6-phosphate dehydrogenase, hemoglobin A, hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F, D-Punjab, beta-thalassemia, hepatitis B virus, HCMV, HIV-1, HTLV-1, Leber hereditary optic neuropathy, MCAD, RNA, PKU,Plasmodium vivax, sexual differentiation, 21-deoxycortisol); desbutylhalofantrine; dihydropteridine reductase; diptheria/tetanus antitoxin; erythrocyte arginase; erythrocyte protoporphyrin; esterase D; fatty acids/acylglycines; triglycerides; glycerol; free B-human chorionic gonadotropin; free erythrocyte porphyrin; free thyroxine (FT4); free tri-iodothyronine (FT3); fumarylacetoacetase; galactose/gal-1-phosphate; galactose-1-phosphate uridyltransferase; gentamicin; glucose-6-phosphate dehydrogenase; glutathione; glutathione perioxidase; glycocholic acid; glycosylated hemoglobin; halofantrine; hemoglobin variants; hexosaminidase A; human erythrocyte carbonic anhydrase I; 17-alpha-hydroxyprogesterone; hypoxanthine phosphoribosyl transferase; immunoreactive trypsin; lactate; lead; lipoproteins ((a), B/A-1, B); lysozyme; mefloquine; netilmicin; phenobarbitone; phenytoin; phytanic/pristanic acid; progesterone; prolactin; prolidase; purine nucleoside phosphorylase; quinine; reverse tri-iodothyronine (rT3); selenium; serum pancreatic lipase; sissomicin; somatomedin C; specific antibodies (adenovirus, anti-nuclear antibody, anti-zeta antibody, arbovirus, Aujeszky's disease virus, dengue virus,Dracunculus medinensis, Echinococcus granulosus, Entamoeba histolytica, enterovirus,Giardia duodenalisa, Helicobacter pylori, hepatitis B virus, herpes virus, HIV-1, IgE (atopic disease), influenza virus,Leishmania donovani, leptospira, measles/mumps/rubella,Mycobacterium leprae, Mycoplasma pneumoniae, Myoglobin,Onchocerca volvulus, parainfluenza virus,Plasmodium falciparum, poliovirus,Pseudomonas aeruginosa, respiratory syncytial virus,rickettsia(scrub typhus),Schistosoma mansoni, Toxoplasma gondii, Trepenoma pallidium, Trypanosoma cruzi/rangeli, Vesicular stomatisvirus,Wuchereria bancrofti, yellow fever virus); specific antigens (hepatitis B virus, HIV-1); acetone (e.g., succinylacetone); acetoacetic acid; sulfadoxine; theophylline; thyrotropin (TSH); thyroxine (T4); thyroxine-binding globulin; trace elements; transferrin; UDP-galactose-4-epimerase; urea; uroporphyrinogen I synthase; vitamin A; white blood cells; and zinc protoporphyrin.
• Salts, sugar, protein, fat, vitamins, and hormones naturally occurring in blood or interstitial fluids can also constitute analytes in certain embodiments. The analyte can be naturally present in the biological fluid or endogenous, for example, a metabolic product, a hormone, an antigen, an antibody, and the like. Alternatively, the analyte can be introduced into the body or exogenous, for example, a contrast agent for imaging, a radioisotope, a chemical agent, a fluorocarbon-based synthetic blood, or a drug or pharmaceutical composition, including but not limited to insulin; glucagon; ethanol; cannabis (marijuana, tetrahydrocannabinol, hashish); inhalants (nitrous oxide, amyl nitrite, butyl nitrite, chlorohydrocarbons, hydrocarbons); cocaine (crack cocaine); stimulants (amphetamines, methamphetamines, Ritalin, Cylert, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine); depressants (barbiturates, methaqualone, tranquilizers such as Valium, Librium, Miltown, Serax, Equanil, Tranxene); hallucinogens (phencyclidine, lysergic acid, mescaline, peyote, psilocybin); narcotics (heroin, codeine, morphine, opium, meperidine, Percocet, Percodan, Tussionex, Fentanyl, Darvon, Talwin, Lomotil); designer drugs (analogs of fentanyl, meperidine, amphetamines, methamphetamines, and phencyclidine, for example, Ecstasy); anabolic steroids; and nicotine. The metabolic products of drugs and pharmaceutical compositions are also contemplated analytes. Analytes such as neurochemicals and other chemicals generated within the body can also be analyzed, such as, for example, ascorbic acid, uric acid, dopamine, noradrenaline, 3-methoxytyramine (3MT), 3,4-dihydroxyphenylacetic acid (DOPAC), homovanillic acid (HVA), 5-hydroxytryptamine (5HT), 5-hydroxyindoleacetic acid (FHIAA), and intermediaries in the Citric Acid Cycle.
• Many embodiments described herein use an adhesive (e.g., the adhesive126 inFIG. 7). One purpose of the adhesive can be to couple a base, a sensor module, and/or a sensor to a host (e.g., to skin of the host). The adhesive can be configured for adhering to skin. The adhesive can include a pad (e.g., that is located between the adhesive and the base). Additional adhesive information, including adhesive pad information, is described in U.S. patent application Ser. No. 14/835,603, which was filed on Aug. 25, 2015. The entire contents of U.S. patent application Ser. No. 14/835,603 are incorporated by reference herein.
Distal Base Location
• As noted above, systems can apply an on-skin sensor assembly to the skin of a host. The system can include a base that comprises an adhesive to couple a glucose sensor to the skin.
• In some applicators, the base is hidden deep inside the applicator until the user moves the needle distally with the base. One challenge with this approach is that the insertion site (on the skin of the host) is not ideally prepared for sensor and/or needle insertion. For example, the distal end of the applicator may be a hoop that presses against the skin. The pressure of the applicator on the skin can cause the area of the skin within the hoop to form a convex shape. In addition, the skin within the hoop can be too easily compressed such that the skin lacks sufficient resilience and firmness. In this state, the sensor and/or needle may press the skin downward without immediately piercing the skin, which may result in improper sensor and/or needle insertion.
• In several embodiments, the base is coupled to a telescoping assembly such that the base protrudes from the distal end of the system while the glucose sensor is located remotely from the base and is located within the telescoping assembly. This configuration enables the base to prepare the insertion site of the skin for sensor and/or needle insertion (e.g., by compressing the skin). Thus, these embodiments can dramatically improve the reliability of sensor and/or needle insertion while reducing pain associated with sensor and/or needle insertion.
• The system can hold the base in a position that is distal relative to a glucose sensor module such that a glucose sensor is not attached to the base and such that the glucose sensor can move relative to the base. Moving the glucose sensor module distally towards the base can attach the glucose sensor to the base. This movement can occur as a result of compressing an applicator.
• FIG. 2 illustrates a perspective view of anapplicator system104 for applying at least portions of an on-skin sensor assembly600 (shown inFIG. 4) to skin of a host (e.g., a person). The system can include a sterile barrier having ashell120 and acap122. Thecap122 can screw onto theshell120 to shield portions of thesystem104 from external contaminants.
• The electronics unit500 (e.g., a transmitter having a battery) can be detachably coupled to thesterile barrier shell120. The rest of theapplicator system104 can be sterilized, and then theelectronics unit500 can be coupled to the sterile barrier shell120 (such that theelectronics unit500 is not sterilized with the rest of the applicator system104).
• The user can detach theelectronics unit500 from thesterile barrier shell120. The user can also couple theelectronics unit500 to the base128 (as shown inFIG. 6) after theapplicator system104 places at least a portion of a sensor in a subcutaneous position (for analyte sensing).
• Many different sterilization processes can be used with the embodiments described herein. Thesterile barrier120 and/or thecap122 can block gas from passing through (e.g., can be hermetically sealed). The hermetic seal can be formed by threads140 (shown inFIG. 3). Thethreads140 can be compliant such that they deform to create a seal. Thethreads140 can be located between thesterile barrier shell120 and thecap122.
• Thecap122 can be made polypropylene and theshell120 can be made from polycarbonate (or vice versa) such that one of thecap122 and theshell120 is harder than the other of thecap122 and the120. This hardness (or flexibility) difference enables one of the components to deform to create thethread140 seal.
• In some embodiments, at least one of theshell120 and thecap122 includes a gas-permeable material to enable sterilization gases to enter theapplicator system104. For example, as explained in the context ofFIG. 60, the system can include acover272h.
• Referring now toFIG. 3, thethreads140 can be configured such that a quarter rotation, at least 15 percent of a full rotation, and/or less than 50 percent of a full rotation uncouples thecap122 from theshell120. Some embodiments do not includethreads140. Thecap122 can be pushed onto the shell120 (e.g., during assembly) even in some threaded embodiments.
• Acap122 can be secured to theshell120 by afrangible member142 configured such that removing thecap122 from theshell120 brakes thefrangible member142. Thefrangible member142 can be configured like the safety ring (with a frangible portion) of a plastic soda bottle. Unscrewing the cap from the plastic soda bottle breaks the safety ring from the soda bottle's cap. This approach provides evidence of tampering. In the same way, theapplicator system104 can provide tamper evidence (due to thefrangible member142 being broken by removing thecap122 from the shell122).
• U.S. Patent Publication No. US-2013-0267811-A1; U.S. Patent Application No. 62/165,837, which was filed on May 15, 2015; and U.S. Patent Application No. 62/244,520, which was filed on Oct. 21, 2015, include additional details regarding applicator system embodiments. 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 by reference herein.
• FIG. 3 illustrates a cross-sectional view of thesystem104. Aglucose sensor module134 is configured to couple aglucose sensor138 to the base128 (e.g., a “housing”). Thetelescoping assembly132 is located in a proximal starting position such that theglucose sensor module134 is located proximally relative to thebase128 and remotely from thebase128. Thetelescoping assembly132 is configured such that collapsing thetelescoping assembly132 connects theglucose sensor module134 to thebase128 via one or more mechanical interlocks (e.g., snap fits, interference features).
• Thesterile barrier shell120 is coupled to atelescoping assembly132. After removing thecap122, thesystem104 is configured such that compressing thesterile barrier shell120 distally (while a distal portion of thesystem104 is pressed against the skin) can insert a sensor138 (shown inFIG. 4) into the skin of a host to place the transcutaneous,glucose analyte sensor138. In many figures shown herein, thesterile barrier shell120 andcap122 are hidden to increase the clarity of other features.
• Collapsing thetelescoping assembly132 also pushes at least 2.5 millimeters of theglucose sensor138 out through a hole in the base128 such that at least 2.5 millimeters of theglucose sensor138 that was previously located proximally relative to a distal end of the base protrudes distally out of thebase128. Thus, in some embodiments, the base128 can remain stationary relative to a distal portion of thetelescoping assembly132 while the collapsing motion of thetelescoping assembly132 brings theglucose sensor module134 towards thebase128 and then couples thesensor module134 to thebase128.
• This relative motion between thesensor module134 and thebase128 has many benefits, such as enabling the base to prepare the insertion site of the skin for sensor and/or needle insertion (e.g., by compressing the skin). The starting position of the base128 also enables the base128 to shield people from a needle, which can be located inside theapplicator system104. For example, if the base128 were directly coupled to thesensor module134 in the proximal starting position of the telescoping assembly, the needle may protrude distally from thebase128. The exposed needle could be a potential hazard. In contrast, the distal starting position of thebase128 enables the base128 to protect people from inadvertent needle insertion. Needle protection is especially important for caregivers (who are not the intended recipients of the on-skin sensor assembly600 shown inFIG. 4).
• FIG. 4 illustrates a perspective view of the on-skin sensor assembly600, which includes thebase128. An adhesive126 can couple the base128 to theskin130 of the host. The adhesive126 can be a foam adhesive suitable for skin adhesion. Aglucose sensor module134 is configured to couple aglucose sensor138 to thebase128.
• The applicator system104 (shown inFIG. 2) can couple the adhesive126 to theskin130. Thesystem104 can also secure (e.g., couple via mechanical interlocks such as snap fits and/or interference features) theglucose sensor module134 to the base128 to ensure theglucose sensor138 is coupled to thebase128. Thus, the adhesive126 can couple theglucose sensor138 to theskin130 of the host.
• After theglucose sensor module134 is coupled to thebase128, a user (or an applicator) can couple the electronics unit500 (e.g., a transmitter) to thebase128 via mechanical interlocks such as snap fits and/or interference features. Theelectronics unit500 can measure and/or analyze glucose indicators sensed by theglucose sensor138. Theelectronics unit500 can transmit information (e.g., measurements, analyte data, glucose data) to a remotely located device (e.g.,110-113 shown inFIG. 1).
• FIG. 5 illustrates a perspective view of theelectronics unit500 coupled to thebase128 via mechanical interlocks such as snap fits and/or interference features. Adhesive126 on a distal face of thebase128 is configured to couple thesensor assembly600 to the skin.FIG. 6 illustrates another perspective view of theelectronics unit500 coupled to thebase128.
• Any of the features described in the context ofFIGS. 1-6 can be applicable to all aspects and embodiments identified herein. For example, many embodiments can use the on-skin sensor assembly600 shown inFIG. 4 and can use thesterile barrier shell120 shown inFIG. 2. Moreover, any of the features of an embodiment is independently combinable, partly or wholly with other embodiments described herein in any way, e.g., one, two, or three or more embodiments may be combinable in whole or in part. Further, any of the features of an embodiment may be made optional to other aspects or embodiments. Any aspect or embodiment of a method can be performed by a system or apparatus of another aspect or embodiment, and any aspect or embodiment of a system can be configured to perform a method of another aspect or embodiment.
• FIGS. 7-11 illustrate cross-sectional views of theapplicator system104 fromFIG. 3. Thesterile barrier shell120 and thecap134 are hidden inFIGS. 7-11 to facilitate viewing thetelescoping assembly132.
• Thetelescoping assembly132 is part of a system for applying an on-skin sensor assembly600 to skin of a host (shown inFIG. 4). Thetelescoping assembly132 can apply portions of the system to the host. Additional portions of the system can be added to the on-skin sensor assembly600 after theapplicator system104 couples initial portions of thesensor assembly600 to the host. For example, as shown inFIG. 4, the electronics unit500 (e.g., a transmitter) can be coupled to the on-skin sensor assembly600 after the applicator system104 (shown inFIG. 3) couples thebase128, theglucose sensor module134, and/or theglucose sensor138 to theskin130 of the host.
• In some embodiments, the applicator system104 (shown inFIG. 3) couples at least one, at least two, at least three, at least four, and/or all of the following items to the skin of the host: theelectronics unit500, theglucose sensor module134, theglucose sensor138, thebase128, and the adhesive126. Theelectronics unit500 can be located inside theapplicator system104 such that theapplicator system104 is configured to couple theelectronics unit500 to the skin of the host.
• FIG. 7 illustrates atelescoping assembly132 having a first portion150 (e.g., a “pusher”) configured to move distally relative to a second portion152 (e.g., a “needle guard”) from a proximal starting position to a distal position along apath154.FIG. 7 illustrates thetelescoping assembly132 in the proximal starting position.FIG. 8 illustrates thetelescoping assembly132 moving between the proximal starting position and the distal position.FIG. 11 illustrates thetelescoping assembly132 in the distal position. The path154 (shown inFIG. 7) represents the travel between the proximal starting position and the distal position.
• A first set of items can be immobile relative to thefirst portion150, and a second set of items can be immobile relative to thesecond portion152 while the first set of items move relative to the second set of items.
• Referring now toFIG. 7, theglucose sensor138 and thesensor module134 are coupled to the first portion150 (e.g., such that they are immobile relative to thefirst portion150 during a proximal portion of the path154). Thebase128 is coupled to thesecond portion152 such that the base128 protrudes from a distal end of the system (e.g., the base protrudes from a distal end of the telescoping assembly132). Thebase128 comprises adhesive126 configured to eventually couple theglucose sensor138 to the skin (e.g., after at least a portion of theglucose sensor138 is rigidly coupled to the base128).
• InFIG. 7, theglucose sensor138 and thesensor module134 are located within thesecond portion152 while the base128 protrudes from the distal end of the system (e.g., from the distal end of the telescoping assembly132) such that the system is configured to couple theglucose sensor138 to thebase128 via moving thefirst portion150 distally relative to thesecond portion152. The progression shown inFIGS. 7-11 illustrates moving thefirst portion150 distally relative to thesecond portion152.
• Thesensor module138 is coupled to a distal portion of thefirst portion150 such that moving thefirst portion150 to the distal position (as described above) couples thesensor module134 to thebase128. Theglucose sensor138 is coupled to the sensor module134 (e.g., immobile relative to the sensor module134) while thefirst portion150 is located in the proximal starting position. Theglucose sensor138 can include a distally protruding portion and a proximal portion. The proximal portion can be rigidly coupled to thesensor module134 such that the proximal portion cannot move relative to thesensor module134 even though the distally protruding portion may bend relative to thesensor module134.
• A needle156 (e.g., a “C-shaped” needle) is coupled to thefirst portion150 such that theglucose sensor138 and theneedle156 move distally relative to thebase128 and relative to thesecond portion152. The system can further comprise aneedle release mechanism158 configured to retract theneedle156 proximally.
• Theneedle156 can have many different forms. Many different types ofneedles156 can be used with the embodiments described herein.FIGS. 51-55 illustrate various needle embodiments that can be used with any of the embodiments described herein.
• Theneedle156 can guide thesensor138 into the skin of the host. A distal portion of thesensor138 can be located in a channel of the needle156 (as shown inFIG. 42). Sometimes, a distal end of thesensor138 sticks out of theneedle156 and gets caught on tissue of the host as thesensor138 andneedle156 are inserted into the host. As a result, thesensor138 may buckle and fail to be inserted deeply enough into the subcutaneous tissue. In other words, in some embodiments, the sensor wire must be placed within the channel of the C-shapedneedle156 to be guided into the tissue and must be retained in thechannel330 during deployment.
• The risk of thesensor138 sticking out of the channel330 (and thereby failing to be property inserted into the host) can be greatly diminished by the embodiment illustrated inFIG. 51. In this embodiment, adhesive376 bonds a distal portion of theglucose sensor138 into thechannel330 of theneedle156. Retracting theneedle156 can break the bond of the adhesive376 to enable a distal portion of thesensor138 to stay in a subcutaneous location while theneedle156 is retracted (and even after theneedle156 is retracted).
• The risk of thesensor138 sticking out of the channel330 (and thereby failing to be property inserted into the host) can be greatly diminished by the embodiment illustrated inFIGS. 52 and 53. In this embodiment, theneedle156acomprises two sides, which can be separated byslots378. Thesensor138 can have a width that is larger than the width of theslots378 such that thesensor138 cannot come out of thechannel330auntil the two sides of theneedle156aare moved apart (to widen the slots378).
• The embodiment illustrated inFIG. 54 can be used with any of the other embodiments described herein. Theneedle156bincludes aramp380 at the distal end of thechannel330b. The distal end of theneedle156bcan include aconical tip382. Theramp380 can be configured to push thesensor138 out of thechannel330bof theneedle156bas theneedle156bis retracted into the telescoping assembly132 (shown inFIG. 7).
• FIG. 55 illustrates cross sectional views ofdifferent needles156c,156d,156e,156f, which can be used asneedle156 inFIG. 7 or in any other embodiment described herein.Needle156cincludes anenclosed channel330c.Needles156d,156e,156fare C-needles, although many other C-needle shapes can be used in several embodiments. The ends of theneedle156dcan be angled relative to each other. In some embodiments, the ends of the needle can be angled away from each other, in an opposite fashion as shown by156d. In some embodiments, the ends of the needle can have flared edges, in which the flared edges are rounded to prevent the sensor from contacting sharp edges. The ends of theneedle156ecan be parallel and/or flat relative to each other. The outside portion of thechannel330fcan be formed by walls that are straight and/or parallel to each other (rather than by curved walls as is the case forother needles156d,156e). Someneedles156dcan be manufactured via laser cutting, someneedles156ecan be manufactured via wire electrical discharge machining (“EDM”), and some needles156fcan be manufactured via stamping.
• As shown inFIG. 7, aneedle hub162 is coupled to theneedle156. The needle hub includes release features160 that protrude outward. In some embodiments, the release features can comprise one, two, or more flexible arms. Outward ends164 of the release features160 catch on inwardly facing overhangs166 (e.g., undercuts, detents) of thefirst portion150 such that moving thefirst portion150 distally relative to thesecond portion152 causes theneedle retraction mechanism158 to move distally until a release point.
• At the release point,proximal protrusions170 of thesecond portion152 engage the release features160 (shown inFIG. 9), which forces the release features160 to bend inward until the release features160 no longer catch on theoverhangs166 of the first portion150 (shown inFIG. 10). Once the release features160 no longer catch on theoverhangs166 of thefirst portion150, thespring234 of theneedle retraction mechanism158 pushes theneedle156 and theneedle hub162 proximally relative to thefirst portion150 and relative to thesecond portion152 until the needle no longer protrudes distally from thebase128 and is completely hidden inside the telescoping assembly132 (shown inFIG. 11).
• Theneedle156 can be removed from the embodiment illustrated inFIG. 7 to make a needle-free embodiment. Thus, aneedle156 is not used in some embodiments. For example, a distal end of theglucose sensor138 can be formed in a conical shape to enable inserting theglucose sensor138 into the skin without using aneedle156. Unless otherwise noted, the embodiments described herein can be formed with or without aneedle156.
• In several embodiments, a needle can help guide the glucose sensor138 (e.g., at least a distal portion of the glucose sensor) into the skin. In some embodiments, a needle is not part of the system and is not used to help guide theglucose sensor138 into the skin. In needle embodiments and needle-free embodiments, skin piercing is an important consideration. Failing to properly pierce the skin can lead to improper placement of theglucose sensor138.
• Tensioning the skin prior to piercing the skin with theglucose sensor138 and/or theneedle156 can dramatically improve the consistency of achieving proper placement of theglucose sensor138. Tensioning the skin can be accomplished by compressing the skin with a distally protruding shape (e.g., a convex shape) prior to piercing the skin and at the moment of piercing the skin with theglucose sensor138 and/or theneedle156.
• FIG. 12A illustrates a portion of the cross section shown inFIG. 7. Thebase128 includes an optionaldistally facing protrusion174 located distally relative to the second portion152 (and relative to the rest of the telescoping assembly132). Thedistal protrusion174 is convex and is shaped as a dome. In some embodiments, thedistal protrusion174 has block shapes, star shapes, and cylindrical shapes.Several base128 embodiments do not include theprotrusion174.
• Thedistal protrusion174 can be located farther distally than any other portion of thebase128. Thedistal protrusion174 can extend through ahole176 in the adhesive126 (as also shown inFIG. 5). A distal portion of theconvex protrusion174 can be located distally relative to the adhesive126 while a proximal portion of theconvex protrusion174 is located proximally relative to the adhesive126.
• Thedistal protrusion174 has ahole180 through which theneedle156 and/or theglucose sensor138 can pass. Thedistal protrusion174 can compress the skin such that thedistal protrusion174 is configured to reduce a resistance of the skin to piercing.
• FIG. 12B illustrates a cross sectional view of a base128bthat is identical to the base128 illustrated inFIGS. 7 and 12B except for the following features: The base128bdoes not include aprotrusion174. The base128bincludes a funnel186 (e.g., a radius) on the distal side of thehole180b.
• Like the embodiment shown inFIG. 12A, the sensor138 (e.g., an analyte sensor) and/or the needle156 (shown inFIG. 12A) can pass through thehole180b(shown inFIG. 12B). Thefunnels182,186 can be mirror images of each other or can be different shapes. The base128bcan be used with any of the embodiments described herein.
• FIG. 13 illustrates a perspective view of a portion of the adhesive126. Theneedle156 can have many different shapes and cross sections. In some embodiments, theneedle156 includes a slot184 (e.g., thechannel330 shown inFIGS. 42 and 43) into which at least a portion of theglucose sensor138 can be placed.
• Theneedle156 having aslot184 passes through thehole180 of the distal protrusion and through thehole176 of the adhesive126. A portion of theglucose sensor138 is located in theslot184 such that theneedle156 is configured to move distally relative to the base128 (shown inFIG. 12A) without dislodging the portion of theglucose sensor138 from theslot184. Thedistal protrusion174 is convex such that thedistal protrusion174 is configured to tension the skin while thefirst portion150 moves distally relative to thesecond portion152 of the telescoping assembly132 (shown inFIG. 7) to prepare the skin for piercing.
• As mentioned above, the adhesive126 comprises ahole176 through which at least a portion of thedistal protrusion174 of the base128 can pass. Thedistal protrusion174 is located within thehole176 of the adhesive126 such that thedistal protrusion174 can tension at least a portion of the skin within the second hole (e.g., located under the hole176). Thehole176 can be circular or any other suitable shape. Thehole176 can be sized such that at least a majority of thedistal protrusion174 extends through thehole176. A perimeter of thehole176 can be located outside of thedistal protrusion174 such that the perimeter of thehole176 is located radially outward relative to a perimeter of theprotrusion174 where theprotrusion174 connects with the rest of thebase128.
• In some embodiments, thehole176 of the adhesive126 is large enough that the adhesive126 does not cover any of thedistal protrusion174. In some embodiments, the adhesive126 covers at least a portion of or even a majority of thedistal protrusion174. Thus, the adhesive126 does not have to be planar and can bulge distally in an area over thedistal protrusion174.
• In several embodiments, the adhesive126 has a non-uniform thickness such that the thickness of the adhesive126 is greater in an area surrounding a needle exit area than in other regions that are farther radially outward from the needle exit area. Thus, thedistal protrusion174 can be part of the adhesive126 rather than part of thebase128. However, in several embodiments, thebase128 comprises the adhesive126, and thedistal protrusion174 can be formed by the plastic of the base128 or by thefoam adhesive126 of thebase128.
• Theneedle156 includes adistal end198 and aheel194. Theheel194 is the proximal end of the angled portion of the needle's tip. The purpose of the angled portion is to form a sharp end to facilitate penetrating tissue. Thesensor138 has a distal end208.
• During insertion of theneedle156 and thesensor138 into the tissue; as theneedle156 and thesensor138 first protrude distally from the system; and/or while theneedle156 and thesensor138 are located within the telescoping assembly, the end208 of thesensor138 can be located at least 0.1 millimeter proximally from theheel194, less than 1 millimeter proximally from theheel194, less than 3 millimeters proximally from theheel194, and/or within plus or minus 0.5 millimeters of theheel194; and/or the end208 of thesensor138 can be located at least 0.3 millimeters proximally from thedistal end198 of theneedle156 and/or less than 2 millimeters proximally from thedistal end198.
• Referring now toFIG. 12A, thedistal protrusion174 can protrude at least 0.5 millimeters and less than 5 millimeters from the distal surface of the adhesive126. In embodiments where the adhesive126 has a non-planar distal surface, thedistal protrusion174 can protrude at least 0.5 millimeters and less than 5 millimeters from the average distal location of the adhesive126.
