Infusion sets, inserter assemblies, systems, and methods

Abstract

The inserter may include a housing having a driver latch. The inserter may further include an insertion driver. The insertion driver may be engaged with the driver latch in an initial position. The inserter may further include a finger displaceable relative to the housing through a first position, a ready position, and an actuated position. The finger is configured to press the insertion driver portion in a first direction when displaced to the ready position and to displace the insertion driver portion in a second direction when displaced to the actuated position, disengaging the insertion driver from the driver latch. The inserter may further include a latch structure and a bias member configured to be held in a deflected state by engagement of the insertion driver with the driver latch. The bias member is released from the deflected state when the insertion driver is disengaged from the driver latch.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 63 / 401,279, filed August 26, 2022, entitled "Infusion Set Assemblies, Devices, Systems, and Methods" (Attorney Docket No. 00101.00337.AA886), the contents of which are incorporated herein by reference in their entirety.

[0002] This application relates generally to infusion sets and inserter assemblies for infusion sets, and more particularly to infusion sets and inserter assemblies and methods of using the same. [Background technology]

[0003] Many potentially valuable drugs or compounds, including biologics, are not orally active due to poor absorption, hepatic metabolism, or other pharmacokinetic factors. Furthermore, some therapeutic compounds can be administered orally, but may need to be taken so frequently that it is difficult for patients to maintain the desired schedule. In these cases, parenteral delivery is often employed or may be considered.

[0004] Effective parenteral delivery routes for drugs, other fluids, and compounds, such as subcutaneous injection, intramuscular injection, and intravenous (IV) administration, involve puncturing the skin with a needle or stylet. Insulin is one example of a therapeutic fluid that millions of diabetic patients self-inject. Users of parenterally delivered drugs could benefit from wearable devices that automatically deliver the required drug / compound over a period of time.

[0005] To this end, efforts have been made to design portable and wearable devices for the controlled release of therapeutic agents. Such devices have reservoirs, such as cartridges, syringes, or bags, and are known to be electronically controlled. These devices have many drawbacks, including a high rate of malfunction. Reducing the size, weight, and cost of these devices is also an ongoing challenge. Furthermore, these devices are often applied to the skin, posing the challenge of frequent repositioning for application. Summary of the Invention

[0006] According to one embodiment of the present disclosure, an inserter assembly may include a housing having an insertion driver latch defined thereon. The inserter assembly may further include an insertion driver displaceable between an initial position and a forward position. The insertion driver may be engaged with the insertion driver latch in the initial position. The inserter assembly may further include a release finger displaceable relative to the housing from a first position to a ready position and from the ready position to an actuated position. The release finger may be configured to press a portion of the insertion driver in a setting direction to hold the insertion driver engaged with the insertion driver latch when the release finger is displaced from the first position to the ready position. The release finger may also be configured to displace a portion of the insertion driver in a release direction to disengage the insertion driver from the insertion driver latch when the release finger is displaced from the ready position to the actuated position. The inserter assembly may further include a latch structure. The inserter assembly may further include an insertion bias member configured to be held in a biased state by engagement of the insertion driver with the insertion driver latch when the latch structure and release finger reach the ready position, and configured to be released from the biased state when the insertion driver disengages from the insertion driver latch.

[0007] In some embodiments, the latch structure may include a plurality of opposing retainer arms and a displaceable retainer therebetween. The retainer arms may have ridges formed thereon that overhang the retainer when the latch structure is engaged. In some embodiments, the retainer may be configured to displace in response to displacement of the release finger from the first position to the armed position. The latch structure may be engaged when the release finger is displaced to the armed position. In some embodiments, the inserter assembly may further include a retraction bias member configured to deflect when the release finger is displaced to the armed position. The retraction bias member may be configured to be held in the deflected state by the latch structure. In some embodiments, the insertion driver may be configured to disengage the latch structure when displaced from the initial position to the forward position. The retraction bias member may be configured to return the insertion driver to the initial position after the latch structure is disengaged. In some embodiments, the insertion driver may include a port connectable to the insertion sharp retainer. The housing may further include a receptacle connectable with the care assembly cartridge. In some embodiments, the receptacle may be formed with a plurality of receiving portions for receiving retaining pins of the care assembly cartridge. The release finger may be configured to deflect around to avoid collision with a portion of the insertion driver when the release finger is displaced to the ready position. The housing may be configured to prevent the release finger from deflecting toward the housing when the release finger is displaced from the ready position to the actuated position. The insertion driver may include a cantilever arm, and the arm may be formed with a locking body that engages with the insertion driver latch. The housing may be configured to prevent the cantilever arm from deflecting toward the housing. The release finger may be configured to collide with a portion of the cantilever arm during displacement from the ready position to the actuated position, deflecting the arm and moving out of the path of travel of the release finger.Flexure of the cantilever arm disengages the locking body from the insertion driver latch.

[0008] According to another exemplary embodiment of the present disclosure, an inserter assembly may include a housing including an outer housing and an end cap. The inserter assembly may further include an inner housing. The inserter assembly may further include an insertion driver included in the inner housing, the insertion driver being displaceable from an initial position to a forward position, and in the initial position, the insertion driver may engage with an insertion driver latch formed on an inner wall of the inner housing. The inserter assembly may further include an insertion bias member disposed between the insertion driver and the end cap. The inserter assembly may further include a retainer configured to engage with the first latch when the housing is displaced in a first direction to reach the ready position. The insertion bias member may be configured to be held in a biased state when the retainer engages with the first latch and the insertion driver is engaged with the insertion driver latch. The inserter assembly may further include a release finger included in the housing and configured to hold the insertion driver in engagement with the insertion driver latch when the housing is displaced to the ready position. The release finger may be configured to disengage the insertion driver from the insertion driver latch when the housing is displaced in a second direction from the ready position to the actuated position. The insertion biasing member may be configured to urge the insertion driver toward the forward position when the insertion driver latch is disengaged, and the insertion driver may be adapted to disengage the retainer from the first latch when displaced toward the forward position.

[0009] In some embodiments, the inserter assembly may further include a retraction bias member configured to deflect when the housing is displaced to the ready position. The retraction bias member may be configured to be held in the deflected state when the first latch and the retainer are engaged. In some embodiments, the retraction bias member may be configured to release from the deflected state when the retainer is disengaged from the first latch. The retraction bias member may be configured to deflect the retainer away from the first latch and to deflect the insertion driver to the initial position when the retainer is disengaged. In some embodiments, the insertion driver may include a port connectable with an insertion sharps holder that holds an insertion sharp. In some embodiments, the inner housing includes a receptacle opposite the end cap, which may be connectable with a care assembly cartridge. In some embodiments, the release finger may be configured to deflect to impact and wrap around a portion of the insertion driver when the housing is displaced to the ready position. In some embodiments, the inner housing may be configured to prevent the release finger from deflecting toward the inner housing when the housing is displaced from the ready position to the actuated position. In some embodiments, the insertion driver may include a cantilever arm including a locking body, the locking body configured to engage with the insertion driver latch. The inner housing may be configured to prevent the cantilever arm from deflecting toward the inner housing. In some embodiments, during displacement of the housing from the ready position to the actuated position, the release finger may be configured to collide with a portion of the cantilever arm, deflecting the arm out of the path of travel of the release finger. This deflection of the cantilever arm disengages the locking body from the insertion driver latch. In some embodiments, the retainer may include a reset body and a retraction spring retainer. A portion of the insertion driver may be disposed between the retraction spring retainer and the reset body. An insertion bias member may be disposed between a portion of the insertion driver and the reset body.In some embodiments, the end cap may include a post that extends into a passage formed in the reset body, and the end cap may be configured to press against the reset body when the housing is displaced to the ready position.

[0010] According to another exemplary embodiment of the present disclosure, an inserter assembly may include a housing including an outer housing and an end cap. The inserter assembly may further include an inner housing, and the housing may be displaceable relative to the inner housing. The inserter assembly may further include a retainer configured to engage with the first latch when the housing is displaced toward the inner housing in a first direction beyond a first predetermined threshold distance. The inserter assembly may further include an insertion driver included in the inner housing and including a routing body displaceable from a first position to a second position. The inserter assembly may further include a release finger included in the housing. The release finger is configured to apply a force in a predetermined direction to the routing body when the housing is displaced in the first direction, such that the insertion driver more firmly engages with the insertion driver latch. The release finger may further be configured to displace the routing body in a release direction to disengage the insertion driver from the insertion driver latch when the housing is pulled in a second direction opposite the first direction beyond a second threshold distance. The inserter assembly may further include a first bias member that is held in a biased state when the retainer is engaged with the first latch and the insertion driver is engaged with the insertion driver latch. The first bias member may be configured to urge the insertion driver toward the second position when the insertion driver disengages from the insertion driver latch. The insertion driver may be configured to disengage the retainer from the first latch when displaced toward the second position.

[0011] In some embodiments, the insertion driver may include a cantilever arm including a locking body that engages with the insertion driver latch. The routing body may be disposed on the cantilever arm. The routing body may include opposing surfaces having first and second surfaces, each including a ramp. The release finger may include a paddle body, the paddle body including opposing first and second paddle body sides, each having a ramp. The ramp on the first paddle body side may be configured to enter the ramp on the second surface of the routing body when the housing is displaced in the first direction. The release finger may be configured to deflect around the second surface of the routing body as the housing further advances in the first direction. The ramp on the second paddle body side may be configured to enter the ramp on the first surface of the routing body when the housing is displaced in the second direction. The cantilever arm may be configured to displace in a release direction out of the path of the paddle body as the housing further advances in the second direction. The cantilever arm may extend along an axis, and the routing body may be configured to protrude generally perpendicular to the axis. The insertion driver latch may be defined by at least one ledge formed on an inner surface of the inner housing. The inner housing may be configured to inhibit deflection of the release finger in a direction opposite to the release direction when the housing is displaced in the second direction. The insertion driver may include a port for engaging with the insertion sharps retainer. The inserter assembly may further include a second bias member. The second bias member may be configured to transition to a deflected state when the housing is displaced in the first direction. The second bias member may be configured to be held in the deflected state while the retainer is engaged with the first latch. The second bias member may be configured to bias the retainer away from the first latch and to bias the insertion driver toward the first position and into engagement with the insertion driver latch. A shaft of the insertion driver may extend through the second bias member.

[0012] According to a further exemplary embodiment of the present disclosure, a cartridge for a reusable inserter assembly may include a housing having a bay (curved recess) recessed in an end of the housing. The housing may include a plurality of retention members projecting into the bay. The cartridge may further include a retainer including a flange. The flange may be configured to be captured between a rim of the end of the bay and an end of each retention member. A plurality of cantilever arms may project from a first side of the flange. The cartridge may further include a first patient care assembly part coupled to the retainer by the cantilever arms. The cartridge may further include a sharps holder to which an insertion sharp is coupled. The cartridge may further include a second patient care assembly part mounted to the insertion sharp.

[0013] In some embodiments, the cartridge may further include a plurality of mating bodies protruding from a surface of the rim furthest from the flange. The mating bodies may be mating pins. The mating bodies may protrude from a second surface of the flange opposite the first surface. The retaining member may be defined by a cantilevered portion of a side wall of the bay. The cantilevered arm may define a guide. The sharps holder may be configured to displace along the guide. The rim may form a stop that limits the range of displacement of the sharps holder in the first direction. The guide may be defined by a slot extending through each cantilevered arm. The first patient care assembly part may be an infusion set base, and the second patient care assembly part may be a cannula subassembly. The housing may be disposed within the container and releasably coupled to the container.

[0014] According to another exemplary embodiment of the present disclosure, a cartridge for a reusable inserter assembly may include a housing having a bay recessed at an end of the housing. The housing may include a plurality of retention members projecting into the bay. The cartridge may further include a retainer including a flange, the flange being captured between a lip at the end of the bay and each end of the retention member. A plurality of cantilever arms may project from a first surface of the flange, each cantilever arm having a guide passage extending along a portion of the arm. The cartridge may further include a first patient care assembly part connected to the retainer by the cantilever arms. The cartridge may further include a sharps holder having an insertion sharp connected thereto, the sharps holder including fins extending from the body through the guide passages. The cartridge may further include a second patient care assembly part mounted on the insertion sharp.

[0015] In some embodiments, the cartridge may further include a plurality of engagement features protruding from a surface of the edge furthest from the flange. The engagement features may be engagement pins. The engagement features may protrude from a second surface of the flange opposite the first surface. The retaining member may comprise a cantilevered portion of the side wall of the bay. A portion of each cantilevered arm including the guide channel may extend from the supported end of each arm to a position just short of the unsupported free end. The edge may form a stop that limits the range of displacement of the sharps holder in the first direction along the guide channel. The first patient care assembly part may be an infusion set base, and the second patient care assembly part may be a cannula subassembly. The housing may be disposed within the container and releasably coupled to the container. A barrier may be attached to the container, and the barrier and container may be configured to completely cover the housing, the retainer, the first and second patient care assembly parts, and the sharps holder.

[0016] According to another exemplary embodiment of the present disclosure, a method for assembling a cartridge for a reusable inserter assembly may include passing an insertion sharp extending from a sharps holder through a septum and cannula of a cannula assembly. The method may further include disposing the sharps holder within a plurality of guides of a retainer. The method may also include advancing the retainer into a bay of the housing through a first displacement range in which flanges of the retainer deflect the plurality of retention members until the flanges reach an edge of the bay end and are released from the retention members. The retention members may be configured to return to their original state to prevent the retainer from returning to a position within the first displacement range. The method may further include releasably coupling an infusion set base to a plurality of cantilever arms included in the retainer.

[0017] In some embodiments, the step of advancing the retainer into the bay may further include using an edge to prevent a portion of the sharps holder from moving along the guide. The method may further include passing a plurality of engagements formed on the retainer through at least one opening provided in the edge. The method may include placing the housing in a container and may further include releasably coupling the housing to the container. The method may further include sealing the opening of the container with a barrier. The barrier and the container may cooperate to completely enclose the housing. The step of placing the sharps holder in the guide may include placing fins on the sharps holder in slots formed in the cantilever arms. Alternatively, the step may include introducing a portion of the sharps holder into a slot extending through the cantilever arms. In this case, the portion of the sharps holder may be introduced into a portion of the slot farthest from the free end of the cantilever arms.

[0018] According to yet another exemplary embodiment of the present disclosure, an inserter assembly may include a housing having an open end and an opposite closed end. The inserter assembly may further include a care assembly base holder to which a care assembly base is releasably coupled. The inserter assembly may further include a trigger body fixed in position relative to the care assembly base holder via an insertion latch structure. The inserter assembly may further include a sharps shuttle that holds an insertion sharp, and the sharps shuttle may be coupled to the trigger body via a retraction latch structure. The inserter assembly may further include a first bias member configured to urge the trigger body, the sharps shuttle, and the insertion sharp toward the open end of the housing when the insertion latch structure is transitioned to a released state. The inserter assembly may also include a second bias member configured to urge the sharps shuttle and the insertion sharp toward the closed end of the housing when the retraction latch structure is displaced by the trigger when the trigger body and the sharps shuttle are displaced to a retracted, released position by the first bias member.

[0019] In some embodiments, the insertion latch structure may be configured to transition to a released state when a force pressing a portion of the trigger body and a portion of the housing together exceeds a predetermined threshold. The insertion latch structure may be configured by a ledge on the trigger body disengaging with a locking portion formed on the care assembly base holder. The trigger body may include an arm with a ledge, and the insertion latch structure may be formed by the ledge engaging with a locking portion formed on the care assembly base holder. The care assembly base holder may have an opening through which an end of the arm passes. The end of the arm may be aligned with a trigger protrusion on the housing. The housing may be configured to be prevented from displacing relative to the trigger body by abutment between the end of the arm and the trigger protrusion. The arm may be configured to deform to a deflected state when a force pressing the trigger protrusion and the end of the arm together exceeds a threshold. When the arm is in the deflected state, the ledge disengages from the locking portion, causing the insertion latch structure to transition to a released state. The trigger may be formed on the care assembly base holder. In some embodiments, the retraction latch structure may be configured by a step on the sharps shuttle and a locking portion formed on the trigger body that can be releasably engaged. The retraction release position may be an end or an intermediate point of the trigger body's displacement range. The first biasing member may be configured to continue urging the trigger body in the insertion direction toward the open end until the end of the trigger body's displacement range after the trigger body reaches the intermediate point. The cannula subassembly may be held by the insertion sharp, and the trigger body may be configured to displace the cannula subassembly toward the open end at the end of the trigger body's displacement range. The cannula subassembly may be held by the insertion sharp. The insertion latch structure may be configured to transition to the released state when the housing is displaced at least relative to the care assembly base in a direction away from the care assembly base.The care assembly base may have an adhesive bonded thereto for securing it to the biological barrier, and may be configured such that the biological barrier is lifted from its resting position when the housing is displaced relative to the care assembly base.

[0020] According to yet another exemplary embodiment of the present disclosure, an inserter assembly may include a housing. The inserter assembly may further include a care assembly base holder to which the care assembly base is releasably coupled. The inserter assembly may further include an insertion unit fixed in position relative to the care assembly base holder by an insertion latch structure, and the insertion unit may include a trigger body. The insertion unit may further include a retraction unit including an insertion sharp, and the retraction unit may be releasably coupled to the trigger body by the retraction latch structure. The inserter assembly may further include a first bias member biased to displace the insertion unit in the insertion direction when the insertion latch structure transitions to the first released state. The inserter assembly may further include a second bias member biased to displace the retraction unit in the retraction direction when the retraction latch structure is displaced by the trigger, which occurs when the insertion unit is displaced to the retracted released position by the first bias member.

[0021] In some embodiments, the second bias member may be held in a distorted state between the trigger body and a portion of the retraction unit while the retraction latch structure is engaged. The retraction release position may be located at an end or midpoint of the trigger body's displacement range. The first bias member may be configured to urge the trigger body toward the open end beyond the retraction release position. In some embodiments, the cannula subassembly may be held by an insertion sharp. The trigger body may be configured to push the cannula subassembly in the insertion direction when displaced in the insertion direction by the first bias member. A care assembly portion separate from the care assembly base may also be held by the insertion sharp. The insertion unit may be configured to displace integrally with the housing, and the housing and insertion unit may not be separated unless a force exceeding a predetermined threshold is applied. The care assembly base may be bonded to an adhesive, and when the adhesive is attached to a biological barrier patch, pulling the housing away from the patch generates a threshold force to lift the patch from its resting state. The insertion latch structure may include a resilient member releasably engaged with the locking portion, and may be configured to deflect the resilient member to disengage from the locking portion and transition the insertion latch structure to a released state when the housing is pulled in a direction away from the care assembly base. Additionally, the retraction latch structure may include a resilient member of the retraction unit releasably engaged with a locking portion formed on the trigger body.

[0022] According to yet another exemplary embodiment of the present disclosure, the inserter assembly may include an insertion unit restrained from displacement in an insertion direction by an insertion latch structure. The inserter assembly may further include a retraction unit including an insertion sharp, and the retraction unit may be releasably coupled to the insertion unit by the retraction latch structure. The inserter assembly may further include a first bias member biased to displace the insertion unit and the retraction unit in the insertion direction when the insertion latch structure is released. The inserter assembly may also include a second bias member biased to displace the retraction unit in the retraction direction. The inserter assembly may further include a retraction trigger, and the retraction latch structure may be configured to transition to a disengaged state when displaced by the retraction trigger at an intermediate point in the displacement path of the insertion unit.

[0023] In some embodiments, the percutaneous access assembly may be held by the insertion sharp. The infusion cannula assembly may also be held by the insertion sharp. The insertion unit may be configured to drive the percutaneous access assembly held by the insertion sharp in the insertion direction after passing the midpoint. Alternatively, the insertion unit may be configured to push the assembly in the insertion direction. The inserter assembly may include a holder and a first patient care assembly part coupled thereto, and may further include a second patient care assembly part held by the insertion sharp. The second patient care assembly part may be configured to couple to the first patient care assembly part as the insertion unit is displaced along the displacement path, or may be configured to couple to the first patient care assembly part after the insertion unit has been displaced beyond the midpoint. The inserter assembly may include an access assembly held by the insertion sharp, and the insertion sharp may have a lead length extending beyond the access assembly. The access assembly is disposed on the displacement path of the insertion unit, and the midpoint may be selected to drive the access assembly in the insertion direction by at least the lead length after the insertion unit has passed the midpoint.

[0024] According to another exemplary embodiment of the present disclosure, an inserter for deploying a device may include a housing. The inserter may further include a device base with an adhesive for securing the base to a portion of the barrier. The inserter may further include a spring-loaded insertion unit held in an initial state by an insertion latch structure. The base may be releasably coupled to the insertion unit and configured to prevent displacement of the insertion unit relative to a portion of the barrier when secured to the portion by the adhesive. The housing may be configured to be displaceable from an initial position to an actuated position in a direction opposite to a direction of insertion displacement of the insertion unit. The housing may be configured to transition the insertion latch structure to a disengaged state when displaced to the actuated position. The insertion latch structure may be configured to prevent relative movement between the housing and the insertion unit until a predetermined force threshold is exceeded.

[0025] In some embodiments, the threshold value may be set to be greater than the force required to lift a portion of the barrier from a resting state when the base is secured to the portion of the barrier by an adhesive. The inserter assembly may further include a percutaneous access assembly. The spring of the insertion unit may be biased to displace in an insertion direction to couple the percutaneous access assembly to the base after the insertion latch structure is released. The insertion unit may include a spring-biased retraction unit including an insertion sharp, which may be releasably coupled to the remainder of the insertion unit by the retraction latch structure and constrained to displace in conjunction with the remainder of the insertion unit while the retraction latch structure is engaged. The insertion unit may be spring-biased in an insertion direction along a displacement path. The retraction latch structure may be configured to displace into the trigger protrusion as the insertion unit is displaced along the displacement path. The retraction latch structure may also be configured to displace into the trigger protrusion when the insertion unit reaches a midpoint of the displacement path. The retraction unit may be spring-biased in a retraction direction opposite to the insertion direction. The retraction unit may include a tipping projection.

[0026] According to yet another exemplary embodiment of the present disclosure, a method for placing a care assembly in a biological barrier may include any of the following steps: adhering a portion of the care assembly coupled to the inserter assembly to the barrier; separating the inserter assembly from the barrier; lifting the barrier from a rest position to a lifted position via the adhesion of the portion of the care assembly; disengaging the insertion latch structure after lifting the barrier and advancing the insertion unit and the access assembly in an insertion direction; and disengaging the retraction latch structure after the insertion unit reaches a retraction-release position and advancing the retraction unit including the insertion sharp in a retraction direction. The displacement of the access assembly in the insertion direction and the displacement of the retraction unit in the retraction direction may be configured to overlap for at least a portion of the time period.

[0027] In some embodiments, the method may further include coupling the access assembly to a portion of the patient care assembly. Propelling the retraction unit in the retraction direction may further include tilting the insertion sharp. Disengaging the insertion latch structure may include displacing a portion of the inserter assembly housing against a portion of the insertion latch structure, deflecting the portion of the insertion latch structure. Disengaging the retraction latch structure may include driving the retraction unit in the insertion direction and into the trigger. Driving the retraction unit in the insertion direction and into the trigger may include displacing the retraction unit and the insertion unit relative to one another while the insertion latch structure is disengaged. Disengaging the retraction latch structure may include disengaging the retraction unit from the insertion unit as the insertion unit is displaced in the insertion direction. Disengaging the insertion latch structure may further include releasing a first bias member held in a first deflected state while the insertion latch structure is in the engaged state, and disengaging the retraction latch structure may include releasing a second bias member held in a second deflected state while the latch structure is in the engaged state. The method may further include removing the locking member from the inserter assembly.

[0028] According to other embodiments of the present disclosure, a method for placing an access device using an inserter assembly may include any of the following steps: coupling the inserter assembly to a biological barrier; lifting the biological barrier from a resting state to a lifted state by displacing the inserter assembly away from the barrier; automatically disengaging an insertion latch structure after the skin has been lifted a predetermined distance and advancing an insertion unit having a retraction unit including an insertion sharp in an insertion direction; automatically disengaging a retraction latch structure coupling the retraction unit to the remainder of the insertion unit after the insertion unit has been displaced to a retraction-release position and advancing the retraction unit in the retraction direction; advancing the remainder of the insertion unit in the insertion direction from the retraction-release position to a forward position.

[0029] In some embodiments, the method may further include preventing displacement of the insertion unit in the retraction direction after the insertion unit reaches the forward position. The method may further include tilting the retraction unit as it is propelled in the retraction direction. The method may further include coupling the access assembly to the access assembly base while at least the remainder of the insertion unit is displacing in the insertion direction. The retraction release point may be reached before the access assembly is coupled to the access assembly base. The access assembly may be a cannula subassembly, and the access assembly base may be an infusion set base. Coupling the inserter assembly to the biological barrier may include adhering the access assembly base to the biological barrier. The method may further include releasing the access assembly base from the inserter assembly.

[0030] According to another exemplary embodiment of the present disclosure, an inserter assembly may include a housing including an outer housing and an end cap. The inserter assembly may further include an inner housing. The inserter assembly may further include an insertion driver disposed within the inner housing and displaceable from an initial position (in which the insertion driver is engaged with an insertion driver latch defined on an inner wall of the inner housing) to a forward position. The inserter assembly may further include an insertion bias member disposed between the insertion driver and the end cap. The inserter assembly may further include a retainer configured to engage with the first latch when the housing is displaced in the first direction to reach the ready position. The insertion bias member may be configured to be held in a biased state when the retainer is engaged with the first latch and the insertion driver is engaged with the insertion driver latch. The insertion bias member may be configured to urge the insertion driver toward the forward position when the insertion driver latch is released. The inserter assembly may further include a disarming lock. The release lock may be configured to be displaceable between an inactivated position and an activated position, and in the activated position configured to prevent release of the insertion driver latch.

[0031] In some embodiments, the insertion driver may be configured to release the retainer from the first latch when displaced to the forward position. The insertion driver may include a cantilever arm including a locking body configured to engage with the insertion driver latch. The inner housing may be configured to prevent the cantilever arm from deflecting toward the inner housing. The release lock may include a body that prevents the cantilever arm from deflecting in a direction away from the inner housing in the activated position. The release lock may include a base portion from which multiple barrier bodies protrude. The barrier bodies may be configured to extend through penetrations in the end cap. The release lock may be configured for rotational displacement between a non-activated position and an activated position. The inserter assembly may further include a retraction bias member configured to deflect when the housing is displaced to the ready state. The retraction bias member may be configured to be held in the deflected state while the retainer is engaged with the first latch. Displacing the insertion driver to the forward position may release the retainer from the first latch. When the retainer is released from the first latch, the retraction bias member may be released from its deflected state, causing the retainer to move away from the first latch and the insertion driver to return to its initial position. The insertion driver may include a port connectable to an insertion sharps holder that holds an insertion sharps. The inner housing may include a receptacle opposite the end cap, the receptacle configured to be connectable to a care assembly cartridge.

[0032] According to another exemplary embodiment of the present disclosure, an inserter assembly may include a housing. The inserter assembly may further include a release lock displaceable between an inactivated position and an unlocked position. The inserter assembly may further include an inner housing. When the release lock is in the inactivated position, the housing may be displaceable relative to the inner housing, and when the release lock is in the unlocked position, relative displacement of the housing relative to the inner housing may be prevented. The inserter assembly may further include a retainer configured to engage with the first latch when the housing is displaced in a first direction toward the inner housing. The inserter assembly may further include an insertion driver disposed within the inner housing and displaceable from a first position to a second position, the insertion driver may include a routing body. The inserter assembly may further include a release finger included in the housing. The release finger may be configured to deflect around the routing body when the housing is displaced in the first direction, and may be configured to displace the routing body in a release direction to disengage the insertion driver from the insertion driver latch when the housing is pulled in the second direction. The inserter assembly may further include a first bias member that is held in a biased state when the retainer is engaged with the first latch and the insertion driver is engaged with the insertion driver latch, and the first bias member may be configured to urge the insertion driver toward the second position when the insertion driver is released from the insertion driver latch.

[0033] In some embodiments, the release lock and the outer housing may be a one-piece, unitary structure. The release lock may be flexible relative to the outer housing and displaceable between an inactivated position and an activated position. When the release lock is in the unlocked position, at least a portion of the release lock may be disposed within a window defined in the inner housing. The insertion driver may include a cantilevered arm including a locking body configured to engage with the insertion driver latch, and the routing body may be disposed on the cantilevered arm. The insertion driver latch may be defined by at least one ledge defined on an inner surface of the inner housing. The insertion driver may include a port for engaging with the insertion sharps retainer. The inserter assembly may further include a second bias member. The second bias member may be configured to transition to a deflected state when the housing is displaced in a first direction. The second bias member may be configured to be retained in the deflected state when the retainer is engaged with the first latch. The second biasing member may also be configured to bias the retainer away from the first latch when the first latch is released and to push the insertion driver back into the first position to re-engage with the insertion driver latch.

[0034] According to another exemplary embodiment of the present disclosure, an inserter assembly may include a housing including an outer housing and an end cap. The inserter assembly may further include an inner housing. The inserter assembly may further include an insertion driver disposed within the inner housing and displaceable from an initial position (in which the insertion driver engages with an insertion driver latch defined on an inner wall of the inner housing) to a forward position. The inserter assembly may further include an insertion bias member disposed between the insertion driver and the end cap. The inserter assembly may further include a retainer configured to be displaced in a first direction with the housing to bias the second bias member and engage with the first latch when the inserter assembly transitions from an unarmed state to a ready state. The insertion bias member may be configured to be held in a biased state when the retainer engages with the first latch and the insertion driver engages with the insertion driver latch. The insertion bias member may be configured to bias the insertion driver toward the forward position when the insertion driver latch is released. The inserter assembly may further include a disarming actuator configured to be displaced from an inactive state to an actuated state to disengage the retainer from the first latch, and the second biasing member may be configured to urge the housing and the retainer toward the disarmed state when the retainer is disengaged from the first latch.

[0035] In some embodiments, the first bias member may abut a surface of the retainer where the insertion driver and the housing abut and be configured to bias the housing and the retainer toward the released state when the retainer is released from the first latch. The insertion driver may include a cantilevered arm having a locking body that engages with the insertion driver latch. The insertion driver latch may be configured by at least one ledge defined on an inner surface of the inner housing. The insertion driver may include a port configured to engage with the insertion sharps retainer. The inner housing may include a receptacle opposite the end cap, the receptacle configured to be matable with the care assembly cartridge. In some embodiments, a release finger may be formed on the housing and configured to hold the insertion driver engaged with the insertion driver latch when the housing is displaced to the ready state. The release finger may be further configured to release the insertion driver from the insertion driver latch when the housing is displaced from the ready state to the actuated position in a direction opposite to the first direction (a second direction), and the release actuator may be configured to displace the release finger to a deflected state by transitioning from the unactuated state to the actuated state. The release finger may be configured not to contact the insertion driver when the housing is displaced from the ready state to the actuated position when the release finger is in the deflected state. The release finger may also be configured to release the insertion driver from the insertion driver latch when the housing is displaced from the ready state to the actuated position in a second direction opposite to the first direction. Furthermore, when the retainer and housing are urged toward the released state by the second biasing member, the retainer may be configured to collide with the insertion driver as the housing passes the actuated position, thereby reversing the forward movement of the insertion driver initiated by the release of the insertion driver latch.

[0036] According to another exemplary embodiment of the present disclosure, an inserter assembly may include a housing including an outer housing and an end cap. The inserter assembly may further include an inner housing. The inserter assembly may further include an insertion driver disposed within the inner housing and displaceable from an initial position (in which the insertion driver engages with an insertion driver latch defined on an inner wall of the inner housing) to a forward position. The inserter assembly may further include an insertion bias member disposed between the insertion driver and the end cap. The inserter assembly may further include a retainer configured to be displaceable in a first direction with the housing and to deflect the second bias member and engage with the first latch when the inserter assembly transitions from a released state (non-actuated state) to a ready state. The insertion bias member may be configured to be held in the deflected state when the retainer engages with the first latch and the insertion driver engages with the insertion driver latch. The insertion bias member may be configured to bias the insertion driver toward the forward position when the insertion driver latch is released. The inserter assembly may further include a release actuator configured to disengage the retainer from the first latch when displaced from an inactivated state to an activated state. The second biasing member may be configured to urge the housing and the retainer through a retraction stroke in a second direction opposite the first direction when the retainer is released from the first latch.

[0037] In some embodiments, the first bias member may abut the insertion driver and abut a surface of the retainer that abuts the housing, urging the housing and the retainer through a retraction stroke when the retainer is released from the first latch. The insertion driver may include a cantilevered arm including a ledge that engages with the insertion driver latch. The insertion driver latch may be defined by a shelf defined on the inner housing. The insertion driver may include a port that engages with the insertion sharps holder. The inner housing may include a receptacle opposite the end cap, the receptacle configured to be matable with the care assembly cartridge. The release finger may be formed on the housing and configured to reinforce engagement of the insertion driver with the insertion driver latch when the housing is displaced to the ready state. The release finger may also be configured to release the insertion driver from the insertion driver latch when the housing is displaced in the second direction from the ready state to the actuated position when the release actuator is in an unactuated state. The release actuator may be configured to deflect the release finger to a deflected state when transitioning from an inactivated state to an activated state. The release finger may be configured to remain in the deflected state and out of contact with the insertion driver when the housing is displaced through a retraction stroke. The release finger may also be configured to release the insertion driver from the insertion driver latch when the housing is displaced through a retraction stroke. Furthermore, the retainer may be configured to impact the insertion driver and reverse the forward movement of the insertion driver initiated by the release of the insertion driver latch when the housing and retainer are displaced through a retraction stroke.

[0038] According to other embodiments of the present disclosure, a method of releasing an inserter having a spring-biased insertion driver and a spring-biased retraction device may include any of the following steps: adhering a portion of the patient-care assembly to a barrier; displacing a release actuator of the inserter from an inactivated state to an activated state; releasing a first latch holding the retraction device when the release actuator is displaced to the activated state; releasing a spring in the spring-biased retraction device to drive the retraction device and the inserter housing through a retraction stroke; and separating the portion of the patient-care assembly from the barrier.

[0039] In some embodiments, the method may further include maintaining a second latch that holds the spring-biased insertion driver while the spring-biased retraction device and the housing are driven through a retraction stroke. The method may also include releasing a spring in the spring-biased insertion driver during the retraction stroke, the spring being configured to bias the insertion driver in an advancement direction. The method may further include the spring-biased retraction device impacting the spring-biased insertion driver during the retraction stroke to reverse the advancement of the insertion driver. Displacing the release actuator may include pressing a button. Alternatively, displacing the release actuator may include depressing at least one tab coupled to the first latch. Releasing the first latch may include deflecting a latch arm to disengage from the spring-biased retraction device. The method may further include deflecting a release finger on the housing out of alignment with a fin on the cantilever arm of the insertion driver when the release actuator is displaced from an inactive state to an activated state. The method may also include automatically returning the release actuator to a deactivated state during the retraction stroke. Automatically returning the release actuator to a deactivated state may include displacing a ramped surface of the release actuator toward the insertion driver. The method may further include driving the release actuator along with the retainer and the housing through the retraction stroke.

[0040] According to another exemplary embodiment of the present disclosure, an inserter assembly may include a housing. The inserter assembly may further include a body having a cavity sandwiched between a plurality of arms. The inserter assembly may further include a patient care assembly including a base and a second portion, the base being releasably engaged with the plurality of arms. The inserter assembly may further include a spring-biased unit having a sharps holder that holds an insertion sharp and the second portion of the patient care assembly. The inserter assembly may further include a spring for the spring-biased unit. The inserter assembly may further include a trigger having a first state that holds the spring in an energized state and a second state that releases the spring from the energized state. When the trigger is actuated, the spring may be configured to urge the spring-biased unit toward the base. The inserter assembly may further include a yoke having at least a portion adjacent each of the plurality of arms. The yoke may be configured to restrain at least a portion of the plurality of arms from deflecting. The arms may include a plurality of nubs. A portion of the spring biasing unit may be configured to impact the nubs and spread the arms to release the base as the insertion sharp and the second portion of the patient care assembly are displaced toward the base.

