US20210338162A1 - Transcutaneous analyte sensors, applicators therefor, and associated methods - Google Patents

Abstract

The present embodiments relate generally to applicators of on-skin sensor assemblies for measuring an analyte in a host, as well as their method of use and manufacture. In some aspects, an applicator for applying an on-skin sensor assembly to a skin of a host is provided. The applicator includes an applicator housing, a needle carrier assembly comprising an insertion element configured to insert a sensor of the on-skin sensor assembly into the skin of the host, a holder releasably coupled to the needle carrier assembly and configured to guide the on-skin sensor assembly while coupled to the needle carrier assembly, and a drive assembly configured to drive the insertion element from a proximal starting position to a distal insertion position, and from the distal insertion position to a proximal retraction position.

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. 17/200,664, filed Mar. 12, 2021, which is a continuation of U.S. application Ser. No. 16/016,493, filed Jun. 22, 2018, which is a continuation of U.S. application Ser. No. 16/016,354, filed Jun. 22, 2018, now U.S. Pat. No. 10,863,944, issued Dec. 15, 2020, which claims the benefit of U.S. Provisional Application No. 62/524,247, filed Jun. 23, 2017 and U.S. Provisional Application No. 62/658,486, filed Apr. 16, 2018. 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
• Systems and methods for measuring an analyte in a host are provided. More particularly, systems and methods are provided for applying a transcutaneous analyte measurement system to a host.
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 (Type2 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 (SMBG) 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 spread so far 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 should result in the sensor assembly being attached to the person in a state where it is capable of sensing glucose level information, communicating the sensed data to the transmitter, and transmitting the glucose level information to the receiver.
• This Background is provided to introduce a brief context for the Summary and Detailed Description that follow. This Background is not intended to be an aid in determining the scope of the claimed subject matter nor be viewed as limiting the claimed subject matter to implementations that solve any or all of the disadvantages or problems presented above.
SUMMARY
• The present systems and methods relate to systems and methods for measuring an analyte in a host, and for applying a transcutaneous analyte measurement system to a host. The various embodiments of the present systems and methods for applying the analyte measurement system have several features, no single one of which is solely responsible for their desirable attributes. Without limiting the scope of the present embodiments as expressed by the claims that follow, their more prominent features now will be discussed briefly. After considering this discussion, and particularly after reading the section entitled “Detailed Description,” one will understand how the features of the present embodiments provide the advantages described herein.
• An applicator for applying an on-skin sensor assembly to a skin of a host is provided. The applicator includes an applicator housing, a needle carrier assembly, which includes an insertion element configured to insert a sensor of the on-skin sensor assembly into the skin of the host, a holder releasably coupled to the needle carrier assembly and configured to guide the on-skin sensor assembly while coupled to the needle carrier assembly, and a drive assembly configured to drive the insertion element from a proximal starting position to a distal insertion position, and from the distal insertion position to a proximal retraction position.
• In some embodiments, the on-skin sensor assembly includes an electronics unit. In some embodiments, the sensor is connected to the electronics unit in the applicator housing. In some embodiments, the holder is configured to release the on-skin sensor assembly after the sensor is inserted at least partially into the skin of the host. In some embodiments, the applicator further includes an activation element configured to activate the drive assembly. In some embodiments, the activation element includes a deflectable feature. In some embodiments, the deflectable feature is configured to provide resistance to activation. In some embodiments, the deflectable feature is configured to return the activation element to a starting position. In some embodiments, the activation element includes one of a button, a switch, a toggle, a slide, a trigger, and a knob. In some embodiments, the applicator further includes a safety element configured to prevent operation of the activation element. In some embodiments, the safety element includes a tab coupled to the activation element by at least one frangible member. In some embodiments, the distal direction and the proximal direction extend along an insertion axis of the insertion element. In some embodiments, the holder includes an elastomer.
• In a first aspect, the applicator housing includes a guide. The drive assembly includes a rotating drive element coupled to the needle carrier assembly and includes a pin configured to travel in the guide during rotation of the rotating drive element, and a spring configured to, upon activation of the drive assembly, rotate the rotating drive element in a single rotational direction thereby driving the insertion element from the proximal starting position to the distal insertion position, and from the distal insertion position to the proximal retraction position. In some embodiments, the rotating drive element is configured to convert rotational motion into linear motion. In some embodiments, the rotating drive element includes a wheel cam. In some embodiments, the pin is radially offset from an axis of rotation of the rotating drive element. In some embodiments, the pin is positioned approximately 30 degrees from a bottom center orientation relative to the axis of rotation of the rotating drive element when the insertion element is in the proximal starting position. In some embodiments, the pin is positioned approximately 180 degrees from a bottom center orientation relative to the axis of rotation of the rotating drive element when the insertion element is in the distal insertion position. In some embodiments, the pin is positioned approximately 330 degrees from a bottom center orientation relative to the axis of rotation of the rotating drive element when the needle carrier assembly is in the proximal retracted position. In some embodiments, the pin travels in the guide in a direction perpendicular to a direction of extension of the insertion element. In some embodiments, the guide includes a slot. In some embodiments, the slot is stationary during sensor insertion. In some embodiments, the slot includes a horizontal slot. In some embodiments, the slot includes a vertical slot configured to receive at least the pin of the rotating drive element when loaded through a bottom of the applicator housing. In some embodiments, the applicator housing is stationary. In some embodiments, the rotating drive element further includes a protrusion in contact with a retention element configured to prevent the rotating drive element from rotating. In some embodiments, the applicator further includes an activation element configured to deflect the retention element, thereby allowing the rotating drive element to rotate. In some embodiments, the rotating drive element further includes a protrusion configured to decouple the on-skin sensor assembly from the needle carrier assembly. In some embodiments, the protrusion is configured to apply a force to the on-skin sensor assembly during rotation of the rotating drive element. In some embodiments, the protrusion of the rotating drive element is configured to pass through a slot in the needle carrier assembly as the rotating drive element rotates.
• In a second aspect, the drive assembly includes a torsion spring. The torsion spring includes a first end coupled to the applicator housing, and a second end coupled to the needle carrier assembly. Upon activation of the drive assembly, the first end and the second end unwind in opposite directions, thereby driving the insertion element from the proximal starting position to the distal insertion position, and from the distal insertion position to the proximal retraction position. In some embodiments, the first end and the second end unwinding in opposite directions drives the torsion spring in an arc. In some embodiments, the arc extends in a direction perpendicular to the distal direction and the proximal direction. In some embodiments, a spool coupled to the torsion spring. In some embodiments, the torsion spring is wrapped around the spool. In some embodiments, the second end of the torsion spring is configured to drive the insertion element. In some embodiments, the torsion spring is a double torsion spring. In some embodiments, the first end of the torsion spring is coupled to a protrusion of the applicator housing. In some embodiments, the second end of the torsion spring is coupled to a protrusion of the needle carrier assembly.
• In a third aspect, the drive assembly further includes a linkage element, which includes a first end coupled to the first end of the torsion spring, a second end coupled to the second end of the torsion spring, and a hinge substantially aligned with a winding axis of the torsion spring. In some embodiments, the linkage element includes a flexible linkage.
• In a fourth aspect, the drive assembly includes a linkage element, which includes a first end coupled to the applicator housing, a second end coupled to the needle carrier assembly, and a hinge disposed between the first end and the second end. The drive assembly further includes a torsion spring, which includes a first end coupled to the needle carrier assembly, and a second end coupled to the linkage element between the second end and the hinge. Upon activation of the drive assembly, the second end is configured to drive the linkage element such that the insertion element is driven from the proximal starting position to the distal insertion position, and from the distal insertion position to the proximal retracted position.
• In a fifth aspect, the drive assembly includes a linkage element, which includes a first end coupled to the applicator housing, a second end coupled to the needle carrier assembly, and a hinge disposed between the first end and the second end. The drive assembly further includes a torsion spring, which includes a first end coupled to the applicator housing, and a second end coupled to the linkage element between the first end and the hinge. Upon activation of the drive assembly, the second end is configured to drive the linkage element such that the insertion element is driven the proximal starting position to the distal insertion position, and from the distal insertion position to the proximal retracted position.
• In a sixth aspect, the drive assembly includes a linkage element, which includes a first end coupled to the applicator housing, a second end coupled to the needle carrier assembly, and a hinge disposed between the first end and the second end. The drive assembly further includes an extension spring coupled to the linkage element. Upon activation of the drive assembly, the extension spring is configured to drive the linkage element such that the insertion element is driven in the distal direction to the distal insertion position and in the proximal direction from the distal insertion position.
• In a seventh aspect, the drive assembly includes a leaf spring, which includes a first end coupled to the applicator housing, and a second end coupled to the needle carrier assembly. Upon activation of the drive assembly, the leaf spring is configured to decompress, thereby driving the insertion element at least in the distal direction to the distal insertion position.
• In an eighth aspect, the drive assembly includes a linkage element, which includes a first end coupled to the applicator housing, a second end coupled to the needle carrier assembly, and a hinge disposed between the first end and the second end. The drive assembly further includes a leaf spring, which includes a first end coupled to the needle carrier assembly, and a second end coupled to the linkage element between the second end and the hinge. Upon activation of the drive assembly, the leaf spring is configured to decompress, thereby driving the insertion element in the distal direction to the distal insertion position and in the proximal direction from the distal insertion position.
• In a ninth aspect, the drive assembly includes a leaf spring, which includes a first end coupled to the applicator housing, and a second end coupled to the needle carrier assembly. Upon activation of the drive assembly, the leaf spring is configured to decompress, thereby driving the insertion element at least in the distal direction to the distal insertion position.
• In a tenth aspect, the drive assembly includes a linkage element, which includes a first end coupled to the applicator housing, a second end coupled to the needle carrier assembly; and a hinge disposed between the first end and the second end. The drive assembly further includes a leaf spring, which includes a first end coupled to the needle carrier assembly, and a second end coupled to the linkage element between the second end and the hinge. Upon activation of the drive assembly, the leaf spring is configured to decompress, thereby driving the insertion element in the distal direction to the distal insertion position and in the proximal direction from the distal insertion position.
• In an eleventh aspect, the drive assembly includes an insertion spring configured to, upon activation of the drive assembly, drive the insertion element in the distal direction to the distal insertion position, and a retraction spring in contact with the needle carrier assembly and configured to drive the insertion element from the distal insertion position to the proximal retracted position. In some embodiments, the insertion spring includes a compression spring. In some embodiments, the retraction spring includes a leaf spring. In some embodiments, the retraction spring is configured retract the insertion element from the skin of the host. In some embodiments, upon activation of the drive assembly, a portion of energy stored in the insertion spring is transferred to the retraction spring as the insertion spring drives the insertion element in the distal direction. In some embodiments, the insertion spring includes a first end coupled to the applicator housing and a second end coupled to the holder, and the holder is coupled to the needle carrier assembly while the insertion spring drives the insertion element in the distal direction to the distal insertion position and decoupled from the needle carrier assembly when the retraction spring drives the insertion element in the proximal direction from the distal insertion position. In some embodiments, the insertion element is configured to travel in an arc when driven in the distal direction and in the proximal direction.
• In a twelfth aspect, the drive assembly includes a rotating drive element, which includes a ridge configured to slide along a channel in the needle carrier assembly, the ridge defining a variable cam path around at least a portion of a circumference of the rotating drive element, and a torsion spring configured to, upon activation of the drive assembly, rotate the rotating drive element thereby driving the insertion element in a distal direction to a distal insertion position and in a proximal direction from the distal insertion position based on the variable cam path. In some embodiments, the torsion spring is configured to, upon activation of the drive assembly, rotate the rotating drive element in a single direction through an angle of greater than zero degrees and less than 360 degrees. In some embodiments, the rotating drive element includes a barrel cam. In some embodiments, the rotating drive element is configured to rotate in a plane substantially perpendicular to the proximal direction and the distal direction.
• In a thirteenth aspect, the drive assembly includes a guide member coupled to the applicator housing, a hub configured to slide along the guide member, the hub in contact with a reverse toggling element through a first portion of travel along the guide member and in contact with the needle carrier assembly through a second portion of travel along the guide member. The reverse toggling element includes a fulcrum, a first end in contact with the hub through the first portion of travel along the guide member, and a second end coupled with the needle carrier assembly. The drive assembly further includes a spring configured to, upon activation of the drive assembly drive the hub in a proximal direction through the first portion of travel along the guide member, thereby driving the insertion element in the distal direction to the distal insertion position, and drive the hub in the proximal direction through the second portion of travel along the guide member, thereby driving the insertion element in the proximal direction from the distal insertion position.
• In a fourteenth aspect, the drive assembly includes a first spring configured to, upon activation of the drive assembly, drive the needle carrier assembly in the distal direction to a distal insertion position, and a second spring configured to drive the needle carrier assembly in the proximal direction from the distal insertion position. In some embodiments, the first spring and the second spring are precompressed before activation of the drive assembly. In some embodiments, at least a portion of energy stored in the first spring is transferred to the second spring as the needle carrier assembly is driven in the distal direction to the distal insertion position.
• In some embodiments, the holder includes at least one retention element configured to immobilize the holder to the applicator housing upon the needle carrier assembly reaching the distal insertion position. In some embodiments, the holder further includes a retention element configured to releasably couple the on-skin sensor assembly to the holder as the needle carrier assembly travels in the distal direction to the distal insertion position, and decouple the on-skin sensor assembly from the holder as the needle carrier assembly travels in the proximal direction from the distal insertion position.
• In some embodiments, the holder includes a retention element, which includes a first end and a second end. The first end is immobilized in a guide of the needle carrier assembly thereby releasably coupling the second end to the on-skin sensor assembly as the needle carrier assembly travels in the distal direction to the distal insertion position, and the first end is unseated from the guide of the needle carrier assembly thereby decoupling the second end from the on-skin sensor assembly as the needle carrier assembly travels in the proximal direction from the distal insertion position and separates from the holder.
• In some embodiments, the needle carrier assembly includes a retention element releasably coupling the on-skin sensor assembly to the holder as the needle carrier assembly travels in the distal direction to the distal insertion position, and the retention element is configured to deform sufficiently to decouple from the on-skin sensor assembly as the needle carrier assembly travels in the proximal direction from the distal insertion position and separates from the holder.
• In some embodiments, the holder includes a deformable retention element releasably coupling the on-skin sensor assembly to the holder, the needle carrier assembly in contact with the deformable retention element thereby preventing the deformable retention element from deforming as the needle carrier assembly travels in the distal direction to the distal insertion position. The needle carrier assembly separates from the holder as the needle carrier assembly travels in the proximal direction from the distal insertion position thereby allowing the retention element to deform sufficiently to decouple from the on-skin sensor assembly.
• In some embodiments, the needle carrier assembly includes a first retention element configured to releasably couple the holder to the needle carrier assembly, and a second retention element configured to releasably couple the on-skin sensor assembly to one of the holder and the needle carrier assembly.
• In some embodiments, the insertion element includes a C-needle having flared edges. In some embodiments, the insertion element includes a deflected-tip needle. In some embodiments, the insertion element includes a needle having a curvilinear profile configured to substantially track a path of insertion of the needle. In some embodiments, the insertion element includes a needle and the needle carrier assembly further includes a needle hub configured as a pass through for the needle during insertion of the sensor and is further configured to enclose a tip of the needle after insertion of the sensor. The insertion element further includes a needle spring configured to drive the needle hub to the tip of the needle after insertion of the sensor.
• In some embodiments, the on-skin sensor assembly includes a fill port configured to receive a fluid or gel and a cannula configured to deliver the fluid or gel through the skin of the host.
• In some embodiments, the applicator further includes an elastomeric sensor retention element coupled to the applicator housing at a first end and coupled to at least one of the insertion element and the sensor. The elastomeric sensor retention element is configured to retain the sensor within the insertion element prior to activation of the drive assembly. In some embodiments upon activation, the insertion element is configured to progress in the proximal direction such that the elastomeric sensor retention element decouples from the at least one of the insertion element and the sensor.
• In some embodiments, the applicator further includes a sensor retention element, which includes a tab configured to retain the sensor within the insertion element prior to activation of the drive assembly.
• In some embodiments, the applicator further includes a sensor retention element disposed against at least one of the insertion element and the sensor in a first position and configured to rotate away from the insertion element and the sensor in a second position.
• In some embodiments, the applicator further includes a sensor retention sleeve disposed around at least a portion of the insertion element and the sensor. The needle carrier assembly includes a tapered needle hub configured to split the sensor retention sleeve during insertion of the sensor.
• In some embodiments, the sensor includes a strain relief feature configured to limit the sensor from bending at a bend radius smaller than a predetermined bend radius. In some embodiments, the strain relief feature includes an elastomeric material.
• In some embodiments, the on-skin sensor assembly includes an open cavity configured to receive the sensor and provide an area for the sensor to bend from extending in a substantially horizontal direction to extending in a substantially vertical direction. In some embodiments, the open cavity is configured to guide bodily fluid released from the host as a result of insertion of the sensor at least partially into the skin of the host. In some embodiments, the on-skin sensor assembly includes a wicking material configured to absorb a bodily fluid released from the host as a result of insertion of the sensor at least partially into the skin of the host.
• In a fifteenth aspect, a method for applying an on-skin sensor assembly to skin of a host is provided. The method includes providing an applicator, which includes an applicator housing, a needle carrier assembly includes an insertion element configured to insert a sensor of the on-skin sensor assembly into the skin of the host, a holder releasably coupled to the needle carrier assembly and configured to guide the on-skin sensor assembly while coupled to the needle carrier assembly and a drive assembly and an activation element. The method includes activating the activation element, wherein activating the activation element causes the drive assembly to drive the insertion element in a distal direction to a distal insertion position and in a proximal direction from the distal insertion position to a proximal retraction position, thereby inserting the sensor of the on-skin sensor assembly at least partially into the skin of the host. In some embodiments, the distal direction and the proximal direction extend along an insertion axis of the insertion element.
• In some embodiments, the applicator housing includes a guide. The drive assembly includes a rotating drive element coupled to the needle carrier assembly and includes a pin configured to travel in the guide during rotation of the rotating drive element, and a spring configured to, upon activation of the drive assembly, rotate the rotating drive element in a single rotational direction thereby driving the insertion element from the proximal starting position to the distal insertion position, and from the distal insertion position to the proximal retraction position. In some embodiments, the rotating drive element is configured to convert rotational motion into linear motion. In some embodiments, the rotating drive element includes a wheel cam. In some embodiments, the pin is radially offset from an axis of rotation of the rotating drive element. In some embodiments, the pin is positioned approximately 30 degrees from a bottom center orientation relative to the axis of rotation of the rotating drive element when the insertion element is in the proximal starting position. In some embodiments, the pin is positioned approximately 180 degrees from a bottom center orientation relative to the axis of rotation of the rotating drive element when the insertion element is in the distal insertion position. In some embodiments, the pin is positioned approximately 330 degrees from a bottom center orientation relative to the axis of rotation of the rotating drive element when the needle carrier assembly is in the proximal retracted position. In some embodiments, the guide includes a slot.
• In some embodiments, the drive assembly includes a torsion spring, the torsion spring includes a first end coupled to the applicator housing, and a second end coupled to the needle carrier assembly. Upon activation of the drive assembly, the first end and the second end unwind in opposite directions, thereby driving the insertion element from the proximal starting position to the distal insertion position, and from the distal insertion position to the proximal retraction position. In some embodiments, the first end and the second end unwinding in opposite directions drives the torsion spring in an arc. In some embodiments, the arc extends in a direction perpendicular to the distal direction and the proximal direction.
• In some embodiments, the drive assembly includes an insertion spring configured to, upon activation of the drive assembly, drive the insertion element in the distal direction to the distal insertion position, and a retraction spring in contact with the needle carrier assembly and configured to drive the insertion element from the distal insertion position to the proximal retracted position. In some embodiments, the insertion spring includes a compression spring. In some embodiments, the retraction spring includes a leaf spring. In some embodiments, upon activation of the drive assembly, a portion of energy stored in the insertion spring is transferred to the retraction spring as the insertion spring drives the insertion element in the distal direction. In some embodiments, the insertion spring includes a first end coupled to the applicator housing and a second end coupled to the holder. The holder is coupled to the needle carrier assembly while the insertion spring drives the insertion element in the distal direction to the distal insertion position and decoupled from the needle carrier assembly when the retraction spring drives the insertion element in the proximal direction from the distal insertion position. In some embodiments, the insertion element is configured to travel in an arc when driven in the distal direction and in the proximal direction.
• In some embodiments, the drive assembly includes a rotating drive element, which includes a ridge configured to slide along a channel in the needle carrier assembly, the ridge defining a variable cam path around at least a portion of a circumference of the rotating drive element, and a torsion spring configured to, upon activation of the drive assembly, rotate the rotating drive element thereby driving the insertion element in a distal direction to a distal insertion position and in a proximal direction from the distal insertion position based on the variable cam path. In some embodiments, the torsion spring is configured to, upon activation of the drive assembly, rotate the rotating drive element in a single direction through an angle of greater than zero degrees and less than 360 degrees. In some embodiments, the rotating drive element includes a barrel cam. In some embodiments, the rotating drive element is configured to rotate in a plane substantially perpendicular to the proximal direction and the distal direction.
• In some embodiments, the drive assembly includes a guide member coupled to the applicator housing, a hub configured to slide along the guide member, the hub in contact with a reverse toggling element through a first portion of travel along the guide member and in contact with the needle carrier assembly through a second portion of travel along the guide member. The reverse toggling element includes a fulcrum, a first end in contact with the hub through the first portion of travel along the guide member, and a second end coupled with the needle carrier assembly; The drive assembly further includes a spring configured to, upon activation of the drive assembly, drive the hub in a proximal direction through the first portion of travel along the guide member, thereby driving the insertion element in the distal direction to the distal insertion position, and drive the hub in the proximal direction through the second portion of travel along the guide member, thereby driving the insertion element in the proximal direction from the distal insertion position.
• In some embodiments, the drive assembly includes a first spring configured to, upon activation of the drive assembly, drive the needle carrier assembly in the distal direction to a distal insertion position, and a second spring configured to drive the needle carrier assembly in the proximal direction from the distal insertion position. In some embodiments, at least a portion of energy stored in the first spring is transferred to the second spring as the needle carrier assembly is driven in the distal direction to the distal insertion position.
• In a sixteenth aspect, an applicator for applying an on-skin sensor assembly to a skin of a host is provided. The applicator includes an insertion assembly configured to translate a needle carrier assembly and the on-skin sensor assembly in a distal direction from an initial proximal position to a distal insertion position. The applicator includes a retraction assembly configured to translate the needle carrier assembly in a proximal direction from the distal inserted position to a proximal retracted position. The retraction assembly is configured to activate in response to the on-skin sensor assembly contacting the skin of the host.
• In some embodiments, the insertion assembly includes a first spring. In some embodiments, the retraction assembly includes a second spring. In some embodiments, the insertion assembly further includes a holder configured to guide the needle carrier assembly at least during translation from the initial proximal position to the distal insertion position. In some embodiments, the holder further includes at least one retention element configured to retain the second spring at least during insertion. In some embodiments, the at least one retention element is disposed along an outside of the second coil and configured to contact and retain a coil of the second spring. In some embodiments, the needle carrier assembly further includes at least one backstop feature configured to prevent lateral deflection of the at least one retention element at least during insertion. In some embodiments, the at least one backstop feature is configured not to contact the at least one retention element in the distal insertion position, thereby allowing the second spring to deflect the at least one retention element and activate the retraction assembly. In some embodiments, the second spring is configured to exert a force sufficient to deflect the at least one retention element in the distal insertion position when the on-skin sensor assembly is in contact with the skin of the host. In some embodiments, the applicator further includes an inner housing. In some embodiments, the applicator further includes an outer housing including an activation element configured to activate the insertion assembly. In some embodiments, the activation element is prevented from activating the insertion assembly until the outer housing is translated a predetermined distance in a distal direction with respect to the inner housing. In some embodiments, the inner housing further includes an engagement element and the needle carrier assembly includes a protrusion. The engagement element is configured to engage with the protrusion upon the needle carrier assembly translating in a distal direction beyond a predetermined threshold, thereby preventing the needle carrier assembly from translating in the distal direction beyond the predetermined threshold. In some embodiments, the engagement feature includes a hook. In some embodiments, the needle carrier assembly further includes a hub configured to couple an insertion element to the needle carrier assembly. In some embodiments, the hub is further configured to couple to the on-skin sensor assembly.
• In some embodiments, the insertion assembly and the retraction assembly both include the first spring. In some embodiments, the first spring is configured to exert a force between a holder and a deployment sleeve. In some embodiments, the holder includes at least one retention element configured to immobilize the holder to the deployment sleeve. In some embodiments, the applicator further includes a housing and an activation element configured to deflect the at least one retention element, thereby enabling the first spring to translate the holder, the needle carrier assembly and the on-skin sensor assembly from the proximal position to the distal insertion position. In some embodiments, the housing further includes at least one protrusion, and the deployment sleeve includes at least one retention element configured to contact the at least one protrusion of the housing. In some embodiments, the first spring is configured to exert a force sufficient to deflect the at least one retention element of the deployment sleeve when the on-skin sensor assembly is in contact with the skin of the host, thereby freeing the at least one retention element of the deployment sleeve from the at least one protrusion of the housing. In some embodiments, the first spring is further configured to translate the deployment sleeve in the proximal direction. In some embodiments, the needle carrier assembly further includes a protrusion configured to contact the deployment sleeve, thereby causing the needle carrier assembly to translate in the proximal direction.
• In a seventeenth embodiment, a needle hub for applying an on-skin sensor assembly to a skin of a host is provided. The needle hub includes at least one upper arm. The needle hub includes a base comprising an anti-rotation feature. The base is configured to be at least partially disposed in an aperture of the on-skin sensor assembly. The needle hub is configured to couple with an insertion element.
• In some embodiments, the anti-rotation feature is configured to prevent rotation of the base within the aperture. In some embodiments, the anti-rotation feature includes a key having a shape complementary to at least a portion of the aperture. In some embodiments, the at least one upper arm is configured to be disposed through an aperture in a needle carrier assembly of an applicator. In some embodiments, the at least one upper arm is configured to contact an upper surface of the needle carrier assembly adjacent to the aperture in the needle carrier assembly. In some embodiments, the at least one upper arm is configured to be disposed in a groove in the upper surface of the needle carrier assembly, thereby immobilizing the needle hub with respect to the needle carrier assembly. In some embodiments, the at least one upper arm is flexible. In some embodiments, the at least one upper arm is configured to flex radially inward. In some embodiments, the needle hub further includes at least one lower arm. In some embodiments, the at least one lower arm is configured to contact a lower surface of the needle carrier assembly adjacent to an aperture in the needle carrier assembly. In some embodiments, the insertion element includes a needle. In some embodiments, the needle includes an open side configured to receive a sensor of the on-skin sensor assembly. In some embodiments, the base includes a flat surface configured to mate with a top surface of the on-skin sensor assembly, thereby maintaining the insertion element in a substantially perpendicular orientation to the top surface of the on-skin sensor assembly.
• In an eighteenth embodiment, a method for applying an on-skin sensor assembly to skin of a host is provided. The method includes providing an applicator. The applicator includes a housing comprising an activation element. The applicator includes an insertion assembly. The applicator includes a retraction assembly. The method includes activating the activation element. Activating the activation element causes the insertion assembly to translate a needle carrier assembly and the on-skin sensor assembly in a distal direction from a proximal position to a distal insertion position, thereby inserting a sensor of the on-skin sensor assembly at least partially into the skin of the host. Activating the activation element causes the retraction assembly to translate the needle carrier assembly in a proximal direction from the distal inserted position to a proximal retracted position. The retraction assembly is configured to activate in response to on-skin sensor assembly contacting the skin of the host.
• In some embodiments, the insertion assembly includes a first spring. In some embodiments, the retraction assembly includes a second spring. In some embodiments, the insertion assembly further includes a holder configured to guide the needle carrier assembly at least during translation from the proximal position to the distal insertion position. In some embodiments, the holder further includes at least one retention element configured to retain the second spring at least during insertion. In some embodiments, the at least one retention element is disposed along an outside of the second coil and configured to contact and retain a coil of the second spring. In some embodiments, the needle carrier assembly further includes at least one backstop feature configured to prevent lateral deflection of the at least one retention element at least during insertion. In some embodiments, the at least one backstop feature is configured not to contact the at least one retention element in the distal insertion position, thereby allowing the second spring to deflect the at least one retention element and activate the retraction assembly. In some embodiments, the second spring is configured to exert a force sufficient to deflect the at least one retention element in the distal insertion position when the on-skin sensor assembly is in contact with the skin of the host. In some embodiments, the second spring includes a tang extending along a diameter of second spring and wherein the at least one retention element is disposed along an inside of the second spring and configured to retain the tang of the second spring. In some embodiments, the housing is an outer housing and the applicator further includes an inner housing. In some embodiments, activating the activation element includes translating the outer housing a predetermined distance in a distal direction with respect to the inner housing. In some embodiments, the inner housing further includes an engagement element and the needle carrier assembly includes a protrusion. The engagement element is configured to engage with the protrusion upon the needle carrier assembly translating in a distal direction beyond a predetermined threshold, thereby preventing the needle carrier assembly from translating in the distal direction beyond the predetermined threshold. In some embodiments, the engagement feature includes a hook. In some embodiments, the needle carrier assembly further includes a needle hub configured to couple the insertion element to the needle carrier assembly.
• In some embodiments, the insertion assembly and the retraction assembly both include the first spring. In some embodiments, the first spring is configured to exert a force between a holder and a deployment sleeve. In some embodiments, the holder includes at least one retention element configured to immobilize the holder to the deployment sleeve. In some embodiments, activating the activation element includes deflecting the at least one retention element of the holder, thereby enabling the first spring to translate the holder, the needle carrier assembly and the on-skin sensor assembly from the proximal position to the distal insertion position. In some embodiments, the housing further includes at least one protrusion, and the deployment sleeve includes at least one retention element configured to contact the at least one protrusion of the housing. In some embodiments, the first spring is configured to exert a force sufficient to deflect the at least one retention element of the deployment sleeve when the on-skin sensor assembly is in contact with the skin of the host, thereby freeing the at least one retention element of the deployment sleeve from the at least one protrusion of the housing. In some embodiments, the first spring is further configured to translate the deployment sleeve in the proximal direction. In some embodiments, the needle carrier assembly further includes a protrusion configured to contact the deployment sleeve, thereby causing the needle carrier assembly to translate in the proximal direction.
• In a nineteenth aspect, an applicator for applying an on-skin sensor assembly to a skin of a host is provided. The applicator includes a first body releasably coupled to a needle. The applicator further includes a second body releasably coupled to the first body by a frictional engagement. The applicator further includes a spring configured to provide a first force to the first body and second body. The first force can drive the first body and second body in a distal direction. The frictional engagement can be configured to be decoupled by a counter force applied to the on-skin sensor assembly in an opposite direction of the first force.
• In some embodiments, the applicator further includes at least one retention element configured to frictionally couple the second body to the first body. In some embodiments, the at least one retention element is formed integral with the second body. In some embodiments, the at least one retention element is frictionally engaged against a wall of the first body. In some embodiments, the counter force decouples the frictional engagement by displacing the at least one retention element from the wall of the first body. In some embodiments, the wall is a backstop. In some embodiments, the wall is configured to prevent the at least one retention element from deflecting.
• In some embodiments, the frictional engagement is decoupled by the counter force exceeding a force threshold. In some embodiments, the force threshold is determined by the frictional force between the at least one retention element and the first body. In some embodiments, the threshold is at least 0.5 lbf. In some embodiments, the threshold is at least 1 lbf.
• In some embodiments, the first body is configured to retract in a proximal direction upon decoupling of the frictional engagement. In some embodiments, the applicator further includes a second spring. The second spring can be configured to drive the first body in a proximal direction. In some embodiments, the second spring is retained from release by at least one retention element of the second body.
• In some embodiments, the decoupling of the frictional engagement is configured to be independent of a distance between the on-skin sensor assembly and a distal end of the applicator. In some embodiments, the first body is configured to retract independent of the distance between the on-skin sensor assembly and the distal end of the applicator. In some embodiments, the counter force applied to the on-skin sensor assembly is provided by the skin of the host opposing the first force. In some embodiments, an interior of the applicator is configured to allow the skin of the host to reside within the interior. In some embodiments, the needle is configured to be inserted into the skin a predetermined depth. In some embodiments, the frictional engagement is configured to decouple at a range of distances between the on-skin sensor assembly and a distal end of the applicator.
• This Summary is provided to introduce a selection of concepts further described in the Detailed Description section. Elements or steps other than those described in this Summary are possible, and no element or step is necessarily required. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended for use as an aid in determining the scope of the claimed subject matter. The claimed subject matter is not limited to implementations that solve any or all disadvantages noted in any part of this disclosure.
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.
• FIGS. 2A-2B illustrate perspective views of an on-skin sensor assembly, according to some embodiments.
• FIGS. 3A-3B illustrate perspective views of another on-skin sensor assembly, according to some embodiments.
• FIG. 4 illustrates a cross-sectional view of the on-skin sensor assembly ofFIGS. 3A-3B, according to some embodiments.
• FIG. 5 illustrates an exploded perspective view of the applicator ofFIG. 5, according to some embodiments.
• FIG. 6A-6H illustrate cutaway views and perspective views of several features of the applicator ofFIG. 5, according to some embodiments.
• FIGS. 7A-7F illustrate several cutaway views of the applicator ofFIG. 5 during operation, according to some embodiments.
• FIG. 8 illustrates a cutaway view of an applicator similar to the applicator ofFIG. 5, however, including an activation element on an upper side of an applicator housing, according to some embodiments.
• FIG. 9 illustrates a cutaway view of an applicator similar to the applicator ofFIG. 5, however, including an activation element on a medial side of an applicator housing, according to some embodiments.
• FIG. 10 illustrates a cutaway view of an applicator similar to the applicator ofFIG. 5, however, including an activation element on a lower side of an applicator housing, according to some embodiments.