• As described above, in some embodiments the base is coupled to a telescoping assembly such that the base protrudes from the distal end of the system while the glucose sensor is located remotely from the base and is located within the telescoping assembly. In other embodiments, however, the base is coupled to a telescoping assembly such that the base is located completely inside the telescoping assembly and the base moves distally with the sensor as the first portion is moved distally relative to the second portion of the telescoping assembly.
• For example,FIG. 59 illustrates a base128 coupled to thesensor module134 and to thesensor138 while thefirst portion150 of thetelescoping assembly132fis located in the proximal starting position. The base128 moves distally as thefirst portion150 is moved distally relative to thesecond portion152. The base128 can be coupled to a distal end portion of thefirst portion150 while thefirst portion150 is located in the proximal starting position. All of the features and embodiments described herein can be configured and used with the base128 positioning described in the context ofFIG. 59.
• All of the embodiments described herein can be used with the base coupled to a telescoping assembly such that the base is located completely inside the telescoping assembly and the base moves distally with the sensor as the first portion is moved distally relative to the second portion of the telescoping assembly. All of the embodiments described herein can be used with the base coupled to a telescoping assembly such that the base protrudes from the distal end of the system while the glucose sensor is located remotely from the base and is located within the telescoping assembly.
Sensor Module Docking and Base Detachment
• As explained above, maintaining the base against the skin during insertion of the sensor and/or needle enables substantial medical benefits. Maintaining the base against the skin, however, can necessitate moving the sensor relative to the base during the insertion process. Once inserted, the sensor needs to be coupled to the base to prevent the sensor from inadvertently dislodging from the base. Thus, there is a need for a system that enables the sensor to move relative to the base and also enables locking the sensor to the base (without being overly burdensome on users).
• Maintaining the base against the skin during the distal movement of the sensor and/or needle is enabled in many embodiments by unique coupling systems that secure the sensor (and the sensor module) to a first portion of a telescoping assembly and secure the base to a second portion of the telescoping assembly. Moving the first portion towards the second portion of the telescoping assembly can align the sensor with the base while temporarily holding the sensor. Then, the system can couple the sensor to the base. Finally, the system can detach the base and sensor from the telescoping assembly (which can be disposable or reusable with a different sensor).
• As illustrated inFIG. 4, thesensor module134 and theglucose sensor138 are not initially coupled to thebase128. Coupling thesensor module134 and theglucose sensor138 to thebase128 via compressing thetelescoping assembly132 and prior to detaching the base128 from thetelescoping assembly132 can be a substantial challenge, yet is enabled by many of the embodiments described herein.
• As illustrated inFIGS. 7 and 14, the sensor module134 (and the glucose sensor138) can be located remotely from the base128 even though they are indirectly coupled via thetelescoping assembly132. In other words, the sensor module134 (and the glucose sensor138) can be coupled to thefirst portion150 of thetelescoping assembly132 while thebase128 is coupled to thesecond portion152 of thetelescoping assembly132. In this state, thesensor module134 and theglucose sensor138 can move relative to the base128 (e.g., as thesensor module134 and theglucose sensor138 move from the proximal starting position to the distal position along the path to “dock” thesensor module134 and theglucose sensor138 to the base128).
• After thesensor module134 and theglucose sensor138 are “docked” with thebase128, the system can detach the base128 from thetelescoping assembly132 to enable thesensor module134, theglucose sensor138, and the base128 to be coupled to the skin by the adhesive126 while thetelescoping assembly132 and other portions of the system are discarded.
• As shown inFIG. 7, thesensor module134 is coupled to thefirst portion150 and is located at least 5 millimeters from the base128 while thefirst portion150 is in the proximal starting position. The system is configured such that moving thefirst portion150 to the distal position couples thesensor module134 to the base128 (as shown inFIG. 11). Theglucose sensor138 is coupled to thesensor module134 while thefirst portion150 is located in the proximal starting position. Theglucose sensor138 is located within thesecond portion152 while the base128 protrudes from the distal end of the system.
• Arrow188 illustrates the proximal direction inFIG. 7.Arrow190 illustrates the distal direction inFIG. 7.Line172 illustrates a horizontal orientation. As used herein, horizontal means within plus or minus 20 degrees of perpendicular to thecentral axis196.
• FIG. 15 illustrates a perspective view of a cross section of portions of the system shown inFIG. 7. The cross section cuts through thehole180 of thebase128. Visible portions include thesensor module134, thesensor138, aseal192, theneedle156, thebase128, and the adhesive126. Thesensor module134 is in the proximal starting position. Theseal192 is configured to block fluid (e.g., bodily fluid) from entering theglucose sensor module134.
• Theglucose sensor138 is mechanically coupled to thesensor module134. Theglucose sensor138 runs into an interior portion of thesensor module134 and is electrically coupled to interconnects in the interior portion of thesensor module134. The interconnects are hidden inFIG. 15 to facilitate seeing the proximal portion of theglucose sensor138 inside the interior portion of thesensor module134. Many other portions of the system are also hidden inFIG. 15 to enable clear viewing of the visible portions.
• In many embodiments, thesensor module134 moves from the position shown inFIG. 15 until thesensor module134 snaps onto thebase128 via snap fits that are described in more detail below.FIG. 11 illustrates thesensor module134 snapped to thebase128. This movement from the proximal starting position to the “docked” position can be accomplished by moving along the path154 (shown inFIG. 7 and illustrated by the progression inFIGS. 7-11). (The arrow representing thepath154 is not necessarily drawn to scale.)
• Referring now toFIGS. 7 and 15, during a first portion of thepath154, thesensor module134 is immobile relative to thefirst portion150, and thebase128 is immobile relative to thesecond portion152 of thetelescoping assembly132. During a second portion of thepath154, the system is configured to move thefirst portion150 distally relative to thesecond portion152; to move thesensor module134 towards thebase128; to move at least a portion of thesensor138 through ahole180 in thebase128; to couple thesensor module134 to thebase128; and to enable the coupledsensor module134 and the base128 to detach from thetelescoping assembly132.
• FIG. 7 illustrates a verticalcentral axis196 oriented from a proximal end to the distal end of the system. (Part of thecentral axis196 is hidden inFIG. 7 to avoid obscuring the arrow that represents thepath154 and to avoid obscuring theneedle156.)
• FIG. 15 illustrates aflex arm202 of thesensor module134. Theflex arm202 is oriented horizontally and is configured to secure thesensor module134 to a protrusion of thebase128. In some embodiments, theflex arm202 is an alignment arm to prevent and/or impede rotation of thesensor module134 relative to thebase128.
• FIG. 16 illustrates a perspective view of a cross section in which thesensor module134 is coupled to thebase128 viaflex arms202.Interconnects204 protrude proximally to connect thesensor module134 to the electronics unit500 (e.g., a transmitter).
• Referring now toFIGS. 15 and 16, theflex arms202 extend from an outer perimeter of thesensor module134. Thebase128 comprisesprotrusions206 that extend proximally from a planar, horizontal portion of thebase128.
• Referring now toFIG. 16, each of theproximal protrusions206 of the base128 are coupled to aflex arm202 of thesensor module134. Thus, the coupling of theproximal protrusions206 to theflex arms202 couples thesensor module134 to thebase128.
• Eachproximal protrusion206 can include a lockingprotrusion212 that extends at an angle of at least 45 degrees from a central axis of eachproximal protrusion206. In some embodiments, the lockingprotrusions212 extend horizontally (e.g., as shown inFIG. 15). Eachhorizontal locking protrusion212 is coupled to anend portion210 of aflexible arm202.
• Theend portion210 of eachflexible arm202 can extend at an angle greater than 45 degrees and less than 135 degrees relative to a central axis of the majority of theflexible arm202. Theend portion210 of eachflexible arm202 can include a horizontal locking protrusion (e.g., as shown inFIG. 15).
• InFIGS. 15 and 16, a first horizontal locking protrusion is coupled to anend portion210 of the firstflexible arm202. A secondhorizontal locking protrusion212 is coupled to the firstproximal protrusion206 of thebase128. InFIG. 16, the first horizontal locking protrusion is located distally under the secondhorizontal locking protrusion212 to secure thesensor module134 to thebase128. The system is configured such that moving thefirst portion150 of thetelescoping assembly132 to the distal position (shown inFIG. 11) causes thefirst flex arm202 to bend to enable the first horizontal locking protrusion of theflex arm202 to move distally relative to the secondhorizontal locking protrusion212. Thus, theflex arm202 is secured between the lockingprotrusion212 and the distal face of thebase128.
• At least a portion of the flex arm202 (e.g., the end portion210) is located distally under thehorizontal locking protrusion212 of the base128 to secure thesensor module134 to thebase128. The system is configured such that moving thefirst portion150 of thetelescoping assembly132 to the distal position causes the flex arm202 (e.g., the end portion210) to bend away (e.g., outward) from the rest of thesensor module134 to enable the horizontal locking protrusion of theflex arm202 to go around the lockingprotrusion212 of theproximal protrusion206. Thus, at least a portion of theflex arm202 can move distally relative to thehorizontal locking protrusion212 of theproximal protrusion206 of thebase128.
• Thesensor module134 can have multipleflex arms202 and the base can have multipleproximal protrusions206 configured to couple thesensor module134 to thebase128. In some embodiments, afirst flex arm202 is located on an opposite side of thesensor module134 relative to a second flex arm202 (e.g., as shown inFIGS. 15 and 16).
• In some embodiments, thebase128 comprises flex arms (e.g., like theflex arms202 shown inFIGS. 15 and 16) and thesensor module134 comprises protrusions that couple to the flex arms of thebase128. The protrusions of thesensor module134 can be like theprotrusions206 shown inFIGS. 15 and 16 except that, in several embodiments, the protrusions extend distally towards the flex arms of thebase128. Thus, the base128 can be coupled to thesensor module134 with flex arms and mating protrusions regardless of whether the base128 or thesensor module134 includes the flex arms.
• In several embodiments, a sensor module is coupled to the glucose sensor. The system comprises a vertical central axis oriented from a proximal end to the distal end of the system. The base comprises a first flex arm that is oriented horizontally and is coupled to the sensor module. The sensor module comprises a first distal protrusion coupled to the first flex arm to couple the sensor module to the base. A first horizontal locking protrusion is coupled to an end portion of the first flexible arm. A second horizontal locking protrusion is coupled to the first distal protrusion of the sensor module. The second horizontal locking protrusion is located distally under the first horizontal locking protrusion to secure the sensor module to the base. The system is configured such that moving the first portion of the telescoping assembly to the distal position causes the first flex arm to bend to enable the second horizontal locking protrusion to move distally relative to the first horizontal locking protrusion. The sensor module comprises a second distal protrusion coupled to a second flex arm of the base. The first distal protrusion is located on an opposite side of the sensor module relative to the second distal protrusion.
• Docking thesensor module134 to the base128 can include securing thesensor module134 to thefirst portion150 of thetelescoping assembly132 while thefirst portion150 moves thesensor module134 towards thebase128. This securing of thesensor module134 to thefirst portion150 of thetelescoping assembly132 needs to be reliable, but temporary so thesensor module134 can detach from thefirst portion150 at an appropriate stage. The structure that secures thesensor module134 to thefirst portion150 of thetelescoping assembly132 generally needs to avoid getting in the way of the docking process.
• FIG. 17 illustrates a cross-sectional view of thefirst portion150 of thetelescoping assembly132.FIG. 17 shows theglucose sensor module134 and theneedle156. Some embodiments do not include theneedle156. Many items are hidden inFIG. 17 to provide a clear view of theflex arms214,216 of thefirst portion150.
• Thefirst portion150 comprises afirst flex arm214 and asecond flex arm216 that protrude distally and latch onto thesensor module134 to releasably secure thesensor module134 to thefirst portion150 while thefirst portion150 is in the proximal starting position (shown inFIG. 7). Theflex arms214,216 can couple to an outer perimeter of thesensor module134 such that distal ends of theflex arms214,216 wrap around a distal face of thesensor module134. In some embodiments, the distal ends of theflex arms214,216 are located distally of thesensor module134 while thefirst portion150 is in the proximal starting position.
• Thebase128 is hidden inFIG. 17, but in the state illustrated inFIG. 17, thesensor module134 is located remotely from the base128 to provide a distance of at least 3 millimeters from thesensor module134 to the base128 while thefirst portion150 is in the proximal starting position. This distance can be important to enable the base to rest on the skin as theneedle156 and/or theglucose sensor138 pierce the skin and advance into the skin during the transcutaneous insertion.
• Referring now toFIGS. 7 and 17, thesensor module134 is located within thesecond portion152 while the base128 protrudes from the distal end of the system such that the system is configured to couple thesensor module134 to thebase128 via moving thefirst portion150 distally relative to thesecond portion152. Thesensor module134 is located within thesecond portion152 while the base128 protrudes from the distal end of the system even though thesensor module134 is moveable relative to thesecond portion152 of thetelescoping assembly132. Thus, thefirst portion150 moves thesensor module134 through an interior region of thesecond portion152 of thetelescoping assembly132 without moving the base128 through the interior region of thesecond portion152.
• The system comprises a verticalcentral axis196 oriented from a proximal end to the distal end of the system. Thefirst flex arm214 and thesecond flex arm216 of thefirst portion150 secure thesensor module134 to thefirst portion150 such that thesensor module134 is releasably coupled to thefirst portion150 with a first vertical holding strength (measured along the vertical central axis196).
• As shown inFIGS. 15 and 16, thesensor module134 is coupled to thebase128 via at least oneflex arm202 such that thesensor module134 is coupled to the base128 with a second vertical holding strength. Theflex arms202 can extend from an outer perimeter of thesensor module134. Theflex arms202 can be part of thebase128.
• Referring now toFIG. 17, in some embodiments, the second vertical holding strength is greater than the first vertical holding strength such that continuing to push thefirst portion150 distally once thesensor module134 is coupled to thebase128 overcomes the first andsecond flex arms214,216 of thefirst portion150 to detach thesensor module134 from thefirst portion150.
• In some embodiments, the second vertical holding strength is at least 50 percent greater than the first vertical holding strength. In several embodiments, the second vertical holding strength is at least 100 percent greater than the first vertical holding strength. In some embodiments, the second vertical holding strength is less than 400 percent greater than the first vertical holding strength.
• FIG. 6 illustrates the on-skin sensor assembly600 in a state where it is attached to a host. The on-skin sensor assembly600 can include theglucose sensor138 and/or the sensor module134 (shown inFIG. 7). In some embodiments, the on-skin sensor assembly600 includes theneedle156. In several embodiments, however, the on-skin sensor assembly600 does not include theneedle156.
• As explained above, maintaining the base against the skin during insertion of the sensor and/or needle enables substantial medical benefits. Maintaining the base against the skin, however, can complicate detaching the base from the applicator. For example, in some prior-art systems, the base detaches after the base moves downward distally with a needle. This relatively long travel can enable several base detachment mechanisms. In contrast, when the base is maintained in a stationary position as the needle moves towards the base, releasing the base can be problematic.
• Many embodiments described herein enable maintaining the base128 against the skin during insertion of thesensor138 and/or theneedle156. As mentioned above in the context ofFIGS. 7-11, after thesensor module134 is coupled to thebase128, thesensor module134 and the base128 need to detach from thetelescoping assembly132 to secure theglucose sensor138 to the host and to enable the telescoping assembly to be thrown away, recycled, or reused.
• As shown inFIGS. 7-11, several embodiments hold the base128 in a stationary position relative to thesecond portion152 of thetelescoping assembly132 as thesensor module134 moves towards thebase128. Referring now toFIG. 18, once thesensor module134 is attached to thebase128, the system can release the base128 by bendingflex arms220 that couple the base128 to thesecond portion152.FIG. 18 shows the system in a state prior to thesensor module134 docking with the base128 to illustratedistal protrusions222 of thefirst portion150 aligned with theflex arms220 such that thedistal protrusions222 are configured to bend the flex arms220 (via thedistal protrusions222 contacting the flex arms220).
• Thedistal protrusions222 bend theflex arms220 to detach the base128 from the telescoping assembly132 (shown inFIG. 7) after thesensor module134 is coupled to the base128 (as shown inFIGS. 11 and 16). Theflex arms220 can include aramp224. A distal end of thedistal protrusions222 can contact theramp224 and then can continue moving distally to bend theflex arm220 as shown byarrow228 inFIG. 18. This bending can uncouple theflex arm220 from alocking feature230 of thebase128. This unlocking is accomplished by thefirst portion150 moving distally relative to thesecond portion152, which causes thedistal protrusions222 to move as shown byarrow226.
• An advantage of the system shown inFIG. 18 is that the unlocking movement (of thearm220 bending as shown by arrow228) is perpendicular (within plus or minus 20 degrees) to the input force (e.g., as represented by arrow226). Thus, the system is designed such that the maximum holding capability (e.g., of the locking feature230) can be many times greater than the force necessary to unlock thearm220 from thebase128. As a result, the system can be extremely reliable and insensitive to manufacturing variability and normal use variations.
• In contrast, if the holding force and the unlocking force were oriented along the same axis (e.g., within plus or minus 20 degrees), the holding force would typically be equal to or less than the unlocking force. However, the unique structure shown inFIG. 18 allows the holding force to be at least two times larger (and in some cases at least four times larger) than the unlocking force. As a result, the system can prevent inadvertent unlocking of the base128 while having an unlocking force that is low enough to be easily provided by a user or by another part of the system (e.g., a motor).
• Another advantage of this system is that it controls the locking and unlocking order of operation. In other words, the structure precludes premature locking and unlocking. In a medical context, this control is extremely valuable because reliability is so critical. For example, in several embodiments, the process follows this order: Thesensor module134 couples to thebase128. Then, thefirst portion150 releases thesensor module134. Then, thesecond portion152 releases thebase128. In several embodiments, the vertical locations of various locking and unlocking structures are optimized to ensure this order is the only order that is possible as thefirst portion150 moves from the proximal starting position to the distal position along the path described previously. (Some embodiments use different locking and unlocking orders of operation.)
• FIG. 7 illustrates the base128 protruding from the distal end of the system while thefirst portion150 of thetelescoping assembly132 is located in the proximal starting position. Thesensor module134 and at least a majority of theglucose sensor138 are located remotely relative to thebase128. The system is configured to couple thesensor module134 and theglucose sensor138 to thebase128 via moving thefirst portion150 distally relative to thesecond portion152.
• Referring now toFIGS. 18 and 19, thebase128 comprises a first radial protrusion230 (e.g., a locking feature) releasably coupled with a first vertical holding strength to a second radial protrusion232 (e.g., a locking feature) of thesecond portion152 of the telescoping assembly132 (shown inFIG. 7). The firstradial protrusion230 protrudes inward and the second radial protrusion protrudes outward232. The system is configured such that moving thefirst portion150 to the distal position moves the secondradial protrusion232 relative to the firstradial protrusion230 to detach the base128 from thetelescoping assembly132.
• Thefirst portion150 of thetelescoping assembly132 comprises afirst arm222 that protrudes distally. Thesecond portion152 of thetelescoping assembly132 comprises asecond flex arm220 that protrudes distally. Thefirst arm222 and thesecond flex arm220 can be oriented within 25 degrees of each other (as measured between their central axes). The system is configured such that moving thefirst portion150 from the proximal starting position to the distal position along the path154 (shown inFIG. 7) causes thefirst arm222 to deflect thesecond flex arm220, and thereby detach thesecond flex arm220 from the base128 to enable the base128 to decouple from the telescoping assembly132 (shown inFIG. 7). Thus, theflex arm220 is configured to releasably couple thesecond portion152 to thebase128.
• When thefirst portion150 is in the proximal starting position, thefirst arm222 of thefirst portion150 is at least partially vertically aligned with thesecond flex arm220 of thesecond portion152 to enable thefirst arm222 to deflect thesecond flex arm220 as the first portion is moved to the distal position.
• Thefirst arm222 and thesecond arm220 can be oriented distally such that at least a portion of thefirst arm222 is located proximally over a protrusion (e.g., the ramp224) of thesecond arm220. This protrusion can be configured to enable a collision between thefirst arm222 and the protrusion to cause thesecond arm220 to deflect (to detach the base128 from the second portion152).
• In the embodiment illustrated inFIG. 18, when thefirst portion150 is in the proximal starting position, at least a section of thefirst arm222 is located directly over at least a portion of thesecond flex arm220 to enable thefirst arm222 to deflect thesecond flex arm220 as thefirst portion150 is moved to the distal position described above. Thesecond flex arm220 comprises a first horizontal protrusion (e.g., the locking feature232). Thebase128 comprises a second horizontal protrusion (e.g., the locking feature230) latched with the first horizontal protrusion to couple the base128 to thesecond portion152 of thetelescoping assembly132. Thefirst arm222 of thefirst portion150 deflects thesecond flex arm220 of thesecond portion152 to unlatch the base128 from thesecond portion152, which unlatches the base128 from thetelescoping assembly132.
• Referring now toFIG. 7, the system is configured to couple theglucose sensor138 to the base128 at a first position. The system is configured to detach the base128 from thetelescoping assembly132 at a second position that is distal relative to the first position.
• A third flex arm (e.g.,flex arm202 inFIG. 15) couples theglucose sensor138 to the base128 at a first position. The second flex arm (e.g.,flex arm220 inFIG. 18) detaches from the base at a second position. The second position is distal relative to the first position such that the system is configured to secure the base128 to thetelescoping assembly132 until after theglucose sensor138 is secured to thebase128.
Spring Compression
• Needles used in glucose sensor insertion applicators can be hazardous. For example, inadvertent needle-sticks can transfer diseases. Using a spring to retract the needle can reduce the risk of needle injuries.
• Referring now toFIG. 7, a spring234 (e.g., a coil spring) can be used to retract theneedle hub162 that supports the c-shapedneedle156. Theneedle hub162 can be released at the bottom of insertion depth (to enable theneedle156 to retract). For example, when theneedle156 reaches a maximum distal position, alatch236 can release to enable thespring234 to push theneedle156 proximally into a protective housing (e.g., into thefirst portion150, which can be the protective housing).
• Many applicators use pre-compressed springs. Many applicators use substantially uncompressed springs that are compressed by a user as the user compresses the applicator. One disadvantage of a pre-compressed spring is that the spring force can cause the components to creep (e.g., change shape over time), which can compromise the reliability of the design. One disadvantage of an uncompressed spring is that the first and second portions of the telescoping assembly can be free to move slightly relative to each other (when the assembly is in the proximal starting position). This “chatter” of the first and second portions can make the assembly seem weak and flimsy.
• Many of the components described herein can be molded from plastic (although springs are often metal). Preventing creep in plastic components can help ensure that an applicator functions the same when it is manufactured and after a long period of time. One way to reduce the creep risk is to not place the parts under a load (e.g., in storage) that is large enough to cause plastic deformation during a storage time.
• Generating the retraction energy by storing energy in a spring during deployment limits the duration of load on the system. For example, the retraction force of the spring can be at least partially generated by collapsing the telescoping assembly (rather storing the system with a large retraction force of a fully pre-compressed spring).
• Transcutaneous and implantable sensors are affected by the in vivo properties and physiological responses in surrounding tissues. For example, a reduction in sensor accuracy following implantation of the sensor is one common phenomenon commonly observed. This phenomenon is sometimes referred to as a “dip and recover” process. Dip and recover is believed to be triggered by trauma from insertion of the implantable sensor, and possibly from irritation of the nerve bundle near the implantation area, resulting in the nerve bundle reducing blood flow to the implantation area.
• Alternatively, dip and recover may be related to damage to nearby blood vessels, resulting in a vasospastic event. Any local cessation of blood flow in the implantation area for a period of time leads to a reduced amount of glucose in the area of the sensor. During this time, the sensor has a reduced sensitivity and is unable to accurately track glucose. Thus, dip and recover manifests as a suppressed glucose signal. The suppressed signal from dip and recover often appears within the first day after implantation of the signal, most commonly within the first 12 hours after implantation. Dip and recover normally resolves within 6-8 hours.
• Identification of dip and recover can provide information to a patient, physician, or other user that the sensor is only temporarily affected by a short-term physiological response, and that there is no need to remove the implant as normal function will likely return within hours.
• Minimizing the time the needle is in the body limits the opportunity for tissue trauma that can lead to phenomena such as dip and recover. Quick needle retraction helps to limit the time the needle is in the body. A large spring retraction force can quickly retract the needle.
• The embodiment illustrated inFIG. 7 solves the “chatter” problem, avoids substantial creep, and enables quick needle retraction. The embodiment places thespring234 in a slight preload between thefirst portion150 and thesecond portion152 of thetelescoping assembly132. In other words, when thefirst portion150 is in the proximal starting position, thespring234 is in a slightly compressed state due to the relaxed length of thespring234 being longer than the length of the chamber in which thespring234 resides inside thetelescoping assembly132.
• In some embodiments, the relaxed length of thespring234 is at least 4 percent longer than the length of the chamber. In several embodiments, the relaxed length of thespring234 is at least 9 percent longer than the length of the chamber. In some embodiments, the relaxed length of thespring234 is less than 18 percent longer than the length of the chamber. In several embodiments, the relaxed length of thespring234 is less than 30 percent longer than the length of the chamber.
• Thespring234 is compressed farther when thefirst portion150 is moved distally relative to thesecond portion152. In some embodiments, this slight preload has a much shorter compression length than the compression length of typical fully pre-compressed springs. In several embodiments, the preload causes a compression length of thespring234 that is less than 25 percent of the compression length of the fullycompressed spring234. In some embodiments, the preload causes a compression length of thespring234 that is greater than 3 percent of the compression length of the fullycompressed spring234. The slight preload eliminates the “chatter” while having a force that is too small to cause substantial creep of non-spring components in the system.
• Thespring234 can be inserted into thefirst portion150 via ahole238 in the proximal end of thefirst portion150. Then, the needle hub162 (and the attached C-shaped needle156) can be loaded through the proximal side of thefirst portion150 of the telescoping assembly (e.g., via thehole238 in the proximal end of the first portion150).
• Theneedle hub162 is slid through thefirst portion150 until radial snaps (e.g., therelease feature160 of the needle hub162) engage a section of the first portion150 (see the latch236). Thus, thespring234 is placed with a slight preload between theneedle hub162 and a distal portion of thefirst portion150 of thetelescoping assembly132.
• During applicator activation and the telescoping (e.g., collapsing of thefirst portion150 into the second portion152), thespring234 is compressed farther. At the bottom of travel (e.g., at the distal ending position), the radial snaps of theneedle hub162 are forced radially inward by features (e.g., the protrusions170) in the telescoping assembly132 (as shown by the progression ofFIGS. 7-11). This releases theneedle hub162 and allows thespring234 to expand to drive theneedle156 proximally out of the host (and into thefirst portion150 and/or the second portion152).
