Infusion apparatus and insert assembly devices, systems, and methods

Abstract

An insert may include a housing having a driver latch. The insert may also include an insertion driver. The insertion driver may be in latching engagement with the driver in a starting position. The insert may also include a finger displaceable relative to the housing through a first position, a ready position, and a trigger position. The finger may be configured to press an insertion driver portion in a first direction when displaced toward the ready position, and to displace the insertion driver portion in a second direction to urge the insertion driver from the driver latch when displaced toward the trigger position. The insert may also include a latch arrangement. The insert may also include a biasing member configured to remain skew by the latch arrangement and engagement of the insertion driver with the driver latch. The biasing member may be released from the skewed condition when the insertion driver is driven out of the driver latch.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Application Serial No. 63 / 401,279, filed on August 26, 2022, entitled “Infusion Set and Inserter Assembly, Apparatuses, Systems, and Methods” (Attorney Docket No. 00101.00337.AA886), the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present 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 Art

[0004] Many potentially valuable drugs or compounds (including biologics) are not orally active due to poor absorption, liver metabolism or other pharmacokinetic factors. In addition, some therapeutic compounds, although they can be administered orally, sometimes need to be taken so often that it is difficult for the patient to maintain the required schedule. In these cases, parenteral delivery is often used or can be used.

[0005] 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 an example of a therapeutic fluid that millions of diabetics self-inject. Users of parenteral delivered drugs may benefit from a wearable device that will automatically deliver the desired drug / compound over a period of time.

[0006] To this end, efforts have been made to design portable, wearable devices for controlled release of therapeutic agents. Such devices are known to have a storage portion such as a cartridge, syringe, or bag and are electronically controlled. Such devices have many disadvantages, including failure rates. Reducing the size, weight, and cost of such devices is also an ongoing challenge. In addition, such devices are typically applied to the skin and present the challenge of frequent repositioning for application. Summary of the invention

[0007] According to an example embodiment of the present disclosure, an insert assembly may include a housing having an insertion driver latch defined on the housing. The insert assembly may also include an insertion driver that can be displaced between a starting position and a forward position. The insertion driver can engage with the insertion driver latch in the starting position. The insert assembly may also include a release finger that can be displaced from a first position to a ready position relative to the housing, and can be displaced from the ready position to a trigger position. The release finger may be configured to: when the release finger is displaced from the first position to the ready position, the release finger presses a portion of the insertion driver in a set direction and keeps the insertion driver engaged with the insertion driver latch. The release finger may be configured to: when the release finger is displaced from the ready position to the trigger position, the release finger displaces a portion of the insertion driver in a release direction to drive the insertion driver out of the insertion driver latch. The insert assembly may also include a latch arrangement. The insert assembly may further include an insertion biasing member configured to be retained in a skewed state by the latch arrangement and engagement of the insertion driver with the insertion driver latch when the release finger reaches the ready position. The insertion biasing member is configured to be released from the skewed state when the insertion driver is driven out of the insertion driver latch.

[0008] In some embodiments, the latch arrangement may include a set of opposing retainer arms and a retainer that can be displaced between the two. The retainer arm may have a flange defined on the retainer arm, and when the latch arrangement is engaged, the flange overhangs the retainer. In some embodiments, the retainer may be configured to shift when the release finger is displaced from the first position to the ready position, and the latch arrangement may engage when the release finger is displaced to the ready position. In some embodiments, the insert assembly may also include a retraction biasing member, which is configured to tilt when the release finger is displaced to the ready position. The retraction biasing member may be configured to be maintained in a skewed state by the latch arrangement. In some embodiments, the insertion driver may be configured to disengage the latch arrangement when it is displaced from the starting position to the forward position. The retraction biasing member may be configured to displace the insertion driver to the starting position when the latch arrangement is disengaged. In some embodiments, the insertion driver may include a port, which is configured to be connected to an insertion tip carrier body. In some embodiments, the housing may include a housing configured to be coupled to a care component cartridge. In some embodiments, the housing may include a housing including a set of receiving boots for a retainer pin of a care component cartridge. In some embodiments, the release finger may be configured to collide with an insertion driver and deflect around a portion of the insertion driver when the release finger is displaced to the ready position. In some embodiments, the housing may block the release finger from deflecting in a direction toward the housing when the release finger is displaced from the ready position to the trigger position. In some embodiments, the insertion driver may include a cantilever arm including a catcher body configured to engage the insertion driver latch. The housing may block the cantilever arm from deflecting in a direction toward the housing. In some embodiments, the release finger may be configured to collide with a portion of the cantilever arm when the release finger is displaced from the ready position to the trigger position, causing the cantilever arm to deflect out of the path of the release finger. Deflection of the cantilevered arm may drive the catcher body out of the insert driver latch.

[0009] According to another exemplary embodiment of the present disclosure, the insert assembly may include a cover portion, the cover portion including an outer shell and an end cap. The insert assembly may also include an inner shell. The insert assembly may also include an insertion driver included in the inner shell. The insertion driver may be capable of shifting from a starting position to a forward position, in which the insertion driver engages with an insertion driver latch defined on an inner side wall of the inner shell. The insert assembly may also include an insertion biasing member between the insertion driver and the end cap. The insert assembly may also include a retainer, the retainer being configured to engage with a first latch when the cover portion is shifted to a ready position in a first direction. When the retainer engages with the first latch and the insertion driver engages with the insertion driver latch, the insertion biasing member is maintained in a skewed state. The insert assembly may also include a release finger, the release finger being included on the cover portion, and the release finger being configured to maintain the insertion driver in engagement with the insertion driver latch when the cover portion is shifted to the ready position. The release finger can be configured to: when the cover portion is displaced from the ready position to the trigger position in the second direction, the release finger drives the insertion driver out of the insertion driver latch. The insertion biasing member can be configured to urge the insertion driver to a forward position when the insertion driver latch is released. The insertion driver can disengage the retainer from the first latch when displaced toward the forward position.

[0010] In some embodiments, the insert assembly may further include a retract biasing member configured to be skewed when the cover portion is displaced to the ready state. The retract biasing member may be configured to be held in a skewed state when the retainer is engaged with the first latch. In some embodiments, the retract biasing member may be released from the skewed state when the retainer is disengaged from the first latch. The retract biasing member may be configured to displace the retainer away from the first latch and displace the insertion driver to a starting position when the retainer is disengaged from the first latch. In some embodiments, the insertion driver may include a port configured to be coupled to an insertion tip holder that carries the insertion tip. In some embodiments, the internal housing may include a receiving portion relative to the end cap, the receiving portion may be configured to be coupled to the care component cartridge. In some embodiments, the release finger may be configured to collide with a portion of the insertion driver and deflect around the portion of the insertion driver when the cover portion is displaced to the ready position. In some embodiments, the internal housing can block the deflection of the release finger in the direction toward the internal housing when the cover portion is displaced from the ready position to the trigger position. In some embodiments, the insertion driver may include a cantilever arm, the cantilever arm including a catch body. The catch body may be configured to engage the insertion driver latch. The internal housing can block the deflection of the cantilever arm in the direction toward the internal housing. In some embodiments, the release finger may be configured to collide with a portion of the cantilever arm when the cover portion is displaced from the ready position to the trigger position, and the cantilever arm is deflected out of the path of the release finger. The deflection of the cantilever arm can drive the catch body out of the insert 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 arranged between the retraction spring retainer and the reset body. The insertion biasing member may be captured between the portion of the insertion driver and the reset body. In some embodiments, the end cap may include a column extending into a passage defined in the reset body. The end cap may be configured to push against the reset body when the cover portion is displaced to the ready position.

[0011] According to another exemplary embodiment of the present disclosure, the insert assembly may include a cover portion, the cover portion including an outer shell and an end cap. The insert assembly may also include an inner shell. The cover portion may be displaceable relative to the inner shell. The insert assembly may also include a retainer, the retainer being configured to engage the first latch when the cover portion is displaced in a first direction toward the inner shell beyond a first threshold distance. The insert assembly may also include an insertion driver, the insertion driver being included in the inner shell and being displaceable from a first position to a second position and including a routing body. The insert assembly may also include a release finger, the release finger being included on the cover portion. The release finger may be configured to: when the cover portion is displaced in the first direction, the release finger is pressed against the routing body in a set direction, and the engagement of the insertion driver with the insertion driver latch is strengthened. The release finger may be configured to: when the cover portion is pulled in a second direction opposite to the first direction beyond a second threshold distance, the release finger causes the routing body to be displaced in a release direction, and the insertion driver is driven out of the insertion driver latch. The insert assembly may also include a first biasing member that is maintained in a skewed state when the retainer is engaged to the first latch and the insertion driver is engaged with the insertion driver latch. The first biasing member may urge the insertion driver toward the second position when the insertion driver is driven out of the insertion driver latch. The insertion driver may disengage the retainer from the first latch when displaced toward the second position.

[0012] In some embodiments, the insertion drive may include a cantilever arm including a catch body that engages the insertion drive latch. In some embodiments, the routing body may be disposed on the cantilever arm. In some embodiments, the routing body may include an opposing first and second faces, each of which includes an inclined portion. In some embodiments, the release finger may include a paddle having an opposing first and second paddle sides, each of which includes an inclined portion. The inclined portion of the first paddle side may be configured to advance into the inclined portion of the second face of the routing body when the cover portion is displaced in the first direction. The release finger may deflect around the second face of the routing body as the cover portion is advanced in the first direction. The inclined portion of the second paddle side may be configured to advance into the inclined portion of the first face of the routing body when the cover portion is displaced in the second direction. As the cover portion is further advanced in the second direction, the cantilever arm is displaced out of the path of the paddle in the release direction. In some embodiments, the cantilever arm can extend along an axis, and the routing body can extend from the cantilever arm in a direction substantially perpendicular to the axis. In some embodiments, the insertion driver latch can be provided by at least one shelf defined on the inner surface of the internal housing. In some embodiments, the internal housing can prevent the deflection of the release finger in the direction opposite to the release direction when the cover is displaced in the second direction. In some embodiments, the insertion driver can include a port configured to match the insertion tip holder. In some embodiments, the insert assembly can also include a second biasing member. In some embodiments, the second biasing member can be configured to transition to a skewed state when the cover is displaced in the first direction. When the retainer is engaged with the first latch, the second biasing member can be maintained in the skewed state. In some embodiments, the second biasing member can be configured to push the retainer away from the first latch, and can be configured to push the insertion driver toward the first position and engage with the insertion driver latch when the first latch is disengaged. In some embodiments, the shaft of the insertion driver can extend through the second biasing member.

[0013] According to yet another exemplary embodiment of the present disclosure, a cartridge for a reusable insert assembly may include a housing having a compartment recessed into an end of the housing. The housing may include a set of retaining members that protrude into the compartment. The cartridge may also include a retainer that includes a flange. The flange may be captured between an edge at the end of the compartment and a corresponding end of the retaining member. A set of cantilever arms may extend from a first face of the flange. The cartridge may also include a first patient care assembly portion that is coupled to the retainer via the set of cantilever arms. The cartridge may also include a tip retainer having an insertion tip coupled thereto. The cartridge may also include a second patient care assembly portion carried on the insertion tip.

[0014] In some embodiments, the cartridge may also include a set of matching bodies, the set of matching bodies protruding from the edge of the surface farthest from the flange. In some embodiments, the matching body may be a matching pin. In some embodiments, the matching body may extend from a second face of the flange opposite to the first face. In some embodiments, the retaining member may be a cantilevered section of the side wall of the compartment. In some embodiments, the cantilevered arm may define a guide. The tip retainer may be configured to shift along the guide. In some embodiments, the edge may form a stopper that limits the displacement range of the tip retainer in a first direction. In some embodiments, the guide may be formed by a slot extending through each cantilevered arm in the cantilevered arm. In some embodiments, the first patient care assembly portion may be an infusion set base, and the second patient care assembly portion may be a cannula subassembly. In some embodiments, the housing may be arranged in a container and releasably coupled to the container.

[0015] According to another exemplary embodiment of the present disclosure, a cartridge for a reusable insert assembly may include a housing having a compartment recessed into an end of the housing. The housing may include a set of retaining members that protrude into the compartment. The cartridge may also include a retainer that includes a flange. The flange may be captured between an edge at the end of the compartment and the corresponding end of the retaining member. A set of cantilever arms may extend from a first face of the flange. The cantilever arms may each include a guide path extending through the cantilever arms along a section of the cantilever arms. The cartridge may also include a first patient care assembly portion that is coupled to the retainer by the set of cantilever arms. The cartridge may also include a tip retainer having an insertion tip coupled thereto. The tip retainer may include fins that extend through the guide path from a main portion of the tip retainer. The cartridge may also include a second patient care assembly portion carried on the insertion tip.

[0016] In some embodiments, the cartridge may also include a set of matching bodies that extend from the surface of the edge that is farthest from the flange. In some embodiments, the matching body may be a matching pin. In some embodiments, the matching body may extend from a second face of the flange opposite to the first face. In some embodiments, the retaining member may be a cantilevered section of the side wall of the compartment. In some embodiments, the section of each cantilevered arm including the guide path may extend from the supporting end of each cantilevered arm to a point close to but not reaching a point away from the non-supporting end of each cantilevered arm. In some embodiments, the edge may form a stopper that limits the displacement range of the tip retainer along the guide path in the first direction. In some embodiments, the first patient care component part may be an infusion set base, and the second patient care component part may be a cannula subassembly. In some embodiments, the housing may be arranged in a container and connected to the container in a releasable manner. In some embodiments, a barrier may be attached to the container. The barrier and container may completely enclose the housing, the retainer, the first patient care component part, the second patient care component part, and the tip retainer.

[0017] According to another exemplary embodiment of the present disclosure, a method for assembling a cartridge for a reusable insert assembly may include placing an insertion tip extending from a tip holder through a diaphragm and a cannula of a cannula assembly. The method may also include positioning the tip holder in a group of guides of a holder. The method may also include advancing the holder into a compartment of a housing through a first displacement range (in which a flange of the holder deflects a group of retaining members), and advancing to a retaining position, in which the flange is advanced against an edge at an end of the compartment and leaves the retaining member. The retaining member may return to a stationary state, thereby blocking the holder from moving to a position within the first displacement range. The method may also include releasably coupling an infusion set base to a group of cantilever arms included in the holder.

[0018] In some embodiments, advancing the holder into the compartment may further include preventing the tip holder from moving along a portion of the guide with the edge. In some embodiments, the method may further include passing a set of matching bodies defined on the holder through at least one opening in the edge. In some embodiments, the method may further include placing the housing into a container. In some embodiments, the method may further include releasably coupling the housing to the container. In some embodiments, the method may further include sealing the opening in the container with a barrier. The barrier and the container together may completely surround the housing. In some embodiments, positioning the tip holder in the guide may include placing a fin on the tip holder in a slot defined by the cantilever arm. In some embodiments, positioning the tip holder in the guide may include introducing a portion of the tip holder into a slot extending through the cantilever arm. A portion of the tip holder may be introduced into a section of the slot that is farthest from the non-supporting end of the cantilever arm.

[0019] According to another exemplary embodiment of the present disclosure, an insert assembly may include a cover having an open end and an opposite closed end. The insert assembly may also include a care assembly base holder having a care assembly base coupled thereto in a releasable manner. The insert assembly may also include a trigger body, the trigger body being held in place relative to the care assembly base holder by an insertion latch arrangement. The insert assembly may also include a tip shuttle bearing an insertion tip. The tip shuttle may be coupled to the trigger body by a retraction latch arrangement. The insert assembly may also include a first biasing member configured to push the trigger body, the tip shuttle, and the insertion tip toward the open end of the cover when the insertion latch arrangement is transitioned to a release state. The insert assembly may also include a second biasing member configured to push the tip shuttle and the insertion tip toward the closed end when the retraction latch arrangement is shifted into the trigger when the trigger body and the tip shuttle are displaced to a retracted release position by the first biasing member.