[0041] In some embodiments, the yoke may be an open-centered member surrounding the arms. The yoke may include a split portion and rest on a sill defined by the multiple arms. The yoke rests on a sill defined by the multiple arms, and a portion of the spring-biased unit may include multiple protrusions configured to impact the yoke and deform the yoke around the sill when the spring urges the spring-biased unit toward the base. The yoke may include multiple pads, each pad disposed adjacent to a corresponding arm. The pads may be connected to a portion of the body via flexures. When the portion of the spring-biased unit is urged toward the base, it may impact each pad, applying a force to the pad and deforming the flexure. The yoke may be configured with multiple lobes on the sharps holder, and the arms may be configured to extend through the lobes. Each of the multiple arms may have a thicker region and a thinner region. Each lobe may be sized to prevent flexing when adjacent a thick region of the arm and to allow flexing when adjacent a thin region of the arm. The base may be an infusion set base, and the second portion of the patient care assembly may be a cannula subassembly. The patient care assembly may also be an analytical sensor. The spring-biased unit may be configured to couple the base and the second portion of the patient care assembly when urged toward the base.

[0042] As an example, a patient care assembly placement system according to another embodiment of the present disclosure may include an inserter assembly including a port and a receptacle body. The port may have a central slot flanked by port edge segments. The receptacle body may include multiple shoes, each shoe curving from a closed shoe to an open shoe along a portion of the axis of the port. Each shoe may have a flared region located most distally from the main portion of the receptacle body. The system may further include a cartridge including a retainer, a patient care assembly coupled to the retainer, and a sharps holder having an insertion sharp extending therefrom. The retainers may include multiple engagement pins, each having a stem portion and a wider head portion. The sharps holder may include a first end opposite a second end from which the insertion sharp extends, and may further include a thinned portion between the first and second ends. When the cartridge is aligned with the receptacle body and rotated to engage, each engagement pin may be displaced from the open end toward the closed end of its respective shoe. The cartridge may also translate to a position where the first end of the sharps holder is inserted into the port and reaches a depth where the thinned portion is aligned with the port edge (within the engagement pin capture displacement range). Within this range, the head of each engagement pin may be displaced along the slope of the protruding region of the corresponding shoe. The first end of the sharps holder may then be rotated over the port edge within the sharps holder capture displacement range.

[0043] According to another exemplary embodiment of the present disclosure, a patient care assembly placement system may include an inserter assembly including ledges on either side of a port and a receptacle body including a plurality of engagement tracks extending in a partially curved fashion around the axis of the port. The inserter may further include a cartridge including a retainer, a patient care assembly coupled to the retainer, and a sharps holder from which an insertion sharp protrudes. The retainer may include a plurality of engagement protrusions, and the sharps holder may have a thinned portion between a first end opposite a second end from which the insertion sharp protrudes. When the cartridge is aligned with the receptacle body and rotated to the mated state, each engagement protrusion may be configured to displace along a corresponding sloped region of the engagement track, translating the cartridge within an engagement protrusion capture displacement range until a first end of the sharps holder is inserted into the port and the thinned portion aligns with the ledge. The first end of the sharps holder may then be rotated over the ledge within the sharps holder capture displacement range of the cartridge.

[0044] In some embodiments, the engagement tracks may include a shoe with a flared shoulder located at a portion of each engagement track furthest from the main section of the receptacle body. Each engagement protrusion may be an engagement pin having a head and a relatively narrow stem connecting the head to the remainder of the retainer. The port may be shaped to receive the first end of the sharps holder when the cartridge is in a rotational position within the engagement protrusion capture displacement range. The first end of the sharps holder may have an elongated cross-sectional shape, and the narrowed region may have a cross-sectional shape that is less elongated than the first end. The narrowed region may be formed by a notch recessed in the sharps holder at an angle substantially perpendicular to the axis of the insertion sharp. The ledge may have a thickness sufficient to substantially fill the notch when the cartridge is rotated through the sharps holder capture displacement range. The sloped region of each engagement track may begin at the open end of the engagement track. The engagement protrusion may be located at the closed end of each engagement track when the cartridge is rotated to the coupled state. In some embodiments, the sloped region of each engagement track may include a steepest portion along a segment closest to the open end. The patient care assembly may be selected from an infusion set or an analytical sensor. The patient care assembly may also include a first portion and a second portion, which are spaced apart from one another within the cartridge. [Brief explanation of the drawings]

[0045] These and other aspects will become more apparent from the following detailed description of various embodiments of the present disclosure, taken in conjunction with the following drawings.

[0046] [Figure 1A] 1 illustrates an exploded view of an exemplary inserter assembly.

[0047] [Figure 1B] 10 illustrates an exploded view of another exemplary inserter assembly.

[0048] [Figure 1C] 10 illustrates an exploded view of another exemplary inserter assembly.

[0049] [Figure 2] 10 illustrates an exploded view of another exemplary inserter assembly.

[0050] [Figure 3] 10 illustrates an exploded view of another exemplary inserter assembly.

[0051] [Figure 4A] 1 shows a perspective view of an exemplary infusion set base.

[0052] [Figure 4B] 4B illustrates another perspective view of the exemplary infusion set base of FIG. 4A.

[0053] [Figure 5A] 1 illustrates an exploded view of an exemplary cannula subassembly.

[0054] [Figure 5B] 5B illustrates a cross-sectional view of the exemplary cannula subassembly shown in FIG. 5A.

[0055] [Figure 6] 1 shows a perspective view of an exemplary infusion set and tubing connector.

[0056] [Figure 7A] 1 shows a perspective view of another exemplary infusion set base.

[0057] [Figure 7B] 7B shows another perspective view of the exemplary infusion set base of FIG. 7A.

[0058] [Figure 8A] 1 illustrates an exploded view of an exemplary cannula subassembly.

[0059] [Figure 8B] 8B illustrates a cross-sectional view of the exemplary cannula subassembly shown in FIG. 8A.

[0060] [Figure 9] 1 shows a perspective view of another exemplary infusion set and tubing connector.

[0061] [Figure 10A] 1 shows a perspective view of an exemplary infusion set base.

[0062] [Figure 10B] 10B shows another perspective view of the infusion set base of FIG. 10A.

[0063] [Figure 11A] 1 shows a perspective view of an exemplary infusion set base.

[0064] [Figure 11B] 11B shows another perspective view of the infusion set base of FIG. 11A.

[0065] [Figure 12A] 1 shows a perspective view of an exemplary infusion set base.

[0066] [Figure 12B] 12B shows another perspective view of the infusion set base of FIG. 12A.

[0067] [Figure 13A] 1 shows a perspective view of an exemplary infusion set base.

[0068] [Figure 13B] 13B shows a bottom plan view of the infusion set base of FIG. 13A.

[0069] [Figure 14A] 1 shows a perspective view of an exemplary infusion set base.

[0070] [Figure 14B]14B shows a bottom plan view of the infusion set base of FIG. 14A.

[0071] [Figure 15] 15A-15F show various views of an exemplary tubing set connector.

[0072] [Figure 16A] 1 shows an exemplary tubing set connector and an exemplary cannula subassembly in an exaggerated, angled position for illustrative purposes.

[0073] [Figure 16B] 1 illustrates an exemplary tubeset connector and an exemplary cannula subassembly, with the cannula subassembly displaced to a home position by the tubeset connector.

[0074] [Figure 16C] 10 illustrates an exemplary tubing set connector and an exemplary cannula subassembly, where the tubing set connector pierces the septum of the cannula subassembly so that the delivery tip of the tubing set connector is in fluid communication with the fluid introduction volume of the cannula subassembly.

[0075] [Figure 17] 1 illustrates an exemplary infusion set base with an exemplary deflector.

[0076] [Figure 18A-B] 1 illustrates an exemplary tubing set connector and an exemplary infusion set assembly, the tubing set connector including exemplary tines.

[0077] [Figure 18C] 1 shows a perspective view of an exemplary tubing set connector including exemplary teeth.

[0078] [Figure 19A]1 illustrates a top view of an exemplary tubing set connector including an exemplary infusion set assembly and an exemplary clamp, the tubing set connector being disconnected from the infusion set assembly.

[0079] [Figure 19B] 1A-1C show diagrams of an exemplary tubing set connector with an exemplary clamp.

[0080] [Figure 19C] 1 shows a diagram of an exemplary tubing set connector with an exemplary clamp coupled to an exemplary infusion set assembly.

[0081]

[0082] [Figure 20A] 1 illustrates a side view of an exemplary infusion set base.

[0083] [Figure 20B] 20B shows another side view of the exemplary infusion set base of FIG. 20A.

[0084] [Figure 20C] 20B shows a perspective view of the exemplary infusion set base of FIG. 20A.

[0085] [Figure 21A-F] 1 shows a perspective view of an exemplary infusion set.

[0086] [Figure 22A-C] 1 illustrates another perspective view of an exemplary infusion set.

[0087] [Figure 23A-C] 10A-10C show various views of another exemplary infusion set base.

[0088] [Figure 24A-C] 10A-10C show various views of another exemplary infusion set base.

[0089] [Figure 25A-C] 1A-1C illustrate various views of an exemplary tubing set connector.

[0090] [Figure 26A] 1 shows a diagram of an exemplary infusion set base and an exemplary tubing set connector.

[0091] [Figure 26B] 26B shows a cross-sectional view of the exemplary infusion set base and exemplary tubing set connector of FIG. 26A.

[0092] [Figure 26C] 26B shows a perspective view of the exemplary tubing set connector of FIG. 26A.

[0093] [Figure 27A] 1 illustrates a perspective view of another exemplary infusion tubing set connector.

[0094] [Figure 27B] 27B illustrates a cross-sectional view of the tubing set connector shown in FIG. 27A connected to an exemplary infusion set base.

[0095] [Figure 28A] 1 shows a perspective view of an exemplary infusion set.

[0096] [Figure 28B] 28B shows another perspective view of the exemplary infusion set of FIG. 28A.

[0097] [Figures 29A-29D] 1A-1C illustrate several views of an exemplary cannula subassembly.

[0098] [Figure 30A-30B] 10 illustrates an embodiment of a cannula that may be used in the cannula subassembly.

[0099] [Figures 31A-31G] 10A-10C show several views of another exemplary cannula subassembly.

[0100] [Figures 32A-32D] 10A-10C show several views of another exemplary cannula subassembly.

[0101] [Figures 33A-33D] 10A-10C show several views of another exemplary cannula subassembly.

[0102] [Figures 34A-34F] 10A-10C show several views of another exemplary cannula subassembly.

[0103] [Figures 35A-35F] 10A-10C show several views of another exemplary cannula subassembly.

[0104] [Figures 36A-36E] 10A-10C illustrate several views of yet another exemplary cannula subassembly.

[0105] [Figure 37A-37B] 1A-1C show diagrams of an exemplary septum that may be included in an exemplary cannula subassembly.

[0106] [Figures 38A-38E] 10A-10C show views of another exemplary cannula subassembly.

[0107] [Figures 39A-39E] 10A-10C show views of another exemplary cannula subassembly.

[0108] [Figures 40A-40C] 1A-1C show diagrams of an exemplary cannula and an exemplary set of septa that may be included in a cannula subassembly.

[0109] [Figure 41A] 1 illustrates a side view of an exemplary inserter assembly with an exemplary locking member mounted therein.

[0110] [Figure 41B] 10 illustrates another side view of an exemplary inserter assembly with an exemplary locking member mounted therein.

[0111] [Figure 42A] 1 shows a perspective view of an exemplary inserter assembly with a locking member and adhesive assembly in place.

[0112] [Figure 42B] FIG. 42B shows a side view of the inserter assembly of FIG. 42A.

[0113] [Figure 43] 1 shows a perspective view of an exemplary infusion set base and an exemplary adhesive assembly.

[0114] [Figure 44] 1 shows a perspective view of an exemplary adhesive assembly for a portion of an infusion set assembly.

[0115] [Figure 45] 45 shows a bottom view of the adhesive assembly of FIG. 44.

[0116] [Figure 46A] 1 illustrates a top view of an exemplary inserter assembly with the outer housing removed.

[0117] [Figure 46B] 1 illustrates a perspective view of an exemplary inserter assembly with its outer housing removed.

[0118] [Figure 46C] A detailed view of a portion of FIG. 46B is shown.

[0119] [Figure 47] 1 illustrates a top view of an exemplary locking member.

[0120] [Figure 48]10 shows a perspective view of another exemplary locking member.

[0121] [Figure 49A] 1 illustrates a cross-sectional view of an exemplary inserter assembly with an exemplary locking member mounted therein.

[0122] [Figure 49B] 49B shows a detailed view of a portion of FIG. 49A.

[0123] [Figure 50] 1 illustrates a perspective view of an exemplary locking member.

[0124] [Figure 51] 10A-10C illustrate views of an exemplary inserter assembly cut away to reveal an exemplary locking member partially disposed within the inserter assembly.

[0125] [Figure 52] 1 illustrates a cross-sectional view of an exemplary inserter assembly with an exemplary locking member attached.

[0126] [Figure 53] 1 illustrates a perspective view of an exemplary locking member.

[0127] [Figure 54A-B] 10A-10C show views of yet another exemplary locking member that may be used to prevent actuation of an exemplary inserter assembly.

[0128] [Figure 55] 1 illustrates a cross-sectional view of an exemplary inserter assembly with an exemplary locking member attached.

[0129] [Figure 56A-E] 1A-1C show views of various exemplary embodiments of a locking member;

[0130] [Figure 57]1 shows a flowchart detailing some actions that can be used to operate the inserter assembly.

[0131] [Figure 58] 1 illustrates a top view of an exemplary inserter assembly.

[0132] [Fig. 59A-B] 1 illustrates a cross-sectional view of an exemplary inserter assembly about to be applied to a user's skin.

[0133] [Figure 60] 1 illustrates a side view of an exemplary sharps holder.

[0134] [Figure 61] 61 illustrates another side view of the exemplary sharps holder shown in FIG. 60.

[0135] [Figure 62] 59. FIG. 60 illustrates yet another side view of the exemplary sharps holder shown in FIG.

[0136] [Figure 63] 61 shows a perspective view of the exemplary sharps holder shown in FIG. 60.

[0137] [Figure 64] 1 shows a perspective view of a sharps holder, a sharps, and a cannula assembly.

[0138] [Figure 65] 1 illustrates a side view of an exemplary sharps holder.

[0139] [Figure 66] 66 illustrates another side view of the exemplary sharps holder of FIG. 65.

[0140] [Figure 67] 66 illustrates a perspective view of the exemplary sharps holder of FIG. 65.

[0141] [Figure 68] FIG. 68 shows a detailed view of the indicated area of ​​FIG. 67.

[0142] [Figure 69] 1 illustrates a perspective view of an exemplary retainer base.

[0143] [Figure 70A] 1 illustrates a perspective view of an exemplary sharp member retractor.

[0144] [Figure 70B] 70B illustrates another perspective view of the exemplary sharp member retractor shown in FIG. 70A.

[0145] [Figure 70C] 70B shows a detailed view of a portion of FIG. 70A.

[0146] [Figure 71] 10A-10C illustrate cross-sectional views of an exemplary inserter assembly taken through an arm included in a sharps retractor of the inserter assembly.

[0147] [Figure 72] 1 illustrates a perspective view of an exemplary outer housing.

[0148] [Figure 73A-B] 73 shows a cross-sectional view of an exemplary inserter assembly including the outer housing shown in FIG. 72.

[0149] [Fig. 74A-B] 1 shows a cross-sectional view of an exemplary inserter assembly being withdrawn from a user after application to the skin.

[0150] [Fig. 74C-D] 1 illustrates a cross-sectional view of an exemplary inserter assembly including an additional spring.

[0151] [Fig. 75A-B]1 shows a cross-sectional view of an exemplary inserter assembly being withdrawn from a user after application to the skin.

[0152] [Figure 76A-B] 10 illustrates a cross-sectional view of an exemplary inserter assembly after a sharp member of the inserter assembly has penetrated a user's skin.

[0153] [Fig. 77A-B] 10 illustrates a cross-sectional view of an exemplary inserter assembly after the sharp retractor has been released and retracted.

[0154] [Figure 78A] FIG. 10 is a cross-sectional view of an alternative inserter assembly.

[0155] [Figure 78B] FIG. 78B is a detailed view of the indicated portion of FIG. 78A.

[0156] [Figures 79A-82C] 1 illustrates an exemplary inserter assembly including various exemplary set-holding supports.

[0157] [Fig. 83A-B] 10A-10C illustrate cross-sectional views of an exemplary inserter assembly during retraction of a sharps retraction device.

[0158] [Figure 83C] 10A-10C show cross-sectional views of an alternative embodiment of the inserter assembly.

[0159] [Fig. 84A-B] 10A-10C illustrate cross-sectional views of an exemplary inserter assembly during retraction of a sharps retraction device.

[0160] [Fig. 84C-D] 10 illustrates a cross-sectional view of an exemplary inserter assembly after actuation of the inserter assembly is complete.

[0161] [Figure 84E] 10 illustrates a bottom plan view of the inserter assembly after actuation of the inserter assembly is complete.

[0162] [Figure 84F] 10 illustrates a bottom view of an exemplary inserter assembly after actuation of the inserter assembly is complete.

[0163] [Figure 84G] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0164] [Figure 85] 1 illustrates a perspective view of an exemplary retainer base.

[0165] [Figure 86] FIG. 1 illustrates a bottom view of an exemplary inserter assembly.

[0166] [Figure 87] showing a cross-sectional view taken at the indicated cutting plane of Fig. 86. 46;

[0167] [Fig. 88A-B] 10 shows a cross-sectional view of another exemplary inserter assembly about to be applied to a user's skin.

[0168] [Figure 89A] 13A-13C show side views of alternative embodiments of sharps holders.

[0169] [Figure 89B] FIG. 89B shows a perspective view of the sharps holder shown in FIG. 89A.

[0170] [Figure 89C] 89B shows another side view of the sharps holder shown in FIG. 89A.

[0171] [Figure 90] 1 illustrates a perspective view of an exemplary retaining cap.

[0172] [Figure 91] 1 illustrates a cross-sectional view of an exemplary retainer cap and sharps holder.

[0173] [Figure 92] 91. FIG. 92 shows a detailed view of a portion of FIG.

[0174] [Figure 93A] 1 illustrates a perspective view of an exemplary sharps retraction device.

[0175] [Figure 93B] 93B shows another perspective view of the sharps retraction device shown in FIG. 93A.

[0176] [Figure 94] 1 illustrates a perspective view of an exemplary inserter assembly including a button.

[0177] [Figure 95A] 94 shows a top view of the inserter assembly shown in FIG. 54;

[0178] [Figure 95B] 95B shows a cross-sectional view taken at section 89B-89B of FIG. 95A.

[0179] [Figure 95C] 95C shows a perspective three-quarter cross-sectional view taken along 95C-95C of FIG. 95A.

[0180] [Figure 96] 1 illustrates a perspective view of an exemplary outer housing of an inserter assembly including a button.

[0181] [Figure 97] 1 illustrates a perspective view of an exemplary inserter assembly with the outer housing of the inserter assembly removed.

[0182] [Figure 98]1 illustrates a perspective view of an exemplary inserter assembly with the outer housing of the inserter assembly removed.

[0183] [Figure 99] FIG. 99 shows a detailed view of the indicated area of ​​FIG. 98.

[0184] [Figure 100] 1 illustrates a perspective view of an exemplary sled that may be included in the inserter assembly.

[0185] [Figure 101] 1 illustrates a perspective view of an exemplary outer housing of an inserter assembly including a deformable region.

[0186] [Figure 102] 10 shows a perspective view of another exemplary outer housing of an inserter assembly including ridges on the inner surface.

[0187] [Figure 103] 10 shows a flowchart detailing several actions that can be used to assemble the inserter assembly.

[0188] [Figure 104] 1 is a flowchart illustrating a series of actions performed to place a patient care assembly using an exemplary inserter assembly.

[0189] [Figure 105] FIG. 1 is an exploded view of an exemplary inserter assembly.

[0190] [Figure 106] FIG. 1 is a cross-sectional view of an exemplary inserter assembly.

[0191] [Figure 107] FIG. 1 is a perspective view of an exemplary locking member.

[0192] [Figure 108] FIG. 1 is a top view of an exemplary inserter assembly.

[0193] [Figure 109A-109B] FIG. 10 is a cross-sectional view of the inserter assembly in a storage state.

[0194] [Figure 110] FIG. 10 is a perspective view of an exemplary sharps shuttle that may be included in some inserter assemblies.

[0195] [Figures 111A-111B] 1A-1C are perspective views of an exemplary trigger body that may be included in some inserter assemblies.

[0196] [Figure 112] FIG. 10 is a perspective view of an exemplary bias member retainer that may be included in some inserter assemblies.

[0197] [Figures 113A-113B] 1A-1C are perspective views of an exemplary care assembly base holder that may be included in some inserter assemblies.

[0198] [Figure 114A-114B] FIG. 1 is a cross-sectional view of an exemplary inserter assembly in a triggered state.

[0199] [Figure 115A-115B] FIG. 10 is a cross-sectional view of the inserter assembly with the patient care assembly released from the inserter assembly.

[0200] [Figure 116A-116B] FIG. 1 is a cross-sectional view of an exemplary inserter assembly in a retracted state.

[0201] [Figure 117A-117B] FIG. 1 is a cross-sectional view of an exemplary inserter assembly in a stowed state.

[0202] [Figure 118] 1A-1C illustrate side views of an example inserter assembly and an example cartridge that can be coupled to the inserter assembly.

[0203] [Figure 119A] 1 illustrates an exploded view of an exemplary cartridge.

[0204] [Figure 119B] 119B illustrates another exploded view of the exemplary cartridge shown in FIG. 119A.

[0205] [Figure 120A-120B] FIG. 10 is an exploded view of another exemplary cartridge.

[0206] [Figure 121] 1 illustrates a perspective view of an exemplary infusion set base retainer.

[0207] [Figure 122] 1 illustrates a perspective view of an exemplary inner housing of an exemplary cartridge.

[0208] [Figure 123] 10A-10C are perspective views of exemplary base retainers that may be included in certain exemplary cartridges.

[0209] [Figure 124] FIG. 1 is a perspective view of an exemplary internal cartridge housing that may be included in a particular exemplary cartridge.

[0210] [Figure 125] 1 illustrates a bottom view of an exemplary cartridge.

[0211] [Figure 126A] 126A shows a cross-sectional view taken at section 126A-126A of FIG.

[0212] [Figure 126B]126B shows another cross-sectional view taken at section 126B-126B of FIG. 125.

[0213] [Figure 127] FIG. 2 is a bottom view of an exemplary cartridge.

[0214] [Figure 128B] FIG. 128 is a cross-sectional view taken along the cutting line shown in FIG. 127.

[0215] [Figure 128B] 128 shows a cross-sectional view along the cutting plane shown in FIG. 127.

[0216] [Figure 129A] 1 shows an exploded view of an example inserter assembly that may be reusable.

[0217] [Figure 129B] 129B shows another exploded view of the exemplary inserter assembly of FIG. 129A.

[0218] [Figure 130A] 10 shows an exploded view of another exemplary inserter assembly that may be reusable.

[0219] [Figure 130B] 130B shows another exploded view of the exemplary inserter assembly of FIG. 130A.

[0220] [Fig. 131A-B] 10 illustrates an exploded view of another exemplary reusable inserter assembly.

[0221] [Figure 132] 1 illustrates an exploded view of an exemplary case that may be included in a particular exemplary inserter assembly.

[0222] [Figure 133] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0223] [Figure 134] 10A-10C illustrate views of an exemplary inserter assembly exploded away from an exemplary cartridge.

[0224] [Figure 135] 135 shows a detailed view of the indicated area of ​​FIG. 134.

[0225] [Figure 136] 135 shows a detailed view of the indicated area of ​​FIG. 134.

[0226] [Figure 137A] FIG. 1 illustrates a bottom view of an exemplary inserter assembly.

[0227] [Figure 137B] 137B shows a detailed view of the receptacle body of the exemplary inserter assembly shown in FIG. 137A.

[0228] [Figure 138A] 1 illustrates a detailed view of a portion of an exemplary receptacle body that may be included in an inserter assembly described herein.

[0229] [Figure 138B] 1 illustrates a top view of an exemplary receptacle body that may be included in the inserter assembly described herein.

[0230] [Figure 139] 1A and 1B show perspective views of an exemplary sharps holder that may be included in an exemplary cartridge of an inserter assembly described herein.

[0231] [Figure 140A] 1 illustrates an exemplary insertion driver that may be included in an inserter assembly described herein.

[0232] [Figure 140B] 1A-1C show views of a portion of an exemplary sharps holder.

[0233] [Figure 141] 1 illustrates a perspective view of an exemplary inserter assembly with a cartridge coupled thereto.

[0234] [Figure 142] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0235] [Figure 143] 1 illustrates a perspective view of an exemplary locking member.

[0236] [Figure 144] FIG. 10 is a perspective view of a retractable latch body.

[0237] [Figure 145] 1 illustrates a perspective view of an exemplary receptacle body for an inserter assembly, having an integrally molded locking member.

[0238] [Figure 146] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0239] [Figure 147] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0240] [Figure 148] FIG. 1 is a cross-sectional view of an exemplary inserter assembly in a storage state.

[0241] [Figure 149] 10A-10C illustrate views of an exemplary reset body coupled to an exemplary retraction spring retainer.

[0242] [Figure 150] 1 illustrates a top plan view of an exemplary inner housing of an exemplary inserter assembly.

[0243] [Figure 151]151-151 of FIG. 150.

[0244] [Figure 152] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0245] [Figure 153] 1 illustrates a cross-sectional view of an exemplary inserter assembly in a ready state.

[0246] [Fig. 154] FIG. 1 is a cross-sectional view of an exemplary inserter assembly.

[0247] [Figure 155] 1 illustrates a top view of an exemplary inserter assembly.

[0248] [Figure 156] 156-156 of FIG. 155.

[0249] [Figure 157A] 10 illustrates a cross-sectional view of another exemplary inserter assembly in a storage state.

[0250] [Figure 157B] 157B shows a perspective view of the inserter assembly shown in FIG. 157A with some components removed. FIG.

[0251] [Figure 157C] 157B shows a cross-sectional view of the inserter assembly shown in FIG. 157A in a ready state.

[0252] [Figure 157D] 157D shows a perspective view of the inserter assembly shown in FIG. 157C with some components removed.

[0253] [Figure 158]1 illustrates a cross-sectional perspective view of an exemplary inserter assembly.

[0254] [Figure 159] 159 shows a detailed view of the indicated area of ​​FIG. 158.

[0255] [Figure 160] 1 illustrates a perspective view of an exemplary inner housing of an exemplary inserter assembly.

[0256] [Figure 161] 1 illustrates a cross-sectional perspective view of an exemplary inserter assembly.

[0257] [Figure 1162A] 1 illustrates a cross-sectional view of a retaining cap of an exemplary inserter assembly.

[0258] [Figure 162B] FIG. 162B shows a detailed view of the indicated area of ​​FIG. 162A.

[0259] [Figure 163] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0260] [Fig. 164] 164 shows a cross-sectional view of an example inserter assembly cut at the cutting plane shown in FIG. 163.

[0261] [Figure 165] 1 illustrates an example end cap that may be included as part of the housing of some example inserter assemblies.

[0262] [Figure 166] 1 illustrates an example insertion driver that may be included in some example inserter assemblies.

[0263] [Figure 167] 1 illustrates a cross-sectional view of an example inserter assembly.

[0264] [Figure 168] 1 illustrates a cross-sectional view of an example inserter assembly.

[0265] [Figure 169] 1 illustrates a cross-sectional view of an example inserter assembly.

[0266] [Figure 170] 1 illustrates a cross-sectional view of an example inserter assembly.

[0267] [Figure 171A] 1 illustrates a cross-sectional view of an example inserter assembly.

[0268] [Figure 171B] 1 illustrates a cross-sectional view of an example inserter assembly.

[0269] [Fig. 172] 1 illustrates a cross-sectional view of an example inserter assembly.

[0270] [Figure 173] FIG. 13 shows a perspective view of the cartridge with the outer housing removed and connected to the inserter assembly.

[0271] [Figure 174A] FIG. 1 illustrates a perspective view of an example inserter assembly with a release lock.

[0272] [Figure 174B] 174B shows a cross-sectional view of the inserter assembly shown in FIG. 174A.

[0273] [Figure 175A] 1 illustrates a perspective view of an example inserter assembly including an example release lock.

[0274] [Figure 175B] 175B shows a cross-sectional view of the inserter assembly shown in FIG. 175A.

[0275]

[0276] [Figures 176A-176C] 10A-10C illustrate various views of another example inserter assembly including an example release lock.

[0277] [Figure 177A-177B] 10A-10C illustrate views of another example inserter assembly including an example release lock.

[0278] [Figure 178A] FIG. 1 illustrates a perspective view of an example inserter assembly with an example release actuator.

[0279] [Figures 178B-178C] 178B shows a view of the inserter assembly shown in FIG. 178A with some components removed.

[0280] [Figure 178D] 178B shows a perspective view of a release actuator included in the inserter assembly shown in FIG. 178A.

[0281] [Figure 179A] 10 illustrates a perspective view of another example inserter assembly including an example release actuator.

[0282] [Figure 179B] 179B shows a perspective view of the inserter assembly shown in FIG. 179A with some components removed.

[0283] [Figure 180A] 10 illustrates a perspective view of another example inserter assembly including an example release actuator.

[0284] [Figure 180B] 180B shows a perspective view of the inserter assembly shown in FIG. 180A with a portion of the housing removed.

[0285] [Figure 180C]180B shows a perspective view of the inserter assembly shown in FIG. 180A with some components removed.

[0286] [Figure 180D] 181B shows a cross-sectional view of the inserter assembly shown in FIG. 181A.

[0287] [Figure 181A] 10 illustrates a perspective view of another example inserter assembly with an example release actuator.

[0288] [Figure 181B] 181B shows a cross-sectional view of the inserter assembly shown in FIG. 181A.

[0289] [Figure 181C] 181B shows a perspective view of a release actuator included in the inserter assembly shown in FIG. 181A.

[0290] [Figure 181D] 181B shows another cross-sectional view of the inserter assembly shown in FIG. 181A.

[0291] [Figure 182A] 10 illustrates a perspective view of another example embodiment of another example inserter assembly with an example release actuator.

[0292] [Figure 182B] 182B shows a perspective view of an example inserter assembly shown in FIG. 182A with some components removed.

[0293] [Figure 183A-183B] FIG. 10 illustrates another embodiment of an inserter assembly, including an example release actuator.

[0294] [Figure 184] 1 illustrates a perspective view of an exemplary tubing connector.

[0295] [Figure 185A] 185 shows a bottom-up view of the tubing connector shown in FIG. 184.

[0296] [Figure 185B] A detailed view of a portion of FIG. 185A is shown.

[0297] [Figure 186] 1 shows a perspective view of the tubing connector in place on the device.

[0298] [Figure 187] 187 shows a bottom-up view of the fixture shown in FIG. 186.

[0299] [Figure 188] FIG. 1 shows a perspective view of a tube connector aligned for attachment to a fixture.

[0300] [Figure 189] 1 shows a cross-sectional view of a fixture with a tubing connector attached and a sharp member introduced into the tubing connector.

[0301] [Figure 190] 10 shows a cross-sectional view of the fixture with the tubing connector attached and the sharp member in place and clocked into position within the tubing connector.

[0302] [Figure 191] 1 shows a flowchart detailing some exemplary actions that may be used to assemble a tubing connector. DETAILED DESCRIPTION OF THE INVENTION

[0303] In various embodiments, the infusion set may be used in combination with infusion devices, systems, and related methods, as well as in combination with an inserter assembly. In various embodiments, the exemplary infusion set may be configured to be inserted into the subcutaneous layer of a user's skin and fluidly connected to a fluid source. In various embodiments, the exemplary infusion set may be fluidly connected to a length of tubing and / or an infusion device. The infusion device may include any infusion pump, and may be any of the infusion devices disclosed in U.S. patent application Ser. No. 15 / 434,906, filed February 16, 2017, entitled "Infusion Set and Inserter Assembly" (Attorney Docket No. U64), which issued October 6, 2020, as U.S. Patent No. 10,792,419; U.S. patent application Ser. No. 13 / 788,260, filed March 7, 2013, entitled "Infusion Pump Assembly," now U.S. Patent Publication No. US-2014-0107579, published April 17, 2014, (Attorney Docket No. K40); and U.S. patent application Ser. No. 13 / 788,260, filed July 23, 2013, entitled "Infusion Pump Assembly," now U.S. Patent Publication No. US-2014-0107579, published April 17, 2014, (Attorney Docket No. K40); No. 8,491,570 (Attorney Docket No. G75), entitled "Fluid Delivery System and Method," issued on April 9, 2013 (Attorney Docket No. E70); U.S. Patent No. 8,262,616 (Attorney Docket No. F51), entitled "Infusion Pump Assembly," issued on September 11, 2012; and U.S. Patent No. 7,306,578 (Attorney Docket No. C54), entitled "Loading Mechanism for Infusion Pump," issued on December 11, 2007, all of which are incorporated herein by reference in their entireties.

[0304] Various embodiments are described and illustrated herein. Each embodiment of each element of each device can be used with any other device embodiment. Each embodiment of the inserter assembly can be used with any embodiment of the infusion set.

[0305] FIG. 1A shows an exploded view of an exemplary embodiment of an inserter assembly 100. An inserter assembly, such as inserter assembly 100, can be used to place an infusion set 102 at a patient's infusion site and introduce a cannula 104 of the infusion set 102 into the patient's body. In some embodiments, the inserter assembly 100 can be used to place other patient-care assemblies into the patient's body. For example, a particular inserter assembly 100 can be operated to place a physiological monitor in functional relationship with the patient's body. In a particular example, an analytical sensor can be placed into the patient using the inserter assembly 100. The infusion set 102 can be used to deliver medication from an infusion pump to a specific location within the patient's body (e.g., subcutaneously).

[0306] The drugs or other agents delivered may include drugs or agents typically delivered as a continuous or substantially continuous infusion. This may include small molecules, biologics, recombinantly produced pharmaceuticals, and their analogs. Hormones such as insulin or glucagon may be administered via the infusion set 102. Other drugs, such as peptides (e.g., amylin), may be provided. Drugs affecting the cardiovascular system may also be provided via the infusion set 102. As another example, vasodilators such as treprostinil may be delivered to a patient with the infusion set 102. Chemotherapy drugs may also be used. Exemplary physiological monitors may include blood glucose monitors, such as continuous glucose monitors. Other types of body analyte monitors, such as interstitial fluid analyte monitors, may also be used.

[0307] In some embodiments, the inserter assembly 100 can position the infusion set 102 at a site and at least partially assemble the infusion set 102. For example, the infusion set 102 can be provided as several parts (e.g., separate components, subassemblies, or a combination thereof) within the inserter assembly 100. Actuation of the inserter assembly 100 can couple the parts of the infusion set 102 together to complete assembly of the infusion set 102. For example, assembly of the infusion set 102 can occur as an initial stage of actuation of the inserter assembly 100, or can occur as part of an insertion stage of actuation of the inserter assembly 100 that results in the cannula 104 being introduced into the patient.

[0308] As shown in the exploded view of FIG. 1A, the inserter assembly 100 includes the components of the infusion set 102. The inserter assembly 100 may not include the assembled infusion set 102 installed therein. The infusion set 102 may include a first portion and a second portion that are separate from each other but are coupled together to form the infusion set 102 during operation of the inserter assembly 100. The first portion may include a base 106 that is applied to the patient's skin and may be part of an infusion pump or may be coupled to a fluid pathway extending from the infusion pump (e.g., via a terminal connector on the pathway). An exemplary infusion pump may include any one or more of the components disclosed in the various references incorporated by reference above, although in various embodiments, any infusion pump may be used. The base 106 may include an adhesive (e.g., an adhesive pad) that holds the infusion set 102 in place on the patient. The adhesive may be covered with an adhesive backing 111, liner, or film that is removed to expose the adhesive before use.