• FIGS. 11A-11D and 11J illustrate perspective views whileFIGS. 11E-11H illustrate side cutaway views of steps for assembling the applicator ofFIG. 5, according to some embodiments.
• FIG. 12 illustrates an exploded perspective view of another applicator for an on-skin sensor assembly of an analyte sensor system, according to some embodiments.
• FIG. 13A-13F illustrate perspective views and cutaway views of several features of the applicator ofFIG. 12, according to some embodiments.
• FIGS. 14A-14E illustrate several cross-sectional views of the applicator ofFIG. 12 during operation, according to some embodiments.
• FIG. 15 illustrates a perspective view of an exemplary double torsional spring for use in an applicator for an on-skin sensor assembly of an analyte sensor system, according to some embodiments.
• FIG. 16 illustrates a perspective view of another exemplary double torsional spring for use in an applicator for an on-skin sensor assembly of an analyte sensor system, according to some embodiments.
• FIG. 17 illustrates a perspective view of yet another exemplary double torsional spring for use in an applicator for an on-skin sensor assembly of an analyte sensor system, according to some embodiments.
• FIG. 18 illustrates a cutaway view of an alternative driving mechanism including a torsional spring and a living hinge for the applicator ofFIG. 12, according to some embodiments.
• FIG. 19 illustrates a cutaway view of another alternative driving mechanism including a torsional spring and a living hinge for the applicator ofFIG. 12, according to some embodiments.
• FIG. 20 illustrates a cutaway view of yet another alternative driving mechanism including a torsional spring and a living hinge for the applicator ofFIG. 12, according to some embodiments.
• FIG. 21 illustrates a cutaway view of yet another alternative driving mechanism including an extension spring and a living hinge for the applicator ofFIG. 12, according to some embodiments.
• FIG. 22 illustrates a cutaway view of yet another alternative driving mechanism including a leaf spring for the applicator ofFIG. 12, according to some embodiments.
• FIG. 23 illustrates a cutaway view of yet another alternative driving mechanism including a leaf spring and a living hinge for the applicator ofFIG. 12, according to some embodiments.
• FIGS. 24A-24F, 2411, 24J and 24L-24M illustrate cross-sectional views whileFIGS. 24G and 24K illustrate perspective views of steps for assembling the applicator ofFIG. 12, according to some embodiments.
• FIG. 25 illustrates an exploded perspective view of yet another applicator for an on-skin sensor assembly of an analyte sensor system, according to some embodiments.
• FIG. 26A-26D illustrate several cutaway perspective views and a bottom view of several features of the applicator ofFIG. 25, according to some embodiments.
• FIGS. 27A-27E illustrate several cross-sectional views of the applicator ofFIG. 25 during operation, according to some embodiments.
• FIGS. 28A-28C and 28H illustrate several perspective views whileFIGS. 28D-28G illustrate cross-sectional views of assembling the applicator ofFIG. 25, according to some embodiments.
• FIG. 29 illustrates an exploded perspective view of an applicator for an on-skin sensor assembly of an analyte sensor system, according to some embodiments.
• FIG. 30 illustrates a cutaway view of a portion of the applicator ofFIG. 29, according to some embodiments.
• FIG. 31 illustrates a cutaway view of yet another applicator for an on-skin sensor assembly of an analyte sensor system, according to some embodiments.
• FIGS. 32A-34B illustrate exploded perspective views of yet another applicator for an on-skin sensor assembly of an analyte sensor system, according to some embodiments.
• FIGS. 33A-33E illustrate several perspective cutaway views of several features of the applicator ofFIG. 32, according to some embodiments.
• FIG. 34A-34D illustrate several cross-sectional views of the applicator ofFIG. 32 during operation, according to some embodiments.
• FIG. 35A-35C illustrate cross-sectional views of an on-skin sensor assembly retention mechanism of the applicator ofFIG. 32, according to some embodiments.
• FIG. 36A-36C illustrate cross-sectional views of another on-skin sensor assembly retention mechanism of the applicator ofFIG. 32, according to some embodiments.
• FIG. 37A-37C illustrate cross-sectional views of yet another on-skin sensor assembly retention mechanism of the applicator ofFIG. 32, according to some embodiments.
• FIG. 38 illustrates a perspective view of an applicator similar to those shown inFIG. 32, including an activation element on a side of the housing, according to some embodiments.
• FIG. 39 illustrates a cutaway perspective view of a portion of the applicator ofFIG. 38, according to some embodiments.
• FIGS. 40A-40G illustrate several perspective views of steps for assembling the applicator ofFIG. 32, according to some embodiments.
• FIGS. 41A-41B illustrate cross-sectional views an exemplary on-skin sensor assembly retention mechanism of an applicator for an analyte sensor system, according to some embodiments.
• FIGS. 42A-42B illustrate cross-sectional views of another exemplary on-skin sensor assembly retention mechanism of an applicator for an analyte sensor system, according to some embodiments.
• FIGS. 43A-43B illustrate cross-sectional views of yet another exemplary on-skin sensor assembly retention mechanism of an applicator for an analyte sensor system, according to some embodiments.
• FIG. 44 illustrates a perspective view of a portion of another exemplary on-skin sensor assembly retention mechanism of an applicator for an analyte sensor system, according to some embodiments.
• FIG. 45 illustrates a perspective view of portion of an exemplary on-skin sensor assembly retention mechanism of an applicator for an analyte sensor system, according to some embodiments.
• FIG. 46 illustrates a perspective view of a portion of an exemplary on-skin sensor assembly retention mechanism of an applicator for an analyte sensor system, according to some embodiments.
• FIG. 47 illustrates a cross-section of a kinked needle for use in an applicator for an analyte sensor system, according to some embodiments.
• FIGS. 48A-48B illustrate a cross-section and a plan view, respectively, of a flared C-needle for use in an applicator for an analyte sensor system, according to some embodiments.
• FIG. 49 illustrates a perspective view of a deflected-tip needle for use in an applicator for an analyte sensor system, according to some embodiments.
• FIG. 50 illustrates a perspective view of a curved needle for use in an applicator for an analyte sensor system, according to some embodiments.
• FIGS. 51A-51B illustrate cutaway views of a needle hub of an applicator for an analyte sensor system, according to some embodiments.
• FIGS. 52A-52B illustrate a cross-sectional view and a plan view, respectively, of an infusion cannula integrated into an on-skin sensor assembly of an analyte sensor system, according to some embodiments.
• FIG. 53 illustrates a cross-sectional view of a sensor retention mechanism for an applicator for an analyte sensor system, according to some embodiments.
• FIG. 54 illustrates a perspective view of another sensor retention mechanism for an applicator for an analyte sensor system, according to some embodiments.
• FIG. 55 illustrates a cutaway view of another sensor retention mechanism for an applicator for an analyte sensor system, according to some embodiments.
• FIGS. 56A-56B illustrate perspective views of another sensor retention element for an applicator for an analyte sensor system, according to some embodiments.
• FIG. 57 illustrates a cross-sectional view of yet another sensor retention element for an applicator for an analyte sensor system, according to some embodiments.
• FIG. 58 illustrates a cross-sectional view of yet another sensor retention element for an applicator for an analyte sensor system, according to some embodiments.
• FIGS. 59A-59B illustrate cross-sectional views of yet another sensor retention element for an applicator for an analyte sensor system, according to some embodiments.
• FIG. 60 illustrates a cutaway view of an on-skin sensor assembly having at least a portion of a sensor potted in a flexible material, according to some embodiments.
• FIG. 61 illustrates a cutaway view of an on-skin sensor assembly comprising an open cavity configured to allow a larger bend radius in a sensor, according to some embodiments.
• FIG. 62 illustrates a cutaway view of an on-skin sensor assembly comprising an open cavity configured to allow a larger bend radius in a sensor, according to some embodiments.
• FIG. 63 illustrates a cutaway view of an on-skin sensor assembly comprising an open cavity configured to allow a larger bend radius in a sensor, according to some embodiments.
• FIGS. 64A-64B illustrate a battery engagement feature for an on-skin sensor assembly, according to some embodiments.
• FIG. 65 illustrates a flowchart of a method for applying an on-skin sensor assembly to skin of a host, according to some embodiments.
• FIG. 66 illustrates exemplary mechanisms for several features of an applicator configured to apply an on-skin sensor assembly to skin of a host, according to some embodiments.
• FIG. 67 illustrates exemplary sterilization, packaging and sealing features of an applicator configured to apply an on-skin sensor assembly to skin of a host, according to some embodiments.
• FIG. 68 illustrates a top perspective view of an on-skin sensor assembly, according to some embodiments.
• FIG. 69 illustrates a bottom perspective view of the on-skin sensor assembly ofFIG. 68, according to some embodiments.
• FIG. 70 illustrates a cross-sectional view of the on-skin sensor assembly ofFIG. 68, according to some embodiments.
• FIG. 71 illustrates yet another applicator for an on-skin sensor assembly of an analyte sensor system, according to some embodiments.
• FIG. 72 illustrates an exploded perspective view of the applicator ofFIG. 71, according to some embodiments.
• FIGS. 73A-73C illustrate several cross-sectional views of the applicator ofFIGS. 71 and 72, taken along the section line A-A′ ofFIG. 71, during operation, according to some embodiments.
• FIGS. 74A-74C illustrate several cross-sectional views of the applicator ofFIGS. 71 and 72, taken along the section line B-B′ ofFIG. 71, during operation, according to some embodiments.
• FIGS. 75A and 75B illustrate magnified views of some features of the applicator ofFIGS. 71 and 72, according to some embodiments.
• FIGS. 76A and 76B illustrate magnified views of some features of the applicator ofFIGS. 71 and 72, according to some embodiments.
• FIG. 77 illustrates a perspective partial cutaway view of the needle carrier assembly, hub, and on-skin sensor assembly of the applicator ofFIGS. 71 and 72, according to some embodiments.
• FIG. 78 illustrates a cross-sectional view of the hub and on-skin sensor assembly of the applicator ofFIGS. 71 and 72, according to some embodiments.
• FIG. 79 illustrates a top view of a portion of the needle carrier assembly and hub ofFIGS. 71 and 72, according to some embodiments.
• FIGS. 80A and 80B illustrate perspective views of locking features for needles for use in an applicator for an analyte sensor system, according to some embodiments.
• FIGS. 81A-81C illustrate several cross-sectional views, and various features and operating positions, of yet another applicator for an on-skin sensor assembly of an analyte sensor system, according to some embodiments.
• FIG. 81D illustrates a perspective view of various features of the applicator ofFIGS. 81A-81D, according to some embodiments.
• FIGS. 82A-82D illustrate several cross-sectional views, and various features and operating positions, of yet another applicator for an on-skin sensor assembly of an analyte sensor system, according to some embodiments.
• FIG. 83 illustrates a cross-sectional view of an applicator comprising a deformable layer disposed over an activation element, according to some embodiments.
• FIG. 84 illustrates a perspective view of an applicator utilizing a twist-to-activate activation mechanism, according to some embodiments.
• FIG. 85 illustrates a cross-sectional view of an applicator comprising a top-mounted activation element, according to some embodiments.
• FIG. 86 illustrates relationships between the axle, insertion element, and a circular arc travelled by the insertion element of at leastFIG. 26C during insertion and retraction, according to some embodiments.
• FIG. 87 illustrates a cross-sectional view of on-skin sensor assembly ofFIGS. 3A, 3B and 4, further comprising anupper patch328, according to some embodiments.
• FIGS. 88A-88B illustrate perspective views of another optional battery connection feature for an on-skin sensor assembly, in accordance with some embodiments.
• FIG. 89 illustrates a flowchart of another method for applying an on-skin sensor assembly to skin of a host, according to some embodiments.
• FIG. 90 illustrates a magnified view of some features of the applicator ofFIGS. 71 and 72, according to some embodiments.
• FIG. 91 illustrates a perspective view of an on-skin sensor assembly, according to some embodiments
DETAILED DESCRIPTION
• The following description and examples illustrate some example embodiments in detail. Those of skill in the art will recognize that there are numerous variations and modifications of this disclosure encompassed by its scope. Accordingly, the description of a certain example embodiment should not be deemed to limit the scope of the present disclosure.
System Introduction
• FIG. 1 is a diagram depicting an example continuousanalyte monitoring system100 including ananalyte sensor system102 comprising an on-skin sensor assembly160 configured to be fastened to the skin of a host via a base (not shown).Analyte sensor system102 is operatively connected to a host and a plurality of display devices110-114 according to certain aspects of the present disclosure. Example display devices110-114 may include computers such as smartphones, smartwatches, tablet computers, laptop computers, and desktop computers. In some embodiments, display devices110-114 may be Apple Watches, iPhones, and iPads made by Apple Inc., or Windows or Google devices. It should be noted thatdisplay device114 alternatively or in addition to being a display device, may be a medicament delivery device that can act cooperatively withanalyte sensor system102 to deliver medicaments to the host.Analyte sensor system102 may include asensor electronics module140 and acontinuous analyte sensor138 associated withsensor electronics module140.Sensor electronics module140 may be in direct wireless communication with one or more of the plurality of display devices110-114 via wireless communications signals. As will be discussed in greater detail below, display devices110-114 may also communicate amongst each other and/or through each other to analytesensor system102. For ease of reference, wireless communications signals fromanalyte sensor system102 to display devices110-114 can be referred to as “uplink” signals128. Wireless communications signals from, e.g., display devices110-114 toanalyte sensor system102 can be referred to as “downlink” signals130. Wireless communication signals between two or more of display devices110-114 may be referred to as “crosslink” signals132. Additionally, wireless communication signals can include data transmitted by one or more of display devices110-113 via “long-range” uplink signals136 (e.g., cellular signals) to one or moreremote servers190 or network entities, such as cloud-based servers or databases, and receive long-range downlink signals142 transmitted byremote servers190.
• In embodiments shown byFIG. 1, one of the plurality of display devices may be acustom display device111 specially designed for displaying certain types of displayable sensor information associated with analyte values received from the sensor electronics module126 (e.g., a numerical value and an arrow, in some embodiments). In some embodiments, one of the plurality of display devices may be ahandheld device112, such as a mobile phone based on the Android, iOS operating system or other operating system, a palm-top computer and the like, wherehandheld device112 may have a relatively larger display and be configured to display a graphical representation of the continuous sensor data (e.g., including current and historic data). Other display devices can include other hand-held devices, such as atablet113, asmart watch110, amedicament delivery device114, a blood glucose meter, and/or a desktop or laptop computer.
• It should be understood that in the case of display device134e, which may be a medicament delivery device in addition to or instead of a display device, the alerts and/or sensor information provided bycontinuous analyte sensor122 vis-à-vis sensor electronics module126, can be used to initiate and/or regulate the delivery of the medicament to host120.
• During use, a sensing portion ofsensor138 may be disposed under the host's skin and a contact portion ofsensor138 can be electrically connected toelectronics unit140.Electronics unit140 can be engaged with a housing (e.g., a base) which is attached to an adhesive patch fastened to the skin of the host. In some embodiments,electronics unit140 is integrally formed with the housing. Furthermore,electronics unit140 may be disposable and directly coupled to the adhesive patch.
• 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,analyte 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,sensor 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, and/or 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.
• 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 maintainsensor138 on, in or under the skin and/or can provide for electrical connection ofsensor138 to sensor electronics inelectronics unit140.
• In some embodiments, description of a base, a housing, a wearable, and/or a transmitter of on-skin sensor assembly160 may be interchangeable. In other embodiments, a base and a housing of on-skin sensor assembly160 may be different in the sense that they may be separate components fromsensor electronics module140, e.g., from a transmitter or receiver.
• In several embodiments,sensor138 is in a form of a wire. A distal end of the wire can be formed, e.g., having a conical shape (to facilitate inserting the wire into the tissue of the host).Sensor138 can include an elongated conductive body, such as an elongated conductive core (e.g., a metal wire) or an elongated conductive core coated with one, two, three, four, five, or more layers of material, each of which may 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, less than 0.002 inches, less than 0.001 inches, and/or less than 0.0005 inches.
• Sensor138 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. In other embodiments,sensor138 may be disposed on a substantially planar substrate. 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 140 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 58 kPsi and less than 2200 kPsi.
• Electronics unit140 can be releasably or permanently coupled tosensor138.Electronics unit140 can include electronic circuitry associated with measuring and processing the continuous analyte sensor data.Electronics unit140 can be configured to perform algorithms associated with processing and calibration of the sensor data. For example,electronics unit140 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.Electronics unit140 may include hardware, firmware, and/or software that enable measurement of levels of the analyte via a glucose sensor, such assensor138.
• For example,electronics unit140 can include a potentiostat, a power source for providing power tosensor138, signal processing components, data storage components, and a communication module (e.g., a telemetry module) for one-way or two-way data communication betweenelectronics unit140 and one or more receivers, repeaters, and/or display devices, such as devices110-114. Electronic components can be affixed to a printed circuit board (PCB), or the like, and can take a variety of forms. The electronic components can take the form of an integrated circuit (IC), such as an Application-Specific Integrated Circuit (ASIC), a microcontroller, and/or a processor. Theelectronics unit140 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.Electronics unit140 may communicate with the devices110-114, and/or any number of additional devices, via any suitable communication protocol. Example communication methods or protocols include radio frequency; Bluetooth; universal serial bus; any of the wireless local area network (WLAN) communication standards, including 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; a proprietary communication protocol, open source communication protocol, and/or any suitable wireless communication method.
• 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. 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 β-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, β); 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, vesicularstomatisvirus,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 may use an adhesive to couple a base or housing, a sensor module, a transmitter or electronics unit, 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.
• As noted above, systems can apply an on-skin sensor assembly to the skin of a host. The on-skin sensor assembly may include a base that comprises an adhesive to couple a glucose sensor to the skin. Other methods are contemplated such as a strap, e.g., a watch band.
• Any of the features described in the context of at leastFIG. 1 can be 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.
• Throughout this disclosure, reference is made to an on-skin sensor assembly, which may also be described as a wearable. Such on-skin sensor assemblies (seeFIGS. 1-4 and 68-70) may be disposable or reusable and may (seeFIGS. 68-70) or may not (seeFIGS. 2-4) comprise a base or base plate. In some embodiments, on-skin sensor assemblies having a base plate (e.g.,FIGS. 68-70) may be reusable, whereas on-skin sensor assemblies without a base plate (e.g.,FIGS. 2-4) may be disposable. AlthoughFIG. 1 has already been discussed with respect to on-skin sensor assembly160,FIGS. 2A-4 and 68-70 describe at least some other embodiments of an on-skin sensor assembly.
• FIG. 2A illustrates a perspective view of an on-skin sensor assembly260, in accordance with some embodiments. On-skin sensor assembly260 may comprise an outer housing comprising a first,top portion292 and a second,lower portion294. In some embodiments, the outer housing may comprise a clamshell design. On-skin sensor assembly260 may include similar components aselectronics unit140 described above inFIG. 1 (e.g. a potentiostat, a power source for providing power tosensor138, signal processing components, data storage components, and a communication module (e.g., a telemetry module) for one-way or two-way data communication, a printed circuit board (PCB), an integrated circuit (IC), an Application-Specific Integrated Circuit (ASIC), a microcontroller, and/or a processor). The outer housing may feature a large rounded body having tapered end opposite the large rounded body. The outer housing may further comprise anaperture296 disposed at the tapered end of the outer housing and adapted forsensor238 and needle insertion.Aperture296 may be an opening featuring a U-shaped channel extending through the tapered end of the outer housing. On-skin sensor assembly260 may further comprise anadhesive patch226 configured to secure on-skin sensor assembly260 to skin of the host. As shown,adhesive patch226 may feature anaperture298 having a similar shape asaperture296 and substantially aligned withaperture296.Sensor238 may be configured to at least partially extend throughapertures296 and298. In some embodiments,adhesive patch226 may comprise an adhesive suitable for skin adhesion, for example a pressure sensitive adhesive (e.g., acrylic, rubber-based, or other suitable type) bonded to a carrier substrate (e.g., spun lace polyester, polyurethane film, or other suitable type) for skin attachment, though any suitable type of adhesive is also contemplated.
• On-skin sensor assembly260 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 insertingsensor238 through the host's skin, and/or connectingsensor238 to the electronics unit. Oncesensor238 has been inserted into the skin (and is connected to the electronics unit), the sensor assembly can detach from the applicator.
• FIG. 2B illustrates a bottom perspective view of on-skin sensor assembly260 ofFIG. 2A.FIG. 2B illustratesaperture296 disposed to a side of the outer housing, andaperture298, each adapted forsensor238 and needle insertion.
• FIG. 3A illustrates a perspective view of an on-skin sensor assembly360, in accordance with some embodiments. On-skin sensor assembly360 may comprise an outer housing comprising a first,top portion392 and a second,lower portion394. In some embodiments, the outer housing may comprise a clamshell design. On-skin sensor assembly260 may include similar components aselectronics unit140 described above inFIG. 1 (e.g. a potentiostat, a power source for providing power tosensor138, signal processing components, data storage components, and a communication module (e.g., a telemetry module) for one-way or two-way data communication, a printed circuit board (PCB), an integrated circuit (IC), an Application-Specific Integrated Circuit (ASIC), a microcontroller, and/or a processor). As shown, the outer housing may feature a generally oblong shape. The outer housing may further comprise ansensor assembly aperture396 disposed substantially through a center portion of outer housing and adapted forsensor338 and needle insertion through a bottom of on-skin sensor assembly360. In some embodiments,sensor assembly aperture396 may be a channel or elongated slot. On-skin sensor assembly360 may further comprise anadhesive patch326 configured to secure on-skin sensor assembly360 to skin of the host. In some embodiments,adhesive patch326 may comprise an adhesive suitable for skin adhesion on its underside, for example a pressure sensitive adhesive (e.g., acrylic, rubber-based, or other suitable type) bonded to a carrier substrate (e.g., spun lace polyester, polyurethane film, or other suitable type) for skin attachment, though any suitable type of adhesive is also contemplated. In some embodiments,adhesive patch326 may further comprise an adhesive on its topside, e.g., the non-skin contacting side to aid adherence ofadhesive patch326 to a portion of an associated applicator during manufacture and/or to maintainadhesive patch326 in a substantially flat orientation before deployment to the skin of a host. In some embodiments, the adhesive applied to the topside may be weaker than the adhesive applied to the underside to ensure appropriate transfer of the on-skin sensor assembly to the skin of the host. As shown,adhesive patch396 may feature anaperture398 aligned withsensor assembly aperture396 such thatsensor338 may pass through a bottom of on-skin sensor assembly360 and throughadhesive patch396.
• FIG. 3B illustrates a bottom perspective view of on-skin sensor assembly360 ofFIG. 3A.FIG. 3B further illustratessensor assembly aperture396 disposed substantially in a center portion of a bottom of on-skin sensor assembly360, andaperture398, both adapted forsensor338 and needle insertion.
• FIG. 91 illustrates a perspective view of an on-skin sensor assembly9160, according to some embodiments. On-skin sensor assembly9160 may be substantially similar to other on-skin sensor assemblies described in this application, such as on-skin sensor assemblies160,260, and360. On-skin sensor assembly9160 may feature anadhesive patch9126 and a clamshell design comprising a top shell and a bottom shell, similar to on-skin sensor assembly360. Further, on-skin sensor assembly9160 may include a plurality ofattachment points9162aand9162b, similar to on-skin sensor assembly160. On-skin sensor assembly9160 may include anaperture9296.Aperture9296 may be a through-hole extending through on-skin sensor assembly9160.Aperture9296 may be configured to allow a needle and/or sensor to pass through. In some embodiments, on-skin sensor assembly9160 may further include anaperture9294.Aperture9294 may extend from a top surface of on-skin sensor assembly9150 a certain depth through on-skin sensor assembly9160. In some embodiments,aperture9294 is configured to engage with an anti-rotational feature such asbase7152 ofneedle hub7150 described inFIG. 78.
• In some embodiments, on-skin sensor assembly9160 includes anidentification tag9150.Identification tag9150 may be located on a top surface of on-skin sensor assembly9150 (as shown), or on a side surface of on-skin sensor assembly.Identification tag9150 may be an image which resembles a logo or mark identifying the manufacturer of the on-skin sensor assembly. Additionally,identification tag9150 may be configured to be scanned by a user to pair the on-skin sensor assembly with a device, such ashandheld device112. In some embodiments,identification tag9150 is a code such as, but not limited to, a QR code, a matrix code, a 2-D barcode, or a 3-D barcode. The code may be imbedded in the image ofidentification tag9150.
• FIG. 4 illustrates a cross-sectional view of on-skin sensor assembly360 ofFIGS. 3A and 3B.FIG. 4 illustrates the first,top portion392 and the second,bottom portion394 of the outer housing,adhesive patch326,sensor assembly aperture396 in the center portion of on-skin sensor assembly360,aperture398 in the center portion ofadhesive patch326, andsensor338 passing throughsensor assembly aperture396. The electronics unit, previously described in connection withFIG. 3A, may further include acircuit board404 and abattery402 configured to provide power to atleast circuit board404.
• FIG. 87 illustrates a cross-sectional view of on-skin sensor assembly360 ofFIGS. 3A, 3B and 4, further comprising anupper patch328, according to some embodiments.Upper patch328 may comprise an adhesive suitable for skin adhesion, device adhesion, or a combination thereof, on its underside, for example a pressure sensitive adhesive (e.g., acrylic, rubber-based, or other suitable type) bonded to a carrier substrate (e.g., spun lace polyester, polyurethane film, or other suitable type) for skin and/or device attachment, though any suitable type of adhesive is also contemplated. In some embodiments, such an adhesive may be the same as the adhesive applied to the underside ofpatch326. In some other embodiments, the adhesive may be different from the adhesive applied to the underside ofpatch326. In some embodiments,upper patch328 may be shaped as a circle, oval, partial strip, as an X, or as any other shape or form suitable for securingupper patch328 tolower patch326 and/or the skin of the host. Theupper patch328 may fully or partially cover on-skin sensor assembly360. Theupper patch328 may improve adhesion lifespan of on-skin sensor assembly360 onskin130 of the host by adding additional adhesive contact area to the surface of theskin130 and/or providing a single surface covering the wearable that reduces the risk of inadvertent mechanical removal (e.g. catching, snagging, tearing) by reducing catch surfaces/edges on on-skin sensor assembly360. It is contemplated that reducing surfaces of on-skin sensor assembly360 that are substantially perpendicular to the body surfaces may improve catch resistance. Such increased wearable lifespan provided byupper patch328 may be a valuable property, especially as systems move toward and beyond 10-14 day wearable adhesion solutions.
• In some embodiments,upper patch328 may be assembled into any applicator in this description, above on-skin sensor assembly360, with underside adhesive exposed. Upon deployment of on-skin sensor assembly360 by the applicator,patch326 may adhere to skin130 of the host andupper patch328 may be adhered over on-skin sensor assembly360 and ontoskin130 of the host by one or more features of the applicator, for example, a holder and/or needle carrier assembly as described in connection with any figure herein.
Applicator Embodiments
• FIG. 5 illustrates an exploded perspective view of anapplicator500 for applying on-skin sensor assembly160 toskin130 of a host, according to some embodiments. In some embodiments,applicator500 may include anapplicator housing502 having an opening at its bottom and configured to house at least one or more mechanisms utilized to apply on-skin sensor assembly160 toskin130 of a host.Applicator housing502 may be formed of any suitable material, e.g., a polymer, polycarbonate, ABS, nylon, polyethylene, polypropylene, etc. In some embodiments,applicator housing502 may be configured to cover at least one feature ofapplicator housing502, for example a guide of a reciprocating or back and forth mechanism, e.g., a scotch-yoke mechanism (seeFIG. 6B).
• Applicator500 includes anactivation element504 configured to activate a drive assembly ofapplicator500. In some embodiments,activation element504 may be a button, a switch, a toggle, a slide, a trigger, a knob, a rotating member, a component that deforms and/or flexes or any other suitable mechanism for activating a drive assembly ofapplicator500.
• Applicator500 may further comprise aneedle carrier assembly508, including an insertion element (not shown inFIG. 5) configured to insertsensor138 of on-skin sensor assembly160 (e.g.,FIG. 1) at least partially intoskin130 of the host. The insertion element is further illustrated inFIG. 6H as attaching toneedle carrier assembly508 and extending in the distal direction, substantially along an axis of insertion. In some embodiments,needle carrier assembly508 comprises a needle carrier or shuttle. In some embodiments, the insertion element comprises a needle, for example, an open sided-needle, a deflected-tip needle with a deflected-tip, a curved needle, a polymer-coated needle, a hypodermic needle, or any other suitable type of needle or structure, as will be described in more detail in connection with at leastFIGS. 47-50 and 80A-B. In yet other embodiments, insertion element may comprisesensor138 itself, sufficiently rigid to be inserted partially intoskin130 of the host with minimal or no structural support, such as described in U.S. Pat. No. 9,357,951, which was filed on Sep. 29, 2010, U.S. Patent Publication No.US 2014/0107450, which was filed on Feb. 28, 2013, and U.S. Patent Publication No. US 2015/0289788, which was filed on Apr. 10, 2014. The entire contents of U.S. Pat. No. 9,357,951, U.S. Patent Publication No. 2014/0107450, and U.S. Patent Publication No. 2015/0289788 are incorporated by reference herein.
• Applicator500 may further comprise adrive assembly510 configured to drive the insertion element ofneedle carrier assembly508 in a distal direction to a distal insertion position and in a proximal direction from the distal insertion position to a proximal retraction position. A distal direction may be defined as extending towards an open-ended side of theapplicator500 along a pathneedle carrier assembly508 is configured to travel. The distal direction may also be defined as towards the skin of a user. A proximal direction may be defined as a direction extending in a substantially opposite direction from the distal direction. In some embodiments, the distal direction and the proximal direction extend along an insertion axis of the insertion element and ofneedle carrier assembly508.
• Drive assembly510 may include arotating drive element514 coupled toneedle carrier assembly508 via anaxle526. In some embodiments, rotatingdrive element514 comprises a cam feature, e.g., a wheel cam, having a substantially circular or ovoid circumference. Rotatingdrive element514 may be configured to rotate with respect toneedle carrier assembly508 about an axis ofrotation518 coincident with a centerline ofaxle526. Rotatingdrive element514 may further include apin516 disposed at a position on a face of rotatingdrive element514 displaced radially from axis ofrotation518.Pin516 is configured to travel in a guide (seeFIG. 6B) ofapplicator housing502.
• Drive assembly510 may further include aspring512.Spring512 may be a torsion spring, a clock spring, a power spring, or any other suitable type of spring.Spring512 may be formed of any suitable material including but not limited to plastic or metal, e.g., stainless steel. In some embodiments,spring512 is pre-compressed before activation of the applicator. In some embodiments,spring512 is configured to be additionally loaded during activation of the applicator.Spring512 may have afirst end520 coupled toneedle carrier assembly508 and asecond end522 coupled to rotatingdrive element514.Spring512 may be disposed coaxially withaxle526.Spring512 may be configured to, upon activation ofdrive assembly510, rotate rotatingdrive element514 in a single direction with respect toneedle carrier assembly508. In some embodiments,spring512 is configured, upon activation ofdrive assembly510, to unwind by rotating greater than zero degrees and less than 360 degrees. In some embodiments,spring512 is pre-wound between 30 and 1440 degrees.
• By virtue of rotatingdrive element514 being configured to rotate with respect toneedle carrier assembly508, about axis ofrotation518, and pin516 being restrained to travel in the guide ofapplicator housing502, rotational motion of rotatingdrive element514, driven byspring512, is converted into linear, reciprocating motion ofneedle carrier assembly508 alongaxis590 and, therefore, of the insertion element (not shown). More specifically, rotation of rotatingdrive element514 drivesinsertion element508 in the distal direction to the distal insertion position and in the proximal direction from the distal insertion position to the proximal retraction position. Such embodiments may be able to omit handoff mechanisms between aspects ofdrive assembly510 that separately drive theneedle carrier assembly508 in the distal and proximate directions by virtue of a single mechanism that converts rotational motion into reciprocating linear motion.
• Applicator500 may further include aholder524 releasably coupled toneedle carrier assembly508 and configured to guide on-skin sensor assembly160 while coupled toneedle carrier assembly508. In some embodiments,holder524 may also be referred to as a carrier or transport member.
• FIG. 6A-6H illustrates cutaway and perspective views of several features ofapplicator500 ofFIG. 5, according to some embodiments.FIG. 6A illustrates a cutaway view ofapplicator500 includingapplicator housing502,activation element504,needle carrier assembly508, rotatingdrive element514,pin516, andholder524. Each of these components may have functionality as previously described in connection with at leastFIG. 5.
• FIG. 6B illustrates guide582 inapplicator housing502. In some embodiments, guide582 may comprise a scotch-yoke track in whichpin516 is configured to travel upon activation ofdrive assembly510, as rotatingdrive element514 rotates.
• FIG. 6C illustrates a plurality oftracks622a,622b,622cinapplicator housing502 in which a respective one of a plurality of protrusions orribs624a,624b,624cofneedle carrier assembly508 are configured to slide. Accordingly, tracks622a-622cinapplicator housing502 define a path of travel forneedle carrier assembly508. In some embodiments, this path of travel is substantially linear and longitudinal. Although three tracks and protrusions are shown inFIG. 6C, any number of tracks and respective protrusions are contemplated. For ease of understanding,FIG. 6C illustrates a partial bottom view ofapplicator500, which also shows portions of on-skin sensor assembly160 andholder524.
• FIG. 6D illustrates an embodiment whereneedle carrier assembly508 comprises alocking element632 configured to preventrotating drive element514 from rotating. Specifically, rotatingdrive element514 comprises aprotrusion634 in contact withretention element632, which preventsprotrusion634 from traveling in a path it would otherwise take asspring512 releases at least a portion of its stored energy in rotatingdrive element514. In some embodiments,retention element632 comprises a deflectable tab formed of a material such as a polymer, polycarbonate, ABS, nylon, polyethylene, polypropylene, or any other suitable material.Activation element504 comprises aprotrusion640 configured to deflectretention element632 such thatprotrusion634 is no longer held byretention element632, thereby allowingrotating drive element514 to rotate and activatingdrive assembly510. Rotatingdrive element514 further comprises aridge636 configured to limit rotation of rotatingdrive element514 as rotatingdrive element514 rotates andridge636 comes in contact withretention element632.