• As shown inFIG. 7, the base128 protrudes from the distal end of the system while thefirst portion150 of thetelescoping assembly132 is located in the proximal starting position and theglucose sensor138 is located remotely relative to thebase128. Theglucose sensor138 is moveably coupled to thebase128 via thetelescoping assembly132 because theglucose sensor138 is coupled to thefirst portion150 and thebase128 is coupled to thesecond portion152 of thetelescoping assembly132.
• The system includes aspring234 configured to retract aneedle156. Theneedle156 is configured to facilitate inserting theglucose sensor138 into the skin. In some embodiments, the system does not include theneedle156.
• When thefirst portion150 is in the proximal starting position, thespring234 is in a first compressed state. The system is configured such that moving thefirst portion150 distally from the proximal starting position increases a compression of thespring234. The first compressed state places thefirst portion150 andsecond portion152 in tension. Latching features hold thefirst portion150 andsecond portion152 in tension. In other words, in the proximal starting position, the latching features are configured to prevent thespring234 from pushing thefirst portion150 proximally relative to thesecond portion152. The latching features resist the first compressed state.
• In several embodiments, the potential energy of the first compressed state is less than the amount of potential energy necessary to retract theneedle156. This low potential energy of the partiallypre-compressed spring234 is typically insufficient to cause creep, yet is typically sufficient to eliminate the “chatter” described above.
• Redundant systems can help ensure that the needle156 (and in some cases the sensor138) can always be removed from the host after they are inserted into the host. If in extreme cases the necessary needle removal force is greater than the spring retraction force, the user can pull theentire telescoping assembly132 proximally to remove theneedle156 and/or thesensor138 from the host.
• Some embodiments include a secondary retraction spring. In other words, in some embodiments, thespring234 inFIG. 7 is actually two concentric springs. (In several embodiments, thespring234 is actually just one spring.) The secondary spring can be shorter than the primary retraction spring. The secondary retraction spring can provide additional needle retraction force and can enable additional tailoring of the force profile.
• Many users desire to minimize the amount of material they throw away (as trash). Moving theneedle156 to the back of the applicator post deployment enables easy access to remove theneedle156 post deployment.
• FIG. 20 illustrates a perspective view of theneedle156, theneedle hub162, and thespring234 just after they were removed proximally from thehole238 in a proximal end of thefirst portion150 of thetelescoping assembly132.
• Thehole238 is an opening at a proximal end of the applicator. Thehole238 is configured to enable removing theneedle156, theneedle hub162, and/or thespring234. This opening can be covered by a removable cover (e.g., a sticker, a hinged lid).
• FIGS. 21 and 22 illustrate perspective views where aremovable cover272 is coupled to thefirst portion150 to cover thehole238 through which theneedle156 can be removed from thetelescoping assembly132. Ahinge274 can couple thecover272 to thefirst portion150 such that thecover272 can rotate to close the hole238 (as shown inFIG. 22) and rotate to open the hole238 (as shown inFIG. 21).
• Removing thecover272 can enable a user to remove theneedle156 from the applicator (e.g., the telescoping assembly132) such that the user can throw theneedle156 in a sharps container and reuse the applicator with a new needle. Removing theneedle156 from the applicator can also enable throwing the rest of the applicator into a normal trash collector to reduce the amount of trash that needs to be held by the sharps container.
• The features described in the context ofFIGS. 20-22 and 60 can be combined with any of the embodiments described herein.
• FIG. 60 illustrates a perspective view of anothertelescoping assembly embodiment132h. Thecover272his adhered to a proximal end of thetelescoping assembly132hto cover a hole configured to retrieve a needle after the needle retracts (e.g., as described in the context ofFIGS. 21 and 22). Peeling thecover272hfrom thetelescoping assembly132hcan enable a user to dump the needle156 (shown inFIG. 7) into a sharps container.
• In this embodiment, thecover272his a flexible membrane such as a Tyvek label made by E. I. du Pont de Nemours and Company (“DuPont”). Thecover272hcan include an adhesive to bond thecover272hto the proximal end of thetelescoping assembly132h.
• In some embodiments, asecond cover272 is adhered to a distal end of thetelescoping assembly132hto cover the end of thetelescoping assembly132hthrough which the sensor138 (shown inFIG. 7) passes. The distal end of thetelescoping assembly132hcan also be covered by aplastic cap122h.
• Thecover272hcan be configured to enable sterilization processes to pass through the material of thecover272hto facilitate sterilization of the interior of thetelescoping assembly132h. For example, sterilization gases can pass through thecover272h.
• Any of the features described in the context ofFIG. 60 can be applicable to all aspects and embodiments identified herein. For example, the embodiments described in the context ofFIG. 60 can be combined with the embodiments described in the context ofFIGS. 1-59 and 61-70.
• Thetelescoping assembly132hcan use the same interior features and components as described in the context ofFIG. 7. One important difference is that thefirst portion150hslides on an outer surface of the second portion152 (rather than sliding inside part of thesecond portion152 as shown inFIG. 7). Also, thetelescoping assembly132hdoes not use a sterile barrier shell120 (as shown inFIG. 2).
• Any of the features described in the context ofFIGS. 7-22 can be applicable to all aspects and embodiments identified herein. For example, the embodiments described in the context ofFIGS. 7-22 can be combined with the embodiments described in the context ofFIGS. 23-70. Moreover, any of the features of an embodiment is independently combinable, partly or wholly with other embodiments described herein in any way, e.g., one, two, or three or more embodiments may be combinable in whole or in part. Further, any of the features of an embodiment may be made optional to other aspects or embodiments. Any aspect or embodiment of a method can be performed by a system or apparatus of another aspect or embodiment, and any aspect or embodiment of a system can be configured to perform a method of another aspect or embodiment.
Force Profiles
• Referring now toFIG. 7, in some embodiments, moving thefirst portion150 of thetelescoping assembly132 distally relative to thesecond portion152 typically involves placing the distal end of the system against the skin of the host and then applying a distal force on the proximal end of the system. This distal force can cause thefirst portion150 to move distally relative to thesecond portion152 to deploy theneedle156 and/or theglucose sensor138 into the skin.
• The optimal user force generated axially in the direction of deployment is a balance between preventing accidental premature deployment and ease of insertion. A force that is ideal at a certain portion of distal actuation may be far less than ideal at another portion of distal actuation.
• The user places the applicator (e.g., the telescoping assembly132) against the skin surface and applies a force distally on the applicator (e.g., by pushing down on the proximal end of the applicator). When the user-generated force exceeds a threshold, the applicator collapses (e.g., telescopes distally) and the user drives the sensor into the body.
• Several embodiments include unique force profiles that reduce accidental premature deployment; dramatically increase the likelihood of complete and proper deployment; and reduce patient discomfort. Specific structures enable these unique force profiles. For example, the following structures can enable the unique force profiles described herein: structures that hold thetelescoping assembly132 in the proximal starting position; structures that attach thesensor module134 to thebase128; structures that release thesensor module134 from thefirst portion150; structures that prevent theneedle156 from retracting prematurely; structures that retract theneedle156; structures that release the base128 from thesecond portion152; structures that pad the collision at the distal position; and structures that hold thetelescoping assembly132 in a distal ending position. These structures are described in various sections herein.
• Several embodiments include a system for applying an on-skin sensor assembly600 to askin130 of a host (shown inFIG. 4). Referring now toFIG. 7, the system can comprise atelescoping assembly132 having afirst portion150 configured to move distally relative to asecond portion152 from a proximal starting position to a distal position along apath154; aglucose sensor138 coupled to thefirst portion150; and alatch236 configurable to impede aneedle156 from moving proximally relative to the first portion.
• Thefirst portion150 is releasably secured in the proximal starting position by a securing mechanism (e.g., the combination of240 and242 inFIG. 7) that impedes moving thefirst portion150 distally relative to thesecond portion152. The system is configured such that prior to reaching the distal position and/or by reaching the distal position, moving thefirst portion150 distally relative to thesecond portion152 releases thelatch236 thereby causing theneedle156 to retract proximally into the system.
• In several embodiments, the securing mechanism is formed by an interference between thefirst portion150 and thesecond portion152. The interference can be configured to impede thefirst portion150 from moving distally relative to thesecond portion152. For example, a radiallyoutward protrusion240 of thefirst portion150 can collide with aproximal end242 of thesecond portion152 such that moving thefirst portion150 distally requires overcoming a force threshold to cause thefirst portion150 and/or thesecond portion152 to deform to enable the radiallyoutward protrusion240 to move distally relative to theproximal end242 of thesecond portion152.
• The system can include a first force profile measured along thepath154. As shown inFIG. 23, theforce profile244 can include force on the Y axis and travel distance on the X axis. Referring now toFIGS. 7 and 23, theforce profile244 can be measured along thecentral axis196.
• One way in which theforce profile244 can be measured is to place thetelescoping assembly132 against the skin; place a force gauge such as a load cell on the proximal end of thetelescoping assembly132; calibrate the measurement system to account for the weight of the force gauge; and then press on the proximal side of the force gauge to drive thetelescoping assembly132 from the proximal starting position to the distal position along thepath154.FIG. 23 illustrates force versus distance from the proximal starting position based on this type of testing procedure.
• Thefirst force profile244 can comprise afirst magnitude246 coinciding with overcoming the securing mechanism (e.g.,240 and242), athird magnitude250 coinciding with releasing the latch236 (e.g., releasing the needle retraction mechanism), and asecond magnitude248 coinciding with an intermediate portion of thepath154 that is distal relative to overcoming the securing mechanism and proximal relative to releasing thelatch236.
• In several embodiments, thesecond magnitude248 is a peak force associated with compressing a needle retraction spring (e.g., thespring234 inFIG. 7) prior to beginning to release thelatch236. This peak force can be at least 0.5 pounds, at least 1.5 pounds, less than 4 pounds, and/or less than 6 pounds.
• In several embodiments, thethird magnitude250 is a peak force associated with releasing the needle retraction mechanism. This peak force can be at least 1 pound, at least 2 pounds, less than 4 pounds, and/or less than 6 pounds.
• In some embodiments, thesecond magnitude248 is less than thefirst magnitude246 and thethird magnitude250 such that the system is configured to promote needle acceleration during the intermediate portion of thepath154 to enable a suitable needle speed at a time the needle156 (or the glucose sensor138) first pierces the skin.
• Thefirst magnitude246 can be the peak force required to overcome the securing mechanism (e.g.,240 and242). This peak force can be at least 5 pounds, at least 6 pounds, less than 10 pounds, and/or less than 12 pounds. Thefirst magnitude246 can be at least 100 percent greater than thesecond magnitude248. Thefirst magnitude246 can be at least 200 percent greater than thesecond magnitude248. Thesecond magnitude248 can be during a portion of theforce profile244 where the compression of thespring234 is at least 50 percent of the maximum spring compression reached just before theneedle156 begins to retract proximally. The slope of theforce profile244 can be positive for at least 1 millimeter during the time at which thesecond magnitude248 is measured (due to the increasing spring force as the spring compression increases).
• Thefirst magnitude246 can be greater than the third magnitude250 (and/or greater than the second magnitude248) such that the system is configured to impede initiating a glucose sensor insertion cycle unless a user is applying enough force to release thelatch236. For example, the force necessary for theprotrusion240 to move distally relative to theproximal end242 can deliberately be designed to be greater than the force necessary to retract theneedle156.
• To provide a sufficient safety margin, thefirst magnitude246 can be at least 50 percent greater than thethird magnitude250. In some embodiments, thefirst magnitude246 is at least 75 percent greater than thethird magnitude250. To avoid a system where thefirst magnitude246 is unnecessarily high in light of the forces required along thepath154 distally relative to thefirst magnitude246, thefirst magnitude246 can be less than 250 percent greater than thethird magnitude250.
• Asecond force profile252 can coincide with the intermediate portion of thepath154. For example, thesecond magnitude248 can be part of thesecond force profile252. Thissecond force profile252 can include a time period in which the slope is positive for at least 1 millimeter, at least 2.5 millimeters, less than 8 millimeters, and/or less than 15 millimeters (due to the increasing spring force as the spring compression increases).
• A proximal millimeter of thesecond force profile252 comprises a lower average force than a distal millimeter of thesecond force profile252 in response to compressing aspring234 configured to enable the system to retract theneedle156 into thetelescoping assembly132.
• The system also includes a first force profile254 (measured along the path154). Thefirst force profile254 comprises a first average magnitude coinciding with moving distally past a proximal half of the securing mechanism and a second average magnitude coinciding with moving distally past a distal half of the securing mechanism. The first average magnitude is greater than the second average magnitude such that the system is configured to impede initiating a glucose sensor insertion cycle unless a user is applying enough force to complete the glucose sensor insertion cycle.
• Afirst force peak256 coincides with moving distally past the proximal half of the securing mechanism. Thefirst force peak256 is at least 25 percent higher than the second average magnitude.
• Thefirst force profile254 comprises afirst magnitude246 coinciding with overcoming the securing mechanism and a subsequent magnitude coinciding with terminating the securing mechanism (e.g., moving past the distal portion of the securing mechanism). Thefirst magnitude246 comprises a proximal vector and the subsequent magnitude comprises a distal vector.FIG. 23 is truncated at zero force, so the distal vector appears to be have a magnitude of zero inFIG. 23, although the actual value is negative (e.g., negative 2 pounds).
• The proximal vector means the system is resisting the distal movement of thefirst portion150 relative to thesecond portion152. The distal vector means that the second half of the securing mechanism can help propel theneedle156 and thesensor138 towards the skin and/or into the skin. In other words, the distal vector assists the distal movement of thefirst portion150 relative to thesecond portion152.
• Thethird force profile260 can include many peaks and values due to the following events: thesensor module134 docking to thebase128; the base detaching from the second portion152 (and thus detaching from the telescoping assembly132); therelease feature160 of theneedle hub162 defecting inward due to theproximal protrusions170 of thesecond portion152; thelatch236 releasing; theneedle156 retracting into an inner chamber of thefirst portion150; and/or thefirst portion150 hits the distal position (e.g., the end of travel).
• As shown inFIG. 7, the securing mechanism can be a radially outward protrusion240 (of the first portion150) configured to collide with aproximal end242 of thesecond portion152 such that moving thefirst portion150 distally requires overcoming a force threshold to cause thefirst portion150 and/or thesecond portion152 to deform to enable the radiallyoutward protrusion240 to move distally relative to theproximal end242 of thesecond portion152. The radiallyoutward protrusion240 is configured to cause thesecond portion152 to deform elliptically to enable thefirst portion150 to move distally relative to thesecond portion152.
• FIG. 24 illustrates another securing mechanism. At least a section of thefirst portion150 interferes with aproximal end242 of thesecond portion152 such that pushing thefirst portion150 distally relative to thesecond portion152 requires a force greater than a force threshold. The force threshold is the minimum force necessary to deform at least one of thefirst portion150 and thesecond portion152 to overcome theinterference266, which is shown inside a dashed circle inFIG. 24.
• Many different interference geometries and types are used in various embodiments. The interference can be between thefirst portion150 and thesecond portion152. The interference can be between theneedle hub162 and thesecond portion152. For example, the interference can resist the distal movement of theneedle hub162.
• In some embodiments, thefirst portion150 includes ataper262. Once an interfering section of thefirst portion150 moves distally past theinterference area266, thetaper262 makes the system such that theinterference266 no longer impedes distal movement of thefirst portion150.
• Thesecond portion152 can also have ataper263. Thetaper263 can be on an interior surface of thesecond portion152 such that the interior size gets larger as measured proximally to distally along thetaper263.
• The interferingportion242 of thesecond portion152 can include a ramp (as shown inFIG. 24) to aid the deformation described above. The interfering section of thefirst portion150 is located proximally relative to the interfering section of thesecond portion152.
• The securing mechanism can comprise a radially outward protrusion (e.g.,240 inFIG. 7) of thefirst portion150 that interferes with a radially inward protrusion of the second portion152 (e.g., as shown by theinterference266 inFIG. 24) such that the securing mechanism is configured to cause thesecond portion152 to deform elliptically to enable thefirst portion150 to move distally relative to thesecond portion152.
• Any of the features described in the context ofFIGS. 24-32 can be applicable to all aspects and embodiments identified herein. For example, the embodiments described in the context ofFIGS. 24-32 can be combined with the embodiments described in the context ofFIGS. 1-23 and 33-70. Moreover, any of the features of an embodiment is independently combinable, partly or wholly with other embodiments described herein in any way, e.g., one, two, or three or more embodiments may be combinable in whole or in part. Further, any of the features of an embodiment may be made optional to other aspects or embodiments. Any aspect or embodiment of a method can be performed by a system or apparatus of another aspect or embodiment, and any aspect or embodiment of a system can be configured to perform a method of another aspect or embodiment.
• FIG. 25 illustrates a cross sectional view of a portion of an embodiment in which the needle holder (e.g., the needle hub162) is configured to resist distal movement of thefirst portion150 relative to thesecond portion152b. Thesecond portion152bis like othersecond portions150 described herein (e.g., as shown inFIG. 7) except that thesecond portion152bincludes flexarms276 that are at least part of the securing mechanism. Theflex arms276 are releasably coupled to the needle holder to releasably secure thefirst portion150 to thesecond portion152bin the proximal starting position (as shown inFIG. 7).
• The needle156 (shown inFIG. 7) is retractably coupled to thefirst portion150 by theneedle holder162. Theneedle holder162 is configured to resist distal movement of thefirst portion150 relative to thesecond portion152bdue to a chamfer and/or aramp278 interfering withflex arms276. Pushing thefirst portion150 distally requires overcoming the force necessary to deflect theflex arms276 outward such that theflex arms276 move out of the way of theramp278.
• FIG. 27 illustrates a perspective view of another securing mechanism, afrangible release280.FIG. 26 illustrates a top view of afrangible ring282. Thering282 includes twofrangible tabs284 that protrude radially inward. In some embodiments, thetabs284 are radially inward protrusions on opposite sides of thering282 relative to each other. The frangible member (e.g., the ring282) can be part of thefirst portion150, thesecond portion152, or any other portion of the system. For example, the frangible member can be a feature of a moldedsecond portion152.
• Thering282 can be made of a brittle material configured to enable thetabs284 to break when thefirst portion150 is pushed distally relative to thesecond portion152. For example, a section of thefirst portion150 can be located proximally over thetab284 when thefirst portion150 is in the proximal starting position (as shown inFIG. 27 by the frangible release280). Moving thefirst portion150 distally can cause the section of thefirst portion150 to bend and/or break thetab284.
• In some embodiments, a radiallyoutward protrusion286 of thefirst portion150 is configured to bend and/or break thetab284. Thering282, thetab284, and the other components described herein can be molded from a plastic such as acrylonitrile butadiene styrene, polyethylene, and polyether ether ketone. (Springs, interconnects, and needles can be made of steel.) In some embodiments, thering282 is at least 0.2 millimeters thick, at least 0.3 millimeters thick, less than 0.9 millimeters thick, and/or less than 1.5 millimeters thick.
• Thering282 can be secured between thefirst portion150 and thesecond portion152 of thetelescoping assembly132. Thering282 can wrap around a perimeter of thefirst portion150 and can be located proximally relative to thesecond portion152 such that thering282 rests against a proximal end of thesecond portion152.
• Thering282 enables a frangible coupling between thefirst portion150 and thesecond portion152 while thefirst portion150 is in the proximal starting position. InFIG. 27, the system is configured such that moving thefirst portion150 to the distal position breaks the frangible coupling (e.g., the frangible release280).
• In some embodiments, thetabs284 are not part of aring282. Thetabs284 can be part of thesecond portion152 or part of thefirst portion150.
• FIG. 27 also includes amagnet system290. Themagnet system290 includes a magnet and a metal element in close enough proximity that the magnet is attracted to the metal element (e.g., a metal disk). For example, thesecond portion152 can include a magnet, and thefirst portion150 can include the metal element. In several embodiments, thesecond portion152 can include a metal element, and thefirst portion150 can include the magnet.
• The magnet and metal element can be located such that they are located along a straight line oriented radially outward from the central axis196 (shown inFIG. 7). This configuration can position the magnet for sufficient attraction to the metal element to resist movement of thefirst portion150. For example, when thefirst portion150 is in the proximal starting position, the magnetic force of themagnet system290 can resist distal movement of the first portion. Thus, the magnet releasably couples thefirst portion150 to thesecond portion152 while thefirst portion150 is in the proximal starting position.
• In several embodiments, a user can compress an internal spring or the spring can be pre-compressed (e.g., compressed fully at the factory). The telescoping assembly can include a button291 configured to release the spring force to cause the needle and/or the sensor to move into the skin.
• Thecover272hdescribed in the context ofFIG. 60 can be adhered to the proximal end of thefirst portion150 shown inFIG. 27. Thecover272hcan be used with any of the embodiments described herein.
• FIG. 31 illustrates a side view of atelescoping assembly132ehaving afirst portion150eand asecond portion152e. Thefirst portion150eincludes a radiallyoutward protrusion286econfigured to engage a radiallyinward ramp296 located on an interior wall of thesecond portion152e. When a user applies a distal, axial force on thefirst portion150e, theprotrusion286ecollides with theramp296. The angle of the ramp causes thefirst portion150eto rotate relative to thesecond portion152e. This rotation resists the distal force and acts as a securing mechanism. Once theprotrusion286emoves beyond the distal end of theramp296, theramp296 no longer causes rotation, and thus, no longer acts as a securing mechanism.
• Many of the embodiments described herein rely on a compressive force of a person. Many unique structures enable the force profiles described herein. The structures help ensure the compressive force caused by a person pushing distally on a portion of the system results in reliable performance. One challenge of relying on people to push downward on the system to generation appropriate forces is that the input force can vary substantially by user. Even a single user can apply different input forces on different occasions.
• One solution to this variability is to replace the need for a user-generated input force with a motor-generated force. The motor can provide reliable input forces. Motors also enable varying the force at different sections of the path from the proximal starting position to the distal position.
• FIGS. 28-30 illustrates embodiments oftelescoping assemblies132c,132dthat include motors290c,290dto drive aneedle156 and/or aglucose sensor138 into the skin. The motors290c,290dcan be linear actuators that use an internal magnetic system to push a rod distally and proximally. The linear actuators can also convert a rotary input into linear motion to push a rod distally and proximally. The movement of the rod can move various portions of the system including theneedle156, theneedle hub162c, thefirst portion150c,150dof thetelescoping assembly132c,132d, thesensor module134, and/or thesensor138. The motors290c,290dcan include internal batteries to supply electricity for the motors290c,290d.
• FIG. 28 illustrates a perspective, cross-sectional view of an embodiment in which the motor290cpushes theneedle hub162cdistally relative to the motor290cand relative to thesecond portion152c. Theneedle hub162ccan include a rod that slides in and out of the housing of themotor292c. The distal movement of theneedle hub162ccan push at least a portion of theneedle156 and/or the sensor138 (shown inFIG. 7) into the skin. The distal movement of theneedle hub162ccan move thesensor module134 distally such that thesensor module134 docks with thebase128. This coupling can precede the detachment of the base128 from thetelescoping assembly132c.
• FIGS. 29 and 30 illustrate side, cross-sectional views of another motor embodiment. In this embodiment, therod294 of themotor292dis coupled to and immobile relative to thesecond portion152dof thetelescoping assembly132d. Themotor292dis coupled to and immobile relative to thefirst portion150dof thetelescoping assembly132d. As a result, pulling therod294 into the housing of themotor292dcauses thefirst portion150dto move distally relative to thesecond portion152d. Theglucose module134 is coupled to a distal portion of thefirst portion150d(as described herein). Thus, theglucose sensor138 is moved distally into the skin of the host and theglucose module134 is coupled to thebase128. As illustrated inFIGS. 29 and 30, the embodiment does not include a needle. Similar embodiments can include a needle.
• FIG. 32 illustrates a perspective, cross-section view of thetelescoping assembly132. In some embodiments, aprotrusion302 of thefirst portion150 couples with ahole304 of thesecond portion152. Theprotrusion302 can be oriented distally to latch with thehole304 in response to thefirst portion150 reaching the distal position.
• In several embodiments, aprotrusion302 of thesecond portion152 couples with ahole304 of thefirst portion150. Theprotrusion302 can be oriented proximally to latch with thehole304 in response to thefirst portion150 reaching the distal position.
• Theprotrusion302 can be a flex arm that is at least 10 millimeters long, at least 15 millimeters long, and/or less than 50 millimeters long. Theprotrusion302 can include an end portion that protrudes at an angle relative to the central axis of the majority of theprotrusion302. This angle can be at least 45 degrees, at least 75 degrees, less than 110 degrees, and/or less than 135 degrees.
• Coupling theprotrusion302 to thehole304 can permanently lock thefirst portion150 in a downward position (that is distal to the proximal starting position and is within 3 millimeter of the distal position) while theneedle156 is in a retracted state. This locking can prevent the system from being reused and can prevent needle-stick injuries.
• Any of the features described in the context ofFIG. 23 can be applicable to all aspects and embodiments identified herein. For example, the embodiments described in the context ofFIG. 23 can be combined with the embodiments described in the context ofFIGS. 1-22 and 24-70. Moreover, any of the features of an embodiment is independently combinable, partly or wholly with other embodiments described herein in any way, e.g., one, two, or three or more embodiments may be combinable in whole or in part. Further, any of the features of an embodiment may be made optional to other aspects or embodiments. Any aspect or embodiment of a method can be performed by a system or apparatus of another aspect or embodiment, and any aspect or embodiment of a system can be configured to perform a method of another aspect or embodiment.
Interconnects
• Referring now toFIG. 4, in many embodiments, theelectronic unit500 drives a voltage bias through thesensor138 so that current can be measured. Thus, the system is able to analyze glucose levels in the host. The reliability of the electrical connection between thesensor138 and theelectronics unit500 is critical for accurate sensor data measurement.
• In many embodiments, the host or a caregiver create the electrical connection between thesensor138 and theelectronics unit500. Aseal192 can prevent fluid ingress as theelectronics unit500 is pressed onto theglucose sensor module134. Oxidation and corrosion can change electrical resistance of the system and are sources of error and noise in the signal.
• The electrical connections should be mechanically stable. Relative movement between the parts of the electrical system can cause signal noise, which can hinder obtaining accurate glucose data.
• A low-resistance electrical connection is more power efficient. Power efficiency can help maximize the battery life of theelectronics unit500.
• In embodiments where the host or caregiver must compress the electrical interconnect and/orseal192, minimizing the necessary force increase user satisfaction. Lowering the user-applied force makes the transmitter easier to install. If the necessary force is too great, users and caregivers may inadvertently fail to apply adequate force, which can jeopardize the reliability and performance of the system. The force that the user needs to apply to couple theelectronics unit500 to thebase128 andsensor module134 is strongly influenced by the force necessary to compress the interconnect. Thus, there is a need for an electrical interconnect with a lower compression force.
• Manufacturing variability, host movement, and temperature variations while the host is using the on-skin sensor assembly600 necessitate providing a robust electrical connection throughout an active compression range (which encompasses the minimum and maximum compression states reasonably possible). Thus, there is a need for electrical connections that are tolerant of compression variation within the active compression range.