[0309] The second portion of the infusion set 102 may be a subassembly 114 of two or more components of the infusion set 102. The second portion may include, for example, the cannula 104, the septum housing 108, the septum 110, and the septum retainer 112. In some embodiments, one or more, but not all, components of the second portion may be provided integral with one another, such that the components are manufactured as a single, monolithic part, for example, during a single molding operation. Thus, attaching, fastening, bonding, mounting, or other assembly of these parts after manufacturing may be avoided. The cannula 104 and the septum housing 108 are shown in the exemplary embodiment as such a single, continuous, unitary part. The cannula-like housing may be a molded part constructed of a single material, such as, for example, PTFE, Teflon, or polypropylene. Certain components may also be bonded to one another during manufacturing. For example, the septum retainer 112 may be overmolded onto the septum 110, or vice versa.

[0310] As shown in FIG. 1A , the inserter assembly 100 may include several additional components. For example, the inserter assembly 100 may include an outer housing 116. The outer housing 116 surrounds various components of the inserter assembly 100 and may serve as the portion of the inserter assembly 100 that a user grasps during operation. While the outer housing 116 in the exemplary embodiment has a circular cross-sectional shape, other embodiments may have different shapes, such as any type of polygon. In certain examples described elsewhere herein, a rectangular cross-sectional shape may be used to fit easily within a pocket. The cross-sectional area in the exemplary embodiment also varies, with the lower section of the outer housing 116 (closest to the skin during use) being wider than the upper section. The outer housing 116 may include various ergonomic features to facilitate gripping of the inserter assembly 100 within which it is contained. For example, texturing or finger or thumb recesses may be included on the exterior surface of the outer housing 116. Alternatively, or in addition, a region of the outer housing 116 may be thinner in width than the remainder of the outer housing 116. This may facilitate a firm grip on the inserter assembly 100.

[0311] The outer housing 116 may include markings, tabs, embossed sections, recessed sections, textured sections, ridges, color coding, appliqués, or other indicia that serve to indicate the position and / or orientation of the infusion set 102 within the inserter assembly 100. For example, the outer housing 116 of FIG. 1A includes a raised rib 118 on the outer surface of the outer housing 116. While the raised rib 118 in this example extends substantially parallel to the elongation direction of the outer housing 116, in alternative embodiments, it may be disposed on any outer surface of the outer housing 116, or in part. The rib 118 is positioned to indicate the orientation of a portion of the infusion set 102 to which a fluid conduit from an infusion device may be connected. This may allow the user to position the inserter assembly 100 in a desired orientation after the infusion set 102 is attached to the user, allowing the infusion tubing to be routed in a planned manner.

[0312] The inserter assembly 100 may also include an inner housing 120. The inner housing 120 may be disposed within the outer housing 116 when the inserter assembly 100 is assembled. Various inner housings 120 may have at least one segment designed asymmetrically. In the exemplary embodiment shown in FIG. 1A, the inner housing 120 includes a rail segment 122 including several rails 124. The rails 124 extend substantially parallel to one another and may be of at least two different widths. The inner surface of the outer housing 116 may include tracks or slots that cooperate with the rails 124. The different widths of the rails 124 may provide a keyed arrangement so that the inner housing 120 can only be nested within the outer housing 116 in a predetermined orientation. The interaction of the rails 124 within the tracks may also inhibit rotation of the inner housing 120 and outer housing 116 relative to one another. While the rails 124 are shown on the inner housing 120 in the example, in some embodiments, the rails 124 may instead be present on the inner surface of the outer housing 116. In such an example, the tracks may be disposed on inner housing 120. Additionally, as shown, at least some of rails 124 may also form channels or tracks in the interior surface of inner housing 120.

[0313] Other embodiments may not use a rail-and-track type arrangement. One of the inner housing 120 or the outer housing 116 may include at least one protrusion, such as a tab, that interfaces with a recess or guide in the other. This may similarly provide keyed engagement and prevent relative rotation. In other embodiments, the cross-sectional shapes of the inner housing 120 and the outer housing 116 may only allow the parts to be placed together in one direction and inhibit any relative rotation. For example, the cross-sections may be teardrop-shaped or various asymmetric polygonal shapes.

[0314] The inner housing 120 may also include an infusion set base interface segment 126. This base interface segment 126 may include several protrusions 352, which may ensure that the base 106 can only be inserted into the inserter assembly 100 in a desired orientation. The protrusions 352 may also optionally help retain the base 106 within the inserter assembly 100; there may be some friction between the protrusions 352 and the surface of the base 106 when the base 106 is attached to the inserter assembly 100. For example, the base 106 may be press-fit onto the protrusions 352. The fit may be minimally airtight, allowing the base 106 to be removed from the base interface segment 126 with little force. The protrusions 352 may also help maintain the base 106 horizontally within the base interface segment 126.

[0315] The inserter assembly 100 may further include a sharps holder 130. The sharps holder 130 may hold an insertion sharp 132 thereon. The insertion sharp 132 may be glued or otherwise attached to the sharps holder 130 so as to be fixedly disposed relative to the sharps holder 130. Any suitable type of sharps 132 may be used. For example, the sharps 132 may be a hollow or solid needle, a stylet, or other pointed member, which may be made of a metallic material such as steel. A sharps retractor 134 and several springs 136, 138 may also be included in the inserter assembly 100. A retainer base 140 may couple to the bottom of the inserter assembly 100 and help hold various components in place within the inserter assembly 100. In this example, the retainer base 140 includes a retention interface 142 that can snap onto a cantilevered retention arm 144 included in the outer housing 116. Other attachments are possible, such as a bayonet mount, interference fit, snap fit, adhesive, glue, threads, solvent bonding, welding, etc. When attached together, the outer housing 116 and the retainer base 140 may form the housing of the inserter assembly 100.

[0316] As described further later in this specification, a latching arrangement may be included in the inserter assembly 100 to hold the sharps holder 130 and sharps retraction device 134 in place before and during actuation of the inserter assembly 100. The latching arrangement may include several locking portions. When free to move, the springs 136, 138 may displace the sharps holder 130 and sharps retraction device 134, and the components retained therein, to complete insertion of the cannula 104 into the patient and attach the infusion set 102 to the infusion site. Retraction of the sharps 132 into the inserter assembly 100 may also occur as part of actuation, displacing the sharps 132 to a point where it is withdrawn from the infusion set 102 and protected from contact with the user.

[0317] When unpacked by a user, the inserter assembly 100 may include a locking member 146. The locking member 146 may be inserted through fenestrations 148, 150. When unpacked by a user, the inserter assembly 100 may include a locking member 146. The locking member 146 may be inserted through fenestrations 148, 150 in the outer housing 116 and the inner housing 120, respectively, to span the width. While present within the inserter assembly 100, the locking member 146 can prevent actuation of the inserter assembly 100. The exemplary locking member 146 can mechanically prevent displacement of one or more components of the inserter assembly 100 to initiate actuation of the inserter assembly 100. In the exemplary embodiment, the locking member 146 includes a flange 152 that can be grasped by a user during removal of the locking member 146.

[0318] As shown, the locking member 146 may include several raised sections 154 (e.g., ridges or bumps) thereon. These raised sections 154 may provide material that can help bond to portions of the adhesive backing 111 during a welding operation. As a result, the locking member 146 may be attached to the adhesive backing 111 so that the user has a visual cue if either the locking member 146 or the adhesive backing 111 is removed while still in place. This may help facilitate removal of both components before actuating the inserter assembly 100 and making the device more intuitive.

[0319] As shown in FIGS. 1B and 1C, in some examples, the inserter assembly 100 may include one or more additional springs 156, 158. As shown in FIG. 1C, the additional spring 158 may be a conventional metal spring. Alternatively, as shown in FIG. 1B, a plastic spring 156 may be used. In certain embodiments, the plastic spring 156 may be injection molded, cut from a tube of material (e.g., by laser cutting), made by a material additive process, or by any other suitable method. Such springs 156, 158 are described further later in this specification.

[0320] Referring now to FIG. 2, another inserter assembly 100 is shown. The inserter assembly 100 of FIG. 2 includes an outer housing 116 that encloses various components of the inserter assembly 100 and can serve as the portion of the inserter assembly 100 that a user grips during operation. While depicted as circular, the outer housing 116 can have other cross-sectional shapes or various ergonomic features, as described above. The outer housing 116 includes a position indicator in the form of a raised rib 118 extending from the exterior surface of the outer housing 116. The rib 118 can be positioned to indicate the orientation of a portion of the infusion set 102 contained within the inserter assembly 100.

[0321] The inner housing 120, also included in FIG. 2, can be keyed to ensure secure assembly to the inserter assembly 100 in a predetermined orientation and prevent relative rotation. As shown in FIG. 2, the inner housing 120 can be made asymmetrical by including at least one protrusion 400, such as a tab, that interfaces with a recess or guide 402 in the outer housing 116. In this example, the guide 402 is provided by a channel formed by a raised rib 118 on the inner surface of the outer housing 116. The protrusion 400 on the inserter assembly 100 of FIG. 2 is included in a spacing plate 404 that ensures the inner housing 120 fits snugly within the outer housing 116. An infusion set base interface segment 126 is also included in the exemplary inner housing shown in FIG. 2.

[0322] In the exemplary embodiment, a sharps holder 130 is shown that can be attached to the insertion sharp 132. Additionally, a sharps retraction device 134 and several springs 136, 138 can also be included. A retainer cap 406 can be coupled to the top of the inserter assembly 100 to help hold various components in place within the inserter assembly 100. In the example, the retainer cap 406 includes a cantilevered retention arm 408 that can snap into a retention interface 411. Other attachments are possible, such as a bayonet mount, interference fit, snap fit, adhesive, glue, threads, solvent bonding, welding, etc. When coupled together, the outer housing 116 and the retainer cap 406 can form the housing of the inserter assembly 100.

[0323] As described in detail elsewhere herein, a latching arrangement may be included in the inserter assembly 100 that can hold the sharps holder 130 and the sharps retraction device 134 in place before and during actuation of the inserter assembly 100. The latching arrangement may include several locking portions. When free to move, the springs 136, 138 can displace the sharps holder 130 and the sharps retraction device 134, and the components retained therein, to complete the insertion of the cannula 104 into the patient and attach the infusion set 102 to the infusion site. Retraction of the sharps 132 into the inserter assembly 100 may also occur as part of actuation.

[0324] In the exemplary embodiment shown in FIG. 2, the inserter assembly 100 does not include a locking member 146. However, in various embodiments, the outer housing 116 and the inner housing 120 can include fenestrations similar to the fenestrations 148, 150 of FIGS. 1A-1C to accommodate the locking member 146. In these embodiments, the adhesive backing 111 can be adhered to the locking member 146. However, in embodiments, the adhesive backing 111 includes two pull tabs 410 (although any suitable number may be included). These pull tabs 410 can be grasped by a user to facilitate removal of the adhesive backing 111. An additional spring 158, shown in FIG. 1C, is included in FIG. 2.

[0325] Referring now to FIG. 3, another exemplary embodiment of an inserter assembly 100 is shown. As shown, the inserter assembly 100 of FIG. 3 includes an outer housing 116 and an inner housing 120 similar to those shown in the example shown in FIG. 2. The sharps holder 130 and sharps retraction device 134 differ from those shown in FIGS. 1A and 2. A retainer cap 406 may couple to the top of the inserter assembly 100 to hold various components in place within the inserter assembly 100 and function to form a housing for the inserter assembly 100. The retainer cap 406 couples to the outer housing 116 in a manner similar to the embodiment described in connection with FIG. 2. However, any other type of coupling may be used in alternative embodiments. The retainer cap 406 also includes a protrusion 412 that may fit within a portion of the sharps holder 130 when the inserter assembly 100 is fully assembled and ready for operation.

[0326] As described in detail elsewhere herein, a latching arrangement may be included in the inserter assembly 100 to hold the sharps holder 130 and sharps retraction device 134 in place before and during actuation of the inserter assembly 100. The latching arrangement may include several locking portions. When free to move, the springs 136, 138 may displace the sharps holder 130 and sharps retraction device 134, and the components retained therein, to complete the insertion of the cannula 104 into the patient and attach the infusion set 102 to the infusion site. Retraction of the sharps 132 into the inserter assembly 100 may also occur as part of actuation.

[0327] In the exemplary embodiment shown in FIG. 3, the inserter assembly 100 does not include a locking member 146. However, in various embodiments, fenestrations similar to the fenestrations 148, 150 of FIGS. 1A-1C may be included in the outer housing 116 and the inner housing 120 to accommodate the locking member 146. In these various embodiments, the adhesive backing 111 may be adhered to the locking member 146. However, in embodiments, the adhesive backing 111 includes two pull tabs 410. These pull tabs 410 may be grasped by a user to facilitate removal of the adhesive backing 111. The additional spring 148 shown in FIG. 1C may also be included in FIG. 3.

[0328] 4A and 4B, top and bottom perspective views, respectively, of the infusion set base 106 are shown. As shown, the base 106 can have a platform portion 160. The platform portion 160 can be placed against the patient's skin while the infusion set 102 is in place at the infusion site. In an exemplary embodiment, the platform portion 160 is substantially circular, in this case having a generally circular, disk-shaped footprint. In other embodiments, the platform portion 160 can be oval (see, e.g., FIGS. 21A-21F), oval, or elliptical (see, e.g., FIGS. 22A-C). The platform portion 160 is also substantially flat; however, this need not be the case in all embodiments.

[0329] In various embodiments, adhesive may be applied to the bottom surface 162 of the platform portion 160. An adhesive backing 111 (see, e.g., FIG. 1A ) may cover the adhesive. In an exemplary embodiment, the bottom surface 162 of the platform portion 160 includes several raised segments 164. The exemplary raised segments 164 are shown as radially arranged ridges spaced at substantially regular angular intervals across a portion of the bottom surface 162. There are also two concentric raised rings around the periphery of the bottom surface 162. In other embodiments, raised segments other than ridges may be included, and / or the raised features are not radially arranged or regularly spaced. In some embodiments, the raised segments 164 may be dots or rounded areas spaced apart around the periphery of the bottom surface 162. In various embodiments, any suitable pattern may be used. The raised segments 164 may allow for adhesive bonding (e.g., ultrasonic or radio frequency welding). The raised segments 154 may allow for an adhesive to be bonded (e.g., ultrasonically or radio frequency welded) to the bottom surface 162. For example, the adhesive may be contained on a substrate, which may be a plastic such as polypropylene or any other plastic suitable for a welding operation. The raised segments 164 and the substrate may melt together during a welding operation to create a bond that holds the adhesive on the bottom surface 162 of the infusion set base 106. In an alternative embodiment, an adhesive such as double-sided tape bonds the substrate to the bottom surface 162, and the bottom surface 162 may not have the raised segments 164.

[0330] In various embodiments, the platform portion 160 may include several through-holes 166. Three circular through-holes 166 are shown in FIGS. 4A-B. However, other examples may include any number, and their shapes may vary. The through-holes 166 may be provided to facilitate manufacturing by allowing protrusions on a portion of an assembly line to interface with them. This interface can aid in orienting or centering the base 106 or any infusion set 102 subassembly that includes the base 106 during manufacturing operations. If the through-holes 166 aid in orientation, it may be desirable for the through-holes 166 to be asymmetrically positioned (although symmetrical through-hole 166 placement is also possible). In this example, the through-holes 166 are positioned in a triangular-type layout so that the base 106 only engages with a corresponding set of protrusions in one direction. Additionally, in some embodiments, the optional adhesive and adhesive liner 111 may include holes that align with the positions of the through-holes 166. Thus, the through-holes 166 can be used to assist in the manufacturing process even when the inserter assembly 100 is fully assembled and ready to be triggered. The through-holes 166 may also be engaged by a portion of any packaging in which the inserter assembly 100 is provided to help hold the inserter assembly 100 in place.

[0331] While the through-holes 166 may be useful during manufacturing, they may also provide other benefits. For example, the through-holes 166 may provide a window for observing the skin around the injection site. As a result, the user may be able to assess the skin for signs of irritation (such as flushing or redness). Additionally, the through-holes 166 may provide a path by which ambient air may communicate with the space between any raised segments 164 on the bottom surface 162 of the infusion set base 106. This may help the area below the infusion set 102 breathe while the infusion set 102 is attached to the skin.

[0332] Extending from the periphery of the platform portion 160 may be a number of tubing retainers 184. The tubing retainers 184 may allow the infusion tube 366 (see, e.g., FIG. 6) to be wrapped around a portion of the infusion set 102 and held in place. This may help to inhibit kinking of the tubing 366 and may help the user conveniently route the infusion tube 366 as needed. In alternative embodiments of the infusion set base 106 described herein, the tubing retainers 184 may be omitted (see, e.g., FIGS. 22A-22C).

[0333] As shown in FIG. 6 , the top surface 168 of the platform portion 160 may include various receiving features extending therefrom that may engage or interface with a connector 368 included at the end of an infusion tube 366 extending from the infusion pump. In various embodiments, the infusion tube 366 may be coupled to an infusion pump reservoir, such as a syringe or an infusion pump outlet. The infusion tube 366 may be coupled to the infusion pump via a luer lock or other mechanical bond, adhesive, solvent bonding, or any other suitable method. The base 106 may include a connector receptacle 170 about which a cantilevered finger 370 on the tubing set connector 368 can deflect when the connector 368 is slid onto the base 106. Once past the connector receptacle 170, the cantilevered finger 370 can return to an undeflected position. A bump or locking protrusion on the cantilevered finger 370 may be displaced into latching engagement with a cooperating feature of the connector receptacle 170. Sharp franking projections 372 may also be present on the connector 368. These sharp franking projections 372 may extend substantially parallel to the sharps 482 (see, for example, FIG. 15F ) included on the connector 368 and may present an obstacle that helps prevent accidental contact between the sharps 482 and a user. A shielding wall 169 may be provided on the base 106 and can help prevent a finger or object from inadvertently disengaging the cantilevered fingers 370 from engagement with the connector receptacle 170. The shielding wall 169 may be continuous with the connector receptacle 170.

[0334] Respective guides 172 for the connector fingers 370 and the sharps side protrusions 372 may also be included and, in the exemplary embodiment, define several slots along which the connector fingers 370 and adjacent protrusions 372 can slide as the connector 368 is displaced. The guides 172 may make it easier for a user to couple the infusion set 102 and the connector 368 together. Additionally, the guides 172 may help ensure that the sharps 482 (see, e.g., FIG. 15F) on the connector 368 are introduced into the infusion set 102 along or near the desired insertion axis. In this example, the guides 172 include notches 174. Each notch 174 may be sized to receive a protrusion on a component of the inserter assembly 100. The notches 174 may also be sized to receive at least a portion of a protrusion included on the cannula subassembly 114 (see, e.g., FIG. 5A). The adjacent protrusion 372 may be sized to extend a shorter distance from the connector 368 than the location of the notch 174 when the connector 368 is attached to the infusion set 102. As described below, the notch 174 may help facilitate release of the base 106 from the inserter assembly 100 during actuation.

[0335] In various embodiments, the base 106 may also include a receptacle 176 for engaging with the cannula subassembly 114 (see, e.g., FIG. 5A ) of the infusion set 102. In this example, the receptacle 176 is generally flanked on either side by guides 172. The receptacle 176 may be at least partially surrounded by a receptacle wall 178 that projects upward from the top surface 168 of the platform portion 160. Thus, the receptacle wall 178 and the portion of the guide 172 including the notch 174 may define the receptacle 176. A portion of the receptacle wall 178 may include a cantilevered portion 180. The cantilevered portion 180 may include a protuberance (e.g., a barb or a ramp) 182. Portions of the receptacle wall 178 and / or guide 172 may include tapered sections (see, e.g., the embodiment shown in FIGS. 10A-10B). The tapered sections may be included in portions of the receptacle wall 178 and / or guide 172 that are most distal to the platform 160. Such tapered sections may help guide the cannula subassembly 114 into position when the infusion set 102 is assembled by funneling the cannula subassembly 114 into the receptacle 176. Additionally or alternatively, the notch 174 may be tapered along at least a portion of its length (see, e.g., FIGS. 21A-21F). This may help guide the cannula subassembly 114 into the proper position when the infusion set 102 is assembled.

[0336] 5A , an exemplary cannula subassembly 114 is shown. As shown, the septum housing 108 may include a notch 186. The notch 186 may be recessed in the outer surface of the septum housing 108. While moving the cannula subassembly 114 into the receptacle 176 of the base 106, the base 106 may deflect around the septum housing 108 until the ridge 182 freely springs back into the notch 186. Once the cantilevered projection 180 returns to its undeflected state and the ridge 182 is positioned within the notch 186, the cannula subassembly 114 may be retained within the base 106. In the retained state, the ear or nub 204 of the septum housing 108 may reside at least partially within the notch 174 of the base 106 (shown in FIG. 6 ).

[0337] Referring now to FIG. 5B , which shows a cross-sectional view of the assembled cannula subassembly 114, the cannula subassembly 114 may further include a septum 110 and a septum retainer 112 in certain embodiments. In alternative embodiments, multiple septums 110 may be included instead of a single septum 110, as described in connection with other examples herein. The septum housing 108 may include a cup-like receiving section or receptacle 192 into which the septum 110 may be introduced. The receptacle 192 may include a raised region 194 at its center. In this example, the raised region 194 may have a frustoconical shape, although other shapes are possible. For example, the shape included in the septum interface region 183 of the cannula 104 shown in FIGS. 29A-29G could be used for the alternative raised region 194. The septum 110 may also include a cup-like septum recess 196 included in its bottom surface. The septum recess 196 may include an enlarged or flared-out section 198 formed as a negative version of the raised region 194 in the receiving section 192 of the septum housing 108 (or other portion corresponding to the shape of the raised region 194 in the example). Accordingly, the enlarged section of the septum recess 196, as the septum 110 is introduced into the receiving section 192, may be referred to herein as the centering wall of the septum recess 196. A second section 200 of the septum recess 196, most distal from the bottom surface of the septum 110, may at least partially define a fluid introduction volume through which a needle or sharp member 482 (see, e.g., FIG. 15F ) included in the tubing connector 368 can penetrate to deliver fluid to the infusion set 102. Fluid can be delivered from the fluid introduction volume into the lumen 202 of the cannula 104 and then to the patient. The second section 200 of the septum recess 196 can have any suitable cross-section, but in this example has a circular, approximately circular cross-section. The septum housing 108 can include a connector needle passage 122 in its sidewall (as shown in FIG. 6), which can allow a needle or sharps 482 of the connector 368 (see, e.g., FIG. 15D) to access the fluid introduction volume 109.In the exemplary embodiment, connector needle passage 122 is shown as a fenestration extending through septum housing 108. Connector needle passage 222 and notch 186 may (but need not) be on opposite sides of septum housing 108, allowing cannula subassembly 114 to be attached to base 106 in two orientations. This may make assembly of inserter assembly 100 easier.

[0338] The receiving section 192 of the septum housing 108 may also receive a portion of the septum retainer 112. The septum retainer 112 may be constructed with a body 206 having at least one cantilevered projection 188 extending therefrom, the cantilevered projection 188 comprising a terminal ridge or latching member. In this example, the body 206 is substantially planar. Additionally, there are two cantilevered projections 188 positioned opposite each other and extending generally perpendicular to the body 206. These cantilevered projections 188 may fit within guides 208 included on the inner surface of the receiving section 192 of the septum housing 108. The illustrated guide 208 is recessed into the inner surface of the receiving section 192 and is substantially flush with the ears 204. The guides 208 are angled such that the distance between the two guides 208 decreases as the distance from the cannula 104 decreases. This can deflect the cantilevered projections 188 of the septum retainer 112 toward the elongated axis of the cannula 104 as the septum retainer 112 advances into the receiving section 192. Once the septum retainer 112 advances a certain distance into the septum housing 108, the cantilevered projections 188 can spring outward such that a ridge 190 on each cantilevered projection 188 latches into engagement with a stop 210 on the septum housing 108, as shown in FIG. 5B . In some embodiments, a portion of the cantilevered projections 188 can extend into or through an opening included in the bottom of the septum housing 108 and latch into engagement with a stop adjacent to or formed by a wall of the opening. With the septum retainer 112 latched in place within the cannula subassembly 114, the septum 110 can be placed in sealing relationship with the septum housing 108. Thus, the fluid contained in the fluid introduction volume 109 of the septum 110 may be provided with a sealed fluid flow path to the outlet 212 of the cannula 104 .

[0339] As shown, septum retainer 112 includes a channel 218 extending therethrough. The illustrative channel 218 is located substantially in the center of body 206. When septum retainer 112 is locked in place within cannula subassembly 114, a nub or protrusion 220 of septum 110 can extend into channel 218. This can provide an access path for insertion sharp 132 of inserter assembly 100 to extend from outlet 212 of cannula 212 through infusion set 102. In the illustrated example, protrusion 220 is frustoconical in shape, and channel 218 is cooperatively shaped to receive protrusion 220. Other shapes of protrusion 220 may be used in alternative embodiments, such as those described herein (see, e.g., FIGS. 32A-32D ).

[0340] The cannula 104 may include an insertion sharp guide section 216 that can help direct the insertion sharp 132 into the lumen 202 of the cannula 104. In an exemplary embodiment, the insertion sharp guide section 216 includes relatively steep sides and is surrounded by a flat (or perhaps chamfered or rounded) peripheral edge that forms the wall of the fluid introduction volume within the infusion set 102. In some embodiments, this peripheral edge may be the top surface of the raised section 192. The insertion sharp guide section 216 may be continuous with the wall of the lumen 202 of the cannula 104 and may be wetted by any fluid delivered through the infusion set 102. The insertion sharp guide section 216 may also be continuous with the raised region 194. The insertion sharp guide section 216 may be continuous with the wall of the lumen 202 of the cannula 104 and may be wetted by any fluid delivered through the infusion set 102. The insertion sharp guide section 216 may also be contiguous with the raised area 194 in the receiving section 192 of the septum housing 108 .

[0341] As primarily shown in FIG. 5B , a recess 214 may be included in the septum housing 108 that surrounds or at least partially surrounds the cannula 104. This recess 214 may not be covered by the adhesive when the adhesive is placed on the infusion set base 106. This may provide room for the cannula 104 to move relative to the base 106 if the infusion set 102 or a portion of the patient's body causes force to be applied to the cannula 104. This may minimize shearing effects on the cannula 104. The recess 214 may function as a volume that can contain a medication. For example, an antiseptic, disinfectant, anti-inflammatory, anesthetic, or other topical medication, such as an ointment, may be included in the recess 214. The medication may be medicinal, nutritional, or some other type of medication. Thus, upon application of the infusion set 102, the medication may be introduced to and maintained in contact with the patient's skin. In some examples, the medication may remain in contact with the recess 214. This can be beneficial for many reasons, including potentially helping to prevent infection, inflammation, or pain, and may provide a convenient method of applying medication. In an exemplary embodiment, recess 214 is shaped in the form of a conical section (e.g., a hyperbola or parabola) that rotates about the central axis of cannula 104.

[0342] In various embodiments, the cannula 104 can be tapered or non-tapered. In some embodiments, the cannula 104 can include one or more tapered sections and one or more non-tapered or straight sections. Any tapered section can extend at an angle relative to the longitudinal axis of the cannula 104. In some embodiments, instead of being at a constant angle relative to this axis, there can be a curvature. The angle or degree of curvature of the tapered section can also vary over the extent of the tapered section.

[0343] In some embodiments, a first portion of the cannula 104 proximal to the outlet 212 is tapered. The taper present in this section reduces the wall thickness as the cannula 104 increases in proximity to the outlet 212. Furthermore, a second portion of the cannula 104 tapers adjacent the point on the septum housing 108 from which it extends. The angle of the taper of the second portion may, in certain embodiments, be substantially equal to the angle of the insertion sharp guide section 216. The taper of the second portion reduces the width of the cannula 104 in this section without substantially reducing the wall thickness of the cannula 104 surrounding the lumen 202. In exemplary embodiments, a straight section may be located intermediate the first and second portions of the cannula 104. Alternatively, a slightly tapered section may be used as the intermediate segment. This section may be tapered to a lesser extent than the first and second portions of the cannula and may or may not be tapered in a manner that maintains a constant wall thickness along the length of the intermediate segment.

[0344] 7A-9, another exemplary infusion set 102 is shown. As shown, the cannula subassembly 114 of the exemplary infusion set 102 is designed to allow for manufacturing by straight pull molding. Features that may require a mold with side action or other special characteristics are not present in the exemplary cannula subassembly 114. For example, in some embodiments, undercut features may not be present. This may allow the cannula subassembly 114, or its components, to be constructed from a wider array of different materials.

[0345] As shown, cannula subassembly 114 includes a septum 110 similar to that shown in FIGS. 5A and 5B. In alternative embodiments, multiple septums 110 may be included instead of the single septum 110 shown. Septum housing 108 does not include notches 186. Instead, septum housing 108 includes protrusions 388 extending outward from the exterior surface of septum housing 108. During mating of cannula assembly 104 to infusion set base 106, one of protrusions 388 can deflect cantilevered portion 180 of base 106 until protrusion 182 is free to spring back into position overhanging protrusion 388. When cantilevered protrusion 180 returns to its undeflected state, with ridge 182 resting on protrusion 388, protrusion cannula subassembly 114 can be retained within base 106. In the retained state (see, for example, FIG. 9 ), the ear or nub 204 of the septum housing 108 may reside at least partially within the notch 174 of the base 106. The receptacle 176 portion of the infusion set base 106 is widened relative to that shown in FIGS. 4A-B to accommodate the larger footprint of the cannula subassembly 114. Additionally, the receptacle 176 includes a protrusion receiving area 398 opposite the cantilevered projection 180 to receive the protrusion 388 not engaged by the ridge 182. The cannula subassembly 114 is made symmetrical, allowing it to be installed on the infusion set base 106 in two orientations. This may help simplify manufacturing and assembly. In other embodiments, the protrusion 388 may be included on only one side of the cannula subassembly 114, and the protrusion receiving area 398 of the base 106 may be omitted.

[0346] Further, in the exemplary embodiment, the septum housing 108 does not include a fenestration in its side wall that forms the connector needle passageway 122 (see, e.g., FIG. 6). The septum housing 108 of FIGS. 8A-9 includes a slot 390 in the side wall 392 of the septum housing 108 that is recessed into the top surface 394 of the side wall 392. The septum retainer 112 may include a protrusion 396 that aligns with the slot 390 when the cantilevered protrusion 188 is mounted within a guide 208 included within the inner surface of the receiving section 192 of the septum housing 108. When the cannula subassembly 114 is coupled together (see, e.g., FIG. 8B), the protrusion 396 is mounted within a guide 208 included within the inner surface of the receiving section 192 of the septum housing 108. Thus, an access hole for a sharps member 482 (see, e.g., FIG. 15D) or needle included in the tubing connector 368 may be provided in the cannula subassembly 114. Septum retainer 112 also includes several through-holes 397. Through-holes 397 may aid in assembly and manufacturing similar to through-holes 166 in infusion set base 106.

[0347] In some embodiments, a slot 390 in a side wall 392 of the septum housing 108 may be used in place of the protrusion 388 as a retention feature that cooperates with a ridge included as part of the base 106. The ridge can hook against or engage with one wall of the slot 390, inhibiting removal of the cannula subassembly 114. In such embodiments, the protrusion 388 may not be included in the septum housing 108. This may help to further simplify manufacturing of the cannula subassembly 114.

[0348] 10A and 10B , another exemplary base 106 is shown. As shown in FIG. 6 , the top surface 168 of the platform portion 160 may include various receiving features extending therefrom that may engage or interface with a connector 368. The base 106 may include connector receptacles 170 that may allow the base 106 to mate with cantilevered fingers 370 on a tubing set connector 368, as described above (see, e.g., the description of FIG. 6 ). Guides 172 for each of the connector fingers 370 may also be included in the exemplary embodiment. As shown, the exemplary guides 172 include a first section 171 and a second section 173. The first section 171 of each guide 172 may be positioned to have a portion that extends substantially parallel to the plane of the platform 160. The second section 173 of each guide 172 may include a portion that is positioned at an angle relative to the first section 171. In this example, each of the first and second portions 171, 173 includes a ledge protruding from the main portion of the guide. The distance between the platform 160 and the proximal surface of the ledge of the second section 173 of the guide 172 can increase as the second section 173 extends distally from the ledge of the first portion 171 of the guide 172. This allows the tubing set connector 368 to initially be introduced at a substantial angle relative to the plane of the platform 160 of the base 106. Further introduction can cause the connector fingers 370 to contact the platform 160 and redirect them to the appropriate displacement path for mating of the tubing set connector 368. Thus, the guide 172 can help enable a user to blindly insert the connector fingers 370 into the connector receptacle 170 when mating of the base 106 and the tubing set connector 368 is performed. As shown, a second set of additional guide ledges 175 can be included on the receptacle wall extension 179. These additional guide ledges 175 may extend to the periphery of the base 106 .In the exemplary embodiment, the second set of guide ledges 175 extend substantially perpendicularly from the receptacle wall extension 179 of the guide 172 toward the axis along which the sharp member 482 of the tubing set connector 368 (see, e.g., FIGS. 184-188 ) is inserted into the cannula subassembly 114. The face of each of the second set of guide ledges 175, located near the end of each guide 172 most proximal to the periphery of the base 106, may include a sloped region.

[0349] 11A-11B, the tubing set connector 368 can include a flow hub 377 to which the tubing 366 and sharps 482 (see, e.g., FIGS. 184-188) can be coupled. Fluid flowing through the connector 368 can pass through lumens 514 and 516 (see, e.g., FIGS. 184-188) of the tubing 366 and sharps 482, respectively, within the flow hub 377. As shown in FIGS. 11A-11B, the flow hub 377 can include an alignment channel 375 embedded therein. As shown, the alignment channel 375 includes a constant-width segment 373 and a variable-width segment 379. Upon coupling of the tubing set connector 368 and the infusion set 102, the alignment channel 375 can interact with the second set of guide ledges 175 of the base 106. The angled section of each of the second set of guide ledges 175 and the variable width section 379 of the alignment channels 375 may allow the tubing set connector 368 to be initially introduced at a substantial angle relative to the plane of the platform 160 of the base 106. Upon further introduction, the second set of guide ledges 175 may contact the walls of the respective alignment channels 375, redirecting the tubing set connector 368 toward the appropriate displacement path for coupling the tubing set connector 368 to the base 106. Thus, the set of guide ledges 175 in conjunction with the alignment channels 375 may help enable a user to blindly couple the base 106 and the tubing set connector 368.

[0350] 12A-12B and 13A-13B, in some embodiments, a sharps side protrusion 372 may be included as part of the tubing set connector 368. As shown, the sharps side protrusion 372 can extend parallel to the axis of the sharps 482 (see, for example, FIGS. 184-188). This may be included in the tubing set connector 368. The sharps side protrusion 372 can help prevent user contact with the sharps 482 by providing an obstacle that blocks fingers from reaching the sharps 482. The sharps side protrusion 372 includes a centrally located protrusion 372 that extends from the top surface of the tubing set connector 368 onto the sharps 482. The sharps side protrusion 372 may also include a pair of protrusions that are in the same plane as, but positioned inboard of, the connector fingers 370 of the tubing set connector 368. In an exemplary embodiment, the connector fingers 370 and their set of protrusions 372 are aligned with the bottom surface of the tubing set connector 368. Each protrusion 372 of the set of protrusions 372 can be positioned to extend from a point on the body 367 of the tubing set connector 368 that is midway between the flow hub 377 and the connector fingers 370. These protrusions 372 can be positioned to interact with guides 172 on the base 106 during coupling of the tubing set connector 368 to a corresponding base 106. In such an embodiment, the connector fingers 370 may not interact with guides 172 on the base 106.