• FIG. 6E illustrates aretention element642 ofholder524 and astop element644 ofapplicator housing502 configured to immobilizeholder524 toapplicator housing502 uponneedle carrier assembly508 reaching the distal insertion position. In some embodiments,retention element642 is a deflectable arm, or any other type of protrusion or snap. For example, asneedle carrier assembly508 travels in the distal direction, as a result ofspring512 turning rotatingdrive element514,retention element642 slides along an inside surface ofapplicator housing502 untilretention element642 is slightly deflected bystop element644, then snapping in an outward direction understop element644. At this point,needle carrier assembly508 may be free to progress in the proximal direction as a result ofspring512 further turningrotating drive element514.Stop element644 will preventretention element642, and soholder524, from traveling in the proximal direction. In this way, movement ofneedle carrier assembly508 in the proximal direction, after reaching the distal insertion position, releasesholder524 fromneedle carrier assembly508 and/or on-skin sensor assembly160.
• FIG. 6F illustrates aprotrusion652 ofholder524 and aprotrusion654 ofapplicator housing502 configured to preventholder524 from travelling beyond the distal insertion position in the distal direction. For example, asholder524 is driven in the distal direction byneedle carrier assembly508,protrusion652 travels along an inside surface of theapplicator housing502 untilprotrusion652 comes in contact withprotrusion654, at whichpoint holder524 is prevented from further travel in the distal direction.
• FIG. 6G illustrates on-skin sensor assembly160 including a plurality of attachment points662a-662fconfigured to mate with respective retention elements onneedle carrier assembly508 and/orholder524 while traveling at least partially toward the distal insertion position, in the distal direction, during applicator activation. In some embodiments, attachment points662a-662fare small grooves or indentations. Although a plurality of attachment points662a-662fare illustrated, any number of attachment points are contemplated. In some embodiments, the respective retention elements may comprise snap fits, friction fits, interference features, elastomeric grips and/or adhesives configured to couple on-skin sensor assembly160 withneedle carrier assembly508 and/orholder524.
• Moreover, during pressure fluctuations, such as at high altitude or vacuum during sterilization processes for example, air present within on-skin sensor assembly160 may exert a deforming force from within the cavity of on-skin sensor assembly160. Although not shown inFIG. 6G, in some embodiments, on-skin sensor assembly160 may have at least a portion formed with a reduced thickness or a second material (e.g. an elastomer) and, therefore, reduced strength and rigidity, such that whenapplicator500 is exposed to such pressure fluctuations, the portions having the reduced thickness or second material deform in a controlled manner, thereby reducing or eliminating damage that would otherwise occur to on-skin sensor assembly160 due to undesirable uncontrolled expansion of on-skin sensor assembly160. The portion formed with reduced thickness or a second material may be selected to direct controlled expansion away from datum and/or retention features securing the on-skin sensor assembly to applicator assembly. Such a feature may be present in any applicator described herein.
• FIG. 6H illustratesretention elements672a,672bof holder528 configured to releasably couple on-skin sensor assembly160 to holder528 asneedle carrier assembly508 travels in the distal direction to the distal insertion position, and to decouple on-skin sensor assembly160 from holder528 asneedle carrier assembly508 travels in the proximal direction from the distal insertion position towards the proximal retraction position. Specifically,retention elements672a,672bmay each comprise afirst end676a,676b, asecond end678a,678b, and apivot point680a,680b. Asneedle carrier assembly508 travels in the distal direction to the distal insertion position,first end676a,676bof each ofretention elements672a,672bis immobilized in arespective guide674a,674bofneedle carrier assembly508 and each ofretention elements672a,672bis immobilized against interference points682a,682bofneedle carrier assembly508, thereby releasably coupling second ends678a,678bto attachment points662a,662bof on-skin sensor assembly160. In some embodiments, guides674a,674bcomprise a slot or a stop element. Sinceretention elements642,644 and/orprotrusions652,654immobilize holder524 at the distal insertion position (as described inFIG. 6E), asneedle carrier assembly508 travels back in the proximal direction,needle carrier assembly508 separates fromholder524, thereby separating first ends676a,676bofretention elements672a,672bfromrespective slots674a,674b, allowing first ends676a,676bto deflect inward and second ends678a,678bto deflect outward from attachment points662a,662bof on-skin sensor assembly160 asretention elements672a,672brotate about pivot points680a,680b. Although two retention elements are illustrated, any number of retention elements are contemplated. Moreover, some alternative mechanisms that may perform such retention and release actions are further described in connection with at leastFIGS. 35A-37C below. Any of these alternative mechanisms are contemplated for use withapplicator500.
• A brief description of the operation ofapplicator500 follows with respect toFIGS. 7A-7F, which illustrate several perspective views of the applicator ofFIG. 5 in sequence, during operation, according to some embodiments.
• FIG. 7A illustrates a pre-activated state ofapplicator500.Applicator housing502 and slot582 remain stationary with respect to the skin of the host during activation.Activation element504 is in a pre-activation position.Insertion assembly508 is also in a pre-activation position, coupled toholder524, which is releasably coupled to on-skin sensor assembly160, as described in connection with at leastFIGS. 6A-6H. At least a portion ofinsertion element674 ofneedle carrier assembly508 is illustrated as protruding, in a distal direction, below on-skin sensor assembly160.Insertion element674 may comprises a needle, for example, an open sided-needle, a needle with a deflected-tip, a curved needle, a polymer-coated needle, a hypodermic needle, deflected-tip or any other suitable type of needle or structure, as will be described in more detail in connection with at leastFIGS. 47-50 and 80A-B. Insertion element674 may be configured to guide at least a portion ofsensor138 of on-skin sensor assembly160. rotatingdrive element514 ofdrive assembly510 is shown in a pre-activation position, havingpin516 located at a first position within guide582 ofapplicator housing502, and havingprotrusion634 in contact withretention element632. InFIG. 7A,pin516 is positioned approximately 30 degrees (illustrated as clockwise, though counterclockwise is also contemplated) from a bottom dead center orientation relative to an axis of rotation of rotatingdrive element514 that passes through a center of the face on whichpin516 is disposed.
• FIG. 7B illustrates a state ofapplicator500 at activation.Activation element504 is illustrated in an activated position, having been pushed longitudinally in the distal direction by a user, for example. In the activated position,activation element504 deflectsretention element632 such thatprotrusion634 of rotatingdrive element514 is unimpeded from moving, thus allowingrotating drive element514 to rotate by the unwinding ofspring512. SinceFIG. 7B illustratesapplicator500 just at activation, rotatingdrive element514,pin516,needle carrier assembly508,insertion element674,holder524 and on-skin sensor assembly160 are still shown in their pre-activation orientations and locations as inFIG. 7A. However, rotatingdrive element514 will rotate in the direction of the circular arrow, andneedle carrier assembly508,insertion element674,holder524 and on-skin sensor assembly160 will be driven, bypin516 under rotatingdrive element514 rotation, in the distal direction to the distal insertion position. However, the present disclosure is not so limited, androtating drive element514 may be configured to rotate in a direction opposite of the direction of the circular arrow.
• FIG. 7C illustrates a state ofapplicator500 during activation.Activation element504 is illustrated in the activated position ofFIG. 7B. Rotatingdrive element514 is shown as having rotated a portion of a revolution, indicated by the circular arrow,protrusion634 having advanced beyondretention element632.Pin516 is shown as having moved to a second position within guide582. This second position is shown as being to the left of the first, pre-activation position.Insertion assembly508,insertion element674,holder524 and on-skin sensor assembly160 are driven in the distal direction toward the distal insertion position when rotatingdrive element514 is rotated by a force generated byspring512.
• FIG. 7D illustratesapplicator500 during activation, in the distal insertion position.Activation element504 is illustrated in the activated position ofFIGS. 7B and 7C. Rotatingdrive element514 is shown as having rotated clockwise further compared toFIG. 7C, indicated by the circular arrow,protrusion634 having advanced yet further beyondretention element632.Pin516 is shown as having moved to a third position within guide582, shown as being to the right of the first, pre-activation position and the second, activation position ofFIG. 7C.Insertion assembly508,insertion element674,holder524 and on-skin sensor assembly160 are driven in the distal direction to the distal insertion position as rotatingdrive element514 is further rotated by the force generated byspring512. In this distal insertion position, at least a portion ofinsertion element674 as well as at least a portion ofsensor138 of on-skin sensor assembly160 may be inserted intoskin130 of the host. At this position,retention elements642,644 (seeFIG. 6) may be engaged andprotrusions652 and654 (seeFIG. 6) may be in contact with one another. InFIG. 7D,pin516 is positioned approximately 180 degrees (illustrated as clockwise, though counterclockwise is also contemplated) from the bottom dead center orientation relative to the axis of rotation of rotatingdrive element514.
• FIG. 7E illustratesapplicator500 during activation.Activation element504 is illustrated in the activated position ofFIGS. 7B-7D. Rotatingdrive element514 is shown as having rotated further compared toFIG. 7D, indicated by the circular arrow.Pin516 is shown as having moved to a fourth position within guide582. This fourth position is shown as being to the right of the first through third positions previously discussed.Insertion assembly508 andinsertion element674 are now shown as being driven in the proximal direction from the distal insertion position as rotatingdrive element514 is further rotated by the force generated byspring512. Sinceretention elements642,644 (seeFIG. 6) are engaged andprotrusions652 and654 (seeFIG. 6) may be in contact with one another,holder524 and on-skin sensor assembly160 are shown as separated fromneedle carrier assembly508. In the position shown byFIG. 7E, on-skin sensor assembly160 may also be decoupled fromholder524, as previously described in connection withFIG. 6H.
• FIG. 7F illustratesapplicator500 post-activation.Activation element504 is illustrated in the activated position ofFIGS. 7B-7E. Rotatingdrive element514 is shown as having rotated further compared toFIG. 7E, indicated by the circular arrow, such thatridge636 is in contact withretention element632, thereby restricting further rotation of rotatingdrive element514.Pin516 is shown as having moved to a fifth position within guide582, which is shown as being to the left of the fourth, right-most position, aspin516 travels back along guide582.Insertion assembly508 andinsertion element674 are shown in the proximal retraction position.Holder524 and on-skin sensor assembly160 are shown as separated fromneedle carrier assembly508. In the position shown byFIG. 7F, on-skin sensor assembly160 may also be decoupled fromholder524, as previously described in connection withFIG. 6H. InFIG. 7F,pin516 is positioned approximately 330 degrees (illustrated as clockwise, though counterclockwise is also contemplated) from the bottom center orientation relative to the axis of rotation of rotatingdrive element514.
• FIGS. 8-10 illustrate cutaway views ofapplicators800,900,1000 similar toapplicator500 ofFIG. 5, however, alternatively havingactivation elements804,904,1004 disposed on an upper, medial, and lower side of, rather than on a top of, anapplicator housing802,902,1002, respectively.Applicators800,900,1000 may comprise substantially all features ofapplicator500 and have substantially the same operation. For example,applicator housing802,902,1002,activation element804,904,1004, aneedle carrier assembly808,908,1008, arotating drive element814,914,1014, including apin816,916,1016 and aprotrusion834,934,1034 and aretention element832,932,1032 may correspond substantially toapplicator housing502,activation element504,needle carrier assembly508, rotatingdrive element514 includingpin516 andprotrusion504, andretention element502 ofapplicator500, respectively.
• However, inFIG. 8,activation element804 is disposed on an upper side, rather than on a top, ofapplicator housing802 and may be configured to, upon activation, deflectretention element832 such thatprotrusion834 no longer restrains rotatingdrive element814 from rotating under force of a spring (not shown inFIG. 8) similar tospring512 ofapplicator500. InFIG. 9,activation element904 is disposed on a medial side, rather than on a top, ofapplicator housing902 and may be configured to, upon activation, deflectretention element932 such that protrusion934 no longer restrains rotating drive element914 from rotating under force of a spring (not shown inFIG. 9) similar tospring512 ofapplicator500. As shown, due to the medial side location ofactivation element904,retention element932 may be located substantially on a side of rotating drive element914.
• InFIG. 10,activation element1004 is disposed on a lower side, rather than on a top, ofapplicator housing1002 and may be configured to, upon activation, deflectretention element1032 such thatprotrusion1034 no longer restrains rotatingdrive element1014 from rotating under force of a spring (not shown inFIG. 10) similar tospring512 ofapplicator500. As shown, due to the lower side location ofactivation element1004,retention element1032 may be located substantially on a side of rotatingdrive element1014.50
• An example of steps for assembling an applicator such asapplicators500,800,900,1000 ofFIGS. 5 and 8-10 will now be discussed in connection withFIGS. 11A-11H.
• FIG. 11A illustrates couplingfirst end520 ofspring512 toneedle carrier assembly508.First end520 may be coupled to, or disposed against, aprotrusion1102 ofneedle carrier assembly508 andspring512 may be inserted around ahub1104 ofneedle carrier assembly508 such thatspring512 andhub1104 are disposed coaxially with one another.
• FIG. 11B illustrates couplingsecond end522 ofspring512 withrotating drive element514 and insertingaxle526 intohub1104 ofneedle carrier assembly508 within whichaxle526 may rotate.Axle526,hub1104, andspring512 may be disposed coaxially with respect to one another. As shown by the circular arrow, rotatingdrive element514 may be rotated aboutaxle526 in a circular direction opposite of a direction that rotatingdrive element514 rotates during activation, thereby pre-storing energy inspring512.Axle524 may be fully inserted into the portion ofneedle carrier assembly508 such thatprotrusion634 is in contact withretention element632, thereby preventingrotating drive element514 from rotating until activation. In some embodiments, rotatingdrive element514 may be rotated aboutaxle504 such thatspring512 is only partially wound. In such embodiments,spring512 may be fully wound at a later stage of assembly. AlthoughFIG. 11B illustratesrotating drive element514 as having a male-type aspect configured to mate with a female-type aspect ofhub1104, the present disclosure also contemplatesrotating drive element514 as having a female-type aspect configured to mate with a male-type aspect ofhub1104.
• FIG. 11C illustrates pushingretention elements672a,672btoward a center ofholder524 andcoupling holder524 toneedle carrier assembly508 by seating first ends676a,676bofretention elements672a,672bintorespective slots674a,674bofneedle carrier assembly508.
• FIG. 11D illustrates coupling on-skin sensor assembly160 toholder524 by snapping second ends678a,678b(not shown inFIG. 11D) ofretention elements672a,672binto attachment points662a,662bof on-skin sensor assembly160. In some embodiments,retention elements672a,672bmay comprise snap fits, friction fits, interference features, elastomeric grips and/or adhesives.
• FIG. 11E illustrates inserting the assembledneedle carrier assembly508, rotatingdrive element514,holder524, and on-skin sensor assembly160 intoapplicator housing502 through the opening in the bottom ofapplicator housing502 and through a vertical portion of guide582 (seeFIG. 11F). During such insertion, pin516 of rotatingdrive element514 is inserted along at least the vertical portion of guide582 inapplicator housing502, as shown inFIG. 11F. Accordingly, spring512 (not shown inFIGS. 11E, 11F) may not be fully wound at this point, instead being partially wound to the extent thatpin516 of rotatingdrive element514 is positioned to be inserted along guide582 inapplicator housing502.
• FIG. 11G illustrates positioning the assembledneedle carrier assembly508, rotatingdrive element514,holder524, and on-skin sensor assembly160 further in the proximal direction intoapplicator housing502 such thatpin516 of rotatingdrive element514 follows guide582 ofapplicator housing502, thereby turningrotating drive element514 fully winding spring512 (not shown inFIG. 11G) andpositioning protrusion634 in contact withretention element632 such that the drive assembly, comprising at leastrotating drive element514, havingpin516, andspring512, are loaded for activation.
• FIG. 11H illustrates a magnified cutaway view ofarea1106 ofFIG. 11G illustrating the relationship betweenrotating drive element514,pin516, guide582,protrusion634 andretention element632.
• FIG. 11J illustrates insertingactivation element504 intoapplicator housing502.
• FIG. 12 illustrates an exploded perspective view of anotherapplicator1200 for applying an on-skin sensor assembly to a skin of a host, according to some embodiments.Applicator1200 may include anapplicator housing1202 having an opening in its bottom and configured to house at least one or more mechanisms utilized to apply on-skin sensor assembly160 to skin130 (seeFIG. 2) of a host.
• Applicator1200 includes anactivation element1204 configured to activate a drive assembly ofapplicator1200. In some embodiments,activation element1204 may be a button, a switch, a toggle, a slide, a trigger, a knob, a rotating member, a component that deforms and/or flexes or any other suitable mechanism for activating a drive assembly ofapplicator1200.Applicator1200 may further comprise aneedle carrier assembly1208, including an insertion element (not shown inFIG. 12) configured to insertsensor138 of on-skin sensor assembly160 (e.g.,FIG. 1) intoskin130 of the host. In some embodiments, the insertion element comprises a needle, for example a C-needle, as will be described in more detail in connection with at leastFIGS. 47-50 and 80A-B.
• Applicator1200 may further comprise adrive assembly1210 configured to drive the insertion element ofneedle carrier assembly1208 in the distal direction to a distal insertion position and in the proximal direction from the distal insertion position to a proximal retraction position. A distal direction may be defined as extending towards an open-ended side of theapplicator1200 along a pathneedle carrier assembly1208 is configured to travel. The distal direction may also be defined as towards the skin of a user. A proximal direction may be defined as a direction extending in a substantially opposite direction from the distal direction. In some embodiments, the distal direction and the proximal direction extend along an insertion axis of the insertion element and ofneedle carrier assembly1208.
• Drive assembly1210 may include aspring1212 having a first tang1220 (e.g., end) and a second tang1222 (e.g., end).Spring1212 may be a torsion spring, a double torsion spring, or any other suitable type of spring.Spring1212 may be supported by aspring spool1250 comprising afirst portion1250aand an optionalsecond portion1250b. In some embodiments,spring1212 is self-supporting and is not supported by a spring spool.First portion1250amay be configured to couple withsecond portion1250bsuch thatspring spool1250 is disposed coaxially withspring1212 and provides support forspring1212 along an axis ofrotation1218 ofspring1212. As will be shown in more detail in connection withFIG. 13,first tang1220 ofspring1212 may be coupled toapplicator housing1202, e.g., to a hook or protrusion ofapplicator housing1202.Second tang1222 may be coupled toneedle carrier assembly1208, e.g., a hook or protrusion ofneedle carrier assembly1208. Upon activation ofdrive assembly1210,first tang1220 andsecond tang1222 ofspring1212 unwind in opposite clockwise or counterclockwise directions, thereby drivingspring1212 in an arc andinsertion element1208 in the distal direction to the distal insertion position and in the proximal direction from the distal insertion position. The arc through whichdrive assembly1210 travels may extend in a direction approximately perpendicular to the distal direction and the proximal direction, or in an arc defined by the tangs of the spring and the rotation points.
• Applicator1200 may further include aholder1224 releasably coupled toneedle carrier assembly1208 and configured to guide on-skin sensor assembly160 while coupled toneedle carrier assembly1208. In some embodiments,holder1224 may comprise a stripper plate. As will be described in more detail below, on-skin sensor assembly160 may be stripped fromholder1224 andneedle carrier assembly1208 once on-skin sensor assembly160 is disposed onskin130 of the host.
• FIG. 13A-13F illustrate perspective and cutaway views of several features ofapplicator1200 ofFIG. 12, according to some embodiments.FIG. 13A illustrates a cross-sectional view ofapplicator1200, includingapplicator housing1202 havingretention element1334,activation element1204,spring spool1250,spring1212 havingfirst tang1220 andsecond tang1222,needle carrier assembly1208 havingretention element1332,holder1224, and on-skin sensor assembly160. In some embodiments,retention element1332 may comprise snap fits, friction fits, interference features, elastomeric grips and/or adhesives configured to couple on-skin sensor assembly160 withneedle carrier assembly1208 and/orholder1224. Each of these components may have functionality as previously described in connection with at leastFIG. 12. Moreover,first tang1220 is configured to, upon activation of the drive assembly, rotate about arotation point1336.Second tang1222 is similarly configured.
• FIG. 13F illustrates a magnified perspective view of aretention element1342 ofholder1224 and astop element1344 ofapplicator housing1202 configured to immobilize holder1228 toapplicator housing1202 uponneedle carrier assembly1208 reaching the distal insertion position. In some embodiments,retention element1342 is a deflectable arm. For example, asneedle carrier assembly1208 travels in the distal direction, as a result ofspring1212 partially unwinding,retention element1342 slides along an inside surface ofapplicator housing1202 and is deflected bystop element1344 untilretention element1342 snaps understop element1344. In some embodiments, the functionality betweenretention element1342 and stopelement1344 may be swapped, e.g., stopelement1344 may be configured to be deflected by and snap overretention element1342. At this point, thoughneedle carrier assembly1208 may be free to progress in the proximal direction, as a result ofspring1212 unwinding further, stopelement1344 will preventretention element1342, and soholder1224, from traveling back in the proximal direction. In this way, movement ofneedle carrier assembly1208 in the proximal direction after reaching the distal insertion position allowsholder1224 and/orneedle carrier assembly1208 to be released from on-skin sensor assembly160.
• FIG. 13B illustrates a magnified cutaway view of a portion ofneedle carrier assembly1208 comprising aretention element1332 configured to interlock with aretention element1334 ofapplicator housing1202 and preventneedle carrier assembly1208 from separating fromapplicator housing1202 in the loaded, pre-activated position.Activation element1204 is configured to deflectretention element1332 such thatretention element1334 no longer holdsretention element1332, thereby allowingspring1212 to separateneedle carrier assembly1208 fromapplicator housing1202 and activatingdrive assembly1210.
• FIG. 13C illustrates a magnified view ofsecond tang1222 of a spring coupled toneedle carrier assembly1208, for example, via ahook1348 configured to immobilizesecond tang1222 toneedle carrier assembly1208. The fastening concept described forsecond tang1222 inFIG. 13C may also be utilized forfirst tang1220.
• FIG. 13D illustrates on-skin sensor assembly160 including a plurality of attachment points662a-662cconfigured to mate with respective retention elements1372a-1372conneedle carrier assembly1208 and/orholder1224 while traveling in the distal direction at least partially toward the distal insertion position during applicator activation. In some embodiments, whereholder1224 comprises a stripper plate,holder1224 may function similarly to a stripper plate in punch and die manufacturing or injection molding processes. Although a plurality of attachment points662a-662care illustrated, any number of attachment points are contemplated. In some embodiments, retention elements1372a-1372cmay comprise snap fits, friction fits, interference features, elastomeric grips and/or adhesives.
• Retention elements1372a-1372cofneedle carrier assembly1208 and/orholder1224 are configured to releasably couple on-skin sensor assembly160 to holder1228 asneedle carrier assembly1208 travels in the distal direction to the distal insertion position, and to decouple on-skin sensor assembly160 fromneedle carrier assembly1208 and/or holder1228 asneedle carrier assembly1208 travels in the proximal direction from the distal insertion position towards the proximal retraction position. Specifically, sinceretention elements1342,1344immobilize holder1224 from traveling in the proximal direction at the distal insertion position, asneedle carrier assembly1208 travels back in the proximal direction. This causesneedle carrier assembly1208 to separate fromholder1224 and on-skin sensor assembly160, thereby decoupling retention elements1372a-1372cfrom attachment points662a-662cof on-skin sensor assembly160. Although two retention elements are illustrated, any number of retention elements are contemplated. Moreover, alternative mechanisms that may perform such retention and release actions are further described in connection with at leastFIGS. 35A-37C below. Any of these alternative mechanisms are contemplated for use withapplicator1200.
• FIG. 13E illustrates a perspective view of a plurality oftracks1322a,1322b,1322cinapplicator housing1202 in which a respective plurality ofprotrusions1324a,1324b,1324cofneedle carrier assembly1208 are configured to slide. Accordingly, tracks1322a-1322cinapplicator housing1202 define a path of travel forneedle carrier assembly1208. In some embodiments, this path of travel is substantially linear and longitudinal. Although three tracks and protrusions are shown inFIG. 13E, a single track or a plurality of tracks and respective protrusions are contemplated.
• A brief description of the operation ofapplicator1200 follows with respect toFIGS. 14A-14E, which illustrate several cross-sectional views of the applicator ofFIG. 12 during operation, according to some embodiments.
• FIG. 14A illustrates a state ofapplicator1200 at activation.Activation element1204 is illustrated in an activated position, having been pushed longitudinally in the distal direction by a user, for example. In the activated position,activation element1204 deflectsretention element1332 such thatretention element1334 ofapplicator housing1202 does not preventneedle carrier assembly1208 from moving whenspring1212 unwinds from a pre-wound state. SinceFIG. 14A illustratesapplicator1200 just at activation,spring1212,needle carrier assembly1208,holder1224 and on-skin sensor assembly160 are shown in their pre-activation orientations and locations. However,spring1212 will unwind partially andneedle carrier assembly1208,holder1224 and on-skin sensor assembly160 will be driven, by such unwinding, in the distal direction to the distal insertion position.
• FIG. 14B illustrates a state ofapplicator1200 during activation.Activation element1204 is illustrated in the activated position ofFIG. 14A.Spring1212 has partially unwound such thatfirst tang1220 unwinds in a first arc-direction andsecond tang1222 unwinds in a second arc-direction opposite of the first arc-direction.Spring1212 travels through an arc-direction approximately perpendicular to the distal direction and the proximal direction, or in an arc defined by the tangs ofspring1212 and their associated rotation points. As a result,needle carrier assembly1208, insertion element1374,holder1224 and on-skin sensor assembly160 are driven in the distal direction toward the distal insertion position by a force generated byspring1212.
• FIG. 14C illustratesapplicator1200 during activation, in a distal insertion position.Activation element1204 is illustrated in the activated position ofFIGS. 14A and 14B.Spring1212 has unwound further, relative to its position as illustrated inFIGS. 14A and 14B, substantially in the direction of the horizontal arrow.Insertion assembly1208,holder1224 and on-skin sensor assembly160 are driven in the distal direction to the distal insertion position by the force generated byspring1212. In this distal insertion position, at least a portion of an insertion element coupled toneedle carrier assembly1208 similarly to that shown inFIG. 6 (not shown inFIGS. 14A-14E) as well as at least a portion ofsensor138 of on-skin sensor assembly160 (e.g.,FIG. 1) may be inserted intoskin130 of the host. At this position, although not shown,retention elements1342,1344 (seeFIG. 13) may be engaged with one another.
• FIG. 14D illustratesapplicator1200 during activation.Activation element1204 is illustrated in the activated position ofFIGS. 14A-14C.Spring1212 has further unwound and travelled in substantially the same direction as shown by the arrow. Where unwinding ofspring1212 inFIGS. 14A-14C caused movement of theneedle carrier assembly1208 in the distal direction, becausespring1212 is now on an opposite side of the points at which thefirst tang1220 and thesecond tang1222 are anchored, further unwinding ofspring1212 results in movement of theneedle carrier assembly1208 in the proximal direction toward the proximal retraction position. Since the retention elements (seeFIG. 13) are engaged,holder1224 and on-skin sensor assembly160 are shown as separated fromneedle carrier assembly1208. In the position shown byFIG. 14D, on-skin sensor assembly160 may also be decoupled fromholder1224, as previously described in connection with call-out1330 ofFIG. 13.
• FIG. 14E illustratesapplicator1200 post-activation.Activation element1204 is illustrated in the activated position ofFIGS. 14A-14D.Spring1212 is illustrated as having unwound further compared to its position as illustrated inFIG. 14D and having travelled substantially in the direction indicated by the arrow.Insertion assembly1208 has travelled in the proximal direction indicated by the vertical arrow to the proximal retraction position.Holder1224 and on-skin sensor assembly160 are shown as separated fromneedle carrier assembly1208.
• FIGS. 15-17 illustrate perspective views of several exemplary double torsional springs that support different configurations ofapplicator1200, according to some embodiments. Accordingly, any of the springs described byFIGS. 15-17 may be utilized forspring1212 previously discussed in connection withFIGS. 12-14E. As shown inFIGS. 15-17, different shaped and/or sized cross-bridges1522c,1622c,1722cofsprings1512,1612,1712 may be provided by flaring one or more tangs in a particular direction.
• For example,FIGS. 15-17 illustrate doubletorsional springs1512,1612,1712, each comprising a first winding1512a,1612a,1712aand a second winding1512b,1612b,1712b. Doubletorsional springs1512,1612,1712 may be formed from a single segment of suitable material, e.g., metal or plastic.First windings1512a,1612a,1712aeach comprise afirst tang1520a,1620a,1720aand asecond tang1522a,1622a,1722a.Second windings1512b,1612b,1712beach comprise afirst tang1520b,1620b,1720band asecond tang1522b,1622b,1722b. For eachspring1512,1612,1712,second tangs1522a,1522b;1622a,1622b;1722a,1722bmay be coupled to one another by a cross-bridge1522c,1622c,1722c. Cross-bridge1522cofFIG. 15 may have a length substantially equal to aspacing1530 between first winding1512aand second winding1512bdefined by the extension ofsecond tangs1522a,1522bfrom first winding1512aand second winding1512b, respectively. Cross-bridge1622cofFIG. 16 may have a length exceeding aspacing1630 between first winding1612aand second winding1612bdefined by the extension ofsecond tangs1622a,1622bfrom first winding1612aand second winding1612b, respectively, due tosecond tang1622bof second winding1612bbeing flared towardfirst tang1620bof second winding1612b. Cross-bridge1722cofFIG. 17 may have a length exceeding aspacing1730 between first winding1712aand second winding1712bdefined by the extension ofsecond tangs1722a,1722bfrom first winding1712aand second winding1712b, respectively, due tosecond tang1722aof first winding1712abeing flared towardfirst tang1720aof first winding1712aandsecond tang1722bof second winding1712bbeing flared towardfirst tang1720bof second winding1712bto provide the increased length of cross-bridge1722ccompared to either cross-bridge1522cshown inFIG. 15 or cross-bridge1622cshown in ofFIG. 16.
• FIGS. 18-23 illustrate alternative drive assemblies for utilization in applicators, such asapplicator1200 ofFIG. 12, according to some embodiments.FIG. 18 illustrates a drive assembly comprising alinkage element1850. In some embodiments,linkage element1850 may comprise a flex linkage. The flex linkage may contain one or more living hinge(s). In other embodiments,linkage element1850 may comprise at least two discrete sections configured to pivot about a hinge coupling the at least two discrete sections.
• A flex linkage is a type of hinge assembly formed from an extension of a parent material (e.g., polypropylene plastic). The hinge flex linkage is a thin section of the parent material that acts as a bending connection with two larger sections of the parent material. Typically, the larger sections of the parent material as well as the hinge will be made of one continuous piece of the parent material. Since it is relatively thin and typically made from flexible materials, the flex linkage is also able to rotate about one axis by 180 degrees or more—potentially for many thousands or even millions of cycles. Contrary to most hinges, which involve multiple parts assembled in a traditional pivoting mechanism, flex linkages are not a separate entity. They may be described as a purposeful fault line at a predetermined point in the material which is designed such that it does not fail after repeated bending.
• Linkage element1850 has afirst end1852 coupled to an applicator housing1802, asecond end1854 coupled to aneedle carrier assembly1808, and ahinge1856 disposed betweenfirst end1852 andsecond end1854.
• The drive assembly further comprises aspring1812, which in some embodiments may be a single or double torsion spring.Spring1812 comprises afirst tang1820 coupled to applicator housing1802 and/or tolinkage element1850 atfirst end1852 or at a position betweenfirst end1852 andhinge1856.Spring1812 further comprises asecond tang1822 coupled toneedle carrier assembly1808 and/or tolinkage element1850 atsecond end1854 or at a position betweensecond end1854 andhinge1856. In some embodiments,hinge1856 may be aligned with an axis ofrotation1818 ofspring1812 to provide smooth operation as well as to reduce any stresses caused by incompatible movement betweenlinkage element1850 andspring1812.
• Applicator1200, utilizing drive assembly1810, may function substantially as described forapplicator1200 ofFIG. 12, however, further including thatfirst end1852,second end1854 and hinge1856 of linkage element150 move substantially in alignment withfirst tang1820,second tang1822 and axis ofrotation1818 ofspring1812, respectively, during activation.
• FIG. 19 illustrates another drive assembly comprising alinkage element1950.Linkage element1950 has afirst end1952 coupled to anapplicator housing1902, asecond end1954 coupled to aneedle carrier assembly1908, and a hinge1956 disposed betweenfirst end1952 andsecond end1954. The drive assembly further comprises aspring1912, which in some embodiments may be a single or double torsion spring.Spring1912 comprises afirst tang1920 coupled tolinkage element1950 betweensecond end1954 and hinge1956.Spring1912 further comprises asecond tang1922 coupled toneedle carrier assembly1908. Upon activation,spring1912 unwinds andfirst tang1952 sweeps an arc whilesecond tang1954 is held substantially stationary againstneedle carrier assembly1908. Asfirst tang1952 sweeps its arc,first tang1952 driveslinkage element1950 from the bent position shown, hinge1956 pivoting, untillinkage element1950 is substantially vertical, and then continuing pivoting untillinkage element1950 is in a substantially mirror orientation from that shown inFIG. 19. This motion drivesneedle carrier assembly1908 in the distal direction, reaching the distal insertion position whenlinkage element1950 is substantially vertical, and then increasingly in the proximal direction aslinkage element1950 is further driven from the substantially vertical orientation to the substantially mirrored orientation to that shown inFIG. 19.