• Metallic springs (e.g., coil or leaf springs) can be compressed between thesensor138 and theelectronics unit500 to provide a robust, reliable electrical connection that requires a low compression force to couple theelectronics unit500 to thebase128.
• FIG. 33 illustrates a perspective view of an on-skin senor assembly just before the electronics unit500 (e.g., a transmitter) is snapped onto thebase128. Coupling theelectronics unit500 to the base128 can compress theseal192 to prevent fluid ingress and can compress an interconnect (e.g., springs306) to create anelectrical connection310 between theglucose sensor138 and theelectronics unit500.
• Creating theelectrical connection310 and/or coupling theelectronics unit500 to the base128 can cause the electronics unit500 (e.g., a transmitter) to exit a sleep mode. For example, conductive members (e.g., of thesensor module134 and/or of the base128) can touch electrical contacts of the electronics unit500 (e.g., electrical contacts of a battery of the electronics unit500), which can cause theelectronics unit500 to exit a sleep mode. The conductive member of thesensor module134 and/or of the base128 can be a battery jumper that closes a circuit to enable electricity from the battery to flow into other portions of theelectronics unit500.
• Thus, creating theelectrical connection310 and/or coupling theelectronics unit500 to the base128 can “activate” theelectronics unit500 to enable and/or to prepare theelectronics unit500 to wirelessly transmit information to other devices110-113 (shown inFIG. 1). U.S. Patent Publication No. US-2012-0078071-A1 includes additional information regarding transmitter activation. The entire contents of U.S. Patent Publication No. US-2012-0078071-A1 are incorporated by reference herein.
• The distal face of theelectronics unit500 can include planar electrical contacts that touch the proximal end portions of thesprings306. The distal end portions of thesprings306 can contact various conductive elements of theglucose sensor138. Thus, thesprings306 can electrically couple theelectronics unit500 to the various conductive elements of theglucose sensor138. In the illustrated embodiment, twometallic springs306 electrically connect theglucose sensor138 and theelectronics unit500. Some embodiments use onespring306. Other embodiments use three, four, five, ten, or more springs306.
• Metallic springs306 (e.g., gold-plated springs) are placed above thesensor wire138 in thesensor module134. Thesensor138 is located between arigid polymer base128 and the bottom surface of thespring306. The top surface of thespring306 contacts a palladium electrode located in the bottom of theelectronics module500. Therigid electronics module500 and therigid polymer base128 are brought together creating a compressed sandwich with thesensor138 and thespring306.
• Thesprings306 can be oriented such that their central axes are within 25 degrees of thecentral axis196 of the telescoping assembly132 (shown inFIG. 7). Thesprings306 can have a helical shape. Thesprings306 can be coil springs or leaf springs.
• Springs306 can have ends that are plain, ground, squared, squared and ground, or any other suitable configuration. Gold, copper, titanium, and bronze can be used to make thesprings306.Springs306 can be made from spring steel. In several embodiments, the steels used to make thesprings306 can be low-alloy, medium-carbon steel or high-carbon steel with a very high yield strength. Thesprings306 can be compression springs, torsion springs, constant springs, variable springs, helical springs, flat springs, machined springs, cantilever springs, volute springs, balance springs, leaf springs, V-springs, and/or washer springs.
• Some embodiments use a spring-loaded pin system. The spring system can include a receptacle. A pin can be located partially inside the receptacle such that the pin can slide partially in and out of the receptacle. A spring can be located inside the receptacle such that the spring biases the pin outward towards theelectronics unit500. The receptacle can be electrically coupled to thesensor138 such that pressing theelectronics unit500 onto the spring-loaded pin system electrically couples theelectronics unit500 and thesensor138.
• Mill-Max Mfg. Corp. of Oyster Bay, N.Y., U.S.A. (“Mill-Max”) makes a spring-loaded pin system with a brass-alloy shell that is plated with gold over nickel. One Mill-Max spring-loaded pin system has a stainless steel spring and an ordering code of0926-1-15-20-75-14-11-0.
• In several embodiments, theelectronics unit500 includes a battery to provide electrical power to various electrical components (e.g., a transmitter) of theelectronics unit500.
• In some embodiments, the base128 can include abattery314 that is located outside of theelectronics unit500. Thebattery314 can be electrically coupled to theelectrical connection310 such that coupling theelectronics unit500 to the base128 couples thebattery314 to theelectronics unit500. FIGS. 22B and 22C of U.S. Patent Publication No. US-2009-0076360-A1 illustrate a battery444, which in some embodiments, can be part of the base (which can have many forms including the form ofbase128 shown inFIG. 33 herein). The entire contents of U.S. Patent Publication No. US-2009-0076360-A1 are incorporated by reference herein.
• FIG. 34 illustrates a perspective view of thesensor module134.Protrusions308 can secure thesprings306 to thesensor module134. (Not all theprotrusions308 are labeled in order to increase the clarity ofFIG. 34.) Theprotrusions308 can protrude distally.
• At least three, at least four, and/or less than tenprotrusions308 can be configured to contact a perimeter of aspring306. Theprotrusions308 can be separated by gaps. The gaps enable theprotrusions308 to flex outward as thespring306 is inserted between theprotrusions308. The downward force of coupling theelectronics unit500 to the base128 can push thespring306 against thesensor138 to electrically couple thespring306 to thesensor138. Thesensor138 can run between at least two of theprotrusions308.
• FIG. 33 illustrates an on-skin sensor system600 configured for transcutaneous glucose monitoring of a host. The on-skin sensor system600 can be used with the other components shown inFIG. 7. Thesensor module134 can be replaced with thesensor modules134d,134eshown inFIGS. 35 and 37. Thus, thesensor modules134d,134eshown inFIGS. 35 and 37 can be used with the other components shown inFIG. 7.
• Referring now toFIGS. 33 and 34, thesystem600 can include asensor module housing312; aglucose sensor138a,138bhaving afirst section138aconfigured for subcutaneous sensing and asecond section138bmechanically coupled to thesensor module housing312; and an electrical interconnect (e.g., the springs306) mechanically coupled to thesensor module housing312 and electrically coupled to theglucose sensor138a,138b. The springs can be conical springs, helical springs, or any other type of spring mentioned herein or suitable for electrical connections.
• Thesensor module housing312 comprises at least twoproximal protrusions308 located around a perimeter of thespring306. Theproximal protrusions308 are configured to help orient thespring306. A segment of theglucose sensor138bis located between the proximal protrusions308 (distally to the spring306).
• Thesensor module housing312 is mechanically coupled to thebase128. Thebase128 includes an adhesive126 configured to couple the base128 to skin of the host.
• Theproximal protrusions308 orient thespring306 such that coupling anelectronics unit500 to the base128 presses thespring306 against a first electrical contact of theelectronics500 unit and a second electrical contact of theglucose sensor138bto electrically couple theglucose sensor138a,138bto theelectronics unit500.
• Referring now toFIGS. 33 and 35-38, thesystem600 can include asensor module housing312d,312e; aglucose sensor138a,138bhaving afirst section138aconfigured for subcutaneous sensing and asecond section138bmechanically coupled to thesensor module housing312d,312e; and an electrical interconnect (e.g., theleaf springs306d,306e) mechanically coupled to thesensor module housing312d,312eand electrically coupled to theglucose sensor138a,138b. Thesensor modules134d,134ecan be used in place of thesensor module134 shown inFIG. 7. The leaf springs306d,306ecan be configured to bend in response to theelectronics unit500 coupling with thebase128.
• As used herein, cantilever springs are a type of leaf spring. As used herein, a leaf spring can be made of a number of strips of curved metal that are held together one above the other. As used herein in many embodiments, leaf springs only include one strip (e.g., one layer) of curved metal (rather than multiple layers of curved metal). For example, theleaf spring306dinFIG. 35 can be made of one layer of metal or multiple layers of metal. In some embodiments, leaf springs include one layer of flat metal secured at one end (such that the leaf spring is a cantilever spring).
• As shown inFIGS. 35 and 36, thesensor module housing312dcomprises aproximal protrusion320dhaving achannel322din which at least a portion of the second section of theglucose sensor138bis located. Thechannel322dpositions a first area of theglucose sensor138bsuch that the area is electrically coupled to theleaf spring306d.
• As shown in the cross-sectional, perspective view ofFIG. 36, theleaf spring306darcs away from the first area and protrudes proximally to electrically couple with an electronics unit500 (shown inFIG. 33). At least a portion of theleaf spring306dforms a “W” shape. At least a portion of theleaf spring306dforms a “C” shape. Theleaf spring306dbends around theproximal protrusion320d. Theleaf spring306dprotrudes proximally to electrically couple with an electronics unit500 (shown inFIG. 33). Theseal192 is configured to impede fluid ingress to theleaf spring306d.
• Theleaf spring306dis oriented such that coupling anelectronics unit500 to the base128 (shown inFIG. 33) presses theleaf spring306dagainst a first electrical contact of theelectronics unit500 and a second electrical contact of theglucose sensor138bto electrically couple theglucose sensor138a,138bto theelectronics unit500. The proximal height of theseal192 is greater than a proximal height of theleaf spring306dsuch that theelectronics unit500 contacts theseal192 prior to contacting theleaf spring306d.
• Referring now toFIGS. 33 and 37-38, thesensor module housing312ecomprises achannel322ein which at least a portion of the second section of theglucose sensor138bis located. A distal portion of theleaf spring306eis located in thechannel322esuch that a proximal portion of theleaf spring306eprotrudes proximally out thechannel322e.
• Thesensor module housing312ecomprises agroove326ethat cuts across thechannel322e(e.g., intersects with thechannel322e). Theleaf spring306ecomprises atab328 located in the groove to impede rotation of the leaf spring. At least a portion of theleaf spring306eforms a “C” shape.
• FIGS. 36 and 38 illustrate two leaf spring shapes. Other embodiments use other types of leaf springs. Elements shown inFIGS. 33-38 can be combined.
• Referring now toFIGS. 33-38, interconnects306,306d,306ecan comprise a palladium contact, an alloy, a clad material, an electrically conductive plated material, gold plated portions, silver material, and/or any suitable conductor.Interconnects306,306d,306edescribed herein can 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 increase battery life compared to higher resistance alternatives.
• Reducing the force necessary to compress aninterconnect306,306d,306e(e.g., as anelectronics unit500 is coupled to the base128) can reduce coupling errors and difficulties. For example, if the necessary force is high, odds are substantial that users will inadvertently fail to securely couple theelectronics unit500 to thebase128. In some cases, if the necessary force is too high, some users will be unable to couple theelectronics unit500 to thebase128. Thus, there is a need for systems that require less force to couple theelectronics unit500 to thebase128.
• Many embodiments described herein (e.g., spring embodiments) dramatically reduce the force necessary to couple theelectronics unit500 to thebase128. Theinterconnects306,306d,306ecan have a compression force of at least 0.05 pounds; less than 0.5 pounds, less than 1 pound, less than 3 pounds; and/or less than 4.5 pounds over an active compression range.
• In some embodiments, theinterconnects306,306d,306emay require a compression force of less than one pound to compress the spring 20 percent from a relaxed position, which is a substantially uncompressed position. In some embodiments, theinterconnects306,306d,306emay require a compression force of less than one pound to compress the spring 25 percent from a relaxed position, which is a substantially uncompressed position. In some embodiments, theinterconnects306,306d,306emay require a compression force of less than one pound to compress the spring 30 percent from a relaxed position, which is a substantially uncompressed position. In some embodiments, theinterconnects306,306d,306echange dependency to independent claim) may require a compression force of less than one pound to compress the spring 50 percent from a relaxed position, which is a substantially uncompressed position.
• Springs306,306d,306ecan have a height of 2.6 millimeters, at least 0.5 millimeters, and/or less than 4 millimeters. Theseal192 can have a height of 2.0 millimeters, at least 1 millimeter, and/or less than 3 millimeters. In some embodiments, in their relaxed state (i.e., a substantially uncompressed state), springs306,306d,306eprotrude (e.g., distally) at least 0.2 millimeters and/or less than 1.2 millimeters from the top of theseal192.
• When theelectronics unit500 is coupled to thebase128, the compression of thesprings306,306d,306ecan be 0.62 millimeters, at least 0.2 millimeters, less than 1 millimeter, and/or less than 2 millimeters with a percent compression of 24 percent, at least 10 percent, and/or less than 50 percent. Active compression range of thesprings306,306d,306ecan be 16 to 40 percent, 8 to 32 percent, 40 to 57 percent, 29 to 47 percent, at least 5 percent, at least 10 percent, and/or less than 66 percent.
• In some embodiments, the electrical connection between thesensor138 and theelectronics unit500 is created at the factory. This electrical connection can be sealed at the factory to prevent fluid ingress, which can jeopardize the integrity of the electrical connection.
• The electrical connection can be made via any of the following approaches: An electrode can pierce a conductive elastomer (such that vertical deformation is not necessary); the sensor can be “sandwiched” (e.g., compressed) between adjacent coils of a coil spring; conductive epoxy; brazing; laser welding; and resistance welding.
• Referring now toFIGS. 4, 6, 7, and 33, one key electrical connection is between the electronics unit500 (e.g., a transmitter) and thesensor module134. Another key electrical connection is between thesensor module134 and theglucose sensor138. Both connections should be robust to enable connecting thesensor module134 to thebase128, and then connecting thebase128 andsensor module134 to the electronics unit500 (e.g., a transmitter). Astable sensor module134 allows thesensor module134 to couple to thebase128 without causing signal noise in the future.
• These two key electrical connections can be made at the factory (e.g., prior to the host or caregiver receiving the system). These electrical connections can also be made by the host or caregiver when the user attaches theelectronics unit500 to thebase128 and/or thesensor module134.
• In some embodiments, the connection between theglucose sensor138 and thesensor module134 can be made at the factory (e.g., prior to the user receiving the system), and then the user can couple theelectronics unit500 to thesensor module134 and/or thebase128. In several embodiments, theelectronics unit500 can be coupled to thesensor module134 and/or to the base128 at the factory (e.g., prior to the user receiving the system), and then the user can couple this assembly to theglucose sensor138.
• Any of the features described in the context ofFIGS. 33-38 can be applicable to all aspects and embodiments identified herein. For example, the embodiments described in the context ofFIGS. 33-38 can be combined with the embodiments described in the context ofFIGS. 1-32 and 39-70. Moreover, any of the features of an embodiment is independently combinable, partly or wholly with other embodiments described herein in any way, e.g., one, two, or three or more embodiments may be combinable in whole or in part. Further, any of the features of an embodiment may be made optional to other aspects or embodiments. Any aspect or embodiment of a method can be performed by a system or apparatus of another aspect or embodiment, and any aspect or embodiment of a system can be configured to perform a method of another aspect or embodiment.
• Referring now toFIG. 33, thebattery314 can be located inside theelectronics unit500 or can be part of thebase128. Maximizing the life of thebattery314 is important to many reasons. For example, theelectronics unit500 may be in storage for months or even years before it is used. If the battery413 is substantially depleted during this storage, the number of days that a host can use the electronics unit (e.g., to measure an analyte) can be dramatically diminished.
• In some embodiments, theelectronics unit500 is in a low-power-consumption state (e.g., a “sleep” mode) during storage (e.g., prior to being received by the host). This low-power-consumption state can drain thebattery314. Thus, there is a need for a system that reduces or even eliminates battery power consumption during storage and/or prior to theelectronics unit500 being coupled to thebase128.
• As described in the context ofFIG. 33, creating theelectrical connection310 and/or coupling theelectronics unit500 to the base128 can cause the electronics unit500 (e.g., a transmitter) to exit a sleep mode. For example, conductive members (e.g., of thesensor module134 and/or of the base128) can touch electrical contacts of the electronics unit500 (e.g., electrical contacts of a battery of the electronics unit500), which can cause theelectronics unit500 to exit a sleep mode and/or can begin the flow of electrical power from the battery. The conductive member of thesensor module134 and/or of the base128 can be a battery jumper that closes a circuit to enable electricity from the battery to flow into other portions of theelectronics unit500.
• Thus, creating theelectrical connection310 and/or coupling theelectronics unit500 to the base128 can “activate” theelectronics unit500 to enable and/or to prepare theelectronics unit500 to wirelessly transmit information to other devices110-113 (shown inFIG. 1). U.S. Patent Publication No. US-2012-0078071-A1 includes additional information regardingelectronics unit500 activation (e.g., transmitter activation). The entire contents of U.S. Patent Publication No. US-2012-0078071-A1 are incorporated by reference herein.
• FIG. 65 illustrates a perspective view of portions of asensor module134j. Some items, such as springs and sensors, are hidden inFIG. 65 to clarify that thesensor module134jcan use any spring or sensor described herein. Thesensor module134jcan use any of thesprings306,306d,306e;sensors138,138a,138b;protrusions308;channels322d,322e; andgrooves326edescribed herein (e.g., as shown inFIGS. 34-40). Thesensor module134jcan be used in the place of any other sensor module described herein. Thesensor module134jcan be used in the embodiment described in the context ofFIG. 7 and can be used with any of the telescoping assemblies described herein.
• FIG. 66 illustrates a cross-sectional side view of the sensor module shown inFIG. 65. Referring now toFIGS. 65-70, thesensor module134jincludes aconductive jumper420f(e.g., a conductive connection that can comprise metal). Theconductive jumper420fis configured to electrically couple twoelectrical contacts428a,428bof the electronics unit500 (e.g., a transmitter) in response to coupling theelectronics unit500 to thesensor module134jand/or to thebase128.
• Theconductive jumper420fcan be located at least partially between two electrical connections426 (e.g., springs306,306d,306eshown inFIGS. 34-38). Theconductive jumper306fcan include twosprings306fcoupled by aconductive link422f. Afirst spring306fof thejumper420fcan be coupled to afirst contact428a, and asecond spring306fof thejumper420fcan be coupled to asecond contact428b, which can complete an electrical circuit to enable the battery to provide electricity to theelectronics unit500. Thesprings306fcan be leaf springs, coil springs, conical springs, and/or any other suitable type of spring. In some embodiments, thesprings306fare proximal protrusions that are coupled with thecontacts428a,428b.
• As shown inFIG. 66, theconductive link422fcan be arched such that asensor138b(shown inFIG. 34) passes under and/or through the arched portion of theconductive link422f. In several embodiments, theconductive link422fis oriented within plus or minus 35 degrees of perpendicular to thesensor138bsuch that theconductive link422fcrosses over the portion of thesensor138bthat is located inside the seal area (e.g., within the interior of the seal192).
• FIG. 67 illustrates a perspective view of portions of asensor module134kthat is similar to thesensor module134jshown inFIGS. 65 and 66.FIG. 68 illustrates a top view of thesensor module134kshown inFIG. 67.
• Referring now toFIGS. 67 and 68, thesensor module134kincludes a different type ofconductive jumper420g, which includes twohelical springs306gconductively coupled by aconductive link422g. Theconductive link422gis configured to cross over or under thesensor138b(shown inFIG. 34). As shown inFIGS. 67 and 68, thesprings306gare conical springs, however, some embodiments do not use conical springs. Thesprings306gare configured to electrically couple twoelectrical contacts428a,428bof theelectronics unit500 to start the flow the electricity within theelectronics unit500. Thus, theconductive jumper420gcan “activate” theelectronics unit500. Theconductive jumper420gcan be used with any of the sensor modules described herein.
• FIGS. 69 and 70 illustrate perspective views of anelectronics unit500 just before theelectronics unit500 is coupled to abase128. As shown inFIG. 70, theelectronics unit500 can have twoelectrical contacts428a,428bconfigured to be electrically coupled to aconductive jumper420f(shown inFIGS. 65 and 66),420g(shown inFIGS. 67 and 68). Theelectronics unit500 can also have twoelectrical contacts428c,428dconfigured to be electrically coupled to thesprings306,306d,306e(shown inFIGS. 34-38) and/or to any other type ofelectrical connection426 between the sensor138 (shown inFIG. 39) and theelectronics unit500.
• Coupling theelectronics unit500 to thesensor module134kand/or to the base128 can electrically and/or mechanically couple theelectrical contacts428a,428bto theconductive jumper420f(shown inFIG. 65),420g(shown inFIG. 67).
• Coupling theelectronics unit500 to thesensor module134kand/or to the base128 can electrically and/or mechanically couple theelectrical contacts428c,428dto thesprings306,306d,306e(shown inFIGS. 34-38) and/or to any other type of electrical connection426 (e.g., as shown inFIG. 67) between the sensor138 (shown inFIG. 39) and theelectronics unit500.
• Any of the features described in the context ofFIGS. 65-70 can be applicable to all aspects and embodiments identified herein. For example, the embodiments described in the context ofFIGS. 65-70 can be combined with the embodiments described in the context ofFIGS. 1-64. Moreover, any of the features of an embodiment is independently combinable, partly or wholly with other embodiments described herein in any way, e.g., one, two, or three or more embodiments may be combinable in whole or in part. Further, any of the features of an embodiment may be made optional to other aspects or embodiments. Any aspect or embodiment of a method can be performed by a system or apparatus of another aspect or embodiment, and any aspect or embodiment of a system can be configured to perform a method of another aspect or embodiment.
Needle Angle and Off Set
• FIG. 43 shows a front view of a “C-shaped”needle156.FIG. 42 illustrates a bottom view of the C-shapedneedle156. Theneedle156 includes achannel330. Asection138a(shown inFIG. 34) of the glucose sensor138 (labeled inFIG. 7) that is configured for subcutaneous sensing can be placed in the channel330 (as shown inFIG. 40).
• Theneedle156 can guide thesensor138 into the skin of the host. A distal portion of thesensor138 can be located in thechannel330 of theneedle156. Sometimes, a distal end of thesensor138 sticks out of theneedle156 and gets caught on tissue of the host as thesensor138 andneedle156 are inserted into the host. As a result, thesensor138 may buckle and fail to be inserted deeply enough into the subcutaneous tissue. In other words, in some embodiments, the sensor wire must be placed within thechannel330 of the C-shapedneedle156 to be guided into the tissue and must be retained in thechannel330 during deployment.
• The risk of thesensor138 sticking out of the channel330 (and thereby failing to be property inserted into the host) can be greatly diminished by placing thesensor138 in thechannel330 of theneedle156 with a particular angle338 (shown inFIG. 41) and offset336 (shown inFIG. 40.Position B334 inFIG. 42 illustrates a sensor sticking out of thechannel330.
• Theangle338 and offset336 cause elastic deformation of thesensor138 to create a force that pushes thesensor138 to the bottom of the channel300 (as shown byposition A332 inFIG. 42) while avoiding potentially detrimental effects ofimproper angles338 and offset336. Theangle338 and offset336 can also cause plastic deformation of thesensor138 to help shape thesensor138 in a way that minimizes the risk of thesensor138 being dislodged from thechannel330 during insertion into the skin.
• In several embodiments, theangle338 and offset336 shape portions of thesensor138 for optimal insertion performance. For example, theangle338 can bend thesensor138 prior to placing portions of thesensor138 in thechannel330 of theneedle156.
• As illustrated inFIG. 39, a portion of theglucose sensor138b(also labeled inFIG. 34) can be placed in a distally facing channel342 (which, in some embodiments, is a tunnel). Thischannel342 can help orient theglucose sensor138btowards thechannel330 of the needle156 (shown inFIG. 43).
• As illustrated inFIG. 41, theglucose sensor138 can include anangle338 between a portion of theglucose sensor138 that is coupled to the sensor module housing312 (shown inFIG. 34) and a portion of the glucose sensor that is configured to be inserted into the host. In some embodiments, thisangle338 can be formed prior to coupling thesensor138 to the sensor module house312 (shown inFIG. 34) and/or prior to placing a portion of thesensor138 in thechannel330 of the needle156 (shown inFIG. 43).
• Referring now toFIG. 41, anangle338 that is less than 110 degrees can result in deployment failures (e.g., with an offset of 0.06 inches plus 0.06 inches and/or minus 0.03 inches). In some embodiments, anangle338 that is less than 125 degrees can result in deployment failures (e.g., with an offset of 0.06 inches plus 0.06 inches and/or minus 0.03 inches). Anangle338 of 145 degrees (plus 5 degrees and/or minus 10 degrees) can reduce the probability of deployment failures. In some embodiments, theangle338 is at least 120 degrees and/or less than 155 degrees.
• In some embodiments, a manufacturing method includes bending thesensor138 prior to placing portions of thesensor138 in thechannel330 of theneedle156. In this manufacturing method, an angle is measured from a central axis of a portion of theglucose sensor138 that is coupled to the sensor module housing312 (shown inFIG. 34) and a portion of the glucose sensor that is configured to be inserted into the needle. According to this angle measurement, an angle that is greater than 70 degrees can result in deployment failures (e.g., with an offset of 0.06 inches plus 0.06 inches and/or minus 0.03 inches). In some embodiments, an angle that is greater than 55 degrees can result in deployment failures (e.g., with an offset 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 failures. In some embodiments, the angle is at least 25 degrees and/or less than 60 degrees.
• An offset336 (shown inFIG. 40) that is too large can result in thesensor138 not being reliably held in the channel330 (shown inFIG. 42). In other words, a large offset336 can result in thesensor138 being located inposition B334 rather than securely inposition A332. An offset336 that is too small can place too much stress on thesensor138, which can break thesensor138. In light of these factors, in several embodiments, the offset336 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, the offset336 is equal to or greater than 0.06 inches and/or less than or equal to 0.10 inches. The offset336 is measured as shown inFIG. 40 from the root of theneedle156.
• In some embodiments, at least a portion of the bend of thesensor138 can include a strain relief. For example, the bend of thesensor138 can be encapsulated in a polymeric tube or an elastomeric tube to provide strain relief for thesensor138. In some instances, the entire bend of thesensor138 can be encapsulated in a polymeric tube or an elastomeric tube. In some embodiments, the tube is composed of a soft polymer. The polymeric tube or elastomeric tube can encapsulate thesensor138 by a heat shrink process. In some embodiments, a silicone gel may be applied to the sensor at or near channel342 (shown inFIG. 39), or along at least a portion of the underside ofproximal protrusion320d(shown inFIG. 35).
• The needle channel width344 (shown inFIG. 42) can be 0.012 inches. In some embodiments, thewidth344 is equal to or greater than 0.010 inches and/or less than or equal to 0.015 inches. Thewidth344 of thechannel330 is measured at the narrowest span in which theglucose sensor138 could be located.
• Referring now toFIG. 40, afunnel182 in the base128 can help guide theneedle156 and/or theglucose sensor138 into thehole180. Thefunnel182 and thehole180 can help secure thesensor138 in the C-shapedneedle156 during storage and deployment. For example, thehole180 can be so small that there is not extra room (within the hole180) for thesensor138 to exit the channel330 (shown inFIG. 42) of theneedle156.
• Another role of thefunnel182 andhole180 is to support theneedle156 and/or thesensor138 against buckling forces during insertion of theneedle156 and/or thesensor138 into the host.