[0351] In some embodiments, as shown in FIGS. 13A-13B , multiple sharps side projections 372 in the plane of the connector fingers 370 can extend beyond the tips 381 of the connector fingers 370. These projections 372 can include a curved end region 383 at the end of the projections 372 opposite that attached to the body 367 of the tubing set connector 368. The curved end region 383 can curve transversely relative to the axis of the sharps 482 of the tubing set connector 368 (see, e.g., FIGS. 184-188 ). In this example, the curved end region 383 can have a curvature that sweeps an arc of greater than 90°. In this example, the curved end region 383 has a curvature such that the curved end region 383 begins to extend posteriorly toward the body 367 of the tubing set connector 368. The radius of the curved end region 383 can be constant or non-constant. Additionally, the curved end region 383 can include one or more straight extensions. As best shown in FIG. 13B , the portions of the curved end regions 383 that terminate in the prongs can be substantially straight. In this example, the curved end regions 383 curve around and in front of a portion of each connector finger 370. The distance between the prongs 372 may be slightly smaller than the spacing between the corresponding guides 172 on the base 106. However, the prongs 372 at the curved end regions 383 may be slightly larger to facilitate maneuvering the prongs 372 into their respective guides 172. Once the prongs 372 are positioned within the guides 172, advancement of the tubing set connector 368 causes the prongs 372 to resiliently spread apart. Due to the resiliency of the prongs 372, they press against the surfaces of the guides 172, ensuring a tight and substantially wiggle-free fit. This can help further limit the displacement of the tubing set connector 368 along a desired path when coupling of the tubing set connector 368 to the base 106 is complete.

[0352] 14A-14B, a set of sharp flanking projections 372 along the connector fingers 370 can extend from the flow hub 377. This can help reduce the gap between the sharp flanking projections 372 of the tubing set connector 368, further minimizing a user's ability to access spaces near the sharp 482 (see, e.g., FIGS. 184-188) with their fingers. The embodiment shown in FIGS. 14A-14B includes a set of sharp flanking projections 372 extending along and from opposing faces of the flow hub 377 transverse to the axis of the sharp 482. These projections 372 can each include a support segment 385. These support segments 385 can be located in the region of the sharp flanking projection 372 that extends beyond the face 387 of the flow hub 377 from which the sharp 482 extends. As shown, the support segment 385 is located in the portion of this region most proximal to the flow hub 377. The support segment 385 in the exemplary embodiment includes an arched surface that can provide additional rigidity to the set of sharps side projections 372. The surface 387 of the flow hub 377 from which the sharps 482 extend can also be arched, which can add further robustness to the projections 372.

[0353] 15A-H, another exemplary tubing set connector 368 is shown. As shown, a pair of sharps side projections 372A aligned with the connector fingers 370 may extend from the flow hub 377, similar to FIGS. 14A-B. As in FIGS. 14A-14B, this may help avoid inadvertent contact with the sharps 382. A centrally located sharps side projection 372B may also be included, extending from the top surface of the tubing set connector 368 onto the sharps 482.

[0354] Sharp side projections 372A, B can include at least one guide surface 371A-D. In some embodiments, each of sharp side projections 372A, B can include at least one guide surface 371A-D. Each of sharp side projections 372A shown in FIGS. 15A-H includes a lateral adjustment guide surface 371A and a height adjustment guide surface 371B. At least one of lateral adjustment guide surface 371A and height adjustment guide surface 371B may include a sloped segment. As shown, both lateral guide surface 371A and height adjustment guide surface 371B can include a first region proximal to flow hub 377 and a second region at the end of sharp side projection 372A distal to flow hub 377. The second region can be sloped (angled or curved), while the first region can be substantially straight or have a more gradual slope.

[0355] Sharp side projection 372B may also include at least one height adjustment guide surface 371C and at least one lateral adjustment guide surface 371D. In this example, at least one of height adjustment guide surface 371C and at least one lateral adjustment guide surface 371D may include a sloped portion. In this example, height adjustment guide surface 371C includes a first region proximal to flow hub 377 and a second region at the distal end of sharp side projection 372B. In the exemplary embodiment, the second region is sloped (inclined or curved). Sharp side projection 372B includes a centrally located trough 369 extending along the underside of sharp side projection 372B (the side closest to sharp 482). The sidewalls of this trough 369 can form two lateral guide surfaces 371D. A portion of at least one of lateral guide surfaces 371D (e.g., the most distal portion of flow hub 377) may be sloped.

[0356] 16A-16C, it may be desirable for portions of the infusion set base 106 and / or the cannula subassembly 114 to have relatively loose tolerances for ease of manufacturing. Thus, in some embodiments, the loose tolerances may cause the cannula subassembly 114 to be slightly angled when held in the infusion set base 106 (see, e.g., FIG. 9). Furthermore, the cannula subassembly 114 may change position slightly due to repeated connection and disconnection of the tubing set connector 368 to the infusion set base 106.

[0357] 16A-16C show cross-sectional views of an exemplary cannula subassembly 114 held stationary as the tubing set connector 368 gradually approaches the cannula subassembly 114. When the tubing set connector 368 is docked to the infusion set base 106 (see, e.g., FIG. 9), the exemplary tubing set connector 368 shown in FIGS. 15A-15F can be moved from an initial position (see, e.g., FIG. 16A) to an intermediate position just before the sharp member 482 pierces the septum 110 material of the cannula subassembly 114 (see, e.g., FIG. 16B). This range of displacement of the tubing set connector 368 is sometimes referred to as the homing displacement range. As the tubing set connector 368 is displaced through the homing displacement range, any of the guide surfaces 371A-D of the tubing set connector 368 may contact various regions or surfaces of the cannula subassembly 114 if the cannula subassembly 114 is angled. For illustrative purposes, the cannula subassembly 114 is shown in an exaggerated angled position in Figure 16A. The infusion set base 106 to which the cannula subassembly 114 is coupled is hidden for clarity.

[0358] As the tubing set connector 368 is further displaced through its homing displacement range, the guide surfaces 371A-D may push, orient, and / or adjust the cannula subassembly 114 to its home position. Inclined sections included on any of the guide surfaces 371A-D may facilitate this process by helping to guide or steer the cannula subassembly 114 to or toward its home position. In FIG. 16B , the cannula subassembly 114 is shown adjusted to its home position (again, the infusion set base 106 is hidden to more clearly show the cannula subassembly 114). The guide surfaces 371A-D may adjust the position of the cannula subassembly 114 along two axes that may be substantially perpendicular to one another and in a plane that is substantially perpendicular to the direction of extension of the sharp member 482 of the tubing set connector 368.

[0359] The tubing set connector 368 may then be displaced through a puncturing displacement range in which the sharp member 482 of the tubing set connector 368 penetrates the septum 110 included in the cannula subassembly 114. As shown in FIG. 16C , at the end of the puncturing displacement range, the tip of the sharp member 482 may be positioned within the fluid introduction volume 109 of the septum 110, and the connector fingers 370 may engage the connector receptacle 170 on the infusion set base 106. When puncturing the septum 110, the cannula subassembly 114 may be substantially restricted in movement by the guide surfaces 371A-D of the tubing set connector 368. The tubing set connector 368 may be considered fully docked to the infusion set base 106 at the end of the puncturing displacement range.

[0360] This two-stage connection of the tubing set connector 368 to the infusion set base 106 can help ensure that the septum 110 of the cannula subassembly 114 is consistently positioned before the tubing set connector 368 punctures the septum 110. This may be the case if loose tolerances are used during the manufacturing of certain components of the infusion set 102. The home position of the cannula subassembly 114 places the septum 110 in the proper position to allow the sharps 482 of the tubing set connector 368 to enter the fluid introduction volume 109 of the cannula assembly 114. This allows for a smaller fluid introduction volume 109, minimizing dead volume. Additionally, the connector needle passage 222 (see, e.g., FIG. 31B ) or other opening in the septum housing 108 that allows the sharps 482 to pass through the septum housing 108 can be smaller. Furthermore, the home position may be consistently achieved each time the tubing set connector 368 is reconnected to the infusion set base 106 so that the sharp member 482 punctures the septum 110 in substantially the same location.

[0361] In certain instances, there may be mechanical interference between at least one of guide surfaces 371C-D on sharp side protrusion 372B and nub 220 of septum 110. The mechanical interference may compress the material of nub 220 in a manner similar to the compression by protrusion 221 described in FIGS. 32A-32D, at least once tubing set connector 368 is moved fully to the docked position. For example, lateral adjustment guide surface 371D may compress the material of nub 220 toward the puncture path of insertion sharp 132 (see FIG. 74B). Height adjustment guide surface 371C may also compress the material of nub 220 to seal against its guide surface 371C.

[0362] In some examples, as primarily shown in FIG. 17 , the infusion set base 106 can include a track 361 that can engage and guide a sharps side protrusion 372 when a tubing set connector 368 (see, e.g., FIGS. 15A-15F ) is docked to the infusion set base 106. The track 361 can include a deflector body 363 that can resiliently deflect the sharps side protrusion 372 when the tubing set connector 368 and the infusion set base 106 are coupled together. In the example shown in FIG. 17 , the track 361 is positioned to interface with sharps side protrusion 372B (see, e.g., FIG. 15D ), although tracks 361 for other sharps side protrusions can also include a deflector body 363. The exemplary track 361 extends from a portion of the receptacle wall 178 that is most distal to the platform portion 160 of the base 106. As shown, in certain examples, the deflector body 363 can be a ramp. Upon contact with deflector body 363, sharp side protrusion 372B may be deflected and pressed against nub 220 (see, e.g., FIG. 5B ) of septum 110 of cannula subassembly 114 mounted on infusion set base 106. In the exemplary embodiment, side protrusion 372B may be deflected against nub 220, and in various embodiments, sharp side protrusions 372A,B may be deflected against any exposed portion of septum 110 of cannula subassembly 114.

[0363] 18A-18C, in some exemplary embodiments, the tube set connector 368 can include a tine 343. The tine 343 can be included in a sharps side projection 372A, B of the tube set connector 368. Such a tine 343 can be cantilevered relative to the remainder of the tube set connector 368. The tine 343 can be constructed to have at least a portion that extends out of the plane of the remaining sharps side projections 372A, B. The tine 343 can be deflectable toward the sharps side projections 372A, B, but can also have a degree of resilience that tends to return the tine 343 to its unstressed state when in a deflected state.

[0364] In the exemplary embodiment, the prongs 343 are included in the sharps side projections 372B of the tube set connector 368. The prongs 343 are attached to the sharps side projections 372B in a region of the prongs 343 that is most distal to a flow hub 377 of the tube set connector 368. The unsupported ends of the prongs 343 are included in a portion of the prongs 343 that extends substantially parallel to the remainder of the sharps side projections 372B. When the tube set connector 368 is coupled to the infusion set 102, the prongs 343 can advance over the cannula subassembly 114 coupled in the receptacle 176 of the infusion set base 106. When this occurs, the prongs 343 can resiliently deflect. When in the coupled state, the cannula subassembly 114 may prevent the prongs 343 from fully returning to an unstressed state. Instead, the pawl 343 may press against the nub 220 of the septum 110 of the cannula subassembly 114 .

[0365] In some embodiments, the end of the sharp side projection 372B most distal to the flow hub 377 may include a ramp 347. Such ramp 347 may be included in a portion of the end (see, e.g., FIG. 18B) or may extend over the entire end (see, e.g., FIG. 18C). The infusion set base 106 may include a deflector 345 that can advance the ramp 347 when the tubing set connector 368 is coupled to the infusion set 102. In some embodiments, the deflector 345 may be a protrusion extending from a portion of the infusion set base 106. Alternatively, the deflector 345 may be a slot in the infusion set base 106 through which the ramp 347 is displaced during coupling of the tubing set connector 368 to the infusion set assembly 102. When the ramp 347 is displaced into the slot 345, the sharp side projection 372B may be deflected toward the platform portion 160 of the infusion set base 106. This may further press the pawl 343 against the nub 220.

[0366] 18A-18C, the tab 343 and ramp 347 may be included in any of the tube set connectors 368 described herein. The deflector 345 may be included in any of the infusion set bases 106 described herein.

[0367] 19A-19C, in some embodiments, the tubing set connector 368 can include a clamp 321. When the tubing set connector 368 including the clamp 321 is coupled into engagement with the infusion set assembly 102, the clamp 321 can act against an exposed portion of the infusion set assembly 102. The clamp 321 can, for example, press against either side of the exposed portion of the septum 110 (e.g., nub 220) to compress the material of the septum 110.

[0368] The clamp 321 may, in some examples, be defined within or form the sharp side projection 372. As shown, the sharp side projection 372B is formed as the clamp 321. The clamp 321 may include a first body 323A and a second body 323B spaced apart by a gap. At least one of the first and second bodies 323A, 323B may be configured to displace toward the other of the first and second bodies 323A, 323B. Any suitable arrangement that facilitates such displacement may be used. In an exemplary embodiment, as best shown in FIG. 19B , the second body 323B is coupled to the flow hub 377 along a portion of the end of the second body 323B proximate the flow hub 377. This partial connection may allow the second body 323A to resiliently deflect or pivot toward the first body 323A. The first body 323A may be connected to the flow hub 377 along its entire second end. Thus, the exemplary first body 323A is resistant to deflection and can remain stationary.

[0369] The infusion set assembly 102 may include a deflector body 363. In an exemplary embodiment, the infusion set base 106 includes a set of ribs 325. The deflector body 363 is defined as an exposed or raised portion of one of the ribs 325. When the tubing set connector 368 is coupled to engage with the infusion set assembly 102, a portion of the clamp 321 may be displaced into the deflector body 363. Further displacement of the tubing set connector 368 may cause the deflector body 363 to deflect a portion of the infusion set assembly 102. In an exemplary embodiment, when the second body 323B is pushed into the deflector body 363, the second body 323B may be deflected toward the first body 323A. The clamp 321 may then surround the nub 220 of the septum 110. The clamping surfaces 329 of the first and second bodies 323A, 323B may press and compress the nub 220. A stop member 331 may be included to prevent rotation or misalignment of the tubing set connector 368 when the clamp 321 contacts the deflector body 363. The stop member 331 may provide a mechanical interference against unwanted movement of the tubing set connector 368 during mating. In the illustrated embodiment, the stop member 331 is a ridge on the rib 325 on the opposite side of the deflector body 363.

[0370] Compressing the nub 220 of the septum 110, as shown in FIGS. 15A-19C, to ensure that the sharp member 482 of the tubing set connector 368 pierces the septum 110 at substantially the same location as described above, is desirable for a variety of reasons. For example, these features may help to extend the range over which the cannula subassembly 114 can withstand leaks at pressures beyond those expected during use. Compressing the nub 220 allows a wider range of materials to be used for the septum 110 of the cannula assembly 114. Similarly, a wider range of material durometers can be used. Compressing the nub 220 via the protrusion 221 (see, e.g., FIGS. 32A-32D) or reducing the potential compressive stress relaxation of the material forming the nub 220 (see the discussion regarding FIGS. 32A-32D) may also help achieve the foregoing.

[0371] Another exemplary base 106 is shown in Figures 20A-20C. The exemplary base 106 can be coupled to a tubing set connector 368, such as that shown in Figures 14A and 14B. The base 106 can include a connector receptacle 170, which can enable the base 106 to mate with cantilevered fingers 370 on the tubing set connector 368, as described elsewhere herein. Although not shown in the exemplary embodiment, guides 172 for each of the connector fingers 370, such as those shown in Figures 6 and 10A, can be included. Such guides 172 can be included on any infusion set base 106 shown or described herein. As shown, the base 106 can define a receiver track 189 that can receive a set of sharps side projections 372 that lie in the plane of the connector fingers 370. As shown, the receptacle wall extensions 179 and portions of the receptacle wall 178 that extend parallel to one another can be separated from one another by a channel. The receiver tracks 189 are recessed in portions of the receptacle wall 178 that extend parallel to and adjacent the receptacle wall extension 179 and the platform 160. Thus, the width of the channel between the receptacle wall extension 179 and the portion of the receptacle wall 178 may be greatest adjacent the platform 160. The width of the channel may decrease as the distance from the platform 160 increases. As shown, the receiver tracks 189 may each include a sloped wall 191. The sloped wall 191 can aid in locating the sharps side protrusion 372 of the tubing set connector 368 within the receiver track 189. Additionally, the base 106 may include a sloped section 193 disposed at the open end of the receiver track 189. The sloped section 193, similar to the second section 173 of the guide 172 in FIGS. 10A-10B , allows the tubing set connector 368 to be initially introduced at a substantial angle relative to the plane of the platform 160. Further introduction may redirect the adjacent protrusion 372 into the receiver track 189 .Thus, angled wall 191 and angled section 193 can facilitate blind insertion of tubing set connector 368 into mating relationship with base 106 .

[0372] Referring now to Figures 21A-24C, additional exemplary infusion set bases 106 are shown. The bases 106 may include connector receptacles 170 that allow the bases 106 to couple with tubing set connectors 368. The tubing set connectors 368 shown in Figures 21A-21F may be coupled to tubing set connectors 368 such as those shown in Figures 15A-16C, as described elsewhere herein. The connectors 368 shown in Figures 22A-24C may be coupled to tubing set connectors 368 such as those shown in Figures 25A-26C.

[0373] As shown, the receptacle wall extensions 179 may be separated from one another by channels. The receptacle wall extensions 179 and the portions of the receptacle wall 178 forming each side of the channel may also include segments 177 that are positioned substantially parallel to the platform portion 160 of the infusion set base 106. Thus, the channel may include a wide portion adjacent to the platform portion 160 and a narrow portion distal to the platform portion. The wide portion of the channel may define a receiver track 189 that can receive multiple sharps side projections 372A. As shown in FIGS. 21A-21F and 22A-24C, in some embodiments, a sloped section 193 (see, e.g., FIGS. 20A-20C) may be included. The receiver track 189 may guide the sharps side projections 372A when the tubing set connector 368 is coupled to the base 106. Thus, the channel may be referred to as a guide channel.

[0374] As shown, the receptacle wall 178 may include a cut 181 in a portion of the receptacle wall 178 that defines the receiver track 189. The cut 181 may align with a notch 174 included in the receptacle wall 178. The cut 181 may extend through a portion of the segments 177 of the receptacle wall 178 that are parallel to the platform portion 160. The inner regions 161 of these segments 177 are uninterrupted by the cut 181. The cut 181 may extend from the segments 177 to the platform portion 160. The cut 181 may define receiving slots for portions of respective arms 332 (see, e.g., FIG. 59A ) of a portion of the inserter assembly 100. These receiving slots are sometimes referred to as inserter interface slots. The inner region 161 adjacent the cut 181 can serve as a stop for the ledge 348 defined on the arm 332 (described further in connection with FIG. 59A ). As best shown in FIG. 21D , the notch 174 in the receptacle wall 178 can be tapered along at least a portion of its length (e.g., the distal-most portion of the platform portion 160). Such a tapered notch 174 can help guide the cannula subassembly 114 into place when the infusion set 102 is assembled. In some embodiments, the entirety of each notch 174 can be tapered to various degrees. For example, a portion of each notch 174 most distal of the platform portion 160 can have a greater taper than a second portion of each notch 174 more proximal to the platform portion 160. Such a tapered notch 174 can be included in any of the infusion set bases 106 described or illustrated herein.

[0375] The exemplary infusion set base 106 of FIGS. 21A-F also includes a receptacle wall 178 that includes a cantilevered portion 180 with a ridge 182. The cantilevered portion 180 may be constructed to resiliently retract when the cannula assembly 114 is introduced, but resist deflection when a force is applied along the longitudinal axis of the cantilevered portion 180. The cantilevered portion 180 may be constructed to resiliently flex out of the way when the cannula assembly 114 is introduced, but resist deflection when a force is applied acting along the longitudinal axis of the cantilevered portion 180. The cantilevered portion 180 may include one or more ribs 163. The ribs 163 may protrude from the cantilevered portion 180 into the receptacle 176 and may extend along the length of the cantilevered portion 180. While ribs 163 are shown, other protrusions may be included in alternative embodiments. One or more recesses 165 may be located on the side of cantilever portion 180 opposite the side from which protrusion 182 extends. Recesses 165 may be located opposite each of ribs 163 or other thickened regions. When cannula assembly 114 is introduced, ribs 163 may help position cannula subassembly 114 within receptacle 176. Ribs 163 may also prevent cannula subassembly 114 from shaking when cannula subassembly 114 is within receptacle 176. Receptacle 176 is connected to base 106.

[0376] 22A-22C includes a plurality of cantilevered portions 180, each including a protrusion 182. Receptacle wall 178 includes cantilevered portions 180. Cantilevered portions 180 protrude from receptacle wall 178 away from platform portion 160 such that the unsupported end including protrusion 182 is the portion of cantilevered portion 180 most distal relative to platform portion 160. Cantilevered portions 180 are also positioned opposite one another on receptacle wall extension 179 adjacent receptacle wall 178. Cantilevered portions 180 extend in a direction (e.g., substantially perpendicular) away from platform portion 160 such that the unsupported end including protrusion 182 is the portion of cantilevered portion 180 most distal relative to platform portion 160. When the cannula subassembly 114 is introduced, each of the cantilevered support sections 180 may resiliently deflect out of the way to allow the cannula subassembly 114 to pass into the infusion set base 106. The angled surfaces of the protrusions 182 may help facilitate this deflection. When the cannula subassembly 114 advances into the receptacle 176 of the infusion set base 106 beyond a threshold amount, the cannula subassembly 114 may be displaced away from the protrusions 182. Each of the cantilevered portions 180 may then return to a less stressed or less deflected state. Each of the protrusions 182 may then overhang a portion of the cannula subassembly 114 (e.g., the septum housing 108). Thus, the cannula subassembly 114 may be captured within the infusion set base 106. While three cantilevered portions 180 are shown, alternative embodiments may include a different number of cantilevered portions 180. The receptacle wall 178, for example, may include a greater number of cantilevered portions 180. In an alternative embodiment, at least some of the cantilevered portions 180 can protrude toward the platform portion 160 such that their unsupported ends, including the protrusions 182, are the portions of the cantilevered portions 180 that are most proximal to the platform portion 160 (see, for example, the cantilevered portions 180 in FIGS. 21A-21F). The height of each cantilevered portion 180 is substantially the same in FIGS. 22A-22C.In alternative embodiments, the height of at least one cantilevered portion 180 may vary. The height may be selected so that the protrusion 182 protrudes to capture the cannula subassembly 114 installed in the receptacle 176. The embodiment of FIGS. 22A-22C may not include the notch 186 (see, e.g., FIG. 5A) or the protrusion 388 (see, e.g., FIG. 8A). The upper surface 394 (see, e.g., FIG. 29C) of the side wall 392 of the septum housing 108 (see, e.g., FIG. 29C) may provide an engagement surface against which the protrusion 182 retains the cannula subassembly 114 within the base 106.

[0377] 23A-24C, two exemplary infusion set base embodiments are shown. As shown, in certain instances, an additional retention member 261 may be included and may protrude from the platform portion 160 of the infusion set base 106. The exemplary embodiment shows a retention member 261 on an infusion set base 106 similar to that shown in FIGS. 22A-22C. However, as shown in FIGS. 22A-22C, such a retention member 261 may be included on any infusion set base 106 described herein (e.g., those shown in FIGS. 21A-F). The retention member 261 is positioned adjacent to the receptacle 176 and closest to the open end of the guide channel. In the exemplary embodiment, the retention member 261 is positioned opposite the cantilever portion 180. Such an exemplary retention member 261 may be hook-shaped or hook-like. When the tube set connector 368 is coupled to the exemplary infusion set base 106, the sharps 482 (see, e.g., FIG. 15F) may move along the entry path within the respective guide channel. The height of the retaining member 261 may be selected so as not to protrude into the entry path of the sharps 482, and therefore the retaining member 261 does not interfere with the sharps 482 during coupling of the tube set connector 368. Here, the cannula subassembly 114 may include a pair of notches 186 (see, e.g., FIG. 5A or FIG. 24E). The notches 186 may be located on opposing portions of an outer sidewall of a portion of the cannula subassembly 114.

[0378] 23A-23C , cantilevered support section 180 of receptacle wall 178 can snap into a first one of notches 186 that retain cannula subassembly 114 within receptacle 176 after cannula subassembly 114 has advanced beyond a certain distance within receptacle 176. Retaining member 261 can deflect as cannula subassembly 114 advances into receptacle 176. Retaining member 261 can return to an undeflected (or at least less deflected) state and snap into second notch 186 once cannula subassembly 114 has been advanced beyond the distance that it is within receptacle 176. In various embodiments, cantilevered section 180 and retaining member 261 can snap into notch 186 substantially simultaneously. 24A-24C, protrusion 182 of cantilever member 180 may be clipped into place against top surface 394 of septum housing 108 of cannula subassembly 114. Retaining member 261 helps limit squeezing of cannula subassembly 114 within receptacle 176, potentially allowing for looser tolerancing. Additionally, retaining member 261 may aid in centering cannula subassembly 114 within receptacle 176.

[0379] 25A-26C, an exemplary tubing set connector 368 is shown that can be used with, for example, the infusion set base 106 shown in FIGS. 22A-24C. The exemplary tubing set connector 368 includes sharps side projections 372A, B but does not include connector fingers 370. The exemplary tubing set connector 368 includes a pair of connector latches 365. As shown in FIGS. 25A-26C, the connector latches 365 may be included in place of the connector fingers 370 of other embodiments of the tubing set connector 368 described herein. The exemplary connector latches 365 may be disposed on an underside of the body 367. When the tubing set connector 368 is coupled to the infusion set 102, the connector latches 365 may engage with the connector receptacle 170 on the infusion set base 106. The body 367 of the tubing set connector 368 can act as a shield to help prevent fingers or objects from inadvertently disengaging the connector latches 365 from the connector receptacle 170. As shown in FIGS. 22A-24C , the connector receptacle 170 may be located on opposing portions of the base 106 lateral to the receptacle wall extension 179, between the closed and open ends of the guide channel. The portions of the body 367 containing the connector latch 365 are attached to and deflectable relative to the flow hub 377 and may be referred to herein as the flexible body portion. A clamping force toward the axis of the sharp member 482 on these portions of the body 367 may disengage the connector latch 365 from the connector receptacle 170. The tubing set connector 368 may then be separated from the infusion set 102, if desired. These portions of the body 367 may include gripping regions 475 that are uneven, wavy, crimped, etc., to assist in grasping the tubing set connector 368. In some examples (best shown in FIG. 26C ), the connector latch 365 may include a stop. The stops 479 can abut against the receptacle wall extensions 179 after deflection beyond a certain amount, thereby limiting the deflection of the flexible body segment.26B , in certain exemplary tubing set connectors 368, the tubing set connector 368 may have a sloped surface 477 on each flexible body portion. When the flexible body portions are pressed toward each other, the sloped surfaces 479 may be displaced relative to the connector receptacle 170. The sloped surfaces 479 may cause the tubing set connector 368 to be pushed out of engagement when pressed into the connector receptacle 170 of the infusion set base 106. Thus, the sloped surfaces 479 may facilitate separation of the tubing set connector 368 from the infusion set base 106.

[0380] 22A-26C, the exemplary tubing set connector 368 covers the connection between the connector latch 365 and the connector receptacle 170, so that the shielding wall 169 (see, e.g., FIG. 21A) is not included in the exemplary infusion set base 106 of FIGS. 22A-24C. When connected together, the exemplary tubing set connector 368 and base 106 can form an assembly with a low profile that reduces the likelihood of catching on clothing, for example.

[0381] As further shown primarily in FIGS. 22A-24C , a portion of the exemplary base 106 opposite the open end of the guide channel can be formed by a contoured wall 357. The contoured wall 357 can extend to a portion of the periphery of the base 106 opposite the open end of the guide channel. The contoured wall 357 can tend to taper toward the plane of the platform portion 160 as it approaches the periphery of the base 106. The platform portion 160 does not have to be continuous below the contoured wall 357. Instead, a cavity may be present below the contoured wall 357 to help facilitate molding. As shown in FIG. 22B , for example, a transition wall 349 can extend from the platform portion 160 to the edge of the contoured wall 357 that is most proximal to the open end of the guide channel. The transition wall 349 can be disposed approximately perpendicular to the axis of the guide channel in some embodiments.

[0382] 25A-25C, the transition wall 349 can include a passageway 341 extending through the transition wall 349 and into a cavity below the contoured wall 357. When the tubing set connector 368 is coupled to the infusion set base 106, the sharps side projection 372A can extend through the passageway 341 in the transition wall 349. The unsupported end of the sharps side projection 372A can protrude into the cavity. The contoured wall 357 of the infusion set base 106 can be approximately flush with the exterior surface of the body 367 of the tubing set connector 368. The flexible body portion of the body 367 of the tubing set connector 368 can fit tightly against the transition wall 349 of the infusion set base 106 such that there is substantially no gap between the transition wall 349 and the tubing set connector 368 when the base 106 and the tubing set connector 368 are connected.

[0383] 27A-27B, the tube set connector 368 shown in FIGS. 26A-C may include connector fingers 370 in addition to the connector latch 365. The infusion set base 106 may include additional passageways 341 within a transition wall 349. When the tube set connector 368 is displaced into an engaged position with the infusion set base 106, the connector fingers 370 may flex around the side walls of each additional passageway 341. When the connector fingers 370 are coupled to the infusion set base 106, they may clip into engagement with the rear surface of the transition wall 349, as shown in FIG. 27B. The connector latch 365 may also engage with the connector interface 170. Thus, the infusion set base 106 and the tube set connector 370 may be coupled to each other by multiple coupling structures.

[0384] 28A and 28B, another example infusion set base 106 is shown. In certain embodiments, base 106 may not include receptacle wall 178 having cantilevered protrusion 180 defined therein (see, e.g., FIG. 4A). As shown in FIGS. 28A and 28B, in some examples, base 106 may include a retaining member 195 extending from platform 160. Retaining member 195 is freestanding and not supported by or continuous with receptacle wall 178. In FIGS. 28A and 28B, retaining member 195 is shown as a hooked body extending from the platform and positioned in an opening between two sections of receptacle wall 178. In other examples, a hooked body may not be used. Instead, a cantilevered member including a protrusion 182, such as a barb or ramp, that engages with a portion of cannula subassembly 114 may be used. The hook body may include a shank region 197 attached to and contiguous with the platform 160. The shank region 197 may extend from the platform 160 to a bend region 199. The shank region 197 may be perpendicular to the platform 160 or angled to extend toward the receptacle 176. The hook body may also include a locking segment 201 extending from the bend region 199. The locking segment may be positioned perpendicular to the shank region 197. In this example, the locking segment 201 extends at an acute angle relative to the shank 197. For example, the locking segment 201 may be positioned at a 35-40° angle relative to the shank 197.

[0385] When cannula subassembly 114 is introduced into base 106, septum housing 108 (see, e.g., FIG. 8A ) contacts locking segment 201 and can elastically deform retaining member 195 so that locking segment 201 is bent out of the way. After cannula subassembly 114 is advanced into receptacle 176 beyond a certain point, the engagement surface of septum housing 108 can pass the end of locking segment 201. At this time, locking segment 201 can include at least a portion that overhangs the engagement surface of septum housing 108 after springing back to its unstressed state. Thus, locking segment 201 can inhibit removal of cannula subassembly 114 from base 106. The engagement surface of septum housing 108 can be any suitable engagement surface on any portion of cannula subassembly 118. For example, the engagement surface may be a notch 186 in the septum housing 108 (see, e.g., FIG. 5A), a wall of a fenestration in the septum housing 108 (see, e.g., connector needle passageway 122 in FIG. 6), a wall of a slot 390 included in the septum housing 108, or a protrusion 388 included as part of the septum housing 108.

[0386] 29A-29D, various views of an exemplary embodiment of a cannula subassembly 114 are shown. The exemplary cannula subassembly 114 includes a septum housing 108, a cannula 104, a septum 110, and a septum retainer 112. The septum housing 108 includes a slot 390 in a side wall 392 of the septum housing 108 recessed into a top surface 394 of the side wall. When installed within the cannula subassembly 114, the septum retainer 112 can block access to the side of the septum 110 in an area near the top surface 394 of the septum housing 108. The end of the slot 390 may be exposed to provide access to a sharp member 482 (see, for example, FIG. 15D) included in the tube connector 368. The terminus of the slot 390 may provide an engagement surface for a cantilevered protrusion 180. A retention member 195 (see, eg, FIG. 4A) or retention member 195 (see, eg, FIG. 27A) is included within the infusion set base 106 that can capture the cannula subassembly 114 .

[0387] As shown, the cannula 104 and the septum housing 108 are shown as separate, individual components in FIGS. 29A-29D. Although shown as separate components, the cannula 104 and the septum housing 108 may be integral with one another, as described elsewhere herein. The exemplary cannula 104 may include an enlarged end region 215. The enlarged end region 215 may include an insertion sharp guide section 216 that may be continuous with the wall of the lumen 202 of the cannula 104. The insertion sharp guide section 216 may assist in directing the insertion sharp 132 (see, e.g., FIG. 1A ) into the lumen 202 of the cannula 104 during assembly. The enlarged end region 215 may also include a septum interface region 183 upon which a corresponding portion 185 of the septum 110 rests. The septum interface region 183 may surround the insertion sharp guide section 216. The septum interface region 183 can contact a corresponding portion 185 of the septum 110 and provide a sealing surface against which the septum 110 can be compressed to form a fluid-tight seal when the cannula subassembly 114 is assembled.

[0388] Septum interface region 183 can have many different geometric shapes, depending on the embodiment. In this example, septum interface region 183 can have a substantially straight wall portion 187 along its distal-most portion from the exit of cannula 104. Straight wall portion 187 can extend substantially parallel to the longitudinal axis of cannula 104. Straight wall portion 187 may transition to a frusto-conical shape 189 that widens as septum interface region 183 extends toward exit 212 of cannula 104. In alternative embodiments, the entire septum interface region 183 can be straight-walled (see, e.g., FIG. 31E) or frusto-conical in shape.

[0389] The recess 214' may be included in a surface of the enlarged portion 215 that surrounds or at least partially surrounds the cannula 104. In an example embodiment, the recess 214' is approximately shaped as a conical section (e.g., a hyperbola or parabola) rotating about the central axis of the cannula 104. The septum housing 108 includes a passageway 399 extending through a bottom wall 395 of the septum housing 108. A cannula seat 401, which may be a protruding wall or post surrounding the passageway 399, may also be included in the septum housing 108. The recess 214' in the enlarged portion 215 of the cannula 104 may receive at least a portion of the cannula seat 401 and may help to position and hold the cannula 104 in place within the cannula seat 401. A bottom surface 217 of the enlarged portion 215 (the surface most proximal to the outlet 212 of the cannula 104) may be located against the bottom wall 395. When the cannula assembly 114 is assembled, the cannula 104 may pass through the passageway 399, with the outlet 212 exiting the septum housing 108. A space may exist between the outside of the cannula 104 and the sidewall of the passageway 399. This space may provide room for the cannula 104 to move relative to the base 106 if the infusion set 102 or a portion of the patient's body applies force to the cannula 104. This may minimize shear forces on the cannula 104. Additionally, this volume may serve as a volume for any agent (medication). For example, any of the agents discussed in connection with FIG. 5B may be used.

[0390] As shown, the septum 110 can include a fluid introduction volume 109. The exemplary fluid introduction volume 109 includes at least one rounded sidewall. In this example, the fluid introduction volume 109 is in the shape of a slice of a sphere with the opposing spherical caps removed. In other embodiments, a generally spherical or other rounded volume without straight sidewalls may be used. Such a shape may help ensure that a relatively large fluid introduction volume 109 remains even under volumetric distortion that may occur when the septum 110 is compressed during assembly of the cannula subassembly 114. Furthermore, such a shape may allow for greater fluid introduction without changing the size of the enlarged portion 215 of the cannula 104. This may allow the fluid introduction volume 109 to present a larger target for the sharp member 482 of the tubing set connector 368 (see, e.g., FIGS. 15A-16C). This may allow components of the infusion set 102 or tubing set connector 368 to be constructed with looser tolerances, simplifying manufacturing.