• FIG. 20 illustrates another drive assembly comprising alinkage element2050.Linkage element2050 has afirst end2052 coupled to anapplicator housing2002, asecond end2054 coupled to aneedle carrier assembly2008, and ahinge2056 disposed betweenfirst end2052 andsecond end2054. The drive assembly further comprises aspring2012, which in some embodiments may be a single or double torsion spring.Spring2012 comprises afirst tang2020 coupled tolinkage element2050 betweenfirst end2052 andhinge2056.Spring2012 further comprises asecond tang2022 coupled toapplicator body2002. Upon activation,spring2012 unwinds andfirst tang2052 sweeps an arc whilesecond tang2054 is held substantially stationary againstapplicator body2002. Asfirst tang2052 sweeps its arc,first tang2052 driveslinkage element2050 from the bent position shown,hinge2056 pivoting, untillinkage element2050 is substantially vertical, and then continuing pivoting untillinkage element2050 is in a substantially mirror orientation from that shown inFIG. 20. This motion drivesneedle carrier assembly2008 in the distal direction, reaching the distal insertion position whenlinkage element2050 is substantially vertical, and then increasingly in the proximal direction aslinkage element2050 is further driven from the substantially vertical orientation to the substantially mirrored orientation to that shown inFIG. 20.
• FIG. 21 illustrates another drive assembly comprising alinkage element2150.Linkage element2150 has afirst end2152 coupled to anapplicator housing2102, asecond end2154 coupled to aneedle carrier assembly2108, and ahinge2156 disposed betweenfirst end2152 andsecond end2154. The drive assembly further comprises aspring2112, which in some embodiments may be an extension spring. A compression spring is also contemplated. However, a compression spring may be coupled betweenhinge2156 and the closer side ofapplicator housing2102.Spring2112 comprises afirst end2120 coupled tolinkage element2150 and asecond end2122 coupled toapplicator body2102. In some embodiments,first end2120 is coupled tolinkage element2150 betweenfirst end2152 andhinge2156. In other embodimentsfirst end2120 is coupled tolinkage element2150 athinge2156. In yet other embodimentsfirst end2120 is coupled tolinkage element2150 betweenhinge2156 andsecond end2154. Upon activation,spring2112 unwinds through an arc that extends in a direction approximately perpendicular to the distal direction and the proximal direction, or in an arc defined by the tangs of the spring and their respective rotation points, drivinglinkage element2150 from the bent position shown,hinge2156 pivoting, untillinkage element2150 is substantially vertical, and then continuing pivoting untillinkage element2150 is in a substantially mirror orientation from that shown inFIG. 21. This motion drivesneedle carrier assembly2108 in the distal direction, reaching the distal insertion position whenlinkage element2150 is substantially vertical, and then increasingly in the proximal direction aslinkage element2150 is further driven from the substantially vertical orientation to the substantially mirrored orientation to that shown inFIG. 21.
• FIG. 22 illustrates another drive assembly comprising aleaf spring2212.Leaf spring2212 comprises afirst end2220 coupled to anapplicator housing2202 and asecond end2222 coupled to aneedle carrier assembly2208. Upon activation,leaf spring2212 unloads in a direction substantially parallel to the axis of insertion, drivingneedle carrier assembly2208 to the distal insertion position whenleaf spring2212 is unloaded.
• FIG. 23 illustrates another drive assembly comprising alinkage element2350. Drive assembly2310 is substantially the same as drive assembly1910 except replacingtorsion spring1912 withleaf spring2312.Linkage element2350 has afirst end2352 coupled to anapplicator housing2302, asecond end2354 coupled to aneedle carrier assembly2308, and ahinge2356 disposed betweenfirst end2352 andsecond end2354. The rive assembly further comprisesleaf spring2312 having afirst end2320 coupled tolinkage element2350 betweensecond end2354 andhinge2356, and asecond end2322 coupled toneedle carrier assembly2308. Upon activation,spring2312 unloads andfirst end2320 sweeps an arc whilesecond end2322 is held substantially stationary againstneedle carrier assembly2308. Asfirst end2320 sweeps its arc,first end2320 driveslinkage element2350 from the bent position shown,hinge2356 pivoting, untillinkage element2350 is substantially vertical, and then continuing pivoting untillinkage element2350 is in a substantially mirror orientation from that shown inFIG. 23. This motion drivesneedle carrier assembly2308 in the distal direction, reaching the distal insertion position whenlinkage element2350 is substantially vertical, and then increasingly in the proximal direction aslinkage element2350 is further driven from the substantially vertical orientation to the substantially mirrored orientation to that shown inFIG. 23.
• An example of steps for assembling an applicator such asapplicator1200 ofFIG. 12 will now be discussed in connection withFIGS. 24A-24M. To the extent any step is compatible, the assembly steps ofFIGS. 24A-24M may also apply to any applicator utilizing the drive assemblies described in connection withFIGS. 18-23.
• FIG. 24A illustrates couplingfirst portion1250aandsecond portion1250bofspring spool1250 together inside the windings ofspring1212.FIG. 24B illustrates the assembledspring spool1250 andspring1212.Spring spool1250 andspring1212 are disposed coaxially with one another.FIG. 24C illustratesspring1212 before winding in the direction indicated by the circular arrow, havingfirst tang1220 andsecond tang1222 in the illustrated positions.FIG. 24D illustratesspring1212 after winding, havingfirst tang1220 andsecond tang1222 in the illustrated positions.
• FIG. 24E illustratescoupling wound spring1212 toneedle carrier assembly1208. In some embodiments, this includes couplingfirst tang1220 to ahook1348 ofneedle carrier assembly1208 and couplingsecond tang1222 to or disposingsecond tang1222 againstneedle carrier assembly1208.FIG. 24F illustrates a side view ofwound spring1212 coupled toneedle carrier assembly1208, whileFIG. 24G illustrates a perspective view of the arrangement shown inFIG. 24F.
• FIG. 2411 illustratescoupling holder1224 toneedle carrier assembly1208 and on-skin sensor assembly160 toholder1224.FIG. 24J illustrates a side view of on-skin sensor assembly160,holder1224, andneedle carrier assembly1208 assembled, whileFIG. 24K illustrates a perspective view of the arrangement shown inFIG. 24J.
• FIG. 24L illustrates assembling the complex including on-skin sensor assembly160,holder1224,needle carrier assembly1208, andspring1212 intoapplicator housing1202 through the opening in the bottom ofapplicator housing1202, and insertion ofactivation element1204 intoapplicator housing1202.FIG. 24M illustrates the result of the assembly shown inFIG. 24L.
• FIG. 25 illustrates an exploded perspective view of yet anotherapplicator2500 for on-skin sensor assembly160 of an analyte sensor system, according to some embodiments.Applicator2500 may include anapplicator housing2502 configured to house one or more mechanisms for applying on-skin sensor assembly160 toskin130 of a host.Applicator housing2502 may be formed of any suitable material, e.g., a polymer, polycarbonate, ABS, nylon, polyethylene, polypropylene, etc.
• Applicator2500 includes anactivation element2504 configured to activate a drive assembly ofapplicator2500. In some embodiments,activation element2504 may be a button, a switch, a toggle, a slide, a trigger, a knob, a rotating member, a component that deforms and/or flexes or any other suitable mechanism for activating a drive assembly ofapplicator2500.Applicator2500 may further comprise aneedle carrier assembly2508, including aninsertion element2574 configured to insert sensor138 (e.g.,FIG. 1) of on-skin sensor assembly160 (e.g.,FIG. 1) into skin130 (e.g.,FIG. 1) of the host. In some embodiments,insertion element2574 comprises a needle, for example, an open sided-needle, a needle with a deflected-tip, a curved needle, a polymer-coated needle, a hypodermic needle, or any other suitable type of needle or structure, as will be described in more detail in connection with at leastFIGS. 47-50 and 80A-B. In yet other embodiments, insertion element may comprisesensor138, sufficiently rigid to be inserted partially intoskin130 of the host with minimal or no structural support.
• Applicator2500 may further comprise adrive assembly2510 configured to driveinsertion element2574 ofneedle carrier assembly2508 in a distal direction to a distal insertion position and in a proximal direction from the distal insertion position to a proximal retraction position.
• Applicator2500 may further include aholder2524 releasably coupled toneedle carrier assembly2508 and configured to guide on-skin sensor assembly160 while coupled toneedle carrier assembly2508. As will be described in more detail below, on-skin sensor assembly160 may be stripped fromholder2524 andneedle carrier assembly2508 once on-skin sensor assembly160 is disposed onskin130 of the host.
• Drive assembly2510 may include aspring2512, which may be any suitable type of spring, e.g., a compression spring, extension spring, leaf spring, flex arm spring, etc.Spring2512 may have afirst end2520 coupled toapplicator housing2502 and a second end coupled toneedle carrier assembly2508.Spring2520 may be configured to, upon activation ofdrive assembly2510, driveneedle carrier assembly2508 in the distal direction. In some embodiments,spring2512 may be pre-loaded, e.g., at the factory. In some other embodiments,spring2512 may be loaded by an action of the user ofapplicator2500.
• Drive assembly2510 further includes aspring2528 that may be coupled to anapplicator base2530 ofapplicator2500. In some embodiments,spring2528 may be a compression spring, extension spring, leaf spring, flex arm spring, etc. In some embodiments,spring2528 may be pre-loaded, e.g., at the factory. In some other embodiments,spring2528 may be loaded by an action of the user. In yet other embodiments,spring2528 may be loaded by unloading ofspring2512.Spring2528 may comprise one or more portions configured to driveneedle carrier assembly2508 in the proximal direction from the distal insertion position, as will be described in more detail below.
• FIG. 26A-26D illustrate several cutaway views and a bottom view of several features ofapplicator2500 ofFIG. 25, according to some embodiments.FIG. 26A illustrates a perspective cutaway view ofapplicator2500 includingapplicator housing2502,activation element2504,applicator base2530 includingprotrusion2602,spring2512, leaf spring(s)2528,needle carrier assembly2508,holder2524, and on-skin sensor assembly160. Each of these components may have functionality as previously described in connection with at leastFIG. 25.
• FIG. 26B illustrates a perspective view of several features ofholder2524,applicator base2530 andactivation element2504.Spring2512 is configured to be coupled toapplicator housing2502 at a first end and toholder2524 at a second end. In a pre-activation state,spring2512 may be configured to store energy for driving holder2512 (and needle carrier assembly2508) in the distal direction to the distal insertion position upon activation.Holder2524 comprises anaxle2614 configured to snap intoapplicator base2530 such thatholder2524 is configured to pivot in a substantially circular arc aboutaxle2614. InFIG. 26B,activation element2504 is illustrated as comprising aprotrusion2612 configured to guideholder2524 in the pre-activation position shown untilactivation element2504 is activated, thereby displacingprotrusion2612 from its pre-activation orientation relative toholder2524 and releasingholder2524.FIG. 26B further illustrates that leaf spring(s)2528 are not coupled toholder2524. Instead, leaf spring(s)2528 are coupled toneedle carrier assembly2508 and are configured to driveneedle carrier assembly2508 in the proximal direction from the distal insertion position. Althoughactivation element2504 is shown as a button, the present disclosure further contemplatesactivation element2504 as a switch, a toggle, a slide, a trigger, a knob, a rotating member, a component that deforms and/or flexes or any other suitable mechanism for activating a drive assembly ofapplicator2500. Moreover, althoughactivation element2504 is illustrated as being disposed on a side ofapplicator housing2502, the present disclosure contemplates any other location, e.g., on a top, bottom, or other side location ofapplicator housing2502, and/or any other angle of disposition with respect toapplicator housing2502.
• FIG. 26C illustrates an exploded perspective view ofneedle carrier assembly2508,insertion element2674, andholder2524.Insertion element2674 is coupled toneedle carrier assembly2508. In some embodiments,insertion element2674 comprises an open-sided needle configured to guide and insertsensor138 of on-skin sensor assembly160 (e.g.,FIG. 1) intoskin130 of the host.Insertion assembly2508 is coupled at a first end toaxle2614 ofholder2524.Insertion assembly2508 further comprises aretention element2622 configured to releasably couple a second end ofneedle carrier assembly2508 toholder2524.Insertion assembly2508 further comprises aretention element2604 configured to releasably couple on-skin sensor assembly160 toneedle carrier assembly2508 andholder2524. In some embodiments,retention element2604 may comprise a snap fit, friction fit, interference feature, elastomeric grip and/or adhesive configured to couple on-skin sensor assembly160 withneedle carrier assembly2508 and/orholder2524.Spring2512 is configured to, upon activation ofapplicator2500, driveneedle carrier assembly2508 andholder2524 in the distal direction along a circular arc defined byaxle2614 to the distal insertion position.Spring2512 transfers at least a portion of its stored energy to leaf spring(s)2528 asneedle carrier assembly2508 is driven in the distal direction along the circular arc. In some other embodiments, leaf spring(s)2528 may be pre-loaded such thatspring2512 does not transfer stored energy to leaf spring(s)2528. Asneedle carrier assembly2508 is driven in the distal direction, aprotrusion2602 ofapplicator base2530 is configured to deflectretention element2622 sufficiently to separateneedle carrier assembly2508 fromholder2524 substantially at the distal insertion position, thereby uncoupling the second end ofneedle carrier assembly2508 fromholder2524. Accordingly, from the distal insertion position, leaf spring(s)2528, now loaded, are configured to driveneedle carrier assembly2508 in the proximal direction from the distal insertion position, along the circular arc, to the proximal retraction position.
• FIG. 26D illustrates aportion2632 ofactivation element2504 coupled toapplicator housing2502 and configured to act as a return spring, returningactivation element2504 to its pre-activation position after activation. For example, asactivation element2504 is pressed to the right as shown inFIG. 26D,portion2632 is deformed againstapplicator housing2502, thereby functioning substantially as a spring, which when unloaded, returnsactivation element2504 to its pre-activation position.
• FIGS. 27A-27E illustrate several cross-sectional views ofapplicator2500 ofFIG. 25 during operation, according to some embodiments.FIG. 86 illustrates relationships betweenaxle2614,insertion element2674, and acircular arc8602 travelled byinsertion element2674 during insertion and retraction, according to some embodiments.FIG. 27A illustratesapplicator2500 at the time of activation. For example,activation element2504 is illustrated in an activated position, e.g., pushed inwardly, which releasesholder2524 from its immobilized, pre-activation state.Spring2512,needle carrier assembly2508,insertion element2674,holder2524, and on-skin sensor assembly160 are all shown in their pre-activation positions.
• FIG. 27B illustratesapplicator2500 during activation.Spring2512 is drivingholder2524, and so releasably coupledneedle carrier assembly2508,insertion element2674, and on-skin sensor assembly160, in the distal direction along the circular arc8602 (seeFIG. 86) defined byaxle2614. In some embodiments, a radius8604 (seeFIG. 86) of thecircular arc8602 may be between 20 millimeters (mm) and 80 mm, inclusive, although radiuses larger or smaller than this range are also contemplated.
• With respect toFIG. 86, theradius8604 of thiscircular arc8602 may depend on one or more of adistance8606 from theskin130 of the host toaxle2614, aheight8608 of the on-skin sensor assembly160 from a bottom opening or surface ofapplicator2500 or fromaxle2614, and/or a location ofsensor138 within on-skin sensor assembly160. Selection of aradius8604 may be made at least in part to minimize tissue trauma, optimize deployment ofsensor138, and to minimize insertion and/or retraction friction between the insertion member and the tissue of the host.
• For example, with respect toFIGS. 27A and 86, anangle2710 between a needle axis and a bottom plane of on-skin sensor assembly may be calculated such that a minimum offset is achieved between the straight needle path and the idealcurved profile8602. In some embodiments, it has been determined that an approximately 71 degree angle between the needle axis and the bottom plane of on-skin sensor assembly produces less lateral motion of the tip of theinsertion element2674 within the skin of the host compared to an approximately 90 degree angle between the needle axis and the bottom plane of on-skin sensor assembly. However, this angle may depend on at least some of the same factors affecting an ideal radius of the circular arc.
• Moreover, various needle geometries may be utilized, including, but not limited to, straight needle geometries, kinked needle geometries (e.g., two or more substantially straight portions with one or more bends disposed therebetween), and fully or partially curved needle geometries (e.g., a curved distal portion configured to at least partially pierce the skin of the host with or without a straight proximal portion), as described in more detail in connection with at leastFIGS. 47-50 and 80A-B.
• FIG. 27C illustratesapplicator2500 in the distal insertion position.Spring2512 has drivenholder2524, and so releasably coupledneedle carrier assembly2508,insertion element2674, and on-skin sensor assembly160, in the distal direction to the distal insertion position. In addition,protrusion2602 ofapplicator base2530 has deflectedretention arm2622 sufficiently to release the second end ofneedle carrier assembly2508 fromholder2524 in preparation for movement in the proximal direction from the distal insertion position.
• FIG. 27D illustratesapplicator2500 during retraction.Spring2512 remains unloaded, pinningholder2524 in the distal insertion position. However, leaf spring(s)2528, still in contact with now-releasedneedle carrier assembly2508, driveneedle carrier assembly2508 and coupledinsertion element2674 in the proximal direction from the distal insertion position to the proximal retraction position. Retention element(s)2604 are released from on-skin sensor assembly160 by virtue ofspring2512 pinningholder2524, and so on-skin sensor assembly160 disposed thereunder, in the distal insertion position. In some embodiments, retention element(s)2604 may comprise snap fits, friction fits, interference features, elastomeric grips and/or adhesives.
• FIG. 27E illustratesapplicator2500 in the proximal retraction position. Leaf spring(s)2528 have drivenneedle carrier assembly2508 andinsertion element2674 in the proximal direction to the proximal retraction position.Applicator2500 may then be released from the skin of the host, whereby all portions of theapplicator2500 will be removed from the skin of the host except the on-skin sensor assembly160 and the sensor138 (e.g.,FIG. 1) which is now at least partially inserted into the skin of the host.
• FIGS. 28A-28H illustrate steps to assembleapplicator2500 ofFIG. 25, according to some embodiments.FIG. 28A illustratescoupling insertion element2674 toneedle carrier assembly2508. In some embodiments,insertion element2674 may be coupled toneedle carrier assembly2508 at an angle that substantially coincides with the circularpath insertion element2674 andneedle carrier assembly2508 traverse during activation.FIG. 28B illustratescoupling holder2524 toneedle carrier assembly2508 by couplingneedle carrier assembly2508 toaxle2614 ofholder2524 andretention element2622 toholder2524.FIG. 28C illustrates coupling on-skin sensor assembly160 toholder2524 andneedle carrier assembly2508 by engaging retention element(s)2604 of needle carrier assembly25089 with on-skin sensor assembly160.
• FIG. 28D illustrates insertingactivation element2504 intoapplicator housing2502.FIG. 28E illustrates coupling a first end ofspring2512 withapplicator housing2502 through an opening in the bottom ofapplicator housing2502.FIG. 28F illustrates inserting theassembly2800cresulting from the step(s) illustrated byFIG. 28C intoapplicator housing2502. Inassembly2800c, shown inFIG. 28F,spring2512 is placed in contact withholder2524 andholder2524 is secured byprotrusion2612 ofactivation element2504.
• FIG. 28G illustratescoupling applicator base2530 toapplicator housing2502.Axle2614 ofholder2524 is coupled toapplicator base2530 and leaf spring(s)2528 are placed in contact withneedle carrier assembly2508.FIG. 28H illustratesapplicator2500 in assembled form. At this step,applicator base2530 may be coupled toapplicator housing2502, for example, via sonic welding, press-fit, snap-fit, adhesive, or any other suitable method of securing plastic materials together.
• FIG. 29 illustrates an exploded perspective view of yet anotherapplicator2900 for applying an on-skin sensor assembly toskin130 of a host, according to some embodiments.Applicator2900 may include anapplicator housing2902 having an opening at its bottom and configured to house at least one or more mechanisms utilized to apply on-skin sensor assembly160 toskin130 of a host.
• Applicator2900 includes anactivation element2904 configured to activate a drive assembly ofapplicator2900. In some embodiments,activation element2904 may be a button, a switch, a toggle, a slide, a trigger, a knob, a rotating member, a component that deforms and/or flexes or any other suitable mechanism for activating a drive assembly ofapplicator2900.Applicator2900 may further comprise aneedle carrier assembly2908, including an insertion element (seeFIG. 30) configured to insertsensor138 of on-skin sensor assembly160 (e.g.,FIG. 1) intoskin130 of the host. In some embodiments, the insertion element comprises a needle, for example, an open sided-needle, a needle with a deflected-tip, a curved needle, a polymer-coated needle, a hypodermic needle, or any other suitable type of needle or structure, as will be described in more detail in connection with at leastFIGS. 47-50 and 80A-B. In yet other embodiments, insertion element may comprisesensor138 itself, sufficiently rigid to be inserted partially intoskin130 of the host with minimal or no structural support.
• Applicator2900 may further comprise adrive assembly2910 configured to drive the insertion element ofneedle carrier assembly2908 in a distal direction to a distal insertion position and in a proximal direction from the distal insertion position to a proximal retraction position. A distal direction may be defined as extending towards an open-ended side ofapplicator2900 along a pathneedle carrier assembly2908 is configured to travel. The distal direction may also be defined as towards the skin of a user. A proximal direction may be defined as a direction extending in a substantially opposite direction from the distal direction. In some embodiments, the distal direction and the proximal direction extend along an insertion axis of the insertion element and ofneedle carrier assembly2908.
• Drive assembly2910 may include arotating drive element2914 disposed withinneedle carrier assembly2908 and configured to rotate with respect toneedle carrier assembly2908 about an axis ofrotation2918 parallel with a centerline ofneedle carrier assembly2908. In some embodiments, rotatingdrive element2914 is configured to rotate in a plane substantially perpendicular to the proximal direction and the distal direction. In some embodiments, rotatingdrive element2914 may comprise a barrel cam. Rotatingdrive element2914 comprises aridge2916 that defines a variable cam path around at least a portion of a circumference of the rotating drive element.Ridge2916 is configured to slide along a channel (seeFIG. 30) on an inside surface ofneedle carrier assembly2908 as rotatingdrive element2914 rotates, thereby drivingneedle carrier assembly2908 in the distal direction to the distal insertion position and then in the proximal direction to the proximal retraction position as defined by the variable cam path ofridge2916.
• Drive assembly2910 may further include aspring2912 disposed within rotatingdrive element2914.Spring2912 may be a torsion spring, or any suitable type of spring.Spring2912 may have afirst end2920 coupled toapplicator housing2902 and asecond end2922 coupled to rotatingdrive element2914.Spring2912 may be disposed coaxially with rotatingdrive element2914 andneedle carrier assembly2908.Spring2920 may be configured to, upon activation ofdrive assembly2910, rotate rotatingdrive element2914 in a single direction with respect toneedle carrier assembly2908.
• By virtue of rotatingdrive element2914 being configured to rotate with respect toneedle carrier assembly2908, about axis ofrotation2918, andridge2916 being restrained to travel in the channel ofneedle carrier assembly2908, rotational motion of rotatingdrive element2914, caused byspring2912, is converted into linear, reciprocating motion ofneedle carrier assembly2908 and, therefore, insertion element (seeFIG. 30). More specifically, rotation of rotatingdrive element2914 drivesinsertion element2908 in the distal direction to the distal insertion position and in the proximal direction from the distal insertion position to the proximal retraction position.
• Applicator2900 may further include aholder2924 releasably coupled toneedle carrier assembly2908 via retention element(s)2980 and configured to guide on-skin sensor assembly160 while coupled toneedle carrier assembly2908. In some embodiments, retention element(s)2980 may comprise snap fits, friction fits, interference features, elastomeric grips and/or adhesives configured to couple on-skin sensor assembly160 withneedle carrier assembly2908 and/orholder2924. On-skin sensor assembly160 may be stripped fromholder2924 and/orneedle carrier assembly2908 once on-skin sensor assembly160 is disposed onskin130 of the host.
• FIG. 30 illustrates a perspective cutaway view of a portion ofapplicator2900 ofFIG. 29, according to some embodiments.FIG. 30 illustrates at least oneprotrusion3024 ofneedle carrier assembly2908 configured to slide within tracks (not shown inFIG. 30) on an inside surface of applicator housing2902 (similar to tracks622a-622cinFIG. 6) that define a linear path of travel forneedle carrier assembly2908.FIG. 30 further illustrateschannel3002 in whichridge2916 of rotatingdrive element2914 is configured to slide asspring2912 rotates rotatingdrive element2914 with respect toneedle carrier assembly2908.FIG. 30 further illustratesinsertion element3074 coupled toneedle carrier assembly2908.
• In some embodiments,holder2924 further includes aretention element3042 configured to engage with a retention element (not shown inFIG. 30) ofapplicator housing2902, similar to stopelement644 of applicator housing462 ofFIG. 6, and immobilizeholder2924 toapplicator housing2902 uponneedle carrier assembly2908 reaching the distal insertion position. Although not shown inFIG. 30, holder2928 may further comprise a protrusion andapplicator housing2902 may further comprise a protrusion configured to preventholder2924 from travelling beyond the distal insertion position in the distal direction, similar toprotrusion652 andprotrusion654 as previously described in connection withFIG. 6F.
• FIG. 31 illustrates a cutaway view of yet anotherapplicator3100 for an on-skin sensor assembly of an analyte sensor system, according to some embodiments. In some embodiments,applicator3100 may include anapplicator housing3102 configured to house one or more mechanisms for applying on-skin sensor assembly160 toskin130 of a host.Applicator3100 may further comprise abase3130 coupled toapplicator housing3102 and configured to form a bottom ofapplicator3100.
• Applicator3100 further includes an activation element (not shown inFIG. 31) configured to activate adrive assembly3110 ofapplicator3100. In some embodiments, the activation element may be a button, a switch, a toggle, a slide, a trigger, a knob, a rotating member, a component that deforms and/or flexes or any other suitable mechanism for activating a drive assembly ofapplicator3100. In addition, the activation element ofapplicator3100 may be disposed in any location and orientation with respect toapplicator housing3102, e.g., a top, any portion of a side, or bottom ofapplicator housing3102 and/or at any angle with respect to the portion ofapplicator housing2102 in which the activation element is disposed.Applicator3100 may further comprise aneedle carrier assembly3108, including aninsertion element3174 releasably coupled to on-skin sensor assembly160 and configured to insertsensor138 of on-skin sensor assembly160 (e.g.,FIG. 1) intoskin130 of the host. In some embodiments, the insertion element comprises a needle, for example, an open sided-needle, a needle with a deflected-tip, a curved needle, a polymer-coated needle, a hypodermic needle, deflected-tip or any other suitable type of needle or structure, as will be described in more detail in connection with at leastFIGS. 47-50 and 80A-B. In yet other embodiments, insertion element may comprisesensor138 itself, sufficiently rigid to be inserted partially intoskin130 of the host with minimal or no structural support,
• Drive assembly3110 may be configured to driveinsertion element3174 ofneedle carrier assembly3108 in a distal direction to a distal insertion position and in a proximal direction from the distal insertion position to a proximal retraction position.Drive assembly3110 may include aguide member3138, aspring3112, ahub3132 and areverse toggling element3136. guidemember3138 may be coupled to at least one ofapplicator housing3102 and base3130 at a first end and/or a second end, respectively.Spring3112 may be disposed aroundguide member3138 such thatguide member3138 extends substantially along a centerline ofspring3112.Spring3112 may be any suitable type of spring, e.g., a compression spring, and may have a first end coupled tobase3130 and a second end coupled to ahub3132, which is disposed on and configured to travel alongguide member3138. Spring3120 may be configured to, upon activation ofdrive assembly3110,drive hub3132 in the proximal direction alongguide member3138, as shown by the arrow.Reverse toggling element3136 may function substantially as a lever with a fulcrum at or near its midpoint, rotatably coupled to base3130 orapplicator housing3102. A first end ofreverse toggling element3136 may be in contact with aprotrusion3134 ofhub3132 for at least a first portion of travel ofhub3132 in the proximal direction and a second end ofreverse toggling element3136 may be in contact withneedle carrier assembly3108.Insertion assembly3108 may be slideably coupled to guidemember3138 on the side ofhub3132opposite spring3112.
• In operation, upon activation ofdrive assembly3110,spring3112 driveshub3132 alongguide member3138 in the proximal direction. For a first portion of travel alongguide member3138,protrusion3134 ofhub3132 is in contact with the first end ofreverse toggling element3136, causing the second end ofreverse toggling element3136 to driveneedle carrier assembly3138, and soinsertion element3174 and on-skin sensor assembly160, in the distal direction. After the first portion of travel alongguide member3138,protrusion3134 ofhub3132 will clear the first end ofreverse toggling element3136 and make contact with the portion ofneedle carrier assembly3138 slideably coupled withguide member3138. At this point,needle carrier assembly3108,insertion element3174 and on-skin sensor assembly160 are in the distal insertion position. For a second portion of travel alongguide member3138 in the proximal direction,hub3132, still driven byspring3112, drivesneedle carrier assembly3108, and soinsertion element3174, in the proximal direction from the distal insertion position to the proximal retraction position. In this way,drive assembly3110 converts linear motion ofspring3112 in a single direction, e.g., the proximal direction, into reciprocating linear motion in the distal direction and then the proximal direction.
• FIG. 32A illustrates an exploded perspective view of yet anotherapplicator3200 for an on-skin sensor assembly of an analyte sensor system, according to some embodiments.Applicator3200 may include anapplicator housing3202 configured to house at least one or more mechanisms utilized to apply the on-skin sensor assembly160 toskin130 of a host.Applicator3200 may further include abase3230 coupled to a bottom opening ofapplicator housing3202.Base3230 defines a bottom surface ofapplicator3200 and a plane for application of on-skin sensor assembly160 toskin130 of a host.
• Applicator3200 includes anactivation element3204 configured to activate a drive assembly ofapplicator3200. In some embodiments,activation element3204 may be a button, a switch, a toggle, a slide, a trigger, a knob, a rotating member, a component that deforms and/or flexes or any other suitable mechanism for activating a drive assembly of applicator460.
• Applicator3200 may further comprise aneedle carrier assembly3208, including aninsertion element3274 configured to insertsensor138 of on-skin sensor assembly160 intoskin130 of the host (e.g.,FIG. 1). In some embodiments, the insertion element comprises a needle, for example, an open sided-needle, a needle with a deflected-tip, a curved needle, a polymer-coated needle, a hypodermic needle, or any other suitable type of needle or structure, as will be described in more detail in connection with at leastFIGS. 47-50 and 80A-B. In yet other embodiments, insertion element may comprisesensor138, sufficiently rigid to be inserted partially intoskin130 of the host with minimal or no structural support.
• Applicator3200 may further include aholder3224 releasably coupled toneedle carrier assembly3208 and configured to guide on-skin sensor assembly160 while coupled toneedle carrier assembly3208. As will be described in more detail below, on-skin sensor assembly160 may be stripped fromholder3224 andneedle carrier assembly3208 once on-skin sensor assembly160 is disposed onskin130 of the host.
• Applicator3200 may further comprise a drive assembly configured to driveinsertion element3274 andneedle carrier assembly3208 in the distal direction to the distal insertion position and in the proximal direction from the distal insertion position to the proximal retraction position. Drive assembly3210 may include afirst spring3212 and asecond spring3228.First spring3212 may be a compression spring, or any suitable type of spring, and may have a first end coupled toapplicator housing3202 and a second end coupled toholder3224.First spring3212 is configured to, upon activation of drive assembly3210,drive holder3224, and also coupledneedle carrier assembly3208,insertion element3274 and on-skin sensor assembly160, in the distal direction to the distal insertion position. Substantially at the distal insertion position,needle carrier assembly3208 may decouple fromholder3224 and on-skin sensor assembly160.
• Second spring3228 may be a compression spring, or any suitable type of spring, and may have a first end coupled toholder3224 and a second end coupled toneedle carrier assembly3208.Second spring3228 is configured to driveneedle carrier assembly3208, and alsoinsertion element3274, in the proximal direction from the distal insertion position to the proximal retraction position. In some embodiments, first spring and/or second spring can be preloaded, partially loaded, or unloaded.
• FIG. 32B illustrates an explodedperspective view3250 ofneedle carrier assembly3208 coupled toinsertion element3274,second spring3228,holder3224 and on-skin sensor assembly160.
• FIG. 33A-33E illustrate perspective cutaway views of several features ofapplicator3200 ofFIGS. 32A-32B, according to some embodiments.FIG. 33A illustrates a perspective cutaway view of theentire applicator3200, includingapplicator housing3202,activation element3204,first spring3212,needle carrier assembly3208 coupled toinsertion element3274,holder3224 coupled to on-skin sensor assembly160, andbase3230. Each of these components may have functionality as previously described in connection with at leastFIGS. 32A-32B.
• FIG. 33B illustrates a magnified perspective cutaway view of aretention element3312 ofholder3224 releasably coupled toapplication housing3202.Retention element3312 is configured to preventholder3224 from traveling in the distal direction and, therefore,spring3212 from unloading.Activation mechanism3204, when activated, is configured to deflectretention element3312 sufficiently to decouple it fromapplicator housing3202, thereby freeingholder3224 to travel in the distal direction, driven byspring3212.
• FIG. 33C illustrates a magnified perspective cutaway view of aretention element3342 ofneedle carrier assembly3208 configured to releasably coupleneedle carrier assembly3208 toholder3224. As shown,retention element3342 may have a sloped surface configured to come in contact with a protrusion (not shown inFIG. 33) of theapplicator housing3202 or base3230 (not shown inFIG. 33) that is configured to deflectretention element3342 sufficiently to decoupleneedle carrier assembly3208 fromholder3224 whenneedle carrier assembly3208 is at or near the distal insertion position.