[0020] In some embodiments, the insertion latch arrangement can be configured to transition to an insertion release state when a force that presses a portion of the trigger body and a portion of the cover against each other exceeds a threshold value. In some embodiments, the insertion latch arrangement can include a flange of the trigger body that releasably engages a catch defined on a care component base holder. In some embodiments, the trigger body can include an arm having a flange defined thereon. The insertion latch arrangement is formed by the flange engaging a catch defined on a care component base holder. In some embodiments, the care component base holder can include an aperture through which a terminal portion of the arm extends. In some embodiments, the terminal portion of the arm can be arranged to align with a trigger protrusion on the cover. By abutting the terminal portion with the trigger protrusion, the displacement of the cover relative to the trigger body can be limited. In some embodiments, the arm can be configured to deflect to a deflected state when a force that presses the trigger protrusion and the terminal portion of the arm against each other exceeds a threshold value. When the arm is in the deflected state, the flange can be displaced and disengaged from the engagement with the catcher, thereby transforming the insertion latch arrangement to a released state. In some embodiments, the trigger can be defined on the care component base holder. In some embodiments, the retract latch arrangement can include a flange of a pointed shuttle, which is releasably engaged with a catcher defined on the trigger body. In some embodiments, the retracted release position can be at the end of the displacement range of the trigger body. In some embodiments, the retracted release position can be at an intermediate point within the displacement range of the trigger body. The first biasing member can be configured to continue to advance the trigger body in the insertion direction toward the open end through the terminal portion of the displacement range of the trigger body after the trigger body reaches the intermediate point. In some embodiments, the cannula subassembly can be carried by the insertion tip, and the trigger body can be configured to displace the cannula subassembly toward the open end in the terminal portion of the displacement range of the trigger body. In some embodiments, the cannula subassembly can be carried by the insertion tip. In some embodiments, the insertion latch arrangement can be configured to be transformed to a released state by the displacement of the hood relative to at least the care component base in a direction away from the care component base. In some embodiments, an adhesive configured to anchor the care component base to the bio-barrier can be coupled to the care component base.When the cover portion is displaced relative to the care component base, the bio-barrier can be lifted from a resting position.

[0021] According to another exemplary embodiment of the present disclosure, an insert assembly may include a cover portion. The insert assembly may also include a care component base holder having a care component base releasably coupled thereto. The insert assembly may also include an insertion unit, which is held in place relative to the care component base holder by an insertion latch arrangement. The insertion unit may include a trigger body. The insertion unit may also include a retraction unit, which includes an insertion tip. The retraction unit may be releasably coupled to the trigger body via a retraction latch arrangement. The insert assembly may also include a first biasing member, which is configured to push the insert unit to shift in the insertion direction when the insertion latch arrangement is converted to a first release state. The insert assembly may also include a second biasing member, which is configured to push the retraction unit to shift in the retraction direction when the insertion unit is displaced to a retracted release position by the first biasing member, when the retraction latch arrangement is displaced into the trigger.

[0022] In some embodiments, when the retract latch arrangement is in an engaged state, the second biasing member can be maintained in a skewed state between the trigger body and a portion of the retracting unit. In some embodiments, the retracted release position can be at the end of the displacement range of the trigger body. In some embodiments, the retracted release position can be at an intermediate point in the displacement range of the trigger body. The first biasing member can be configured to push the trigger body toward the open end beyond the retracted release point. In some embodiments, the cannula subassembly can be carried by the insertion tip. The trigger body can be configured to push the cannula subassembly in the insertion direction when the trigger body is displaced in the insertion direction by the first biasing member. In some embodiments, the care component portion separated from the care component base can be carried by the insertion tip. In some embodiments, the insertion unit can be configured to be displaced with the cover until a force exceeding a threshold force is applied to pull the cover and the insertion unit apart. In some embodiments, the care component base can be connected to an adhesive. When the adhesive is adhered to a patch of a biological barrier, the threshold force can be generated by removing the cover from the patch and the patch is lifted from a static state. In some embodiments, the insertion latch arrangement may include a resilient member releasably engaged with a catch. The cover portion may be configured to deflect the resilient member out of engagement with the catch when the cover portion is pulled in a direction away from the care component base to transform the insertion latch arrangement into a released state. In some embodiments, the retraction release arrangement may include a resilient member of the retraction unit releasably engaged with a catch defined on the trigger body.

[0023] According to another exemplary embodiment of the present disclosure, an insert assembly may include an insertion unit, which is restricted by an insertion latch arrangement so as not to be displaced in an insertion direction. The insert assembly may also include a retraction unit, which includes an insertion tip. The retraction unit may be releasably coupled to the insertion unit by a retraction latch arrangement. The insert assembly may also include a first biasing member, which is configured to push the insertion unit and the retraction unit to be displaced in the insertion direction when the insertion latch arrangement is released. The insert assembly may also include a second biasing member, which is configured to push the retraction unit to be displaced in the retraction direction. The insert assembly may also include a retraction trigger. The retraction latch arrangement may be configured to: when displaced into the retraction trigger at an intermediate point of the displacement path of the insertion unit, the retraction latch arrangement is transformed into a disengaged state.

[0024] In some embodiments, the percutaneous access assembly can be carried by the insertion tip. In some embodiments, the infusion cannula assembly can be carried by the insertion tip. In some embodiments, the insertion unit can be configured to: after passing through the intermediate point, the insertion unit drives the percutaneous access assembly carried by the insertion tip in the insertion direction. In some embodiments, the insertion unit can be configured to: after passing through the intermediate point, the insertion unit presses the percutaneous access assembly carried by the insertion tip in the insertion direction. In some embodiments, the insert assembly can also include a retainer and a first patient care assembly part connected to the retainer. The insert assembly can also include a second patient care assembly part carried by the insertion tip. In some embodiments, when the insertion unit is displaced along the displacement path, the second patient care assembly part can be connected to the first patient care assembly part. In some embodiments, once the insertion unit is displaced beyond the intermediate point, the second patient care assembly part can be connected to the first patient care assembly part. In some embodiments, the insert assembly can include an entry assembly carried by the insertion tip. The insertion tip can have a leading length extending beyond the entry assembly. In some embodiments, the entry assembly may be positioned in the displacement path of the insertion unit, and an intermediate point may be selected such that after passing the intermediate point, the insertion unit drives the entry assembly in the insertion direction a distance at least equal to the leading length.

[0025] According to another exemplary embodiment of the present disclosure, an insert for placing a device may include a cover. The insert may also include a device base having an adhesive thereon, the adhesive being configured to anchor the base to a portion of the barrier. The insert may also include a spring-biased insert unit, the spring-biased insert unit being held in a starting state by an insertion latch arrangement. The base may be releasably coupled to the insert unit, and when the base is anchored to the portion of the barrier by the adhesive, the base anchors the insert unit to avoid displacement relative to the portion of the barrier. The cover may be displaceable from a starting position to a trigger position in a direction opposite to the insertion displacement direction of the insert unit. The cover may be configured to transform the insertion latch arrangement to a disengaged state when the cover is displaced to the trigger position. The insertion latch arrangement may prevent relative movement of the cover and the insert unit until a force threshold is exceeded.

[0026] In some embodiments, when the base is anchored to a portion of the barrier via an adhesive, the force threshold may be greater than the threshold required to lift the portion of the barrier from a stationary position. In some embodiments, the insert assembly may also include a percutaneous access assembly. The insertion unit spring may be biased to shift in the insertion direction and the percutaneous access assembly may be coupled to the base when the insertion latch arrangement is released. In some embodiments, the insertion unit may include a spring-biased retraction unit, the retraction unit including an insertion tip. The retraction unit may be releasably coupled to the remainder of the insertion unit by the retraction latch arrangement, and when the retraction latch arrangement is in an engaged state, the retraction unit is constrained to be mutually cooperatively displaced with the remainder of the insertion unit. In some embodiments, the insertion unit may be spring-biased to shift in the insertion direction along a displacement path. The retraction latch arrangement may be configured to shift into a trigger projection when the insertion unit shifts along the displacement path. In some embodiments, the retraction latch arrangement may be configured to shift into a trigger projection when the insertion unit reaches an intermediate point in the displacement path. In some embodiments, the retraction unit may be spring biased to displace in a retraction direction opposite to the insertion direction. In some embodiments, the retraction unit may include an inclined protrusion.

[0027] According to another exemplary embodiment of the present disclosure, a method of placing a care component on a biological barrier may include adhering a portion of the care component connected to the insert component to the barrier. The method may also include pulling the insert component away from the barrier. The method may also include lifting the barrier from a static position to a lifted position by adhering a portion of the care component. The method may also include disengaging an insertion latch arrangement and advancing the insertion unit and the entry component in an insertion direction after lifting the barrier. The method may also include disengaging a retraction latch arrangement and advancing a retraction unit including an insertion tip in a retraction direction once the insertion unit reaches a retraction release position. The displacement of the entry component in the insertion direction and the displacement of the retraction unit in the retraction direction may overlap at least partially in time.

[0028] In some embodiments, the method may further include coupling the entry assembly to a portion of the patient care assembly. In some embodiments, advancing the retraction unit in the retraction direction may further include tilting the insertion tip. In some embodiments, disengaging the insertion latch arrangement may include displacing a portion of the cover portion of the insert assembly into a portion of the insertion latch arrangement and deflecting the portion of the insertion latch arrangement. In some embodiments, disengaging the retraction latch arrangement may include driving the retraction unit in the insertion direction and driving it into a trigger. In some embodiments, driving the retraction unit in the insertion direction and driving it into the trigger may include displacing the retraction unit and the insertion unit cooperatively when disengaging the insertion latch arrangement. In some embodiments, disengaging the retraction latch arrangement may include disengaging the retraction unit from the insertion unit when the insertion unit is displaced in the insertion direction. In some embodiments, disengaging the insertion latch arrangement may also include releasing a first biasing member held in a first skewed state when the insertion latch arrangement is in an engaged state, and disengaging the retraction latch arrangement may include releasing a second biasing member held in a second skewed state when the retraction latch arrangement is in an engaged state. In some embodiments, the method may further include removing the locking member from the insert assembly.

[0029] According to another exemplary embodiment of the present disclosure, a method for placing an access device through an insert assembly may include coupling the insert assembly to a biological barrier. The method may also include lifting the biological barrier coupled to the insert assembly from a stationary state to a lifted state by displacing the insert assembly in a direction away from the barrier. The method may also include: automatically disengaging an insertion latch arrangement after the skin has been lifted at least a certain distance, and pushing the insertion unit including a retraction unit (which has an insertion tip) in an insertion direction. The method may also include: automatically disengaging a retraction latch arrangement that couples the retraction unit to the remainder of the insertion unit once the insertion unit is displaced to a retraction release position; and pushing the retraction unit in the retraction direction. The method may also include pushing the remainder of the insertion unit from a retraction release position to a forward position in the insertion direction.

[0030] In some embodiments, the method may further include blocking the displacement of the insertion unit in the retraction direction after the insertion unit reaches the forward position. In some embodiments, the method may further include tilting the retraction unit when the retraction unit is pushed in the retraction direction. In some embodiments, the method may further include connecting the entry assembly to the entry assembly base when at least the remainder of the insertion unit is displaced in the insertion direction. In some embodiments, the retraction release point may be reached before the entry assembly is connected to the entry assembly base. In some embodiments, the entry assembly may be a cannula subassembly, and the entry assembly base is an infusion set base. In some embodiments, connecting the insert assembly to the biological barrier may include adhering the entry assembly base to the biological barrier. In some embodiments, the method may further include releasing the entry assembly base from the insert assembly.

[0031] According to another exemplary embodiment of the present disclosure, an example insert assembly may include a cover portion, the cover portion including an outer shell and an end cap. The insert assembly may also include an inner shell. The insert assembly may also include an insertion driver, the insertion driver is included in the inner shell, and can be displaced from a starting position to a forward position, in which the insertion driver engages with an insertion driver latch defined on the inner side wall of the inner shell. The insert assembly may also include an insertion biasing member located between the insertion driver and the end cap. The insert assembly may also include a retainer, the retainer being configured to engage a first latch when the cover portion is displaced to a ready position along a first direction. When the retainer engages with the first latch and the insertion driver engages with the insertion driver latch, the insertion biasing member may remain in a skewed state. The insertion biasing member may be configured to push the insertion driver to a forward position when the insertion driver latch is released. The insert assembly may also include a release lock. The release lock may be configured to shift between an inactive position and an active position. The release lock may block the release of the insertion driver latch in the active position.

[0032] In some embodiments, when displaced toward the forward position, the insertion driver can disengage the retainer from the first latch. In some embodiments, the insertion driver can include a cantilevered arm, which includes a catch body configured to engage with the insertion driver latch. The internal housing can prevent the cantilevered arm from deflecting in the direction toward the internal housing. In some embodiments, the release lock can include a body, which prevents the cantilevered arm from deflecting in the direction away from the internal housing when the release lock is in the active position. In some embodiments, the release lock can include a base portion, from which a group of barrier bodies extend. The barrier body can be configured to extend through the passage in the end cap. In some embodiments, the release lock can be configured to be rotationally displaced between the inactive position and the active position. In some embodiments, the insert assembly can also include a retract biasing member, which is configured to be skewed when the cover portion is displaced to the ready state. The retract biasing member can be configured to remain in a skewed state when the retainer engages with the first latch. In some embodiments, when displaced toward the forward position, the insertion driver can disengage the retainer from the first latch. When the retainer is disengaged from the first latch, the retraction biasing member can be released from the skewed state. The retraction biasing member can be configured to displace the retainer away from the first latch when the retainer is disengaged from the first latch and displace the insertion driver to a starting position. In some embodiments, the insertion driver can include a port configured to be coupled to an insertion tip holder that carries the insertion tip. In some embodiments, the internal housing can include a receiving portion opposite the end cap, the receiving portion being configured to be coupled to the care component cartridge.

[0033] According to another exemplary embodiment of the present disclosure, the insert assembly may include a cover. The insert assembly may also include a release lock, which may be displaced between an inoperative position and a release position. The insert assembly may also include an internal housing. When the release lock is in the inoperative position, the cover may be displaced relative to the internal housing, and when the release lock is in the release position, it is prevented from being displaced relative to the internal housing. The insert assembly may also include a retainer, which is configured to engage the first latch when the cover is displaced toward the internal housing in a first direction. The insert assembly may also include an insertion driver, which is included in the internal housing and can be displaced from a first position to a second position, and includes a routing body. The insert assembly may also include a release finger included on the cover. The release finger may be configured to deflect around the routing body when the cover is displaced in the first direction, and is configured to displace the routing body in a release direction when the cover is pulled along the second direction, which disengages the insertion driver from the insertion driver latch. The insert assembly may further include a first biasing member that maintains the first biasing member in a skewed state when the retainer is engaged to the first latch and the insertion driver is engaged with the insertion driver latch. The first biasing member may urge the insertion driver toward the second position when the insertion driver is disengaged from the insertion driver latch.

[0034] In some embodiments, the release lock and the outer housing can be continuous integral parts. In some embodiments, the release lock can be deflected relative to the outer housing so that the release lock is displaced between the inoperative position and the active position. In some embodiments, when the release lock is in the release position, at least a portion of the release lock can be arranged in a window defined in the inner housing. In some embodiments, the insertion driver can include a cantilever arm, and the cantilever arm includes a catch body, and the catch body engages with the insertion driver latch, and the routing body is arranged on the cantilever arm. In some embodiments, the insertion driver latch can be provided by at least one shelf defined on the inner surface of the inner housing. In some embodiments, the insertion driver can include a port, and the port is configured to match the insertion tip holder. In some embodiments, the insert assembly can also include a second biasing member. In some embodiments, the second biasing member can be configured to be converted to a skewed state when the cover portion is displaced in the first direction. When the retainer engages with the first latch, the second biasing member can remain in a skewed state. In some embodiments, the second biasing member can be configured to push the retainer away from the first latch when the first latch is disengaged, and the insertion driver is pushed toward the first position and engaged with the insertion driver latch.