[0391] 30A-30B, two exemplary cannula embodiments are shown. In some embodiments, the cannula 104 may include a fluid introduction volume reinforcement body 107 at the end of the enlarged region 215 most distal to the outlet 212. The reinforcement body 107 may extend into the fluid introduction volume 109 or abut a sidewall of the fluid introduction volume 109. The reinforcement body 107 can prevent distortion of the fluid introduction volume 109 when the septum 110 is compressed. The reinforcement body 107 can include a passageway 105 that can align with a slot 390 (see, e.g., FIG. 28C) or a connector needle passageway (see, e.g., FIG. 6). This allows a sharp member 482 on the tubing set connector 368 (see, e.g., FIG. 15C) to have a path through the reinforcement body 107 to the fluid introduction volume 109 when the tubing set connector 368 is connected to the infusion set base 106. As shown, the passageway 105 can be an opening (oblong in the example, but can be any suitable shape) or a slot. Such a reinforcement 107 can be included in any of the cannulas 104 described and / or shown herein.

[0392] 30A-30G, another exemplary cannula assembly 114 is shown. Referring to FIGS. 28A-28D, the exemplary cannula subassembly 114 includes a cannula 104 and a septum housing 108, which are separate components (although in alternative embodiments, they may be integral with one another). The cannula 104 can have an enlarged region 215 that includes a septum interface region 183 that surrounds an insertion sharps guide 216 of the cannula 104. When assembled, a corresponding portion 185 of the septum 110 can seat against the septum interface region 183. The enlarged region 215 can also include a flange 219 that can be located at the end of the enlarged region 215 closest to the exit port 212 of the cannula 104. As shown in FIG. 31E, the bottom wall 395 of the septum housing 108 can include a seat for the cannula 104. In this example, the seat is shown as a receptacle 393 in which the flange 219 seats. The receptacle 393 can aid in centering the cannula 104 within the septum housing 108 .

[0393] The recess 214' may be included in a surface of the enlarged portion 215 that surrounds or at least partially surrounds the cannula 104. In an exemplary embodiment, the recess 214' is approximately shaped as a conical section (e.g., a hyperbola or parabola) revolving around the central axis of the cannula 104. The septum housing 108 includes a passageway 399 extending through a bottom wall 395 of the septum housing 108. The walls of the passageway 399 may be angled or contoured to match and be an extension of the recess 214'. This may create a volume that can be filled with a medication (described elsewhere herein) and / or may allow some movement of the cannula 104 relative to the infusion set base 106. A receptacle 393 (or other seat) may surround the passageway 399.

[0394] The septum housing 108 may include multiple protrusions 391 (best shown in FIG. 31F ) extending from the wall of the receptacle 192 of the septum housing 108 toward the elongation axis of the cannula 104. In embodiments, these protrusions 391 are in the form of substantially straight ridges or ribs. Each of the protrusions 391 may be the same length, or at least one of the protrusions 391 may have a different length than at least one of the other protrusions 391. In certain embodiments, the end of the protrusion 391 most distal to the outlet 212 of the cannula 104 may be beveled or curved (shown in FIG. 31F ). Each of the connector needle passages 222 (which are openings in the illustrated example, but potentially slots 390 in alternative examples where slots 390 are present in the septum housing 108) may be flanked by protrusions 391, which may extend immediately adjacent each side of the connector needle passage. The protrusions 391 may contact the septum 110 (or at least one of the septums 110 in embodiments having multiple septums 110) when the septum 110 is installed within the septum housing 108. The space between the protrusions 391 may provide a volume into which the material of the septum 110 is forced when the cannula subassembly 114 is assembled and the septum 110 is under compression. The septum retainer 112 also includes a pair of protrusions 391′ included on cantilevered protrusions 188 extending from the body 206 of the septum retainer 112. When the cannula subassembly 114 is fully assembled, the protrusions 391, 391′ may contact the septum 110, further compressing the septum 110 and increasing the robustness of the fluid-tight seal formed by the septum 110. Such protrusions 391, 391′ also allow for relaxed tolerances used to simplify manufacturing.

[0395] 32A-32D , another example cannula subassembly 114 is shown. The example cannula subassembly 114 includes a septum retainer 112 including a channel 218 located substantially in the center of the body 206 of the septum retainer 112. A nub 220 of the septum 110 may protrude into, and perhaps partially through, the channel 218. The septum 110 may have a diameter slightly larger than the diameter of the channel 218. Thus, the nub 220 may be compressed by the channel 218. Furthermore, the channel 218 may have a diameter that traverses a majority or majority of the diameter of the body 206 of the septum retainer 112. This allows compression exerted by the walls of the channel 218 to be spread across a relatively large amount of the material of the septum 110. As a result, compressive stress relaxation of the material of the septum 110 may be reduced over the shelf life of the inserter assembly 100.

[0396] The insertion sharp 132 of the inserter assembly 100 can extend through the nub 220 before the inserter assembly 100 is used (see, for example, FIG. 74B). The septum 110 can completely self-seal and prevent leakage once the insertion sharp 132 is removed. In certain examples, the average width or diameter of the nub 220 can be selected such that the diameter of the insertion sharp 132 is less than 10% of the average width of the nub 220. This can further reduce stress relaxation of the septum 110 material while the inserter assembly 110 is waiting to be used.

[0397] As shown, the channel 218 may include sidewalls that are primarily straight and extend parallel to the elongation axis of the cannula 104. Thus, the compression exerted by the sidewalls of the channel 218 on the protrusion 220 may be directed primarily perpendicular to the elongation axis of the cannula 104. This may maximize the compression exerted by the channel 218 toward the puncture path of the insertion sharp 132. Furthermore, by reducing the compressive stress relaxation of the septum 110, a greater degree of elasticity may be maintained in the material of the septum 110. Thus, the channel 218 of FIGS. 31A-31D may help resist leakage at pressures even greater than those expected during use. Additional potential advantages are discussed above in connection with FIGS. 15A-16C and 17.

[0398] The exemplary septum retainer 112 may include one or more protrusions 221 protruding from the exposed surface of the septum retainer 112, which may at least partially surround the channel 218. In some embodiments, the protrusions 221 may surround the entire channel 218. In the exemplary embodiment, the protrusions 221 are included as part of the crenellations surrounding the channel 218. In this example, only two merlons and associated crenels are shown. The merlons may be positioned opposite each other to surround the channel 218. In other embodiments, any suitable number of crenels may be included, and the crenels may or may not be positioned at regular angular intervals. In the example, at least one protrusion 221 extends approximately perpendicular to the body 206 of the septum retainer 112. In other embodiments, at least one protrusion 221 may extend toward the axis of the channel 218, or may extend partially toward the axis of the channel 218.

[0399] 33A-33D , in some examples, channel 218 may be completely surrounded by protrusion 221, at least a portion of which is angled toward the axis of channel 218. Thus, protrusion 221 may block all but a small portion of nub 220. Protrusion 221 in FIGS. 33A-33D forms a cap or cover over nub 220 and may be referred to herein as the cap or cover portion of septum retainer 112. The portion of protrusion 221 most distal to outlet 212 of cannula 104 is substantially planar and oriented perpendicular to the axis of channel 218. In certain examples, the wall of protrusion 221 adjacent nub 220 may include one or more protrusions similar to protrusion 391 described with respect to FIG. 31F.

[0400] When the nub 220 of the septum 110 is compressed during assembly of the cannula subassembly 114, the material may tend to "mushroom" as it protrudes through the channel 218. The protrusion 221 helps prevent this "mushrooming," forcing the material of the septum 110 toward the puncture path of the insertion sharp 132 (see, e.g., FIG. 74B). This may help the cannula subassembly 114 resist leakage at pressures even beyond those expected during use. Additional potential advantages are described above in connection with FIGS. 15A-16C and 17.

[0401] 34A-34F, another example cannula subassembly 114 is shown. As shown, cannula subassembly 114 includes cannula 104 and septum housing 108. Septum retainer 112 (see, e.g., FIG. 32A) is not included in the embodiment shown in FIGS. 34A-34F. This reduces the number of parts and may help simplify manufacturing of cannula assembly 114.

[0402] The exemplary cannula 104 includes an enlarged region 215 that includes a septum interface region 183 that surrounds an insertion sharps guide 216 of the cannula 104. When assembled, a corresponding portion 185 of a septum 110 (not shown in FIGS. 34A-34F, but see, for example, FIG. 32D) can be positioned against the septum interface region 183. The enlarged region 215 can also include an outwardly extending flange 219. The surface of the flange 219 farthest from the cannula outlet 212 can include a recess 223 that can receive the end of the septum 110. The recess 223 can include a contoured surface that helps center and position the septum 110 within the cannula subassembly 114. The opposite surface of the flange 219 can include a set of recesses 214A, B. Recess 214A provides space for the portion of cannula 104 extending from this surface to move relative to infusion set base 106, minimizing shearing effects on cannula 104. Medication may be provided in either recess 214A, B, as described elsewhere herein.

[0403] A number of cantilever arms 231 may be included around the flange 219. A terminal projection or latch member 233 may be included on the unsupported end of each of the cantilever arms 231. Thus, the cantilever arms 231 may sometimes be referred to as latch arms. During assembly, the latch member 233 of each cantilever arm 231 may slide within its respective guide 208, which is included on the inner surface of the receptacle 192 of the septum housing 108. The illustrated guides 208 are recessed into the inner surface of the septum housing 108. When the latch member 233 is within the guide 208, the cantilever arms 231 may be resiliently deflected toward the axis of extension of the cannula 104. After a certain distance, the latch member 233 may exit the guide 208 and pass through an opening 235 included in the septum housing 108. This allows the cantilever arms 231 to resiliently recover and spring outward, actuating the latch member 233 on each cantilever arm. 231 latch into engagement with locking surfaces 210 defined by each of the openings 235. In the exemplary embodiment, the cannula 104 includes a set of four cantilever arms 231. The cantilever arms 231 are also spaced apart from one another at substantially regular angular intervals, although this need not be the case in all exemplary embodiments. In other embodiments, a greater or lesser number of cantilever arms 231 may be included. The openings 235 in this example are notches recessed into a first end wall 241 of the septum housing 108 and partially into a side wall 243 of the septum housing 108. The first end wall 241 closes one end of the septum housing 108, and a flange 219 of the cannula 104 can close a second end of the septum housing 108 when the cannula 104 is coupled to the septum housing 108. The septum 110 (not shown) may be captured between the flange 219 and the first end wall 241. Septum housing 108 when cannula subassembly 114 is assembled. First end wall 241 may include a channel 218′ extending therethrough that receives nub 220 of septum 110 (see, e.g., FIG. 33D).

[0404] As shown, the flange 219 may also include a number of ledge members 237 that may extend outward from the periphery of the flange 219. When the cannula subassembly 114 is assembled, the ledge members 237 may provide a retention interface that engages with, for example, the protrusions 182 on the cantilevered protrusions 180 (see, for example, FIG. 4A ) of the infusion set base 106. Thus, the ledge members 237 may aid in coupling the cannula subassembly 114 to the infusion set base 106. The septum housing 108 may include a recess 245 adjacent at least one of the ledge members 237.

[0405] 35A-35F and 36A-36E, additional exemplary cannula subassembly 114 embodiments are shown. The ears 204 extending from the main portion of the exemplary septum housing 108 can include wedge bodies 205. Such wedge bodies 205 may be included in the ears 204 of the other cannula subassemblies 114 shown and described herein. The wedge bodies 205 may be positioned on each portion of the ears 204 that is most distal from the outlet 212 of the cannula 104 and may be positioned opposite each other on opposite sides of the ears 204. The thickness of the wedge bodies 205 may decrease as the distance to the outlet 212 of the cannula 104 decreases. The wedge bodies 205 may extend from a sidewall 207 of the septum housing 108.

[0406] Additionally, the ear 204 may include an extension 209 extending from the main portion 211 of the ear 204 toward the outlet 212 of the cannula 104. Such an extension 209 may be included in other cannula subassemblies 114 illustrated and described herein. The extension 209 may be tapered such that the width of the extension 209 decreases as it approaches the outlet 212 of the cannula 104. When the cannula subassembly 114 is displaced into the infusion set base 106, the tapering of the extension 209 may help orient the cannula subassembly 114 into the notch 174 (see, e.g., FIG. 4A ) of the infusion set base 106. In certain examples, the distal-most end of the extension 209 of the main portion 211 of the ear 204 may be thinned and potentially become a sacrificial portion. If the extension 209 is too long (e.g., due to tolerances), this sacrificial portion of the extension 209 may deform as it moves into the interference structure of the base 106. Thus, the sacrificial portion of extension 209 allows cannula subassembly 114 to couple to base 106 without issue, even if relatively loose tolerances are used. Wedge body 205 can help ensure that cannula subassembly 114 is held snugly within notch 174 during assembly (see, e.g., FIG. 4A ) and can help center cannula subassembly 114 within receptacle 176 (see, e.g., FIG. 4A ). Wedge body 205 may allow notch 174 and / or septum housing 108 to be made to less tight tolerances, while minimizing the likelihood that cannula subassembly 114 will have room to wiggle when held within receptacle 176 (see, e.g., FIG. 4A ). Wedge body 205 may also help guide cannula subassembly 114 into place during assembly to base 106.

[0407] 37A-37B in addition to FIGS. 35A-36E, in certain embodiments in which the cannula 104 and the septum housing 108 are separate components, multiple septa 110A, 110B may be included. Other embodiments may also include multiple septa 110A, 110B. Each of the exemplary septa 110A, 110B may be made of the same or different materials and / or durometers. The cannula 104 may include an enlarged region 215 and a flange 219, as described in connection with FIGS. 31A-31G, for example. The flange 219 may be captured in a fluid-tight manner between each of the septa 110A, 110B. In the exemplary embodiment, the first septum 110A may include the fluid introduction volume 109 and a corresponding portion 185 that seats in the septum interface region 183 of the cannula 104. The second septum 110B may be positioned opposite the first septum 110A. The second septum 110B may include a protruding portion 113 that extends into the passageway 399 of the septum housing 108. An orifice 115 may be included in a central region of the protruding portion 113. The cannula 104 may extend through the orifice 115 to the exterior of the cannula subassembly 114 (best shown in FIGS. 37A-37B). The orifice 115 may also seal against the surface of the cannula 104. Because the material of the septum 110B is elastomeric, the septum 110B may allow relative movement of the cannula 104 with respect to the infusion set base 106, minimizing shearing effects on the cannula 104.

[0408] Referring primarily to Figures 37A-37B, views of septa 110A, B from Figures 35A-35F and 36A-36E are shown, respectively. At least one of septa 110A, B may include a peripheral edge 117 on a side of the septum 110A, B closest to the opposing septum 110A, B. The peripheral edge 117 forms a fluid-tight seal and may extend adjacent an edge of a flange 219 of the enlarged portion 215 of the cannula 104 when the cannula subassembly 114 is assembled. The peripheral edge 117 may also surround a receptacle area of ​​the septum 110A, B in which the peripheral edge 117 is included. The receptacle area can receive the flange 219 of the cannula 104 during assembly.

[0409] 38A-38E and 39A-39E, a further exemplary embodiment of the cannula subassembly 114 is shown. As shown, the cannula subassembly 114 includes multiple septa 110A, 110B. In the exemplary embodiment, the first septum 110A is cup-shaped. The second septum 110B is also cup-shaped, but is inverted relative to the first septum 110A when the septa 110A, 110B are installed within the receptacle 192 of the septum housing 108. As described herein, the receptacle 192 of the septum housing 108 may include a protrusion 391 (further described above in connection with FIGS. 31-31).

[0410] As shown in FIGS. 38A-39E, the second septum 110B is sized to fit within the cup or cavity formed by the first septum 110A. The inner wall of the cup of the first septum 110A can establish a fluid seal against the outer sidewall of the second septum 110B. The second septum 110B can seal against the septum interface portion 183 of the enlarged region 215 of the cannula 104. The flange 219 of the cannula 104 can be captured in a fluid-tight sealing relationship between the two septums 110A, 110B (see FIGS. 38A-38E). Alternatively, the second septum 110B may include a recess 119 defined in the inner wall of the cup portion of the second septum 110B (see FIGS. 39A-39E). The flange 219 of the cannula 104 may fit within this recess 119 when the cannula subassembly 114 is assembled, and the recess 119 may establish a fluid-tight seal against the flange 219. The first septum 110A may include a protrusion 113 that protrudes into a passage defined in the septum housing 108. The cannula 104 may extend out of the septum housing 108 through an orifice 115 in the protrusion 113. The elastomeric material of the septum 110A allows for displacement of the cannula 104 relative to the infusion set base 106, minimizing any shear stress that may be experienced by the cannula 104 during use.

[0411] 40A-40C, in some embodiments, the flange 219 can extend non-radially from the cannula 104 and need not be substantially planar. The flange 219 can extend from the cannula 104 such that as the flange 219 widens, the distance from the outlet 212 of the cannula 104 increases in a linear (or alternatively, non-linear) relationship. Thus, the flange 219 may be in the shape of a hollow frustum cone. In other embodiments, the relationship between the distance from the outlet 212 and the width of the flange 219 need not be linear, and at least a portion of the flange 219 may have a curved profile when viewed in cross section. The first and second septa 110A,B may include cooperating sloped or contoured surfaces that engage opposing sides of the flange 219 to form a fluid-tight seal. The second septum 110B can include a protrusion 113 having an orifice 115 into which the cannula 104 can extend. Flange 219 establishes a ball-and-socket type relationship with septa 110A, B, which can allow for greater movement of cannula 104 relative to the rest of infusion set 102 while maintaining a robust seal. Such a ball-and-socket type arrangement between cannula 104 and septa 110A, B may be used in any embodiment in which cannula 104 is not integrally formed with septum housing 108.

[0412] Various embodiments of the infusion set base 106, tubing set connector 368, and cannula subassembly 114 are described herein. While certain features of these components may be described in the context of certain exemplary embodiments, the scope of the present disclosure is not limited thereto. It is contemplated that features of any infusion set base 106, tubing set connector 368, or cannula subassembly 114 may be incorporated into other infusion set base 106, tubing set connector 368, or cannula subassembly 114 embodiments without departing from the scope of the present disclosure. Furthermore, any of the tubing set connectors 368 described herein may be constructed as a cap body that does not include a sharp member 482 (e.g., see FIG. 15D ), an attached infusion tube 366 (e.g., see FIG. 6 ), and / or any flow channels, tube receptacles 512 (e.g., see FIG. 190 ), adhesive introduction openings 520 (e.g., see FIG. 1190 ), etc. Such a cap body may be placed on the infusion set assembly 102 when the infusion set assembly 102 is not connected to the tubing set connector 368 (eg, when the infusion pump is disconnected during bathing).

[0413] Referring to FIGS. 41A and 41B, two side views of the inserter assembly 100 are shown. The inserter assembly 100 in FIG. 41B is rotated 90 degrees clockwise from the orientation of FIG. 41A. The exemplary inserter assembly 100 is an assembled version of the exploded view shown in FIG. 1A. The two views may represent the appearance of the inserter assembly 100 before use and after the inserter assembly 100 has been removed from its shipping / storage package. As shown, the outer housing 116 of the inserter assembly 100 is visible, with the locking member 146 in place. Additionally, an adhesive backing 111 is present and covers the adhesive layer present on the bottom surface 162 of the infusion set base 106. The adhesive backing 111 may include a gripping area 224, which may be a backing material in the form of a flange, tab, or other protrusion, that extends beyond the footprint of the inserter assembly 100. This gripping area 224 can be grasped by a user and used to peel the adhesive backing 111 from the infusion set 106. Once the backing 111 is removed, the inserter assembly 100 can be positioned relative to the desired injection site, using the raised ribs 118 to aid in alignment. The locking member 146 can then be pulled from the inserter assembly 100 to actuate the inserter assembly 100. Because the exemplary adhesive backing 111 is attached to the locking member 146, extraction of the locking member 146 can complete the separation of the adhesive backing 111 from the inserter assembly 100. If the user is dissatisfied with the position of the inserter assembly 100, the user can leave the locking member 146 on the inserter assembly 100 and pull the inserter assembly 100 from the body. The presence of the locking member 146 can prevent actuation when this occurs and may allow the user to select a different injection site.

[0414] 42A and 42B, two additional views of the inserter assembly 100 are shown. The exemplary adhesive backing 111 includes a strip 225 extending from a portion of the adhesive backing 111 that covers the adhesive layer present on the bottom surface 162 of the infusion set base 106 (see, e.g., FIGS. 43-45). In some embodiments, the strip 225 can extend substantially parallel to and adjacent to the gripping region 224 of the adhesive backing 111. In the example shown in FIGS. 42A and 42B, the adhesive backing 111 is coupled to the outer housing 116 of the inserter assembly 100 in place of the locking member 146. The strip 225 may have a length that is longer than the height of the inserter assembly 100. Thus, a terminal region 227 of the strip 225 can be coupled to the top surface of the outer housing 116. The termination region 227 may be attached via, for example, heat staking, welding (e.g., sonic welding), or adhesive (e.g., double-sided tape or other adhesive). The termination region 227 may be bonded to a location that does not obstruct the view of the raised alignment ribs 118 present on the top surface of the outer housing 116. The strip 225 may be attached to another portion of the inserter assembly 100 (e.g., the side of the outer housing 116 and / or the locking member 146) in certain embodiments. In other embodiments, the length of the strip 225 may be different, and the termination region 227 may be bonded to another portion of the inserter assembly 100 (e.g., the side of the outer housing 116 or the locking member 146).

[0415] 43-45, an exemplary adhesive assembly 602 is shown. The exemplary adhesive assembly 602 shown in FIGS. 43-45 can be attached to the inserter assembly 100 in the manner shown in connection with FIGS. 42A-42B. The exemplary adhesive assembly 602 is shown in FIG. 43 with the infusion set base 106. The infusion set base 106 is not shown in FIGS. 44-45. In some examples, the infusion set base 106 may be installed within the inserter assembly 100, and then the adhesive assembly 602 may be coupled to the base 106.

[0416] As shown, the adhesive assembly 602 can include a liner 111 or backing. The liner 111 can cover and protect an adhesive patch 614 affixed to the infusion set base 106. The liner 111 can be constructed of any suitable material, such as a polymer or wax paper, and can be removed from the infusion set base 106 prior to use of the inserter assembly 100 in which it is included. Optionally, the adhesive assembly 602 can include an adhesive 616 that is separate from the adhesive patch 614 on another area of ​​the liner 111. This adhesive 616 can be used to bond the liner 111 to a portion of the inserter assembly 100, such as the outer housing 115 of the inserter assembly 100 or the flange 152 of the locking member 146.

[0417] As shown, the liner 111 may have a substantially flat, elongated shape (e.g., die-cut, laser-cut, etc., from a larger sheet of material), but may also be flexible and bendable or foldable for routing as shown in FIGS. 42A-42B . One end of the liner 111 may include an enlarged region 604. The enlarged region 604 may be an adhesive patch covering portion of the liner 111 that can cover the adhesive of an adhesive patch 614 attached to the infusion set base 106. The enlarged region 604 and adhesive patch 614 may have at least a partially rounded footprint, which may be aesthetically pleasing. The liner 111 may also include an appendage or strip portion 611 extending from the enlarged region 604 to the opposite end of the liner 111. The strip portion 611 may, but need not be, substantially straight and may, but need not be, have a generally uniform width. The opposite end of the enlarged region 604 may be rounded. The strip portion 611 may have a width smaller than the enlarged region 604. The strip portion 611 may have a length that is greater than the height of the inserter assembly 100 .

[0418] The liner 111 may also include a tab or flap 610. The flap 610 may be connected at a first end to the enlarged region 604. The flap 610 may extend in a direction substantially parallel to the strip portion 611 to a second end opposite the first end. The flap 610 may extend immediately adjacent to the section of the strip portion 611 closest to the circular region 604. This may give the liner 111 a compact appearance and help conserve material during manufacturing.

[0419] The exemplary adhesive patch 614 may be comprised of a substrate with a skin-compatible adhesive on one side. The adhesive patch 614 may include a main region 620 and a protruding region 622. The main region 620 may be flat and circular and may have a footprint larger than the footprint of the infusion set base 106 to which it is attached. The protruding region 622 may extend from the periphery of the main region 620 partially along the strip portion 611 of the liner 111. The segment of the strip portion 611 closest to the enlarged region 604 may cover the adhesive on the protruding region 622. Once the infusion set base 106 is attached to the infusion site, the protruding region 622 may function as a removal tab to facilitate peeling the adhesive patch 614 and the infusion set base 106 from the infusion site.

[0420] The adhesive patch 614 can be attached to the bottom surface 162 of the infusion set base 106 (see, e.g., FIG. 4B) in any suitable manner. In a particular example, the adhesive patch 614 can be coupled to the base 106 using double-sided tape 606 or other adhesive, as best shown in FIG. 44. In alternative embodiments, the adhesive patch 614 can include a substrate that can be heat staked or welded (e.g., sonic, RF). The adhesive patch 614, liner 111, and optional double-sided tape 606 can include openings therethrough.

[0421] As shown primarily in FIG. 45 , the liner 111 may include a partition dividing a portion of the liner 111. In the exemplary embodiment, slits 608 extending through the liner 111 are included, although perforations and / or cuts may be used in place of the slits 608. In the exemplary embodiment, a single slit 608 is used, extending across a portion of the enlarged region 604. The slit 608 is oriented to facilitate peeling of the liner 111 from the adhesive patch 614 in one piece, limiting the possibility of high stress areas forming within the liner 111 as it is removed. The shape of the opening 612 in the liner 111 may also be selected to facilitate this.

[0422] The orientation of slits 608 and the shape of openings 612 can facilitate simple, quick, and consistent removal of liner 111 from adhesive patch 614, even if the user actively removes liner 111 or uses a rough or loose prescribed removal motion to peel liner 111 from adhesive patch 614. Additionally, the orientation of slits 608 and the shape of openings 612 can facilitate the use of a wider range of materials for liner 111.

[0423] As shown, the slit 608 can extend from a point between the first end of the flap 610 and the strip portion 611 of the liner 111. The slit 608 can extend to an opening 612 in the liner 111. The slit 608 is angled so that it is tangent to the edge wall of the opening 612. The slit 608 can also extend in a straight line. The slit 608 can be angled so that it is tangent to the flap 610 on the opposite side of the opening 612. The opening 612 can be constructed to minimize corners or areas where the side walls of the opening change direction from one direction to a different direction. As shown, the side walls of the opening 612 include a first rounded span 624 and an opposing second rounded span 626. These spans 624, 626 can be the only spans of the opening 612 wall where the wall changes direction. The first round span 624 may have a tighter curvature (e.g., a smaller radius) than the second round span 626. The opening 612 may also include two substantially straight sidewall spans 628 connecting the first and second round spans 624, 626. These spans 624, 626, 628 are gentle. The first round span 624 may be closer to the flap 610 than the second round span 626. The slit 608 may terminate at a point of contact with the first round span 624. In some embodiments, the slit 608 may be collinear with the straight sidewall spans 628 of the opening 612.

[0424] As the liner 111 unfolds from the adhesive patch 614, the exemplary liner 111 can rotate around a portion of the opening 612. In the exemplary embodiment, the liner 111 can rotate around the second rounded span 626 of the opening as it peels away from the adhesive pad 614. Because the second rounded span 626 has a gentler curvature (e.g., a wider radius), the rotation made by the liner 111 can be relatively gradual. This can reduce the chance of high stress points developing in the liner 111 during removal. Furthermore, the shortest distance between a point on the second rounded span 626 and the periphery of the liner 111 can be shorter than the shortest distance between the periphery of the liner 111 and other portions of the opening 612. As a result, a relatively small surface area of ​​the liner 111 can be attached to the adhesive patch 614 in the area where the liner 111 rotates around the opening 612 during removal of the liner 111. The liner 111 may be least strongly or relatively weakly adhered to the adhesive patch 614 in this area, which may further help limit stress on the liner 111 material as the liner 111 is peeled away from the adhesive patch 614 around the second round span 626.

[0425] As the liner 111 is unrolled around the opening 612, the orientation of the slits 608 can help ensure that only the portion of the liner 111 adhered to the adhesive patch 614 is positioned ahead of the area where the liner 111 is peeling from the adhesive patch 614. Thus, the direction in which the user pulls to remove the liner 111 does not need to be significantly different from the direction of the lagging portion of the liner 111. This prevents high stress points in the material of the liner 111 if the area behind where the liner 111 begins to peel from the adhesive patch 614 is still attached to the adhesive patch 614.

[0426] When a user pulls the flap 610 to peel the liner 111 from the adhesive patch 614, the tangential direction of the slit 608 relative to the opposite side of the opening 612 may be preferable because it may help to easily and integrally peel the liner 222. The orientation of the slit 608 may encourage the user to naturally peel the liner 111 along the extension direction of the slit 608. Pulling the liner 111 straight along this direction may substantially suppress the formation of stress points at the end of the liner 111 along the second round span 626. When the liner 111 is separated from the adhesive patch 614 around the second round span 626, a situation in which the liner 111 is pulled by the user in a direction significantly different from the direction of the adjacent downstream portion of the liner 111 may be avoided. Therefore, the region of the liner 111 that turns around the second round span 626 can be more easily peeled from the adhesive patch 614.

[0427] 46A-47 show various views of the inserter assembly 100 with the outer housing 116 removed and a view of the isolated locking member (FIG. 47). As shown, when in place within the inserter assembly 100, the locking member 146 can function as a safety device. The inserter assembly 100 can be designed so that it cannot be activated until the locking member 146 is removed. The locking member 146 extends the entire width of the inner housing 120 and may overlie other components of the inserter assembly 100. The locking member 146 may be directly adjacent to at least one of the other components to prevent its movement.

[0428] The locking member 146 may include a flange 152 that can be gripped to assist in withdrawal. The locking member 146 may also include a stem portion 226 or appendage that protrudes from the flange 152. The stem portion 226 may support several arms 228, 230. In the exemplary embodiment, the arms 228, 230 are arranged in an "H"-like pattern, with the stem portion 226 connected to the arms 228, 230 via a crosspiece of the "H." The arms 230 may reside within the fenestrations 150 in the inner housing 120 distal-most to the flange 152. The arms 230 may also include a chamfered feature 232 that can help guide the locking member 146 during installation into the inserter assembly 100.

[0429] As shown, the arms 228 can be cantilevered to deflect inward toward the stem portion 226. The distance between the outer edges of the arms 228 can be greater than the width of the fenestration 150 through which they pass when the locking member 146 is attached to the inserter assembly 100. During attachment, the arms 228 can deflect toward the stem portion 226 to allow the arms 228 to pass through the fenestration 150. Once past the fenestration 150, the arms 228 can spring outward to an unstressed state. Thus, as shown in FIG. 46C , the width between the outer edges of the arms 228 can be greater than the width of the fenestration 150 when the locking member 146 is in place. This may require some force to remove the locking member 146 from the inserter assembly 100 and may prevent the locking member 146 from inadvertently becoming dislodged. As shown, the arms 228 can include a chamfered region 234. A chamfered region 234 may abut the wall of the fenestration 150 of the inner housing 120 most proximal to the flange 152. The chamfered region 234 may aid in the deflection of the arm 228 toward the stem portion 226 during withdrawal of the locking member 146 from the inserter assembly 100. While an angled chamfer is shown, a rounded or curved region may be included in alternative embodiments.

[0430] In various examples, at least one component of the inserter assembly 100 may include at least one locking member restraining member, such as a raised bumper 238. In an exemplary embodiment, the bumper 238 is included on the needle retractor 134 and extends from its top plate 328. The raised bumper 238 may be adjacent to, disposed beside, or adjacent to at least a portion of the locking member 146. Thus, the bumper 238 may prevent wobbling or pivoting of the locking member 146 within the inserter assembly 100. The bumper 238 may redirect the locking member 146 during installation if the locking member 146 is introduced crookedly into the inserter assembly 100. The bumper 238 may also be provided to limit the depth to which the locking member 146 can be forced into the inserter assembly 100.

[0431] Referring now to FIG. 48, an alternative embodiment of the locking member 146 shown in FIGS. 46A-47 is shown. As shown, the flange 152 of the locking member 146 can include an opening 151 extending therethrough. The opening 151 can be centrally located within the flange 152. The cap body 153 can be coupled to the locking member 146 by a strand or strip 155 of flexible material. In this exemplary embodiment, a strip 155 of material is used that extends from the periphery of the flange 152 to the periphery of the cap body 153. The flexible strand or strip 155 can allow the cap body 153 to be displaceable relative to the flange 152 while it is attached to the flange 152. In other embodiments, the cap body 153 can be a separate component. The cap body 153 includes multiple latch fingers 157 protruding therefrom. The latch fingers 157 can be positioned to deflect when introduced into the opening 151 through a first side of the flange 152. When the opening 151 is displaced beyond a certain distance, the latch fingers 157 may resiliently return to their original position and be captured by the opposing surface of the flange 152. In certain examples, an adhesive liner 111 (see, for example, FIGS. 41A-41B ) may be captured between the cap body 153 and the flange 152 when the cap body 153 engages with the flange 152. Thus, it may not be necessary to use tape, adhesive, heat staking, RF welding, ultrasonic welding, or the like to attach the liner 111 to the flange 152. In some embodiments, the liner 111 may include passages through which the latch fingers 157 protrude. In other embodiments, the passages are not included, and the liner 111 may be crushed into the opening 151 when the cap body 153 is coupled to the flange 152. Additionally, the cap body 153 and the flange 152 may include raised portions 154. The raised portions 154 may be spaced apart to interlock with each other when the cap body 153 is coupled to the flange 152. This may help to hold the liner 111 securely between the cap body 153 and the flange 152 .Other embodiments may include rounded raised portions (e.g., concentric circles) that can similarly capture the liner 111 therebetween when the cap body 153 and flange 152 are joined. The cap body 153 and optional strand or strip 155 may be included in other locking members shown or described herein. Any of the locking member 146 embodiments described herein may be modified to include a stringed or separate cap body 153.

[0432] 49A-50, various views of the inserter assembly 100 with an alternative locking member 146 are shown, as well as a view of the alternative locking member 146 in isolation (FIG. 50). As noted above, when in place within the inserter assembly 100, the locking member 146 functions as a safety device, preventing firing until the locking member 146 is removed. The illustrative locking member 146 extends across a portion, but not all, of the width of the inner housing 120 and is positioned over other components of the inserter assembly 100 to prevent movement. As best shown in FIG. 49A, the illustrative locking member 146 also directly abuts an arm 296 of the sharps retainer 130, providing mechanical interference against displacement of the arm 296 in the general direction of the flange 152. The inner housing 120 may include only one fenestration 150 instead of a pair of opposing fenestrations 150.

[0433] The locking member 146 may include a flange 152 that can be gripped to assist in extraction. The locking member 146 may also include an appendage 376 that protrudes from the flange 152. Tines 378 may be included within the appendage 376. The tines 378 are cantilevered to the appendage 376 at the portions of the tines 378 most distal from the flange. The tines 378 are also constructed to naturally protrude above a face 380 of the appendage 376, but are flexible when force is applied to the unsupported ends of the tines 378. As shown, the unsupported ends of the tines 378 include a sloped region 382. The end of the appendage 376 most distal to the flange 152 may also include a chamfered feature 384 that can help guide the locking member 146 during installation into the inserter assembly 100. When the locking member 146 is attached to the inserter assembly 100, the upper wall of the fenestration 150 can bias the tines 378 toward the surface of the appendage 376 to allow the tines 378 to pass through the fenestration 150. After installation of the locking member 146 is complete, the tines 378 can spring back toward their initial, unstressed state. Thus, as best shown in FIG. 49B , a portion of the tines 378 can be disposed above the upper wall of the fenestration 150 when the locking member 146 is in place. This may require some force to remove the locking member 146 from the inserter assembly 100 and may prevent the locking member 146 from inadvertently disengaging. As shown, a sloped portion 382 may abut the upper wall of the fenestration 150. The sloped portion 382 can help bias the tines 378 toward the surface 380 of the appendage 376 during withdrawal of the locking member 146 from the inserter assembly 100. Although angled portion 382 is shown, rounded or curved areas may be included in alternative embodiments. A locking member restraining feature similar to raised bumper 238 shown in Figures 46A-47 may also be included.