• FIG. 33D illustrates a perspective view of a plurality ofretention elements3372a,3372bofneedle carrier assembly3208 configured to pass throughholder3224 and releasably couple on-skin sensor assembly160 toholder3224 and toneedle carrier assembly3208. As previously described, at the distal insertion position, deflectedretention element3342 decouplesneedle carrier assembly3208 fromholder3224, allowingsecond spring3228 to driveneedle carrier assembly3208 in the proximal direction. Asneedle carrier assembly3208 is driven in the proximal direction,retention elements3372a,3372bdetach from on-skin sensor assembly160. Although two retention elements are illustrated, any number of retention elements are contemplated. In some embodiments, retention element(s)3372a,3372bmay comprise snap fits, friction fits, interference features, elastomeric grips and/or adhesives configured to couple on-skin sensor assembly160 withneedle carrier assembly3208 and/orholder3224. Moreover, alternative mechanisms that may perform such retention and release actions are further described in connection with at leastFIGS. 35A-37C below.
• FIG. 33E illustrates a perspective cutaway view of aretention element3346 ofholder3224 and aretention element3348 ofapplicator housing3202 configured to immobilizeneedle carrier assembly3208 toholder3346 uponneedle carrier assembly3208 reaching the distal insertion position. This interaction immobilizesinsertion element3274 in the proximal retraction position, thereby ensuring the end ofinsertion element3274 is not exposed out the bottom ofapplicator3200.
• A brief description of the operation ofapplicator3200 follows with respect toFIGS. 34A-34F, which illustrate several perspective views of the applicator ofFIG. 32 during operation, according to some embodiments.
• FIG. 34A illustrates a state ofapplicator3200 at activation.Activation element3204 is illustrated in the process of being activated, having been pushed down by a user, for example.Activation element3204 deflectsretention element3312 such thatholder3224 is not prevented from traveling in the distal direction.Holder3224,needle carrier assembly3208,insertion element3274,first spring3212 andsecond spring3228 are all shown in pre-activation positions.
• FIG. 34B illustratesapplicator3200 during activation.Activation element3204 is illustrated in the activated position.Spring3212 is drivingholder3224, and also needlecarrier assembly3208,insertion element3274, and on-skin sensor assembly160, in the distal direction toward the distal insertion position.
• FIG. 34C illustratesapplicator3200 during activation, asneedle carrier assembly3208 approaches the distal insertion position.Activation element3204 is illustrated in the activated position.Insertion assembly3208,insertion element3274,holder3224 and on-skin sensor assembly160 are driven in the distal direction to the distal insertion position. At or near this distal insertion position, at least a portion ofinsertion element3274 as well as at least a portion ofsensor138 of on-skin sensor assembly160 may be inserted into the skin of the host. At this position,retention element3342 is deflected by a portion of applicator housing3302 orbase3230, thereby decouplingneedle carrier assembly3208 fromholder3224.
• FIG. 34D illustratesapplicator3200 during activation.Activation element3204 is illustrated in the activated position.Second spring3228 drivesneedle carrier assembly3208 andinsertion element3274 in the proximal direction from the distal insertion position. Although not shown inFIG. 34D, once needle carrier assembly reaches the proximal retraction position,retention elements3346 and3348 may be engaged with one another immobilizingneedle carrier assembly3208 andinsertion element3274 in the proximal retraction position, thereby maintaininginsertion element3274 in a locked, retracted position.
• FIG. 35A-35C illustrate several cross-sectional views of an on-skin sensor assembly retention mechanism ofapplicator3200 ofFIG. 32, according to some embodiments. The retention mechanism described in connection withFIGS. 35A-35C is similar to the retention mechanism previously described in connection withFIGS. 6A-6H.FIG. 35A illustrates the retention mechanism whileapplicator3200 is in the pre-activated state.Retention element3372ais illustrated as a portion ofholder3224 and configured to releasably couple on-skin sensor assembly160 toholder3224 asneedle carrier assembly3208 travels in the distal direction to the distal insertion position, and to decouple on-skin sensor assembly160 fromholder3224 asneedle carrier assembly3208 travels in the proximal direction from the distal insertion position towards the proximal retraction position. Specifically,retention element3372amay comprise afirst end3376aand asecond end3378a. The second end may be releasably coupled to on-skin sensor assembly160 in the pre-activation state. As previously stated, retention element(s)3372a,3372bmay comprise snap fits, friction fits, interference features, elastomeric grips and/or adhesives configured to couple on-skin sensor assembly160 withneedle carrier assembly3208 and/orholder3224.FIG. 35A further illustratesapplicator housing3202 comprising an optional reinforcingelement3510 configured to prevent lateral motion ofretention element3372ain the proximal starting position, thereby supporting releasable coupling ofsecond end3378aofretention element3372awith on-skin sensor assembly160.
• FIG. 35B illustratesapplicator3200 in the distal insertion position after activation. Asneedle carrier assembly3208 travels in the distal direction to the distal insertion position,retention element3342 ofneedle carrier assembly3208 is released fromholder3224. The second end ofretention element3372amay still be releasably coupled to on-skin sensor assembly160.FIG. 35B further illustrates optional reinforcingelement3510 as no longer being in physical contact withretention element3372ain the distal insertion position, thereby allowing for the uncoupling ofsecond end3378aofretention element3372afrom on-skin sensor assembly160.
• FIG. 35C illustratesapplicator3200 whereneedle carrier assembly3208 is moving in the proximal direction from the distal insertion position. Sinceretention element3342 ofneedle carrier assembly3208 was uncoupled fromholder3224 at the distal insertion position, asneedle carrier assembly3208 travels back in the proximal direction,needle carrier assembly3208 separates fromholder3224. Asneedle carrier assembly3208 travels in the proximal direction,first end3376aofretention element3372ais deflected byneedle carrier assembly3208, thereby decouplingsecond end3378aofretention element3372afrom on-skin sensor assembly160.FIG. 35C further illustrates optional reinforcingelement3510 as no longer being in physical contact withretention element3372ain the distal insertion position.
• FIG. 36A-36C illustrate several cross-sectional views of another on-skin sensor assembly retention mechanism ofapplicator3200 ofFIG. 32, according to some embodiments.FIG. 36A illustrates the retention mechanism whileapplicator3200 is in the pre-activated state.Retention element3372ais illustrated as a portion ofneedle carrier assembly3208 and is configured to releasably couple on-skin sensor assembly160 toholder3224 asneedle carrier assembly3208 travels in the distal direction to the distal insertion position, and to decouple on-skin sensor assembly160 fromholder3224 asneedle carrier assembly3208 travels in the proximal direction from the distal insertion position towards the proximal retraction position. Specifically,retention element3372amay releasably couple on-skin sensor assembly160 asneedle carrier assembly3208 travels in the distal direction to the distal insertion position.FIG. 36A further illustratesapplicator housing3202 comprising an optional reinforcingelement3610 configured to prevent lateral motion ofretention element3372aand/orretention element3342 in the proximal starting position, thereby supporting releasable coupling ofretention element3372awith on-skin sensor assembly160.
• FIG. 36B illustratesapplicator3200 at the distal insertion position.Retention element3342 ofneedle carrier assembly3208 is uncoupled fromholder3224 at the distal insertion position,retention element3224 being deflected by a portion ofapplicator housing3202 or an applicator base ofapplicator housing3202 sufficient forretention element3224 to clear a stop element of needle carrier assembly. Accordingly,needle carrier assembly3208 separates fromholder3224 asneedle carrier assembly3208 travels back in the proximal direction by a force provided byspring3228. Rather than being physically deflected in orientation asneedle carrier assembly3208 travels in the proximal direction,retention element3372ais formed to be easily deflected or deformed simply by the separation ofholder3224 fromneedle carrier assembly3208.FIG. 36B further illustrates optional reinforcingelement3610 as no longer being in physical contact withretention element3372aand/orretention element3342 in the distal insertion position, thereby allowing for the uncoupling ofretention element3372afrom on-skin sensor assembly160 and/or the uncoupling ofholder3224 fromneedle carrier assembly3208.
• FIG. 36C illustratesneedle carrier assembly3208 moving in the proximal direction from the distal insertion position ofFIG. 36B. As shown,retention element3372ahas been released from on-skin sensor assembly160 by separation ofneedle carrier assembly3208 fromholder3224, andneedle carrier assembly3208 is driven in the proximal direction by a force provided byspring3228.FIG. 36C further illustrates optional reinforcingelement3610 as no longer being in physical contact withretention element3372aand/orretention element3342 in the proximal retracted position.
• FIG. 37A-37C illustrate several cross-sectional views of yet another on-skin sensor assembly retention mechanism ofapplicator3200 ofFIG. 32, according to some embodiments.FIG. 37A illustratesapplicator3200 in the pre-activated position.Retention element3372ais illustrated inFIG. 37A as an integral portion ofholder3208 and is configured to releasably couple on-skin sensor assembly160 toholder3224 asneedle carrier assembly3208 travels in the distal direction to the distal insertion position, and to decouple on-skin sensor assembly160 fromholder3224 asneedle carrier assembly3208 travels in the proximal direction from the distal insertion position towards the proximal retraction position. Specifically,retention element3372amay releasably couple on-skin sensor assembly160 asneedle carrier assembly3208 travels in the distal direction to the distal insertion position.FIG. 37A further illustratesapplicator housing3202 comprising an optional first reinforcingelement3710 configured to prevent lateral motion ofretention element3342 in the proximal retracted position.FIG. 37A further illustratesneedle carrier3208 comprising an optional second reinforcingelement3712 configured to prevent lateral motion ofretention element3372a, thereby supporting releasable coupling ofretention element3372awith on-skin sensor assembly160.
• FIG. 37B illustratesneedle carrier assembly3208 in the distal insertion position.Retention element3342 ofneedle carrier assembly3208 is uncoupled fromholder3224 at the distal insertion position. Accordingly,needle carrier assembly3208 separates fromholder3224 asneedle carrier assembly3208 travels back in the proximal direction under influence of a force provided byspring3228 asspring3228 unloads, pushing againstholder3224 andneedle carrier assembly3208.FIG. 37B further illustrates optional first reinforcingelement3710 as no longer being in physical contact withretention element3342 in the distal insertion position, thereby allowing for the uncoupling ofholder3224 fromneedle carrier assembly3208. Optional second reinforcingelement3712 is still illustrated as being in physical contact withretention element3372ain the distal insertion position.
• FIG. 37C illustrates needle carrier assembly as it begins to travel in the proximal direction, afterretention element3372aofneedle carrier assembly3208 is uncoupled fromholder3224. Rather than being physically deflected in orientation asneedle carrier assembly3208 travels in the proximal direction, as inFIGS. 35A-35C,retention element3372adetaches from on-skin sensor assembly160 simply by theuser removing applicator3200 from the skin. In some embodiments, an adhesive patch that holds on-skin sensor assembly160 to the skin of the host provides sufficient bonding strength to decouple on-skin sensor assembly160 from the skin of the host whenapplicator3200 is removed from the skin.FIG. 37C further illustrates optional first reinforcingelement3710 as no longer being in physical contact withretention element3372ain the proximal retracted position, thereby supporting uncoupling ofretention element3372afrom on-skin sensor assembly160.
• FIG. 38 illustrates a perspective view of anapplicator3800 similar to those shown inFIG. 32, including anactivation element3804 on a side of anapplicator housing3802, according to some embodiments.Applicator3800 may have substantially the same features as eitherapplicator3200 ofFIG. 32, except thatactivation element3804 is located on a side ofapplicator housing3802, rather than on a top of the applicator housing. Such an arrangement may provide for an applicator having a reduced height compared to top-activated applicators, though potentially having an increased width or diameter compared to the top-activated applicators.
• FIG. 39 illustrates a cutaway view of a portion ofapplicator3800 ofFIG. 38, according to some embodiments.Activation element3804 may be configured to, upon activation, deflect a retention element3902 ofholder3824 configured to preventholder3824 from traveling in the distal direction. All other features ofapplicator3800 not discussed may be substantially as previously described for eitherapplicator3200 ofFIG. 32.
• FIGS. 40A-40G illustrate several perspective views of an assembly process for the applicator ofFIG. 32, according to some embodiments.FIG. 40A illustrates insertingsecond spring3228 intoholder3224.FIG. 40B illustrates next insertinginsertion element3274 intoneedle carrier assembly3208 and then insertinginsertion element3274 intoneedle carrier assembly3208 intoholder3224. In some embodiments, insertinginsertion element3274 intoneedle carrier assembly3208 intoholder3224 pre-compressessecond spring3228.FIG. 40C illustrates coupling on-skin sensor assembly160 to at least one ofholder3224 andneedle carrier assembly3208 by coupling retention elements (not shown inFIG. 40C) ofholder3224 or ofneedle carrier assembly3208 to attachment points (not shown inFIG. 40C) of on-skin sensor assembly160.
• FIG. 40D illustratescoupling activation element3204 toapplicator housing3202. InFIG. 40D,activation element3204 is coupled on a top ofapplicator housing3202. In some embodiments,activation element3204 may be pressed into an opening ofapplicator housing3202 configured to receiveactivation element3204. However, in other embodiments,applicator housing3202 may accommodateactivation element3204 in other locations, for example, an upper, medial or lower side of applicator housing.FIG. 40E illustrates insertingfirst spring3212 intoapplicator housing3202.FIG. 40F illustrates inserting the assembly described inFIG. 40C (comprisingholder3224,second spring3228,needle carrier assembly3208,insertion element3274 and on-skin sensor assembly160) intoapplicator housing3202. In some embodiments, the act of inserting the assembly described inFIG. 40C pre-compressesfirst spring3212.FIG. 40G illustratescoupling base3230 toapplicator housing3202.
On-Skin Sensor Assembly Retention Mechanisms
• In some embodiments of applicators described herein, on-skin sensor assembly160 is held in place during at least travel in the distal direction to the distal insertion position. In some such embodiments, on-skin sensor assembly160 is then released or decoupled from a portion of the applicator during application to the skin of the host so that a needle carrier assembly and insertion element may travel back in the proximal direction.FIGS. 41A-45 illustrate several alternative retention mechanisms that may be utilized in any of the applicators described herein.
• FIGS. 41A-41B illustrate an exemplary on-skin sensor assembly retention mechanism of an applicator for an analyte sensor system, according to some embodiments. The retention mechanism illustrated byFIGS. 41A-41B may be considered a first on-skin sensor assembly retention configuration, and is similar to the retention mechanism previously described in connection withFIG. 5.
• FIG. 41A illustrates a retention mechanism in a state where on-skin sensor assembly160 is retained, whileFIG. 41B illustrates the retention mechanism in a state where on-skin sensor assembly160 is decoupled.
• FIG. 41A illustratesretention elements4172a,4172bof aholder4124 configured to releasably couple on-skin sensor assembly160 toholder4124 as needle carrier assembly4108 (and so insertion element4172,holder4124, and on-skin sensor assembly160) travels in the distal direction to the distal insertion position. Specifically,retention elements4172a,4172bmay each comprise afirst end4176a,4176b, asecond end4178a,4178b, and apivot point4180a,4180b.First end4176a,4176bis immobilized in arespective guide4174a,4174bofneedle carrier assembly4108 and each ofretention elements4172a,4172bis immobilized againstinterference points4182a,4182bofneedle carrier assembly4108, thereby releasably coupling and immobilizingsecond end4178a,4178btoattachment points4162a,4162bof on-skin sensor assembly160 asneedle carrier assembly4108 travels in the distal direction to the distal insertion position. In some embodiments, the profile ofslots4174a,4174bmay be such that the sides ofslots4174a,4174bexert a force onfirst ends4176a,4176bofretention elements4172a,4172bsufficient to holdsecond ends4178a,4178bofretention elements4172a,4172bin engagement withattachment points4162a,4162bof on-skin sensor assembly160. Although two retention elements are illustrated, any number of retention elements are contemplated.
• FIG. 41B illustrates the retention mechanism asneedle carrier assembly4108 andinsertion element4174 travel in the proximal direction from the distal insertion position to the proximal retraction position. Asneedle carrier assembly4108 travels back in the proximal direction,needle carrier assembly4108 separates fromholder4124, thereby removingfirst ends4176a,4176bofretention elements4172a,4172bfromrespective slots4174a,4174b, allowing first ends4176a,4176bto deflect inward andsecond ends4178a,4178bofretention elements4172a,4172bto deflect outward fromattachment points4162a,4162bof on-skin sensor assembly160 asretention elements4172a,4172brotate aboutpivot points4180a,4180b.
• FIGS. 42A-42B illustrate an exemplary on-skin sensor assembly retention mechanism of an applicator for an analyte sensor system, according to some embodiments. The retention mechanism illustrated byFIGS. 42A-42B may be considered a second on-skin sensor assembly retention configuration, and is similar to the retention mechanism previously described in connection withFIG. 36.FIG. 42A illustrates a retention mechanism in a state where on-skin sensor assembly160 is retained, whileFIG. 42B illustrates the retention mechanism in a state where on-skin sensor assembly160 is decoupled.
• FIG. 42A illustratesretention elements4272a,4272bas portions ofneedle carrier assembly4208 that pass through or aroundneedle carrier assembly4208, rather than as portions ofholder4224.Retention elements4272a,4272bare configured to releasably couple on-skin sensor assembly160 to holder4228 as needle carrier assembly4208 (and so an insertion element,holder4224, and on-skin sensor assembly4224) travels in the distal direction to the distal insertion position.
• FIG. 42B illustrates the retention mechanism asneedle carrier assembly4208 and insertion element4274 travel in the proximal direction from the distal insertion position to the proximal retraction position. Asneedle carrier assembly4208 travels in the proximal direction,needle carrier assembly2508 separates fromholder4224 andretention elements4272a,4272bare uncoupled fromrespective attachment points4262a,4262bof on-skin sensor assembly160. Rather than being physically deflected in orientation asneedle carrier assembly4208 travels in the proximal direction, as described forretention elements4172a,4172bofFIGS. 41A-41B,retention elements4272a,4272bare pulled out ofattachment points4262a,4262bby the energy of the retraction.
• FIGS. 43A-43B illustrate an exemplary on-skin sensor assembly retention mechanism of an applicator for an analyte sensor system, according to some embodiments. The retention mechanism illustrated byFIGS. 43A-43B may be considered a passive snap design. FIG.43A illustrates a retention mechanism in a state where on-skin sensor assembly160 is retained, whileFIG. 43B illustrates the retention mechanism in a state where on-skin sensor assembly160 is decoupled.
• FIG. 43A illustratesretention elements4372a,4372bas portions of aholder4324.Retention elements4372a,4372bare configured to releasably couple on-skin sensor assembly160 toholder4324 as needle carrier assembly4308 (and so an insertion element,holder4324, and on-skin sensor assembly4324) travels in the distal direction to the distal insertion position.FIG. 43A further illustratesprotrusions4380a,4380bofneedle carrier assembly4308 configured to physically contactretention elements4372a,4372bofholder4324 thereby preventingretention elements4372a,4372bfrom disengaging from on-skin sensor assembly4324 whileneedle carrier assembly4308 is in contact withholder4324.
• FIG. 43B illustrates the retention mechanism asneedle carrier assembly4308 travels in the proximal direction from the distal insertion position to the proximal retraction position. Asneedle carrier assembly4308 travels in the proximal direction,needle carrier assembly4308 separates fromholder4324. Although not shown inFIGS. 43A-43B,holder4324 may be immobilized to an applicator housing or base by one or more retention elements, similar toretention elements642,644 ofFIG. 6E. Accordingly,retention elements4372a,4372bmay be uncoupled fromrespective attachment points4362a,4362bof on-skin sensor assembly160 as the applicator is removed from the skin of the host. In some embodiments, an adhesive patch that holds on-skin sensor assembly160 to the skin of the host provides sufficient bonding strength to decouple on-skin sensor assembly160 from the skin of the host when the applicator is removed from the skin.
• FIG. 44 illustrates another portion of an exemplary on-skin sensor assembly retention mechanism of an applicator for an analyte sensor system, according to some embodiments.FIG. 44 illustrates aneedle carrier assembly4408, aholder4424, and on-skin sensor assembly160. Contrary to several previous embodiments of retention mechanisms for on-skin sensor assembly160,needle carrier assembly4408 comprises at least oneretention element4472aandholder4424 comprises at least onealignment element4473 a, in whichretention element4472ais configured to releasably couple to on-skin sensor assembly160, andalignment element4473ais configured to align on-skin sensor assembly160 within the applicator. This distribution of retention elements between both a needle carrier assembly and a holder may be implemented for any on-skin sensor assembly retention mechanism described herein.
• FIGS. 45 and 46 illustrate portions of exemplary on-skin sensor assembly retention mechanisms of an applicator for an analyte sensor system, according to some embodiments.FIGS. 45 and 46 illustrate aneedle carrier assembly4508,4608, arotating drive element4514,4614 similar to that previously described in connection withFIG. 5, and on-skin sensor assembly160. Accordingly, the retention mechanisms ofFIGS. 45 and 46 may function similarly to that described inFIG. 5. Rotatingdrive element4514,4614 may be a wheel cam and may comprise a cam lobe4518 (e.g., a ramp or protrusion, not shown inFIG. 46, seeFIG. 45) disposed along at least a portion of a circumference of rotatingdrive element4514,4614. InFIG. 45, as rotatingdrive element4514 is rotated,protrusion4518 may travel alongsideneedle carrier assembly4508 and come into contact with and increasingly apply a force to on-skin sensor assembly160 such that on-skin sensor assembly160 decouples fromneedle carrier assembly4508. InFIG. 46, as rotatingdrive element4614 is rotated, the protrusion may travel at least partially through a guide orslot4620 inneedle carrier assembly4608 and come into contact with and increasingly apply a force to on-skin sensor assembly160 such that on-skin sensor assembly160 decouples fromneedle carrier assembly4608. In this way, rotatingdrive element4514,4614 may serve both to driveneedle carrier assembly4508,4608 in the distal and proximal directions, as previously described in connection withFIG. 5, and to release on-skin sensor assembly160 upon deposition to the skin of the host.
• In some embodiments, on-skin sensor assembly retention mechanisms may incorporate features to couple an on-skin sensor assembly to the needle carrier assembly and/or the holder. Methods of coupling on-skin sensor assembly are described in U.S. patent application Ser. No. 15/387,088, which is incorporated herein by reference it its entirety. For non-limiting example, on-skin sensor assembly retention mechanisms may include a frangible release (e.g.FIGS. 137-140), a frangible elastomer (e.g.FIGS. 134-136), a releasable adhesive (e.g.FIG. 123-125), or a releasable friction-fit coupling (e.g.FIG. 126-133).
• For example, a frangible release can be implemented in the current embodiments by a structure attached between an on-skin sensor assembly (e.g.160), a holder (e.g.524), a needle carrier (e.g.508), and/or an applicator housing (e.g.502). The frangible component may include features such has a weakened portion or a portion designated to fracture during release of the on-skin sensor assembly from the applicator. Frangible components configured to fracture may include patch material (e.g. spun lace) or molded components (e.g. ABS, PC, polymer, elastomeric polymer, etc.).
• For example, a releasable adhesive can be implemented in the current embodiments by a releasable adhesive releasably attached between an on-skin sensor assembly (e.g.160), a holder (e.g.524), a needle carrier (e.g.508), and/or an applicator housing (e.g.502). The releasable adhesive may consist of a double sided adhesive tape, a glue, or a hot melt polymer. The releasable adhesive is configured to detach during release of the on-skin sensor assembly from the applicator via an applicator mechanism (e.g. retraction mechanism) or user force.
• For example, a releasable friction-fit coupling can be implemented in the current embodiments by a surface contact between an on-skin sensor assembly (e.g.160), a holder (e.g.524), a needle carrier (e.g.508), and/or an applicator housing (e.g.502). The releasable friction-fit coupling may consist of a rigid or elastomeric material (e.g. silicone, TPE, TPU, rubber, etc.) or a combination thereof. The coupled components (e.g. on-skin sensor assembly160 and holder524) have a frictional material interaction (e.g. interference fit, deformable fit, etc.). The releasable friction-fit coupling is configured to detach during release of the on-skin sensor assembly from the applicator via an applicator mechanism (e.g. retraction mechanism) or user force.
• Discussion with respect toFIGS. 71-89 below may be directed to, among other aspects, applicators that account for skin tenting (e.g., the skin bowing in a substantially convex fashion as the host pushes the applicator against the skin).FIGS. 71-89 may be further directed to preventing an insertion mechanism, assembly or spring from stalling due to such skin tenting by, among other aspects, initiating retraction, after insertion, based on an on-skin sensor assembly and/or other features of the applicator pushing against the skin of the host with a force sufficient to initiate the retraction, as opposed to retraction being triggered by the on-skin sensor assembly and/or other features of the applicators reaching a predetermined physical displacement in the distal direction. It is contemplated that such force-based retraction trigger allows the transition from insertion to retraction at a variety of distally displaced positions based at least in part on the location of the surface of the skin of the host during application.
• FIG. 71 illustrates anapplicator7100 for an on-skin sensor assembly of an analyte sensor system, according to some embodiments. As will be described below,applicator7100 may comprise anactivation element7104 disposed on a side ofapplicator7100, for example, on a side of anouter housing7101 ofapplicator7100. In some embodiments,activation element7104 may be a button, a switch, a toggle, a slide, a trigger, a knob, a rotating member, a portion ofapplicator7100 that deforms and/or flexes or any other suitable mechanism for activating an insertion and/or retraction assembly ofapplicator7100. In some embodiments,activation element7104 may be disposed in any location, e.g., a top, upper side, lower side, or any other location ofapplicator7100.Applicator7100 may be large enough for a host to grasp with a hand and push, or otherwise activate,activation element7104 with, for example, a thumb, or with an index finger and/or a middle finger.
• Applicator7100 may be configured with one or more safety features such thatapplicator7100 is prevented from activating until the safety feature is deactivated. In one example, the one or more safety features preventsapplicator7100 from activating unlessapplicator7100 is pressed against the skin of a host with sufficient force. Moreover, as will be described in more detail in connection with one or more ofFIGS. 72-80B below,applicator7100 may be further configured such that one or more components therein retract based at least in part on the one or more components pushing against the skin of the host with a force exceeding a predetermined threshold, rather than based on the one or more components translating beyond a predetermined and static distal position. In other words,applicator7100 may implement force-based retraction triggering rather than being limited to displacement-based retraction triggering.
• FIG. 72 illustrates an exploded perspective view ofapplicator7100 ofFIG. 71, according to some embodiments.Applicator7100 may includeouter applicator housing7101 comprisingactivation element7104.Outer applicator housing7101 may be configured to translate in a distal direction by a force applied by a host toapplicator7100, specifically toinner housing7102, thereby aligningactivation element7104 in a position that allowsapplicator7100 to fire. Further explanation of the alignment process will be explained below.
• Applicator7100 further comprisesinner housing7102, configured to house at least one or more mechanisms utilized to apply on-skin sensor assembly360 toskin130 of a host. Adistal surface7130 of a bottom opening ofinner housing7102 may define a bottom surface ofapplicator7100. In some embodiments, upon pressingapplicator7100 againstskin130 of the host,skin130 may deform in a substantially convex shape atdistal surface7130 such that at least a portion of a surface ofskin130 disposed at the bottom opening ofapplicator housing7102 extends into the bottom opening ofinner housing7102 beyond a plane defined bydistal surface7130 in a proximal direction.
• In some embodiments, afirst barrier layer7192 may be disposed over one or more apertures ininner housing7102, for example, anaperture7106 through which at least a portion ofactivation element7104 may be configured to extend through during activation ofapplicator7100. In such embodiments, a portion ofactivation element7104 may be configured to pierce or deformfirst barrier layer7192 upon activation ofapplicator7100.First barrier layer7192 may comprise a gas permeable material such as Tyvek, or a non-gas permeable material such as metallic foil, polymer film, elastomer, or any other suitable material.
• Applicator7100 may further comprise aneedle carrier assembly7108, including aneedle hub7150 configured to couple aninsertion element7174 toneedle carrier assembly7108. In some other embodiments,insertion element7174 may be directly coupled toneedle carrier assembly7108.Insertion element7174 is configured to insertsensor338 of on-skin sensor assembly360 (seeFIGS. 3A-4) intoskin130 of the host (e.g.,FIG. 1). In some embodiments, the insertion element comprises a needle, for example, an open sided-needle, a needle with a deflected-tip, a curved needle, a polymer-coated needle, a hypodermic needle, or any other suitable type of needle or structure, as described in connection with at leastFIGS. 47-50 and 80A-B. In yet other embodiments,insertion element7174 may be integrally formed withsensor338 and may be sufficiently rigid to be inserted partially intoskin130 of the host with minimal or no structural support.
• Applicator7100 may further include aholder7124 releasably coupled toneedle carrier assembly7108 and configured to guideneedle carrier assembly7108 and on-skin sensor assembly360 while coupled toneedle carrier assembly7108, e.g., at least during translation from a proximal position to a distal insertion position. As will be described in more detail below, on-skin sensor assembly360 may be stripped or released fromholder7124 and/orneedle carrier assembly7108 once on-skin sensor assembly360 is disposed onskin130 of the host.
• Applicator7100 may further comprise an insertion assembly configured to translateinsertion element7174,needle hub7150,needle carrier assembly7108, and on-skin sensor assembly360 from a proximal position, in the distal direction, to a distal insertion position. Such an insertion assembly may include afirst spring7112.First spring7112 may be a compression spring, or any suitable type of spring, and may have a first end in contact with or coupled toinner applicator housing7102 and a second end in contact with or coupled toholder7124.First spring7112 is configured to, upon activation of the insertion assembly, translateholder7124,needle carrier assembly7108,needle hub7150,insertion element7174 and on-skin sensor assembly360, in the distal direction to the distal insertion position. Substantially at the distal insertion position,needle carrier assembly7108 may decouple fromholder7124 and on-skin sensor assembly360.
• Applicator7100 may further comprise a retraction assembly configured to translateneedle carrier assembly7108,needle hub7150 andinsertion element7174, in the proximal direction, from the distal insertion position to a proximal retracted position. In some embodiments the initial proximal position may be the same as the proximal retracted position. In other embodiments, the initial proximal position may be different from the proximal retracted position. Such a retraction assembly may include asecond spring7128.Second spring7128 may be a compression spring, or any suitable type of spring, and may have a first end contacting or coupled toholder7124 and a second end in contact with or coupled to at least one spring retention element (e.g.,7442a,7442binFIGS. 74A-75B), at least until retraction.Second spring7128 is configured to translateneedle carrier assembly7108,needle hub7150, andinsertion element7174 in the proximal direction from the distal insertion position to the proximal retracted position in response to on-skin sensor assembly360 contactingskin130 of the host, and/or reaching a limit of travel with a force exceeding a predetermined threshold sufficient to cause first end ofsecond spring7128 to overcome the at least one spring retention element (e.g.,7442a,7442binFIGS. 74A-75B). In some embodiments, a stop feature (not shown) may be disposed at a bottom ofapplicator7100, e.g., on a distal portion ofinner housing7102. Such a stop feature may be configured to contact one or more of on-skin sensor assembly360,needle carrier7108, orholder7124 in the distal insertion position.
• In some embodiments, transfer of on-skin sensor assembly360 between insertion and retraction may occur as previously described in connection with, for example, any ofFIGS. 35A-37C.
• In some embodiments, asecond barrier layer7194 may be disposed over the bottom opening ofinner housing7102.Second barrier layer7194 may comprise a gas permeable material such as Tyvek, or a non-gas permeable material such as metallic foil, film. In some embodiments,second barrier layer7194 may be removed by the host prior to use ofapplicator7100. In embodiments comprising one or both of first andsecond barrier layers7192,7194, such layers may provide a sterile environment betweenapplicator7100 and the outside environment and/or may allow ingress and egress of gas such as during sterilization.
• Although not shown inFIGS. 71-72, in some embodiments,applicator7100 may comprise a cap configured to be secured todistal surface7130 ofinner housing7102 and that may be removed before use. In some embodiments, such a cap may also function as a sterile barrier, as previously described in U.S. patent application Ser. No. 16/011,527, hereby incorporated by reference in its entirety.
• A brief description of some aspects of the operation ofapplicator7100 follows with respect toFIGS. 73A-73C, which illustrate several cross-sectional views ofapplicator7100 ofFIGS. 71 and 72 during operation, according to some embodiments.FIGS. 73A-73C may correspond toapplicator7100 cut along the section line A-A′ shown inFIG. 71, for example.
• FIG. 73A illustrates a state ofapplicator7100 prior to activation.Holder7124 comprises an insertionassembly retention element7332 configured to contactinner housing7102, thereby immobilizingholder7124,needle carrier assembly7108,needle hub7150,insertion element7174 and on-skin sensor assembly360, in the pre-activated state.
• Needle carrier assembly7108 comprises a plurality of wearable retention and/oralignment elements7372a,7372bconfigured to extend throughholder7124 and releasably couple on-skin sensor assembly360 toholder7124 and/or toneedle carrier assembly7108.Wearable retention elements7372a,7372bmay comprise, e.g., arms, deflection element, tabs, detents, snaps or any other features capable of a retaining function. In some embodiments,wearable retention elements7372a,7372bmay extend around rather than throughholder7124. Although two wearable retention elements are illustrated, any number of wearable retention elements are contemplated. In some embodiments, wearable retention element(s)7372a,7372bmay comprise snap fits, friction fits, interference features, elastomeric grips and/or adhesives configured to couple on-skin sensor assembly360 withneedle carrier assembly7108 and/orholder7124.
• Inner housing7102 may comprise a spring7320 configured to contactouter housing7101 and maintain a predetermined spacing betweenouter housing7101 andinner housing7102 in the pre-activation orientation ofFIG. 73A. Spring7320 may be a compression spring, leaf spring, flex arm spring, a piece of foam or rubber, etc. In some other embodiments,outer housing7101 may comprise spring7320 and spring7320 may be configured to contactinner housing7102, in a reverse fashion from that shown inFIG. 73A.