[0035] According to another exemplary embodiment of the present disclosure, the insert assembly may include a cover portion, the cover portion including an outer housing and an end cap. The insert assembly may also include an inner housing. The insert assembly may also include an insertion driver, the insertion driver included in the inner housing, and can be moved from a starting position to a forward position, in which the insertion driver is engaged with an insertion driver latch defined on the inner side wall of the inner housing. The insert assembly may also include an insertion biasing member located between the insertion driver and the end cap. The insert assembly may also include a retainer, the retainer being configured to tilt the second biasing member and engage the first latch when the cover portion is displaced from a release state to a ready state along a first direction. When the retainer is engaged with the first latch and the insertion driver is engaged with the insertion driver latch, the insertion biasing member may remain in a tilted state. The insertion biasing member may be configured to push the insertion driver to a forward position when the insertion driver latch is released. The insert assembly may also include a release actuator, the release actuator being configured to disengage the retainer from the first latch when displacing from an inoperative state to an actuated state. The second biasing member may be configured to urge the cover and the retainer to the released state when the retainer is disengaged from the first latch.

[0036] In some embodiments, the first biasing member can abut the face of the insertion driver and the retainer adjacent to the cover portion, and is configured to push the retainer and the cover portion to a released state when the retainer is disengaged from the first latch. In some embodiments, the insertion driver may include a cantilevered arm, which includes a catcher body that engages with the insertion driver latch. In some embodiments, the insertion driver latch may be provided by at least one shelf defined on the inner surface of the internal housing. In some embodiments, the insertion driver may include a port that is configured to match the insertion tip retainer. In some embodiments, the internal housing may include a housing relative to the end cap. The housing may be configured to be connected to a care component cartridge. In some embodiments, the release finger may be defined on the cover portion and is configured to keep the insertion driver engaged with the insertion driver latch when the cover portion is displaced toward the ready state. In some embodiments, the release finger can also be configured to: when the release actuator is in the inactive state, when the cover portion is displaced from the ready state to the trigger position in a second direction opposite to the first direction, the release finger drives the insertion driver out of the insertion driver latch. In some embodiments, the release actuator can be configured to deflect the release finger to a deflected state when it is transitioned from the inactive state to the active state. In some embodiments, when the cover portion is displaced from the ready state to the trigger position and the release finger is in the deflected state, the release finger may not contact the insertion driver. In some embodiments, the release finger can be configured to: when the cover portion is displaced from the ready state to the trigger position in a second direction opposite to the first direction, the release finger drives the insertion driver out of the insertion driver latch. In some embodiments, when the retainer and the cover portion are pushed toward the release state by the second biasing member and the cover portion is displaced through the trigger position, the retainer can be configured to collide with the insertion driver and reverse the advancement of the insertion driver toward the forward state caused by the release of the insertion driver latch.

[0037] According to another exemplary embodiment of the present disclosure, an insert assembly may include a cover portion, the cover portion including an outer shell and an end cap. The insert assembly may also include an inner shell. The insert assembly may also include an insertion driver, the insertion driver is included in the inner shell, and can be displaced from a starting position to a forward position, in which the insertion driver is engaged with an insertion driver latch defined on the inner side wall of the inner shell. The insert assembly may also include an insertion biasing member, the insertion biasing member being located between the insertion driver and the end cap. The insert assembly may also include a retainer, the retainer being configured to be displaced from a release state to a ready state in a first direction together with the cover portion, the retainer skews the second biasing member and the retainer engages a first latch. When the retainer engages with the first latch and the insertion driver engages with the insertion driver latch, the insertion biasing member may be maintained in a skewed state, the insertion biasing member being configured to push the insertion driver to the forward position when the insertion driver latch is released. The insert assembly may further include a release actuator configured to disengage the retainer from the first latch when displaced from the inactive state to the actuated state. The second biasing member may be configured to: when the retainer is disengaged from the first latch, the second biasing member pushes the cover portion and the retainer through a retraction stroke in a second direction opposite to the first direction.

[0038] In some embodiments, a first biasing member may abut the face of the insertion driver and the retainer abutting the hood, and the first biasing member is configured to push the retainer and the hood through the retraction stroke when the retainer is disengaged from the first latch. In some embodiments, the insertion driver may include a cantilevered arm including a flange that engages with the insertion driver latch. In some embodiments, the insertion driver latch may include a shelf defined on an internal housing. In some embodiments, the insertion driver may include a port configured to match an insertion tip retainer. In some embodiments, the internal housing may include a housing relative to the end cap. The housing may be configured to be connected to a care component cartridge. In some embodiments, a release finger may be defined on the hood and may be configured to strengthen the engagement of the insertion driver with the insertion driver latch when the hood is displaced toward the ready state. In some embodiments, the release finger can also be configured to: when the cover portion is shifted from the ready state to the trigger position in the second direction and the release actuator is in the inoperative state, the release finger drives the insertion driver out of the insertion driver latch. In some embodiments, the release actuator can be configured to deflect the release finger to a deflected state when it is transitioned from the inoperative state to the active state. In some embodiments, when the cover portion is displaced through the retraction stroke, the release finger can be in a deflected state and maintained to be out of contact with the insertion driver. In some embodiments, the release finger can be configured to: when the cover portion is displaced through the retraction stroke, the release finger drives the insertion driver out of the insertion driver latch. In some embodiments, when the cover portion and the retainer are displaced through the retraction stroke, the retainer can be configured to collide with the insertion driver and reverse the advancement of the insertion driver towards the forward state caused by the release of the insertion driver latch.

[0039] According to another embodiment of the present disclosure, a method of releasing an insert having a spring-loaded insertion driver and a spring-loaded retractor may include adhering a portion of a patient-care component to a barrier. The method may also include shifting a release actuator of the insert from an inactive state to an active state. The method may also include, when the release actuator is shifted to the active state, disengaging a first latch that holds the retractor in place. The method may also include releasing a spring of the spring-loaded retractor and driving the spring-loaded retractor and a cover portion of the insert through a retraction stroke. The method may also include disassociating a portion of the patient-care component from the barrier.

[0040] In some embodiments, the method may further include: holding a second latch holding the spring-loaded insertion driver in place as the spring-loaded retractor and the cover portion are driven through a retraction stroke. In some embodiments, the method may further include: releasing a spring of the spring-loaded insertion driver during the retraction stroke, the spring of the spring-loaded insertion driver may push the insertion driver in a forward direction. In some embodiments, the method may further include: bumping into the spring-loaded insertion driver with the spring-loaded retractor as the spring-loaded retractor is displaced through the retraction stroke and reversing the advancement of the insertion driver toward the forward direction. In some embodiments, displacing the release actuator may include depressing a button. In some embodiments, displacing the release actuator may include depressing at least one tab coupled to the first latch. In some embodiments, displacing the first latch may include deflecting a latch arm to disengage from engagement with the spring-loaded retractor. In some embodiments, the method may further include: deflecting a release finger of the cover portion to disengage from alignment with a fin on a cantilevered arm of the insertion driver as the release actuator is displaced from an inactive state to an active state. In some embodiments, the method may further include automatically returning the release actuator to an inactive state during the retraction stroke. In some embodiments, automatically returning the release actuator to an inactive state may include displacing an inclined surface on the release actuator into the insertion drive. In some embodiments, the method may further include driving the release actuator together with the retainer and the cover portion through the retraction stroke.

[0041] According to another exemplary embodiment of the present disclosure, an example insert assembly may include a cover. The insert assembly may also include a body, the body including a cavity flanked by a set of arms. The insert assembly may also include a patient care assembly, the patient care assembly including a base and a second portion, the base engaging the set of arms in a releasable manner. The insert assembly may also include a spring biasing unit, the spring biasing unit including a tip holder, the insertion tip and the second portion of the patient care assembly being carried on the tip holder. The insert assembly may also include a spring for the spring biasing unit. The insert assembly may also include a trigger, the trigger having a first state and a second state, in the first state, the spring is maintained in an energy storage state, and in the second state, the spring is released from the energy storage state. When the trigger is actuated, the spring may push the spring biasing unit toward the base. The insert assembly may also include a yoke, the yoke having at least a portion adjacent to each of the arms in the set of arms. The yoke may limit at least a portion of each of the arms in the set of arms to avoid deflection. The arm may include a set of tumor-like portions. When the insertion tip and the second portion of the patient care assembly are displaced toward the base, a portion of the spring biasing unit may collide with the nub and cause the set of arms to expand to release the base.

[0042] In some embodiments, the yoke can be an open centering member around the arm. In some embodiments, the yoke can include a spliced ​​section and be placed on a bottom beam defined on the set of arms. In some embodiments, the yoke can be placed on a bottom beam defined on the set of arms, and a portion of the spring biasing unit can include a set of protrusions. When the spring pushes the spring biasing unit toward the base, the protrusions can collide with the yoke and cause the yoke to tilt around the bottom beam. In some embodiments, the yoke can include a set of pads. Each of the pads can be adjacent to a corresponding arm in the set of arms. The pad can be connected to a section of the body via a flexure. In some embodiments, when the spring biasing unit is pushed toward the base and the spring biasing unit applies a force causing the flexure to yield, the portion of the spring biasing unit will collide with each pad. In some embodiments, the yoke can be provided by a set of lugs on a pointed retainer, and the arm extends through the set of lugs. Each arm in the set of arms can have a thick area and a thin area. When the lug is adjacent to the thick area of ​​the corresponding arm, each of the lugs can block the deflection of the corresponding arm in the group of arms. The lug is sized to allow deflection of the corresponding arm when adjacent to the thin area of ​​the corresponding arm. In some embodiments, the base can be an infusion set base, and the second part of the patient care assembly can be a cannula subassembly. In some embodiments, the patient care assembly can be an analyte sensor. In some embodiments, when the spring bias unit is pushed toward the base, the base and the second part of the patient care assembly can be connected together.

[0043] According to another exemplary embodiment of the present disclosure, an exemplary patient care component placement system may include an insert assembly, the insert assembly including a port and a housing body. The port may have a central slot flanked on opposite sides by segments of the port edge. The housing body may include a set of boots, each of which sweeps from a closed boot end to an open boot end around a portion of the axis of the port. The boots may each have an overhanging area that is farthest from the main section of the housing body. The system may also include a cartridge, the cartridge including a retainer, a patient care assembly coupled to the retainer, and a tip bearing body from which an insertion tip protrudes. The retainer may include a set of matching pins, each of which has a stem and a wider head. The tip bearing body may include a first end, the first end being opposite to a second end from which the insertion tip protrudes. The tip bearing body includes a tapered region located between the first end and the second end. When the cartridge is placed in an aligned position relative to the housing body and rotated to a coupled state, each matching pin may be displaced from the open boot end of the corresponding boot to the closed boot end. The cartridge can be translationally displaced to a position in which the first end of the tip carrier body is advanced into the port to a depth in which the tapered region is aligned with the port rim over the matching pin capture displacement range. The head of each matching pin can be displaced along the slope of the overhanging region of the corresponding shoe over the matching pin capture displacement range. The first end of the tip carrier body can then be rotated over the port rim over the tip carrier body capture displacement range.

[0044] According to another exemplary embodiment of the present disclosure, an exemplary patient care component placement system may include an insert component, the insert component including a port and a housing body, the port being flanked on opposite sides by a shelf, the housing body including a set of matching tracks, the set of matching tracks partially sweeping around the axis of the port. The insert may also include a cartridge, the cartridge including a retainer, a patient care component coupled to the retainer, and a tip holder from which an insertion tip protrudes. The retainer may include a set of matching protrusions. The tip holder may include a tapered region between a first end and an opposite second end, and the insertion tip protrudes from the second end. When the cartridge is placed in an aligned position relative to the housing body and rotated to a coupled state, the matching protrusion may be displaced along an inclined region of a corresponding matching track within a matching protrusion capture displacement range to drive the cartridge translationally to a position in which the first end of the tip holder is advanced into the port to a depth in which the tapered region is aligned with the shelf. The first end of the tip holder may then be rotated on the shelf within the tip holder capture displacement range of the cartridge.

[0045] In some embodiments, the matching track may include a shoe having an extended shoulder section at a portion of the main section of each matching track that is farthest from the body of the receiving portion. In some embodiments, the matching protrusions may each be a matching pin having a head and a relatively thin stem that connects the head to the rest of the holder. In some embodiments, the port may be shaped to receive the first end of the tip holder when the cartridge is in a rotational position within the matching protrusion capture displacement range. In some embodiments, the first end of the tip holder may have an elongated cross-sectional shape, and the cross-sectional shape of the first end is more elongated than the cross-sectional shape of the tapered region. In some embodiments, the tapered region may be formed by a notch that is recessed into the tip holder at an angle substantially perpendicular to the axis of the insertion tip. In some embodiments, the thickness of the shelf may be sufficient to substantially fill the notch when the cartridge has been rotated through the tip holder capture displacement range. In some embodiments, the inclined region of each corresponding matching track may start from the open end of the matching track. When the cartridge is rotated to the coupled state, the matching protrusion may be located at the closed end of the corresponding matching track. In some embodiments, the inclined region of each corresponding matching track may include a steepest portion along a portion of the inclined region closest to the open end. In some embodiments, the patient care component may be selected from a list consisting of an infusion set and an analyte sensor. In some embodiments, the patient care component may include a first portion and a second portion spaced apart from the first portion within the cartridge. BRIEF DESCRIPTION OF THE DRAWINGS

[0046] These and other aspects will become more apparent from the following detailed description of various embodiments of the present disclosure with reference to the accompanying drawings, in which:

[0047] Figure 1A depicts an exploded view of an exemplary insert assembly;

[0048] Figure 1B depicts an exploded view of another exemplary insert assembly;

[0049] Figure 1C depicts an exploded view of another exemplary insert assembly;

[0050] Figure 2 depicts an exploded view of another exemplary insert assembly;

[0051] Figure 3 depicts an exploded view of another exemplary insert assembly;

[0052] Figure 4A depicts a perspective view of an exemplary infusion set base;

[0053] Figure 4B Draws Figure 4A Another perspective view of an example infusion set base;

[0054] Figure 5A depicts an exploded view of an exemplary cannula subassembly;

[0055] Figure 5B Draws Figure 5A A cross-sectional view of an example cannula subassembly shown in ;

[0056] Figure 6 depicts a perspective view of an example infusion set and tubing connector;

[0057] Fig. 7A depicts a perspective view of another exemplary infusion set base;

[0058] Figure 7B Draws Fig. 7A Another perspective view of an example infusion set base;

[0059] Fig. 8A depicts an exploded view of an exemplary cannula subassembly;

[0060] Figure 8B Draws Fig. 8A A cross-sectional view of an example cannula subassembly shown in ;

[0061] Fig. 9 depicts a perspective view of another example infusion set and tubing connector;

[0062] Fig. 10A depicts a perspective view of an example infusion set base;

[0063] Fig. 10B Draws Fig. 10A Another perspective view of the infusion set base;

[0064] Fig.11A depicts a perspective view of an example infusion set base;

[0065] Fig. 11B Draws Fig.11A Another perspective view of the infusion set base;

[0066] Fig. 12A depicts a perspective view of an example infusion set base;

[0067] Fig. 12B Draws Fig. 12A Another perspective view of the infusion set base;

[0068] Fig.13A depicts a perspective view of an example infusion set base;

[0069] Fig. 13B Draws Fig.13A A bottom plan view of an infusion set base;

[0070] Fig.14A depicts a perspective view of an example infusion set base;

[0071] Fig. 14B Draws Fig.14A A bottom plan view of an infusion set base;

[0072] FIG. 15A to FIG. 15F depicts various views of an exemplary tube set connector;

[0073] Fig.16A An example tube set connector and an example cannula subassembly are depicted, the example cannula subassembly being in an exaggerated deflected position for purposes of illustration;

[0074] Fig. 16B An example tube set connector and an example cannula subassembly are depicted, wherein the cannula subassembly is displaced to a home position by the tube set connector;

[0075] Fig. 16C An example tube set connector and an example cannula subassembly are depicted, wherein the tube set connector pierces a septum of the cannula subassembly such that a delivery tip of the tube set connector is in fluid communication with a fluid introduction volume of the cannula subassembly;

[0076] Fig.17 An example infusion set base with an example deflector is depicted;

[0077] FIG. 18A to FIG. 18B depicts views of an example tubing set connector and an example infusion set assembly, the tubing set connector including an example tine;