[0434] 51-53, various views of the inserter assembly 100 with an alternative locking member 146 are shown, as well as an isolated view of the alternative locking member 146 (FIG. 53). As mentioned above, when in place within the inserter assembly 100, the locking member 146 functions as a safety device, preventing activation until the locking member 146 is removed. An exemplary locking member 146 may include a flange 152 that can be grasped to assist in extraction. The locking member 146 may also include an appendage 376 that projects away from the flange 152. The appendage 376 may include a pair of protrusions 277 spaced apart by a slot 275 in the region of the appendage 376 most distal to the flange 152. As shown in FIG. 52, the sharps holder 130 (further described in connection with FIGS. 60-68) is symmetrical and may include two cantilevered arms 296 of substantially the same height. The slot 275 can accommodate these arms 296.

[0435] The portion of the appendage 376 closest to the flange 152 may include a pair of arcuate members 273. The arcuate members 273 may be located on either side of the appendage 376. There may be an opening 271 between each arcuate member 273 and the body 279 of the appendage 376. The distance between the outsides of the arcuate members 273 may be greater than the width of the fenestration 150 through which the locking member 146 passes when attached to the inserter assembly 100. During attachment, the openings 271 allow the arcuate members 273 to resiliently flex toward the body 279 of the appendage 376 to allow the locking member 146 to engage through the fenestration 150. Once the arcuate members 273 have passed through the fenestration 150, they may return to their unstressed state. Deflecting the arcuate members 273 to remove the locking member 146 from the inserter assembly 100 may prevent the locking member 146 from being inadvertently disengaged. Alternatively, when fully installed, the arcuate member 273 may not be advanced completely through the fenestration 150, with the arcuate member 273 in a biased state pressing against the sidewall of the fenestration 150. This again helps ensure that some force is required to remove the locking member 146 and prevents inadvertent dislodgement. When installed in the inserter assembly 100, the end of the slot 275 most proximal to the flange 152 can be located immediately adjacent to the arm 296 of the sharps holder 130. This can help ensure that the cantilevered arm 296 of the sharps holder 130 is securely held in place on the stop 306 of the sharps retraction device 134 while the locking member 146 is in place.

[0436] 54A-54B, yet another example locking member 146 is shown. The example locking member 146 includes an arcuate body 351. An appendage 376 can extend from the arcuate body 351. As shown, the appendage 376 extends from the midpoint of the arcuate body 351. While any appendage 376 may be used in the embodiments herein, in the example embodiment, the appendage 376 is the one shown in FIGS. 46A-47. When the locking member 146 is in place on the inserter assembly 100, the appendage 376 can extend into the inserter assembly 100 and prevent triggering of the inserter assembly 100. The arcuate body 351 can at least partially wrap around the inserter outer housing 116. An end region 353 of the crescent-shaped body 351 can be angled to aid in mounting the locking member 146 within the inserter assembly 100. As the locking member 146 advances toward the inserter assembly, the angled end regions 353 can help center the inserter assembly 100 relative to the appendages 376. The arcuate body 351 can bias the end regions 353 away from each other during part of the attachment of the locking member 146 to the inserter assembly 100. The locking member 146 includes a flange 152 that can be gripped to aid in withdrawal.

[0437] The arcuate body 351 may include one or more slots 355. In the exemplary embodiment, two slots are included. The slots 355 may be located adjacent the end region 353 of the arcuate body 351. The slots 355 may be sized so that a portion of the liner 111 can be fed through one of the slots 355. The liner 111 may then be coupled to a portion of the inserter assembly 100 (see, for example, FIG. 42A ). If a user attempts to remove the locking member 146 before removing the liner 111, the portion of the liner 111 passing through the slot 355 may prevent the locking member 146 from being withdrawn. This may provide the user with a cue to remove it. This prompts the user to remove the liner 111 from the inserter assembly 100 before removing the locking member 146.

[0438] Referring to Figures 55-56A, another example inserter assembly 100 and locking member 146 are shown. As shown, the fenestrations 148, 150 in the outer housing 116 and inner housing 120, respectively, can be positioned to provide an introduction path for the locking member 146, which extends between the arms 296 of the sharps holder 130. The locking member 146 can include a flange 152 projecting from a protrusion 376. At least one spreader protrusion 257 can be included on the portion of the protrusion 376 opposite the flange (see, e.g., Figures 56B-56E for an example embodiment having a single spreader protrusion 257). In an example embodiment, two spreader protrusions 257 are included, extending generally parallel to one another, such that the example locking member 146 is substantially symmetrical. The symmetrical nature of the locking member 146 allows the locking member 146 to be attached in multiple orientations for ease of assembly. When attached to the exemplary inserter assembly 100, the sides of the spreader protrusions 257 can prevent deflection of the arms 296 of the sharps holder 130 toward the midplane of the inserter assembly 100. Thus, the exemplary locking member 146 can maintain the arms 296 apart from one another. In some embodiments, the spreader protrusions 257 can contact and push the arms 296 outward from the midplane when the locking member 146 is attached to the inserter assembly 100. This can help securely hold the arms 296 of the sharps holder 130 in the locking portion 306 of the sharps retraction device 134 while the locking member 146 is in place.

[0439] In an exemplary embodiment, the sharps retraction device 134 includes at least one interference body 255. In an exemplary embodiment, a set of interference bodies 255 is included. The interference bodies 255 may reside in the gaps between the spreader prongs 257 when the locking member 146 is installed. The interference bodies 255 may prevent the spreader prongs 257 from displacing toward each other. In some embodiments, the interference bodies 255 may cause the spreader prongs 257 to spread apart. The interference bodies 255 may help to hold the arms 296 firmly in engagement with the catches 306 (see, for example, FIG. 52 ).

[0440] In the exemplary embodiment, the top plate 328 of the sharps retraction device 134 includes a passageway through which a bumper 238 (further described in connection with FIG. 46C ) and a portion of the locking member 146 extend. In this example, the passageway is defined by a bridge 239. At least one of the spreader protrusions 257 can extend below the bridge 239 when installed in the inserter assembly 100. This can prevent movement of the sharps retraction device 134 along the axis of the inserter assembly when the locking member is installed and help prevent relative displacement of components within the inserter assembly 100. A portion of the bridge 239 is received between the spreader protrusions 257 and can double as an interference body 255 in some examples.

[0441] In various examples, each spreader protrusion 257 can include a flexible region. In an exemplary embodiment, each spreader protrusion 257 includes a flexible arm 263. When the locking member 146 is installed within the inserter assembly 100, one of the flexible arms 263 can contact a surface of the bridge 239. The flexible arms 263 can include a nub 265 that allows the flexible arms 263 to bend toward the extending spreader protrusion 257 as the locking member 146 advances further toward the installed position. When the locking member 146 reaches its fully installed position, the nub 265 can be displaced away from the bridge 239, allowing the flexible arms 263 to return to an undeflected state. Audible feedback (e.g., a click or a tap) can be generated as the flexible arms 263 return to their undeflected state. Haptic feedback may also be perceived by the user as the arms 263 return to their undeflected state. The nub 265 can also prevent the locking member 146 from being accidentally removed.

[0442] Referring to Figures 56B-56E, several additional locking members 146 are shown. Each of the locking members 146 includes a flange 152 from which an appendage 376 extends. Each example locking member 146 includes a single spreader protrusion 257 that protrudes from a portion of the appendage 276 opposite the flange 152. Alternatively, each example locking member 146 may be symmetrical with two substantially parallel spreader protrusions 257. Each of the locking members 146 includes a flexible region. Figures 56D-56E include a flexible arm 263 with a nub 265, as described above in connection with Figures 55-56A. The spreader protrusion 257 in the exemplary embodiment shown in Figures 56B-56C includes a slot 269. The slot 269 may allow the region of the spreader protrusion 257 adjacent to the slot 269 to be deflected toward the slot 269. As shown in FIG. 56C, when the locking member 146 is attached (installed) to the inserter assembly 100, the nubs 265 on the spreader projections 257 may contact the surface of the bridge 239. Further advancement toward the installed position may cause the portions of the spreader projections 257 adjacent the slots 269 to bend or deflect inward. When the locking member 146 is in the fully installed position, the nubs 265 are clear of the bridge 239, allowing the deflected portions of the spreader projections 257 to freely return to their undeflected state. As shown in FIG. 56B, the nubs 265 may engage the locks 306 and abut the arms 296 of the sharps holder 130 (see, e.g., FIG. 52). When in the fully installed position, the portions of the spreader projections 257 adjacent the slots 269 may bend or deflect inward, allowing the nubs to press against the arms 296 and hold them engaged with the locks 306.

[0443] Referring now to FIG. 57 , a flowchart 240 is shown illustrating some exemplary actions that may be performed to place an infusion set 102 in a patient with an inserter assembly 100. Certain inserter assemblies 100, such as the one shown in FIG. 1A , may be designed to be placed on the skin and prevent actuation until the skin is displaced from its normal resting position on the body. To this end, the inserter assembly 100 may include an actuation limiting structure (described elsewhere herein). Actuation of the inserter assembly 100 may be precluded until a certain amount of skin displacement occurs. Actuation of the inserter assembly 100 may be inhibited until a certain amount of relative displacement occurs between components of the inserter assembly 100. This relative displacement may occur when the skin is lifted and the inserter assembly 100 is pulled away from the body. Adhesion of the base 106 of the infusion set 102 to the skin may cause displacement of certain components (e.g., at least one component coupled to the base 106) to be limited when the user withdraws the inserter assembly 100. When pulled, the skin's elasticity can apply a force to the base 106 (and any coupled components) to pull it toward or close to the body. At least one other component of the inserter assembly 100 can be freely displaced or can be displaced with greater freedom when the inserter assembly 100 is removed. Thus, the inserter assembly 100 can be decomposed into a first unit and a second unit that has a more limited displacement capability than the first unit when the inserter assembly 100 is pulled away from the body. In certain examples, relative movement can be inhibited until a certain force is applied by the skin against the base 106. The user may need to pull the inserter assembly 100 away from the body with enough force to stretch the skin to the extent that relative movement of different portions of the inserter assembly 100 is initiated. When the user pulls the inserter assembly 100 away from the injection site and the skin's elasticity pulls the second unit in the opposite direction toward the injection site, a threshold force can be provided that forces separation of the first and second units.When a threshold force is applied, relative motion is initiated.

[0444] The trigger of the inserter assembly 100 can be held unactuated until the skin is pulled away from the rest of the body a sufficient distance to generate the force necessary to initiate relative movement. The trigger may not be triggered until the required amount of relative displacement has occurred. Once triggered, the inserter actuation assembly (exemplary embodiment described below) of the inserter assembly 100 is freed to complete placement of the infusion set 102 at the desired infusion site. The actuation assembly may include a trigger device that, once released, pushes the insertion sharp 132 into the infusion site. The actuation assembly may also retract the insertion sharp 132 into the inserter assembly 100. The actuation assembly may couple the cannula subassembly 114 to the infusion set base 106. The actuation assembly may also disconnect the infusion set 102 from the inserter assembly 100 once the infusion set 102 is placed at the desired infusion site.

[0445] In some embodiments, the inserter assembly 100 may be placed on the skin and trigger actuation when the inserter assembly 100 is lifted and removed. No trigger, button, housing sleeve, or other pressing, twisting, squeezing, or the like of a trigger, button, housing sleeve, or other part of the inserter assembly 100 is required to trigger actuation, although actuation may still be under the user's control. Relative movement of a free component of the inserter assembly 100 relative to a restricted component can trigger actuation, for example, by moving or removing a latch and releasing one or more biasing members to begin driving actuation. Thus, a trigger internal to the inserter assembly 100 may be actuated as a result of the act of removing the inserter assembly 100 from the body. The trigger may be automatically actuated, for example, when the skin at the injection site is lifted at least a certain distance from the underlying anatomical structure. From the user's perspective, such an inserter assembly 100 may simply be placed on the skin and then withdrawn to perform infusion set 102 placement.

[0446] In alternative embodiments, a separate manual trigger action can be used to trigger actuation of the inserter assembly 100. Any configuration apparent to one skilled in the art can be used to facilitate manual triggering. The inserter assembly 100 can include one or more buttons that, when displaced, can trigger actuation by disengaging a latch within the inserter assembly 100. Alternatively, a portion of the inserter assembly 100 can be deformable, and compression of the inserter assembly 100 can move a protrusion that moves with the deformable section into the latch to disengage the latch. The button or deformable section can be included in the outer housing 116, for example, in certain instances. A twisting action can be used to trigger actuation of the inserter assembly 100. Such a twisting action of one portion of the inserter assembly 100 (e.g., the housing) relative to another portion (e.g., the remainder of the inserter assembly 100) can sweep the protrusion of the inserter assembly 100 against the latch, disengaging the latch. In other embodiments, a pin or similar member may be withdrawn from the inserter assembly 100 after the inserter assembly is pulled away from the skin to trigger actuation. In embodiments including a locking member 146 (see, e.g., FIG. 47 ), the locking member 146 may be held in place until the user begins to pull the inserter assembly 100 away from the skin. Actuation may be triggered when removal of the locking member 146 allows components of the inserter assembly 100 to displace relative to one another, for example, so that a latch may be released. Various combinations of manual triggering devices may also be used. For example, actuation may be triggered by pressing or squeezing a button followed by a twist, or vice versa. Manual triggering may not be possible after the skin is displaced from a resting position and / or until some degree of relative movement between the free and restrictive components of the inserter assembly 100 has occurred. Any arrangement apparent to one skilled in the art may be used to facilitate such lockout.For example, the interlock may prevent displacement, twisting, squeezing, etc. of the button until the skin is displaced or a relative movement above a threshold amount occurs. Alternatively, the interlock may block access to a latch within the inserter assembly 100, preventing the latch from disengaging until the skin is displaced or a relative movement above a threshold amount occurs. In some embodiments, the button may be displaced, twisted, squeezed, etc., but is disabled by the interlock until the skin is displaced or a relative movement above a threshold amount occurs. As one skilled in the art will appreciate, the embodiments of the inserter assembly 100 described herein may be modified in other ways to allow for various types of additional manual actuation schemes.

[0447] While such a design can make trigger actuation simple, intuitive, and more reliable, other advantages may also be realized. For example, when the inserter assembly 100 is lifted, the inserter assembly 100 may be designed to pull the skin to which the base 106 of the infusion set 102 is attached, away from underlying muscle and other body or anatomical structures. Thus, upon insertion, the cannula 104 of the infusion set 102 may be more securely positioned within the subcutaneous layer of fatty tissue. This may reduce insertion pain, minimize bruising, increase the potential body area for injection site selection, and lead to more predictable absorption of medications such as insulin. The skin may also be pulled taut to facilitate easy penetration of the insertion sharp 132 through the skin. Because the skin is passively lifted with the inserter assembly 100, there is no need to generate a pneumatic vacuum. This allows the inserter assembly 100 to be manufactured with less complexity and fewer parts. Additionally, pneumatic seals, either against the skin or within the inserter assembly 100, may be omitted. Skin lifting may be achieved more reliably because the contours of the body at the injection site (which may present sealing challenges) may be largely irrelevant. Furthermore, pinching the skin to separate it from the underlying structures may not be necessary. This may aid in more comfortable insertion, may limit bruising, and may more reliably separate the skin from the underlying structures. The inserter assembly 100 may also ensure that the insertion of the cannula 104 into the skin occurs in a predetermined orientation. The skin may be held in place so that it is parallel or perpendicular to a reference plane or axis (e.g., parallel to the bottom surface 162 of the base 106 of the infusion set 102 or perpendicular to the insertion sharp 132 or the axis of the insertion sharp). Therefore, the angle of the inserter assembly 100, or the path along which the inserter assembly 100 is separated from the body, should not change the angle of insertion.While the exemplary embodiments shown herein depict an insertion angle substantially perpendicular to the skin, insertion at any angle (greater than 0° up to 90°, e.g., 30°, 45°, 60°, etc.) may similarly be ensured by anchoring the skin relative to a reference plane or axis that moves with the inserter assembly 100. Another potential advantage is that psychological concerns associated with triggering actuation may be reduced. Because the user may not need to depress, twist, squeeze, etc., some actuators, less anxiety may build up in anticipation of triggering actuation. The exact moment of actuation as the inserter assembly 100 is withdrawn may be unknown to the user. This may help limit psychological concerns and may reduce perceived pain.

[0448] As shown in FIG. 57 , in block 242, the adhesive liner or backing 111 may be removed from the infusion set base 102 held within the inserter assembly 100. Next, the inserter assembly 100 may be placed at the desired infusion site in block 246, causing the adhesive on the infusion set base 102 to adhere to the patient's skin. It may be desirable to press the inserter assembly 100 against the skin to ensure the adhesive firmly adheres to the skin. The locking member 146 may be removed from the inserter assembly 100 in block 250. The inserter assembly 100 may begin to be removed from the body in block 254. In block 258, the skin may be pulled away from underlying muscle and body structures via adhesive adhesion. The outer housing 116 and retainer base 140 may also be displaced relative to the remainder of the inserter assembly 100 in block 258. As previously described, relative displacement may not occur until the skin is lifted from the underlying anatomical structures and the skin's elasticity exerts sufficient force to overcome the built-in resistance to relative displacement. At block 262, at least one latch within the inserter assembly 100 may be released. As described above, this may occur automatically or as a result of a manual triggering action. The insertion sharp 132 and cannula subassembly 114 may be driven toward the insertion site at block 266. The cannula subassembly 114 may be coupled to the infusion set base 106 at block 270. Additionally, the latch may be released from the infusion set base 106 at block 270. The act of coupling the cannula subassembly 114 to the set base 106 may cause the latch to release from the infusion set base 106, thereby releasing the infusion set base 106 from the rest of the inserter assembly 100. When the locking portion is engaged with the infusion set base 106, the locking portion can hold the sharps retraction device 134 in place.Once the lock is released, the sharp retractor 134 may be driven through a dwell distance (described below) at block 274. The insertion sharp retractor 134 and the insertion sharp 132 may be driven away from the injection site at block 278. Removal of the inserter assembly 100 may be completed at block 282. With removal of the inserter assembly 100 complete, the infusion set 102 is fully assembled and positioned at the injection site. Additionally, the cannula 104 may be positioned in the subcutaneous layer of the skin.

[0449] Referring to FIG. 58, a top view of the inserter assembly 100 is shown with first and second cross-sectional planes superimposed. The first cross-sectional plane is labeled AA. The second cross-sectional plane is labeled BB. This view is provided for reference purposes in connection with several subsequent views, some of which are cross-sectional views of the inserter assembly 100 taken at one of these planes, showing the inserter assembly 100 in various stages of operation. Unless otherwise noted, if one of the cross-sections of the inserter assembly 100 below is designated by the figure number followed by the letter A, the view shows the cross-section of the inserter assembly 100 at plane AA. If one of the cross-sections of the inserter assembly 100 below is designated by the figure number followed by the letter B, the view shows the cross-section of the inserter assembly 100 at plane BB.

[0450] Two cross-sectional views of the inserter assembly 100 are shown in Figures 59A-59B. The inserter assembly 100 is depicted as it is about to be applied to the skin 356. The locking member 146 (see, e.g., Figure 50) and adhesive backing 111 (see, e.g., Figure 1A) have been removed in Figures 59A-59B. Adhesive 374 is shown on the bottom surface 162 of the infusion set base 106. As shown, both springs 136, 138 may be in an energy storage state, which in this particular embodiment is in a compressed state. In this example, spring 136 functions as an insertion drive bias member, and spring 138 functions as an insertion sharp retraction drive bias member. Spring 136 is held in a compressed state between the insertion sharp holder 130 and the insertion sharp retractor 134, and when released, drives the sharp holder 130 and the components carried therein from a raised state to a forward state. The spring 138 is held in compression between the inner housing 120 and the sharps retraction device 134. When released, the spring 138 drives the sharps retraction device 134 and the sharps holder 130 from the post-insertion state to the retracted state.

[0451] 60-64 depict several views of the sharps holder 130. The sharps holder 130 may include a biasing member that receives a bay 290 in which the spring 136 may be positioned. The sharps holder 130 may also include a wall 292 that surrounds the biasing member that receives the bay 290. The wall 292 may include two protrusions 294 on its outer surface. In the exemplary embodiment, the two protrusions 294 are rails positioned opposite each other on the sharps holder 130. These rails may ride along guides 354 (see, e.g., FIGS. 70A and 70B) on a portion of the sharps retraction device 134. The protrusions 294 may extend from the sharps holder 130 to match the width of the cannula subassembly 114 in the plane of the cannula subassembly 114, including the ears 204 of the septum housing 108.

[0452] In various embodiments, the wall 292 may also include an interrupted region that creates one or more cantilevered arms 296. In an exemplary embodiment, the cantilevered arms 296 are positioned opposite one another on the sharps holder 130. One of the cantilevered arms 296 may have a longer length than the other of the cantilevered arms 296. In other embodiments, both cantilevered arms 296 may be identical mirror images (see, for example, FIG. 78C ) to facilitate easier assembly of the inserter assembly 100. The cantilevered arms 296 may extend above the remaining top surface 298 of the wall 292. Each of the cantilevered arms 296 may include a ridge 300 located at its unsupported or distal end. A ledge portion 302 may be defined by a portion of each of the ridges 300. At least one of the ledge portions 302 may extend substantially perpendicular to the cantilevered arms 296. At least one of the ledge portions 302 may be angled relative to the cantilevered arms 296 that include the undercut region such that the undercut region has a triangular cross-section. In the exemplary embodiment, the ledge 302 of the longer of the two cantilevers 296 is so undercut. The sharps holder 130 may also include a port 304. The port 304 may be used to supply adhesive or glue to the sharps holder 130 to securely hold the insertion sharps 132 in the sharps holder 130.

[0453] An alternative embodiment of the sharps holder 130 is shown in FIGS. 30-33. As shown, the longer of the two cantilevered arms 296 of the sharps holder 130 includes a ridge 300 and a ridge portion 301. The ridge portion 301 may be located inside the ridge 300, but may be located in another position in other embodiments. As shown, the ridge 300 may be double beveled. The portion of the ridge 300 adjacent the ledge portion 302 may have a steeper bevel than the portion of the ridge 300 distal to the ledge portion 302. The ridge 301 may be formed on the portion of the ridge adjacent to the ledge portion 302. For example, the ridge 301 may be formed as a beveled extension from the portion of the ridge 300 distal to the ledge portion 302, extending to the portion of the ridge 300 adjacent to the ledge portion 302. Such ridges 301 may be included in any of the embodiments of sharps holder 130 shown herein.

[0454] As best shown in FIG. 59B , the longer ledge 302 of the cantilever arm 296 can rest on a stop 306. The stop 306 of the exemplary embodiment is included in the sharps retraction device 134. It can inhibit the release of energy stored in the spring 136 and hold the spring 136 under compression in the exemplary embodiment. The stop 306 can be angled to cooperate with any angle of the ledge 302 to securely hold the ledge 302 on the stop 306. A finger 308 extending from the base retainer 140 of the inserter assembly 100 can extend through a gap 322 adjacent the stop 306 (see, for example, FIG. 70C ). Displacement of the finger 308 relative to the stop 306 can cause the ledge 302 to disengage from the stop 306. This may cause the sharps retainer 130 to release and the spring 136 to release from its stored energy state. While shown as an upstanding finger 308, other types of actuation protrusions may be used. Additionally, in some embodiments, the finger 308 or other actuation protrusion may be included on another portion of the inserter assembly 100. For example, the finger 308 may protrude from the inner surface of the top surface of the outer housing 116. The engagement of the lock 306 and the ledge 302 is one example of a trigger that may be manipulated to initiate actuation of the inserter assembly 100 (see, e.g., the description of FIG. 57).

[0455] 69-70C show several views of the retainer base 140 and sharps retraction device 134. As shown, the fingers 308 of the retainer base 140 (FIG. 69) are formed as a continuous portion of the retainer base 140. The illustrative retainer base 140 includes a first ring portion 310 and a second ring portion 312. The first ring portion 310 and the second ring portion 312 may be connected by an intermediate region 314 and may be concentric with one another. The intermediate region 314 may be generally flat and may serve as a skin-contacting portion of the inserter assembly 100 that is substantially level with the bottom surface 162 of the infusion set base 106. The fingers 308 extend from the second ring portion 312. As shown, the fingers 308 include an upstanding segment 316 and a fin 318.

[0456] In various embodiments, the sharps retraction device 134 can include a guide 320 along which the fin 318 can slide during assembly. The guide 320 can also, in certain embodiments, ride along the fin 318 during at least a portion of the retraction of the sharps retraction device 134. An exemplary guide 320 is formed as two raised parallel ribs. The stop 306 includes two supports 324 with which the ledge 302 of the cantilever arm 296 can engage. The supports 324 can include a gap 326 between them. The gap 326 can have a width equal to or greater than the width of the fin 318. The fin 318 can advance through the gap 326 while lifting the inserter assembly 100 from the skin 356, which can cause the fin 318 to burr. The guide 320 abuts the ridge 300 of the cantilever arm 296, forcing the cantilever arm 296 to bend inward. Once the fin 318 advances a certain distance, the cantilevered arm 296 may be deflected to a point where the ledge 302 no longer engages the stop 306, releasing the spring 136 and triggering actuation. The position of the fin 318 on the finger 308 and / or the height of the finger 308 may be adjusted to change the displacement distance at which release of the ledge 302 from the stop 306 occurs. In embodiments in which the protuberance 300 includes a ridge 302 (see, e.g., FIGS. 65-68 ), the ridge 302 may be sized to fit through the gap 326. Thus, the ridge 302 may increase the total amount of cantilevering. The arm 296 may be deflected by the fin 318, providing additional assurance that the ledge 302 will fully displace from the stop 306. As a result, greater tolerances may be tolerated for various features associated with the stop 306 and the sharps holder 130.

[0457] 59A-59B in conjunction with FIGS. 69-70B, the spring 138 may also be held in an energized state by at least one latching engagement. As shown, the sharps retraction device 134 may include a first set of arms 330 and a second set of arms 332. The first set of arms 330 may extend from a top plate 328 of the sharps retraction device 134. Further, the first set of arms 330 may extend transversely relative to a central cavity 334 of the sharps retraction device 134. In some embodiments, the first set of arms 330 may be attached to the top plate 328 of the sharps retraction device 134 at a cutout region 336 of the top plate 328. Thus, the arms 330 may fit within channels formed by the rails 124 of the inner housing 120 to prevent rotation and guide displacement of the sharps retraction device 134 during actuation. Additionally, the cutout regions 336 may be included asymmetrically on the sharps retraction device 134 to ensure that the sharps retraction device 134 is assembled to the inserter assembly 100 in a predetermined orientation. The first set of arms 330 may be cantilevered and attached to a second plate 338 that may extend parallel to and below the top plate 328 and the sharps retraction device 134. Thus, the arms 330 may form resilient projections or members that can deflect when sufficient force is applied against them. The unsupported ends of the arms 330 may include a curved or angled section 340. This section 340 may abut a complementary contoured surface of a deflection member 358 to facilitate and / or direct such deflection. A notch or pair of notches 342 may also be present on each of the first set of arms 330. In this example, each arm 330 includes a pair of notches 342 located near the unsupported end of the arm 330.

[0458] FIG. 71 shows a cross-section of the inserter assembly 100 taken through one plane of the arm 330 extending along its length. As shown, each of the one or more notches 342 can engage with a cooperating protrusion 344. The cooperating protrusions 344 can be included on the inner housing 120. Thus, the interaction of the notches 342 and the cooperating protrusions 344 can keep the spring 138 under compression and function as an anti-retraction latch. This can be particularly useful during assembly, as the infusion set base 106 may not be in place, otherwise allowing the spring 138 to relax freely. Furthermore, this engagement can ensure that the top plate 328 of the sharps retraction device 134 is positioned slightly below the fenestrations 148, 150 to allow for the introduction of the locking member 146. While notches 342 are shown, the arm 330 and inner housing 120 can engage in other ways. For example, the arm 330 or the inner housing 120 can include a protrusion forming a ledge. The ledge can engage with a capturing recess on the arm 330 or the other of the inner housing 120 .

[0459] 69A-70B in conjunction with FIGS. 59A-59B, in some embodiments, an additional latch may be included in the inserter assembly 100 to help maintain one of the springs 136, 138 in an energized state. In an exemplary embodiment, the spring 138 is held in an energized state by an additional latch configuration. As shown, the second set of arms 332 of the sharps retraction device 134 extend from the bottom of the wall defining the central cavity 334. The arms 332 of the second set may be disposed in an opposed relationship to one another and may be cantilevered. Each of the second set of arms 332 may include a ridge 346 disposed on its unsupported end. Each ridge 346 may form a ledge 348 on the arm 332 to which it is attached. Additionally, the arms 332 may include nubs 350 or raised ramps that increase in thickness as the distance from the cavity 334 increases. The nub 350 may be located intermediate the unsupported end of the arm 332 and its attachment point to the remainder of the sharps retraction device 134 .

[0460] As best shown in FIG. 59A , the ledge 348 can capture a portion of the infusion set base 106. Specifically, the ledge 348 can hook onto a cutout portion of the infusion set base 106, providing a complementary locking surface for the ledge 348. In certain embodiments, the ledge 348 can hook onto a guide 172 (see, e.g., FIG. 4A ) on the infusion set base 106. Thus, the infusion set base 106 can be retained within the inserter assembly. In an alternative embodiment, for example, when an infusion set base 106 of the type shown in FIGS. 21A-21F is used, a portion of each arm 332 can extend at least partially into each receiving slot defined in the base 106. The ledge 348 can engage a locking portion at the end of each receiving slot to retain the base 106 within the inserter assembly 100.

[0461] The ledges 348 can be angled relative to the cantilevered arms 332 in which they are contained so that the undercuts have a triangular cross-section. For example, the portions of the guide 172 (or any other locking feature) to which each ledge 348 locks can be cooperatively angled to help ensure a secure engagement. The retention base 140 (or the outer housing 116 in the embodiment shown in FIGS. 73A-73B) can include retention protrusions 359 adjacent or nearly adjacent the arms 332 and can retain the arms 332 from displacement out of engagement with the infusion set base 106 before the inserter assembly 100 is actuated. This can help prevent accidental firing of the inserter assembly 100.

[0462] In certain embodiments, only one arm 332 may be included. In some embodiments, the arm 332 on the sharps retraction device 134 may not engage the infusion set base 106. The arm 332 may engage a portion of the inner housing 120 to prevent premature retraction of the sharps retraction device 134. A latch may also be included that may interface with the guide 172 or another cooperating portion of the infusion set base 106 to hold the infusion set base 106 in place.

[0463] To help ensure that the infusion set base 106 is securely assembled to the inserter assembly 100 in a desired orientation, several standoffs or alignment protrusions 352 may be included on the inserter assembly 100. The standoffs 352 may be located on the inner housing 120 of the inserter assembly 100, as shown. While held by the arm 332 of the sharps retraction device 134, the infusion set base 106 may be held so that a surface of the infusion set base 106 is adjacent the standoffs 352, which may prevent the infusion set base 106 and the sharps retraction device 134 it is held on from moving within the inserter assembly 100 due to mechanical interference presented by the standoffs 352. As a result, the capture of the ledge 348 of the arm 332 on the infusion set base 106 may also help retain the energized spring 138. The standoffs 352 may also ensure that the infusion set base 106 is positioned within the inserter assembly 100 so that the adhesive 374 is pressed against the skin 356. In this example, the standoffs 352 ensure that the infusion set base 106 is substantially even with the skin-contacting surface on the retention base 140.

[0464] With the infusion set base 106 so positioned, it can also function as a protective barrier. Because the cannula subassembly 114 and the insertion sharp 132 can be internal to the inserter assembly 100, the user can be protected from accidental contact with the insertion sharp 132 when the infusion set base 106 is in the initial holding position, preventing contact of the cannula 104 or the insertion sharp 132 with contaminants. The cavity for receiving the cannula subassembly 114 can extend throughout the infusion set base 106, but the cavity can be sized to prevent finger penetration (e.g., have a cross-section smaller than that of the fingers). Thus, the infusion set base 106 can present an obstacle that prevents unintended access to the insertion sharp 132 and the cannula 104. Additionally, because the cannula subassembly 114 is internal to the inserter assembly 100, the adhesive backing 111 provided on the infusion set base 106 does not include an interruption to allow the cannula 104 to pass through. Thus, the gap within the infusion set base 106 for the cannula subassembly 114 can be blocked by the adhesive backing 111 until immediately prior to use. This may further prevent finger penetration and reduce the likelihood of debris entering the inserter assembly 100. In some examples, the adhesive 374 may also extend beyond this opening and be punctured during insertion of the cannula 104 into the skin 356.

[0465] FIG. 72 illustrates an exploded view of the alternative outer housing 116 shown in the embodiment of the inserter assembly 100 of FIG. 2. As shown, instead of the retainer base 140, various features of the retainer base 140 may be included in the outer housing 116. All of these features may be integrally and unitarily formed with one another as a single monolithic component, for example, during a molding operation. As shown, fingers 308 and fins 318 are included as part of the outer housing 116. Fingers 308 may extend from a central ring portion 313 connected by a middle region 314 to the remainder of the outer housing 116. A biasing member 358 is likewise included as part of the outer housing 116.

[0466] Cross-sectional views of the exemplary embodiment of the inserter assembly 100 of FIG. 2 are shown in FIGS. 73A-73B. This inserter assembly 100 includes the outer housing 116 shown in FIG. 72. The views of FIGS. 73A-73B show this alternative embodiment of the inserter assembly 100 in the same state as the inserter assembly 100 shown in FIGS. 59A-59B and 71. The inserter assembly 100 shown in FIGS. 73A-73B can operate similarly to the inserter assembly 100 shown in FIGS. 59A-59B and 71. For brevity, the following describes various operational states of the inserter assembly 100 shown in FIGS. 59A-59B and 71.

[0467] 74A-74B show two cross-sectional views of the inserter assembly 100. In FIGS. 74A-74B, the exemplary inserter assembly 100 has been positioned against the skin 356 at the desired injection site and is beginning to be pulled by the user. As shown, the adhesive 374 on the bottom surface 162 of the infusion set base 106 can adhere to the skin 356, such that when the inserter assembly 100 is pulled away from the body by the user, the skin 356 is pulled upward with the inserter assembly 100. The adhesive 374 can be selected to be strong enough to maintain adhesion to the skin 356 even while the skin 356 is being lifted from the underlying anatomical structures. The outer housing 116 and the retainer base 140 can form a housing for the inserter assembly 100 and can be displaced with the user's hand as the user removes the inserter assembly 100 from the body. Other components of the inserter assembly 100 may not need to displace (move) together with the outer housing 116 and the retainer base 140 (at least during a portion of the removal of the inserter assembly 100). The infusion set base 106 is in latching engagement with the sharps retraction device 134, which latches. Engagement with the inner housing 120 and the sharps holder 130 may hold these components together. Thus, these components form a first unit of the inserter assembly 100, which may have more limited mobility than a second housing unit of the inserter assembly 100. As discussed elsewhere herein, these components can move relative to the housing during at least an initial portion of the removal of the inserter assembly 100. The first and second units can be releasably engaged with one another during this portion of the removal. For example, an interference or interference relationship may exist between the first and second units. This interference may prevent relative movement of the first and second units until a force exceeding a threshold is applied. When a force above the threshold is applied, the interference is overcome and the first and second units can begin to move relative to each other.