• Thefunnel182 and thehole180 also protect against inadvertent needle-stick injuries (because they are too small to enable, for example, a finger to reach theneedle156 prior to needle deployment).
• Thesensor module134 is unable to pass through thefunnel182 and hole180 (e.g., due to the geometries of thesensor module134 and the funnel182). Preventing thesensor module134 from passing through thebase128 ensures thesensor module134 is removed from the host's body when thebase128 is detached from the host. Theangle338 can prevent all of thesensor138 from passing through thehole180 to ensure thesensor138 is removed from the host's body when thebase128 is detached from the host.
• Any of the features described in the context ofFIGS. 39-43 can be applicable to all aspects and embodiments identified herein. For example, the embodiments described in the context ofFIGS. 39-43 can be combined with the embodiments described in the context ofFIGS. 1-38 and 44-70. Moreover, any of the features of an embodiment is independently combinable, partly or wholly with other embodiments described herein in any way, e.g., one, two, or three or more embodiments may be combinable in whole or in part. Further, any of the features of an embodiment may be made optional to other aspects or embodiments. Any aspect or embodiment of a method can be performed by a system or apparatus of another aspect or embodiment, and any aspect or embodiment of a system can be configured to perform a method of another aspect or embodiment.
Needle-Free
• Some embodiments use a needle to help insert a glucose sensor into subcutaneous tissue. Some people, however, are fearful of needles. In addition, needle disposal can require using a sharps container, which may not be readily available.
• Many embodiments do not use a needle to insert the sensor, which can help people feel more comfortable inserting the sensor and can eliminate the need to use a sharps container to dispose of the applicator or portions thereof.
• U.S. Patent Publication No. US-2011-0077490-A1, U.S. Patent Publication No. US-2014-0107450-A1, and U.S. Patent Publication No. US-2014-0213866-A1 describe several needle-free embodiments. The entire contents of U.S. Patent Publication No. US-2011-0077490-A1, U.S. Patent Publication No. US-2014-0107450-A1, and U.S. Patent Publication No. US-2014-0213866-A1 are incorporated by reference herein.
• Any of the embodiments described herein can be used with or without a needle. For example, the embodiments described in the context ofFIGS. 1-50 can be used with or without a needle. For example, the embodiment shown inFIG. 7 can be used in a very similar way without theneedle156. In this needle-free embodiment, moving thefirst portion150 distally drives a distal portion of theglucose sensor138 into the skin (without the use of a needle156). In needle-free embodiments, thesensor138 can have sufficient buckling resistance such that (when supported by the hole180) thesensor138 does not buckle. Sharpening a distal tip of thesensor138 can also facilitate needle-free insertion into the host.
• FIG. 56 illustrates an embodiment very similar to the embodiment shown inFIG. 7 except that the embodiment ofFIG. 56 does not include a needle. Thetelescoping assembly132bpushes the sensor138 (which can be any type of analyte sensor) into the body of the host. The embodiment shown inFIG. 56 does not include aneedle hub162, aspring234, or a needle retraction mechanism158 (as shown inFIG. 7) but can include any of the items and features described in the context of other embodiments herein.
• FIG. 57 illustrates thefirst portion150 moving distally relative to thesecond portion152 of thetelescoping assembly132bto move thesensor module134 and thesensor138 towards the base128 in preparation to couple thesensor module134 and thesensor138 to thebase128.
• FIG. 58 illustrates thefirst portion150 in a distal ending position relative to thesecond portion152. Thesensor module134 and thesensor138 are coupled to thebase128. Thebase128 is no longer coupled to thetelescoping assembly132bsuch that thetelescoping assembly132bcan be discarded while leaving the adhesive126 coupled to the skin of the host (as described in the context ofFIGS. 4-6).
• The embodiment illustrated inFIGS. 56-58 can be integrated into theapplicator system104 shown inFIGS. 2 and 3.
• The items and features described in the context ofFIGS. 12A-50 can also be used with the embodiment illustrated inFIGS. 56-58. Items and features are described in the context of certain embodiments to reduce redundancy. The items and features shown in all the drawings, however, can be combined. The embodiments described herein have been designed to illustrate the interchangeability of the items and features described herein.
• FIGS. 44 and 45 illustrate another embodiment of atelescoping assembly132g. This embodiment includes afirst portion150gthat moves distally relative to asecond portion152gto push aglucose sensor138gthrough a hole in a base128gand into a host.
• Thefirst portion150g(e.g., a pusher) of thetelescoping assembly132gcan include adistal protrusion352 that supports a substantially horizontal section of theglucose sensor138g(e.g., as theglucose sensor138gprotrudes out from the sensor module134g). The end of thedistal protrusion352 can include agroove354 in which at least a portion of theglucose sensor138gis located. Thegroove354 can help retain theglucose sensor138g. Thedistal protrusion352 can provide axial support to theglucose sensor138g(e.g., to push theglucose sensor138gdistally into the tissue of the host).
• The base128gcan include a funnel182gthat faces proximally to help guide a distal end of theglucose sensor138ginto ahole180gin the base128g. Thehole180gcan radially support thesensor138gas thesensor138gis inserted into the tissue of the host.
• When thefirst portion150gof thetelescoping assembly132gis in the proximal starting position, the distal end of theglucose sensor138gcan be located in thehole180gto help guide theglucose sensor138gin the proper distal direction.
• Thehole180gcan exit a convex distal protrusion174gin the base128g. The convex distal protrusion174gcan help tension the skin prior to sensor insertion. As described more fully in other embodiments, the base128gcan rest against the skin of the host as the sensor module134gmoves distally towards the base128gand then is coupled to the base128g.
• Thetelescoping assembly132g(e.g., an applicator) does not include a needle. As a result, there is no sharp in the applicator, which eliminates any need for post-use sharp protection. This design trait precludes a need for a retraction spring or needle hub. The distal end of thesensor wire138gcan be sharpened to a point to mitigate a need for an insertion needle.
• Thetelescoping assembly132g(e.g., an applicator) can include thefirst portion150gand thesecond portion152g. The base128gcan be coupled to a distal end of thefirst portion150g. Theglucose sensor138gand the sensor module134gcan be coupled to a distal end of thefirst portion150gsuch that he applicator does not require a spring, needle, or needle hub; thefirst portion150gis secured in a proximal starting position by an interference between thefirst portion150gand thesecond portion152gof thetelescoping assembly132g; and/or applying a distal force that is greater than a breakaway threshold of the interference causes thefirst portion150gto move distally relative to thesecond portion152g(e.g., until thesensor138gis inserted into the tissue and the sensor module134gis coupled to the base128g).
• FIGS. 46 and 47 illustrate a similar needle-free embodiment. This embodiment does not use thedistal protrusion352 shown inFIG. 45. Instead, thesensor module134hincludes a distally orientedchannel358 that directs thesensor138hdistally such that theglucose sensor138hincludes a bend that is at least 45 degrees and/or less than 135 degrees. Achannel cover362 secures theglucose sensor138hin the distally orientedchannel358.
• The embodiments illustrated inFIGS. 44-47 can be integrated into theapplicator system104 shown inFIGS. 2 and 3. Referring now toFIG. 2, the electronics unit500 (e.g., a transmitter having a battery) can be detachably coupled to thesterile barrier shell120. The rest of theapplicator system104 can be sterilized, and then theelectronics unit500 can be coupled to the sterile barrier shell120 (such that theelectronics unit500 is not sterilized with the rest of the applicator system104).
• The items and features described in the context ofFIGS. 12A-43 and 48-70 can also be used with the embodiments illustrated inFIGS. 44-47. Items and features are described in the context of certain embodiments to reduce redundancy. The items and features shown in all the drawings, however, can be combined. The embodiments described herein have been designed to illustrate the interchangeability of the items and features described herein.
• Any of the features described in the context ofFIGS. 44-47 can be applicable to all aspects and embodiments identified herein. For example, the embodiments described in the context ofFIGS. 44-47 can be combined with the embodiments described in the context ofFIGS. 1-43 and 48-70. Moreover, any of the features of an embodiment is independently combinable, partly or wholly with other embodiments described herein in any way, e.g., one, two, or three or more embodiments may be combinable in whole or in part. Further, any of the features of an embodiment may be made optional to other aspects or embodiments. Any aspect or embodiment of a method can be performed by a system or apparatus of another aspect or embodiment, and any aspect or embodiment of a system can be configured to perform a method of another aspect or embodiment.
• In some embodiments, thesensor138 can be deployed (e.g., into the skin of the host) in response to coupling the electronics unit500 (e.g., a transmitter) to thebase128. Thesensor138 can be any type of analyte sensor (e.g., a glucose sensor).
• Premature deployment of thesensor138 can cause insertion of thesensor138 into the wrong person and/or insufficient sensor insertion depth. Premature deployment can also damage thesensor138, which in some embodiments, can be fragile. Thus, there is a need to reduce the likelihood of premature sensor deployment.
• One way to reduce the likelihood of premature sensor deployment is for the system to include an initial resistance (e.g., to coupling theelectronics unit500 to the base128). The initial resistance can necessitate a force buildup prior to overcoming the initial resistance. When the initial resistance is overcome, thesensor138 is typically deployed faster than would be the case without an initial resistance (e.g., due to the force buildup, which can be at least 0.5 pounds, 1 pound, and/or less than 5 pounds). This fast deployment can reduce pain associated with the sensor insertion process.
• In some embodiments, the resistance to coupling theelectronics unit500 to the base128 after overcoming the initial resistance is less than 10 percent of the initial resistance, less than 40 percent of the initial resistance, and/or at least 5 percent of the initial resistance. Having a low resistance to coupling theelectronics unit500 to the base128 after overcoming the initial resistance can enable fast sensor insertion, which can reduce the pain associated with the sensor insertion process.
• FIGS. 56-58 illustrate thefirst portion150 deploying thesensor138 into the skin of the host. In some embodiments, thefirst portion150 is replaced with theelectronics unit500 shown inFIG. 4 such that coupling theelectronics unit500 to thebase128 pushes thesensor138 into the skin of the host. Referring now toFIGS. 4 and 56-58, the protrusion240 (as explained in other embodiments) can be a portion of theelectronics unit500 such that moving the electronics unit distally relative to thesecond portion152 and/or coupling theelectronics unit500 to thebase128 requires overcoming the initial resistance of theprotrusion240.
• In some embodiments configured such that thesensor138 is deployed (e.g., into the skin of the host) in response to coupling theelectronics unit500 to thebase128, atelescoping assembly132bis not used. Instead, features of the base128 provide the initial resistance to coupling theelectronics unit500 to thebase128. Although thelocking feature230 inFIG. 33 is used for different purposes in some other embodiments, thelocking feature230 of the base128 can couple with a corresponding feature of theelectronics unit500. This coupling can require overcoming an initial resistance.
• Any of the features and embodiments described in the context ofFIGS. 1-70 can be applicable to all aspects and embodiments in which thesensor138 is deployed (e.g., into the skin of the host) in response to coupling the electronics unit500 (e.g., a transmitter) to thebase128.
Vertical Locking
• After a telescoping assembly (e.g., an applicator) has been used to insert a glucose sensor, the needle used to insert the glucose sensor could inadvertently penetrate another person. To guard against this risk, the telescoping assembly can protect people from subsequent needle-stick injuries by preventing the first portion of the telescoping assembly from moving distally relative to the second portion after the sensor has been inserted into the host.
• FIG. 48 illustrates a perspective, cross-sectional view of a telescoping assembly132ithat includes a first portion150iand a second portion152i. Referring now toFIGS. 48-50, the first portion150iis configured to telescope distally relative to the second portion152i. The second portion152iof the telescoping assembly132ican include aproximal protrusion364 that can slide past a lock-out feature366 of the first portion150iof the telescoping assembly132ias the first portion150iis moved distally.
• Theproximal protrusion364 can be biased such that elastic deformation of theproximal protrusion364 creates a force configured to press theproximal protrusion364 into the bottom of the lock-out feature366 once theproximal protrusion364 engages the lock-out feature366.
• Theproximal protrusion364 does not catch on the lock-out feature366 as the first portion150imoves distally a first time. Once the first portion150iis in a distal ending position, a spring can push the first portion150ito a second proximal position. Rather than returning to the starting proximal position, theproximal protrusion364 catches on the lock-out feature366 (due to the bias of theproximal protrusion364 and thedistally facing notch368 of the lock-out feature366).
• Once a proximal end of theproximal protrusion364 is captured in the lock-out feature366, the rigidity of theproximal protrusion364 prevents the first portion150iof the telescoping assembly132ifrom moving distally a second time.
• As the first portion150imoves distally relative to the second portion152i, aramp370 of the first portion150ipushes theproximal protrusion364 outward (towards the lock-out feature366). Theproximal protrusion364 can be located between twodistal protrusions372 of the first portion150i. Thedistal protrusions372 can guide theproximal protrusion364 along theramp370.
• As a portion of theproximal protrusion364 slides along the ramp370 (as the first portion150imoves distally), the ramp bends theproximal protrusion364 until a portion of theproximal protrusion364 that was previously between the twodistal protrusions372 is no longer between thedistal protrusions372. Once the portion of theproximal protrusion364 is no longer between the twodistal protrusions372, theproximal protrusion364 is in a state to catch on thenotch368. Thenotch368 can be part of thedistal protrusions372.
• The second portion152iof the telescoping assembly132ican include aproximal protrusion364, which can be oriented at an angle between zero and 45 degrees relative to a central axis). The first portion150iof the telescoping assembly132ican include features that cause theproximal protrusion364 to follow a first path as the first portion150imoves distally and then to follow a second path as the first portion150imoves proximally. The second path includes alocking feature366 that prevents the first portion150ifrom moving distally a second time.
• The first portion150ican include aramp370 that guides theproximal protrusion364 along the first path. A distal protrusion (e.g., the ramp370) of the first portion150ican bias theproximal protrusion364 to cause theproximal protrusion364 to enter the second path as the first portion150imoves proximally. Theproximal protrusion364 can be a flex arm. Thelock366 can comprise adistally facing notch368 that catches on a proximal end of theproximal protrusion364.
• As shown inFIGS. 48 and 50, the telescoping assembly132ican include a sensor module134i. The sensor module134ican be any of the sensor modules described herein.
• Any of the features described in the context ofFIGS. 48-50 can be applicable to all aspects and embodiments identified herein. For example, the embodiments described in the context ofFIGS. 48-50 can be combined with the embodiments described in the context ofFIGS. 1-47 and 51-70. Moreover, any of the features of an embodiment is independently combinable, partly or wholly with other embodiments described herein in any way, e.g., one, two, or three or more embodiments may be combinable in whole or in part. Further, any of the features of an embodiment may be made optional to other aspects or embodiments. Any aspect or embodiment of a method can be performed by a system or apparatus of another aspect or embodiment, and any aspect or embodiment of a system can be configured to perform a method of another aspect or embodiment.
Dual-Spring Assembly
• Partial sensor insertion can lead to suboptimal sensing. In some cases, partial sensor insertion can create a needle-stick hazard (due to the needle not retracting into a protective housing). Thus, there is a need for systems that ensure full sensor insertion.
• The embodiment illustrated inFIGS. 61-64 dramatically reduces the odds of partial sensor insertion by precluding sensor insertion until sufficient potential energy is stored in the system. The potential energy is stored in afirst spring402.
• The system includes many items from the embodiment illustrated inFIG. 7 (e.g., thebase128 and the sensor module134). The system includes anoptional needle156 andneedle hub162. The embodiment illustrated inFIGS. 61-64 can also be configured to be needle-free by removing theneedle156, thesecond spring234, theneedle hub162, and theneedle retraction mechanism158.
• The telescoping assembly132khas threeportions150k,152k,392. Moving thethird portion392 distally relative to thesecond portion152kstores energy in the first spring402 (by compressing the first spring402). Once thefirst portion150kis unlocked from thesecond portion152k, the energy stored in the compressedfirst spring402 is used to push thefirst portion150kdistally relative to thesecond portion152kto drive the sensor138 (shown inFIG. 7) into the skin of the host.
• To ensure thefirst portion150kdoes not move distally relative to thesecond portion152kuntil thefirst spring402 is sufficiently compressed (and thus has enough stored energy), thefirst portion150kis locked to thesecond portion152k. Once thefirst spring402 is sufficiently compressed (and thus has enough stored energy), the system unlocks thefirst portion150kfrom thesecond portion152kto enable the stored energy to move the sensor138 (and in some embodiments the needle156) into the skin of the host.
• The telescoping assembly132kcan lock thethird portion392 to thesecond portion152kin response to thethird portion392 reaching a sufficiently distal position relative to thesecond portion152k. Aprotrusion408 can couple with ahole410 to lock thethird portion392 to thesecond portion152k.
• Some embodiments do not include lockingprotrusion408 and do not lock thethird portion392 to thesecond portion152kin response to thethird portion392 reaching a sufficiently distal position relative to thesecond portion152k.
• In several embodiments, sufficiently distal positions are at least 3 millimeters, at least 5 millimeters, and/or less than 30 millimeters distal relative to the proximal starting position.
• The telescoping assembly132kcan lock thefirst portion150kto thesecond portion152kin response to thefirst portion150kreaching a sufficiently distal position relative to thesecond portion152k. A protrusion412 (e.g., a distal protrusion) can couple with a hole414 (e.g., in a surface that is within plus or minus 30 degrees of perpendicular to the central axis of the telescoping assembly132k) to lock thefirst portion150kto thesecond portion152k.
• Some embodiments include aneedle156 to help insert a sensor into skin of a host. In embodiments that include aneedle156, the telescoping assembly132kcan include theneedle retraction mechanism158 described in the context ofFIG. 7. Moving thefirst portion150kto a sufficiently distal position relative to thesecond portion152kcan trigger the needle retraction mechanism158 (e.g., can release a latch) to enable asecond spring234 to retract theneedle156.
• FIG. 61 illustrates a system for applying an on-skin sensor assembly600 (shown inFIGS. 4-6) to a skin of a host. The system comprises a telescoping assembly132khaving afirst portion150kconfigured to move distally relative to asecond portion152kfrom a proximal starting position (e.g., the position shown inFIG. 61) to a distal position (e.g., the position shown inFIG. 64) along a path; a sensor138 (shown inFIG. 64) coupled to thefirst portion150k; and a base128 comprising adhesive126 configured to couple thesensor138 to the skin. The telescoping assembly132kcan further comprise athird portion392 configured to move distally relative to thesecond portion152k.
• In some embodiments, thefirst portion150kis located inside of thesecond portion152ksuch that thesecond portion152kwraps around thefirst portion150kin a cross section taken perpendicularly to the central axis of the telescoping assembly132k.
• In some embodiments, afirst spring402 is positioned between thethird portion392 and thesecond portion152ksuch that moving thethird portion392 distally relative to thesecond portion152kcompresses thefirst spring402. Thefirst spring402 can be a metal helical spring and/or a metal conical spring. In several embodiments, thefirst spring402 is a feature molded as part of thethird portion392, as part of thesecond portion152k, or as part of thefirst portion150k. Thefirst spring402 can be molded plastic.
• The telescoping assembly132kcan be configured such that thefirst spring402 is not compressed in the proximal starting position and/or not compressed during storage. In several embodiments, the telescoping assembly132kcan be configured such that thefirst spring402 is not compressed more than 15 percent in the proximal starting position and/or during storage (e.g., to avoid detrimental spring relaxation and/or creep of other components such as at least one of thethird portion392, thesecond portion152k, and thefirst portion150k).
• Some embodiments that include aneedle156 do not include aneedle hub162. In these embodiments, thesecond spring234 can be located between thesecond portion152kand thefirst portion150ksuch that moving thefirst portion150kdistally relative to thesecond portion152kcompresses thesecond spring234 to enable thesecond spring234 to push thefirst portion150kproximally relative to thesecond portion152kto retract the needle156 (e.g., after sensor insertion).
• In several embodiments, thesecond spring234 is compressed while the telescoping assembly132kis in the proximal starting position. For example, thesecond spring234 can be compressed at the factory while the telescoping assembly132kis being assembled such that when the user receives the telescoping assembly132k, thesecond spring234 is already compressed (e.g., compressed enough to retract the needle156).
• Thesecond spring234 can have any of the attributes and features associated with thespring234 described in the context of other embodiments herein (e.g., in the context of the embodiment ofFIG. 7).
• In some embodiments, the movement of the sensor module134 (e.g., an analyte sensor module) and the sensor138 (e.g., an analyte sensor) relative to the base128 can be as described in the context of other embodiments (e.g., as shown by the progression illustrated byFIGS. 7-11).
• In the proximal starting position of the telescoping assembly132k, thefirst portion150kcan be locked to thesecond portion152k. The system can be configured such that moving thethird portion392 distally relative to thesecond portion152kunlocks thefirst portion150kfrom thesecond portion152k.
• In several embodiments, a firstproximal protrusion394 having afirst hook396 passes through afirst hole398 in thesecond portion152kto lock thefirst portion150kto thesecond portion152k. Thethird portion392 can comprise a firstdistal protrusion404. The system can be configured such that moving thethird portion392 distally relative to thesecond portion152kengages aramp406 to bend the firstproximal protrusion394 to unlock thefirst portion150kfrom thesecond portion152k.
• In some embodiments, thesensor138 is located within thesecond portion152kwhile the base128 protrudes from the distal end of the system such that the system is configured to couple thesensor138 to thebase128 by moving thefirst portion150kdistally relative to thesecond portion152k.
• In several embodiments, asensor module134 is coupled to a distal portion of thefirst portion150ksuch that moving thefirst portion150kto the distal position couples thesensor module134 to thebase128. This coupling can be as described in the context of other embodiments herein. Thesensor138 can be coupled to thesensor module134 while thefirst portion150kis located in the proximal starting position.
• The system can be configured such that thethird portion392 moves distally relative to thesecond portion152kbefore thefirst spring402 moves thefirst portion150kdistally relative to thesecond portion152k. The system can be configured such that moving thethird portion392 distally relative to thesecond portion152kunlocks thefirst portion150kfrom thesecond portion150kand locks thethird portion392 to thesecond portion152k.
• Afirst protrusion408 couples with ahole410 of at least one of thesecond portion152kand thethird portion392 to lock thethird portion392 to thesecond portion152k.
• In some embodiments, the system comprises asecond protrusion412 that couples with ahole414 of at least one of thefirst portion150kand thesecond portion152kto lock thefirst portion150kto thesecond portion152kin response to moving thefirst portion150kdistally relative to thesecond portion152k.
• In several embodiments, afirst spring402 is positioned between thethird portion392 and thesecond portion152ksuch that moving thethird portion392 distally relative to thesecond portion152kcompresses thefirst spring402 and unlocks thefirst portion150kfrom thesecond portion152k, which enables the compressedfirst spring402 to push thefirst portion150kdistally relative to thesecond portion152k, which pushes at least a portion of thesensor138 out of the distal end of the system and triggers aneedle retraction mechanism158 to enable asecond spring234 to retract aneedle156.
• In yet another aspect, disclosed herein is a dual spring-based sensor insertion device having a pre-connected sensor assembly (i.e. an analyte sensor electrically coupled to at least one electrical contact before sensor deployment). Such a sensor insertion device provides convenient and reliable insertion of a sensor into a user's skin by a needle as well as reliable retraction of a needle after the sensor is inserted, which are features that provide convenience to users as well as predictability and reliability of the insertion mechanism. The reliability and convenience of a dual spring based sensor insertion device having an automatic insertion and automatic retraction provide is a significant advancement in the field of sensor insertion devices. Furthermore, such a device can provide both safety and shelf stability.
• In several embodiments, the insertion device can include a first spring and a second spring. In such embodiments, either or both of the first spring and the second spring can be integrally formed with portions of a telescoping assembly, such as the first portion and the second portion of a telescoping assembly. In several embodiments, either or both of the first spring and the second spring can be formed separately from and operatively coupled to portions of the telescoping assembly. For example, in some embodiments, the insertion spring can be integrally formed with a portion of the telescoping assembly while the retraction spring is a separate part which is operatively coupled to a portion of the telescoping assembly.
• In some embodiments, rather than being configured to undergo compression during energization, either or both of the first spring and the second spring can be configured to undergo tensioning during energization. In these embodiments, the couplings between the springs and the portions of the telescoping assembly, as well as the couplings between the moving portions of the assembly (for example in the resting state, and during activation, deployment, and retraction) can be adjusted to drive and/or facilitate the desired actions and reactions within the system. For example, in an embodiment employing a tensioned retraction spring to drive the insertion process, the retraction spring can be coupled to or integrally formed with the second portion of the telescoping assembly. In such an embodiment, the retraction spring can be pre-tensioned in the resting state. In other such embodiments, the retraction spring can be untensioned in the resting state, and tensioned during the sensor insertion process.
• In several embodiments, either or both of the first spring and the second spring can be substantially unenergized and/or unstressed when the system is in a resting state. In several embodiments, either or both of the first spring and the second spring can be energized and/or stressed when the system is in a resting state. As used herein, the term “energized” means that enough potential energy is stored in the spring to perform the desired actions and reactions within the system. In some embodiments, the first spring can be partly energized in the resting state, such that the user can supply a lesser amount of force to fully energize the first spring. In some embodiments, the second spring can be partly energized in the resting state, such that the energy stored in the first spring (either in the resting state or after energization by a user) can provide force to energize the second spring. In some embodiments, the energy stored in the first spring can provide 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 spring and the second spring can be compressed or tensioned by 50% or more, 60% or more, 70% or more, 80% or more, 90% or more, or 100% in the resting state. In other embodiments, either or both of the first spring and the second spring can be compressed or tensioned 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 resting state.
• In embodiments in which both the first spring and the second spring are substantially unenergized in the resting state, they can be stressed by the same amounts, similar amounts, or entirely different amounts. In embodiments in which both the first spring and the second spring are effectively energized in the resting state, they can be stressed by the same amounts, similar amounts, or entirely different amounts. In embodiments in which the second spring is substantially unenergized in the resting state, the first spring can be configured to store enough energy to drive both the desired movement in the system (e.g., the movement of the first portion in a distal direction), as well as the energization of the second spring.
• With reference now toFIGS. 71-75, another embodiment of asystem104mfor applying an on-skin sensor assembly to skin of a host is illustrated. The embodiment illustrated inFIGS. 71-75 may reduce the potential of incomplete sensor insertion by precluding sensor insertion until sufficient potential energy is stored in the system. The potential energy for inserting the sensor can be stored in an actuator, such as afirst spring402m. The embodiment may provide other advantages such as controlled speed, controlled force, and improved user experience.
• Thesystem104mmay include many features from the embodiment illustrated inFIG. 7 (e.g., theneedle156, thebase128 and the sensor module134). Thesystem104mmay include alternative elements, such as, but not limited to, aneedle hub162m, asecond spring234m, and aneedle retraction mechanism158m. The embodiment illustrated inFIGS. 71-75 can also be configured to be needle-free by removing theneedle156, thesecond spring234m, theneedle hub162m, and theneedle retraction mechanism158m. In such embodiments, the sensor may be a self-insertable sensor.