[0078] Fig.18C depicts a perspective view of an exemplary tube set connector including exemplary tines;

[0079] Fig.19A depicts a top view of an example infusion set assembly and an example tubing set connector including an example clamp, the tubing set connector being decoupled from the infusion set assembly;

[0080] Fig.19B depicts a view of an example tube kit connector with an example clamp;

[0081] Fig.19C depicts a view of an example tubing set connector with an example clamp coupled to an example infusion set assembly;

[0082] Fig. 20A depicts a side view of an example infusion set base;

[0083] Fig. 20B Draws Fig. 20A Another side view of an example infusion set base;

[0084] Fig. 20C Draws Fig. 20A A perspective view of an example infusion set base;

[0085] FIG. 21A to FIG. 21F Various views of another example infusion set base are depicted;

[0086] FIG. 22A to FIG. 22C Various views of another example infusion set base are depicted;

[0087] FIG. 23A to FIG. 23C Various views of another example infusion set base are depicted;

[0088] FIG. 24A to FIG. 24C Various views of another example infusion set base are depicted;

[0089] FIG. 25A to FIG. 25C depicts various views of an exemplary tube set connector;

[0090] Fig.26A depicts views of an exemplary infusion set base and an exemplary tubing set connector;

[0091] Fig.26B Draws Fig.26A A cross-sectional view of an exemplary infusion set base and an exemplary tubing set connector;

[0092] Fig.26C Draws Fig.26A A perspective view of an exemplary tube kit connector;

[0093] Fig.27A depicts a perspective view of another example tube kit connector;

[0094] Fig.27B An example infusion set base is shown coupled to the Fig.27A A cross-sectional view of an example tube kit connector;

[0095] Fig.28A depicts a perspective view of an example infusion set;

[0096] Fig.28B Draws Fig.28A Another perspective view of an example infusion set;

[0097] FIG. 29A to FIG. 29D depicts multiple views of an exemplary cannula subassembly;

[0098] FIG. 30A to FIG. 30B An embodiment of a cannula that may be used in a cannula subassembly is depicted;

[0099] FIG. 31A to FIG. 31G depicts multiple views of another example cannula subassembly;

[0100] FIG. 32A to FIG. 32D depicts multiple views of another example cannula subassembly;

[0101] FIG. 33A to FIG. 33D depicts multiple views of another example cannula subassembly;

[0102] FIG. 34A to FIG. 34F depicts multiple views of another exemplary cannula subassembly;

[0103] FIG. 35A to FIG. 35F depicts multiple views of another example cannula subassembly;

[0104] FIG. 36A to FIG. 36E depicts multiple views of yet another example cannula subassembly;

[0105] Fig.37A and Fig.37B depicts a view of an example septum that may be included in an example cannula subassembly;

[0106] FIG. 38A to FIG. 38E depicts a view of another example cannula subassembly;

[0107] FIG. 39A to FIG. 39E depicts a view of another example cannula subassembly;

[0108] FIG. 40A to FIG. 40C depicts a view of an example cannula and a set of exemplary septa that may be included in a cannula subassembly;

[0109] Fig.41A depicts a side view of an example insert assembly with an example locking member installed therein;

[0110] Fig.41B depicts another side view of an example insert assembly with an example locking member installed therein;

[0111] Fig.42A depicts a perspective view of an example insert assembly with a locking member and an adhesive assembly in place;

[0112] Fig.42B Draws Fig.42A a side view of an insert assembly;

[0113] Fig.43 depicts a perspective view of an example infusion set base and an example adhesive assembly;

[0114] Fig.44 depicts a perspective view of an exemplary adhesive assembly for use with a portion of an infusion set assembly;

[0115] Fig.45 Draws Fig.44 A bottom plan view of the adhesive assembly;

[0116] Fig.46A depicts a top view of an example insert assembly with its outer housing removed;

[0117] Fig.46B depicts a perspective view of an example insert assembly with its outer housing removed;

[0118] Fig.46C Draws Fig.46B Detail of a portion of

[0119] Fig.47 depicts a top view of an example locking member;

[0120] Fig.48 depicts a perspective view of another example locking member;

[0121] Fig.49A depicts a cross-sectional view of an example insert assembly having an example locking member installed therein;

[0122] Fig.49B Draws Fig.49A Detail of a portion of

[0123] Fig.50 depicts a perspective view of an example locking member;

[0124] Fig.51 depicts a view of an example insert assembly that has been cut away to show an example locking member partially disposed within the insert assembly;

[0125] Fig.52 depicts a cross-sectional view of an example insert assembly with an example locking member installed;

[0126] Fig.53 depicts a perspective view of an example locking member;

[0127] FIG. 54A to FIG. 54B depicts a view of yet another example locking member that may be used to prevent activation of an example insert assembly;

[0128] Fig.55 depicts a cross-sectional view of an example insert assembly with an example locking member installed;

[0129] Figures 56A to 56Edepicts views of various exemplary embodiments of locking members;

[0130] Fig.57 A flow chart is depicted detailing a number of actions that may be used to actuate an insert assembly;

[0131] Fig.58 depicts a top view of an example insert assembly;

[0132] FIG. 59A to FIG. 59B depicts a cross-sectional view of an exemplary insert assembly to be applied to a user's skin;

[0133] Fig.60 depicts a side view of an exemplary tip holder;

[0134] Fig.61 Draws Fig.60 Another side view of the exemplary tip holder shown;

[0135] Fig.62 depicts another side view of the example tip holder shown in FIG. 59 ;

[0136] Fig.63 Draws Fig.60 A perspective view of an example tip holder shown in ;

[0137] Fig.64 depicts a perspective view of a tip holder, tip, and cannula assembly;

[0138] Fig.65 depicts a side view of an example tip holder;

[0139] Fig.66 Draws Fig.65 Another side view of an example tip holder;

[0140] Fig.67 Draws Fig.65 A perspective view of an example tip holder;

[0141] Fig.68 Draws Fig.67 Detailed view of the indicated area;

[0142] Fig.69 depicts a perspective view of an example holder base;

[0143] Fig.70A depicts a perspective view of an example pointed retractor;

[0144] Fig.70B Draws Fig.70A Another perspective view of an exemplary tip retractor shown in;

[0145] Fig.70C Draws Fig.70B Detail of a portion of

[0146] Fig.71 depicts a cross-sectional view of an example insert assembly taken through an arm included on a pointed retractor of the insert assembly;

[0147] Fig.72 depicts a perspective view of an example outer housing;

[0148] FIG. 73A to FIG. 73B Shown include Fig.72 A cross-sectional view of an example insert assembly of an outer housing shown in ;

[0149] FIG. 74A to FIG. 74B depicts a cross-sectional view of an example insert assembly being withdrawn from a user after application to the skin;

[0150] FIG. 74C to FIG. 74D depicts a cross-sectional view of an exemplary insert assembly including an additional spring;

[0151] FIG. 75A to FIG. 75B depicts a cross-sectional view of an example insert assembly being withdrawn from a user after application to the skin;

[0152] FIG. 76A to FIG. 76B depicts a cross-sectional view of an example insert assembly after a prong of the insert assembly has pierced the skin of a user;

[0153] FIG. 77A to FIG. 77B depicts a cross-sectional view of an example inserter assembly after a tip retractor has been released and thereby retracted;

[0154] Fig.78A depicts a cross-sectional view of an alternative example insert assembly;

[0155] Fig.78B Draws Fig.78A Detailed drawing of the indicated part;

[0156] Figures 79A to 82C An example insert assembly including various example kit retention supports is depicted;

[0157] FIG. 83A to FIG. 83B depicts a cross-sectional view of an example inserter assembly during retraction of a tip retractor;

[0158] Fig.83C depicts a cross-sectional view of an alternative embodiment of an insert assembly;

[0159] FIG. 84A to FIG. 84B depicts a cross-sectional view of the insert assembly after actuation of the insert assembly has been completed;

[0160] FIG. 84C to FIG. 84D depicts a cross-sectional view of an example insert assembly after actuation of the insert assembly has been completed;

[0161] Figure 84E depicts a bottom plan view of an example insert assembly after insert assembly actuation has been completed;

[0162] Figure 84F depicts a cross-sectional view of an example insert assembly;

[0163] Figure 84G depicts a cross-sectional view of an example insert assembly;

[0164] Fig.85 depicts a perspective view of an example holder base;

[0165] Fig.86 depicts a bottom view of an example insert assembly;

[0166] Fig.87 Draws in Fig.86 a cross-sectional view taken at the indicated section of;

[0167] FIG. 88A to FIG. 88B depicts a cross-sectional view of another exemplary insert assembly to be applied to a user's skin;

[0168] Fig.89A depicts a side view of an alternative embodiment of a tip retainer;

[0169] Fig.89B Draws Fig.89A a perspective view of the pointed holder shown;

[0170] Fig.89C Draws Fig.89A Another side view of the pointed holder shown in;

[0171] Fig.90 depicts a perspective view of an exemplary retainer cap;

[0172] Fig.91 depicts a cross-sectional view of an exemplary retainer cap and a pointed retainer;

[0173] Fig.92 Draws Fig.91 Detail of a portion of

[0174] Fig.93A depicts a perspective view of an exemplary tip retractor;

[0175] Fig.93B Draws Fig.93A Another perspective view of the pointed retractor is shown;

[0176] Fig.94 depicts a perspective view of an example insert assembly including a button;

[0177] Fig.95A Draws Fig.94 A top view of the insert assembly shown in ;

[0178] Fig.95B Draws in Fig.95A A cross-sectional view taken at section 89B-89B of ;

[0179] Fig.95C Draw along Fig.95A A three-quarter cross-sectional perspective view taken at 95C-95C;

[0180] Fig.96 depicts a perspective view of an example outer housing of an insert assembly including a button;

[0181] Fig.97 depicts a perspective view of an example insert assembly with an outer housing of the insert assembly removed;

[0182] Fig.98 depicts a perspective view of an example insert assembly with an outer housing of the insert assembly removed;

[0183] Fig.99 Draws Fig.98 Detailed view of the indicated area;

[0184] Fig.100 depicts a perspective view of an exemplary skid that may be included in the insert assembly;

[0185] Fig.101 depicts a perspective view of an example outer housing of an insert assembly including a deformable region;

[0186] Fig.102 depicts a perspective view of another example outer housing of an insert assembly including protuberances on an inner surface thereof;

[0187] Fig.103 A flow chart is depicted detailing a number of actions that may be used to assemble an insert assembly;

[0188] Fig.104 depicts a flow chart detailing a number of example actions that may be performed to place a patient-care assembly utilizing an example insert assembly;

[0189] Fig.105 depicts an exploded view of an example insert assembly;

[0190] Fig.106 depicts a cross-sectional view of an example insert assembly;

[0191] Fig.107 depicts a perspective view of an example locking member;

[0192] Fig.108 depicts a top view of an example insert assembly;

[0193] FIG. 109A to FIG. 109B depicts a cross-sectional view of the insert assembly in a stored state;

[0194] Fig.110 depicts a perspective view of an example pointed shuttle that may be included in certain example insert assemblies;

[0195] FIG. 111A to FIG. 111B depicts views of example trigger bodies that may be included in certain example insert assemblies;

[0196] Fig.112 depicts a perspective view of an example biasing member retainer that may be included in certain example insert assemblies;

[0197] FIG. 113A to FIG. 113B depicts views of example treatment component base holders that may be included in certain example insert components;

[0198] FIG. 114A to FIG. 114B depicts a cross-sectional view of an example insert assembly in a triggered state;

[0199] FIG. 115A to FIG. 115B depicts a cross-sectional view of an example insert assembly in a state in which an example patient-care component of the insert assembly is released from the insert assembly;

[0200] FIG. 116A to FIG. 116B depicts a cross-sectional view of an example insert assembly in a retracted, released state;

[0201] FIG. 117A to FIG. 117B depicts a cross-sectional view of an example insert assembly in a retracted state;

[0202] Fig.118 depicts a side view of an example insert assembly and an example cartridge that may be coupled to the insert assembly;

[0203] Fig.119A depicts an exploded view of an example cartridge;

[0204] Fig.119B Draws Fig.119A Another exploded view of the example cartridge shown in ;

[0205] FIG. 120A to FIG. 120B depicts an exploded view of another example cartridge;

[0206] Fig.121depicts a perspective view of an exemplary infusion set base holder;

[0207] Fig.122 depicts a perspective view of an example inner housing of an example cartridge;

[0208] Fig.123 depicts a perspective view of an example base retainer that may be included in certain example cartridges;

[0209] Fig.124 depicts a perspective view of an example inner cartridge housing that may be included in certain example cartridges;

[0210] Fig.125 depicts a bottom plan view of an example cartridge;

[0211] Fig.126A Draws in Fig.125 A cross-sectional view taken at section 126A-126A of ;

[0212] Fig.126B Draws in Fig.125 Another cross-sectional view taken at section 126B-126B of FIG.

[0213] Fig.127 depicts a bottom plan view of an example cartridge;

[0214] Fig.128A Draws in Fig.127 a cross-sectional view taken at the indicated section of;

[0215] Fig.128B Draws in Fig.127 a cross-sectional view taken at the indicated section of;

[0216] Fig.129A depicts an exploded view of an example reusable insert assembly;

[0217] Fig.129B Draws Fig.129A Another exploded view of the example insert assembly in;

[0218] Fig.130A depicts an exploded view of another example reusable insert assembly;

[0219] Fig.130B Draws Fig.130A Another exploded view of the example insert assembly in;

[0220] Figures 131A to 131B depicts an exploded view of another example reusable insert assembly;

[0221] Fig.132depicts an exploded view of an example hood portion that may be included in certain example insert assemblies;

[0222] Fig.133 depicts a cross-sectional view of an example insert assembly;

[0223] Fig.134 depicts a view of an example insert assembly exploded from an example cartridge;

[0224] Fig.135 Draws Fig.134 Detailed view of the indicated area;

[0225] Fig.136 Draws Fig.134 Detailed view of the indicated area;

[0226] Fig.137A depicts a bottom plan view of an example insert assembly;

[0227] Fig.137B Draws Fig.137A A detailed view of an exemplary receiver body of an exemplary insert assembly shown in FIG.