[0468] Referring to FIGS. 74A-74B, during removal, the outer housing 116 and the retainer base 140 may be displaced away from the skin 356 relative to this component of the second unit substantially along the axis of the insertion sharp 132. This may cause the biasing member 358 included in the retainer base 140 to bend the resilient members or arms 330 inward. This may also cause the fingers 308 on the retainer base 140 to advance into the gaps 322 (see, e.g., FIG. 70C). Thus, the fingers 308 may move a sufficient distance to ultimately cause movement of the inserter assembly 100. The resilience of the arms 330 and interference from the biasing member 358 may cause the entire inserter assembly 100 to move as a unit during at least a portion of the insertion assembly 100's withdrawal from the body. The biasing member 358 can bend or deflect the arm 330 from its interference with the biasing member 358. Portions of the inserter assembly 100 can be displaced relative to one another when a force exerted by the elasticity of the skin exceeds a threshold force. Thus, interference preventing relative movement between the first and second units can be overcome by deflecting at least a portion of one unit from its interference with the other unit. This can occur after a threshold force is applied to separate the first and second units. The separation force can be generated by the user moving the housing away from the body and the elasticity of the pulled or lifted skin 356 pulling the first unit in the opposite direction.

[0469] In various embodiments, the resilience of the elastic member or arms 330 can at least partially control the distance a given user's skin 356 can be pulled away from the body before actuation of the inserter assembly 100 occurs. As the skin 356 is pulled away from the body, the elasticity of the skin 356 can exert a pulling force that presses the arms 330 against the biasing member 358. The type, amount, and / or placement of the adhesive 374 on the infusion set base 106 can be selected to withstand this force while maintaining adhesion to and conformability with the skin 356. Once this force overcomes the resilience of the arms 330, the components of the inserter assembly 100 begin to move relative to one another. Alternatively, the fingers 308 can begin to advance into the gap 322. Prior to this, triggering of actuation can be inhibited. Thus, the releasable engagement and trigger between the first and second units can form a motion-limiting arrangement, ensuring that the skin is lifted before the inserter assembly is actuated. The elasticity can be selected to allow the inserter assembly 100 to be used by a wide range of individuals with different skin 356 characteristics (e.g., elasticity), while ensuring that the skin 356 is pulled at least a minimum distance before actuation is triggered. In some embodiments, the inserter assembly 100 can be manufactured with different arm 330 elasticities that may be suitable for different user groups. For example, a less elastic arm 330 (e.g., geriatric elasticity) may be used for an older user group whose skin 356 tends to have less elasticity.

[0470] The steepness of the sloped section 340 of each arm 330 can be modified to change the amount of force applied before relative movement occurs. A shallower angle of the sloped section 340 can be used when more force is desired before relative movement occurs. A sharper angle on the sloped section 340 can be used when a lower force is desired. In certain implementations, there may be high (e.g., young), medium (e.g., adult), and low (e.g., elderly) skin elasticity slope angles. Additionally, the thickness of the arms 330 can be varied to alter their elasticity. Thinner arms can be used when a lower force is desired, and thicker arms can be used when a higher force is desired. Various support features, such as buttresses, can also be included to support the arms 330 against deflection at points near the supported ends of the arms 330. The location of the second plate 338 also affects the flexible portions of the arms 330, making them more or less elastic in certain instances. The material used to form the arms can also be selected based on its elasticity characteristics.

[0471] The length of the fingers 308 and the position of the fins 318 on the fingers 308 can play a role in controlling, at least in part, the distance that the user's skin 356 is pulled away from the body. These parameters can be altered to change this distance.

[0472] Referring now to Figures 74C-74D, two additional cross sections of an exemplary inserter assembly 100 are shown. Each of the exemplary inserter assemblies 100 includes additional springs 156, 158. These springs 156, 158 are described above in connection with Figures 1A-1C. The additional springs 156, 158 can be used to adjust the amount of force accumulated before the fin 318 triggers the initiation of actuation of the inserter assembly 100 (e.g., via disengagement of the locking portion 306 and the ledge 302, see, e.g., Figure 59B). The springs 156, 158 can also help eliminate mechanical bias that may exist due to the tolerances of various components of the inserter assembly 100. By varying the features described in the preceding paragraphs, appropriate designs for various patient populations (e.g., young, adult, elderly, or those with high, medium, or low skin elasticity) can be empirically determined. Skin turgor testing, elastomer, or other tests may be used to match the appropriate inserter assembly 100 type to a particular patient.

[0473] 75A-75B show two cross-sectional views of the inserter assembly 100. In FIGS. 75A-75B, the exemplary inserter assembly 100 has been further withdrawn from the skin 356. The outer housing 116 and retainer base 140 continue to displace away from the skin 356 relative to the remainder of the inserter assembly 100. This continues to cause the arms 330 on the retainer base 140 to bend or deflect inward. The fingers 308 on the retainer ring 140 advance into the gaps 322 (see, e.g., FIG. 70C), causing the fins 318 of the fingers 308 to disengage the cantilevered arms 296 of the sharps holder 130 from the locks 306 (see, e.g., FIG. 70C). Thus, movement of the outer housing 116 and retainer base 140 has advanced the inserter assembly 100 to the insertion release point of FIGS. 75A-75B. Once the cantilever arm 296 is disengaged from the stop 306 , the spring 136 is free to release its stored energy and begin actuating the inserter assembly 100 .

[0474] Before the magnitude of relative displacement between portions of the inserter assembly 100 increases to this insertion release threshold, the inserter assembly 100 may be removed from triggering actuation. This may ensure that some skin lift occurs before actuation of the trigger arrangement of the inserter assembly 100 (e.g., release of the locking portion 306 and ledge 302, see, e.g., FIG. 59B ) can occur.

[0475] 76A-76B show two cross-sectional views of the inserter assembly 100. In FIGS. 76A-76B, the exemplary inserter assembly 100 has been further withdrawn from the skin 356. As shown, the restoring action of the spring 136 can drive the sharps holder 130, the insertion sharp 132, and the cannula subassembly 114 along the insertion track toward the skin 356. In the exemplary embodiment, the sharps holder 130 extends at least partially from the cavity 334 of the sharps retraction device 130. As shown, the insertion sharp 132 and cannula 104 have just pierced the skin 356. Upon piercing, the skin 356 may be pulled away from muscle or other underlying body structures. The cannula subassembly 114 has also begun to advance toward the infusion set base 106. Note that the spring 136 is still depicted in a compressed state in the following figures. This is for ease of explanation. As will be understood by those skilled in the art, the exemplary spring 136 will expand over the course of the insertion movement. Also, as shown, the retainer base 140 of the inserter assembly 100 may include a stop 364 that prevents relative movement between the inner housing 120 and the enclosure formed by the outer housing 116 and the retainer base 140 (which may be connected to one another) beyond a certain point. This stop 364 may be included as part of the second ring 312 of the retainer base 140.

[0476] 77A-77B show two cross-sectional views of the inserter assembly 100. As shown, the spring 136 has returned to a relaxed state, completing the insertion movement of the sharps holder 130, the insertion sharp 132, and the cannula subassembly 114 into the skin 356. The relaxed state can be a fully relaxed state or a relatively relaxed state. Here, the spring 136 still exerts some pressure on the sharps holder 130 to prevent it from swinging around. The notch 186 on the cannula subassembly 114 is shown engaging with the ridge 182 on the infusion set base 106, locking the cannula subassembly 114 in place and completing assembly of the infusion set 102. As shown, the ear 204 on the cannula subassembly 114 can press against the nub 350 included on the arm 332 when the cannula subassembly 114 latches to the base 106. This spreads the arms 332, allowing them to disengage from the infusion set base 106. This, in turn, releases the spring 138, initiating the release of stored energy. Thus, Figures 77A-77B show the inserter assembly 100 in a retracted, released state, where the arms 332 can function as an anti-retraction latch.

[0477] 78A-78B, in some examples, the arm 332 of the sharps retraction device 134 can include a rib 333. The rib 333 increases the stiffness of the arm 332 while allowing the arm 332 to flex when the ear 204 of the cannula subassembly 114 is pressed against the knob 350 by the spring 136. The rib 333 helps prevent or control flexing of the arm 332 if the inserter assembly 100 is mishandled (e.g., if the inserter assembly 100 is dropped or otherwise subjected to a severe impact), thereby helping to prevent unintentional removal of the base 106. The rib 333 can include a sloped surface 335 that may collide with the edge of the wall 337 of the inner housing 120 in situations where the inserter assembly 100 is slightly displaced toward the open end. The angled ends of the walls 337 cause the ribs 333 to clamp the arms 332 against the base 106, helping to securely retain the base 106 within the inserter assembly 100 as displacement progresses. Additionally, as shown, at least one of the first set of arms 330 of the sharps retraction device 134 may be molded in an outwardly deflected state. While shown in FIG. 78A as molded, the arms 330 are in an inwardly deflected state when engaged with the protrusions 344 on the inner housing 120 (discussed in more detail in connection with FIG. 71). Thus, the arms 330 are biased toward engagement with the protrusions 344, further improving the inserter assembly 100's resistance to mishandling.

[0478] In other embodiments, referring to Figures 79A-82C, the inserter assembly 100 can be provided with a set-retaining support, such as a yoke 311. The exemplary support can help securely retain the infusion set base 106 within the inserter assembly 100, even if the inserter assembly 100 is mishandled. While the following embodiments describe the infusion set base 106, the support can also be used to retain the base of other patient care assemblies. The support contacts the arm 332 and increases the force required to deform the arm 332 to release the infusion set base 106. Various support embodiments may be positioned adjacent to the arm 332 and limit the displacement of the arm 332, at least until the inserter assembly 100 is actuated.

[0479] Referring primarily to FIGS. 79A-79B, the yoke 311 may be positioned to surround the arm 332, for example. The arm 332 may be shaped to be preloaded to help retain the yoke 311. While the yoke 311 is depicted as a separate component, in other embodiments, the yoke 311 may be integrated with another component of the inserter assembly 100 (e.g., the inner housing 120). The yoke 311 divides each portion of the arm 332 into a constrained portion and a flexible portion. The flexible portion is positioned closer to the open end of the inserter assembly 100 than the yoke 311, with the remaining arm 332 forming the constrained portion. As described in connection with FIGS. 77A-B, the ear 204 of the cannula subassembly 114 presses against a knob 350 included in the arm 332 when the spring 136 returns to its relaxed state. At this time, the force provided by the spring 136 is sufficient to deform the flexible portion of the arm 332 and release the infusion set base 106 (see FIGS. 77A, B). However, the yoke 311 may help ensure that the infusion set base 106 is held securely in place if the inserter assembly 100 is mishandled.

[0480] In other embodiments including a yoke 311, referring to FIGS. 80A-80B , the yoke 311 may transition from a constrained state to a released state when the inserter assembly 100 is actuated. For example, the yoke 311 may disengage from the arms 332 as the cannula subassembly 114 advances toward the infusion set base 106. In such embodiments, the yoke 311 may be defined as a ring 315 having a split 317. The inner circumference of the ring may include protrusions 319. In the illustrated embodiment, each arm 332 is sandwiched between the protrusions 319. The protrusions 319 are positioned in the path of displacement of a portion of the sharps holder 130 as it moves toward the open end. As shown, the sharps holder 130 includes wings 327 that collide with the protrusions 319 when the sharps holder 130 is actuated by the spring 136.

[0481] The arm 332 may include a step 339 upon which the yoke 311 can rest when the inserter assembly 100 is in the storage state. Additionally, the inner wall of the yoke 311 may abut the side of the arm 332. In some embodiments, the yoke 311 may be held in place by a slight interference fit with the arm 332. Thus, the yoke 311 can restrain the arm 332 when the inserter assembly 100 is in the storage state and prevent the infusion set base 106 from detaching during improper handling. When the sharps holder 130 strikes the yoke 311, the yoke 311 may be forced into the step 339. The slit 317 may facilitate deformation of the yoke 311 over the step 339 and toward the open end of the inserter assembly 100, transitioning to the release state. When the yoke 311 is in the released state, the ears 204 of the cannula subassembly 114 engage the nubs 350 on the arms 332 during actuation, releasing the infusion set base 106 as described above (see, e.g., FIGS. 77A and 77B). As shown, the arms 332 may be thickened adjacent the shoulders 339, allowing for a wider yoke 311 to be used. In the released state, the larger opening in the yoke 311 provides clearance for the arms 332 to open sufficiently to release the infusion set base 106. Although not shown, in some embodiments, a stop (e.g., on the retainer base 140) may be provided to hold the yoke 311 in place to prevent it from falling out of the assembly 100 in the released state.

[0482] 81A and 81B, in another embodiment, the yoke 311 may be configured as a set of pads 389, each coupled to other components of the inserter assembly 100 via a flexure 303. As best shown in FIG. 81A, the pads 389 may be coupled to the inner housing 120 via a flexure 303. While half of the inner housing 120 is removed in the cross-sectional view of FIG. 81A, the opposite side is similar and would likely also include pads 389. As best shown in the enlarged view of FIG. 81B, each pad 389 may abut a corresponding arm 332 of the sharps retraction device 134. The pads 389 may prevent displacement of the arms 332 and help keep the infusion set base 106 engaged with the arms 332 during improper handling.

[0483] When the inserter assembly 100 is actuated, the yoke 311 may transition from a restrained state to a released state due to deformation of the flexures 303 connecting each pad 389 to the inner housing 120. Release of the spring 136 may propel the sharps holder 130 toward the open end of the inserter assembly 100 and impact the pads 389. As shown, each pad 389 includes a leg 305 that may extend within the displacement path of the sharps holder 130. As shown in FIGS. 81A and 81B , the leg 305 may be positioned to be struck, for example, by the wing 327 of the sharps holder 130. Impact of the sharps holder 130 against the pads 389 elastically deforms the flexures 303, causing the pads 389 to move away from the arm 332. When the ear portion 204 of the cannula subassembly 114 is pressed into the nub 350 of the arm 332, the pad 389 is displaced, freeing the arm 332 to spread outward and move the infusion set base 106 to a releasable position. In a preferred embodiment, the pad 389 remains attached to the inner housing 120 when the sharps holder 130 drives the yoke 311 to the release state. The bend 303 may be permanently deformed but not fractured, while in other embodiments, the bend 303 may fracture, separating the pad 389 from the inserter assembly 100.

[0484] 80A-81B is released by impact with a portion of sharps holder 130, in other embodiments, another portion of the spring-biased unit formed by sharps holder 130, insertion sharp 132, and cannula subassembly 114 may impact yoke 311. Cannula subassembly 114 may include wings similar to wings 327 on sharps holder 130 in certain embodiments, which may impact yoke 311 to release yoke 311 when inserter assembly 100 is actuated.

[0485] Referring to FIGS. 82A-82C, in some embodiments, a yoke 311 may be incorporated into the sharps holder 130. As best shown in FIG. 82B, the exemplary sharps holder 130 may include multiple lobes 307 with a central or passageway opening. The lobes 307 may be located on either side of the sharps holder 130 and may slide over the arms 332 during assembly of the inserter assembly 100. At least a portion of the arms 332 may be tapered to reduce in thickness toward the free end of each arm 332, or may have a graduated thickness depending on the embodiment. The lobes 307 may be sized to snugly accommodate the thickest portion of each arm 332 in a stored position. In some instances, slight interference may occur between the arms 332 and the lobes 307 when the lobes 307 are positioned around the thicker regions of the arms 332. In the storage position, the lobes 307 are positioned against the thickened portions of the arms 332, limiting flexure of the arms 332. When the inserter assembly 100 is actuated and the sharps holder 130 advances toward the open end of the inserter assembly, the lobes 307 reach the thinned portions of each arm 332. The dimensions of the opening defined by the lobes 307 may be configured to allow the arms 332 to expand outward and release the infusion set base 106 when the ears 204 of the cannula subassembly 114 impact the nubs 350 of the arms 332. Thus, the yoke 311 defined by the lobes 307 can transition between a restrained state and a released state as the sharps holder 130 displaces during the insertion stroke of the inserter assembly 100.

[0486] Referring primarily to FIGS. 77A-77B, in certain embodiments, retraction may not be automatic and / or spring biased. For example, the insertion sharp 132 may remain in a forward position, and a user removal motion may manually withdraw the insertion sharp 132 from the cannula 104. In such embodiments, the spring 138 may be omitted. In some embodiments, release of the arm 332 from the infusion set base 106 may not be automatic. Any arrangement apparent to one of ordinary skill in the art may be used to facilitate manual separation of the arm 332 from the infusion set base 106. A twisting motion may be used to release the arm 332 from the infusion set base 106, allowing the insertion sharp 132 to subsequently retract automatically or be manually withdrawn. In alternative embodiments, one or more buttons may be included. Displacement of one or more buttons may disengage the arm 332 from the infusion set base 106 and allow manual or automatic withdrawal of the insertion sharp 132 from the cannula 104. Squeezing a deformable portion of the inserter assembly 100 can similarly cause separation. As will be appreciated by those skilled in the art, the embodiments of the inserter assembly 100 described herein can be modified in other ways to allow for various types of other manual arm 332 release schemes.

[0487] In an alternative embodiment in which the infusion set base 106 is retained by a portion of the inner housing 120 and the arms 332 engage with a portion of the inner housing 120, displacement of the sharps holder 130 similarly causes release of the infusion set 102 and triggers retraction. For example, the ears 204 may impinge on and cause displacement of locking members on the inner housing 120 (e.g., spreading them away from the infusion set 102), thereby separating them from the infusion set 102. Additional ears 204 or other protrusions on the cannula subassembly 114 may be included to cause release of the arms 332 from the inner housing 120 (e.g., via spreading of the arms 332) to enable retraction.

[0488] In certain embodiments, there may be a dwell period during actuation of the inserter assembly 100 during which retraction of the insertion sharp 132 is triggered and the sharps retraction device 134 is displaced, but the insertion sharp 132 remains substantially stationary. During this dwell period, the spring 136 may continue to apply pressure to the cannula subassembly 114 through the sharps holder 130. This may block and ensure any tendency for the cannula subassembly 114 to bounce or recoil as it is propelled into the infusion set base 106. As shown, upon completion of the insertion operation, a dwell gap 360 may exist between the stop 362 of the sharps retraction device 134 and the ledge 302 of each cantilever arm 296 of the sharps holder 130. The spring 136 may still have energy stored therein and continue to press against the sharps holder 130. The dwell gaps 360 on each side may be the same size.

[0489] In FIGS. 83A-83B, which show two cross-sectional views of the inserter assembly 100, the retention gap 360 can decrease until the stop 362 on the sharps retraction device 134 contacts the ledge 302 of the cantilever arm 296 on the sharps holder 130. The restoring action of the spring 138 can begin to displace the sharps holder 130 and the insertion sharp 132 mounted thereon, along with the sharps retraction device 134. This displacement can retract the insertion sharp 132 from the cannula 104 and infusion set 102. An alternative embodiment of the inserter assembly 100 at this stage of operation is shown in FIG. 83C. In FIG. 83C, the cantilever arms 296 are mirror images of each other and of equal length. In such an embodiment, the stops 362 on the sharps retraction device 134 can be of uniform height relative to each other.

[0490] As shown in FIGS. 84A-84B , once retraction is complete, the sharps retraction device 134 may be pressed against the outer housing 116 by the spring 138. For ease of illustration, the spring 138 is depicted still in a compressed state, but as will be understood by those skilled in the art, it will uncompress into a relaxed state while retraction is in progress. Similar to the spring 136, the relaxed state may be a fully relaxed state or a relatively relaxed state in which the spring 138 still exerts some pressure on the sharps retraction device 134, preventing it from swinging around. After retraction, the insertion sharp 132 may be retracted within the inserter assembly 100 to help protect against unintentional finger sticks and the like. In an exemplary embodiment, the insertion sharp 132 is retracted further within the inserter assembly 100 compared to its starting position. In other embodiments, the retracted position of the insertion sharp 132 may be different, but may be retracted at least as deep within the inserter assembly 132 as its initial starting position. The infusion set 102 may be held in place on the skin 356 with the cannula 104 remaining in place in the patient.

[0491] Referring to Figures 84C-E, an alternative embodiment of the inserter assembly 100 is shown. As shown in Figures 84C-D, the inner housing 120 of the inserter assembly 100 is shorter compared to, for example, that shown in Figure 84B. In the exemplary embodiment shown in Figures 84A-B, when the sharps retraction device 134 is retracted, the arm 330 of the sharps retraction device 134 can ride within a rail 124 defined within the inner housing 120. Thus, the inner housing 120 functions as a guide, and the sharps retraction device 134 can be guided to a retracted state by the inner housing 120. As shown in Figures 84C-D, the height of the inner housing 120 is such that the sharps retraction device 134 is guided during a first portion of the retraction stroke but not during the remainder of the stroke. The at least partially unguided retraction displacement of the sharps retraction device 134 may allow some movement of the sharps retraction device 134 within the outer housing 116 as the retraction stroke occurs.

[0492] In certain embodiments, the outer housing 116 may include at least one tipping projection 135 that prevents retraction of a portion of the sharps retraction device 134. This portion of the sharps retraction device 134 may collide with the tipping projection 135 during the unguided portion of the retraction stroke. The tipping projection 135 may have an end face spaced apart from the inner surface of the closed end of the outer housing 116. An example tipping projection 135 may extend from the inner surface of the closed end of the outer housing. The tipping projection 135 may be positioned off-center and may connect to both the inner surface of the closed end and the sidewall of the outer housing 116, as shown. In some examples, the tipping projection 135 may have a cross-section in the shape of the Latin letter "T." An example tipping projection 135 may include at least one nub body extending from the inner surface of the closed end of the outer housing 116 to the open end of the outer housing 116. In other embodiments, at least one angled body may extend at an angle from the inner surface of the closed end of the outer housing 116 to a point on the interior sidewall of the outer housing 116. In still other embodiments, the angled protrusion 135 may include at least one protrusion that extends up the inner wall of the outer housing 116 (e.g., near the closed end) into the interior volume of the outer housing 116. While such an angled protrusion 135 may not directly connect to or contact the inner surface of the closed end of the outer housing, such an angled protrusion 135 may still be referred to as being disposed at the closed end of the outer housing 116.

[0493] Thus, the sharps retraction device 134 may fully contact the inner surface of the outer housing 116 on one side, but be blocked early on by the angled protrusion 135 on the other side. As the sharps retraction device 134 advances toward the closed end of the outer housing 116, a portion of the sharps retraction device 134 may contact the angled protrusion 135, which may block further displacement of that portion of the sharps retraction device 134. During the second stage of the retraction stroke, the sharps retraction device 134 is unguided, and as retraction continues (e.g., as the rear spring 138 continues to relax), the sharps retraction device 134 may begin to tilt at an angle relative to the axis of the remainder of the inserter assembly 100. As a result, the insertion sharp 132 on the sharps holder 130 will tilt out of alignment with the axis of the inserter assembly 100. Alternatively, the surface of the sharps retraction device 134 closest to the inner surface of the closed end of the inner housing may be uneven, as described above, to cause the sharps retraction device 134 to tilt. For example, the sharps retraction device 134 may include a ramped protrusion 135 (e.g., a ramped projection, nub, "T" shaped projection, etc.) to create a ramp as the retraction stroke progresses.

[0494] Upon completion of the retraction stroke, the insertion sharp 132 may be in a tilted state. This may further aid in storing the insertion sharp 132 within the inserter assembly 100 after retraction. At the end of the retraction stroke, the retraction spring 138 may not be fully relaxed. Thus, the retraction spring 138 may press the sharp retractor 134 against the closed end of the outer housing 116, maintaining the insertion sharp 134 in a tilted state. This may also help prevent rocking of the sharp retractor 134 when in the retracted state, so that there is substantially no wobble when handling the inserter assembly 100 after use.

[0495] The p...

Claims

1. a housing defining an insertion driver latch; an insertion driver displaceable between an initial position and a forward position, the insertion driver engaging the insertion driver latch in the initial position; a release finger displaceable relative to the housing from a first position to a ready position and further from the ready position to an actuated position, the release finger configured to press a portion of the insertion driver in a setting direction to engage the insertion driver with the insertion driver latch when the release finger displaces from the first position to the ready position, and to displace a portion of the insertion driver in a release direction to disengage the insertion driver from the insertion driver latch when the release finger displaces from the ready position to the actuated position; a latch structure; and an insertion bias member configured to be held in a deflected state by the latch structure and engagement of the insertion driver with the insertion driver latch when the release finger reaches the ready position, and to be released from the deflected state when the insertion driver is disengaged from the insertion driver latch. an inserter assembly including:

2. 10. The inserter assembly of claim 1, The inserter assembly, characterized in that the latch structure includes a plurality of opposing retention arms and a retainer displaceable therebetween, the retention arms having a stepped portion that overhangs the retainer when the latch structure is in an engaged state.

3. 3. The inserter assembly of claim 2, the retainer is configured to displace when the release finger is displaced from the first position to the ready position, and the latch structure is engaged when the release finger is displaced to the ready position.

4. 10. The inserter assembly of claim 1, The inserter assembly is further configured to deflect when the release finger is displaced to the ready position, and the retraction bias member is configured to be retained in the deflected state by the latch structure.

5. 10. The inserter assembly of claim 1, the insertion driver is configured to disengage the latch structure by being displaced from the initial position to the forward position, and the retraction bias member is configured to displace the insertion driver to the initial position when the latch structure is disengaged.

6. 10. The inserter assembly of claim 1, The inserter assembly, wherein the insertion driver includes a port connectable to an insertion sharps holder.

7. 10. The inserter assembly of claim 1, The inserter assembly, wherein the housing includes a receptacle connectable to a care assembly cartridge.

8. 10. The inserter assembly of claim 1, The inserter assembly, wherein the housing has a receptacle including a plurality of receiving shoes that correspond to a plurality of retainer pins of the care assembly cartridge.

9. 10. The inserter assembly of claim 1, 11. The inserter assembly of claim 1, wherein the release finger is configured to deflect to impact and avoid a portion of the insertion driver when displaced to the ready position.

10. 10. The inserter assembly of claim 9, 10. The inserter assembly of claim 9, wherein the housing prevents the release finger from deflecting toward the housing when the release finger is displaced from the ready position to the actuated position.

11. 10. The inserter assembly of claim 1, The inserter assembly of claim 1, wherein the insertion driver comprises a cantilever arm including a locking body that engages with the insertion driver latch, and the housing prevents the cantilever arm from deflecting toward the housing.

12. 12. The inserter assembly of claim 11, the release finger is configured to collide with a portion of the cantilever arm, bending the cantilever arm and moving the cantilever arm out of the path of travel of the release finger when the release finger is displaced from the ready position to the actuated position, and the bending of the cantilever arm disengages the locking body from the insertion driver latch.

13. an enclosure including an outer housing and end caps; inner housing; an insertion driver contained within the inner housing and displaceable from an initial position engaged with an insertion driver latch provided on an inner wall of the inner housing to a forward position; an insertion bias member disposed between the insertion driver and the end cap; a retainer configured to engage a first latch when the housing is displaced in a first direction to reach a ready position, the insertion bias member being held in a deflected state when the retainer engages the first latch and the insertion driver engages the insertion driver latch; and a release finger on the housing configured to hold the insertion driver engaged with the insertion driver latch when the housing is displaced to the ready position and to disengage the insertion driver from the insertion driver latch when the housing is displaced in a second direction from the ready position to an actuated position, and wherein the insertion bias member is configured to bias the insertion driver toward the forward position when the insertion driver is released from the insertion driver latch. wherein the insertion driver disengages the retainer from the first latch when the insertion driver is displaced toward the forward position.

14. 14. The inserter assembly of claim 13, The inserter assembly further includes a retraction bias member configured to deflect when the housing is displaced to the ready state and configured to be held in the deflected state when the retainer is engaged with the first latch.

15. 15. The inserter assembly of claim 14, 11. The inserter assembly of claim 10, wherein when the retainer disengages from the first latch, the retraction bias member is released from the deflected state, displacing the retainer away from the first latch and displacing the insertion driver to the initial position.

16. 14. The inserter assembly of claim 13, The inserter assembly, wherein the insertion driver includes a port connectable to an insertion sharps holder having an insertion sharps.

17. 14. The inserter assembly of claim 13, The inserter assembly, wherein the inner housing includes a receptacle opposite the end cap, the receptacle configured to be connectable to a care assembly cartridge.

18. 14. The inserter assembly of claim 13, 11. An inserter assembly according to claim 1, wherein the release finger is configured to deflect to impact and avoid a portion of the insertion driver when the housing is displaced to the ready position.

19. 14. The inserter assembly of claim 13, 11. An inserter assembly, comprising: an inner housing that prevents deflection of the release finger toward the inner housing when the enclosure is displaced from the ready position to the actuated position.

20. 14. The inserter assembly of claim 13, The inserter assembly of claim 1, wherein the insertion driver includes a cantilevered arm having a locking body that engages an insertion driver latch, and the inner housing prevents the cantilevered arm from deflecting toward the inner housing.

21. 21. The inserter assembly of claim 20, the release finger is configured to strike and deflect a portion of the cantilever arm when the housing is displaced from the ready position to the actuated position, causing the cantilever arm to move out of the path of the release finger, and the deflection of the cantilever arm disengages the locking body from the insertion driver latch.

22. 14. The inserter assembly of claim 13, the retainer includes a reset body and a retraction spring retainer, a portion of the insertion driver is disposed between the reset body and the retraction spring retainer, and the insertion bias member is sandwiched between the portion of the insertion driver and the reset body.

23. 23. The inserter assembly of claim 22, the end cap includes a post that extends into a passage formed in the reset body, the end cap configured to apply a pressing force to the reset body when the housing is displaced to the ready position.

24. an enclosure including an outer housing and end caps; an inner housing, the enclosure being displaceable relative to the inner housing; a retainer configured to engage the first latch when the enclosure is displaced in a first direction toward the inner housing beyond a first predetermined threshold distance; an insertion driver contained within the inner housing, displaceable from a first position to a second position, the insertion driver including a routing body; a release finger provided on the housing, the release finger configured to apply a pressing force in a set direction to the routing body to more firmly engage the insertion driver with the insertion driver latch when the housing is displaced in the first direction, and to displace the routing body in a release direction to disengage the insertion driver from the insertion driver latch when the housing is pulled in a second direction opposite the first direction beyond a second threshold distance; and a first biasing member configured to be held in a deflected state when the retainer is engaged with the first latch and the insertion driver is engaged with the insertion driver latch, and to bias the insertion driver toward the second position when the insertion driver is disengaged from the insertion driver latch; wherein the insertion driver disengages the retainer from the first latch when the insertion driver is displaced toward the second position.

25. 25. The inserter assembly of claim 24, The inserter according to claim 1, wherein the insertion driver includes a cantilevered arm having a locking body that engages the insertion driver latch.

26. 26. The inserter assembly of claim 25, The inserter assembly, wherein the routing body is disposed on the cantilever arm.

27. 27. The inserter assembly of claim 26, The inserter assembly, wherein the routing body includes opposing first and second surfaces, each including a ramp.

28. 28. The inserter assembly of claim 27, the release finger includes a paddle body having opposing first and second paddle body sides, each having a ramp, the ramp on the first paddle body side configured to enter the ramp on the second surface of the routing body when the housing is displaced in the first direction, such that further displacement of the housing in the first direction causes the release finger to flex around the second surface; an inclined portion on the second paddle body side enters the inclined portion on the first surface of the routing body when the housing is displaced in the second direction, and further displacement of the housing in the second direction displaces the cantilever arm in the release direction so as to move out of the path of the paddle body.

29. 26. The inserter assembly of claim 25, The inserter assembly, wherein the cantilever arm extends along an axis, and the routing body projects in a direction substantially perpendicular to the axis.

30. 25. The inserter assembly of claim 24, The inserter assembly of claim 1, wherein the insertion driver latch comprises at least one ledge formed on an interior surface of the inner housing.

31. 25. The inserter assembly of claim 24, The inserter assembly, wherein the inner housing prevents the release finger from bending in a direction opposite to the release direction when the enclosure is displaced in the second direction.

32. 25. The inserter assembly of claim 24, The inserter assembly, wherein the insertion driver includes a port engageable with an insertion sharps holder.

33. 25. The inserter assembly of claim 24, The inserter assembly further includes a second bias member.

34. 34. The inserter assembly of claim 33, the second bias member is configured to transition to a deflected state when the housing is displaced in the first direction and to be retained in the deflected state when the retainer is engaged with the first latch.

35. 35. The inserter assembly of claim 34, the second biasing member is configured to bias the retainer away from the first latch when the first latch is disengaged and to bias the insertion driver to the first position and engage the insertion driver latch.

36. 34. The inserter assembly of claim 33, The inserter assembly of claim 1, wherein the shaft of the insertion driver extends through the second bias member.

37. 1. A cartridge for a reusable inserter assembly, comprising: a housing having a recessed bay at one end thereof, the housing including a plurality of retaining members projecting into the bay; a retainer including a flange sandwiched between a lip at an end of the bay and each end of the holding member, the flange having a plurality of cantilever arms projecting from a first surface of the flange; a first patient care assembly portion connected to the retainer by the plurality of cantilever arms; a sharps holder having an insertion sharps attached thereto; and a second patient care assembly part supported on the insertion sharp; A cartridge comprising:

38. 38. The cartridge of claim 37, The cartridge further includes a plurality of engagement bodies protruding from a surface of the edge portion located farthest from the flange.

39. 39. The cartridge of claim 38, The cartridge is characterized in that the engagement body is an engagement pin.

40. 39. The cartridge of claim 38, The cartridge is characterized in that the engaging body protrudes from a second surface opposite to the first surface.

41. 38. The cartridge of claim 37, The cartridge is characterized in that the holding member is a cantilever portion of a side wall of the bay portion.

42. 38. The cartridge of claim 37, The cartridge of claim 1, wherein the cantilevered arm defines a guide, and the sharps holder is displaceable along the guide.

43. 43. The cartridge of claim 42, The cartridge, wherein the edge portion functions as a stopper that limits the range of displacement of the sharp member holder in the first direction.

44. 43. The cartridge of claim 42, The cartridge wherein the guide is formed by a slot extending through each cantilever arm.

45. 38. The cartridge of claim 37, The cartridge of claim 1, wherein the first patient care assembly portion is an infusion set base and the second patient care assembly portion is a cannula subassembly.

46. 38. The cartridge of claim 37, The cartridge is characterized in that the housing is disposed within a container and is detachably connected to the container.

47. 1. A cartridge for a reusable inserter assembly, comprising: a housing having a recessed bay at one end thereof, the housing including a plurality of retaining members projecting into the bay; a retainer including a flange sandwiched between an edge of the end of the bay and each end of the retention member, the retainer having a plurality of cantilever arms projecting from a first surface of the flange, each cantilever arm including a guide passage extending therethrough; a first patient care assembly portion connected to the retainer by the plurality of cantilever arms; a sharps holder having an insertion sharp attached thereto, the sharps holder including fins extending from a main portion of the sharps holder through the guide passage; and a second patient care assembly part supported on the insertion sharp; A cartridge comprising:

48. 48. The cartridge of claim 47, The cartridge further includes a plurality of engagement bodies protruding from a surface of the edge portion located farthest from the flange.

49. 49. The cartridge of claim 48, The cartridge is characterized in that the engagement body is an engagement pin.

50. 49. The cartridge of claim 48, The cartridge is characterized in that the engaging body protrudes from a second surface opposite to the first surface.

51. 48. The cartridge of claim 47, The cartridge is characterized in that the holding member is a cantilever portion of a side wall of the bay portion.

52. 48. The cartridge of claim 47, A cartridge characterized in that the portion of each cantilever arm including the guide passage extends from the support end of the cantilever arm to a position just before the free end of the cantilever arm.

53. 48. The cartridge of claim 47, The cartridge, wherein the edge portion forms a stopper that limits the range of displacement of the sharps holder in a first direction along the guide passage.

54. 48. The cartridge of claim 47, The cartridge of claim 1, wherein the first patient care assembly portion is an infusion set base and the second patient care assembly portion is a cannula subassembly.

55. 48. The cartridge of claim 47, The cartridge is characterized in that the housing is disposed within a container and is detachably connected to the container.

56. 56. The cartridge of claim 55, a barrier attached to the container, the barrier and the container configured to completely enclose the housing, the retainer, the first patient care assembly portion, the second patient care assembly portion, and a sharps holder.