• The system104mmay include many features that are similar to those of the embodiment illustrated inFIGS. 61-64 (e.g., a telescoping assembly132m) including a first portion150m, a second portion152m, and a third portion392m; with locking features396mand398mconfigured to releasably lock the first portion150mto the second portion152muntil the third portion392mhas reached a sufficiently distal position relative to the second portion152mto compress the first spring402mand store enough energy in the spring402mto drive insertion of the sensor138 (and in some embodiments the needle156) into the skin of a host; locking features408mand410mconfigured to lock the third portion392mto the second portion152m(e.g., to prevent proximal movement of the third portion392mrelative to the second portion152m) in response to the third portion392mreaching a sufficiently distal position relative to the second portion152m; unlocking features404mand406mconfigured to unlock the locking features396mand398mat least after the third portion392mis locked to the second portion152mand/or the first spring402mis sufficiently compressed; locking features412mand414mconfigured to lock the first portion150mto the second portion152min response to the first portion150mreaching a sufficiently distal position relative to the second portion152mto drive the sensor138 (and in some embodiments the needle156) into the skin of the host; and a needle retraction mechanism158mconfigured to unlock the needle hub162mfrom the first portion150m(e.g., to allow proximal movement of the needle hub162mwith respect to the first portion150m) at least once the needle hub162mhas reached a sufficiently distal position and thereby enable a second spring234mto retract the needle156).
• FIG. 71 illustrates a cross-sectional perspective view of theapplicator system104min a resting state (e.g., as provided to the consumer, before activation by the user and deployment of the applicator system). As illustrated in the figure, thefirst spring402mcan be neither in tension nor compression, such that the first spring is substantially unenergized. In some embodiments, thefirst spring402mcan be slightly in tension or slightly in compression (e.g., neither tensioned nor compressed by more than 15 percent) in a resting state, such that the first spring is substantially or mostly unenergized in the resting state. In some embodiments, the first spring can be effectively unenergized, e.g. can be minimally energized but not to an extent that would create any type of chain reaction in the system, in a resting state.
• In the embodiment illustrated inFIGS. 71-75, thefirst spring402mis integrally formed as part of thethird portion392m. In some embodiments, thefirst spring402mcan be integrally formed as part of other components of thesystem104m, such as, but not limited to, thefirst portion150m,second portion152m, etc. An integrally formed spring such as the one illustrated inFIGS. 71-75 offers advantages including the reduction in the number of parts in a system as well as the reduction in the amount of assembly processes. Thefirst spring402mcan be molded plastic. As illustrated inFIG. 71, in the resting state, thesecond spring234mis also substantially unenergized (e.g., neither tensioned nor compressed by more than 15 percent). Thesecond spring234mis integrally formed as part of theneedle hub162m. In some embodiments, thesecond spring234mcan be integrally formed as part of other components of thesystem104m, such as, but not limited to, thefirst portion150m,second portion152m,base128, etc. Thesecond spring234mcan be molded plastic. Such a configuration can simplify manufacture and assembly of thesystem104m, while avoiding detrimental relaxation and/or creep of thefirst spring402m, thesecond spring234m, or other components of thesystem104mduring storage and/or before deployment. It is also contemplated that in other embodiments, thefirst spring402mand/or thesecond spring234mcan comprise metal.
• In some embodiments,first spring402mand/orsecond spring234mcan comprise a molded plastic, such as, but not limited to: polycarbonate (PC), acrylonitrile butadiene styrene (ABS), PC/ABS blend, Nylon, polyethylene (PE), polypropylene (PP), and Acetal. In some embodiments,first spring402mand/orsecond spring234mhave a spring constant less than 10 lb/inch.
• Applicator system104 may be energized by moving one component relative to another. For example, moving thethird portion392mdistally relative to thesecond portion152m, when thesecond portion152mis placed against the skin of a host or another surface can store energy in thefirst spring402mas it compresses againstfirst portion150m. Thethird portion392mmay be moved distally until the locking features408mand410m(seeFIG. 73) engage together. In some embodiments, thethird portion392mmay be moved further distally until unlockingfeatures404mengages lockingfeature396m. Unlockingfeature404mmay engage and release lockingfeature396mand allowfirst portion150mto move distally. In some embodiments, locking features408mand410mcouple together before lockingfeature396mis disengaged from lockingfeature398m. In other embodiments, unlockingfeature404mengages lockingfeature396mand causes lockingfeature396mto disengage from lockingfeature398m, locking features408mand410mmay couple together. In some embodiments, lockingfeature408mis a protrusion featuring a hook portion, lockingfeature410mis a hole featuring an angled surface, unlockingfeature404mis a distal protrusion featuring an angled surface, lockingfeature396mis a hook featuring aramp406m, and lockingfeature398mis an aperture. Thesensor module134 remains in a proximal starting position while thefirst spring402mis being energized.
• FIG. 72 illustrates a cross-sectional perspective view of theapplicator system104m, with thefirst spring402mcompressed and with the unlockingfeatures404mand406mengaged so as to unlock thefirst portion150mfrom thesecond portion152m. Until thefirst portion150mis unlocked from thesecond portion152m, thesensor module134 remains at its proximal starting position, and thesecond spring234mremains substantially unenergized.FIG. 73 illustrates a rotated cross-sectional perspective view of theapplicator system104m, and shows the locking features408mand410mengaged to prevent proximal movement of thethird portion392mwith respect to thesecond portion152m. In some embodiments, as illustrated inFIG. 73, the system can include asecondary locking feature409mwhich is configured to cooperate with theopening410mto prevent thethird portion392 from falling off or otherwise separating from the remainder of thesystem104mprior to deployment.
• FIG. 74 illustrates a cross-sectional perspective view of theapplicator system104m, with thesystem104mhaving been activated by the disengagement of thefirst portion150mwith respect to thesecond portion152m. As can be seen inFIG. 74, once thefirst portion150mand thesecond portion152mare disengaged or released, the potential energy stored in thefirst spring402mdrives thefirst portion150min a distal direction along with theneedle hub162mand thesensor module134. This movement compresses thesecond spring234mand deploys theneedle156 and thesensor module134 distally to a distal insertion position in which thesensor module134 is coupled to thebase128 and theneedle156 extends distally of thebase128. Once theneedle156 and thesensor module134 reach the distal insertion position, the locking features412m,414m(seeFIG. 73) engage to prevent proximal movement of thefirst portion150mwith respect to thesecond portion152m, and the unlocking features of theneedle retraction mechanism158m(e.g., theproximal protrusions170m, therelease feature160m, and the latch236mcomprising ends164mof therelease feature160mand overhangs166mof thefirst portion150m) cooperate to release the latch236m. Optionally, the user may hear a click after the second spring243mis activated, which may indicate to the user that the cap is locked in place.
• Once the latch236mis released, the potential energy stored in the compressedsecond spring234mdrives theneedle hub162mback in a proximal direction, while thefirst portion150mremains in a distal deployed position along with thesensor module134. The potential energy stored can be between 0.25 pounds to 4 pounds. In preferred embodiments, the potential energy stored is between about 1 to 2 pounds.FIG. 75 illustrates a cross-sectional perspective view of theapplicator system104mwith thesensor module134 in a distal deployed position, coupled to thebase128, and with theneedle hub162mretracted to a proximal retracted position.
• Systems configured in accordance with embodiments may provide an inherently safe and shelf stable system for insertion of a sensor. An unloaded (i.e. substantially uncompressed and substantially unactivated) spring may not fire prematurely. Indeed, such a system is largely incapable of unintentional firing without direct interaction from a user since the first spring and/or second spring are substantially un-energized on the shelf. Moreover, it is contemplated that a system having a substantially uncompressed spring prior to activation possesses shelf stability since elements of the system are not exposed to a force or phase change over time (such as creep, environment, defects from time dependent load conditions, etc.) as compared to pre-energized insertion devices. Substantially uncompressed first and second springs can provide a system where the substantially unenergizedfirst spring404mis configured to load energy sufficient to drive a sensor from a proximal position to a distal position and also to transfer energy to thesecond spring234mto drive a needle to a fully retracted position.
• Other embodiments can also be configured to achieve these benefits. For example,FIGS. 76-79 illustrate another embodiment of asystem104nfor applying an on-skin sensor assembly to skin of a host. Thesystem104nincludes many features that are similar to those of the embodiment illustrated inFIGS. 71-75 (e.g., a telescoping assembly132nincluding afirst portion150n, asecond portion152n, and athird portion392n; aneedle hub162n; afirst spring402n; and asecond spring234n). In the embodiment illustrated inFIGS. 76-79, thefirst spring402nis formed separately from and operatively coupled to thethird portion392n. Thesecond spring234nis formed separately from and operatively coupled to theneedle hub162n. The first spring and/or the second spring can each comprise a helical spring having a circular cross section. In some embodiments, the first spring and/or the second spring can each comprise a helical spring having a square or non-circular cross section. The first spring and/or the second spring can comprise metal, such as, but not limited to, stainless steel, steel, or other types of metals. Alternatively, in some embodiments, one or both of the first spring and the second spring can be integrally formed with a portion of the applicator assembly. For example and without limitation, in some embodiments the first spring can be integrally formed with the first portion. In some embodiments, the second spring can be integrally formed with the needle hub. In several embodiments, the first spring and/or the second spring can be molded plastic, such as, but not limited to, PC or ABS.
• FIG. 76 illustrates a cross-sectional side view of thesystem104nin a resting state, in which both thefirst spring402nand thesecond spring234nare unstressed and unenergized. In the resting state, thefirst portion150ncan be fixed with respect to thesecond portion152n, at least in an axial direction, whereas thethird portion392nis movable in at least a distal direction with respect to thefirst portion150n. Thefirst portion150nand thesecond portion152ncan be fixed with respect to one another in any suitable fashion, for example by cooperating releasable locking features (e.g., the locking features as described inFIGS. 71-75, or similar features) coupled to or forming part of thefirst portion150nand thesecond portion152n. Thesystem104nincludes an on-skin component134nwhich is releasably coupled to theneedle hub162n. The on-skin component can comprise a sensor module, such as thesensor module134 described in connection withFIG. 3, or a combined sensor module and base assembly, or an integrated sensor module/base/transmitter assembly, or any other component which is desirably applied to the skin of a host, whether directly or indirectly, for example via an adhesive patch.
• In the resting state illustrated inFIG. 76, the on-skin component134nis disposed at a proximal starting position, between the proximal and distal ends of thesystem104n. The distal end of theneedle156 may also be disposed between the proximal and distal ends of thesystem104n. In the resting state, the distal end of thefirst spring402nabuts a proximally-facing surface of thefirst portion150n. The application of force against the proximally-facing surface of thethird portion392ncauses thethird portion392nto move distally with respect to thefirst portion150n, compressing and thus energizing thefirst spring402n. In some embodiments, this process may be similar to the spring energization process described in connection withFIG. 71.
• FIG. 77 illustrates a cross-sectional side view of the applicator system ofFIG. 76, with thefirst spring402nenergized. When thethird portion392nhas been moved sufficiently distally to energize thefirst spring402n, thethird portion392nbecomes fixed, at least in an axial direction, with respect to thesecond portion152n. At or about the same time (e.g. simultaneously or subsequently), thefirst portion150nbecomes movable in at least a distal direction with respect to thesecond portion152n. Thethird portion392nand thesecond portion150ncan be fixed with respect to one another in any suitable fashion, for example by cooperating locking features (e.g., the locking features described inFIGS. 71-75, or similar features) coupled to or forming part of thethird portion392nand thesecond portion152n, which are configured to engage with one another once thethird portion392nhas reached a sufficiently distal position. Thefirst portion150nand thesecond portion152ncan be rendered movable with respect to one another by structure(s) (not shown inFIGS. 76-79) configured to release the locking features which coupled them together in the resting configuration illustrated inFIG. 76. Thefirst portion150nincludes overhangs (sometimes referred to as detents, undercuts, and/or needle hub engagement features)166nwhich cooperate withrelease feature160nof theneedle hub162nto fix theneedle hub162nwith respect to thefirst portion150n, both while the system is in a resting state and during energization of thespring392n.
• FIG. 78 illustrates a cross-sectional side view of thesystem104n, with thefirst portion150nand thesecond portion152nunlocked, activating thefirst spring402nand allowing the energy stored therein to drive thefirst portion150nin a distal direction. The movement of thefirst portion150nalso urges theneedle hub162n(as well as the on-skin component134nwhich is coupled to theneedle hub162n) in a distal direction, compressing thesecond spring234nagainst a proximally-facing surface of thesecond portion152n, coupling the on-skin component134nto the base128n, and driving theneedle156 into the distal insertion position illustrated inFIG. 78. When theneedle hub162nhas reached a sufficiently distal position to achieve these functions, the ends of therelease feature160ncontact ramps170nof thesecond portion152nwhich cause therelease feature160nto compress inward (towards the central axis of thesystem104n), disengaging the ends of therelease feature160nfrom the overhangs166n. In some embodiments, this process may be similar to the spring compression process described in connection withFIG. 74. In some embodiments,ramps170nare proximally facing ramps. In other embodiments,ramps170nare distally facing ramps (not shown). In some embodiments, the release feature or features can be configured to be compressed inward (or otherwise released) by relative rotational movement of certain components of the system, such as, for example, by twisting or other rotational movement of the first portion with respect to the second portion. In some embodiments, the release feature or features can extend in a direction normal to the axis of the system, and/or can extend circumferentially about the axis of the system, instead of (or in addition to) extending generally parallel to the axis of the system as illustrated inFIG. 78.
• FIG. 79 illustrates a cross-sectional side view of thesystem104n, with theneedle hub162nreleased from engagement with theoverhangs166, activating thesecond spring234nand allowing the energy stored therein to drive theneedle hub162nin a proximal direction. As theneedle hub162nretracts to a proximal position, the on-skin component134ndecouples from theneedle hub162nto remain in a deployed position, coupled to the base128n.
• FIGS. 80-85 illustrate another embodiment of asystem104pfor applying an on-skin sensor assembly to skin of a host. A sensor insertion system such as the one illustrated inFIGS. 80-85 may provide enhanced predictability in spring displacement of the second energizedspring234pbecause thesecond spring234pis already compressed. Such a configuration can aid in properly ensuring the needle is retracted at a sufficient distance from the skin. In some embodiments, a system incorporating a pre-energized retraction spring can provide effective and reliable insertion and retraction while requiring a lesser amount of user-supplied force than, for example, a system in which both the insertion and retraction springs are substantially unenergized prior to deployment, making such a configuration more convenient for at least some users. Further, in some embodiments, a system incorporating one or more metal springs can provide effective and reliable insertion and retraction while requiring a lesser amount of force than a system in which both the insertion and retraction springs comprise plastic. Thesystem104pincludes many features that are similar to those of the embodiment illustrated inFIGS. 76-79 (e.g., atelescoping assembly132pincluding afirst portion150p, asecond portion152p, and athird portion392p; aneedle hub162p; afirst spring402p; asecond spring234p; an on-skin component134n, and a base128p). In the embodiment illustrated inFIGS. 80-85, thefirst spring402pis formed separately from and operatively coupled to thethird portion392p. Thesecond spring234pis formed separately from and operatively coupled to theneedle hub162p. The first spring and/or the second spring can comprise metal. Alternatively, in some embodiments, one or both of the first spring and the second spring can be integrally formed with a portion of the applicator assembly. For example and without limitation, in some embodiments the first spring can be integrally formed with the first portion. In some embodiments, the second spring can be integrally formed with the needle hub. In several embodiments, the first spring and/or the second spring can be molded plastic.
• FIG. 80 illustrates a cross-sectional side view of thesystem104pin a resting state, in which thefirst spring402pis substantially unstressed and unenergized, but in which thesecond spring234nis pre-energized (e.g., compressed). In the resting state illustrated inFIG. 80, thefirst portion150pis locked to thesecond portion152pso as to prevent proximal or distal movement of thefirst portion150pwith respect to thesecond portion152p. Thefirst portion150pand thesecond portion152ncan be locked together in any suitable fashion, for example by cooperating releasable locking features396pand398p(seeFIGS. 84 and 85) coupled to or forming part of thefirst portion150pand thesecond portion152p. Theneedle hub162nis also releasably fixed to thefirst portion150p. Theneedle hub162ncan be fixed to thefirst portion150pin any suitable fashion, for example by features of thefirst portion150pconfigured to engage or compress release feature (sometimes referred to as needle hub resistance features)160pof theneedle hub162p.
• In the resting state illustrated inFIG. 80, the on-skin component134pis disposed at a proximal starting position, such that the distal end of theneedle156 is disposed between the proximal and distal ends of thesystem104p. In the resting state, the distal end of thefirst spring402pabuts a proximally-facing surface of thefirst portion150p. The application of force against the proximally-facing surface of thethird portion392pcauses thethird portion392pto move distally with respect to thefirst portion150p, compressing and thus energizing thefirst spring402p. In some embodiments, this process may be similar to the spring energization process described in connection withFIG. 76.
• FIG. 81 illustrates a cross-sectional side view of thesystem104pofFIG. 80, after thethird portion392nhas been moved to a sufficiently distally position to energize thefirst spring402pand optionally lock thethird portion392pto thesecond portion152p. Thethird portion392nand thesecond portion150ncan lock together in any suitable fashion, for example by cooperating locking features (e.g., the locking features described inFIGS. 76-79, or similar features) coupled to or forming part of thethird portion392pand thesecond portion152p. At or about the same time as thethird portion392plocks to thesecond portion152p(e.g. simultaneously or subsequently), the unlockingfeatures404pand406p(seeFIGS. 84 and 85) cooperate to release the lock between thefirst portion150pand thesecond portion152p.
• FIG. 82 illustrates a cross-sectional side view of thesystem104p, with thefirst spring402pactivated to drive thefirst portion150pin a distal direction. The movement of thefirst portion150palso urges theneedle hub162p(as well as the on-skin component134pwhich is coupled to theneedle hub162p) in a distal direction, coupling the on-skin component134pto the base128p, and also driving theneedle156 in a distal direction, past a distal end of thesystem104p. At or about the time theneedle hub162preaches the distal insertion position illustrated inFIG. 82 (e.g., immediately before, simultaneously, or subsequently), the ends of therelease feature160pcontact ramps170pof thesecond portion152p, causing therelease feature160pto compress inward (towards the central axis of thesystem104p), unlocking theneedle hub162pfrom thefirst portion150pand releasing or activating thesecond spring234p. In some embodiments,ramps170pare proximally facing ramps. In other embodiments,ramps170pare distally facing ramps (not shown). Activation of thesecond spring234purges theneedle hub162pin a proximal direction.
• FIG. 83 illustrates a cross-sectional side view of thesystem104p, with theneedle hub162punlocked from thefirst portion150pand retracted to a proximal position. As theneedle hub162pretracts to a proximal position, the on-skin component134pdecouples from theneedle hub162pto remain in a deployed position, coupled to the base128p.
• FIG. 84 illustrates a perspective view of thesystem104pin a resting state, with thefirst portion150pand thethird portion392pshown in cross section to better illustrate certain portions of thesystem104p, such as the locking features396p,398pand the unlockingfeatures404p,406p.FIG. 85 illustrates another perspective view of thesystem104p, also with thefirst portion150pand thethird portion392pshown in cross section, with thefirst spring402penergized but not yet activated.
• FIGS. 86-88 illustrate another embodiment of asystem104qfor applying an on-skin sensor assembly to skin of a host, wherein the insertion spring is pre-compressed and the retraction spring is substantially uncompressed. Such a system may allow a user to activate the insertion and retraction of a needle with fewer steps. It is contemplated that advantages may include a relatively smaller applicator size and more predictable spring displacement of the first spring because the first spring is already compressed, thereby aiding in ensuring proper needle insertion into the skin of a user. In some embodiments, a system incorporating a pre-energized insertion spring can provide effective and reliable insertion and retraction while requiring a lesser amount of user-supplied force than, for example, a system in which both the insertion and retraction springs are substantially unenergized prior to deployment, making such a configuration more convenient for at least some users. Thesystem104qincludes many items that are similar to those of the embodiment illustrated inFIGS. 76-79 (e.g., atelescoping assembly132qincluding afirst portion150q, asecond portion152q, and athird portion392q; aneedle hub162q; afirst spring402q; asecond spring234q; an on-skin component134q, and a base128q). In thesystem104q, thefirst spring402qis formed separately from and operatively coupled to thethird portion392q. Thesecond spring234qis formed separately from and operatively coupled to theneedle hub162q. The first spring and/or the second spring can comprise metal. Alternatively, in some embodiments, one or both of the first spring and the second spring can be integrally formed with a portion of the applicator assembly.
• FIG. 86 illustrates a cross-sectional side view of thesystem104qin a resting state, in which thefirst spring402qis already energized but in which thesecond spring234qis substantially unenergized (e.g. mostly uncompressed or unstressed; can be partially energized). In the resting state illustrated inFIG. 86, thefirst portion150qis locked to thesecond portion152qso as to prevent proximal or distal movement of thefirst portion150qwith respect to thesecond portion152q. Thefirst portion150qand thesecond portion152qcan be locked together in any suitable fashion, for example by cooperating releasable locking features (e.g., the locking features described inFIGS. 76-79 or other suitable locking features) coupled to or forming part of thefirst portion150qand thesecond portion152q. Theneedle hub162qis also releasably locked to thefirst portion150q. Theneedle hub162qcan be locked to thefirst portion150qin any suitable fashion, for example by features of thefirst portion150qconfigured to engage or compress release feature160qof theneedle hub162q. Thethird portion392qand thesecond portion152qare also locked together, so as to prevent relative movement of thethird portion392pand thesecond portion152qin the axial direction. Thethird portion392qand thesecond portion152qcan be locked together in any suitable fashion, for example by cooperating locking features (not shown inFIGS. 86-89), which may be coupled to or form part of thethird portion392qand thesecond portion152q. In the resting state illustrated inFIG. 80, the on-skin component134qis disposed at a proximal starting position, such that the distal end of theneedle156 is disposed between the proximal and distal ends of thesystem104q.
• To trigger deployment of thesystem104q, the locking features coupling thefirst portion150qto thesecond portion152qcan be unlocked, decoupling these two portions and thereby releasing or activating thefirst spring402q. The locking features can be unlocked by a user-activated trigger mechanism, such as, for example, a button disposed on or in a top or side surface of thesystem104q, or a twist-release feature configured to disengage the locking features when thethird portion392qis rotated about the axis of the system, relative to thefirst portion150qand/or thesecond portion152q. Some examples of triggering mechanisms are described in connection withFIGS. 92-104.
• FIG. 87 illustrates a cross-sectional side view of thesystem104q, after thefirst portion150qand thesecond portion152qhave been unlocked. As can be seen inFIG. 87, thefirst spring402qdrives thefirst portion150qin a distal direction as thefirst spring402qexpands. The movement of thefirst portion150qalso urges theneedle hub162q(as well as the on-skin component134qwhich is coupled to theneedle hub162q) in a distal direction, coupling the on-skin component134qto the base128q, compressing thesecond spring234q, and driving theneedle156 in a distal direction past a distal end of thesystem104q. At or about the time theneedle hub162qreaches the distal insertion position illustrated inFIG. 87 (e.g., immediately before, simultaneously, or subsequently), the ends of the release feature160qcontact interference features170qof thesecond portion152q, causing the release feature160qto compress inward (towards the central axis of thesystem104q), unlocking theneedle hub162qfrom thefirst portion150qand activating the now-energizedsecond spring234q. In some embodiments, interference features170qare proximally facing interference features. In other embodiments, interference features170qare distally facing interference features (not shown).
• Activation of thesecond spring234qby the user or mechanisms urges theneedle hub162qin a proximal direction, while the on-skin component134q, having been coupled to the base128q, remains in a deployed distal position.FIG. 88 illustrates a cross-sectional side view of thesystem104q, with the on-skin component134qin a deployed position and theneedle hub162qretracted to a proximal position.
• FIGS. 89-91 illustrate another embodiment of a system104rfor applying an on-skin sensor assembly to skin of a host. It is contemplated that the system104ras illustrated with reference toFIGS. 89-91 provides for predictable spring displacement of thefirst spring402rbecause it is compressed, thereby aiding in proper needle insertion into the skin of the user. Moreover, it is contemplated that the compressedsecond spring234rprovides predictable spring displacement and aids in properly ensuring that the needle is properly retracted from the skin of the user. In some embodiments, a system incorporating pre-energized insertion and retraction springs can provide effective and reliable insertion and retraction while requiring a lesser amount of user-supplied force than, for example, a system in which one or both of the insertion and retraction springs are substantially unenergized prior to deployment, making such a configuration more convenient for at least some users. The system104rincludes many items that are similar to those of the embodiment illustrated inFIGS. 76-79 (e.g., a telescoping assembly132rincluding afirst portion150r, asecond portion152r, and athird portion392r; aneedle hub162r; afirst spring402r; asecond spring234r; an on-skin component134r, and a base128r). As illustrated inFIGS. 89-91, both thefirst spring402rand thesecond spring234rare pre-compressed. In the system104r, thefirst spring402ris formed separately from and operatively coupled to thethird portion392r. Thesecond spring234ris formed separately from and operatively coupled to theneedle hub162r. The first spring and/or the second spring can comprise metal. Alternatively, in some embodiments, one or both of the first spring and the second spring can be integrally formed with a portion of the applicator assembly.
• FIG. 89 illustrates a cross-sectional side view of the system104rin a resting state, in which both thefirst spring402rand thesecond spring234rare pre-energized (e.g., compressed sufficiently to drive the needle insertion and retraction processes). In the resting state illustrated inFIG. 89, thefirst portion150ris locked to thesecond portion152rso as to prevent proximal or distal movement of thefirst portion150rwith respect to thesecond portion152r. Thefirst portion150rand thesecond portion152rcan be locked together in any suitable fashion, for example by cooperating releasable locking features (e.g., the locking features described in connection withFIGS. 80-83, or other suitable locking features) coupled to or forming part of thefirst portion150rand thesecond portion152r. Theneedle hub162ris also releasably locked to thefirst portion150r. Theneedle hub162rcan be locked to thefirst portion150rin any suitable fashion, for example by features of thefirst portion150rconfigured to engage or compressrelease feature160rof theneedle hub162r. Thethird portion392rand thesecond portion152rare also locked together, so as to prevent relative movement of thethird portion392pand thesecond portion152rin at least the axial direction. Thethird portion392rand thesecond portion152rcan be locked together in any suitable fashion, for example by cooperating locking features (not shown inFIGS. 89-91), which may be coupled to or form part of thethird portion392rand thesecond portion152r. In the resting state illustrated inFIG. 89, the on-skin component134ris disposed at a proximal starting position, such that the distal end of theneedle156 is disposed between the proximal and distal ends of the system104r.