[0228] Fig.138A depicts a detailed view of a portion of an exemplary receiver body that may be included in the insert assembly described herein;

[0229] Fig.138B depicts a plan view of an example receptacle body that may be included in the insert assembly described herein;

[0230] Fig.139 depicts a perspective view of an example tip retainer that may be included in an example cartridge of an insert assembly described herein;

[0231] Fig.140A An example insert driver that may be included in the example insert assembly described herein is depicted;

[0232] Fig.140B depicts a view of a portion of an example tip retainer;

[0233] Fig.141 depicts a perspective view of an example insert assembly coupled with a cartridge;

[0234] Fig.142 depicts a cross-sectional view of an example insert assembly;

[0235] Fig.143 depicts a perspective view of an example locking member;

[0236] Fig.144 depicts a perspective view of a retracted latch body;

[0237] Fig.145 depicts a perspective view of an example receiver body of an insert assembly having an integrally formed locking member;

[0238] Fig.146 depicts a cross-sectional view of an example insert assembly;

[0239] Fig.147 depicts a cross-sectional view of an example insert assembly;

[0240] Fig.148 depicts a cross-sectional view of an example insert assembly in a stored state;

[0241] Fig.149 depicts a view of an example reset body coupled with an example retraction spring retainer;

[0242] Fig.150 depicts a top view of an example inner housing of an example insert assembly;

[0243] Fig.151 Draw along Fig.150 A cross-sectional view taken along section 151-151 of ;

[0244] Fig.152 depicts a cross-sectional view of an example insert assembly;

[0245] Fig.153 depicts a cross-sectional view of an example insert assembly in a ready state;

[0246] Fig.154 depicts a cross-sectional view of an example insert assembly;

[0247] Fig.155 depicts a top view of an example insert assembly;

[0248] Fig.156 Draws in Fig.155 A cross-sectional view at 156-156 of ;

[0249] Fig.157A depicts a cross-sectional view of another exemplary insert assembly in a storage state;

[0250] Fig.157B Draws Fig.157A a perspective view of an insert assembly with certain parts removed;

[0251] Fig.157C Shows the ready state Fig.157A a cross-sectional view of an insert assembly;

[0252] Fig.157D Draws Fig.157Ca perspective view of an insert assembly with certain parts removed;

[0253] Fig.158 depicts a cross-sectional perspective view of an example insert assembly;

[0254] Fig.159 Draws Fig.158 Detailed view of the indicated area;

[0255] Fig.160 depicts a perspective view of an example inner housing of an example insert assembly;

[0256] Fig.161 depicts a cross-sectional perspective view of an example insert assembly;

[0257] Fig.162A depicts a cross-sectional view of a retainer cap of an example insert assembly;

[0258] Fig.162B Draws Fig.162A Detailed view of the indicated area;

[0259] Fig.163 depicts a side view of an example insert assembly;

[0260] Fig.164 Draws in Fig.163 a cross-sectional view of an example insert assembly taken at an indicated section plane;

[0261] Fig.165 An example end cap that may be included as part of a hood portion of certain example insert assemblies is depicted;

[0262] Fig.166 An example insert driver that may be included in certain example insert assemblies is depicted;

[0263] Fig.167 depicts a cross-sectional view of an example insert assembly;

[0264] Fig.168 depicts a cross-sectional view of an example insert assembly;

[0265] Fig.169 depicts a cross-sectional view of an example insert assembly;

[0266] Fig.170 depicts a cross-sectional view of an example insert assembly;

[0267] Fig.171A depicts a cross-sectional view of an example insert assembly;

[0268] Fig.171B depicts a cross-sectional view of an example insert assembly;

[0269] Fig.172 depicts a cross-sectional view of an example insert assembly;

[0270] Fig.173 depicts a perspective view of a cartridge coupled to an insert assembly with an outer housing of the cartridge removed;

[0271] Fig.174A depicts a perspective view of an example insert assembly including a released latch;

[0272] Fig.174B Draws Fig.174A a cross-sectional view of an insert assembly;

[0273] Figure 175A depicts a perspective view of an example insert assembly including an example release latch;

[0274] Fig.175B Draws Figure 175A a cross-sectional view of an insert assembly;

[0275] Figures 176A to 176C depicts various views of another example insert assembly including an example release latch;

[0276] Figures 177A to 177B depicts a view of another example insert assembly including an example release latch;

[0277] Figure 178A depicts a perspective view of an example insert assembly including an example release actuator;

[0278] Figures 178B to 178C Draws Figure 178A a view of an example insert assembly with various components removed;

[0279] Fig.178D Draws Figure 178A A perspective view of an example release actuator of an insert assembly shown in;

[0280] Fig.179A depicts a perspective view of another example insert assembly including an example release actuator;

[0281] Fig.179B Draws Fig.179A A perspective view of an insert assembly with certain components removed;

[0282] Figure 180A depicts a perspective view of another example insert assembly including an example release actuator;

[0283] Fig.180B Draws Figure 180Aa perspective view of the insert assembly with a portion of the housing removed;

[0284] Fig.180C Draws Figure 180A a perspective view of an insert assembly with certain parts removed;

[0285] Fig.180D Draws Fig.181A a cross-sectional view of an insert assembly;

[0286] Fig.181A depicts a perspective view of another example insert assembly including an example release actuator;

[0287] Fig.181B Draws Fig.181A a cross-sectional view of an insert assembly;

[0288] Fig.181C Draws Fig.181A A perspective view of a release actuator of the insert assembly shown in ;

[0289] Fig.181D Draws Fig.181A Another cross-sectional view of the insert assembly shown in ;

[0290] Fig.182A depicts a perspective view of another example embodiment of an insert assembly including an example release actuator;

[0291] Fig.182B Draws Fig.182A a perspective view of an example insert assembly with certain components removed;

[0292] Figures 183A to 183B depicts a view of another example embodiment of an insert assembly including an example release actuator;

[0293] Fig.184 depicts a perspective view of an example tube connector;

[0294] Fig.185A Draws Fig.184 A bottom view of the pipe connector shown in ;

[0295] Fig.185B Draws Fig.185A Detail of a portion of

[0296] Fig.186 depicts a perspective view of a pipe connector in place on a fixture;

[0297] Fig.187 Draws Fig.186 A bottom view of the fixture shown in ;

[0298] Fig.188 depicts a perspective view of a pipe connector aligned for installation into a fixture;

[0299] Fig.189 depicts a cross-sectional view of a fixture with a tube connector mounted thereon and a prong introduced into the tube connector;

[0300] Fig.190 depicts a cross-sectional view of the fixture with the pipe connector mounted thereon and the prong in place and rotationally clocked to a specified position within the pipe connector; and

[0301] Fig.191 A flow chart is depicted detailing a number of example actions that may be used to assemble a pipe connector. DETAILED DESCRIPTION

[0302] In various embodiments, an infusion set can be used in conjunction with an infusion device, system, and related methods and in conjunction with an insert assembly. In various embodiments, an example infusion set can be configured to be inserted into a subcutaneous layer of a user's skin and fluidly connected to a fluid source. In various embodiments, an example infusion set can be fluidly connected to a length of tubing and / or an infusion set. Infusion devices include any infusion pumps and may include, but are not limited to, the various infusion devices described in the following patents: U.S. patent application serial number 15 / 434906 (attorney docket number U64), filed on February 16, 2017, and entitled Infusion Set and Inserter Assembly, now U.S. Patent No. 10792419, issued on October 6, 2020; U.S. patent application serial number 13 / 788,260, filed on March 7, 2013, and entitled Infusion Pump Assembly, now U.S. Publication No. US-2014-0107579, published on April 17, 2014 (attorney docket number K40); U.S. patent application serial number 13 / 788,260, filed on March 7, 2013, and entitled Infusion Pump Assembly, now U.S. Publication No. US-2014-0107579, published on April 17, 2014 (attorney docket number K40); U.S. patent application serial number 13 / 788,260, filed on March 7, 2013, and entitled Infusion Pump Assembly, now U.S. Publication No. US-2014-0107579, published on April 17, 2014 No. 13 / 788,260, entitled “Infusion Pump Assembly,” now U.S. Publication No. US-2014-0107579, published on April 17, 2014 (Attorney Docket No. K40); U.S. Patent No. 8,491,570, entitled “Infusion Pump Assembly,” issued on July 23, 2013 (Attorney Docket No. G75); U.S. Patent No. 8,414,522, entitled “Fluid Delivery Systems and Methods,” issued on April 9, 2013 (Attorney Docket No. E70); U.S. Patent No. 8,262,616, entitled “Infusion Pump Assembly,” issued on September 11, 2012 (Attorney Docket No. F51); and U.S. Patent No. 8,491,570, entitled “Infusion Pump Assembly,” issued on July 23, 2013 (Attorney Docket No. G75); No. 7,306,578 (Attorney Docket No. C54) for "Pump"; all of which are hereby incorporated by reference in their entirety.

[0303] Various embodiments are described and illustrated herein. Each embodiment of each element of each device can be used in any other device embodiment. Each embodiment of the insert assembly can be used with any embodiment of the infusion set.

[0304] Figure 1A An exploded view of an embodiment of an example insert assembly 100 is depicted. An insert assembly such as insert assembly 100 can be used to place an infusion set 102 on a patient's infusion site and introduce a cannula 104 of the infusion set 102 into the patient's body. In some embodiments, the insert assembly 100 can be used to place other patient care components on the patient's body. For example, certain insert assemblies 100 can be operated to place a physiological monitor in a working relationship with the patient's body. In some examples, an analyte sensor can be placed on the patient via the insert assembly 100. The infusion set 102 can be used to supply a drug from an infusion pump to a specific location (e.g., subcutaneous) in the patient's body.

[0305] The drugs or other agents supplied may include drugs or agents that are typically supplied as a continuous or substantially continuous infusion, but other drugs or agents may also be used. This may include small molecules, biologics, recombinantly produced drugs 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 that affect the cardiovascular system may also be provided via the infusion set 102. As another example, vasodilators such as treprostinil may be delivered to the patient via the infusion set 102. Chemotherapeutic drugs may also be used. Exemplary physiological monitors may include blood glucose monitors, such as continuous glucose monitors. Any other type of body analyte monitor, such as an interstitial fluid analyte monitor, may also be used.

[0306] In some embodiments, insert assembly 100 can place infusion set 102 at a location and at least partially assemble infusion set 102. For example, infusion set 102 can be provided as multiple parts (e.g., separate components, subassemblies, or combinations thereof) within insert assembly 100. Actuation of insert assembly 100 can cause each part of infusion set 102 to be coupled together to complete assembly of infusion set 102. For example, assembly of infusion set 102 can occur as an initial stage of actuation of insert assembly 100, or can occur as part of an insertion stage of actuation of insert assembly 100 that results in cannula 104 being introduced into a patient.

[0307] like Figure 1AAs shown in the exploded view in , the insert assembly 100 includes components of the infusion set 102. The insert assembly 100 may not be provided with an 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 actuation of the insert assembly 100. The first portion may include a base 106 that can be applied to the patient's skin and can be coupled to a fluid pathway (e.g., via a terminal connector on a path) that is part of an infusion pump or extends from an infusion pump. An example infusion pump may include any one or more disclosed in the various references incorporated by reference above, but in various embodiments, any infusion pump may be used. The base 106 may be provided with an adhesive (e.g., an adhesive pad) that holds the infusion set 102 in place on the patient. The adhesive may be covered by an adhesive backing 111, a liner, or a film that is removed to expose the adhesive before use.

[0308] The second part of the infusion set 102 can be a subassembly 114 of two or more components of the infusion set 102. For example, the second part can include a cannula 104, a diaphragm housing 108, a diaphragm 110, and a diaphragm retainer 112. In some embodiments, although not all, one or more components of the second part can be provided integrally with each other so that the components are manufactured as a single integral part during, for example, a single molding operation. Therefore, any attachment, fastening, bonding, fitting together or other assembly of these parts after manufacturing can be avoided. In an exemplary embodiment, the cannula 104 and the diaphragm housing 108 are shown as such a single continuous integral part. The housing with the cannula can be a molded component composed of a single material such as, for example, PTFE, Teflon, polypropylene, etc. Certain components may also be connected to each other during manufacturing. For example, the diaphragm retainer 112 can be overmolded onto the diaphragm 110, and vice versa.

[0309] like Figure 1AAs shown, the insert assembly 100 may include a plurality of additional components. For example, the insert assembly 100 may include an outer shell 116. The outer shell 116 may enclose various components of the insert assembly 100 and serve as a portion for the user of the insert assembly 100 to grasp during operation. The outer shell 116 in the exemplary embodiment has a circular cross-sectional shape, but other embodiments may have different shapes, such as any type of polygonal shape. In certain examples described elsewhere in the specification, a rectangular cross-sectional shape that is easily fitted in the pocket portion may be used. The cross-sectional area in the exemplary embodiment also varies with the bottom section of the outer shell 116 (which is closest to the skin when in use) being wider than the top. The outer shell 116 may include various ergonomic features that help grasp the insert assembly 100 contained in the outer shell 116. For example, textures or finger or thumb depressions may be included on the outer surface of the outer shell 116. Alternatively or additionally, the width of an area of ​​the outer shell 116 may be thinner than the width of the rest of the outer shell 116. This may make it easier to firmly grasp the insert assembly 100.

[0310] The outer housing 116 may include markings, tabs, embossed sections, recessed sections, textured sections, protuberances, color coding, decals, or other markings to indicate the position and / or orientation of the infusion set 102 within the insert assembly 100. For example, Figure 1A The outer housing 116 in the embodiment includes a raised rib 118 on an outer surface of the outer housing 116. The raised rib 118 in the example extends substantially parallel to the elongated direction of the outer housing 116, but in alternative embodiments, the raised rib 118 can be disposed on any (one or more) outer surfaces of the outer housing 116 or partially disposed on any (one or more) outer surfaces of the outer housing 116. The rib 118 is arranged to indicate the orientation of a portion of the infusion set 102 to which a fluid conduit from the infusion set can be connected. This can allow a user to position the insert assembly 100 in a desired orientation so as to allow a section of infusion tubing to be arranged in a planned manner once the infusion set 102 is attached to the user.

[0311] The insert assembly 100 may also include an inner housing 120. When the insert assembly 100 is assembled, the inner housing 120 may be disposed inside the outer housing 116. Various inner housings 120 may have at least one segment of an asymmetrical design. Figure 1AIn the exemplary embodiment shown, the inner housing 120 includes a track section 122, which includes a plurality of guide rails 124. The guide rails 124 extend substantially parallel to each other and may have at least two different widths. The inner surface of the outer housing 116 may include a track or slot that cooperates with the guide rails 124. Due to the different widths of the guide rails 124, a keyed arrangement may be provided so that the inner housing 120 can be nested in the outer housing 116 only in a specified orientation. The interaction of the guide rails 124 within the track may also inhibit the rotation of the inner housing 120 and the outer housing 116 relative to each other. Although the guide rails 124 are shown on the inner housing 120 in the example, in some embodiments the guide rails 124 may alternatively be present on the inner surface of the outer housing 116. In such an example, the track may be located on the inner housing 120. In addition, as shown, at least some of the guide rails 124 may also form a channel or track in the inner surface of the inner housing 120.

[0312] In other embodiments, rail and track type arrangements may not be used. 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 of the other of the inner housing 120 or the outer housing 116. This can similarly provide a key engagement and prevent relative rotation. In other embodiments, the cross-sectional shape of the inner housing 120 and the outer housing 116 can only allow the components to be placed together in one orientation and can inhibit any relative rotation. For example, the cross-section can be a teardrop shape or various asymmetric polygonal shapes.

[0313] The inner housing 120 may also include an infusion set base interface section 126. The base interface section 126 may include a plurality of protrusions 352 that may ensure that the base 106 may be inserted into the insert assembly 100 only in a desired orientation. The protrusions 352 may also optionally help to retain the base 106 within the insert assembly 100, and when the base 106 is installed in the insert assembly 100, there may be some friction between the protrusions 128 and the surface of the base 106. For example, the base 106 may form a press fit with the protrusions 352. The tightness of the fit may be minimal to allow the base 106 to be removed from the base interface section 126 with little force. The protrusions 352 may also help maintain a flush orientation of the base 106 within the base interface section 126.

[0314] The insert assembly 100 may also include a tip holder 130. The tip holder 130 may hold an insertion tip 132 thereon. The insertion tip 132 may be glued or otherwise incorporated into the tip holder 130 to be fixedly positioned relative to the tip holder 130. Any suitable type of tip 132 may be used. For example, the tip 132 may be a hollow or solid needle, a stylet or other sharp member, which may be made of a metal material such as steel. A tip retractor 134 and a plurality of springs 136, 138 may also be included in the insert assembly 100. A retainer base 140 may be used to couple to the bottom of the insert assembly 100 to hold various components in place within the insert assembly 100. In this example, the retainer base 140 includes a retaining interface 142 that may snap into a cantilever retainer arm 144 included on the outer housing 116. Other couplings are possible, such as bayonet mounts, interference fits, snap fits, adhesives, glues, threads, solvent bonding, welding, etc. When coupled together, the outer housing 116 and the holder base 140 may form a cover portion of the insert assembly 100 .

[0315] As will be further described later in this specification, a latch arrangement can be included in the insert assembly 100, and the latch arrangement can hold the tip retainer 130 and the tip retractor 134 in place before and during partial actuation of the insert assembly 100. The latch arrangement can include a plurality of catches. When free to move, the springs 136, 138 can displace the tip retainer 130 and the tip retractor 134 and the components held thereon to complete the insertion of the cannula 104 into the patient and the attachment of the infusion set 102 to the infusion site. Retraction of the tip 132 into the insert assembly 100 can also occur as part of the actuation to move the tip 132 to a point where it is pulled out of the infusion set 102 and prevented from contacting the user.