57. 1. A method of assembling a cartridge for a reusable inserter assembly, comprising: (a) placing an insertion sharp extending from a sharp holder through a first percutaneous access assembly portion; (b) positioning the sharps holder in a plurality of guides of a retainer; (c) advancing the retainer through a first displacement range within the bay of the housing, wherein a flange of the retainer deflects a plurality of retention members within the first displacement range, and the flange reaches a retention position where it abuts an edge at an end of the bay and is spaced from the retention members, causing the retention members to return to their original rest state and prevent the retainer from moving to positions within the first displacement range; and (d) removably connecting a second percutaneous access assembly portion to the plurality of cantilever arms included in the retainer. A method comprising:

58. 58. The method of claim 57, The method, wherein step (c) further comprises preventing displacement of the sharps holder along a portion of the guide with the edge.

59. 58. The method of claim 57, The method further includes the step of passing a plurality of engagement bodies provided on the retainer through at least one opening formed in the edge portion.

60. 58. The method of claim 57, The method further includes placing the housing within the container.

61. 61. The method of claim 60, The method further includes removably connecting the housing to the container.

62. 61. The method of claim 60, The method further includes sealing the opening of the container with a barrier, the barrier and the container completely enclosing the housing.

63. 58. The method of claim 57, Step (b) includes positioning fins on the sharps holder within a plurality of slots formed in the cantilevered arm.

64. 58. The method of claim 57, and step (b) includes inserting portions of the sharps holder into a plurality of slots extending through the cantilevered arm, the portions of the sharps holder being inserted into portions of the slots furthest from the free ends of the cantilevered arms.

65. a housing having an open end and an opposite closed end; a care assembly base holder to which the care assembly base is detachably connected; a trigger body held in position relative to the care assembly base holder via an insertion latch structure; a sharps shuttle for holding an insertion sharps, the sharps shuttle being connected to the trigger body via a retractable latch structure; a first biasing member configured to bias the trigger body, the sharps shuttle, and the insertion sharps toward the open end of the housing when the insertion latch structure transitions to a released state; and a second bias member configured to bias the sharps shuttle and the insertion sharps toward the closed end by displacing a retraction latch structure into an activated state when the trigger body and the sharps shuttle are displaced to the retracted release position by the first bias member; An inserter assembly comprising:

66. 66. The inserter assembly of claim 65, The inserter assembly, characterized in that the insertion latch structure is configured to transition to the released state when a force pressing a portion of the trigger body and a portion of the housing together exceeds a predetermined threshold.

67. 66. The inserter assembly of claim 65, The inserter assembly, characterized in that the insertion latch structure includes a stepped portion of the trigger body, and the stepped portion removably engages with a locking portion formed on the care assembly base holder.

68. 66. The inserter assembly of claim 65, An inserter assembly characterized in that the trigger body includes an arm with a stepped portion formed thereon, and the insertion latch structure is configured by the stepped portion engaging with a locking portion formed on the care assembly base holder.

69. 69. The inserter assembly of claim 68, The inserter assembly is characterized in that the care assembly base holder has an opening through which the end of the arm passes.

70. 70. The inserter assembly of claim 69, An inserter assembly characterized in that the end of the arm is aligned with a trigger protrusion of the housing, and when the end abuts the trigger protrusion, relative displacement between the housing and the trigger body is prevented.

71. 71. The inserter assembly of claim 70, The arm is configured to displace into a deflected state when the force pressing the trigger protrusion and the end of the arm against each other exceeds a predetermined threshold, and in this deflected state, the step portion disengages from the engaging portion and the insertion latch structure transitions to the released state.

72. 66. The inserter assembly of claim 65, The inserter assembly, wherein the trigger is formed on the care assembly base holder.

73. 66. The inserter assembly of claim 65, The inserter assembly, wherein the retractable latch structure includes a stepped portion of the sharps shuttle, the stepped portion releasably engaging a stop formed on the trigger body.

74. 66. The inserter assembly of claim 65, The inserter assembly, wherein the retracted release position is located at an end of a displacement range of the trigger body.

75. 66. The inserter assembly of claim 65, the release position is located at a midpoint within a range of displacement of the trigger body, and the first biasing member is configured to continue urging the trigger body in the insertion direction toward the open end through an end of the range of displacement of the trigger body after the trigger body reaches the midpoint.

76. 76. The inserter assembly of claim 75, 10. An inserter assembly comprising: a cannula subassembly supported by the insertion sharp; and a trigger body configured to displace the cannula subassembly in the insertion direction at an end of the trigger body's displacement range.

77. 66. The inserter assembly of claim 65, An inserter assembly, wherein a cannula subassembly is held by the insertion sharp.

78. 66. The inserter assembly of claim 65, The inserter assembly, wherein the insertion latch structure is configured to transition to the released state when the housing is displaced relative to the care assembly base in a direction away from the care assembly base.

79. 79. The inserter assembly of claim 78, An inserter assembly characterized in that the care assembly base is connected to an adhesive for fixing the care assembly base to the biological barrier, and the biological barrier is lifted from its resting position when the housing is displaced relative to the care assembly base.

80. Housing; a care assembly base holder to which the care assembly base is detachably connected; an insertion unit held in position relative to the care assembly base holder via an insertion latch structure, the trigger body; and a retraction unit including an insertion sharp, the retraction unit being removably coupled to the trigger body via a retraction latch structure; an insertion unit including: a first bias member that biases the insertion unit to displace in the insertion direction when the insertion latch structure transitions to a first release state; and a second bias member that biases the retraction unit in a retracting direction when the retraction unit is displaced to the retraction release position by the first bias member, causing the retraction latch structure to transition to an activated state; An inserter assembly comprising:

81. 81. The inserter assembly of claim 80, The inserter assembly, wherein the second bias member is held in a biased state between the trigger body and a portion of the retraction unit while the retraction latch structure is in an engaged state.

82. 81. The inserter assembly of claim 80, The inserter assembly, wherein the retracted release position is located at an end of a displacement range of the trigger body.

83. 81. The inserter assembly of claim 80, the release position is located at a midpoint within a range of displacement of the trigger body, and the first bias member is configured to urge the trigger body past the midpoint toward the open end.

84. 81. The inserter assembly of claim 80, an inserter assembly, wherein a cannula subassembly is supported by the insertion sharp member, and the trigger body is configured to push the cannula subassembly in the insertion direction when displaced in the insertion direction by the first bias member.

85. 81. The inserter assembly of claim 80, An inserter assembly, wherein a care assembly portion separate from the care assembly base is supported by the insertion sharp.

86. 81. The inserter assembly of claim 80, 10. An inserter assembly, wherein the insertion unit is adapted to displace with the housing until a force exceeding a predetermined threshold is applied to separate the housing and the insertion unit.

87. 87. The inserter assembly of claim 86, The inserter assembly is characterized in that the care assembly base is connected to an adhesive, and when the adhesive is adhered to a biological barrier patch, the threshold force is generated by pulling the housing away from the care assembly base, thereby lifting the patch from its resting state.

88. 81. The inserter assembly of claim 80, The inserter assembly is characterized in that the insertion latch structure includes an elastic member that releasably engages a locking portion, and the housing is configured to deflect the elastic member to disengage from the locking portion and transition the insertion latch structure to the released state, which operation is performed by pulling the housing in a direction away from the care assembly base.

89. 81. The inserter assembly of claim 80, The inserter assembly, wherein the retraction latch structure includes an elastic member of the retraction unit that removably engages with a locking portion formed on the trigger body.

90. an insertion unit whose displacement in the insertion direction is restricted by an insertion latch structure; a retraction unit including an insertion sharp, the retraction unit being removably coupled to the insertion unit by a retraction latch mechanism; a first biasing member configured to displace the insertion unit and the retraction unit in an insertion direction when the insertion latch structure is released; a second biasing member configured to bias the retraction unit in a retraction direction; and a retraction trigger, the retraction latch structure configured to transition to a disengaged state upon being displaced by the retraction trigger at an intermediate point of a displacement path of the insertion unit; An inserter assembly comprising:

91. 91. The inserter assembly of claim 90, An inserter assembly, characterized in that a percutaneous access assembly is supported by the insertion sharp.

92. 91. The inserter assembly of claim 90, An inserter assembly, wherein the sharp insertion member supports an injection cannula assembly.

93. 91. The inserter assembly of claim 90, The inserter assembly is characterized in that the insertion unit is configured to propel the percutaneous access assembly supported by the insertion sharp member in an insertion direction after passing the intermediate point.

94. 91. The inserter assembly of claim 90, The inserter assembly, wherein the insertion unit is configured to push the percutaneous access assembly supported by the insertion sharp in the insertion direction after passing the intermediate point.

95. 91. The inserter assembly of claim 90, The inserter assembly further includes a holder and a first patient care assembly part coupled to the holder, and a second patient care assembly part supported on the insertion sharp.

96. 96. The inserter assembly of claim 95, The inserter assembly of claim 1, wherein the second patient care assembly portion is coupled to the first patient care assembly portion as the insertion unit moves along the movement path.

97. 96. The inserter assembly of claim 95, The inserter assembly of claim 1, wherein the second patient care assembly portion is coupled to the first patient care assembly portion when the insertion unit is displaced beyond the midpoint.

98. 91. The inserter assembly of claim 90, An inserter assembly comprising an access assembly supported by the insertion sharp, the insertion sharp having a lead length extending beyond the access assembly.

99. 99. The inserter assembly of claim 98, an inserter assembly, characterized in that the access assembly is positioned on a displacement path of the insertion unit, and the midpoint is set to drive the access assembly in the insertion direction a distance equal to or greater than the lead length after the insertion unit passes the midpoint.

100. 1. An inserter assembly for placing a device, comprising: Housing; a device base with an adhesive for securing the device base to a portion of the barrier; and a spring-biased insertion unit held in an initial state by an insertion latch structure, the base being releasably coupled to the insertion unit and securing the insertion unit to prevent displacement of the insertion unit relative to the portion of the barrier when the base is secured to the portion of the barrier by the adhesive; the housing is displaceable from an initial position to an actuated position in a direction opposite to an insertion direction of the insertion unit, the displacement of the housing to the actuated position is configured to transition the insertion latch structure to a released state, and the insertion latch structure is configured to inhibit relative movement between the housing and the insertion unit until a predetermined force threshold is exceeded.

101. 101. The inserter assembly of claim 100, The inserter assembly, wherein the threshold value is greater than the force required to lift the portion of the barrier from a resting state when the adhesive secures the base to the portion of the barrier.

102. 101. The inserter assembly of claim 100, The inserter assembly further includes a percutaneous access assembly, the insertion unit being spring-biased to be displaced in the insertion direction, and configured to couple the access assembly to the base when the insertion latch structure is released.

103. 101. The inserter assembly of claim 100, the insertion unit includes a spring-biased retraction unit including an insertion sharp, the retraction unit removably coupled to the remainder of the insertion unit via a retraction latch structure and constrained to move integrally with the remainder of the insertion unit while the retraction latch structure is engaged.

104. 104. The inserter assembly of claim 103, The insertion unit is spring-biased in the insertion direction along a displacement path, and the retraction latch structure is configured to reach a trigger protrusion when the insertion unit is displaced along the displacement path.

105. 105. The inserter assembly of claim 104, The inserter assembly, wherein the retractable latch structure is configured to reach the trigger protrusion when the insertion unit reaches an intermediate point of the displacement path.

106. 104. The inserter assembly of claim 103, The inserter assembly is characterized in that the retraction unit is spring-biased so as to be displaced in a retraction direction that is opposite to the insertion direction.

107. 104. The inserter assembly of claim 103, The inserter assembly, wherein the retraction unit includes a tilting protrusion.

108. 1. A method of placing a care assembly on a barrier, comprising: adhering a portion of the care assembly connected to an inserter assembly to the barrier; pulling the inserter assembly away from the barrier; lifting the barrier from a rest position to a lifted position by adhering a portion of the care assembly; after lifting the barrier, disengaging the insertion latch structure and urging the insertion unit and access assembly in an insertion direction; and disengaging the retraction latch structure after the insertion unit reaches the retraction release position and propelling the retraction unit including the insertion sharp in the retraction direction; wherein displacement of the access assembly in the insertion direction and displacement of the retraction unit in the retraction direction overlap at least part of the time.

109. 109. The method of claim 108, The method further comprising the step of connecting the access assembly to a portion of the care assembly.

110. 109. The method of claim 108, 10. The method of claim 9, wherein the step of propelling the retraction unit in the retraction direction further comprises tilting the insertion sharp.

111. 109. The method of claim 108, 10. The method of claim 9, wherein disengaging the insertion latch structure comprises displacing a portion of a housing of the inserter assembly against a portion of the insertion latch structure, causing the portion of the insertion latch structure to flex.

112. 109. The method of claim 108, The method, wherein disengaging the retraction latch structure includes driving the retraction unit in the insertion direction and into a trigger.

113. 113. The method of claim 112, the step of driving the retraction unit in the insertion direction and into the trigger includes displacing the retraction unit and the insertion unit relative to one another when the insertion latch structure is disengaged.

114. 109. The method of claim 108, The method of claim 1, wherein disengaging the retraction latch structure comprises disengaging the retraction unit from the insertion unit as the insertion unit is displaced in the insertion direction.

115. 109. The method of claim 108, wherein disengaging the insertion latch structure comprises releasing a first bias member held in a first deflected state while the insertion latch structure is in an engaged state, and disengaging the retraction latch structure comprises releasing a second bias member held in a second deflected state while the retraction latch structure is in an engaged state.

116. 109. The method of claim 108, The method further comprising the step of removing a locking member from the inserter assembly.

117. 1. A method of placing an access device using an inserter assembly, comprising: connecting the inserter assembly to a biological barrier; lifting the barrier coupled to the inserter assembly from a resting state to a lifted state by displacing the inserter assembly away from the barrier; automatically disengaging the insertion latch structure after the barrier has been lifted a predetermined distance and propelling the insertion unit, which includes a retraction unit including an insertion sharp, in the insertion direction; automatically disengaging a retraction latch structure coupling the retraction unit with the remainder of the insertion unit when the insertion unit is displaced to a retraction-release position, and urging the retraction unit in a retraction direction; and propelling the remainder of the insertion unit in the insertion direction from a retracted release position to a forward position. A method comprising:

118. 118. The method of claim 117, The method further comprises the step of preventing displacement of the insertion unit in the retraction direction after the insertion unit reaches the forward position.

119. 118. The method of claim 117, The method further comprises tilting the retraction unit as the retraction unit is driven in the retraction direction.

120. 118. The method of claim 117, The method further comprises coupling an access assembly to an access assembly base when at least a remainder of the insertion unit is displaced in the insertion direction.

121. 121. The method of claim 120, the retraction release point is reached before the access assembly is coupled to the access assembly base.

122. 121. The method of claim 120, The method, wherein the access assembly is a cannula subassembly and the access assembly base is an infusion set base.

123. 118. The method of claim 117, The method, wherein the step of connecting the inserter assembly to the biological barrier comprises adhering an access assembly base to the biological barrier.

124. 124. The method of claim 123, The method further includes separating the access assembly base from the inserter assembly.

125. an enclosure including an outer housing and end caps; inner housing; an insertion driver contained within the inner housing and displaceable from an initial position to a forward position, the insertion driver in the initial position engaging an insertion driver latch formed on an inner wall of the inner housing; an insertion bias member disposed between the insertion driver and the end cap; a retainer configured to engage a first latch when the housing is displaced in a first direction to reach a ready position, wherein the insertion bias member is held in a deflected state when the retainer engages the first latch and the insertion driver engages the insertion driver latch, and the insertion bias member is configured to bias the insertion driver toward the forward position when the insertion driver latch is released; and a release lock configured to be displaceable between an inactive position and an active position, the release lock configured to prevent release of the insertion driver latch in the active position; An inserter assembly comprising:

126. 126. The inserter assembly of claim 125, The inserter assembly of claim 1, wherein the insertion driver is configured to release the retainer from the first latch when displaced to the forward position.

127. 126. The inserter assembly of claim 125, 10. The inserter assembly of claim 9, wherein the insertion driver includes a cantilevered arm including a locking body configured to engage the insertion driver latch, and the inner housing is configured to prevent deflection of the cantilevered arm toward the inner housing.

128. 128. The inserter assembly of claim 127, The inserter assembly according to claim 1, wherein the release lock includes a body that prevents the cantilever arm from deflecting away from the inner housing in the actuated position.

129. 126. The inserter assembly of claim 125, 10. The inserter assembly of claim 9, wherein the release lock includes a base having a plurality of barrier bodies protruding from the base, the barrier bodies configured to extend through passages formed in the end cap.

130. 126. The inserter assembly of claim 125, The inserter assembly, wherein the release lock is configured to be pivotally displaceable between the inoperative position and the operative position.

131. 126. The inserter assembly of claim 125, The inserter assembly further includes a retraction bias member configured to deflect when the housing is displaced to the ready state and to be held in the deflected state while the retainer is engaged with the first latch.

132. 132. The inserter assembly of claim 131, 10. The inserter assembly of claim 9, wherein the retainer is disengaged from the first latch when the insertion driver is displaced to the forward position, the retraction bias member is configured to release the retainer from the first latch when the retainer is disengaged from the first latch, and the retraction bias member is configured to move the retainer away from the first latch and thereafter displace the insertion driver to the initial position.

133. 126. The inserter assembly of claim 125, The inserter assembly, wherein the insertion driver includes a port configured to couple to an insertion sharps holder having an insertion sharps.

134. 126. The inserter assembly of claim 125, The inserter assembly, wherein the inner housing includes a receptacle located opposite the end cap and adapted to be mated with a care assembly cartridge.

135. Housing; a release lock displaceable between an inoperative position and a released position; an inner housing, wherein the enclosure is displaceable relative to the inner housing when the release lock is in the inactivated position and the displacement is prevented when the release lock is in the released position; a retainer configured to engage a first latch when the enclosure is displaced toward the inner housing in a first direction; an insertion driver disposed within the inner housing and displaceable from a first position to a second position, the insertion driver including a routing body; a release finger on the housing configured to flex around the routing body when the housing is displaced in the first direction and configured to displace the routing body in a release direction to release the insertion driver from the insertion driver latch when the housing is pulled in a second direction; and a first biasing member that is held in a deflected state when the retainer is engaged with the first latch and the insertion driver is engaged with the insertion driver latch, the first biasing member being configured to bias the insertion driver toward the second position when the insertion driver is released from the insertion driver latch. an inserter assembly including:

136. 136. The inserter assembly of claim 135, The inserter assembly, wherein the release lock and the outer housing are an integral, single component.

137. 136. The inserter assembly of claim 135, The inserter assembly of claim 1, wherein the release lock is configured to deflect relative to the outer housing to move between the inactivated position and the activated position.

138. 136. The inserter assembly of claim 135, The inserter assembly of claim 1, wherein at least a portion of the release lock is disposed within a window formed in the inner housing when the release lock is in the released position.

139. 136. The inserter assembly of claim 135, The inserter assembly of claim 1, wherein the insertion driver includes a cantilevered arm having a locking body that engages the insertion driver latch, and the routing body is mounted on the cantilevered arm.

140. 136. The inserter assembly of claim 135, The inserter assembly of claim 1, wherein the insertion driver latch is defined by at least one ledge formed on an interior surface of the inner housing.

141. 136. The inserter assembly of claim 135, The inserter assembly, wherein the insertion driver includes a port configured to engage an insertion sharps holder.

142. 136. The inserter assembly of claim 135, The inserter assembly further comprises a second bias member.

143. 143. The inserter assembly of claim 142, The inserter assembly, wherein the second bias member is configured to transition to a deflected state when the housing is displaced in the first direction, and is maintained in the deflected state when the retainer is engaged with the first latch.

144. 144. The inserter assembly of claim 143, the second bias member is configured to bias the retainer away from the first latch when the first latch is released and to bias the insertion driver toward the first position to engage the insertion driver latch.

145. an enclosure including an outer housing and end caps; inner housing; an insertion driver disposed within the inner housing and displaceable from an initial position to a forward position, the insertion driver engaging an insertion driver latch formed on an inner wall of the inner housing in the initial position; an insertion bias member disposed between the insertion driver and the end cap; a retainer configured to deflect a second bias member and engage a first latch when the housing is displaced in a first direction from a released state to a ready state, the retainer being configured to hold the insertion bias member in a deflected state when the retainer engages the first latch and the insertion driver engages the insertion driver latch, and to bias the insertion driver toward the forward position when the insertion driver latch is released; and a release actuator configured to be displaced from an inactivated state to an activated state to release the retainer from the first latch; wherein the second bias member is configured to bias the housing and the retainer toward a released state when the retainer is released from the first latch.

146. 146. The inserter assembly of claim 145, the insertion bias member abuts the insertion driver and a surface of the retainer that abuts the housing, and the insertion bias member is configured to bias the retainer and the housing toward the released state when the retainer is released from the first latch.

147. 146. The inserter assembly of claim 145, An inserter assembly, wherein the insertion driver includes a cantilevered arm with a locking body that engages the insertion driver latch.

148. 146. The inserter assembly of claim 145, 10. An inserter assembly according to claim 9, wherein the insertion driver latch is defined by at least one ledge formed on an inner surface of the inner housing.

149. 146. The inserter assembly of claim 145, An inserter assembly, wherein the insertion driver includes a port configured to engage an insertion sharp holder.

150. 146. The inserter assembly of claim 145, The inserter assembly, wherein the inner housing includes a receptacle located opposite the end cap for mating with a care assembly cartridge.

151. 146. The inserter assembly of claim 145, the housing includes a release finger configured to hold the insertion driver in engagement with the insertion driver latch when the housing is displaced toward the ready state.

152. 152. The inserter assembly of claim 151, the release finger is configured to disengage the insertion driver from the insertion driver latch when the housing is displaced from the ready position in a second direction opposite to the first direction to reach an actuated position under a release actuator in an inactive state.

153. 153. The inserter assembly of claim 152, The inserter assembly, wherein the release actuator is configured to flex the release finger to a deformed condition when transitioning from the unactuated condition to the actuated condition.

154. 154. The inserter assembly of claim 153, 10. An inserter assembly, wherein when the housing is displaced from the ready position to the actuated position and the release finger is in a flexed state, the release finger does not contact the insertion driver.

155. 152. The inserter assembly of claim 151, the release finger is configured to disengage the insertion driver from the insertion driver latch when the housing is displaced from the ready state in a second direction opposite the first direction to reach an actuated position.

156. 156. The inserter assembly of claim 155, 11. The inserter assembly of claim 10, wherein when the housing and the retainer are urged toward a released state by the second bias member, the retainer collides with the insertion driver and reverses forward movement of the insertion driver caused by release of the insertion driver latch.

157. 1. An inserter assembly comprising: an enclosure including an outer housing and end caps; inner housing; an insertion driver disposed within the inner housing and displaceable from an initial position to a forward position, wherein in the initial position the insertion driver engages with an insertion driver latch formed on an inner wall of the inner housing; an insertion bias member disposed between the insertion driver and the end cap; a retainer configured to deflect a second bias member and engage a first latch when the housing is displaced in a first direction from a released state to a ready state, the insertion bias member being held in a deflected state when the retainer engages the first latch and the insertion driver engages the insertion driver latch, and configured to bias the insertion driver to the forward position when the insertion driver latch is released; and a release actuator configured to transition from an unactuated state to an actuated state to release the retainer from the first latch; wherein the second biasing member is configured to urge the housing and the retainer through a retraction stroke in a second direction opposite the first direction when the retainer is released from the first latch.

158. 158. The inserter assembly of claim 157, the insertion bias member abuts the insertion driver and a surface of the retainer that abuts the housing, and is configured to urge the retainer and the housing through a retraction stroke when the retainer is released from the first latch.

159. 158. The inserter assembly of claim 157, The inserter assembly according to claim 1, wherein the insertion driver includes a cantilevered arm with a step that engages the insertion driver latch.

160. 158. The inserter assembly of claim 157, 10. The inserter assembly of claim 9, wherein the insertion driver latch is formed by a ledge formed on the inner housing.

161. 158. The inserter assembly of claim 157, The inserter assembly, wherein the insertion driver includes a port configured to engage an insertion sharps holder.

162. 158. The inserter assembly of claim 157, The inserter assembly, wherein the inner housing includes a receptacle disposed opposite the end cap, the receptacle configured to mate with a care assembly cartridge.

163. 158. The inserter assembly of claim 157, a release finger formed on the housing configured to reinforce engagement between the insertion driver and the insertion driver latch when the housing is displaced toward the ready state.

164. 164. The inserter assembly of claim 163, the release finger is further configured to disengage the insertion driver from the insertion driver latch when the housing is displaced in the second direction from the ready state to the actuated position and the release actuator is in an unactuated state.

165. 165. The inserter assembly of claim 164, The inserter assembly, wherein the release actuator is configured to displace the release finger to a deflected state when transitioning from the unactuated state to the actuated state.

166. 166. The inserter of claim 165, The inserter assembly of claim 1, wherein the release finger is in the deflected state and is maintained out of contact with the insertion driver when the housing is displaced on the retraction stroke.

167. 164. The inserter assembly of claim 163, The inserter of claim 1, wherein the release finger is configured to disengage the insertion driver from the insertion driver latch when the housing is displaced through the retraction stroke.

168. 168. The inserter of claim 167, When the housing and the retainer are displaced during the retraction stroke, the retainer collides with the insertion driver, reversing the forward movement of the insertion driver caused by the release of the insertion driver latch.

169. 1. A method of releasing an inserter having a spring-biased insertion driver and a spring-biased retraction device, comprising: adhering a portion of the patient care assembly to the barrier; transitioning a release actuator of the inserter from an inactive state to an active state; disengaging a first latch holding the retraction device in place upon displacement of the release actuator; releasing the spring of the spring-biased retraction device to drive the retraction device and the inserter housing through a retraction stroke; Separating a portion of the patient care assembly from the barrier. A method comprising:

170. 170. The method of claim 169, The method further includes retaining a second latch that retains the spring biased insertion driver when the spring biased retraction device and the housing are driven through the retraction stroke.

171. 170. The method of claim 169, The method further includes releasing a spring in the spring-biased insertion driver during the retraction stroke to bias the spring-biased insertion driver in a forward direction.

172. 172. The method of claim 171, The method further includes impacting a spring-biased insertion driver against the spring-biased retraction device as the spring-biased retraction device is displaced through the retraction stroke, reversing forward travel of the insertion driver.

173. 170. The method of claim 169, The method of claim 1, wherein the step of displacing the release actuator comprises depressing a button.

174. 170. The method of claim 169, 10. The method of claim 9, wherein the step of displacing the release actuator includes depressing at least one tab connected to the first latch.

175. 170. The method of claim 169, The method of claim 1, wherein the step of releasing the first latch includes deflecting a latch arm to disengage the spring-biased retraction device.

176. 170. The method of claim 169, The method further includes deflecting a release finger of the housing out of alignment with a fin formed on a cantilevered arm of an insertion driver when the release actuator is displaced from an inactivated state to an activated state.

177. 170. The method of claim 169, The method further includes automatically returning the release actuator to a deactivated state during the retraction stroke.

178. 178. The method of claim 177, 10. The method of claim 9, wherein automatically returning the release actuator to a non-actuated state includes displacing a ramp formed on the release actuator into the insertion driver.

179. 170. The method of claim 169, The method further includes driving the release actuator through the retraction stroke with the retainer and the housing.

180. Housing; a body having a cavity sandwiched between a plurality of arms; a patient care assembly including a base and a second portion removably engaged with the plurality of arms; a spring biased unit including an insertion sharp and a sharps holder supporting the second portion of the patient care assembly; a spring for the spring-biased unit; a trigger having a first state that holds a spring in an energized state and a second state in which the spring is released from the energized state, the spring urging the spring biasing unit toward the base when the trigger is actuated; and a yoke including at least a portion adjacent to each of the plurality of arms, the yoke constraining deflection of at least a portion of each of the plurality of arms; the plurality of arms include a plurality of nubs configured to impact the nubs and spread the plurality of arms to release the base when the insertion sharp and the second portion of the patient care assembly are displaced toward the base.

181. 181. The inserter assembly of claim 180, The inserter assembly according to claim 1, wherein the yoke is a hollow member surrounding the plurality of arms.

182. 182. The inserter assembly of claim 181, The inserter assembly according to claim 1, wherein the yoke includes a split portion and rests on steps formed on the arms.

183. 182. The inserter assembly of claim 181, the yoke rests on a step formed on the arms, and a portion of the spring-biased unit includes a plurality of protrusions that collide with and deform the yoke around the step when the spring urges the spring-biased unit toward the base.

184. 181. The inserter assembly of claim 180, The inserter assembly, characterized in that the yoke includes a plurality of pads, each of which is adjacent to a respective arm of the plurality of arms, and the pad is connected to a portion of the body via a bent portion.

185. 185. The inserter assembly of claim 184, An inserter assembly characterized in that, when the spring-biased unit is driven in a base direction, a portion of the spring-biased unit collides with each pad, and the spring-biased unit applies a force that causes the bending portion to bend.

186. 181. The inserter assembly of claim 180, the yoke is defined by a plurality of lobes on a sharps holder that are positioned through the plurality of arms, each arm having a thick region and a thin region, and each lobe is sized to prevent flexure of a corresponding one of the plurality of arms when adjacent to the thick region of that arm and to allow flexure of that arm when adjacent to the thin region of that arm.

187. 181. The inserter assembly of claim 180, The inserter assembly, wherein the base is an infusion set base and the second portion of the patient care assembly is a cannula subassembly.

188. 181. The inserter assembly of claim 180, The inserter assembly, wherein the patient care assembly is an analytical sensor.

189. 181. The inserter assembly of claim 180, The inserter assembly of claim 1, wherein the base and second portion of the patient care assembly are coupled to one another when the spring biasing unit is driven in a proximal direction.

190. 1. A patient care assembly placement system comprising: an inserter assembly including a port and a receptacle body, the port including a central slot and port edge segments located on either side of the central slot, the receptacle body including a plurality of shoes each curved to surround a portion of the port from its closed end to its open end, each shoe having an overhanging region furthest from the main portion of the receptacle body; and a cartridge including a retainer, a patient care assembly coupled to the retainer, and a sharps holder having an insertion sharp protruding therefrom, the retainer including a plurality of engagement pins having a stem portion and a wider head, the sharps holder having a first end opposite a second end from which the insertion sharp protruding, the cartridge including a thinned portion between the first end and the second end; when the cartridge is aligned with the receptacle body and rotated into a mating state, each engagement pin is displaced from the open end to the closed end of the corresponding shoe, the cartridge moves translationally, the first end of the sharps holder enters the port to a depth where the thinned portion is aligned with the port edge in an engagement pin capture displacement range, the head of each engagement pin moves along the sloped surface of the overhanging region of the corresponding shoe in the engagement pin capture displacement range, and then the first end of the sharps holder is rotated over the port edge in the sharps holder capture displacement range.

191. 1. A patient care assembly placement system comprising: an inserter assembly including a port and a receptacle body, the port including ledges on either side thereof, and the receptacle body including a plurality of engagement tracks arranged partially around an axis of the port; and 1. A cartridge comprising: a retainer; a patient care assembly coupled to the retainer; and a sharps holder having an insertion sharp protruding therefrom, the retainer having a plurality of engagement projections, the sharps holder including a thinned portion between a first end and a second end opposite the first end, the insertion sharp protruding from the second end. when the cartridge is positioned in an aligned position relative to the receptacle body and rotated toward a mating state, the engagement protrusions move along the sloped regions of their respective engagement tracks to translationally drive the cartridge within an engagement protrusion capture range, causing a first end of the sharps holder to enter the port to a depth where the thinned portion is aligned with the ledge, and then causing the first end of the sharps holder to rotate over the ledge within the sharps holder capture range of the cartridge.

192. 192. The system of claim 191, The system according to claim 1, wherein the plurality of engagement tracks include a shoe having an overhanging shoulder at a position in each engagement track furthest from a main portion of the receptacle body.

193. 192. The system of claim 191, The system wherein the engagement projections are engagement pins each having a head and a relatively thin stem portion connecting the head to the remainder of the retainer.

194. 192. The system of claim 191, The port is configured to receive the first end of the sharps holder when the cartridge is in the engagement projection capture displacement range rotational position.

195. 192. The system of claim 191, The system of claim 1, wherein the first end of the sharps holder has an elongated cross-sectional shape, and the thinned portion has a cross-sectional shape that is less elongated than the first end.

196. 192. The system of claim 191, The system of claim 1, wherein the thinned portion is defined by a notch formed in the sharps holder at a substantially perpendicular angle to the axis of the insertion sharps.

197. 202. The system of claim 196, The ledge has a thickness sufficient to substantially fill the notch when the cartridge is rotated through a sharps retainer capture displacement range.

198. 192. The system of claim 191, The system is characterized in that the sloped region of each engagement track begins at the open end of the engagement track and is configured so that when the cartridge is rotated to the coupled state, the engagement protrusion is located at the closed end of the corresponding engagement track.

199. 200. The system of claim 198, comprising: The system of claim 1, wherein the sloped region of each engagement track includes a steepest slope along a segment of the sloped region closest to the open end.

200. 192. The system of claim 191, The system wherein the patient care assembly is selected from an infusion set or an analytical sensor.

201. 192. The system of claim 191, The patient care assembly includes a first portion and a second portion spaced apart from the first portion within the cartridge.

202. 1. A patient care assembly placement system comprising: an inserter assembly having a port with a port mating interface and a receptacle body including a plurality of engagement tracks disposed partially around an axis of the port; and a cartridge including a retainer, a patient care assembly coupled to the retainer, and a sharps holder having an insertion sharp protruding therefrom, the retainer including a plurality of protrusions, the sharps holder including a sharps holder coupling interface located opposite a first end of the sharps holder from which the insertion sharp protrudes; wherein when the cartridge is positioned in an aligned position relative to the receptacle body and rotated to a mated state, the protrusions displace along corresponding ramped regions of engagement tracks to translate the cartridge to a position where the sharps holder mating interface is aligned with the port mating interface in a first range of displacement, and rotate the cartridge to engage the sharps holder mating interface in a second range of displacement.

203. 203. The system of claim 202, The system, wherein the port mating interface and the sharps holder mating interface are threaded interfaces.

204. 203. The system of claim 202, the port mating interface includes a plurality of ledges disposed on opposite sides of the port, and the sharps holder mating interface includes a protrusion having a thinned portion disposed between a first end and a second end opposite the first end of the sharps holder.

205. 205. The system of claim 204, The system of claim 1, wherein a second end of the sharps holder rotates and moves on the ledge as the cartridge is rotated through the second range of displacement.

206. 206. The system of claim 205, the shelf has a thickness sufficient to substantially fill the notch when the cartridge is rotated through the second range of displacement.

207. 203. The system of claim 202, The system, wherein the cartridge further comprises a housing and a container, the retainer, the patient care assembly, and the sharps holder being at least partially disposed within the housing.

208. 208. The system of claim 207, The housing includes a plurality of arms that are deflectable from a container engagement state in which a portion of each arm is positioned in a corresponding recess in the container to a container release state in which a portion of each arm is displaced from the corresponding recess, and when the arms are in the container release state, the container is separated from the remainder of the cartridge.

209. 209. The system of claim 208, The receptacle body includes a plurality of tilting deflectors positioned to impact the plurality of arms and deflect them from the container engaging state to the container releasing state when the cartridge is rotated from the aligned position to the coupled state.

210. 210. The system of claim 209, The receptacle body includes a plurality of protrusions protruding from a main surface of the receptacle body and each protrusion is connected to the remainder of the receptacle body via a bent portion, the bent portion being configured to allow the protrusions to be pushed in by the container when the cartridge is rotated from the aligned position to the coupled state, and to be restored between a plurality of stop surfaces of the housing when the container is separated from the remainder of the cartridge and the cartridge is in the coupled state.

211. 203. The system of claim 202, The system is characterized in that the sloped region of each engagement track begins at the open end of the engagement track and is configured so that the protrusion is located at the closed end of the respective engagement track when the cartridge is rotated to the coupled state.

212. 210. The system of claim 209, The system of claim 1, wherein the sloped region of each engagement track includes a steepest portion along a segment of the sloped region closest to the open end.

213. Any of the devices, systems and methods shown and described herein.

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