• To trigger deployment of the system104r, the locking features coupling thefirst portion150rto thesecond portion152rcan be unlocked, decoupling these two portions and thereby releasing or activating thefirst spring402r.FIG. 90 illustrates a cross-sectional side view of the system104r, after thefirst portion150rand thesecond portion152rhave been unlocked. As can be seen inFIG. 90, thefirst spring402rdrives thefirst portion150rin a distal direction as thefirst spring402rexpands or decompresses. The movement of thefirst portion150ralso urges theneedle hub162r(as well as the on-skin component134rwhich is coupled to theneedle hub162r) in a distal direction until the on-skin component134ris coupled to the base128r, and until theneedle156 reaches a distal insertion position beyond a distal end of the system104r. At or about the time theneedle hub162rreaches the distal insertion position illustrated inFIG. 87 (e.g., immediately before, simultaneously, or subsequently), the ends of therelease feature160rcontact corresponding interference features170rof thesecond portion152r, causing therelease feature160rto compress inward (towards the central axis of the system104r), unlocking theneedle hub162rfrom thefirst portion150rand releasing or activating thesecond spring234r.
• Activation of thesecond spring234rdrives theneedle hub162rin a proximal direction, while the on-skin component134r, having been coupled to the base128r, remains in a deployed distal position.FIG. 91 illustrates a cross-sectional side view of the system104r, with the on-skin component134rin a deployed position and theneedle hub162rretracted to a proximal position. From this configuration, the system104rcan be removed and separated from the deployed on-skin component134rand the base128r.
• FIGS. 92-100 illustrate yet another embodiment of asystem104sfor applying an on-skin sensor assembly to skin of a host comprising a safety feature to prevent accidental firing of the sensor insertion device. Thesystem104sincludes many items that are similar to those of the embodiment illustrated inFIGS. 76-79 (e.g., atelescoping assembly132sincluding afirst portion150s, asecond portion152s, and athird portion392s; aneedle hub162s; afirst spring402s; asecond spring234s; an on-skin component134s, and a base128s). In thesystem104s, thefirst spring402smay be formed separately from and operatively coupled to thethird portion392s. Thesecond spring234smay be formed separately from and operatively coupled to theneedle hub162s. The first spring and/or the second spring can comprise metal. Alternatively, in some embodiments, either or both of the first spring and the second spring can be integrally formed with a portion of the applicator assembly.
• FIG. 92 illustrates a side view of thesystem104sin a resting state, in which thefirst spring402sis unstressed and unenergized, but in which thesecond spring234sis already energized (e.g., compressed). Thesystem104sincludes acocking mechanism702 by which thefirst spring402scan be energized (e.g. compressed) without automatically triggering deployment of thefirst portion150sor activation of thefirst spring402s. Thesystem104salso includes atrigger button720 configured to activate thefirst spring402safter the system is cocked.FIG. 93 illustrates a side view of theapplicator system104s, after being cocked but before being triggered.
• FIG. 94 illustrates a cross-sectional perspective view of thesystem104sin a resting state, showing thefirst spring402ssubstantially uncompressed. Thecocking mechanism702 includes a pair of proximally-extendinglever arms704, each with a radially-extendingangled tab706. In some embodiments, thelever arms704 can be integrally formed with thesecond portion152s, as shown inFIG. 94, while in other embodiments, thelever arms704 can be separate from and operatively coupled to thesecond portion152s. In the resting state illustrated inFIG. 94, theangled tabs706 extend throughdistal apertures708 in thethird portion392sso as to prevent proximal movement of thethird portion392swith respect to thesecond portion152s. Theangled tabs706 are also configured to inhibit distal movement of thethird portion392swith respect to thesecond portion152s, unless and until a sufficient amount of force is applied to thethird portion392sto deflect theangled tabs706 and thelever arms704 inward, as illustrated inFIG. 95.
• As sufficient force is applied to thethird portion392sin a distal direction (e.g. by the hand or thumb of a user), theangled tabs706 deflect inward and release from engagement with thedistal apertures708, allowing thethird portion392sto move distally with respect to thesecond portion152s. This may allow the user to compress and energize thefirst spring402s. When thethird portion392shas reached a sufficiently distal position to compress thefirst spring402senough to drive the sensor into the skin of a host, theangled tabs706 engage withproximal apertures710 of thethird portion392sto lock the position of thethird portion392swith respect to thesecond portion152s, as illustrated inFIG. 96. Theangled tabs706 may be configured to generate a “click” sound when engaged toproximal apertures710 so as to prevent proximal movement of thethird portion392swith respect to thesecond portion152s, so that a user can feel and/or hear when these parts are engaged. In the configuration illustrated inFIG. 96, thesystem104sis energized in which thethird portion392 is in a cocked position. Thesystem104sis ready to deploy the sensor, but does not deploy until further action is taken by the user.
• FIG. 97 illustrates a cross-sectional side view of thesystem104s, in a cocked but untriggered state. In this state, thefirst portion150sis locked to thesecond portion152sso as to prevent proximal or distal movement of thefirst portion150swith respect to thesecond portion152s. Thefirst portion150sand thesecond portion152scan be locked together in any suitable fashion, for example by cooperating releasable locking features396sand398soperatively coupled to or forming part of thefirst portion150sand thesecond portion152s. Thetrigger button720 includes a distally-extendingprotrusion722 which, once depressed to a sufficiently distal position by a user, is configured to cooperate with an unlockingfeature406sof thelocking feature396sto decouple thefirst portion150sfrom thesecond portion152s. Thetrigger button720 can be operatively coupled to thethird portion392s, as illustrated inFIGS. 92-100, or can be integrally formed with the third portion, for example as a lever arm formed within a proximal or side surface of the third portion. In some embodiments, the trigger button can be disposed at the top of the system (such that the application of force in the distal direction triggers the system to activate), or at a side of the system (such that the application of force in a radially inward direction, normal to the direction of needle deployment, triggers system to activate).
• FIG. 98 illustrates a cross-sectional side view of the energizedsystem104sas thetrigger button720 has been depressed sufficiently to cause theprotrusion722 to flex thelocking feature396sradially inward, disengaging it from theopening398sand unlocking thefirst portion150sfrom thesecond portion152s. Depressing thetrigger button720 thus activates thefirst spring402, pushing thefirst portion150sand theneedle hub162s, along with the on-skin component134swhich is coupled thereto, in a distal direction until the on-skin component is coupled to the base128s, as illustrated inFIG. 99. At or about the time theneedle hub162sreaches the distal insertion position illustrated inFIG. 99 (e.g., immediately before, simultaneously, or subsequently), corresponding release features of theneedle hub162sand thefirst portion150scan engage (via, for example, the release features described in any ofFIGS. 76-91, or any other suitable release features), releasing theneedle hub162sfrom thefirst portion150sand releasing or activating thesecond spring234s. Activation of thesecond spring234surges theneedle hub162sin a proximal direction.
• FIG. 100 illustrates a cross-sectional side view of the applicator system ofFIG. 92, with the on-skin component134sin a deployed position and theneedle hub162sretracted to a proximal position. As theneedle hub162sretracts to a proximal position, the on-skin component134sdecouples from theneedle hub162sto remain in a deployed position, coupled to the base128s. From this configuration, the remainder of thesystem104scan be removed and separated from the deployed on-skin component134sand the base128s.
• Any of the features described in the context of any ofFIGS. 61-99 can be applicable to all aspects and embodiments identified herein. For example, the embodiments described in the context ofFIGS. 61-64 can be combined with the embodiments described in the context ofFIGS. 1-60 and 65-70. As another example, any of the embodiments described in the context ofFIGS. 92-109 can be combined with any of the embodiments described in the context ofFIGS. 1-60 and 65-91 and 110-143. Moreover, any of the features of an embodiment is independently combinable, partly or wholly with other embodiments described herein in any way, e.g., one, two, or three or more embodiments may be combinable in whole or in part. Further, any of the features of an embodiment may be made optional to other aspects or embodiments. Any aspect or embodiment of a method can be performed by a system or apparatus of another aspect or embodiment, and any aspect or embodiment of a system can be configured to perform a method of another aspect or embodiment.
Trigger Mechanisms and Safety Locks
• In some embodiments, the application of enough force to sufficiently energize the first spring to drive insertion of the sensor can also serve to activate the first spring. In other embodiments, the energizing of the first spring can be decoupled from the activation of the first spring, requiring separate actions on the part of the user to energize (e.g. compress) the first spring and to trigger deployment of the system.
• For example, the embodiment illustrated inFIGS. 92-100 includes a trigger mechanism in the context of a user-energized actuator. In such an embodiment, the user first cocks thesystem104sto energize thefirst spring402s, and then, in a separate action, triggers the activation of thefirst spring402susing thetrigger button720. The locking feature is easy to release by the user and when combined with a trigger mechanism, allows for single handed use.
• In some embodiments, the actuator or insertion spring is already energized when the system is in a resting state. In these embodiments, a trigger mechanism, such as the trigger mechanism described in the context ofFIGS. 92-100, can be used to activate the already-energized insertion spring without any action by the user to energize the spring.
• FIG. 101 illustrates a side view of one such applicator system104t, with aside trigger button730. The system104tcan be configured substantially similar to thesystem104qor the system104rillustrated within the context ofFIGS. 86-88 and 89-91, respectively, with like reference numerals indicating like parts. As can be seen inFIG. 101, thetrigger button730 is operatively coupled to the third member392t.
• FIG. 102 illustrates another side view of the system104t, with the first portion150tand the third portion392tshown in cross-section to illustrate the trigger mechanism. As can be seen inFIG. 102, thetrigger button730 includes aprotrusion732 that extends radially inward, toward a central axis of the system104t. Theprotrusion732 is radially aligned with the locking feature396tof the first portion150t. When a user exerts a sideways (e.g., radially inward) force on thetrigger button730, theprotrusion732 urges the locking feature396tradially inward, releasing it from engagement with the ledge feature398t(which may be configured similarly to, for example, theledge locking feature398pillustrated inFIGS. 84 and 85) in the second portion152tand activating the first spring402t. In other embodiments, the locking features396,398 can comprise cooperating structure of a key/keyway mechanism which is configured to release when thefeatures396,398 are brought into a certain orientation with respect to one another (e.g., using a radially applied force, an axially applied force, a twisting movement or rotational force, or other type of activation).
• FIG. 103 illustrates a side view of another applicator system104u, with an integratedside trigger button730. The system104ucan be configured substantially similar to thesystem104qor the system104rillustrated within the context ofFIGS. 86-88 and 89-91, respectively, with like reference numerals indicating like parts. As can be seen inFIG. 103, thetrigger button740 is a distally-extending lever arm integrally formed in thethird member392u.FIG. 104 illustrates another side view of the system104u, with thefirst portion150uand thethird portion392ushown in cross-section to better illustrate the trigger mechanism. As can be seen inFIG. 104, thetrigger button740 is radially aligned with a radially-extendingtab742 of thefirst portion150u. Thetab742 is connected to thelocking feature396uvia anelongated member394u, which acts as a lever arm. In some embodiments,tab742locking feature396u, andelongated member394uare integrally formed together. When a user exerts a sideways (e.g., radially inward) force on thetrigger button740, thebutton740 pushes thetab742 radially inward, releasing thelocking feature396ufrom engagement with thelocking feature398uin thesecond portion152uand activating thefirst spring402u.
• Trigger mechanisms such as those described in the context of any ofFIGS. 92-104 can be used in embodiments comprising pre-energized actuators or insertion springs, as well as in embodiments comprising user-energized actuators or insertion springs.
• In several embodiments, a sensor inserter system can include a safety mechanism configured to prevent premature energizing and/or actuation of the insertion spring.FIGS. 105-109 illustrate onesuch system104v, which incorporates asafety lock mechanism750.FIG. 105 illustrates a perspective view of thesystem104v. Thesystem104vcan be configured substantially similar to any of thesystems104m,104n,104pillustrated within the context ofFIGS. 71-87, with like reference numerals indicating like parts. Thesafety lock mechanism750 includes arelease button760, which can be integrally formed with thethird portion392vas shown inFIG. 105 (similar to thetrigger button740 described in connection withFIGS. 103-104), or which can be operatively coupled to thethird portion392v. In thesystem104v, therelease button760 comprises a lever arm which is integrally formed in a side of thethird portion392v, although other configurations (e.g. a top button) are also contemplated. The release button can be configured to protrude radially from a side or a top of the third portion, or can be configured with an outer surface which is flush with the surrounding surface of thethird portion392v.
• FIG. 106 illustrates a cross-sectional perspective view of a portion of thesystem104v, with thesafety mechanism750 in a locked configuration and thefirst spring402vunenergized. Thesafety mechanism750 includes a proximally-extendinglocking tab752 of the second portion and an inwardly-extending overhang (or undercut)754 of thethird portion392v. In the locked configuration illustrated inFIG. 106, thetab752 is flexed radially outward and its proximal end is constrained by theoverhang754, preventing distal movement of thethird portion392vwith respect to thesecond portion152vand thus preventing energization of thespring392v. Therelease button760 includes aprotrusion758 which extends inwardly, in radial alignment with a portion of thetab752. A lateral (e.g. radially inward) force applied to therelease button760 pushes thetab752 radially inward, sliding the proximal end of thetab752 against anangled surface756 of theoverhang754 and out of engagement with theoverhang754, so that thetab752 can release to an unstressed configuration as shown inFIG. 108. Once thetab752 is released, thethird portion392vcan be moved distally with respect to thesecond portion152v, for example to energize thefirst spring402v. In some embodiments, as illustrated inFIG. 109, thetab752 can be configured to prevent further distal movement of thethird portion392vbeyond a desired threshold, for example by abutting a distally-facingsurface762 of thethird portion392v.
• Although thesafety lock mechanism750 is illustrated in the context of a system configured to be energized by a user, in some embodiments, a pre-energized system can also employ a safety lock mechanism, for example to prevent premature triggering or activation of an already energized spring.
• In some embodiments, the locking and unlocking (and/or coupling and decoupling) of the components of a sensor inserter assembly can follow this order: The sensor inserter assembly begins in a resting state in which thethird portion392 is locked with respect to thefirst portion150, thefirst portion150 is locked with respect to thesecond portion152, and thesensor module134 is coupled to the first portion150 (optionally via the needle hub162). Before energizing or triggering of theinsertion spring402, thethird portion392 is unlocked with respect to thefirst portion150 and/or thesecond portion150. Theinsertion spring402, if not already energized, is then energized by distal movement of thethird portion392. Then, thethird portion392 is locked with respect to thesecond portion152. Thefirst portion150 is then released from thesecond portion152 to activate theinsertion spring402. As theinsertion spring402 deploys, thesensor module134 couples to thebase128. Then the first portion150 (and/or the needle hub162) releases thesensor module134, and thesecond portion152 releases thebase128. In several embodiments, the locations of the various locking and unlocking (and/or coupling and decoupling) structures along the axis of the assembly are optimized to ensure this order is the only order that is possible. (Some embodiments use different locking and unlocking orders of operation.)
• Systems such as those illustrated inFIGS. 92-109 provide reliable trigger mechanisms to release an insertion spring when the insertion spring is in a loaded condition. It is contemplated such systems provide several advantages to the user including ease in firing, single handed firing (by allowing the user to hold onto the sides of the insertion device and fire the insertion device using the same hand). It is contemplated that a system comprising a top trigger can provide a smaller width profile than a system having a side button while requiring less user dexterity.
• Release after Deployment
• In several embodiments, a sensor inserter system is configured to move an on-skin component (such as, for example, asensor module134, a sensor assembly (for example comprising a sensor, electrical contacts, and optionally a sealing structure), a combination sensor module and base, an integrated sensor module and transmitter, an integrated sensor module and transmitter and base, or any other component or combination of components which is desirably attached to the skin of a host) from a proximal starting position within the sensor inserter system to a distal deployed position in which it can attach to the skin of a host, while at the same time inserting a sensor (which may form part of the on-skin component) into the skin of the host. In some embodiments, the sensor is coupled to electrical contacts of the on-skin component during the deployment and/or insertion process. In other embodiments, the on-skin component is pre-connected, that is to say, the sensor is coupled to electrical contacts of the on-skin component before the deployment and/or insertion processes begin. The sensor assembly can be pre-connected, for example, during manufacture or assembly of the system.
• Thus, in several embodiments, a sensor inserter system can be configured to releasably secure the on-skin component in its proximal starting position, at least before or until deployment of the inserter system, and can also be configured to release the on-skin component in a distal position after the inserter system is deployed. In some embodiments, the system can be configured to couple the on-skin component to a base and/or to an adhesive patch during the deployment process, either as the on-skin component is moved from the proximal starting position to the distal deployed position or once it reaches the distal deployed position. In some embodiments, the system can be configured to separate from (or become separable from) the on-skin component, base, and/or adhesive patch after the on-skin component is deployed in the distal position and the needle hub (if any) is retracted.
• In embodiments, various mechanical interlocks (e.g., snap fits, friction fits, interference features, elastomeric grips) and/or adhesives can be used to couple the on-skin component to the sensor inserter system and releasably secure it in a proximal starting position, and/or to couple the on-skin component (and base, if any) to the adhesive patch once the on-skin component is deployed. In addition, various mechanical features (e.g. snap fits, friction fits, interference features, elastomeric grips, pushers, stripper plates, frangible members) and/or adhesives can be used to decouple the on-skin component from the sensor inserter system once it reaches the distal deployed position. Further, various mechanical features, (e.g. snap fits, friction fits, interference features, elastomeric grips, pushers, stripper plates, frangible members) and/or adhesives can be used to separate, unlock, or otherwise render separable the on-skin component, base, and/or adhesive patch from the remainder of the system after the on-skin component is deployed in the distal position and the needle hub (if any) is retracted.
• With reference now toFIGS. 110-119, asensor inserter system104waccording to some embodiments is illustrated. Thesystem104wcan be configured substantially similar to thesystem104villustrated within the context ofFIGS. 105-109 andsystem104millustrated within the context ofFIGS. 71-75, with like reference numerals indicating like parts. Thesystem104wincludes, for example, atelescoping assembly132wincluding afirst portion150w, asecond portion152w, and athird portion392w; asafety mechanism750, aneedle hub162w; afirst spring402w; asecond spring234w; an on-skin component134w, and a base128w.
• FIG. 110 illustrates a cross-sectional perspective view of thesystem104win a resting and locked state, with the on-skin component134wsecured in a proximal starting position. In this state, as well as in the unlocked state illustrated inFIG. 111 and the energized state illustrated inFIG. 112, the on-skin component134wis secured in the proximal starting position by asecurement member800. As can be seen inFIG. 110, thesystem104wincludes asecondary locking feature409w, configured as a ledge extending from the distal end of the lockingprotrusion408w, which is configured to cooperate with anopening410wto prevent thethird portion392 from moving in a proximal direction with respect to thesecond portion152wprior to deployment. In the embodiment illustrated inFIGS. 110-119, thesecurement member800 is integrally formed with theneedle hub162w. In other embodiments, the securement member can be integrally formed with thefirst portion150w. In still other embodiments, the securement member can be separately formed from and operatively coupled to theneedle hub162wand/or to thefirst portion150w. Thesecurement member800 extends substantially parallel to theneedle158. In the embodiment illustrated inFIGS. 110-119, thesecurement member800 comprises a pair of distally-extending legs802 (seeFIGS. 115 and 116). Some embodiments can, however, include only one distally-extendingleg802, while others can include three, four, ormore legs802. In embodiments comprising only oneleg802, the leg can be configured to adhere or otherwise couple to a center region or a perimeter of the on-skin component. In embodiments comprising more than oneleg802, the legs can be configured to adhere or otherwise couple to the on-skin component symmetrically or asymmetrically about a center of the on-skin component. Thelegs802 can have an ovoid cross section, or can have any other suitable cross section, including circular, square, triangular, curvilinear, L-shaped, O-shaped, U-shaped, V-shaped, X-shaped, or any other regular or irregular shape or combination of shapes. In embodiments, thesecurement member800 can comprise legs, columns, protrusions, and/or elongate members, or can have any other suitable configuration for holding the on-skin component in the proximal starting position.
• FIG. 113 illustrates a cross-sectional perspective view of thesystem104w, in an activated state, with theinsertion spring402wactivated, theretraction spring234wenergized, and theneedle hub162wand thesecurement member800 moved to a distal deployed position. The on-skin component134w, being coupled to thesecurement member800 until this stage, has also been moved to a distal deployed position. When the on-skin component134wreaches the distal deployed position, it is coupled to the base128w.
• FIG. 114 illustrates a cross-sectional perspective view of thesystem104wafter the on-skin component has been coupled to the base128wand theneedle hub162w(along with the securement member800) has been retracted to a proximal position. After the on-skin component134wis coupled to the base128w, aresistance member804 facilitates decoupling of the on-skin component134wfrom thesecurement member800 by resisting unwanted proximal movement of the on-skin component134waway from the base128w. Generally, theresistance member804 can be a backstop or backing structure configured to inhibit or prevent, or otherwise resist any tendency of the on-skin component134wto move in a proximal direction as thesecurement member800, which is releasably coupled to the on-skin component134w, moves in a proximal direction. Because thefirst portion150wis fixed to thesecond portion152wat this stage, and theneedle hub162wis released from thefirst portion150w, theneedle hub162wcan retract in a proximal direction while thefirst portion150w(and the resistance member804) remains planted in a distal position, inhibiting proximal movement of the on-skin component134w. The energy stored in theretraction spring234wis sufficient to overcome a retention force and decouple the on-skin component134wfrom thesecurement member800 and urge theneedle hub162 in a proximal direction. The potential energy stored can be between 0.25 pounds to 4 pounds. In preferred embodiments, the potential energy stored is between about 1 to 2 pounds.
• In some embodiments, a sensor inserter system can be configured such that the on-skin component couples with the base at approximately the same time the retraction mechanism is activated. In some embodiments, a sensor inserter system can be configured such that the on-skin component couples with the base before the retraction mechanism is activated, before the second spring is activated, or otherwise before the second spring begins retracting the needle hub in a proximal direction away from the deployed position. In some embodiments, a sensor inserter system can be configured such that the second spring is activated at least 0.05 seconds, at least 0.1 seconds, at least 0.2 seconds, at least 0.3 seconds, at least 0.4 seconds, at least 0.5 seconds, at least 0.6 seconds, at least 0.7 seconds, at least 0.8 seconds, at least 0.8 seconds, at least 1 second, or longer than 1 second after the on-skin component couples with the base. In other embodiments, a sensor inserter system can be configured such that the second spring is activated at most 0.05 seconds, at most 0.1 seconds, at most 0.2 seconds, at most 0.3 seconds, at most 0.4 seconds, at most 0.5 seconds, at most 0.6 seconds, at most 0.7 seconds, at most 0.8 seconds, at most 0.8 seconds, or at most 1 second after the on-skin component couples with the base.
• The on-skin component134wis now coupled with the base128w. The base128w(and adhesive patch) is initially coupled to thesecond portion152wby a latch orflex arm220wcoupled to an undercut or lockingfeature230w(similarly shown inFIGS. 18-19). When thefirst portion150wreaches its most distal position during insertion of thesensor138, a delatching feature of thefirst portion150wpushes the latch of thesecond portion152wout of the undercut. This decouples the base128wfrom thesecond portion152w, and thus allows the user to take the remainder of thesystem104woff the skin, leaving only the adhesive patch, the base128w, and the on-skin component134won the skin.
• In the embodiment illustrated inFIGS. 110-119, theresistance member804 is integrally formed with thefirst portion150w. In other embodiments, the resistance member can be integrally formed with thesecond portion152w. In still other embodiments, the resistance member can be separately formed from and operatively coupled to thefirst portion150wand/or to thesecond portion152w. In the embodiment illustrated inFIGS. 110-119, theresistance member804 comprises a distally-facing surface of thefirst portion150w.
• Thesystem104wcan be configured to couple the on-skin component134wto the base128wvia an adhesive806.FIG. 115 illustrates a perspective view of theneedle hub162w, shown securing the on-skin component134wduring deployment, with the base128wremoved to illustrate the adhesive806 disposed on a distally-facing surface of the on-skin component134w. The adhesive806 can be configured to couple the on-skin component134wto the base128won contact. Alternatively or in addition to the adhesive806, some embodiments can include an adhesive disposed on a proximally-facing surface of the base, so as to couple the on-skin component to the base upon contact. In some embodiments, the adhesive can be a pressure-sensitive adhesive. In some embodiments, the securement member can be configured to couple the on-skin component to the needle hub only along a plane extending normal to the axial direction of the system. In addition or in the alternative, the securement can be configured to couple the on-skin component in a lateral or radial direction.
• FIG. 116 illustrates another perspective view of theneedle hub162w, shown decoupled from the on-skin component134w, with the base128wremoved to illustrate the adhesive808 disposed on the distally-facing surfaces of thesecurement member800. The adhesive808 can be configured to couple the on-skin component134wto thesecurement member800 while in the proximal starting position and during movement of the on-skin component134win the proximal direction, and to allow the release of the on-skin component134wfrom thesecurement member800 after the on-skin component134wis coupled to the base128w. Alternatively or in addition to the adhesive808, some embodiments can include an adhesive disposed on a proximally-facing surface of the on-skin component134w. In some embodiments, the adhesive can be a pressure-sensitive adhesive. In some embodiments, the adhesive808 can have a smaller surface area and/or a lower adhesion strength than the adhesive806, such that the adhesion strength of the adhesive806 which couples the on-skin component to the base outweighs the adhesion strength of the adhesive808 which couples the on-skin component to the securement member. In other embodiments, the adhesion strength of the adhesive808 can be the same or greater than the adhesion strength of the adhesive806. In these embodiments, a resistance member can be employed to facilitate the decoupling of the on-skin component134wfrom thesecurement member800 after deployment.
• FIG. 117 illustrates a perspective view of a portion of thesystem104w, illustrating theresistance member804. Theresistance member804 is configured to rest above and/or contact a proximally-facing surface of the on-skin component134w, at least when the on-skin component134wis in a distal deployed position. Theresistance member804 can serve to inhibit proximal movement of the on-skin component134was theneedle hub162wandsecurement member800 retract in a proximal direction. Theresistance member804 can function in a manner similar to a stripper plate in punch and die manufacturing or injection molding processes.
• In embodiments, the resistance member can have any configuration suitable for resisting decoupling of the on-skin component from the base. In the embodiment illustrated inFIGS. 110-119, theresistance member804 has a curvilinear cross section, and extends through an arc of roughly 300 degrees about the perimeter of the on-skin component134w. In some embodiments, theresistance member804 can extend through an arc of roughly 30 degrees, 60 degrees, 90 degrees, 120 degrees, 150 degrees, 180 degrees, 210 degrees, 240 degrees, 270 degrees, 300 degrees, or 330 degrees about the perimeter of the on-skin component134w, or through an arc greater than, less than, or within a range defined by any of these numbers. In some embodiments, theresistance member804 can extend continuously or discontinuously about the perimeter of the on-skin component. In some embodiments, theresistance member804 can extend about the entire perimeter of the on-skin component. In some embodiments, theresistance member804 can comprise one or more contact points or surfaces that hold the on-skin component134win the distal position as thesecurement feature800 moves in an opposite (e.g., proximal) direction.