[0316] When the user opens the package, the insert assembly 100 can be provided with a locking member 146. The locking member 146 can be inserted through the openings 148, 150 in the outer shell 116 and the inner shell 120, respectively, to span the width of at least a portion of the inner shell 120. When present in the insert assembly 100, the locking member 146 can prevent actuation of the insert assembly 100. The example locking member 146 can mechanically prevent displacement of one or more components of the insert assembly 100 that would trigger an actuation action of the insert assembly 100. In an exemplary embodiment, the locking member 146 includes a flange 152 that can be grasped by a user during removal of the locking member 146.

[0317] As shown, locking member 146 can include a plurality of raised sections 154 (e.g., ridges or bumps) thereon. These raised sections 154 can provide material that can aid in bonding to a portion of adhesive backing 111 during a welding operation. As a result, locking member 146 can be attached to adhesive backing 111 so that a user will have a visual cue if one of locking member 146 or adhesive backing 111 is removed while the other is still in place. This can help encourage removal of both components before attempting to actuate insert assembly 100, making the device more intuitive.

[0318] Now also refer to Figure 1B and Figure 1C In some examples, the insert assembly 100 may include one or more additional springs 156, 158. Figure 1C As shown, the additional spring 158 may be a conventional metal spring. Figure 1B As shown, a plastic spring 156 can be used. In some embodiments, the plastic spring 156 can be injection molded, cut from a tube (e.g., by laser cutting), made by an additive process, or any other suitable method. Such springs 156, 158 will be further described later in the specification.

[0319] Now also refer to Figure 2 , another insert assembly 100 is shown. Figure 2 The insert assembly 100 in the embodiment of the present invention includes an outer housing 116, which can surround various components of the insert assembly 100 and serve as the portion of the insert assembly 100 that a user grasps during operation. Although illustrated as a circle, the outer housing 116 can have other cross-sectional shapes or various ergonomic features as described above. The outer housing 116 includes position markings in the form of raised ribs 118 that extend from an outer surface of the outer housing 116. The ribs 118 can be arranged to indicate the orientation of a portion of the infusion set 102 contained within the insert assembly 100.

[0320] The inner housing 120 also includes Figure 2 and may be keyed to ensure that it is assembled into the insert assembly 100 in a specified orientation and to prevent relative rotation. Figure 2 , the inner housing 120 can be made asymmetrical by including at least one protrusion 400, such as a tab, which engages with a recess or guide 402 in the outer housing 116. In this example, the guide 402 is provided by a channel formed by the raised ribs 118 on the inner surface of the outer housing 116. Figure 2The protrusion 400 on the insert assembly 100 is included on the spacer 404, which ensures that the inner housing 120 fits snugly within the outer housing 116. The infusion set base interface section 126 is also included Figure 2 Example shown on the inner housing.

[0321] In the example embodiment, a tip retainer 130 is shown that can be attached to the insertion tip 132. In addition, a tip retractor 134 and a plurality of springs 136, 138 can also be included. A retainer cap 406 can be used to connect to the top of the insert assembly 100 to hold various components in place within the insert assembly 100. In this example, the retainer cap 406 includes a cantilevered retainer arm 408 that can be snapped into a retaining interface 411 included on the outer shell 116. Other connections are also possible, such as a bayonet mount, an interference fit, a snap fit, an adhesive, a glue, a thread, a solvent bond, a weld, etc. When connected together, the outer shell 116 and the retainer cap 406 can form a cover portion of the insert assembly 100.

[0322] As described in detail elsewhere herein, a latch arrangement can be included in the insert assembly 100 that can hold the tip retainer 130 and the tip retractor 134 in place before and during a partial actuation of the insert assembly 100. The latch arrangement can include a plurality of catches. When free to move, the springs 136, 138 can displace the tip retainer 130 and the tip retractor 134 and the components held thereon to complete the insertion of the cannula 104 into the patient and the attachment of the infusion set 102 to the infusion site. Retraction of the tip 132 into the insert assembly 100 can also occur as part of the actuation.

[0323] exist Figure 2 In the illustrated exemplary embodiment, the insert assembly 100 does not include the locking member 146. However, in various embodiments, similar locking members may be included in the outer housing 116 and the inner housing 120. Figures 1A to 1C The openings 148, 150 in the adhesive backing 111 are provided to accommodate the locking member 146. In these embodiments, the adhesive backing 111 can be bonded to the locking member 146. However, in the exemplary embodiment, 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. Figure 2 Also included Figure 1C The additional spring 158 is shown in FIG.

[0324] Reference now Figure 3 , depicts another example embodiment of the insert assembly 100. As shown, Figure 3 The insert assembly 100 includes Figure 2The outer housing 116 and inner housing 120 are similar to those shown in the illustrated example. The tine retainer 130 and tine retractor 134 are different from Figure 1A to Figure 2 The retainer cap 406 may be used to couple to the top of the insert assembly 100 to hold the various components in place within the insert assembly 100 and to form a cover for the insert assembly 100. The retainer cap 406 may be used to couple to the top of the insert assembly 100 to hold the various components in place within the insert assembly 100 and to form a cover for the insert assembly 100. Figure 2 The depicted embodiment couples to the outer housing 116 in a similar manner, 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 prong retainer 130 when the insert assembly 100 is fully assembled and ready for actuation.

[0325] As described in detail elsewhere herein, a latch arrangement can be included in the insert assembly 100 that can hold the tip retainer 130 and the tip retractor 134 in place before and during a partial actuation of the insert assembly 100. The latch arrangement can include a plurality of catches. When free to move, the springs 136, 138 can displace the tip retainer 130 and the tip retractor 134 and the components held thereon to complete the insertion of the cannula 104 into the patient and the attachment of the infusion set 102 to the infusion site. Retraction of the tip 132 into the insert assembly 100 can also occur as part of the actuation.

[0326] exist Figure 3 In the illustrated example embodiment, the insert assembly 100 does not include the locking member 146. However, in various embodiments, similar locking members may be included in the outer housing 116 and the inner housing 120. Figures 1A to 1C The openings 148, 150 in the adhesive backing 111 are provided to accommodate the locking member 146. In these various embodiments, the adhesive backing 111 can be bonded to the locking member 146. However, in an exemplary embodiment, the adhesive backing 111 includes two pull tabs 410. These pull tabs 410 can be grasped by a user to facilitate removal of the adhesive backing 111. Figure 3 Also included Figure 1C The additional spring 158 is shown in FIG.

[0327] Reference now Figure 4A and Figure 4B , showing top and bottom perspective views of the infusion set base 106, respectively. As shown, the base 106 can have a platform portion 160. The platform portion 160 can be positioned against the patient's skin while the infusion set 102 is in place over the infusion site. In an exemplary embodiment, the platform portion 160 has a generally circular, and in this case generally circular, disc-shaped footprint. In other embodiments, the platform portion 160 can be an inverted circular shape (see FIG. 21A to FIG. 21F), egg-shaped or oval (see FIG. 22A to FIG. 22C ). The platform portion 160 is also substantially flat. However, this need not be the case in all embodiments.

[0328] In various embodiments, an adhesive can be applied to the bottom surface 162 of the platform portion 160. The adhesive backing 111 (see, e.g., Figure 1A ) can be covered with adhesive. In an exemplary embodiment, the bottom surface 162 of the platform portion 160 includes a plurality of raised segments 164. The exemplary raised segments 164 are depicted as radially arranged ridges that are spaced at substantially regular angular intervals on a portion of the bottom surface 162. Two concentric raised rings also exist around the periphery of the bottom surface 162. In other embodiments, raised segments other than ridges may be included, and / or raised features may not be radially arranged or regularly spaced. In some embodiments, the raised segments 164 may be points or circular areas separated around the bottom surface 162. In various embodiments, any suitable pattern may be used. The raised segments 164 may allow the adhesive to be bonded (e.g., ultrasonically or by high frequency welding) to the bottom surface 162. For example, an adhesive may be included on the substrate, and the adhesive may be a plastic, such as polypropylene or any other plastic that can be processed with a welding operation. The raised segments 164 and the substrate may be gradually mixed together during the welding operation, thereby forming a bond that keeps the adhesive on the bottom surface 162 of the infusion set base 106. In alternative embodiments, an adhesive, such as double-sided tape, may couple the substrate to the bottom surface 162 , and the bottom surface 162 may be free of the raised sections 164 .

[0329] In various embodiments, the platform portion 160 may include a plurality of through holes 166 . FIG. 4A to FIG. 4B 166, but any number of through holes may be included in other examples and their shapes may be different. Through holes 166 may be provided to facilitate manufacturing because they may allow protrusions on a portion of the assembly line to dock with them. During manufacturing operations, the interface may assist in the orientation or centering of the base 106 or any infusion set 102 subassembly including the base 106. In the case where the through holes 166 assist in orientation, it may be desirable that the through holes 166 be arranged in an asymmetrical manner (although symmetrical through hole 166 arrangements are also possible). In this example, the through holes 166 are arranged in a triangular type layout so that the base 106 will only match a set of corresponding protrusions in one orientation. In addition, in some embodiments, any adhesive and adhesive liner 111 may include holes aligned with the positions of the through holes 166. Therefore, even when the insert assembly 100 is fully assembled and ready to be triggered, the through holes 166 may be used to assist in the manufacturing process. The through holes 166 may also engage with a portion of any packaging in which the insert assembly 100 is disposed to help keep the insert assembly 100 in place.

[0330] Although the through-holes 166 may be helpful during manufacturing, the through-holes 166 may also provide other benefits. For example, the through-holes 166 may provide a window to observe the skin surrounding the infusion site. Thus, a user may be able to assess the skin for signs of irritation or inflammation (e.g., redness or swelling). In addition, the through-holes 166 may provide a path through which ambient air may communicate with the space between any raised sections 164 on the bottom surface 162 of the infusion set base 106. This may help allow the area below the infusion set 102 to breathe while the infusion set 102 is adhered against the skin.

[0331] A plurality of tube holders 184 may extend from the periphery of the platform portion 160. The tube holders 184 may allow the infusion tube 366 to be wrapped around a portion of the infusion set 102 and held in place. This may help inhibit kinking of the tube 366 and help the user to conveniently arrange the infusion tube 366 as desired. In alternative embodiments of the infusion set base 106 described herein, the tube holders 184 may be omitted (e.g., see FIG. 22A to FIG. 22C ).

[0332] Now also refer to Figure 6 , the top surface 168 of the platform portion 160 may include various receiving features extending therefrom, which may be matched or docked with a connector 368 included at the terminal end of an infusion tube 366 extending from an infusion pump. In various embodiments, the infusion tube 366 may be coupled to an infusion pump storage portion, 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 coupling, adhesive, solvent bonding, or in any other suitable manner. The base 106 may include a connector receiver 170, around which a cantilevered finger 370 on the tube set connector 368 may deflect when the connector 368 slides onto the base 106. Once past the connector receiver 170, the cantilevered finger 370 may be restored to their undeflected position, and the bump or catch protrusion on the cantilevered finger 370 may be displaced into a latching engagement with the cooperating features of the connector receiver 170. Pointed side protrusions 372 may also be present on the connector 368. These side protrusions 372 may be substantially parallel to the prongs 482 included on the connector 368 (see, e.g., Fig.15F ) extends from the cantilevered finger 370 and there may be a barrier that helps prevent accidental contact between the prong 482 and the user. The shield wall 169 may be provided on the base 106 and may help prevent a finger or object from inadvertently disengaging the cantilevered finger 370 from engagement with the connector receiver 170. The shield wall 169 may be continuous with the connector receiver 170.

[0333] A guide 172 may also be included for each of the connector fingers 370 and the side projections 372, and in the exemplary embodiment defines a plurality of slots along which the connector fingers 370 and the side projections 372 may slide when the connector 368 is displaced into engagement with the infusion set 102. The guide 172 may make it easier for a user to couple the infusion set 102 and the connector 368 together. In addition, the guide 172 may help ensure that the prongs 482 on the connector 368 (e.g., see Fig.15F ) is introduced into the infusion set 102 along or near the desired insertion axis. In this example, the guide 172 includes notches 174. Each notch 174 can be sized to receive a protrusion on a component of the insert assembly 100. The notches 174 can also be sized to receive at least a portion of a protrusion included on the cannula subassembly 114 (see, e.g., Figure 5A ). When the connector 368 is attached to the infusion set 102, the side protrusions 372 can be sized to extend from the connector 368 a distance shorter than the location of the notch 174. As described in further detail later in this specification, the notch 174 can help facilitate the release of the base 106 from the insert assembly 100 during actuation.

[0334] In various embodiments, the base 106 may also include a cannula subassembly 114 for use with the infusion set 102 (see, e.g., Figure 5A ) is provided to provide a receptacle 176 that matches the base 106. In this example, the receptacle 176 is generally centrally disposed on the base 106, and the receptacle 176 is flanked on each side by the guide 172. The receptacle 176 can be at least partially surrounded by a receptacle wall 178 that protrudes upward from the top surface 168 of the platform portion 160. Thus, the receptacle wall 178 and the portion of the guide 172 that includes the recess 174 can define the receptacle 176. A portion of the receptacle wall 178 can include a cantilevered section 180. The cantilevered section 180 can include a protrusion (e.g., a barb or ramp) 182. In some embodiments, the receptacle wall 178 and / or a portion of the guide 172 can include a tapered section (see, e.g., FIG. 10A to FIG. 10B 160 ). A tapered section may be included at the portion of the receiving portion wall 178 and / or guide 172 that is farthest from the platform 160. Such a tapered section may help guide the cannula subassembly 114 into place when the infusion set 102 is assembled by funneling the cannula subassembly 114 into the receiving portion 176. Additionally or alternatively, the recess 174 may taper along at least a portion of its length (e.g., see FIG. 21A to FIG. 21F ). This may help guide the cannula subassembly 114 into place when assembling the infusion set 102.

[0335] Now also refer to Figure 5A, depicts an example cannula subassembly 114. As shown, the diaphragm housing 108 can include a recess 186. The recess 186 can be recessed into the exterior face of the diaphragm housing 108. During movement of the cannula subassembly 114 into the receptacle 176 of the base 106, the cantilevered section 180 of the base 106 can be deflected about the diaphragm housing 108 until the protrusion 182 springs freely into the recess 186. Once the cantilevered protrusion 180 has returned to its undeflected state and the protrusion 182 is disposed within the recess 186, the cannula subassembly 114 can be retained within the base 106. In the retained state, the ear or knob 204 of the diaphragm housing 108 can be at least partially located within the recess 174 of the base 106 (e.g., Figure 6 shown).

[0336] Now refer to Figure 5B , which depicts a cross-sectional view of an assembled cannula subassembly 114, which in certain embodiments may also include a septum 110 and a septum retainer 112. In alternative embodiments, as described herein with respect to other examples, a plurality of septa 110 may be included in place of a single septum 110. The septum housing 108 may include a cup-shaped receiving section or receptacle 192 into which the septum 110 may be introduced. The receiving section 192 may include a raised area 194 at its center. In this example, the raised area 194 may have a truncated cone type shape, but other shapes are possible. For example, such as FIG. 29A to FIG. 31G Shapes other than those included on the diaphragm interface region 183 of the cannula 104 shown in FIG. 4 may be used as an alternative to the raised region 194. The diaphragm 110 may also have a cup-shaped diaphragm recess 196 included in a bottom surface thereof. The diaphragm recess 196 may include an enlarged or flared section 198 (or a section otherwise corresponding to the shape of the example raised region 194) that is formed as an inverse version of the raised region 194 in the receiving section 192 of the diaphragm housing 108. Thus, when the diaphragm 110 is introduced into the receiving section 192, the enlarged section of the diaphragm recess 196 may self-center the diaphragm 110 and may be referred to herein as a centering wall of the diaphragm recess 196. The second section 200 of the diaphragm recess 196 farthest from the bottom surface of the diaphragm 110 may at least partially define the fluid introduction volume 109 as follows: a needle or tip 482 (e.g., see FIG. 4 ) included on the tube connector 368. Fig.15F ) can penetrate into the fluid introduction volume to deliver fluid to the infusion set 102. The fluid can flow from the fluid introduction volume 109 to the lumen 202 of the cannula 104 and into the patient. The second section 200 of the septum recess 196 can have any suitable cross-section, but in the example has a circular, generally circular cross-section. The septum housing 108 may include a connector needle passage 222 (such as Figure 6), the connector needle passage 222 can allow the needle or tip 482 of the connector 368 (e.g., see Fig.15D ) into the fluid introduction volume 109. In the illustrated embodiment, the connector needle passage 222 is depicted as an opening extending through the septum housing 108. The connector needle passage 222 and the recess 186 may (although need not) be present on opposite sides of the septum housing 108 to facilitate allowing the cannula subassembly 114 to be installed into the base 106 in two orientations. This may make assembly of the insert assembly 100 simpler.