• Activation ofapplicator7100 may include ahost pressing applicator7100 against their skin with sufficient force to translateouter housing7101 in a distal direction, as shown byarrow7302, toward and with respect toinner housing7102 untilactivation element7104 is aligned withaperture7106 ofinner housing7102 and insertionassembly retention element7332 ofholder7124. Insertionassembly retention element7332 may comprise, e.g., an arm, a deflection element, a tab, a detent, a snap or any other feature capable of a retaining function. Once such an alignment is achieved, a host may initiate (e.g. pushing)activation element7104, as shown byarrow7304, thereby deflecting insertionassembly retention element7332 sufficiently to releaseholder7124 frominner housing7102. In some other embodiments,applicator7100 may be configured such thatactivation element7104 may be activated first, but that actual insertion is not triggered untilouter housing7101 is translated sufficiently in the distal direction toward and with respect toinner housing7102. In yet other embodiments,activation element7104 may be biased toward a center ofapplicator7100 such thatactivation element7104 need not be explicitly activated by the host but, instead,activation element7104 may be configured to automatically initiate insertion uponouter housing7101 being translated sufficiently in the distal direction toward and with respect toinner housing7102.
• Such configurations provide several benefits. First, translation ofouter housing7101 with respect toinner housing7102 before activation provides a measure of drop protection such that ifapplicator7100 is accidentally dropped, it may not prematurely fire. Second, spring7320 provides a force bias that the host has to affirmatively overcome by pressingapplicator7100 into their skin prior to firing, thereby reducing the probability of activatingapplicator7100 before it is properly positioned. Further, the host may decide to not fireapplicator7100 and discontinuepressing applicator7100 against their skin, in which spring7320 will bias againstouter housing7101 and allowouter housing7101 to return to its initial state.
• Holder7124,needle carrier assembly7108,needle hub7150,insertion element7174, on-skin sensor assembly360,first spring7112 andsecond spring7128 are all shown in pre-activation positions inFIG. 73A.
• FIG. 73B illustratesapplicator7100 during insertion of on-skin sensor assembly360 but before retraction ofneedle carrier assembly7108.First spring7112 drivesholder7124,needle carrier assembly7108,needle hub7150,insertion element7174, and on-skin sensor assembly360, in the distal direction toward the distal insertion position.FIG. 73B illustrates a position where on-skin sensor assembly360 is in contact withskin130 of the host but whereholder7124 is not yet fully driven, byfirst spring7112, into contact with on-skin sensor assembly360 orskin130 of the host.
• In some embodiments, masses of each ofholder7124,needle carrier assembly7108,needle hub7150,insertion element7174, and on-skin sensor assembly360 may be specifically designed to reduce or substantially eliminate a tendency ofneedle carrier assembly7108,needle hub7150,insertion element7174, and on-skin sensor assembly360 to detach due to inertial forces fromholder7124 while being driven in the distal direction during insertion. In some embodiments, a force exerted byfirst spring7112 may be selected to be sufficient for proper operation ofapplicator7100, while not so large as to further exacerbate such above-described inertially triggered detachment. In some embodiments, a spring (not shown) may be configured to exert a force against a portion ofneedle carrier assembly7108, for example in a distal direction, sufficient to preventneedle carrier assembly7108 from inertially triggered detaching fromholder7124 during insertion.
• FIG. 73C illustratesapplicator7100 during activation, asneedle carrier assembly7108,needle hub7150 andinsertion element7174 are retracted in the proximal direction bysecond spring7128. InFIG. 73C,first spring7112 has fully driven on-skin sensor assembly360 to the skin of the host. In this position,second spring7128 is released from spring retention elements (e.g.,7442a,7442binFIGS. 74A-75B) and drivesneedle carrier assembly7108,needle hub7150, andinsertion element7174 in the proximal direction from the distal insertion position. Uponneedle carrier assembly7108 reaching the proximal retraction position, needlecarrier retention element7334 ofholder7124 engages withneedle carrier assembly7108, thereby maintainingneedle carrier assembly7108,needle hub7150 andinsertion element7174 in a locked, retracted position limiting access toinsertion element7174. Needlecarrier retention element7334 may comprise, e.g., an arm, a deflection element, a tab, a detent, a snap or any other feature capable of a retaining function. In this retracted position,needle carrier assembly7108,needle hub7150, andinsertion element7174 is prevented from travelling in a distal direction.
• A further description of some aspects of the operation ofapplicator7100 follows with respect toFIGS. 74A-74C, which illustrate several cross-sectional views ofapplicator7100 ofFIGS. 71 and 72 during operation, according to some embodiments.FIGS. 74A-74C may correspond toapplicator7100 cut along the section line B-B′ shown inFIG. 71, for example. For ease of illustration,needle hub7150 andinsertion element7174 are not shown inFIGS. 74A-74C.
• FIG. 74A illustrates a state ofapplicator7100 prior to activation. For ease of illustration, on-skin sensor assembly360 is not illustrated inFIG. 74A.Holder7124 comprisesspring retention elements7442a,7442bconfigured to contact and retain a first end ofsecond spring7128 in the pre-activated state, e.g., during insertion, while a second end ofspring7128 is in contact withneedle carrier assembly7108.Spring retention elements7442a,7442bmay comprise, e.g., arms, deflection element, tabs, detents, snaps or any other features capable of a retaining function. Although twospring retention elements7442a,7442bare shown, at least one spring retention element is contemplated. In some embodiments,applicator7100 may include one spring retention element, as shown inFIGS. 81A-81D. In some embodiments,applicator7100 may include three spring retention elements. In some embodiments,applicator7100 may include four spring retention elements. In some embodiments,spring retention elements7442a,7442bare deflectable arms, rigid arms, deformable features, snaps, catches, or hooks. In some embodiments,spring retention elements7442a,7442bmay be actively deflected by one or more features withinapplicator7100.
• Needle carrier assembly7108 comprises backstop features7444a,7444b, configured to prevent lateral deflection ofspring retention elements7442a,7442bin the proximal starting position, e.g., at least during insertion, thereby supporting retention ofsecond spring7128 betweenspring retention elements7442a,7442bandholder7124 until retraction. Although two backstop features are illustrated, any number of backstop features are contemplated. The number of backstop features may equal the number of spring retention elements.
• FIG. 75A illustrates a magnified view ofspring retention element7442bandbackstop feature7444b. InFIG. 75A,first spring7112 is drivingholder7124,needle carrier assembly7108 and on-skin sensor assembly360, in the distal direction toward the distal inserted position.Backstop feature7444bis shown engaged tospring retention element7442b, preventingspring retention element7442bfrom deflecting laterally, thereby preventingsecond spring7128 from releasing. As shown inFIG. 75A, a proximal end ofspring retention element7442bmay be offset from a distal end ofbackstop feature7444bby a distance a. In some embodiments, distance a is the length required forspring retention element7442bto traverse alongbackstop feature7444bsuch thatspring retention element7442bclearspast backstop feature7444b.Backstop feature7444bmay feature a ramp to guidespring retention element7442b. A distal end ofneedle carrier assembly7108 and a distal end ofholder7124 may be offset from each other at least the same distance a to allow forspring retention element7442bto traverse distallypast backstop feature7444b.
• It may be appreciated that the frictional force between corresponding contacting surfaces ofbackstop feature7444bandspring retention element7442bmay at least partly determine an amount of force to releasespring retention element7442bfrombackstop feature7444b. This force may allow for lateral deflection ofspring retention element7442band thus allow the expansion ofsecond spring7128. In some embodiments, the amount of force is at least 0.1 pounds. In some embodiments, the amount of force is at least 0.5 pounds. In some embodiments, the amount of force is at least 1 pound. In some embodiments, the amount of force is at least 2 pounds. In some embodiments, the amount of force is at least 3 pounds. In some embodiments, the amount of force is at least 4 pounds. In some embodiments, the amount of force is at least 5 pounds.
• Although the figure showsbackstop feature7444bpreventing lateral deflection ofspring retention element7442bin a radially outward direction, it is contemplated that an inverse structural relationship can be achieved. For instance, the ramped surface ofspring retention element7442bcan be reversed to face the opposite direction as shown inFIG. 75A. Further, the ramped surface ofspring retention element7442bmay be biased in a radially inward direction bysecond spring7128 againstbackstop feature7444b. In such embodiments,backstop feature7444bmay be located radially inward ofspring retention element7442b.
• Accordingly, in some embodiments, materials utilized to formholder7124 andneedle carrier assembly7108 may be selected based on a desired amount of force to releasespring retention element7442bfor lateral deflection. Examples of such materials may include Polycarbonate, ABS, PC/ABS, Polypropylene, HIPS (High impact polystyrene), Polybutylene Terephthalate (PBT), Polyoxymethylene (POM), Acetal, polyacetal, polyformaldehyde, PTFE, High density polyethylene (HDPE), Nylon, Polyethylene terephthalate (PET), Thermoplastic elastomer (TPE), Thermoplastic polyurethane (TPU), TPSiv, Cyclo olefin polymer (COP), Cyclo olefin copolymer (COC), and/or Liquid-crystal polymer (LCP).
• An angle θ of a portion ofspring retention element7442bin contact withsecond spring7128 may also affect the amount of frictional force to laterally deflectspring retention element7442band so to releasesecond spring7128. Accordingly, the angle θ may be selected based on a desired amount of force to laterally deflectspring retention element7442bsufficiently to releasesecond spring7128. In some embodiments, the angle θ is at least 1 degree with respect to a vertical axis of thespring retention element7442b. In some embodiments, the angle θ is at least 5 degrees. In some embodiments, the angle θ is at least 10 degrees. In some embodiments, the angle θ is at least 15 degrees. In some embodiments, the angle θ is at least 20 degrees. In some embodiments, the angle θ is about 30 to 45 degrees. In addition, the force profile ofsecond spring7128 may affect a target amount of frictional force to laterally deflectspring retention element7442b. Accordingly, in some embodiments, the force profile ofsecond spring7128 may be taken into account when selecting one or both of the materials for formingholder7124 andneedle carrier assembly7108 and the angle θ of the portion ofspring retention element7442bin contact withsecond spring7128.
• An angle β ofspring retention element7442bwith respect to a vertical axis may also affect the amount of frictional force to laterally deflectspring retention element7442band so to releasesecond spring7128. By contactingspring retention element7442b,second spring7128 may exert a force onspring retention element7442bat a distance d from a bottom ofspring retention element7442bthat causes a torque moment sufficient to induce a lateral deflection ofspring retention element7442b.
• FIG. 75A further illustratesneedle carrier assembly7108 comprising adeflecting element7522 configured to contactspring retention element7442band maintainspring retention element7442bin a laterally deflected orientation oncesecond spring7128 has initially deflectedspring retention element7442band sufficiently drivenneedle carrier assembly7108 in the proximal direction, as will be shown in more detail inFIG. 75B. Deflectingelement7522 may preventspring retention element7442bfrom contacting the windings ofsecond spring7128 whilesecond spring7128 is extending, smoothing the operation ofapplicator7100 and preventing energy released bysecond spring7128 and designed for drivingneedle carrier assembly7128 in the proximal direction from being absorbed by undesired contact withspring retention element7442bduring the release ofsecond spring7128.
• In some embodiments, the angle θ of the portion ofspring retention element7442bin contact withsecond spring7128 may be substantially 90° (e.g., flat) and deflectingelement7522 may have a ramped or angled surface in contact withspring retention element7442bin the position illustrated inFIG. 75A. In such embodiments, deflectingelement7522, in addition to the above-described functionality, may be configured to initially deflectspring retention element7442basfirst spring7112 drivesholder7124 from the position illustrated inFIG. 75A to the position illustrated inFIG. 75B.
• In some embodiments,inner housing7102 may comprise aprotrusion7546 extending frominner housing7102 in the distal direction.Protrusion7546 may be configured to contact at least one ofspring retention elements7442a,7442band backstop features7444a,7444bin the pre-activation state such thatspring retention elements7442a,7442bare prevented from laterally deflecting untilholder7124 andneedle carrier assembly7108 have translated at least a predetermined minimum distance in the distal direction. Accordingly,protrusion7546 may provide a measure of drop protection such thatapplicator7100 may not prematurely fire in response to a concussive shock from being dropped before intentional activation.
• Turning back toFIG. 74A,inner housing7102 may further comprise anengagement element7448 configured to engage with aprotrusion7449 ofneedle carrier assembly7108 uponneedle carrier assembly7108 translating in the distal direction beyond a predetermined threshold, thereby preventingneedle carrier assembly7108 from translating in the distal direction beyond the predetermined threshold. It is contemplated that this may ensure needle carrier assembly retraction in the event of an air firing or dry firing in whichapplicator7100 is somehow activated when not held against the skin of the host. In some embodiments, the predetermined threshold may correspond to the distal end ofneedle carrier assembly7108 extending beyond a point proximal to the distal end ofinner housing7102, to a point substantially in line with the distal end ofinner housing7102 or to a point distal of the distal end ofinner housing7102. In some embodiments,engagement element7448 comprises a hook, a U-shaped structure, a loop, a protrusion, or any other structure capable of engaging withprotrusion7449 as described above.
• FIG. 74B illustratesapplicator7100 after activation, at a beginning of a force retraction feature process at or near the distal insertion position where on-skin sensor assembly360 may be in contact with the skin of the host.First spring7112 has drivenholder7124,needle carrier assembly7108,needle hub7150, insertion element, and on-skin sensor assembly360, in the distal direction toward the distal insertion position. During proper operation,holder7124 and on-skin sensor assembly360 should be pressing against the skin of the host. However,FIG. 74B may also illustrate a dry fire condition, whereapplicator7100 is not properly pressed against the skin of the host before triggeringapplicator7100. Accordingly, uponfirst spring7112driving holder7124 andneedle carrier assembly7108 in the distal direction beyond the predetermined threshold,engagement element7448 contacts protrusion7449, which preventsneedle carrier assembly7108 from traveling further in the distal direction, whileholder7124 is driven sufficiently further in the distal direction such that backstop features7444a,7444bofneedle carrier assembly7108 no longer contactspring retention elements7442a,7442bin the distal insertion position, thereby releasing the first end ofsecond spring7128 and initiating retraction even whenapplicator7100 is dry fired. The insertion force provided byfirst spring7112 may be sufficient to additionally overcome the frictional force between corresponding contacting surfaces ofbackstop feature7444bandspring retention element7442b.
• Turning toFIG. 75B,first spring7112 has drivenholder7124,needle carrier assembly7108 and on-skin sensor assembly360 in the distal direction to the skin of the host. Asfirst spring7112 drivesholder7124,needle carrier assembly7108 and on-skin sensor assembly360 against the skin of the host, the skin provides a counter force to the force generated byfirst spring7112. The skin may oppose the force offirst spring7112 and bias against the distal end of on-skin sensor assembly360. Because the distal end ofholder7124 is offset from the distal end of on-skin sensor assembly360 as shown inFIG. 75A, the counter force provided by the skin is transferred toholder7124 asfirst spring7112 continues to driveholder7124 towards the skin while on-skin sensor assembly360 is pressed against the skin. The counter force provided by the skin allowsspring retention element7442bto displacepast backstop feature7444b. Oncespring retention element7442bhas cleared distance apast backstop feature7444b,second spring7128 can laterally deflectspring retention element7442b, thereby releasingsecond spring7128, which drivesneedle carrier assembly7108 in the proximal direction. Alternatively, as described above in connection withFIG. 75A, where the angle θ of the portion ofspring retention element7442bin contact withsecond spring7128 is substantially 90° (e.g., flat), the ramped or angled surface of deflectingelement7522 in contact withspring retention element7444bdeflectsspring retention element7442bsufficiently to releasesecond spring7128, which drivesneedle carrier assembly7108 in the proximal direction.
• In some embodiments,engagement element7448 may engageprotrusion7449 even whenapplicator7100 is pressed against the skin of a user. In such embodiments,engagement element7448 engagesprotrusion7449 asfirst spring7112 drivesholder7124,needle carrier assembly7108, and on-skin sensor assembly360 against the skin of the host. As explained above,engagement element7448 preventsneedle carrier assembly7108 from moving distally whenengagement element7448 engagesprotrusion7449. This allowsspring retention elements7442a,7442bto separate away from backstop features7444a,7444band allow for release ofsecond spring7128. The engagement ofengagement element7448 andprotrusion7449 may add additional force to the counter force provided by the skin, thus increasing the energy needed to overcome the frictional engagement ofspring retention elements7442a,7442band backstop features7444a,7444b. In some instances, the engagement ofengagement element7448 andprotrusion7449 provides an immediate impulse force that converts at least some of the initial energy offirst spring7112 into energy needed to overcome the frictional engagement ofspring retention elements7442a,7442band backstop features7444a,7444b. It is contemplated that such embodiments may benefit users with soft skin or higher body fat percentage.
• Turning back toFIG. 74C, which illustratesapplicator7100 during activation,needle carrier assembly7108 is retracted in the proximal direction bysecond spring7128, as indicated byarrow7402. InFIG. 74C, withbackstop features7444a,7444bno longer immobilizingspring retention elements7442a,7442b, first end ofsecond spring7128 pushes againstspring retention elements7442a,7442bwith sufficient force to deflectspring retention elements7442a,7442bin the distal insertion position when on-skin sensor assembly360 is in contact withskin130 of the host, allowingsecond spring7128 to clearspring retention elements7442a,7442band driveneedle carrier assembly7108 in the proximal direction, thereby maintainingneedle carrier assembly7108, needle hub7150 (seeFIGS. 73A-73C) and insertion element7174 (seeFIGS. 73A-73C) in a locked, retracted position even in the event of a dry fire.
• FIGS. 76A and 76B illustrate magnified views of some features of an applicator, such asapplicator7100, according to some embodiments.
• InFIG. 76A, first spring7112 (seeFIGS. 72-74C) is drivingholder7124, as well as the needle carrier assembly and on-skin sensor assembly360 in the distal direction, illustrated byarrow7602, toward the distal insertion position.Retention element7372bof the needle carrier assembly is releasably coupled to on-skin sensor assembly360. As illustrated, during insertion and near the distal inserted position,holder7124 is in contact withspring retention element7372b, preventingspring retention element7372bfrom deflecting laterally and thereby rigidly securing on-skin sensor assembly360 to the needle carrier assembly.
• InFIG. 76B, second spring7128 (seeFIGS. 72-74C) is drivingneedle carrier assembly7108 in the proximal direction from the distal insertion position. Becauseholder7124 has been driven sufficiently in the distal direction, at the distal insertion position,holder7124 is no longer in contact withwearable retention element7372b. Accordingly,wearable retention element7372bis free to deflect laterally, thereby releasing on-skin sensor assembly360 fromwearable retention element7372band thus from theneedle carrier assembly7108.Needle carrier assembly7108 is now driven in the proximal direction bysecond spring7128, while on-skin sensor assembly360 is secured to the skin of the host. Moreover, in some embodiments, becauseholder7124 is driven to the distal inserted position and substantially held in that position byfirst spring7112,holder7124 may press against one or both of on-skin sensor assembly360 or an adhesive patch of on-skin sensor assembly360, supporting one or both during attachment to the skin of the host.
• FIG. 90 illustrates a magnified view of some features of the applicator ofFIGS. 71 and 72, according to some embodiments. As shown,applicator7100 is in a pre-activation state. In this state,spring retention elements7442a,7442bmay be retained against backstop features7444a,7444b.Second spring7128 may be biasingspring retention elements7442a,7442bagainst backstop features7444a,7444b. As described above, sufficient force is needed to deflectspring retention elements7442a,7442bpast backstop features7444a,7444b. The sufficient force may be determined or at least partly determined by the frictional force betweenspring retention elements7442a,7442band backstop features7444a,7444b. It may be appreciated that backstop features7444aand7444bmay feature agroove7446aand agroove7446b, respectively, to engage withspring retention elements7442a,7442b.Grooves7446a,7446bmay increase a drag force betweenspring retention elements7442a,7442band backstop features7444a,7444b. In such embodiments,grooves7446a,7446bcan increase the force required to deflectspring retention elements7442a,7442bfrom backstop features7444a,7444bwhile the materials ofspring retention elements7442a,7442band/or backstop features7444a,7444bhave low or lower coefficient of friction. Further,grooves7446a,7446bcan increase the force required to deflectspring retention elements7442a,7442bfrom backstop features7444a,7444bwhilesecond spring7128 has a small or smaller diameter or has a low or lower spring constant. In some embodiments,grooves7446a,7446bmay each feature a concave channel. The concave shape of the channel may feature angled surfaces configured to drag against multiple edges ofspring retention elements7442a,7442b. In such embodiments,spring retention element7442a,7442bcan be wedges configured to drag withingrooves7446a,7446b. In some embodiments,applicator7100 may include as many grooves7446 as backstop features7444.
• FIG. 77 illustrates a perspective partial cutaway view ofneedle carrier assembly7108,needle hub7150, and on-skin sensor assembly360 ofapplicator7100 ofFIGS. 71 and 72, according to some embodiments.FIG. 78 illustrates a cross-sectional view ofneedle hub7150 and on-skin sensor assembly360, according to some embodiments.FIG. 79 illustrates a top view of a portion ofneedle carrier assembly7108 andneedle hub7150, according to some embodiments. The following is a description of these features with reference toFIGS. 77-79.
• On-skin sensor assembly360 comprisessensor assembly aperture396.Hub7150 is configured to coupleinsertion element7174 toneedle carrier assembly7108 and to substantially maintain a desired orientation ofinsertion element7174 during insertion of the sensor of on-skin sensor assembly360 into the skin of the host.
• Needle hub7150 comprises a plurality ofupper arms7156a,7156b, a plurality oflower arms7154a,7154b, and abase7152. Although two upper arms and two lower arms are illustrated, any number of arms, including a single upper and lower arm, are contemplated. In some embodiments,upper arms7156a,7156bandlower arms7154a,7154bmay be flexible such that, whenneedle hub7150 is coupled toneedle carrier assembly7108,upper arms7156a,7156bandlower arms7154a,7154bsecure needle hub7150 in a desired orientation with respect toneedle carrier assembly7108. For example,upper arms7156a,7156bmay be configured to flex radially inward, such that when disposed through acarrier aperture7712 inneedle carrier assembly7108,upper arms7156a,7156bare in contact with an upper surface ofneedle carrier assembly7108 adjacent tocarrier aperture7712 andlower arms7154a,7154bare in contact with a lower surface ofneedle carrier assembly7108 adjacent tocarrier aperture7712. Such an arrangement allows a compliant fit betweenneedle carrier assembly7108 andneedle hub7150 wherelower arms7154a,7154bdeflect to allowupper arms7156a,7156bto expand after clearing surface ofcarrier aperture7712. Thelower arms7154a,7154bcan partially or fully relax to bias the needle hub in a distal direction and decrease the clearance between the needle hub and the needle carrier that would otherwise exist with a non-compliant fit. In addition,upper arms7156a,7156bandlower arms7154a,7154balso help to maintain contact betweenbase7152 and a top surface of on-skin sensor assembly360.
• Base7152 comprises an anti-rotation feature. The anti-rotation feature may comprise a key having a shape complementary to at least a portion ofsensor assembly aperture396 of on-skin sensor assembly360 and may be configured to substantially preventneedle hub7150 from rotating about anaxis7702 parallel toinsertion element7174 with respect to on-skin sensor assembly360, e.g., to prevent rotation ofbase7152 withinsensor assembly aperture396. In addition, or the alternative, the upper surface ofneedle carrier assembly7108 adjacent tocarrier aperture7712 may comprise agroove7910 configured to acceptupper arms7156a,7156bwhenupper arms7156a,7156bare disposed throughcarrier aperture7712 in an orientation complementary to an orientation ofgroove7910, as illustrated inFIG. 79, thereby immobilizingneedle hub7150 with respect toneedle carrier assembly7108.
• In some embodiments,base7152 further comprises a substantially flat surface configured to mate with a top surface of on-skin sensor assembly360 and maintaininsertion element7174 in a substantially perpendicular orientation to the top surface of on-skin sensor assembly360, in some cases, when the anti-rotation feature ofbase7152 is engaged withinsensor assembly aperture396 of on-skin sensor assembly360.
• Based at least upon the above-described features ofneedle hub7150, on-skin sensor assembly360, and/orneedle carrier assembly7108,base7152 allows easy assembly during manufacture, including but not limited to proper alignment and preassembly ofinsertion element7174 onto on-skin sensor assembly360, and/or the ability to easily engage an assembly ofneedle hub7150,insertion element7174,sensor338 and on-skin sensor assembly360 to other portions of assembledapplicator7100.
• FIGS. 80A and 80B illustrate perspective views of locking features for needles8074a,8074bfor use in an applicator for an analyte sensor system, according to some embodiments. For example, needle8074aofFIG. 80A comprises a locking feature comprising a ridge8076 configured to mate with a complementary-shaped feature withinneedle hub7150, for example. In the alternative, needle8074bofFIG. 80B comprises a locking feature comprising a groove8078 configured to mate with a complementary-shaped feature withinneedle hub7150, for example.
• In yet another alternative, any insertion element described in this disclosure may comprise a locking feature that heat stakes the selected insertion element toneedle hub7150, for example. In yet another alternative, any insertion element described in this disclosure may comprise a locking feature comprising one or more friction-fit or snap-fit elements securing the selected insertion element toneedle hub7150, for example. In yet another alternative, any insertion element described in this disclosure may comprise a locking feature comprising complementary clamshell elements on the selected insertion element andneedle hub7150, for example, configured to mate with one another. In yet another alternative, any insertion element described in this disclosure may comprise a locking element comprising one or more inserted molded elements configured to couple the selected insertion element toneedle hub7150, for example.
• During manufacture,applicator7100 may be assembled in stages. For example, and not limitation, if present,first barrier layer7192 may be affixed toinner housing7102.Insertion element7174 may be coupled toneedle hub7150, which may then be coupled to on-skin sensor assembly360.Second spring7128 may be placed intoholder7124 orneedle carrier assembly7108 and then needlecarrier assembly7108 may be disposed intoholder7124 and attached toneedle hub7150 and to on-skin sensor assembly360 viawearable retention elements7372a,7372b.First spring7112 may be disposed inholder7124, which may then be installed intoinner housing7102.Inner housing7102 may be inserted into and secured toouter housing7102. If present,second barrier layer7194 may be affixed toinner housing7102. If a separate element,activation element7104 may then be disposed intoouter housing7101. Any labeling, sterilizing and/or packaging may then be applied toapplicator7100.
• FIGS. 81A-81C illustrate several cross-sectional views, and various features and operating positions, of yet anotherapplicator8100 for an on-skin sensor assembly of an analyte sensor system, according to some embodiments.
• Applicator8100 may includeouter applicator housing7101 comprisingactivation element7104.Outer applicator housing7101 may be configured to translate in a distal direction under force applied by a host ofapplicator8100, thereby aligningactivation element7104 in a position that allowsapplicator8100 to fire, an alignment illustrated byFIG. 81A. As previously described in connection withapplicator7100, in some embodiments,activation element7104 may be disposed in any location, e.g., a top, upper side, lower side, or any other location ofapplicator8100.
• Applicator8100 further comprisesinner housing7102, configured to house one or more mechanisms utilized to apply on-skin sensor assembly360 to skin of a host.Distal surface7130 of a bottom opening ofinner housing7102 may define a bottom surface ofapplicator8100. In some embodiments, upon pressingapplicator8100 against the skin of the host, the skin may deform in a substantially convex shape atdistal surface7130 such that at least a portion of a surface of the skin disposed at the bottom opening ofapplicator housing7102 extends into the bottom opening ofinner housing7102, in a proximal direction, beyond a plane defined bydistal surface7130.
• Although not illustrated inFIGS. 81A-81C,inner housing7102 may comprise a spring7320 configured to contactouter housing7101 and maintain a predetermined spacing betweenouter housing7101 andinner housing7102 in the pre-activation orientation (seeFIG. 73A). Spring7320 may be a compression spring, leaf spring, flex arm spring, a piece of foam or rubber, etc. In some other embodiments,outer housing7101 may comprise spring7320 and spring7320 may be configured to contactinner housing7102.
• Applicator8100 may further comprise aneedle carrier assembly8108.Needle carrier assembly8108 comprises wearable retention and/oralignment elements7372a,7372bconfigured to pass throughholder8124 and releasably couple on-skin sensor assembly360 toholder8124 and/or toneedle carrier assembly8108. Although two wearable retention and/or alignment elements are illustrated, any number of wearable retention and/or alignment elements are contemplated.
• Applicator8100 further comprisesneedle hub7150 configured to coupleinsertion element7174 toneedle carrier assembly8108.Insertion element7174 is configured to insertsensor338 of on-skin sensor assembly360 intoskin130 of the host (e.g.,FIGS. 3A-4). In some embodiments,insertion element7174 comprises a needle, for example, an open sided-needle, a needle with a deflected-tip, a curved needle, a polymer-coated needle, a hypodermic needle, or any other suitable type of needle or structure, as described in connection with at leastFIGS. 47-50 and 80A-B. In yet other embodiments,insertion element7174 may be integrally formed withsensor338, in whichinsertion element7174 may be sufficiently rigid to be inserted partially intoskin130 of the host with minimal or no structural support.
• Applicator8100 may further includeholder8124 releasably coupled toneedle carrier assembly8108 and configured to guide on-skin sensor assembly360 while coupled toneedle carrier assembly8108, e.g., at least during translation from a proximal position to a distal insertion position. As previously described in connection withapplicator7100, on-skin sensor assembly360 may be stripped or released fromholder8124 and/orneedle carrier assembly8108 once on-skin sensor assembly360 is disposed on the skin of the host.
• Applicator8100 may further comprise an insertion assembly configured to translateinsertion element7174,needle hub7150, andneedle carrier assembly8108 from a proximal position, in the distal direction, to a distal insertion position. Such an insertion assembly may includefirst spring7112.First spring7112 may be a compression spring, or any suitable type of spring, and may have its first end in contact with or coupled toinner applicator housing7102 and its second end in contact with or coupled toholder8124.First spring7112 is configured to, upon activation of the insertion assembly, translateholder8124,needle carrier assembly8108,needle hub7150,insertion element7174 and on-skin sensor assembly360, in the distal direction to the distal insertion position. Substantially at the distal insertion position,needle carrier assembly8108 may decouple fromholder8124 and on-skin sensor assembly360.
• Applicator8100 may further comprise a retraction assembly configured to translateneedle carrier assembly8108,needle hub7150 andinsertion element7174, in the proximal direction, from the distal insertion position to a proximal retracted position. In some embodiments the initial proximal position may be the same as the proximal retracted position. In other embodiments, the initial proximal position may be different from the proximal retracted position. Such a retraction assembly may include asecond spring8128.Second spring8128 may be a compression spring, or any suitable type of spring, and may have a first end contacting or coupled toholder8124 and a second end, comprising a tang8129 (e.g., a spring portion or spring end) disposed substantially along a diameter ofsecond spring8128, in contact with or coupled to aspring retention element8142 ofholder8124, at least until retraction.Spring retention element8142 may comprise, e.g., an arm, a deflection element, a tab, a detent, a snap or any other feature capable of a retaining function.Spring retention element8142 may have substantially the same form and function asspring retention elements7442a,7442bofapplicator7100 except as described below.Second spring8128 is configured to translateneedle carrier assembly8108,needle hub7150, andinsertion element7174 in the proximal direction from the distal insertion position to the proximal retracted position.Tang8129 ofsecond spring8128 is released fromspring retention element8142 in the distal insertion position whenspring retention element8142 is not backed up bybackstop element8144 and in response totang8129 ofsecond spring8128 pushing againstspring retention element8142 with a force exceeding a predetermined threshold sufficient to overcome and deflectspring retention element8142.
• In some embodiments, transfer of on-skin sensor assembly360 between insertion and retraction may occur as previously described in connection with, for example, any ofFIGS. 35A-37C.
• Needle carrier assembly8108 further comprises abackstop feature8144, configured to prevent lateral motion ofspring retention element8142 ofholder8124 in at least the proximal pre-activation position, thereby supporting retention ofsecond spring8128 betweenspring retention element8142 andholder8124 until retraction. In the orientation shown inFIG. 81A,second spring8128 is exerting a force againstspring retention element8142 butbackstop feature8144 prevents lateral deflection ofretention element8142.
• Holder8124 further comprises needlecarrier retention element7334, which may comprise a deflectable arm, rigid arm, deformable feature, snap, catch, or hook. Uponneedle carrier assembly8108 reaching the proximal retraction position after activation, needlecarrier retention element7334 is configured to engage withneedle carrier assembly8108, thereby maintainingneedle carrier assembly8108,needle hub7150 andinsertion element7174 in a locked, retracted position, limiting access toinsertion element7174.
• Although not illustrated inFIGS. 81A-81C,inner housing7102 ofapplicator8100 may further compriseengagement element7448 andneedle carrier assembly8108 may further compriseprotrusion7449 and may function substantially as previously described in connection with at leastFIGS. 74A-74C.
• Although not illustrated inFIGS. 81A-81C,inner housing7102 ofapplicator8100 may further comprise a protrusion extending frominner housing7102 in the distal direction, substantially as previously describedprotrusion7546. Similar to that previously described in connection withFIG. 75A, this protrusion may be configured to contact at least one ofspring retention element8142 andbackstop feature8144 in the pre-activation state such thatspring retention element8142 is prevented from laterally deflecting untilholder8124 andneedle carrier assembly8108 have translated at least a predetermined minimum distance in the distal direction. Accordingly, the protrusion may provide a measure of drop protection such thatapplicator8100 may not prematurely fire in response to a concussive shock from being dropped before activation.
• Applicator8100 functions substantially similarly toapplicator7100 with the exception that instead of utilizingspring retention elements7442a,7442b, which are disposed along an outside ofsecond coil7128 and are configured to contact and retain a coil ofsecond spring7128,applicator8100 utilizesspring retention element8142, which is disposed along an inside ofsecond spring8128 and is configured to contact and retaintang8129 ofsecond spring8128 along a diameter ofsecond spring8128. Disposingspring retention element8142 within and substantially along a center ofsecond spring8128, as opposed to along an outside ofsecond spring8128, further ensures thatspring retention element8142 does not contact the coils ofsecond spring8128 assecond spring8128 extends during retraction, thereby smoothing the operation ofapplicator8100. In addition, the arrangement includingspring retention element8142, as opposed tospring retention elements7442a,7442bmitigates the risk of, and difficulty ensuring that, multiple spring retention elements trigger or are overcome at substantially the same time.
