79635.02597
`
`PATENT
`
`TRANSCUTANEOUS ANALYTE SENSORS, APPLICATORS THEREFOR,
`
`AND ASSOCIATED METHODS
`
`INCORPORATION BY REFERENCE TO RELATED APPLICATIONS
`
`[0001]
`
`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 No. 17/200,664, filed March 12, 2021, which is a continuation
`
`of U.S. Application No. 16/016,493, filed June 22, 2018, which is a continuation of U.S.
`
`Application No. 16/016,354, filed June 22, 2018, now U.S. Patent No. 10,863,944, issued
`
`December 15, 2020, which claims the benefit of U.S. Provisional Application No. 62/524,247,
`
`filed June 23, 2017 and U.S. Provisional Application No. 62/658,486, filed April 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
`
`[0002]
`
`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
`
`[0003]
`
`Diabetes mellitus is a disorder in which the pancreas cannot create sufficient insulin
`
`(Type I or insulin dependent) and/or in which insulin is not effective (Type 2 or non-insulin
`
`dependent). In the diabetic state, the victim suffers from high blood sugar, which can cause an
`
`array of physiological derangements associated with the deterioration of small blood vessels, for
`
`example, kidney failure, skin ulcers, or bleeding into the vitreous of the eye. A hypoglycemic
`
`reaction (low blood sugar) can be induced by an inadvertent overdose of insulin, or after a normal
`
`dose of insulin or glucose-lowering agent accompanied by extraordinary exercise or insufficient
`
`food intake.
`
`[0004]
`
`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
`
`- 1 -
`
`Abbott Ex. 1002 - 1/663
`
`

`

`79635.02597
`
`PATENT
`
`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.
`
`[0005]
`
`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.
`
`[0006]
`
`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
`
`[0007]
`
`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.
`
`[0008]
`
`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.
`
`[0009]
`
`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
`
`- 2 -
`
`Abbott Ex. 1002 - 2/663
`
`

`

`79635.02597
`
`PATENT
`
`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.
`
`[0010]
`
`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
`
`- 3 -
`
`Abbott Ex. 1002 - 3/663
`
`

`

`79635.02597
`
`PATENT
`
`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.
`
`[0011]
`
`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.
`
`[0012]
`
`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.
`
`[0013]
`
`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,
`
`- 4 -
`
`Abbott Ex. 1002 - 4/663
`
`

`

`79635.02597
`
`PATENT
`
`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.
`
`[0014]
`
`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.
`
`[0015]
`
`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.
`
`[0016]
`
`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.
`
`[0017]
`
`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
`
`- 5 -
`
`Abbott Ex. 1002 - 5/663
`
`

`

`79635.02597
`
`PATENT
`
`distal direction to the distal insertion position and in the proximal direction from the distal insertion
`
`position.
`
`[0018]
`
`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.
`
`[0019]
`
`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.
`
`[0020]
`
`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.
`
`- 6 -
`
`Abbott Ex. 1002 - 6/663
`
`

`

`79635.02597
`
`PATENT
`
`[0021]
`
`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.
`
`[0022]
`
`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.
`
`[0023]
`
`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.
`
`- 7 -
`
`Abbott Ex. 1002 - 7/663
`
`

`

`79635.02597
`
`PATENT
`
`[0024]
`
`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.
`
`[0025]
`
`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.
`
`[0026]
`
`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.
`
`[0027]
`
`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.
`
`[0028]
`
`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.
`
`- 8 -
`
`Abbott Ex. 1002 - 8/663
`
`

`

`79635.02597
`
`PATENT
`
`[0029]
`
`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.
`
`[0030]
`
`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.
`
`[0031]
`
`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.
`
`[0032]
`
`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.
`
`[0033]
`
`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.
`
`[0034]
`
`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.
`
`[0035]
`
`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.
`
`- 9 -
`
`Abbott Ex. 1002 - 9/663
`
`

`

`79635.02597
`
`PATENT
`
`[0036]
`
`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(cid:173)
`
`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.
`
`[0037]
`
`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.
`
`[0038]
`
`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
`
`- 10 -
`
`Abbott Ex. 1002 - 10/663
`
`

`

`79635.02597
`
`PATENT
`
`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.
`
`[0039]
`
`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.
`
`[0040]
`
`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.
`
`[0041]
`
`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
`
`- 11 -
`
`Abbott Ex. 1002 - 11/663
`
`

`

`79635.02597
`
`PATENT
`
`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.
`
`[0042]
`
`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 seco