[0337] The receiving section 192 of the diaphragm housing 108 may also receive a portion of the diaphragm retainer 112. The diaphragm retainer 112 may be configured with a body 206 from which extends at least one cantilevered protrusion 188 including a terminal protuberance or latch member 190. In this example, the body 206 is substantially planar. In addition, there are two cantilevered protrusions 188 disposed opposite each other and extending generally perpendicular to the body 206. These cantilevered protrusions 188 may fit within guides 208 included on the inner surface of the receiving section 192 of the diaphragm housing 108. The guides 208 are shown recessed into the inner surface of the receiving section 192 and are substantially in the same plane as the ears 204. The guides 208 are angled so that the distance between the two guides 208 decreases as the distance from the cannula 104 decreases. This may cause the cantilevered projection 188 of the septum retainer 112 to deflect toward the extension axis of the cannula 104 when the septum retainer 112 is advanced into the receiving section 192. Figure 5B , once the septum retainer 112 has been advanced a certain distance into the septum housing 108, the cantilevered protrusions 188 may spring outwardly such that the protuberances 190 on each cantilevered protrusion 188 latch into engagement with a catch 210 on the septum housing 108. In some embodiments, a portion of the cantilevered protrusions 188 may extend into or through an aperture included in the bottom of the septum housing 108 and into latching engagement with a catch adjacent to or formed by the wall of the aperture. With the septum retainer 112 latched into place within the cannula subassembly 114, the septum 110 may form a sealing relationship with the septum housing 108. Thus, a sealed fluid flow path may be provided for the fluid contained in the fluid introduction volume 109 of the septum 110 to the outlet 212 of the cannula 104.

[0338] As shown, the septum retainer 112 includes a channel 218 extending therethrough. The example channel 218 is disposed substantially at the approximate center of the body 206. When the septum retainer 112 is locked in place within the cannula subassembly 114, the nub or protrusion 220 of the septum 110 can extend into the channel 218. Thus, the channel 218 can provide an access path for the insertion tip 132 of the insert assembly 100 to extend through the infusion set 102 and out of the outlet 212 of the cannula 212. In the example shown, the nub 220 is in the shape of a frustoconical cone, and the channel 218 is cooperatively formed to receive the nub 220. In alternative embodiments, other nub 220 shapes may be used, such as any of the embodiments described herein (e.g., see FIG. 32A to FIG. 32D ).

[0339] The cannula 104 can include an insertion tip guide section 216 that can help guide the insertion tip 132 into the lumen 202 of the cannula 104. The insertion tip guide section 216 can have a funnel-like shape, but other shapes are possible. In an example embodiment, the insertion tip guide section 216 includes relatively steep sides and is surrounded by a flat (or possibly chamfered or rounded) peripheral edge that forms the wall of the fluid introduction volume within the infusion set 102. In some embodiments, the peripheral edge can be the uppermost of the raised section 192. The insertion tip guide section 216 can be continuous with the wall of the lumen 202 of the cannula 104 and can be wetted by any fluid conveyed by the infusion set 102. The insertion tip guide section 216 can also be continuous with the raised area 194 in the receiving section 192 of the septum housing 108.

[0340] Main references Figure 5B, a recess 214 may be included in the diaphragm housing 108 so that the recess 214 surrounds or at least partially surrounds the cannula 104. When the adhesive is placed on the infusion set base 106, the recess 214 may not be covered by the adhesive. If the infusion set 102 or a part of the patient's body causes a force to be applied to the cannula 104, the recess 214 can provide the cannula 104 with space to move relative to the base 106. This can minimize the shearing effect on the cannula 104. In addition, the recess 214 can be used as a volume in which a medicament can be placed. For example, an antiseptic, disinfectant, anti-inflammatory agent, anesthetic or other topical agent such as an ointment may be included in the recess 214. The agent may be a medicinal, nutraceutical or some other type of agent. Therefore, when the infusion set 102 is applied, the agent can be introduced into the patient's skin and can be kept in contact with it. In some examples, the agent can be kept in contact with the recess 214. This may be desirable or beneficial for a variety of reasons, including that it may help prevent infection, inflammation, or pain and may provide a means of applying medication in a convenient manner. In an exemplary embodiment, recess 214 is shaped in the form of a conical section (e.g., a hyperbola or parabola) of revolution about the central axis of cannula 104.

[0341] 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 to the major axis of the cannula 104. In some embodiments, instead of being at a constant angle to the axis, there can be a curvature. The angle or degree of curvature on the tapered section can also vary within the range of the tapered section.

[0342] In some embodiments, the first portion of the cannula 104 near the outlet 212 is tapered. As the outlet 212 toward the cannula 104 increases, the tapering present in this section causes the wall thickness to decrease. In addition, the second portion of the cannula 104 adjacent to the point from which the cannula 104 on the diaphragm housing 108 extends is also tapered. In certain embodiments, the angle of the tapering of the second portion can be substantially equal to the angle of the insertion tip guide section 216. The tapering at the second portion reduces the width of the cannula 104 at the section without significantly reducing the thickness of the wall of the cannula 104 surrounding the lumen 202. In an example embodiment, a straight section can be arranged between the first and second portions of the cannula 104. Alternatively, a slightly tapered section can be used as an intermediate section. The section can 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 section.

[0343] Reference now FIG. 7A to FIG. 9, depicts another example infusion set 102. As shown, the cannula subassembly 114 of the example infusion set 102 is designed to allow for production via straight-draw molding. There are no features on the example cannula subassembly 114 that may require a mold with side action or other special characteristics. For example, in some embodiments, there may be no undercut features. This can allow the cannula subassembly 114 or its components to be constructed from a wide variety of different materials.

[0344] As shown, the cannula subassembly 114 includes a FIG. 5A to FIG. 5B The diaphragm 110 shown. In alternative embodiments, a plurality of diaphragms 110 may be included in place of the single diaphragm 110 shown. The diaphragm housing 108 does not include the notch 186. In place of the notch 186, the diaphragm housing 108 includes lobes 388 extending outwardly from an outer surface of the diaphragm housing 108. During coupling of the cannula assembly 104 to the infusion set base 106, for example, one of the lobes 388 may deflect the cantilevered section 180 of the base 106 until the protrusion 182 is free to spring back to a position cantilevered from the protrusion 388. Once the cantilevered protrusion 180 returns to its undeflected state and the protrusion 182 is above the protrusion 388, the cannula subassembly 114 may be retained within the base 106. In this retained state (see, e.g., Fig. 9 ), the ear or knob 204 of the diaphragm housing 108 may be at least partially located within the recess 174 of the base 106. The receiving portion 176 of the infusion set base 106 is partially relative to Figure 4A Figure 4B The portion shown in FIG. 1 is widened to accommodate the larger footprint of the cannula subassembly 114. In addition, the receptacle 176 includes a cam receiving area 398 opposite the cantilevered protrusion 180 to receive a cam 388 that is not engaged by the protuberance 182. This can allow the cannula subassembly 114 to be made symmetrical and allow it to be installed in the infusion set base 106 in two orientations. This can help to simplify manufacturing and assembly. In other embodiments, the cam 388 can be included on only one side of the cannula subassembly 114, and the cam receiving area 398 of the base 106 can be omitted.

[0345] Additionally, in the exemplary embodiment, diaphragm housing 108 does not include a connector needle passage 222 formed in a side wall thereof (see, e.g., Figure 6 ) opening. FIG. 8A to FIG. 9 The diaphragm housing 108 in the embodiment of the present invention includes a slot 390 in a side wall 392 of the diaphragm housing 108, the slot 390 being recessed into a top surface 394 of the side wall 392. The diaphragm retainer 112 may include a protrusion 396 that aligns with the slot 390 when the cantilevered protrusion 188 is engaged within a guide 208 included on the inner surface of the receiving section 192 of the diaphragm housing 108. When the cannula subassembly 114 is coupled together (see, e.g., Figure 8B ), the protrusion 396 can occupy a portion of the slot 390. Thus, a tip 482 (e.g., see FIG. 4 ) can be provided in the cannula subassembly 114 for inclusion on the tube connector 368. Fig.15D ) or an entry hole for a needle. The septum holder 112 also includes a plurality of through holes 397. Similar to the through holes 166 in the infusion set base 106, the through holes 397 can help with manufacturing and assembly.

[0346] In some embodiments, slots 390 in side walls 392 of diaphragm housing 108 may be used as a retention arrangement in lieu of lobes 388, cooperating with protuberances included as part of base 106. The protuberances may snap against or engage the walls of one of slots 390, thereby preventing removal of cannula subassembly 114. In such embodiments, lobes 388 may not be included on diaphragm housing 108. This may help further simplify the production of cannula subassembly 114.

[0347] Reference now Fig. 10A and Fig. 10B , another example base 106 is shown. Figure 6 As shown, the top surface 168 of the platform portion 160 may include various receiving features extending therefrom that may mate or interface with the connector 368. The base 106 may include a connector receiver 170 that may allow the base 106 to couple with the cantilevered finger 370 on the tube set connector 368 as described above (see, e.g., Figure 6). In the example embodiment, a guide 172 for each connector finger 370 may also be included. As shown, the exemplary guide 172 includes a first section 171 and a second section 173. The first section 171 of each guide 172 can be configured to have a portion extending in a manner substantially parallel to the plane of the platform 160 of the base 106. The second section 173 of each guide 172 can include a portion that is angled relative to the first section 171. In the example, each of the first section 171 and the second section 173 includes a flange that protrudes from the main portion of the guide 172. As the second section 173 extends distally from the flange of the first section 171 of the guide 172, the distance between the proximal surface of the platform 160 and the flange of the second section 173 of the guide 172 can increase. This can allow the tube set connector 368 to be initially introduced at a considerable angle 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 be redirected to the appropriate displacement path for coupling the tube set connector 368 to the base 106. Thus, when performing the coupling of the base 106 and the tube set connector 368, the guides 172 can help allow the user to blindly insert the connector fingers 370 into the connector receiver 170. As shown, a second set of additional guide flanges 175 can be included on the receiving portion wall extension 179. These additional guide flanges 175 can extend to the periphery of the base 106. In the example embodiment, the second set of guide flanges 175 extend substantially vertically from the inner side of the receiving portion wall extension 179 and toward the tip 482 of the tube set connector 368 (see, e.g., Figures 184 to 188 ) is inserted into the cannula subassembly 114 along an axis extending. The face of each of the second set of guide flanges 175 may include an inclined region, which is arranged near the end of each guide 172 closest to the periphery of the base 106.

[0348] Now also refer to FIG. 11A to FIG. 11B , the tube set connector 368 may include a flow hub 377, a tube 366 and a tip 482 (see, e.g. Figures 184 to 188 ) can be coupled to the flow hub 377. Fluid flowing through the connector 368 can pass through the lumens 514 and 516 of the tube 366 and the tip 482, respectively, within the flow hub 377 (see, e.g. Figures 184 to 188 ).like FIG. 11A to FIG. 11BAs shown, the flow hub 377 may include an alignment channel 375 recessed therein. As shown, the alignment channel 375 includes a constant width section 373 and a variable width section 379. When the tube set connector 368 and the infusion set 102 are coupled, the alignment channel 375 may interact with the second set of guide flanges 175 of the base 106. The angled section of each of the second set of guide flanges 175 and the variable width section 379 of the alignment channel 375 may allow the tube tip connector 368 to be initially introduced at a considerable angle to the plane of the platform 160 of the base 106. Further introduction may cause the second set of guide flanges 175 to contact the walls of their respective alignment channels 375 and redirect the tube set connector 368 toward the appropriate displacement path to couple the tube set connector 368 to the base 106. Therefore, the second set of guide flanges 175 combined with the alignment channel 375 may help allow the user to blindly couple the base 106 and the tube set connector 368.

[0349] Reference now FIG. 12A to FIG. 12B and FIG. 13A to FIG. 13B In some embodiments, the pointed side protrusion 372 can be included as part of the tube set connector 368. As shown, the pointed side protrusion 372 can extend parallel to the axis of the tip 482 (see, for example, Figures 184 to 188 ), the prong 482 can be included in the tube set connector 368. The prong side protrusions 372 can help prevent any user from contacting the prong 482 by providing a barrier to prevent fingers from reaching the prong 482. The prong side protrusions 372 can include a centrally arranged protrusion 372 that extends from the top surface of the tube set connector 368 on the prong 482. The prong side protrusions 372 can also include a set of protrusions that are in the same plane as the connector fingers 370 of the tube set connector 368, but are arranged more centrally than the connector fingers 370. In an example embodiment, the connector fingers 370 and the set of protrusions 372 are in line with the bottom surface of the tube set connector 368. Each protrusion 372 in the set of protrusions 372 can be arranged to extend from a point on the body 367 of the tube set connector 368 that is located in the middle of the flow hub 377 and the connector fingers 370. These protrusions 372 may be arranged to interact with the guides 172 of the base 106 during coupling of the tube set connector 368 to the corresponding base 106. In such an embodiment, the connector fingers 370 may not interact with the guides 172 on the base 106.

[0350] In some embodiments, and as FIG. 13A to FIG. 13BAs shown, a pair of pointed side protrusions 372 located in the plane of the connector finger 370 can extend beyond the end 381 of the connector finger 370. These protrusions 372 can include a curved end region 383 located at the end of the protrusion 372 opposite the end attached to the body 367 of the tube set connector 368. The curved end region 383 can be curved in a transverse direction to the axis of the protrusion 482 of the tube set connector 368 (see, e.g. Figures 184 to 188 ). In this example, the curved end region 383 may have a curvature that swings through an arc greater than 90°. In this example, the curvature of the curved end region 383 is such that the curved end region 383 begins to extend back toward the body 367 of the tube set connector 368. The radius of the curved end region 383 may or may not be constant. In addition, the curved end region 383 may include one or more straight extensions. Fig. 13B As best shown in FIG. 1 , the portion of the terminal end of the curved end region 383 leading to the projection can be substantially straight. In this example, the curved end region 383 is curved around and in front of a portion of the corresponding connector finger 370. The distance between the projections 372 can be slightly less than the spacing between the guides 172 of the corresponding base 106. However, the distance between the projections 372 at the curved end region 383 can be slightly larger, which helps to manipulate the projections 372 into their respective guides 172. Once the projections 372 are located in the guides 172, the advancement of the tube set connector 368 can cause the projections 372 to elastically open. Due to the elasticity of the projections 372, the projections 372 are pressed against the surface of the guides 172, ensuring a tight and substantially free swing fit. When the connection of the tube set connector 368 to the base 106 is completed, this can help to further limit the displacement of the tube set connector 368 along the desired path.

[0351] In some examples, and now with reference to FIG. 14A to FIG. 14B A set of pointed side projections 372 in line with the connector fingers 370 may extend from the flow hub 377. This may reduce the gap between the pointed side projections 372 of the tube set connector 368 and may help further minimize the risk of a user entering the prongs 482 with their fingers (see, e.g., Figures 184 to 188 ) nearby space. FIG. 14A to FIG. 14BIn the exemplary embodiment depicted in FIG, a set of pointed side protrusions 372 are included, which extend along and from opposite faces of the flow hub 377 that are transverse to the axis of the protrusion 482. These protrusions 372 can each include a support segment 385. These support segments 385 can be located in a region of the pointed side protrusions 372 that extends beyond a face 387 of the flow hub 377 from which the protrusion 482 extends. As shown, the support segment 385 is disposed in a portion of the region that is closest to the flow hub 377. The support segment 385 in the exemplary embodiment includes an arched face that can provide additional robustness to the set of pointed side protrusions 372. The face 387 of the flow hub 377 from which the protrusion 482 extends can also be arched, which can further increase the robustness of the protrusion 372.