• Although not shown inFIGS. 81A-81C, in some embodiments,applicator8100 may comprise a cap configured to be secured todistal surface7130 ofinner housing7102, which may be removed before use. In some embodiments, such a cap may also function as a sterile barrier, as previously described in U.S. patent application Ser. No. 16/011,527, hereby incorporated by reference in its entirety.
• FIG. 81A illustrates a state ofapplicator8100 prior to activation, according to some embodiments.Holder8124,needle carrier assembly8108,needle hub7150,insertion element7174, on-skin sensor assembly360,first spring7112 andsecond spring7128 are all shown in pre-activation positions.
• Retention element7332 ofholder8124 is in contact withinner housing7102, thereby immobilizingholder8124, and therefore also needlecarrier assembly8108,needle hub7150,insertion element7174 and on-skin sensor assembly360, in the pre-activated state.
• Backstop feature8144 ofneedle carrier assembly8108 is in contact with and preventsspring retention element8142 from deflecting laterally, thereby ensuringspring retention element8142 retainstang8129 ofsecond spring8128 in the loaded or pre-activation position shown.
• Activation ofapplicator8100 may include ahost pressing applicator8100 against their skin with sufficient force to translateouter housing7101 in a distal direction toward and with respect toinner housing7102 untilactivation element7104 is aligned with insertionassembly retention element7332 ofholder8124, as shown inFIG. 81A. Once such an alignment is achieved, a host may initiateactivation element7104, thereby deflecting insertionassembly retention element7332 sufficiently to releaseholder8124 frominner housing7102. In some other embodiments,applicator8100 may be configured such thatactivation element7104 may be activated first, but that actual insertion is not triggered untilouter housing7101 is translated sufficiently in the distal direction toward and with respect toinner housing7102. In yet other embodiments,activation element7104 may be biased toward a center ofapplicator8100 such thatactivation element7104 need not be explicitly activated by the host but, instead,activation element7104 may be configured to automatically initiate insertion uponouter housing7101 being translated sufficiently in the distal direction toward and with respect toinner housing7102.
• FIG. 81B illustratesapplicator8100 after activation and during insertion, according to some embodiments.First spring7112 drivesholder8124, and so needlecarrier assembly8108,needle hub7150,insertion element7174, and on-skin sensor assembly360, in the distal direction toward the distal insertion position.FIG. 81B illustrates on-skin sensor assembly360 in contact withskin130 of the host but whereholder8124 is not yet fully driven, byfirst spring7112, into contact with on-skin sensor assembly360 orskin130 of the host.
• In some embodiments, masses of each ofholder8124,needle carrier assembly8108,needle hub7150,insertion element7174, and on-skin sensor assembly360 may be specifically designed to reduce or substantially eliminate a tendency ofneedle carrier assembly8108,needle hub7150,insertion element7174, and on-skin sensor assembly360 to detach fromholder8124 while being driven in the distal direction during insertion. In some embodiments, a force exerted byfirst spring7112 may further be selected to be sufficient for proper operation ofapplicator7100, while not so large as to further exacerbate such above-described inertially triggered detachment. In some embodiments, a spring (not shown) may be configured to exert a force against a portion ofneedle carrier assembly8108, for example in the distal direction, sufficient to preventneedle carrier assembly7108 from inertially triggered detaching fromholder8124 during insertion.
• FIG. 81C illustratesapplicator8100 after activation and at or near the distal insertion position, according to some embodiments.First spring7112 has drivenholder8124,needle carrier assembly8108 and on-skin sensor assembly360 in the distal direction to the distal inserted position. Sincefirst spring7112 has driven holder8124 a short distance farther in the distal direction thanneedle carrier assembly8108,backstop feature8144 is no longer in contact withspring retention element8142, allowing second spring8128 (e.g. tang8129) to laterally deflectspring retention element8142, thereby releasingsecond spring8128, which drivesneedle carrier assembly8108 in the proximal direction. Alternatively, similar to that described above in connection withapplicator7100 inFIG. 75A, where the angle θ of the portion ofspring retention element8142 in contact withtang8129 ofsecond spring7128 is substantially 90° (e.g., flat),spring retention element8142 may be biased to automatically deflect sufficiently to releasesecond spring7128 oncebackstop feature8144 is no longer in contact withspring retention element8142, thereby freeingsecond spring8128 to driveneedle carrier assembly8108 in the proximal direction. Although not shown inFIGS. 81A-81C,inner housing7102 may further compriseengagement element7448 configured to engage with aprotrusion7449 ofneedle carrier assembly8108, and to function substantially as previously described in connection with at leastFIGS. 74A-74C. In some embodiments, a stop feature (not shown) may be disposed at a bottom ofapplicator8100, e.g., on a distal portion ofinner housing7102. Such a stop feature may be configured to contact one or more of on-skin sensor assembly360,needle carrier8108, orholder8124 in the distal insertion position.
• Upon release ofsecond spring8128,second spring8128 is configured to driveneedle carrier assembly8108,needle hub7150 andinsertion element7174, in the proximal direction. Although not shown inFIG. 81C, asneedle carrier assembly8108 travels to the proximal retracted position, needlecarrier retention element7134 may engage withneedle carrier assembly8108, thereby retentionneedle carrier assembly8108,needle hub7150 andinsertion element7174, in a locked, retracted position limiting access toinsertion element7174.
• FIG. 81D illustrates a perspective view ofholder8124,first spring7112 andsecond spring8128 ofapplicator8100, according to some embodiments.FIG. 81D illustratesspring retention element8142,retention tang8129 ofsecond spring8128 in an orientation withinapplicator8100 before retraction.
• During manufacture,applicator8100 may be assembled in stages. For example, and not limitation, if present, as previously described in connection withapplicator7100, first barrier layer7192 (seeFIG. 72) may be affixed toinner housing7102.Insertion element7174 may be coupled toneedle hub7150, which may then be coupled to on-skin sensor assembly360. Second spring may be placed intoholder8124 orneedle carrier assembly8108 and then needlecarrier assembly8108 may be disposed intoholder8124 and attached toneedle hub7150 and to on-skin sensor assembly viawearable retention elements7372a,7372b.First spring7112 may be disposed inholder8124, which may then be installed intoinner housing7102.Inner housing7102 may be inserted into and secured toouter housing7102. If present, as previously described in connection withapplicator7100, second barrier layers7194 (seeFIG. 72) may be affixed toinner housing7102. If a separate element,activation element7104 may then be disposed intoouter housing7101. Any labeling, sterilizing and/or packaging may then be applied toapplicator8100.
• FIGS. 82A-82D illustrate several cutaway views, and various features and operating positions, of yet anotherapplicator8200 for an on-skin sensor assembly of an analyte sensor system, according to some embodiments. In contrast toapplicators7100 and8100,applicator8200 utilizes a single spring for both insertion and retraction of aninsertion element8274 for placing an associatedsensor338 and on-skin sensor assembly360.
• Applicator8200 comprises ahousing8202 and anactivation element8204 disposed on a top ofapplicator8200. However,activation element8204 may be disposed on a side or any other location onapplicator8200.
• Applicator8200 may further comprise aneedle carrier assembly8208.Needle carrier assembly8208 comprises wearable retention and/oralignment elements8272a,8272bconfigured to pass throughholder8224 and releasably couple on-skin sensor assembly360 toholder8224 and/or toneedle carrier assembly8208. In some embodiments,wearable retention elements8272a,8272bmay extend around rather than throughholder8224.Wearable retention elements8272a,8272bmay comprise, e.g., arms, deflection element, tabs, detents, snaps or any other features capable of a retaining function. Although two wearable retention and/or alignment elements are illustrated, any number of wearable retention and/or alignment elements are contemplated.Needle carrier assembly8208 further comprises aprotrusion8266 configured to contact or hook adeployment sleeve8206 during retraction, thereby causingneedle carrier assembly8208 to translate in a proximal direction during retraction, as will be described in more detail below.
• Applicator8200 further comprises aninsertion element8274 configured to insertsensor338 of on-skin sensor assembly360 intoskin130 of the host (e.g.,FIG. 1). In some embodiments,insertion element8274 comprises a needle, for example, an open sided-needle, a needle with a deflected-tip, a curved needle, a polymer-coated needle, a hypodermic needle, or any other suitable type of needle or structure, as described in connection with at leastFIGS. 47-50 and 80A-B. In yet other embodiments,insertion element8274 may comprisesensor338, sufficiently rigid to be inserted partially intoskin130 of the host with minimal or no structural support.
• Although not illustrated inFIGS. 82A-82D, in some embodiments,applicator8200 may further compriseneedle hub7150, configured to coupleinsertion element8274 toneedle carrier assembly8208, as previously described in connection with at leastFIGS. 77-79. In some other embodiments,insertion element8274 may be directly coupled toneedle carrier assembly8208 as shown inFIGS. 82A-82D.
• Applicator8200 may further includeholder8224 releasably coupled todeployment sleeve8206 viaholder retention elements8232a,8232band toneedle carrier assembly8208.Holder retention elements8232a,8232bmay comprise, e.g., arms, deflection elements, tabs, detents, snaps or any other features capable of a retaining function.Holder8224 is configured to guide on-skin sensor assembly360 while coupled toneedle carrier assembly8208 during insertion, e.g., at least during translation from a proximal position to a distal insertion position. As previously described in connection withapplicators7100 and8100, on-skin sensor assembly360 may be stripped or released fromholder8224 and/orneedle carrier assembly8208 once on-skin sensor assembly360 is disposed on the skin of the host.
• Applicator8200 may further comprise an insertion assembly configured to translateholder8224,insertion element8274 andneedle carrier assembly8208, in the distal direction, from a proximal position to a distal insertion position. Such an insertion assembly may include aspring8212.First spring8212 may be a compression spring, or any suitable type of spring, and may have a first end in contact with or coupled todeployment sleeve8206 and a second end in contact with or coupled toholder8224.First spring8212 is configured to, upon activation of the insertion assembly, translateholder8224,needle carrier assembly8208,insertion element8274 and on-skin sensor assembly360 in the distal direction to the distal insertion position. Substantially at the distal insertion position,needle carrier assembly8208 may decouple fromholder8224 and on-skin sensor assembly360.
• Applicator8200 may further comprise a retraction assembly configured to translateneedle carrier assembly8208 andinsertion element8274, in the proximal direction, from the distal insertion position to a proximal retracted position. In some embodiments the initial proximal position may be the same as the proximal retracted position. In other embodiments, the initial proximal position may be different from the proximal retracted position. Such a retraction assembly may also includespring8212.First spring8212 is also configured to translatedeployment sleeve8206,needle carrier assembly8208 andinsertion element8274 in the proximal direction from the distal insertion position to the proximal retracted position in response to on-skin sensor assembly360 contactingskin130 of the host and/or reaching a limit of travel with a force exceeding a predetermined threshold. For example, although not illustrated,housing8202 may further compriseengagement element7448 configured to engage with aprotrusion7449 ofneedle carrier assembly8208, and to function substantially as previously described in connection with at leastFIGS. 74A-74C. In some embodiments, a stop feature (not shown) may be disposed at a bottom ofapplicator8200, e.g., on a distal portion ofhousing8202. Such a stop feature may be configured to contact one or more of on-skin sensor assembly360,needle carrier8208,holder8224 ordeployment sleeve8206 in the distal insertion position.Spring8212 is configured to exert a force sufficient to deflect deploymentsleeve retention elements8262a,8262bofdeployment sleeve8206 when on-skin sensor assembly360 is in contact withskin130 of the host, thereby freeing deploymentsleeve retention elements8262a,8262bofdeployment sleeve8206 fromprotrusions8264a,8264bof housing8202 (seeFIGS. 82C-82D), thereby allowingspring8212 to translatedeployment sleeve8206, and thus needlecarrier assembly8208 andinsertion element8274, in the proximal direction from the distal inserted position. Deploymentsleeve retention elements8262a,8262bmay comprise, e.g., arms, deflection elements, tabs, detents, snaps or any other features capable of a retaining function.
• In some embodiments, transfer of on-skin sensor assembly360 between insertion and retraction may occur as previously described in connection with any prior figure, for example, any ofFIGS. 35A-37C.
• Such dual insertion/retraction operability ofspring8212 is possible because, during insertion,deployment sleeve8206 is immobilized by deploymentsleeve retention elements8262a,8262b, being in contact withrespective protrusions8264a,8264bofhousing8202. Thus, whenspring8212 exerts force betweendeployment sleeve8206 andholder8224,spring8212 drivesholder8224, and coupledneedle carrier assembly8208,insertion element8274 and on-skin sensor assembly360, in the distal direction to the distal deployed position, where on-skin sensor assembly360 is in contact with theskin130 of the host. Once on-skin sensor assembly360 is in contact with the host,holder8224 is immobilized against on-skin sensor assembly360, a travel-limiting feature ofapplicator8200, and/or the skin of the host. Accordingly, withholder8224 immobilized, the force exerted byspring8212 between immobilizedholder8224 anddeployment sleeve8206 now acts to pushdeployment sleeve8206 in the proximal direction with sufficient force to deflect deploymentsleeve retention elements8262a,8262bsufficiently to clearprotrusions8264a,8264bofhousing8202, thereby freeingdeployment sleeve8206 to be driven further in the proximal direction byspring8212. Sinceprotrusion8266 ofneedle carrier assembly8208 is configured to contact, couple orhook deployment sleeve8206 asdeployment sleeve8206 translates in the proximal direction, the action ofspring8212 translatingdeployment sleeve8206 in the proximal direction also translatesneedle carrier assembly8208, and coupledinsertion element8274, in the proximal direction to the proximal retracted position. Positions of the above-described features will now be discussed with respect toFIGS. 82A-82D.
• Although not shown inFIGS. 82A-82D, in some embodiments,applicator8200 may comprise a cap configured to be secured to a distal surface ofinner housing8202 oractivation element8204, which may be removed before use. In some embodiments, this cap may create a sealed volume that provides a sterile barrier, as previously described in U.S. patent application Ser. No. 16/011,527, hereby incorporated by reference in its entirety.
• FIG. 82A illustrates a state ofapplicator8200 prior to activation, according to some embodiments. Prior to activation,holder retention elements8232a,8232bimmobilize holder8224 todeployment sleeve8206.Holder retention elements8232a,8232bmay comprise, e.g., arms, deflection elements, tabs, detents, snaps or any other features capable of a retaining function.Needle carrier assembly8208 is coupled toholder8224.Insertion element8274 is coupled toneedle carrier assembly8208. And on-skin sensor assembly360 is coupled toneedle carrier assembly8208 viawearable retention elements8272a,8272b. The positions illustrated may correspond to the proximal position.
• FIG. 82B illustrates a state ofapplicator8200 at activation, according to some embodiments.Activation element8204 is shown as activated (e.g., pressed down) such thatprotrusions8264a,8264btranslate in the distal direction sufficiently to laterally deflectholder retention elements8232a,8232b, therebydecoupling holder8224 fromdeployment sleeve8206 and freeingspring8212 to driveholder8224,needle carrier assembly8208,insertion element8274 and on-skin sensor assembly360. As inFIG. 82A, the illustrated positions ofdeployment sleeve8206,holder8224,needle carrier assembly8208,insertion element8274 and on-skin sensor assembly360 may correspond to the initial proximal position.
• FIG. 82C illustrates a state ofapplicator8200 at the end of insertion, according to some embodiments.First spring8212 has translatedholder8224,needle carrier assembly8208,insertion element8274 and on-skin sensor assembly360 in the distal direction to the distal insertion position. On-skin sensor assembly360 is shown in contact withskin130 of the host,insertion element8274 is inserted intoskin130 of the host, andholder8224 is being pressed against on-skin sensor assembly360 byspring8212. In the illustrated positions,spring8212 is exerting a force ondeployment sleeve8206 sufficient to laterally deflect deploymentsleeve retention elements8262a,8262b, thereby freeingdeployment sleeve8206 to be translated in the proximal direction byspring8212. The illustrated positions ofholder8224,needle carrier assembly8208,insertion element8274 and on-skin sensor assembly360 may correspond to the distal inserted position.
• In some embodiments, masses of each ofholder8224,needle carrier assembly8208,insertion element8274, and on-skin sensor assembly360 may be specifically designed to reduce or substantially eliminate a tendency ofneedle carrier assembly8208,insertion element8274, and on-skin sensor assembly360 to prematurely detach fromholder8224 while being driven in the distal direction during insertion. In some embodiments, a force exerted byspring8212 may further be selected to be sufficient for proper operation ofapplicator8200, while not so large as to further exacerbate such above described inertially triggered detachment. In some embodiments, a spring (not shown) may be configured to exert a force, in the distal direction for example, against a portion ofneedle carrier assembly8208 sufficient to preventneedle carrier assembly8208 from inertially triggered detaching fromholder8224 during insertion.
• FIG. 82D illustrates a state ofapplicator8200 after retraction, according to some embodiments. As illustrated,wearable retention elements8272a,8272bdetach from on-skin sensor assembly360 during retraction.First spring8212 has translateddeployment sleeve8206 in the proximal direction. Becauseprotrusion8266 ofneedle carrier assembly8208 is configured to contactdeployment sleeve8206 during retraction, asdeployment sleeve8206 is driven in the proximal direction, so isneedle carrier assembly8208 andinsertion element8274. In some embodiments, it is this proximal translation that causeswearable retention elements8272a,8272bto detach from on-skin sensor assembly360. Sincespring8212 pushesholder8224 in the distal direction anddeployment sleeve8206,needle carrier assembly8208 andinsertion element8274 in the proximal direction,insertion element8274 is locked, safely, in the second proximal retracted position.
• Although not shown inFIGS. 82A-82D,applicator8200 may further comprise a displacement-based lockout feature that preventsdeployment sleeve8206 from translating in the proximal direction, thereby preventing retraction, untilholder8224 has translated at least a predetermined distance in the distal direction. Such a displacement-based lockout feature may operate substantially asprotrusions7546,8146 previously described in connection withFIGS. 75A and 81A-81D. For example, such a protrusion may extend in the proximal direction from one or more ofholder8224 orneedle carrier assembly8208 and may be configured to be in physical contact with deploymentsleeve retention elements8262a,8262bat least untilholder8224 orneedle carrier assembly8208 has translated at least the predetermined distance in the distal direction, thereby preventing inertial (i.e., reaction force generated by the acceleration of mass) or accidental activation ofapplicator8200, for example, due to concussive shock from droppingapplicator8200.
• During manufacture,applicator8200 may be assembled in stages. For example, and not limitation, if present,first barrier layer7192 or similar may be affixed tohousing8202.Insertion element8274 may be coupled toneedle hub7150, if present, which may then be coupled to on-skin sensor assembly360. Ifneedle hub7150 is not present,insertion element8274 may be coupled directly to on-skin sensor assembly360.Needle carrier assembly8208 may be at least partly disposed withindeployment sleeve8206 andspring8212 may be placed intoholder7124.Deployment sleeve8206 andneedle carrier assembly7108 may be disposed intoholder7124 and attached toneedle hub7150, if present, or directly toinsertion element8274 ifneedle hub7150 is not present, and to on-skin sensor assembly360 viawearable retention elements8272a,8272b. Theassembly including holder8224,deployment sleeve8206 andneedle carrier assembly8208 may then be installed intohousing8202. If present,second barrier layer7194 or similar may be affixed tohousing8202. If a separate element,activation element8204 may then be disposed intohousing8202. Any labeling, sterilizing and/or packaging may then be applied toapplicator8200.
• FIGS. 83-85 illustrate several alternatives for activation elements in an applicator. Such alternatives may be directly applied to any applicator described in this disclosure, especially, though not in any way limited to,applicators7100,8100 and8200 described above.
• FIG. 83 illustrates a cross-sectional view of anapplicator8300 comprising adeformable layer8305 disposed over anactivation element8304, according to some embodiments. Althoughactivation element8304 is shown on a side of anouter housing8301, any other suitable location fordeformable layer8305 andactivation element8304 is contemplated, e.g., a top, a high side, a low side ofouter housing8301. In some embodiments,deformable layer8305 may be molded overactivation element8304. In some other embodiments,deformable layer8305 may be glued or welded overactivation element8304, for example, utilizing ultrasonic, laser, radio frequency, heat stake welding processes, or any other suitable process. In some embodiments,deformable layer8305 may comprise a film, an elastomer, a plastic or any other material with sufficient deformability to allow activation ofactivation element8304 as well as to provide an air and/or fluid-tight sealed surface overactivation element8304.
• FIG. 84 illustrates a perspective view of anapplicator8400 utilizing a twist-to-activate activation mechanism, according to some embodiments.Applicator8400 comprises anouter housing8401 and aninner housing8402. In some embodiments,outer housing8401 andinner housing8402 may, together, comprise an activation element in thatapplicator8400 is activated by pushing down onapplicator8400 with sufficient force to immobilizeinner housing8402 against the skin of the host asouter housing8401 is twisted with respect toinner housing8402. Such a design ensuresapplicator8400 is pressed against the skin of the host with at least a minimum force, which can be designed to a particular desired threshold based on, for example, a predetermined amount of force that ensures proper seating and orientation ofapplicator8400 for use, the friction coefficient betweeninner housing8402 and the skin of the host, as well as based on the twisting force to triggerapplicator8400.
• FIG. 85 illustrates a cross-sectional view of anapplicator8500 comprising a top-mountedactivation element8504, according to some embodiments. In some embodiments,activation element8504 may comprise any type of activation element described in this disclosure, including, but not limited to, a dome-shaped button. In some embodiments, such a dome-shaped button may comprise a deformable material, as previously described in connection withFIG. 83 or, alternatively, may be sufficiently rigid to hold its form when pressed or otherwise utilized by the host.
Insertion Element Embodiments
• Several embodiments of an insertion element, as previously described herein, will now be described in connection with at leastFIGS. 47-50, in which the insertion element is illustrated as being a needle.
• FIG. 47 illustrates a cross-sectional view of akinked needle4774 for use in an applicator for an analyte sensor system, according to some embodiments.Kinked needle4774 may have at least two substantiallystraight portions4790,4792 with abend4796 between each substantially straight portion such that anangle4796 between the substantially straight portions is substantially optimized to reduce lateral motion of a tip ofneedle4774 through the skin of the host asneedle4774 traces an arc during activation.
• FIGS. 48A-48B illustrate a cross-section and a plan view, respectively, of a flared open-sided needle4874 for use in an applicator for an analyte sensor system, according to some embodiments. AlthoughFIGS. 48A-48B illustrate open-sided needle4874 having a C-shaped cross-section, the open-sided needle4874 may have any shaped cross-section, e.g., a C-shape, a U-shape, a V-shape.FIG. 48A illustrates a cross-section of an open-sided needle4874 having at least one flarededge4876. For example, flarededge4876 may be flared in a lateral direction from a longitudinal centerline of open-sided needle4874. Such a flarededge4876 may prevent or substantially reduce the incidence of damage to sensor138 (e.g.,FIG. 1) caused by sharp edges of the open-sided needle coming in contact withsensor138 before or during insertion into the skin of a host.
• FIG. 48B illustrates a plan view of open-sided needle4874. Open-sided needle4874 is illustrated as formed with an end opposite its tip having aneedle skirt4878.Needle skirt4878 may aid directingsensor138 into the needle lumen to assist with loading ofsensor138 and/or reduce the opportunity for damage ofsensor138 during use and/or loading.
• FIG. 49 illustrates a perspective view of a deflected-tip needle4974 for use in an applicator for an analyte sensor system, according to some embodiments. Deflected-tip needle4974 may comprise a substantially straight shaft having a substantiallycurved tip4980, such that an angle of entry of deflected-tip needle4974 is offset from the substantially straight shaft. Such an angle offset of the substantiallycurved tip4980 may be particularly useful for reducing tissue damage and insertion resistance for applicators such asapplicator2500, as previously described in connection withFIGS. 25-28H, that have an insertion path for the insertion element that is a substantially curved path. The substantiallycurved tip4980 may steer deflected-tip needle4974 in the direction of the substantially curved insertion path, thereby reducing tissue damage caused by lateral movement of the needle with respect to its direction of extension.FIG. 49 illustrates a magnified view4950 of thecurved tip4980.
• FIG. 50 illustrates acurved needle5074 for use in an applicator for an analyte sensor system, according to some embodiments. As shown,curved needle5074 has a profile that is substantially curvilinear. Such a curvilinear profile may be particularly useful for reducing tissue damage and insertion resistance for applicators such asapplicator2500, as previously described in connection withFIGS. 25-28H, that have an insertion path for the insertion element that is a substantially curved path. The substantially curvilinear profile ofneedle5074 may reduce tissue damage caused by lateral movement of the needle with respect to its direction of extension. In some embodiments, the curvilinear profile ofneedle5074 may substantially track or trace the insertion path for the applicator, thereby substantially eliminating, or at least greatly reducing, lateral movement of the needle with respect to the skin of the host. In some embodiments,sensor138 of on-skin sensor assembly160 may have a curvilinear profile also, thereby allowingsensor138 to rest within a portion ofcurved needle5074. In yet other embodiments, the insertion element, for example a C-needle may have at least a portion coated with a polymer that prevents damage to the tissue of the host and/or to the sensor wire. Such a polymer may include, but is not limited to, cyanoacrylate, epoxy, elastomeric polymers, urethanes or any other suitable polymer.
• In some embodiments, at least a sensing portion ofsensor138 may be coated with AgCl to improve the reference capacity ofsensor138. However, AgCl is a catalyst for corroding the metal in the insertion element (e.g., open-sided needle). Accordingly, an AgCl coating onsensor138 that comes into contact with the insertion element may be undesirable. One method of decreasing corrosion ofsensor138 and/or the insertion element is to selectively remove or substantially decrease the content of AgCl on at least a proximal end ofsensor138 without substantially affecting the region ofsensor138 that is inserted into the skin of the host. This may be accomplished by exposing the desired portion ofsensor138 to a single frequency or multiple frequencies of ultraviolet radiation for a predetermined length of time and at a predetermined intensity. Such a process may be performed at any time, for example, during the skiving or singulation process. Another method of removing AgCl is to expose the desired portion ofsensor138 to an ammonia (NH₃) rinse at a desired concentration and for a desired length of time.
Sharp Protection
• FIGS. 51A-51B illustrate cutaway views of a needle hub of an applicator for an analyte sensor system, according to some embodiments.FIG. 51A illustrates aneedle hub5104, aninsertion element5174, aneedle guard5102, aspring5174, and abase5130 of the applicator.First needle hub5104 may be fixed to a portion other than a tip ofinsertion element5174.Second needle hub5102 may be configured to encapsulate the tip ofinsertion element5174 and may comprise a material thatinsertion element5174 may pierce during deployment and/or may include an aperture or hole through whichinsertion element5174 may pass.Spring5106 is configured to keep a predetermined spacing betweenneedle hub5104 andneedle guard5102 such that the tip ofinsertion element5174 is encapsulated byneedle guard5102 when the predetermined spacing is maintained.FIG. 51A illustrates a pre-activation position that may be returned to after activation, under a returning force provided byspring5106, compressed during deployment ofinsertion element5174. In some embodiments, the spring can be integrated intoneedle hub5104 orneedle guard5102.
• FIG. 51B illustratesneedle hub5104,insertion element5174,needle guard5102,spring5174, andbase5130 of the applicator in the distal, deployed position. As shown,insertion element5174 has been driven throughneedle guard5102 and through an opening inbase5130. Sinceneedle hub5104 is fixed toinsertion element5174, deployment ofinsertion element5174 to the distal, deployed position closes the distance betweenneedle hub5104 andneedle guard5102, thereby compressing spring5106 (not shown inFIG. 51B). The energy stored in compressingspring5106 is then utilized to forceneedle guard5102 substantially to its pre-activation position, thereby encapsulating the tip ofinsertion element5174. It is contemplated that the features described inFIGS. 51A-51B provide protection from needle stick hazards.
• FIGS. 52A-52B illustrate a cross-sectional view and a top plan view, respectively, of aninfusion cannula5264 integrated into on-skin sensor assembly160 of an analyte sensor system, according to some embodiments. InFIG. 52A, on-skin sensor assembly160 is illustrated as includingsensor138 and afill port5262 configured to receive a fluid, gel, or medication (e.g., insulin) andcannula5264 configured to deliver the fluid or gel throughskin130 of the host. In some embodiments, fillport5262 comprises a septum material that maintains a seal for the transcutaneous cannula and is capable of being pierced (e.g. by a hypodermic needle attached to a syringe) and allow for dosing the medication. This septum may be configured to self-seal after removal of the needle from the skin of the host. The infusion cannula and analyte sensor may be inserted transcutaneously by the same applicator device. It is envisioned that a sharp (e.g. needle) placed within the lumen of an infusion cannula and placed in parallel with the insertion element (e.g. attached to needle carrier assembly such as508) for analyte sensors may be added to the analyte applicators (e.g. applicator500,800,900,1000, etc.). InFIG. 52B, on-skin sensor assembly160 is illustrated as including anadhesive patch5264 configured to adhere on-skin sensor assembly160 toskin130 of the host.
Sensor Retention Embodiments
• In some embodiments, an insertion element, such as an open-sided needle may be utilized to insert at least a portion of a sensor wire into the skin of a host. However, such embodiments generally operate best when the sensor wire remains seated in a channel of the open-sided needle before and during insertion. In addition, if the open-sided needle does not retain the sensor in the channel of the needle, the sensor may fail to deploy into the tissue. Accordingly,FIGS. 53-59 illustrate several embodiments of applicators that include sensor retention features configured to retain the sensor wire within a channel of the insertion element at least before activation of the applicator. Although particular applicators are shown, these retention features may be incorporated into any applicator described by this disclosure.
• FIG. 53 illustrates a cross-sectional view of a sensor retention mechanism for anapplicator5300 for an analyte sensor system, according to some embodiments.Applicator5300 includes anapplicator housing5302 having aretention feature5384, for example a hook or protrusion.Applicator5300 further includes on-skin sensor assembly160 havingsensor138, and aninsertion element5374 configured to guidesensor138.Applicator5300 further comprises aretention element5382, which may comprise an elastomeric band (e.g., a rubber band), a flexible plastic, or metallic wire configured to press against an open side ofinsertion element5374 therebyretention sensor138 ininsertion element5374. Upon activation ofapplicator5300, an orientation or position of one or more ofretention feature5384,retention element5382 orinsertion element5374 may be altered such thatsensor138 is no longer actively retained withininsertion element5374. For example,insertion element5374 may be configured to progress in the proximal direction at the beginning of activation. Theinsertion element5374 is withdrawn from the retention element allowing the retention element to recoil and clear the pathway of insertion for the on-skin sensor assembly.
• FIG. 54 illustrates a perspective view of anothersensor retention mechanism5482 for anapplicator5400 for an analyte sensor system, according to some embodiments. InFIG. 54,sensor retention mechanism5482 comprises a flexible or substantially rigid insert configured to rest againstapplicator housing5402 and againstinsertion element5474, therebyretention sensor138 ininsertion element5474. For example,retention mechanism5482 may comprise a paper, plastic, elastomeric, metallic or polymeric sheet configured for removal before activation ofapplicator5400. In some embodiments,retention mechanism5482 may be manufactured or cut to include atab5486 configured to press againstinsertion element5474, therebyretention sensor138 ininsertion element5474.
• In some embodiments,retention mechanism5482 may be coupled to a liner of an adhesive patch of on-skin sensor assembly160 such that when the liner is removed, in preparation for application of on-skin sensor assembly160,retention mechanism5482 may be simultaneously removed.
• In some other embodiments,tab5486 may be disposed at such an angle that, rather than holdinginsertion element5474 andsensor138 betweentab5486 and another portion ofretention mechanism5482,insertion element5474 andsensor138 are configured to pierce and pass at least partially throughtab5486 such thatsensor138 is retained within a channel ofinsertion element5474.
• FIG. 55 illustrates a cutaway view of anothersensor retention element5592 for anapplicator5500 for an analyte sensor system, according to some embodiments. As shown,retention element5592 may comprise a pad comprising foam, an elastomer, or any other suitable material, andinsertion element5574 may be inserted at least partially intoretention element5592 such that sensor138 (not shown inFIG. 55) is retained withininsertion element5574.Retention element5592 may be coupled to abottom cap5590 which is removable prior to activation ofapplicator5500.
• FIGS. 56A-56B illustrate perspective views of anothersensor retention element5682 for anapplicator5600 for an analyte sensor system, according to some embodiments.Sensor retention element5682 may comprise a paddle or other surface configured to rest againstinsertion element5674 in a retention position, therebyretention sensor138 in theinsertion element5674.FIG. 56A illustratessensor retention element5682 in the retention position.Sensor retention element5682 is configured to rotate, slide, or move away frominsertion element5674 into a non-retaining position, thereby puttingapplicator5600 in a state for activation. In some embodiments the arm ofsensor retention element5682 is configured to automatically move during or after activation into a non-retaining position via a linkage attached to an element of the applicator.FIG. 56B illustratessensor retention element5682 in the non-retaining position.
• In some embodiments,sensor138 may be retained in a channel of an insertion element by an elastomeric band disposed around at least a portion of insertion element (e.g., an O-ring or any other flexible band material). The elastomeric band may be removed manually before deployment, or alternatively, may be removed from insertion element automatically by some operation of the applicator upon activation. In some embodiments (e.g. applicator500) the insertion element is configured to move in the proximal direction during the first portion (e.g. by changing the starting position of the scotch-yoke mechanism) of the insertion cycle. In this embodiment the elastomeric element is able to clear the distal tip of the insertion element and recoil to clear the pathway of insertion of the on skin assembly.
• In some other embodiments,sensor138 may be retained in a channel of an insertion element by a foam, paper, cardboard, plastic, polymeric tab configured to be pierced by insertion element such that the tab is disposed substantially around a tip of insertion element, thereby retainingsensor138 in the channel of the insertion element. The tab may be removed manually before deployment, or alternatively, may be removed from insertion element automatically by some operation of the applicator upon activation.