• In other embodiments, theresistance member804 can comprise multiple discrete members (e.g., legs) configured to contact multiple locations about the perimeter of the on-skin component134w. For example, in some embodiments, theresistance member804 can include at least two legs disposed apart from one another about a center point of the on-skin component. In some embodiments, theresistance member804 can include two legs disposed roughly 180 degrees about a center point of the on-skin component. In some embodiments, theresistance member804 can include three legs disposed roughly 120 degrees about a center point of the on-skin component. In such an embodiment, the legs can be arranged symmetrically about the on-skin component (e.g. with radial symmetry, or reflectional/bilateral symmetry).
• FIG. 117 also illustrates locator features810 which can be formed in, or integrally coupled to, thefirst portion150wand/or theresistance member804. The locator features810 can comprise distally-extending tabs of thefirst portion150wand/or of theresistance member804. The locator features810 can be configured to align with correspondingindentations812 in the on-skin component (seeFIG. 119) so as to ensure proper positioning of thesensor module134wwith respect to thefirst portion150wand/or theresistance member804 during assembly.
• FIG. 118 illustrates a perspective view of thesensor module134w, before being coupled to the base128wby contacting the adhesive806. The base128witself is coupled (for example by an adhesive) to a proximal surface of anadhesive patch900.FIG. 119 illustrates a perspective view of thesensor module134wafter being coupled to the base128won theadhesive patch900.
• In embodiments, providing a resistance member can facilitate a reliable transfer of the on-skin component to the base, by creating a counterforce against the securement member as the needle hub retracts in the proximal direction. The counterforce allows the securement member to separate from the on-skin component while inhibiting or preventing the disengagement of the on-skin component from the base (if any) and/or from the adhesive patch. In embodiments, the retraction spring can be configured to store and provide sufficient energy to both retract the needle and decouple the on-skin component from the needle hub. The combination of the resistance member and securement member can also be configured to provide positional control of the on-skin component from a secured configuration (e.g., in the proximal starting position and during movement of the on-skin component toward the distal deployed position) to a released configuration (when the on-skin component reaches the distal deployed position and/or couples to the base and/or adhesive patch).
• It is contemplated that providing a base which begins in the distal deployed position when the system is in a resting or stored state can serve to protect the needle (and the user) before the system is deployed. For example, a base which is coupled to a distal end of the system in a resting or pre-deployment state can prevent a user from reaching into the distal end of the system and pricking him or herself. This configuration can thus potentially reduce needle stick hazards. In addition, a base which is coupled to a distal end of the system in a resting or pre-deployment state facilitate the setting of the adhesive patch on the skin before deployment. For example, with such a configuration, the user can use the body of the sensor inserter system to assist in applying a force in a distal direction to adhere the adhesive patch to the skin. In addition, the base can provide structural support to guide the needle into the skin during deployment.
• FIGS. 120-122 illustrate another configuration for coupling an on-skin component to a base, in accordance with several embodiments.FIG. 120 shows a side view of an on-skin component134xand a base128x, prior to coupling of the on-skin component134xto the base128x. The on-skin component134xincludes a distally-extendingsensor138, and the base128xis coupled to anadhesive patch900.FIG. 121 illustrates a perspective view of these same components. The base128xcomprises a flexible elastomeric member with a proximally-extending ridge814 extending about a proximally-facing surface816. The base128xcan have a shape configured to correspond to a shape of the on-skin component134x. In a relaxed state, as illustrated inFIGS. 120 and 121, and before making contact with the on-skin component134x, the base128xhas a deformed, somewhat convex curvature. The base128xand theadhesive patch900 can be coupled to the other components of a sensor inserter assembly in this configuration. During deployment, as the on-skin component134xbegins to contact the base128x, the proximally-facing surface816 flexes up to meet the distal surface of the on-skin component134x, causing the ridge814 to grip securely about the perimeter of the on-skin component134x, as illustrated inFIG. 122.
• FIG. 123 illustrates a perspective view of a portion of another inserter system104y, according to some embodiments. The system104ycan be configured substantially similar to any of thesystems104 illustrated herein, with like reference numerals indicating like parts. The inserter system104yincludes an on-skin component134ywhich includes a combination sensor module and base. In embodiments, the combination sensor module and base can be integrally formed with one another, as illustrated inFIG. 123, or operatively coupled to one another. The system104yalso includes asecurement member800ywhich is configured to releasably secure the on-skin component134yin a proximal starting position, at least until the system104yis activated. Thesecurement member800yis integrally formed with theneedle hub162y, and includes three proximally-extendinglegs802yconfigured to releasably couple to (e.g. via adhesive808) various locations on the proximal surface of the on-skin component134y. It is contemplated that the addition of a third (or further)leg802ycan help to balance the sensor module and prevent it from canting to one side or another during deployment and/or retraction. The system104yalso includes aresistance member804. Theresistance member804 may be integrally molded withfirst portion150y.
• FIG. 124 illustrates another perspective view of the on-skin component134yand theneedle hub162y, with the remainder of the system104yremoved to illustrate the configuration of thesecurement member800y.FIG. 125 illustrates a perspective view of a portion of the applicator system shown inFIG. 123, with the on-skin component134yin a released configuration and separated from theneedle hub162yand with two of thelegs802yremoved for purposes of illustration. Theresistance member804ycan be configured to encompass or at least partially encompass the sensor module portion of the on-skin component134y. Theresistance member804ycan comprise one or more elongate members, columns, legs, and/or protrusions, or can have any other suitable configuration for facilitating the release of the on-skin component from theneedle hub162y. Theresistance member804y(or any portion thereof) can have a curvilinear cross section, as illustrated inFIG. 125, or can have any other suitable cross section, including circular, square, triangular, ovoid, L-shaped, O-shaped, U-shaped, V-shaped, X-shaped, or any other regular or irregular shape or combination of shapes.
• As shown inFIG. 125, the system104ycan include anadhesive patch818 disposed on the distally-facing surface of the on-skin component134y. Theadhesive patch818 can be configured to couple the on-skin component134yto the skin on contact. In some embodiments, the adhesive patch can be a pressure-sensitive adhesive. In some embodiments, theadhesive patch818 is a double sided adhesive, in which an adhesive is disposed on both the proximally facing surface of theadhesive patch818 and the distally facing surface of theadhesive patch818. The proximally facing adhesive can be configured to couple with the distal end of the on-skin component134y, and the distally facing adhesive can be configured to couple with the skin. In other embodiments, the proximally facing surface of theadhesive patch818 is configured to couple with the distally facing surface of the on-skin component by a coupling process such as, but not limited to, heat staking, fastening, welding, or bonding. In some embodiments, theadhesive patch818 can be covered by a removable liner prior to deployment. In other embodiments, theadhesive patch818 can be exposed (e.g., uncovered) within the system prior to deployment.
• Alternatively, in some embodiments theadhesive patch818 can be releasably secured to the distal end of the system before deployment, with an adhesive disposed on a proximally-facing surface of theadhesive patch818, so as to couple the on-skin component to theadhesive patch818 upon contact as part of the sensor insertion process. In addition, in such an embodiment, theadhesive patch818 can include an adhesive disposed on a distally-facing surface of theadhesive patch818 to couple the on-skin component to the skin.
• Such a configuration can include fewer components to be coupled and decoupled during the deployment and insertion process, which can increase reliability of systems configured in accordance with embodiments. For example, systems configured in accordance with embodiments can reduce the chance of improper transfer of system components to the skin. In addition, it is contemplated that embodiments comprising an adhesive patch disposed within the system in a resting state (as opposed to an adhesive patch disposed at a distal end of the system in the resting state) can allow for the system to be more easily re-positioned on the skin as many times as desired before being adhered to the skin.
• FIGS. 126-128 illustrate another configuration for releasably securing an on-skin component in a proximal position, in accordance with several embodiments.FIG. 126 illustrates a perspective view of a portion of asecurement member800zshown secured to an on-skin component134zcomprising a sensor module. Thesecurement member800zcan include at least oneleg802z. As shown in the figure, thesecurement member800zincludes two proximally-extendinglegs802z. The on-skin component134zincludes twoelastomeric grips824 extending laterally from the sensor module. Thegrips824 are sized and shaped to cooperate with laterally-facing surfaces of thelegs802zto releasably secure the on-skin component134zin a proximal position. In the embodiment illustrated inFIGS. 126-128, thegrips824 are integrally formed with the sensor module, and have a bracket-shaped cross section, as viewed in a plane extending normal to the axial direction. In embodiments, thesecurement member800zand thegrips824 can have any suitable cooperating configuration to allow the on-skin component134zto releasably couple thesecurement member800zto thegrips824, for example via a friction fit, interference fit, or corresponding undercut engagement features. Some embodiments can additionally employ an adhesive disposed between thesecurement member800zand the on-skin component134z, to provide additional securement of the on-skin component134z.
• FIG. 127 illustrates a perspective view of a portion of thesecurement member800z, with the sensor module of the on-skin component134zshown in cross section to illustrate the configuration of thegrips824.FIG. 127 also shows a decoupling feature804zconfigured to resist proximal movement of the on-skin component134zafter deployment of the on-skin component134zto the distal deployed position, for example during retraction of theneedle hub162z. The decoupling feature804zcan be fixed with respect to the remainder of the sensor inserter system as theneedle hub162zretracts in a proximal direction, providing enough resistance to overcome the friction fit (and adhesive, if any) between thesecurement member800zand thegrips824 to release thesecurement member800zfrom thegrips824.FIG. 128 illustrates a perspective view of the on-skin component134z, after decoupling of the on-skin component134zfrom the securingmember800z.
• FIGS. 129-131 illustrate still another configuration for releasably securing an on-skin component, in accordance with several embodiments.FIG. 129 illustrates a perspective view of a portion of asensor inserter assembly104aawith thesecond portion150aashown in cross section, and with a securingmember800aashown securing an on-skin component134aain a proximal position. The on-skin component134aamay comprise an integrally formed sensor module/base assembly. As shown in the figure, thesecurement member800aacomprises an elastomeric cap which is coupled to a portion of the on-skin component134aa. As shown, thesecurement member800aacan be coupled to a protrusion (or neck)826 formed in the on-skin component134aa.FIG. 130 illustrates a perspective view of a portion of theassembly104aaofFIG. 129, shown with a portion of the securingmember800aacut away to better illustrate the configuration of the securingmember800aaand theprotrusion826. Theprotrusion826 can be configured to encircle, or at least partially encircle, theneedle158 when it extends in a proximal direction through the on-skin component134aa. Theprotrusion826 can also be configured to secure thesecurement member800aato the on-skin component134aa. Thesecurement member800aahas anopening828 which is sized and shaped to create a friction fit between theopening828 and theneedle158. In the configuration illustrated inFIGS. 129 and 130, with theneedle158 extending distally through thesecurement member800aaand theprotrusion826, the friction fit between thesecurement member800aaand theneedle158 serves to resist at least distal movement of the on-skin component134aawith respect to theneedle158.
• The embodiment illustrated inFIGS. 129-131 may also include aresistance member804aa. The resistance member may be substantially similar to any resistance member described inFIGS. 110-128. Theresistance member804aacan include a distally-facing surface of thefirst portion150aa, and can have a similar configuration to theresistance member804 described in the context ofFIG. 117. Theresistance member804aacan provide enough resistance in a distal direction to allow the second spring and needle hub (not shown) to overcome the friction fit between thesecurement member800aaand theneedle158. It is contemplated that this would allow theneedle158 to retract away from the skin and at the same time allow the needle to decouple from thesecurement member800aa.FIG. 131 illustrates a perspective view of a portion of theassembly104aa, after decoupling of the on-skin component134aafrom theneedle158, shown with theprotrusion826 of the on-skin component134aaand the securingmember800aacut away for purposes of illustration.
• FIGS. 132-133 illustrate another configuration for releasably securing an on-skin component in a proximal position, in accordance with several embodiments.FIG. 132 illustrates a perspective view of a portion of asecurement member800abshown secured to an on-skin component134abcomprising a sensor module, with thesecond portion150abshown in cross section. Thesecurement member800abmay include at least one engagement feature. As shown in the figure, the at least one engagement feature can be two proximally-extendinglegs802ab. The on-skin component134abmay include at least one receiving feature. As shown, the at least one receiving feature can be twoelastomeric grips824abextending laterally from the on-skin component134ab. Thegrips824abare deformable and sized and shaped to receive thelegs802abvia friction or interference fit and thereby releasably secure the on-skin component134abin a proximal position. In the embodiment illustrated inFIGS. 132-133, thelegs802abof thesecurement member800abhave a circular cross-section. Thegrips824abare integrally formed with the sensor module, and have an annular-shaped cross section, as viewed in a plane extending normal to the axial direction. Thegrips824abmay each include an opening which can be configured to receive thelegs802abvia frictional engagement. In embodiments, thesecurement member800aband thegrips824abcan have any suitable cooperating configuration to releasably couple thesecurement member800abto thegrips824ab. Some embodiments can additionally employ an adhesive disposed axially between thesecurement member800aband the on-skin component134ab, to provide additional securement of the on-skin component134abin the proximal starting position.FIG. 133 illustrates a perspective view of theneedle hub162aband the on-skin component134ab, after decoupling of the on-skin component134abfrom theneedle hub162ab.
• FIGS. 134-136 illustrate yet another configuration for releasably securing an on-skin component in a proximal position.FIG. 134 illustrates an exploded perspective view of a portion of anassembly134ac, with asecurement member800acconfigured to releasably couple an on-skin component134acto aneedle hub162ac. Thesecurement member800acmay include at least one engagement feature. As shown in the figure, thesecurement member800accan include two proximally-extendinglegs802ac. The on-skin component134acincludes twoelastomeric grips824acextending laterally from the sensor module. Thegrips824acare sized and shaped to receive thelegs802acin a snap fit to securely hold the on-skin component134acin a proximal position. In the embodiment illustrated inFIGS. 134-136, thelegs802acof thesecurement member800achave a circular cross-section, with a recessedsection832 configured to receive thegrips824ac. Thegrips824accan be integrally formed with the sensor module, each grip having afrangible link830 coupling thegrips824acto the sensor module. Thegrips824achave an annular-shaped cross section, as viewed in a plane extending normal to the axial direction, the grips being configured to receive the recessedsections832 of the legs in a secure interlocking engagement. In embodiments, thesecurement member800aband thegrips824abcan have any suitable cooperating configuration to securely couple thesecurement member800acto thegrips824acand prevent slippage of the grips along thelegs802acas theneedle hub162acdeploys and as it retracts after deployment. Some embodiments can additionally employ an adhesive disposed axially between thesecurement member800acand the on-skin component134ab, to provide additional securement of the on-skin component134acin the proximal starting position and during deployment.
• FIG. 135 illustrates a perspective view of a portion of thesystem104ac, with thesecurement member800acsecurely coupled to the on-skin component134ac. Some embodiments can additionally employ an adhesive disposed axially between thesecurement member800acand the on-skin component134ac, to provide additional securement of the on-skin component134acin the proximal starting position. Thefrangible links830 are configured to shear or otherwise detach upon application of a minimum threshold of force, as theneedle hub162 retracts in a proximal direction after deployment, separating thegrips824acfrom the remainder of the on-skin component134acand leaving the on-skin component824acin the deployed distal position.FIG. 136 illustrates a perspective view of a portion of thesystem104ac, with thefrangible links830 broken and thesecurement member800acdecoupled from the on-skin component134ac. In some embodiments, a resistance member can also be employed to prevent proximal movement of the on-skin component134acas theneedle hub162acretracts, facilitating the breakage of thefrangible links830.
• Frangible couplings can also be employed between an on-skin component and the second portion of a sensor inserter system to releasably secure the on-skin component in a proximal starting position prior to deployment. For example,FIGS. 137-140 illustrate various perspective views of asensor inserter system104adwith an on-skin component134adreleasably secured in a proximal position within thesystem104ad. The on-skin component134adcan include a combination sensor module and base disposed on anadhesive patch900ad. To facilitate in releasably securing the on-skin component134adto thesecond portion152ad, thesecond portion152adcan include at least one distally-extendingprotrusion834. As shown in the figure, thesecond portion152adincludes four distally-extendingprotrusions834 configured to securely couple withcorresponding sockets836 formed in or otherwise extending from theadhesive patch900ad. Thesockets836 are connected to theadhesive patch900adviafrangible links838, which can also be integrally formed in theadhesive patch900ad. In the resting state illustrated inFIG. 137, theadhesive patch900adis secured in a proximal position by the coupling of thesockets836 to theposts838. As thesystem104adis deployed and a force is applied to the on-skin component134adin a distal direction, thefrangible links838 detach, allowing theadhesive patch900ad(and the on-skin component134adwhich is already coupled thereto) to move to the distal deployed position.FIG. 138 illustrates a perspective view of thesensor inserter system104ad, with thefrangible links838 detached and theadhesive patch900adreleased from securement.FIGS. 139 and 140 illustrate perspective views of theadhesive patch900adand the on-skin component134ad, with thefrangible links838 in intact and detached configurations, respectively. Once thefrangible links838 are detached and the on-skin component134ad(along with thepatch900ad) is deployed in the distal position, the remainder of thesystem104adcan easily be lifted off the skin of the host and removed.
• FIG. 141 illustrates another configuration for releasably securing a base and adhesive patch to a sensor inserter assembly.FIG. 141 illustrates a cross-sectional perspective view of a portion of asystem104ae, with thefirst portion150ae, thesecond portion152ae, and thethird portion392aeshown in cross section. Thesystem104aeincludes an on-skin component134aewhich is releasably secured in a proximal starting position. Thesystem104aealso includes a base128aecoupled to anadhesive patch900ae. The base128aeand theadhesive patch900aeare disposed in a distal position, at a distal end of thesystem104ae. The base128aeis coupled to thesystem104aevia a plurality ofribs840 extending radially inward from thesecond portion152ae. Theribs840 can be sized and shaped to grip the edges of the base128aewith a friction/interference fit. The friction/interference fit between theribs840 and the base128aecan be configured to be strong enough to securely couple the base128aeto thesystem104aeduring storage and prior to deployment, but weak enough that the adhesive coupling between theadhesive patch900aeand the skin of the host overcomes the strength of the friction fit. Thus, once theadhesive patch900aeis adhered to the skin of the host, thesecond portion152aecan be lifted off the base128aeand thesensor system104aecan be removed without pulling the base128 in a proximal direction. In some embodiments, the base128aemay comprise an elastomeric material. Further, in some embodiments, the base128aemay have a hardness value less than a hardness value of the on-skin component134ae. In other embodiments, the base128aemay have a hardness value more than a hardness value of the on-skin component134ae.
• FIGS. 142 and 143 illustrate yet another configuration for releasably securing an adhesive patch, optionally including a base, to a sensor inserter system.FIG. 142 shows asensor inserter system104afwith anadhesive patch900afcoupled to thesecond portion152afof thesystem104af.FIG. 143 shows thesystem104afwith thepatch900afseparated from thesecond portion152af. As shown inFIG. 143, thesecond portion152afincludes a plurality ofadhesive dots842 disposed on a distally-facing surface or edge of thesecond portion152af. Theadhesive dots842 can be configured to be strong enough to securely couple theadhesive patch900af(and base, if any) to thesystem104afduring storage and prior to deployment, but weak enough that the adhesive coupling between theadhesive patch900afand the skin of the host overcomes the strength of theadhesive dots842. Thus, once theadhesive patch900afis adhered to the skin of the host, thesecond portion152afcan be lifted off theapplicator patch900af(and base, if any) and thesensor system104afcan be removed without pulling theadhesive patch900af(or base, if any) in a proximal direction. Alternatively or in addition to theadhesive dots842, some embodiments can include an adhesive disposed on a proximally-facing surface of theadhesive patch900af. In some embodiments, the adhesive can be a pressure-sensitive adhesive.
Interpretation
• For ease of explanation and illustration, in some instances the detailed description describes exemplary systems and methods in terms of a continuous glucose monitoring environment; however it should be understood that the scope of the invention is not limited to that particular environment, and that one skilled in the art will appreciate that the systems and methods described herein can be embodied in various forms. Accordingly any structural and/or functional details disclosed herein are not to be interpreted as limiting the systems and methods, but rather are provided as attributes of a representative embodiment and/or arrangement for teaching one skilled in the art one or more ways to implement the systems and methods, which may be advantageous in other contexts.
• For example, and without limitation, described monitoring systems and methods may include sensors that measure the concentration of one or more analytes (for instance glucose, lactate, potassium, pH, cholesterol, isoprene, and/or hemoglobin) and/or other blood or bodily fluid constituents of or relevant to a host and/or another party.
• By way of example, and without limitation, monitoring system and method embodiments described herein may include finger-stick blood sampling, blood analyte test strips, non-invasive sensors, wearable monitors (e.g. smart bracelets, smart watches, smart rings, smart necklaces or pendants, workout monitors, fitness monitors, health and/or medical monitors, clip-on monitors, and the like), adhesive sensors, smart textiles and/or clothing incorporating sensors, shoe inserts and/or insoles that include sensors, transdermal (i.e. transcutaneous) sensors, and/or swallowed, inhaled or implantable sensors.
• In some embodiments, and without limitation, monitoring systems and methods may comprise other sensors instead of or in additional to the sensors described herein, such as inertial measurement units including accelerometers, gyroscopes, magnetometers and/or barometers; motion, altitude, position, and/or location sensors; biometric sensors; optical sensors including for instance optical heart rate monitors, photoplethysmogram (PPG)/pulse oximeters, fluorescence monitors, and cameras; wearable electrodes; electrocardiogram (EKG or ECG), electroencephalography (EEG), and/or electromyography (EMG) sensors; chemical sensors; flexible sensors for instance for measuring stretch, displacement, pressure, weight, or impact; galvanometric sensors, capacitive sensors, electric field sensors, temperature/thermal sensors, microphones, vibration sensors, ultrasound sensors, piezoelectric/piezoresistive sensors, and/or transducers for measuring information of or relevant to a host and/or another party.
• None of the steps described herein is essential or indispensable. Any of the steps can be adjusted or modified. Other or additional steps can be used. Any portion of any of the steps, processes, structures, and/or devices disclosed or illustrated in one embodiment, flowchart, or example in this specification can be combined or used with or instead of any other portion of any of the steps, processes, structures, and/or devices disclosed or illustrated in a different embodiment, flowchart, or example. The embodiments and examples provided herein are not intended to be discrete and separate from each other.
• The section headings and subheadings provided herein are nonlimiting. The section headings and subheadings do not represent or limit the full scope of the embodiments described in the sections to which the headings and subheadings pertain. For example, a section titled “Topic1” may include embodiments that do not pertain toTopic1 and embodiments described in other sections may apply to and be combined with embodiments described within the “Topic1” section.
• Some of the devices, systems, embodiments, and processes use computers. Each of the routines, processes, methods, and algorithms described in the preceding sections may be embodied in, and fully or partially automated by, code modules executed by one or more computers, computer processors, or machines configured to execute computer instructions. The code modules may be stored on any type of non-transitory computer-readable storage medium or tangible computer storage device, such as hard drives, solid state memory, flash memory, optical disc, and/or the like. The processes and algorithms may be implemented partially or wholly in application-specific circuitry. The results of the disclosed processes and process steps may be stored, persistently or otherwise, in any type of non-transitory computer storage such as, for example, volatile or non-volatile storage.
• Any of the features of each embodiment is applicable to all aspects and embodiments identified herein. Moreover, any of the features of an embodiment is independently combinable, partly or wholly with other embodiments described herein in any way, e.g., one, two, or three or more embodiments may be combinable in whole or in part. Further, any of the features of an embodiment may be made optional to other aspects or embodiments. Any aspect or embodiment of a method can be performed by a system or apparatus of another aspect or embodiment, and any aspect or embodiment of a system can be configured to perform a method of another aspect or embodiment.
• The various features and processes described above may be used independently of one another, or may be combined in various ways. All possible combinations and subcombinations are intended to fall within the scope of this disclosure. In addition, certain method, event, state, or process blocks may be omitted in some implementations. The methods, steps, and processes described herein are also not limited to any particular sequence, and the blocks, steps, or states relating thereto can be performed in other sequences that are appropriate. For example, described tasks or events may be performed in an order other than the order specifically disclosed. Multiple steps may be combined in a single block or state. The example tasks or events may be performed in serial, in parallel, or in some other manner. Tasks or events may be added to or removed from the disclosed example embodiments. The example systems and components described herein may be configured differently than described. For example, elements may be added to, removed from, or rearranged compared to the disclosed example embodiments.
• Conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and/or steps. Thus, such conditional language is not generally intended to imply that features, elements and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and/or steps are included or are to be performed in any particular embodiment. The terms “comprising,” “including,” “having,” and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Conjunctive language such as the phrase “at least one of X, Y, and Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require at least one of X, at least one of Y, and at least one of Z to be present.
• The term “and/or” means that “and” applies to some embodiments and “or” applies to some embodiments. Thus, A, B, and/or C can be replaced with A, B, and C written in one sentence and A, B, or C written in another sentence. A, B, and/or C means that some embodiments can include A and B, some embodiments can include A and C, some embodiments can include B and C, some embodiments can only include A, some embodiments can include only B, some embodiments can include only C, and some embodiments can include A, B, and C. The term “and/or” is used to avoid unnecessary redundancy.
• All references cited herein are incorporated herein by reference in their entirety. To the extent publications and patents or patent applications incorporated by reference contradict the disclosure contained in the specification, the specification is intended to supersede and/or take precedence over any such contradictory material.
• Unless otherwise defined, all terms (including technical and scientific terms) are to be given their ordinary and customary meaning to a person of ordinary skill in the art, and are not to be limited to a special or customized meaning unless expressly so defined herein. It should be noted that the use of particular terminology when describing certain features or aspects of the disclosure should not be taken to imply that the terminology is being re-defined herein to be restricted to include any specific characteristics of the features or aspects of the disclosure with which that terminology is associated. Terms and phrases used in this application, and variations thereof, especially in the appended claims, unless otherwise expressly stated, should be construed as open ended as opposed to limiting.
• While certain example embodiments have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of the inventions disclosed herein. Thus, nothing in the foregoing description is intended to imply that any particular feature, characteristic, step, module, or block is necessary or indispensable. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms; furthermore, various omissions, substitutions, and changes in the form of the methods and systems described herein may be made without departing from the spirit of the inventions disclosed herein.

Claims (1)

What is claimed is:

1. A transcutaneous analyte sensor system comprising:

a transcutaneous analyte sensor; and

sensor electronics operably connectable to the transcutaneous analyte sensor.

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