• FIG. 57 illustrates a perspective view of yet another sensor retention element5782 for an applicator for an analyte sensor system, according to some embodiments. Sensor retention element5782 includes a needle hub (not shown inFIG. 57) configured to guide insertion element5774 (e.g., a C-needle), which is it turn configured to guidesensor138. A flexible sleeve comprising afirst portion5706aand asecond portion5706bis disposed oversensor138 andinsertion element5774, thereby retainingsensor138 ininsertion element5774. Upon activation, the needle hub is configured to driveinsertion element5774 in the distal direction, thereby splitting the flexible sleeve and separatingfirst portion5706aandsecond portion5706b. Once split, the flexible sleeve may no longer retainsensor138 ininsertion element5774.
• FIG. 58 illustrates a perspective view of yet another sensor retention element5882 for an applicator for an analyte sensor system, according to some embodiments. Sensor retention element5882 includes a needle hub (not shown inFIG. 58) configured to guide insertion element5874 (e.g., a C-needle), which is it turn configured to guidesensor138. A flexible sleeve comprising afirst portion5806aand asecond portion5806bis disposed oversensor138 within a channel ofinsertion element5874, thereby retainingsensor138 ininsertion element5874. Upon activation, the needle hub is configured to driveinsertion element5874 in the distal direction, thereby splitting the flexible sleeve and separatingfirst portion5806aandsecond portion5806b. Once split, the flexible sleeve may no longer retainsensor138 ininsertion element5874.
• FIGS. 59A-59B illustrate cutaway views of yet another sensor retention element for an applicator for an analyte sensor system, according to some embodiments.FIG. 59A illustrates a position of on-skin sensor assembly160, aninsertion element5974 guidingsensor138, and a cannula (e.g. a tube such as PTFE, PE, polymer, metallic, etc.)5962, configured to retainsensor138 in an opensided insertion element5974, during and before applicator activation. InFIG. 59A,cannula5962 may be coupled to on-skin sensor assembly160 or at least configured to be driven to the distal inserted position along with on-skin sensor assembly160.
• FIG. 59B illustrates on-skin sensor assembly160,sensor assembly138, andcannula5962 in the inserted distal position with respect toskin130 of the host,insertion element5974 having been retracted to the proximal retracted position (not shown inFIG. 59B). As shown,sensor138 may be inserted and disposed throughcannula5962, intoskin130 of the host.Cannula5962 may provide strain relief and a minimum bend radius forsensor138, thereby reducing the probability of damage tosensor138 during deployment and operation. A significant portion of the elongated body of the analyte sensor may extend subcutaneously beyond the cannula so as not to interfere with sensor function.
On-Skin Sensor Assembly Features
• FIG. 68 illustrates a perspective view of an on-skin sensor assembly6860, which may include abase6828. Anadhesive patch6826 can couple the base6828 to theskin6830 of the host. In some embodiments, theadhesive patch6826 may comprise an adhesive suitable for skin adhesion, for example a pressure sensitive adhesive (e.g., acrylic, rubber-based, or other suitable type) bonded to a carrier substrate (e.g., spun lace polyester, polyurethane film, or other suitable type) for skin attachment, though any suitable type of adhesive is also contemplated. An on-skin sensor assembly6860 may comprise an electronics unit6840 (e.g., a transmitter) which may further comprise aglucose sensor module6834 coupled to aglucose sensor6838 and tobase6828.
• The applicator system can coupleadhesive patch6826 toskin6830. Theglucose sensor module6834 may be secured to base6828 (e.g., via retention elements such as snap fits and/or interference features, adhesive, welding, etc.) to ensureglucose sensor6838 is coupled tobase6828. In alternative embodiments, thesensor module6834 andbase6828 are preassembled or manufactured as a single component.
• After on-skin sensor assembly6860 is applied to a user's skin, a user (or an applicator) can couple electronics unit6840 (e.g., a transmitter) to on-skin sensor assembly6860 via retention elements such as snap fits and/or interference features.Electronics unit6840 can measure and/or analyze glucose indicators sensed byglucose sensor6838.Electronics unit6840 can transmit information (e.g., measurements, analyte data, glucose data) to a remotely located device (e.g.,110-114 shown inFIG. 1).
• On-skin sensor assembly6860 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 attachingelectronics unit6840 tobase6840, insertingsensor6838 through the host's skin, and/or connectingsensor6838 toelectronics unit6840. Onceelectronics unit6840 is engaged with the base andsensor6838 has been inserted into the skin (and is connected to the electronics unit6840), the sensor assembly can detach from the applicator.
• FIG. 69 illustrates a perspective view ofelectronics unit6840 coupled tobase6828 via retention elements such as snap fits and/or interference features. In some embodiments,electronics unit6840 andbase6828 are coupled by adhesive, welding, or other bonding techniques.Adhesive patch6826, on a distal face ofbase6828, is configured to couplesensor assembly6860 to the skin.
• Reverting to on-skin sensor assembly160 as previously described in connection withFIG. 1,FIG. 70 illustrates a perspective view of on-skin sensor assembly6860. On-skin sensor assembly6860 may be disposable or reusable.FIG. 70 further illustrateselectronics unit6840 coupled to abase6828, andadhesive patch6826 configured to be attached to on-skin sensor assembly6860, which, when combined, may be held within the applicator.Adhesive patch6826 may or may not have a non-adhesive liner when held in the applicator.
• Further, with respect to any of on-skin sensor assembly160,260,360 ofFIGS. 1 and 2A-4, or on-skin sensor assembly6860 ofFIGS. 68-70, on-skin sensor assembly160,260,360,6860 is subjected to stress on portions ofsensor138,238,338,6838 that are bent as the direction of extension ofsensor138,238,338,6838 transitions from substantially horizontal, within on-skin sensor assembly160,260,360,6860 to substantially vertical, at the interface between on-skin sensor assembly160,260,360,6860 andskin130.FIGS. 58-63 describe several embodiments that minimize the incidence of sensor damage as well as host discomfort at this interface. While the following description may identify portions of on-skin sensor assembly160 ofFIG. 1, such description may be equally applicable to on-skin sensor assembly260,360,6860 ofFIGS. 2A-4, and 68-70.
• FIG. 60 illustrates a cutaway view of on-skin sensor assembly160 having at least a portion ofsensor138 potted in a flexible material, according to some embodiments. On-skin sensor assembly160 is shown as including atleast sensor electronics140, aninsertion element6074, such as a C-needle for example, passing through an opening in on-skin sensor assembly160, andsensor138 coupled or couplable tosensor electronics140 at a first end, and having a portion that is bent along a bend radius such that a portion ofsensor138 beyond the bend is nested within or againstinsertion element6074.Sensor138 is further illustrated as having aflexible material6002, e.g., an elastomeric material such as silicone, disposed around at least a portion of the bend insensor138.Flexible material6002 may operate as a strain-relief element by limiting the bend radius of the bend to some predetermined minimum radius that substantially reduces or eliminates damage tosensor138. In some embodiments,flexible material6002 may extend to the hole through whichsensor138 passes at the on-skin sensor assembly-to-skin interface, which further provides a seal from moisture ingress to on-skin sensor assembly160. In some embodiments, a dedicated seal comprising a flexible material may be provided at the hole through whichsensor128 passes in addition to or as an alternative toflexible material6002.
• FIG. 61 illustrates a cutaway view of on-skin sensor assembly160 comprising an open cavity configured to allow a larger bend radius insensor138, compared to that shown inFIG. 60, according to some embodiments. On-skin sensor assembly160 is shown as including atleast sensor electronics140, aninsertion element6174, such as a C-needle for example, passing through an opening in on-skin sensor assembly160, andsensor138 coupled or couplable tosensor electronics140 at a first end, and having a portion that is bent along a bend radius such that a portion ofsensor138 beyond the bend is nested within or againstinsertion element6174. A bottom of on-skin sensor assembly160 further includes anopen cavity6102.Open cavity6102 allowssensor138 to bend along a larger minimum bending radius than would be possible for an on-skin sensor assembly that does not includeopen cavity6102.Sensor138 is shown inFIG. 61 as initiating this bend in advance of reachingopen cavity6102 and arcing in an upward direction at the beginning of the bend, further increasing the potential minimum bend radius ofsensor138. Such a larger bend radius reduces stress and strain onsensor138, thereby reducing the probability of damage tosensor138.
• Open cavity6102 may further promote healing of the open wound caused by insertion ofsensor138 byinsertion element6174 by providing access air access that improves drying of the wound site. Although not shown inFIG. 61, on-skin sensor assembly160 may further include a porous, woven, or spun lace material configured to wick away moisture from sweating or any other source, such as blood from the wound.Open cavity6102 would further provide a location for small amounts of this liquid, e.g., blood, to collect, thereby preventing it from seeping out and being visible to the host. Although not shown inFIG. 61,sensor138 may further includeflexible material6002, e.g., silicone, disposed around at least a portion of the bend insensor138 and/or a seal at the hole through whichsensor138 passes, as previously described in connection withFIG. 60.
• FIG. 62 illustrates a cutaway view of on-skin sensor assembly160 comprising an open cavity configured to allow a larger bend radius insensor138, compared to that shown inFIG. 60, according to some embodiments. On-skin sensor assembly160 is shown substantially as previously described in connection withFIG. 61, however,sensor138 is shown as initiating the upward bend upon reaching, rather than in advance of reaching,open cavity6102. Although not shown inFIG. 62,sensor138 may further includeflexible material6002, e.g., silicone, disposed around at least a portion of the bend insensor138 and/or a seal at the hole through whichsensor138 passes, as previously described in connection withFIG. 60. Such a larger bend radius reduces stress and strain onsensor138, thereby reducing the probability of damage tosensor138.
• FIG. 63 illustrates a cutaway view of on-skin sensor assembly160 comprising an open cavity configured to allow a larger bend radius insensor138, compared to that shown inFIG. 60, according to some embodiments. Such a larger bend radius reduces stress and strain onsensor138, thereby reducing the probability of damage tosensor138. On-skin sensor assembly160 is shown substantially as previously described in connection withFIG. 61, however,sensor138 is shown as initiating a bend upon reaching, rather than in advance of reaching,open cavity6102 and this bend is substantially in the downward direction, rather than first in an upward direction. Although not shown inFIG. 63,sensor138 may further includeflexible material6002, e.g., silicone, disposed around at least a portion of the bend insensor138 and/or a seal at the hole through whichsensor138 passes, as previously described in connection withFIG. 60.
• In yet other embodiments, at least a portion ofsensor138 may have a braided polyurethane material disposed thereon to provide further strain relief. In addition, or in the alternative, additional materials such as an elastomer, flexible adhesive, or other braided or molded polymer material may be disposed thereon, in some embodiments, at least on the bend insensor138 and/or at a transition into on-skin sensor assembly160, to provide further strain relief. It is contemplated that the components and features described above and/or with respect toFIGS. 60-63 can be implemented in other on-skin sensor assemblies described herein, such as on-skin sensor assembly260 and360.
• In addition, during pressure fluctuations, such as at high altitude or vacuum during sterilization processes for example, air present within the applicator may exert a deforming force on on-skin sensor assembly160. Although not shown in any ofFIGS. 60-63, in some embodiments, on-skin sensor assembly160 may have at least a portion formed with a reduced thickness and, therefore, reduced strength and rigidity, such that when applicator460 is exposed to such pressure fluctuations, the portions having the reduced thickness expand in a controlled manner, thereby reducing or eliminating damage that would otherwise occur to on-skin sensor assembly160 due to undesirable uncontrolled expansion of on-skin sensor assembly160. Such a feature may be present in the applicator housing of any applicator described herein.
• FIGS. 64A-64B illustrate an optional battery connection feature for on-skin sensor assembly160,260,360 in accordance with some embodiments.FIG. 64A illustrates a storage mode, pre-activation. On-skin sensor assembly160 is illustrated as including abattery6410 configured to power at least sensor electronics (e.g., transmitter/sensor electronics140, seeFIG. 1). On-skin sensor assembly160 further includes anelectrical contact6402, configured to physically andelectrically contact battery6410, an electrically insulating material6404 (e.g., polyethylene terephthalate (PET), or any other electrically insulative material) disposed betweenelectrical contact6402, and a flexible material6406 (e.g., ductile PET, TPSiV® or any other suitable material) coupled to on-skin sensor assembly160 and to electrically insulatingmaterial6404. In operation, pre-activation, electrically insulatingmaterial6404 prevents electrical contact betweenelectrical contact6402 andbattery6410, maintaining on-skin sensor assembly160 in an unpowered storage mode that prevents battery drain before deployment. During activation, someportion6408 of applicator may be configured to push down onflexible material6406, which is physically coupled to electrically insulatingmaterial6404, thereby shifting electrically insulatingmaterial6404 such thatelectrical contact6402 comes into electrical contact withbattery6410 and shifting on-skin sensor assembly160 into a battery connected operational mode, as will be shown in more detail in connection withFIG. 64B.
• FIG. 64B illustrates the battery connected, operational mode of on-skin sensor assembly160,260,360 discussed inFIG. 64A.Portion6408 of applicator is illustrated as having pushed down or deformedflexible material6406 and moved electrically insulatingmaterial6404 laterally such thatelectrical contact6402 is in electrical contact withbattery6410.
• FIGS. 88A-88B illustrate another optional battery connection feature for on-skin sensor assembly160,260,360 in accordance with some embodiments.FIG. 88A illustrates a first perspective view of abattery socket8804 configured to hold a coin battery8810 (seeFIG. 88B), according to some embodiments.FIG. 88B illustrates a second perspective view of thebattery socket8804, according to some embodiments.Battery socket8804 comprises a first terminal comprising atab8806, configured to make physical and electrical contact with one of a positive terminal or a negative terminal ofbattery8810.Battery socket8804 further comprises a second terminal comprising one ormore clips8808 configured to make physical and electrical contact with the other of the positive terminal or the negative terminal ofbattery8810. In some embodiments, a portion of aPCB8802 may insulatetab8806 from the one ormore clips8808. In some embodiments,battery socket8804 may be soldered toPCB8802 to provide electrical and/or structural connections betweenbattery socket8804 and one or more electrical components onPCB8802. In some embodiments,PCB8802 may comprise a single unitary piece. In some embodiments,battery8810 may be secured tobattery socket8804 during assembly of on-skin sensor assembly160,260,360. In some embodiments,battery8810 may be secured totab8806 via one or more tack welds. In some embodiments,battery8810 may be additionally or alternatively secured totab8806 utilizing a spring, a piece of foam, or any other element disposed betweenbattery8810 and a housing or other portion of on-skin sensor assembly160,260,360 and configured to push or retainbattery8810 againsttab8806. In some embodiments,battery8810 may additionally or alternatively be secured to the one ormore clips8808 via one or more respective tack welds.
Sterilization, Packaging, and Sealing Embodiments
• For any of the embodiments of applicators expressly described herein, sterilization, packaging, and/or sealing features may also be included. In some embodiments, a user removing the applicator from its packaging and/or its sterilization features may partially or fully energize the applicator (e.g., load unloaded springs). For example, motions such as pulling, twisting, pushing, or tilting required to remove an applicator from its packaging or to remove one or more sterilization and/or sealing features from the applicator may be harnessed to load partially unloaded or fully unloaded springs within the applicator. Such features would provide a benefit in that less energy would have to be stored in the springs of the applicator during its shelf life, prior to its use. Examples of sterilizing, sealing and packaging features contemplated for inclusion with any applicator described herein are described more fully in U.S. patent application Ser. No. 16/011,527, which is incorporated herein by reference it its entirety.
• FIG. 67 illustrates exemplary sterilization, packaging and sealing features of an applicator configured to apply an on-skin sensor assembly to skin of a host, according to some embodiments. In some embodiments, the applicator (e.g. applicator500,800,900,1000, etc.). may incorporate features such as sterile barrier, tamper evidence, device sealing and/or device protection. Methods of sterile barrier, tamper evidence, device sealing, and/or device protection are also described in U.S. patent application Ser. No. 16/011,527. Non-limiting examples may include a tamper evident feature6810 (e.g.FIGS. 1A-5B), a capsule sealing feature6820 (e.g.FIGS. 1A-3C), a gas permeable6830 and/or non-gas permeable sterile barrier6840 (e.g.FIGS. 1A, 2B, 4B, 5B, 7B, 8B, 9, 11A, 13A, 15A-27B, 29-30B), or device protection feature6850 (e.g.FIG. 1A-24B).
• Tamper evident sealing or other tamper evidence features6810 allow a consumer to identify when an applicator has been previously used or containment has been breached and, thus, avoid using an applicator that may be faulty or pose an increased health risk if used. Non-limiting examples of tamperevident features6810 also described in U.S. patent application Ser. No. 16/011,527, include ring, peelable layer, perforated tab, adhesive mounted tab, and/or twist-off collar. These features may be incorporated in current embodiments within an applicator housing (e.g.502) or additional bodies added to the applicator assembly (e.g. cap, shell, lid, tab, peelable layer, frangible, ring, etc.).
• Capsule sealing features6820 create an enclosed volume from multiple components. Non limiting examples of capsule sealing features also described in U.S. patent application Ser. No. 16/011,527, include one or more removable caps on the top (e.g., proximal) or bottom (e.g., distal) ends of the applicator, through one or more trigger mechanisms comprising integrated caps, through one or more sealing layers that cover one or more orifices, apertures or vents of the applicator, through sterilizable gas-permeable polymers, through sterilizable gas-permeable trigger mechanisms, through protective cups, or any combinations of the same, described in more detail with at least some ofFIGS. 1A-33. These features may be incorporated in current embodiments within an applicator housing (e.g.502) or additional bodies added to the applicator assembly (e.g. cap, shell, lid, tab, peelable layer, elastomer, O-ring, adhesive, button, etc.).
• Gas permeablesterile barriers6830 allow a device to create an enclosed volume that is permeable to a gas (e.g. a sterilization gas) and maintain a microbial barrier to an exterior volume. A non-gas permeablesterile barrier6840 performs the same functions of a gas permeable sterile barrier with the additional function of blocking gasses than may have deleterious effects (e.g. water vapor). Gas permeable6830 and/or non-gas permeablesterile barrier6840 may be used in conjunction or independently as also described in U.S. patent application Ser. No. 16/011,527. These features may be incorporated in current embodiments within an applicator housing (e.g.502) or additional bodies added to the applicator assembly (e.g. cap, shell, lid, tab, peelable layer, packaging, seal, button, etc.).
• Device protection features6850 may be adapted to protect functional components of applicators (e.g. applicator500,800,900,1000, etc.). Functions may include inadvertent activation prevention, drop protection, needle damage protection, or other functions also disclosed in U.S. patent application Ser. No. 16/011,527. These features may be incorporated in current embodiments within an applicator housing (e.g.502) or additional bodies added to the applicator assembly (e.g. cap, shell, lid, tab, peelable layer, frangible, packaging, seal, button, etc.).
Methods of Applying an On-Skin Sensor Assembly to Skin of a Host
• FIG. 65 illustrates aflowchart6500 of a method for applying an on-skin sensor assembly to skin of a host, according to some embodiments. Steps inflowchart6500 may be performed utilizing any applicator as previously described in connection with any of the previous FIGs. Although certain steps are set forth below, a method of using such an applicator may comprise more, fewer, or different steps, in the same or different order from that set forth below.
• Flowchart6500 illustratesblock6502, including providing an applicator comprising an applicator housing, a needle carrier assembly comprising an insertion element configured to insert a sensor of the on-skin sensor assembly into the skin of the host, a holder releasably coupled to the needle carrier assembly and configured to guide the on-skin sensor assembly while coupled to the needle carrier assembly, a drive assembly, and an activation element. In some embodiments, the distal direction and the proximal direction extend along an insertion axis of the insertion element.
• Flowchart6500 further illustratesblock6504, including activating an activation element, wherein activating the activation element causes the drive assembly to drive the insertion element in a distal direction to a distal insertion position and in a proximal direction from the distal insertion position to a proximal retraction position, thereby inserting the sensor of the on-skin sensor assembly at least partially into the skin of the host.
• FIG. 89 illustrates aflowchart8900 of another method for applying an on-skin sensor assembly to skin of a host, according to some embodiments. Steps inflowchart8900 may be performed utilizing any applicator as described in connection with any FIGs., for example but not limitation,FIGS. 71-88. Although certain steps are set forth below, a method of using such an applicator may comprise more, fewer, or different steps, in the same or different order from that set forth below.
• Flowchart8900 illustratesblock8902, including providing an applicator comprising a housing having an activation element, an insertion assembly, and a retraction assembly.
• Flowchart8900 further illustratesblock8904, including activating the activation element, wherein activating the activation element causes the insertion assembly to translate a needle carrier assembly and the on-skin sensor assembly in a distal direction from a proximal position to a distal insertion position, thereby inserting a sensor of the on-skin sensor assembly at least partially into the skin of the host, and the retraction assembly to translate the needle carrier assembly in a proximal direction from the distal inserted position to a proximal retracted position, the retraction assembly configured to activate in response to on-skin sensor assembly contacting the skin of the host. In some embodiments, the distal direction and the proximal direction extend along an insertion axis of an insertion element of the applicator.
Exemplary Mechanisms for Applicator Features
• FIG. 66 illustrates exemplary mechanisms for several features of an applicator configured to apply an on-skin sensor assembly to skin of a host, according to some embodiments. The mechanisms described in connection withFIG. 66 are exemplary and not limiting.
• For example, thefeature activation element6610 as used herein may be considered to include any type of mechanism that, when operated as intended, serves to activate a drive mechanism of an applicator and, thereby, apply an on-skin sensor assembly to skin of a host. For example, an activation element may include an element configured to trigger when pushed, pulled, switched, toggled, slid, triggered, deflected, rotated, deformed or flexed from a first position or state to at least a second position or state. General examples include but are not limited to buttons, slides, hooks, switches, a flexible portion of the applicator housing itself, tabs, or strings. Moreover, although certain embodiments of applicators are described herein as having an activation element in a particular location, any applicator described herein is also contemplated having one or more activation members in any other position, e.g., a top, upper side, medial side, lower side, or bottom of the applicator. Moreover, in some embodiments, two or more activation elements may be operated in tandem in order to activate the applicator. The above-described activation elements may be applied or utilized in connection with any applicator described herein.
• Thefeature insertion element6620 as used herein may be considered to include any type of mechanism that, when operated as intended, serves to insert a sensor or sensor wire at least partially into a skin of a host. For example, an insertion element may include, but is not limited to, a regular, circumferential needle, an open sided-needle (e.g.,FIGS. 48A-48B), a needle with a deflected tip (e.g.,FIG. 49), a curved, bent or kinked needle (e.g.,FIGS. 47 and 50), a polymer-coated needle, a hypodermic needle, or the sensor or sensor wire tip itself.
• The feature retention element or on-skin sensorassembly retention element6630 as used herein may be considered to include any type of mechanism that, when operated as intended, serves to retain an on-skin sensor assembly in a particular position, orientation or constrain the feature to a particular path of motion. For example, a retention element may include, but is not limited to, a hook, a claw, a tab, an arm, an undercut and snap feature, a press fit feature, a deformable and/or elastomeric element (as described in connection with any ofFIGS. 5-7D, 12-14E,25-27E,32A-37C and41A-46), or any on-skin sensor assembly retention element illustrated in U.S. patent application Ser. No. 15/387,088 as described above.
• The feature spring and/orenergy source6650 as used herein may be considered to include any suitable type of spring configured to store potential energy when loaded and configured to release at least a portion of that stored potential energy to drive one or more portions of an applicator as required or desired. For example, a spring may include, but is not limited to, a compression spring, which is configured to store energy when compressed to less than its resting length (e.g.,FIG. 32), an extension spring, which is configured to store energy when stretched to greater than its resting length (e.g.,FIG. 21), a single or double torsion spring (e.g.,FIG. 12), clock spring or power spring, which are configured to store energy in torsional deformation of a portion of the spring from its resting profile, or a leaf spring (e.g.,FIGS. 22 and 25), which is configured to store energy in the physical deformation of the spring from its resting profile.
• Insertion and/orretraction mechanisms6660 may be considered to include any suitable mechanism for causing a movement of an insertion element in a distal direction to a distal inserted position, and/or in a proximal direction to a proximal retracted position. For example, such mechanisms may include, but are not limited to, a scotch yoke mechanism (e.g.,FIG. 5) a barrel cam (e.g.,FIG. 29), opposing springs mechanism, a reverse toggling mechanism comprising a lever having a first end, a second end, and a fulcrum at a point between the first and second ends (e.g.,FIG. 31), a flexible linkage (e.g.,FIGS. 18-23), a spring linkage (e.g.FIG. 12-14E), or any hinging or pivoting (e.g.FIG. 25-28H) apparatus that operates as described in this disclosure.
• Energy storage6640, for example, as potential energy stored in a spring, for any applicator described in this disclosure may be pre-loaded (e.g., in the factory or before provision to a user), mechanism loaded (e.g., some operation of the applicator loads the spring), or user loaded (e.g., the user provides energy in some form of motion that is utilized to store potential energy in a spring).
• Sensor retention6670 for any applicator described in this disclosure may be user-removable (e.g.,FIGS. 54, 57, 58), mechanism-removable (e.g.,FIGS. 53, 56A-56B, 57 and 58), ex-vivo support feature (e.g.,FIGS. 55-58), or in-vivo support feature (e.g.,FIGS. 59A-59B). For example, an elastomeric element such as a rubber band (seeFIG. 53), a foam, rubber or other pad (seeFIG. 55), a frangible element (seeFIGS. 57-58), an adhesive layer, or a wire.
• Elements within each feature category (e.g.,6610,6620,6630,6640,6650,6660,6670) are interchangeable for any applicator described herein. For instance,applicator500 shown inFIGS. 5-611 includes a push button and deflectingarm activation element504, an open-sidedneedle insertion element674, an undercut/snap feature678a,678bfor on-skin sensor assembly160 retention, a pre-loaded energy storage in which the energy source is asingle torsion spring512, and a scotch yoke insertion/retraction mechanism510. However, in an alternative embodiment,applicator500 may instead include a switch/toggle activation element, a curved/bent needle insertion element (e.g.,5074), a press fit on-skin sensor assembly retention, and an ex-vivo support feature sensor retention (e.g.,FIGS. 55-58).
• In another example,applicator2500 shown inFIGS. 25-28H includes a push button and deflectingarm activation element2504, an open-sidedneedle insertion element2674, an undercut/snap feature (e.g., similar to678a,678b) onneedle carrier assembly2508 for on-skin sensor assembly160 retention, a pre-loaded energy storage in which the energy source is acompression spring2512 andleaf springs2528, and a hinging or pivotingapparatus2508,2524. However, in an alternative embodiment,applicator2500 may instead include a switch/toggle activation element, a curved/bent needle insertion element (e.g.,5074), a press fit on-skin sensor assembly retention, and an ex-vivo support feature sensor retention (e.g.,FIGS. 55-58).
• It should be appreciated that all methods and processes disclosed herein may be used in any glucose monitoring system, continuous or intermittent. It should further be appreciated that the implementation and/or execution of all methods and processes may be performed by any suitable devices or systems, whether local or remote. Further, any combination of devices or systems may be used to implement the present methods and processes.
• Methods and devices that are suitable for use in conjunction with aspects of the preferred embodiments are disclosed in U.S. Pat. Nos. 4,757,022; 4,994,167; 6,001,067; 6,558,321; 6,702,857; 6,741,877; 6,862,465; 6,931,327; 7,074,307; 7,081,195; 7,108,778; 7,110,803; 7,134,999; 7,136,689; 7,192,450; 7,226,978; 7,276,029; 7,310,544; 7,364,592; 7,366,556; 7,379,765; 7,424,318; 7,460,898; 7,467,003; 7,471,972; 7,494,465; 7,497,827; 7,519,408; 7,583,990; 7,591,801; 7,599,726; 7,613,491; 7,615,007; 7,632,228; 7,637,868; 7,640,048; 7,651,596; 7,654,956; 7,657,297; 7,711,402; 7,713,574; 7,715,893; 7,761,130; 7,771,352; 7,774,145; 7,775,975; 7,778,680; 7,783,333; 7,792,562; 7,797,028; 7,826,981; 7,828,728; 7,831,287; 7,835,777; 7,857,760; 7,860,545; 7,875,293; 7,881,763; 7,885,697; 7,896,809; 7,899,511; 7,901,354; 7,905,833; 7,914,450; 7,917,186; 7,920,906; 7,925,321; 7,927,274; 7,933,639; 7,935,057; 7,946,984; 7,949,381; 7,955,261; 7,959,569; 7,970,448; 7,974,672; 7,976,492; 7,979,104; 7,986,986; 7,998,071; 8,000,901; 8,005,524; 8,005,525; 8,010,174; 8,027,708; 8,050,731; 8,052,601; 8,053,018; 8,060,173; 8,060,174; 8,064,977; 8,073,519; 8,073,520; 8,118,877; 8,128,562; 8,133,178; 8,150,488; 8,155,723; 8,160,669; 8,160,671; 8,167,801; 8,170,803; 8,195,265; 8,206,297; 8,216,139; 8,229,534; 8,229,535; 8,229,536; 8,231,531; 8,233,958; 8,233,959; 8,249,684; 8,251,906; 8,255,030; 8,255,032; 8,255,033; 8,257,259; 8,260,393; 8,265,725; 8,275,437; 8,275,438; 8,277,713; 8,280,475; 8,282,549; 8,282,550; 8,285,354; 8,287,453; 8,290,559; 8,290,560; 8,290,561; 8,290,562; 8,292,810; 8,298,142; 8,311,749; 8,313,434; 8,321,149; 8,332,008; 8,346,338; 8,364,229; 8,369,919; 8,374,667; 8,386,004; 8,394,021; 8,527,025; 7,896,809; 9,119,528; and 9,119,529.
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• The above description presents the best mode contemplated for carrying out the present invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains to make and use this invention. This invention is, however, susceptible to modifications and alternate constructions from that discussed above that are fully equivalent. Consequently, this invention is not limited to the particular embodiments disclosed. On the contrary, this invention covers all modifications and alternate constructions coming within the spirit and scope of the invention as generally expressed by the following claims, which particularly point out and distinctly claim the subject matter of the invention. While the disclosure has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive.
• 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. As examples of the foregoing, the term ‘including’ should be read to mean ‘including, without limitation,’ ‘including but not limited to,’ or the like; the term ‘comprising’ as used herein is synonymous with ‘including,’ ‘containing,’ or ‘characterized by,’ and is inclusive or open-ended and does not exclude additional, unrecited elements or method steps; the term ‘having’ should be interpreted as ‘having at least;’ the term ‘includes’ should be interpreted as ‘includes but is not limited to;’ the term ‘example’ is used to provide exemplary instances of the item in discussion, not an exhaustive or limiting list thereof; adjectives such as ‘known’, ‘normal’, ‘standard’, and terms of similar meaning should not be construed as limiting the item described to a given time period or to an item available as of a given time, but instead should be read to encompass known, normal, or standard technologies that may be available or known now or at any time in the future; and use of terms like ‘preferably,’ ‘preferred,’ ‘desired,’ or ‘desirable,’ and words of similar meaning should not be understood as implying that certain features are critical, essential, or even important to the structure or function of the invention, but instead as merely intended to highlight alternative or additional features that may or may not be utilized in a particular embodiment of the invention. Likewise, a group of items linked with the conjunction ‘and’ should not be read as requiring that each and every one of those items be present in the grouping, but rather should be read as ‘and/or’ unless expressly stated otherwise. Similarly, a group of items linked with the conjunction ‘or’ should not be read as requiring mutual exclusivity among that group, but rather should be read as ‘and/or’ unless expressly stated otherwise.
• Where a range of values is provided, it is understood that the upper and lower limit, and each intervening value between the upper and lower limit of the range is encompassed within the embodiments.
• With respect to the use of substantially any plural and/or singular terms herein, those having skill in the art can translate from the plural to the singular and/or from the singular to the plural as is appropriate to the context and/or application. The various singular/plural permutations may be expressly set forth herein for sake of clarity. The indefinite article ‘a’ or ‘an’ does not exclude a plurality. A single processor or other unit may fulfill the functions of several items recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. Any reference signs in the claims should not be construed as limiting the scope.
• It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases ‘at least one’ and ‘one or more’ to introduce claim recitations. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles ‘a’ or ‘an’ limits any particular claim containing such introduced claim recitation to embodiments containing only one such recitation, even when the same claim includes the introductory phrases ‘one or more’ or ‘at least one’ and indefinite articles such as ‘a’ or ‘an’ (e.g., ‘a’ and/or ‘an’ should typically be interpreted to mean ‘at least one’ or ‘one or more’); the same holds true for the use of definite articles used to introduce claim recitations. In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of ‘two recitations,’ without other modifiers, typically means at least two recitations, or two or more recitations). Furthermore, in those instances where a convention analogous to ‘at least one of A, B, and C, etc.’ is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., ‘a system having at least one of A, B, and C’ would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). In those instances where a convention analogous to ‘at least one of A, B, or C, etc.’ is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., ‘a system having at least one of A, B, or C’ would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). It will be further understood by those within the art that virtually any disjunctive word and/or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms. For example, the phrase ‘A or B’ will be understood to include the possibilities of ‘A’ or ‘B’ or ‘A and B.’
• All numbers expressing quantities of ingredients, reaction conditions, and so forth used in the specification are to be understood as being modified in all instances by the term ‘about.’ Accordingly, unless indicated to the contrary, the numerical parameters set forth herein are approximations that may vary depending upon the desired properties sought to be obtained. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of any claims in any application claiming priority to the present application, each numerical parameter should be construed in light of the number of significant digits and ordinary rounding approaches.
• Furthermore, although the foregoing has been described in some detail by way of illustrations and examples for purposes of clarity and understanding, it is apparent to those skilled in the art that certain changes and modifications may be practiced. Therefore, the description and examples should not be construed as limiting the scope of the invention to the specific embodiments and examples described herein, but rather to also cover all modification and alternatives coming with the true scope and spirit of the invention.

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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