[0352] Reference now Fig.15A 15H, another exemplary tube set connector 368 is shown. As shown, a set of pointed side protrusions 372A can be aligned with the connector fingers 370, similar to FIG. 14A to FIG. 14B The set of pointed side protrusions 372A can extend from the flow hub 377. FIG. 14A to FIG. 14B As shown, this can help avoid inadvertent contact with the prongs 482. A centrally disposed prong side protrusion 372B can also be included that extends from the top surface of the tube set connector 368 over the prongs 482.

[0353] The pointed side protrusions 372A, 372B may include at least one guide surface 371A-371D. In some embodiments, each of the pointed side protrusions 372A, 372B may include at least one guide surface 371A-371D. Fig.15A The pointed side protrusions 372A shown in FIG. 15H each include a lateral adjustment guide surface 371A and a height adjustment guide surface 371B. At least one of any of the lateral adjustment guide surfaces 371A and the height adjustment guide surface 371B may include an inclined section. As shown, the lateral guide surface 371A and the height adjustment guide surface 371B may include a first region near the flow hub 377 and a second region at the end of the pointed side protrusion 372A away from the flow hub 377. The second region may be inclined (ramped or curved), while the first region may be substantially straight, or may be inclined to a lesser degree.

[0354] The pointed side protrusion 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 the height adjustment guide surface 371C and at least one lateral adjustment guide surface 671D may include an inclined section. In this example, the height adjustment guide surface 371C includes a first area near the flow hub 377 and a second area at the distal end of the pointed side protrusion 372B. In an exemplary embodiment, the second area is inclined (sloped or curved). The pointed side protrusion 372B includes a centrally arranged groove 369 that extends along the lower side of the pointed side protrusion 372B (closest to the lower side of the tip 482). The sidewalls of the groove 369 may form two lateral guide surfaces 371D. A portion of at least one of the lateral guide surfaces 371D (e.g., the portion farthest from the flow hub 377) may be inclined.

[0355] Now also refer to FIG. 16A to FIG. 16C , it may be desirable for portions of the infusion set base 106 and / or cannula subassembly 114 to have relatively loose tolerances to facilitate manufacturing. Thus, in some embodiments, the cannula subassembly 114 may be slightly deflected when held in the infusion set base 106 due to the loose tolerances (see FIG. Fig. 9 ). Additionally, as the tubing set connector 368 is repeatedly connected and disconnected from the infusion set base 106, the cannula subassembly 114 may change position slightly.

[0356] FIG. 16A to FIG. 16C A cross-sectional view of an exemplary cannula subassembly 114 is depicted, with the cannula subassembly remaining stationary as the tubing set connector 368 is gradually advanced toward the cannula subassembly 114. When the tubing set connector 368 is docked to the infusion set base 106 (e.g., see Fig. 9 ), FIG. 15A to FIG. 15F The exemplary tubing set connector 368 shown in FIG. 3 can be connected from a starting position (e.g., see Fig.16A ) is displaced to an intermediate position just before the tip 482 to pierce the septum 110 material of the cannula subassembly 114 (see, for example, Fig. 16B ). This range of displacement of the tube set connector 368 may be referred to as a homing displacement range. When the tube set connector 368 is displaced through the homing displacement range, any guide surface 371A-371D of the tube set connector 368 may contact various areas or surfaces of the cannula subassembly 114 when the cannula subassembly 114 is deflected. For ease of description, Fig.16A , the cannula subassembly 114 is shown in an exaggeratedly skewed position. For clarity, the infusion set base 106 to which the cannula subassembly 114 is coupled is hidden.

[0357] As the tube set connector 368 is further displaced through the home displacement range, the guide surfaces 371A-371D can push, guide and / or adjust the cannula subassembly 114 to the home position. The inclusion of an inclined section on any of the guide surfaces 371A-371D can facilitate this by helping to funnel the cannula subassembly 114 into or toward its home position. Fig. 16B , the cannula subassembly 114 is depicted as being adjusted to an original position (again hiding the infusion set base 106 to more clearly show the cannula subassembly 114). The guide surfaces 371A-371D can adjust the position of the cannula subassembly 114 along two axes, which can be substantially perpendicular to each other and in a plane substantially perpendicular to the direction of elongation of the prong 482 of the tube set connector 368.

[0358] Then, the tube set connector 368 can be displaced through a piercing displacement range in which the tip 482 of the tube set connector 368 pierces the septum 110 included in the cannula subassembly 114. At the end of the piercing displacement range, and as Fig. 16C , the tip of the prong 482 can be disposed within the fluid introduction volume 109 of the septum 110, and the connector finger 370 can engage the connector receiver 170 on the infusion set base 106. During puncture of the septum 110, the cannula subassembly 114 can be substantially restrained from displacement by the guide surfaces 371A-371D of the tubing set connector 368. At the end of the puncture displacement range, the tubing set connector 368 can be considered to be in a fully docked position on the infusion set base 106.

[0359] This two-stage connection of the tube set connector 368 to the infusion set base 106 can help ensure that the septum 110 of the cannula subassembly 114 is in a consistent position before the prong 482 of the tube set connector 368 pierces the septum 110. This can be the case even if loose tolerances are employed during the manufacturing of certain components of the infusion set 102. The original position of the cannula subassembly 114 can place the septum 110 in the proper position to allow the prong 482 of the tube set connector 368 to enter the fluid introduction volume 109 in the cannula subassembly 114. This can allow the fluid introduction volume 109 to be made smaller to minimize dead volume. Additionally, any connector needle passage 222 (e.g., see FIG. 2 ) in the septum housing 108 can be made smaller to minimize dead volume. Fig.31B ) or other openings that allow the tip 482 to pass through the septum housing 108 can be made smaller. In addition, since the original position can be consistently achieved each time the tubing set connector 368 is reconnected to the infusion set base 106, the tip 482 can pierce the septum 110 at substantially the same position.

[0360] In some examples, there may be mechanical interference between at least one of the guide surfaces 371C-371D on the pointed side protrusion 372B and the nub 220 of the septum 110. At least when the tube set connector 368 is shifted to the fully docked position, the mechanical interference may cause the nub 220 material to be similar to the relative FIG. 32A to FIG. 32D The compression of the projection 221 described above is compressed. For example, the lateral adjustment guide surface 371D can compress the material of the tumor-shaped portion 220 toward the puncture path of the insertion tip 132 (see, for example, Fig.74B ). The height adjustment guide surface 371C can compress and seal the material of the tumor-shaped portion 220 on the guide surface 371C.

[0361] In some examples, and now mainly referring to Fig.17 , the infusion set base 106 may include a track 361, when the tubing set connector 368 (e.g., see FIG. 15A to FIG. 15F ) is docked to the infusion set base 106, the track 361 can engage with and guide the pointed side protrusion 372. The track 361 may include a deflector body 363 that can elastically deflect the pointed side protrusion 372 when the tube set connector 368 and the infusion set base 106 are coupled to each other. Fig.17 In the example shown, the track 361 is arranged to engage with the pointed side protrusion 372B (see, for example, Fig.15D ), but the track 361 for other pointed side protrusions may also include a deflector body 363. The example track 361 extends from the portion of the receiving portion wall 178 that is farthest from the platform portion 160 of the base 106. As shown, in some examples, the deflector body 363 can be a ramp. Upon contacting the deflector body 363, the pointed side protrusion 372B can be deflected and pressed against the tumor 220 of the septum 110 of the cannula subassembly 114 installed in the infusion set base 106 (for example, see Figure 5B Although in the exemplary embodiment, the pointed side projections 372B may be deflected against the nub 220 , in various embodiments, the pointed side projections 372A, 372B may also be deflected against any exposed portion of the septum 110 of the cannula subassembly 114 .

[0362] In some example embodiments, and referring now to 18A to 18C, the tube set connector 368 may include a tine 343. The tine 343 may be included in the pointed side protrusions 372A, 372B of the tube set connector 368. Such a tine 343 may be cantilevered relative to the remainder of the pointed side protrusions 372A, 372B. The tine 343 may be configured to have at least a section extending out of the plane of the remaining portion of the pointed side protrusions 372A, 372B. The tine 343 may be deflected toward the pointed side protrusions 372A, 372B, but may have a degree of resilience that, when in a deflected state, urges the tine 343 to return to its unpressurized state.

[0363] In this exemplary embodiment, the tines 343 are included in the pointed side protrusions 372B of the tube set connector 368. The tines 343 are attached to the pointed side protrusions 372B in the area of ​​the tines 343 that is farthest from the flow hub 377 of the tube set connector 368. The unsupported ends of the tines 343 are included in the portion of the tines 343 that extends substantially parallel to the remainder of the pointed side protrusions 372B. When the tube set connector 368 is coupled to the infusion set 102, the tines 343 can be advanced on the cannula subassembly 114 coupled within the receptacle 176 of the infusion set base 106. When this occurs, the tines 343 can be elastically deflected. When in the coupled state, the cannula subassembly 114 can prevent the tines 343 from fully returning to the pressure-free state. In turn, the tines 343 can be pressed against the tumor-like portion 220 of the diaphragm 110 of the cannula subassembly 114.

[0364] In some embodiments, the end of the pointed side protrusion 372B farthest from the flow hub 377 may include a ramp 347. Such a ramp 347 may be included on a portion of the end (e.g., see Fig.18B ), or may extend through the entirety of the end portion (see, for example, Fig.18C ). The infusion set base 106 can include a deflector 345 into which the ramp 347 can be advanced when the tubing set connector 368 is coupled to the infusion set 102. In some embodiments, the deflector 345 can be a protrusion extending from a portion of the infusion set base 106. Alternatively, the deflector 345 can be a slot in the infusion set base 106 into 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 pointed side protrusion 372B can be deflected toward the platform portion 160 of the infusion set base 106. This in turn can cause the tines 343 to be further pressed against the tumor-like portion 220.

[0365] Despite 18A to 18CThe tines 343 and ramps 347 are shown in relation, but may be included on any of the tube set connectors 368 described herein. The deflector 345 may be included on any of the infusion set bases 106 described herein.

[0366] Reference now FIG. 19A to FIG. 19C In some embodiments, tubing set connector 368 may include clamp 321. When tubing set connector 368 including clamp 321 is coupled to engage with infusion set assembly 102, clamp 321 may abut against an exposed portion of septum 110 of cannula subassembly 114 of infusion set assembly 102. For example, clamp 321 may press onto opposite sides of an exposed portion of septum 110 (e.g., tumor 220) to compress material of septum 110.

[0367] In some examples, the clamp 321 can be defined in the pointed side protrusion 372, or the pointed side protrusion 372 can be formed. As shown, the pointed side protrusion 372B is formed as the clamp 321. The clamp 321 may include a first body 323A and a second body 323B spaced apart from each other by a gap. At least one of the first body 323A and the second body 323B can be configured to shift toward the other of the first body 323B and the second body 323B. Any suitable arrangement can be used to facilitate such displacement. In an exemplary embodiment, and as Fig.19B , the second body 323B is coupled to the flow hub 377 along a portion of the end of the second body 323 proximal to the flow hub 377. This partial connection can allow the second body 323 to resiliently deflect or pivot toward the first body 323A. The first body 323A can be connected to the flow hub 377 along the entirety of its second end. Thus, the exemplary first body 323A can resist deflection and can remain stationary.

[0368] 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 outcrop or bump in 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 clamp 321. In an exemplary embodiment, when the second body 323B is driven into the deflector body 363, the second body 324B may be deflected toward the first body 323A. In turn, the clamp 321 may be closed around the tumor 220 of the septum 110. The clamping surfaces 329 of the first body 323A and the second body 323B may press against and compress the tumor 220. To help inhibit rotation or turning of the tube set connector 368 when the clamp 321 contacts the deflector body 363, a stop member 331 may be included. During the coupling process, the stop member 331 may provide mechanical interference with undesired movement of the tube set connector 368. In an exemplary embodiment, the stop member 331 is a protrusion on the rib 325 opposite the deflector body 363.

[0369] refer to FIG. 15A to FIG. 19C For a variety of reasons, it may be desirable to compress the knob 220 of the septum 110 and ensure that the prong 482 of the tubing set connector 368 pierces the septum 110 in substantially the same location as described above. For example, these features can help expand the range over which the cannula subassembly 114 can resist leaks to pressures even in excess of those expected during use. Compression of the knob 220 can allow a wider range of materials to be used for the septum 110 of the cannula assembly 114. Likewise, a wider range of material durometers can be used. Compressing the knob 220 via the protrusion 221 (e.g., see FIG. 32A to FIG. 32D ) or reduce the potential compressive stress relaxation of the material forming the tumor-like portion 220 (see FIG. 32A to FIG. 32D ) may also help to implement the above construction.

[0370] Now also refer to FIG. 20A to FIG. 20C , depicts another example base 106. The example base 106 can be coupled to a Fig.14A and Fig. 14B 368 shown in FIG. 1 . The base 106 may include a connector receiver 170 that may allow the base 106 to couple with a cantilevered finger 370 on the tube set connector 368, as described elsewhere herein. Although not shown in the example embodiment, a connector for use such as Figure 6 and Fig. 10A160. Such guides 172 may also be included on any other infusion set base 106 shown or described herein. As shown, the base 106 may define a receiver track 189 that may receive a set of pointed side projections 372 located in the plane of the connector fingers 370. As shown, the receiving wall extension 179 and the portions of the receiving wall 178 that extend parallel to each other may be separated from each other by a channel. The receiver track 189 is recessed into the receiving wall extension 179 and into the portions of the receiving wall 178 that extend parallel to each other near the platform 160. Therefore, the width of the channel between the receiving wall extension 179 and the portions of the receiving wall 178 that extend parallel to each other near the platform 160 may be greatest near 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 an inclined wall 191. The angled wall 191 may help position the pointed side protrusion 372 of the tube set connector 368 in the receiver track 189. In addition, the base 106 may include an angled section 193 at the open end of the receiver track 189. FIG. 10A to FIG. 10B By means of the second section 173 of the guide 172 in the housing 106, the angled section 193 can allow the tube set connector 368 to be initially introduced at a substantial angle to the plane of the platform 160. Further introduction can cause the side protrusions 372 to be redirected into the receiver track 189. Thus, the angled wall 191 and the angled section 193 can facilitate blind insertion of the tube set connector 368 into a coupled relationship with the base 106.

[0371] Reference now FIG. 21A to FIG. 24C , an additional example infusion set base 106 is shown. The base 106 may include a connector receiver 170, which may allow the base 106 to be coupled to a tubing set connector 368. FIG. 21A to FIG. 21F The exemplary base 106 shown may be coupled to a FIG. 15A to FIG. 16C A tubing kit connector 368 is shown, as described elsewhere herein. FIG. 22A to FIG. 24C The example base 106 shown in FIG. 1 may be coupled to a tubing set connector 368 such as FIG. 25A to FIG. 26C Those tube kit connectors shown in .

[0372] As shown, the receiving wall extensions 179 can be separated from each other by a channel. The receiving wall extensions 179 and the portions of the receiving wall 178 that form each side of the channel can also include segments 177 that are arranged substantially parallel to the platform portion 160 of the infusion set base 106. Therefore, the channel can include a wide section adjacent to the platform portion 160 and a narrow section away from the platform portion 160. The wide section of the channel can define a receiver track 189 that can receive a set of pointed side protrusions 372A. Although FIG. 21A to FIG. 21F and FIG. 22A to FIG. 24C 193 (see, e.g., FIG. 20A to FIG. 20C ). When the tube set connector 368 is coupled to the base 106, the receiver track 189 can guide the pointed side protrusion 372A. Therefore, this channel can be referred to as a guide channel.

[0373] As shown, the receiving portion wall 178 can include a break 181 in a portion of the receiving portion wall 178 that defines the receiver track 189. The break 181 can be aligned with the notch 174 included in the receiving portion wall 178. The break 181 can extend through a portion of the segment 177 of the receiving portion wall 178 that is parallel to the platform portion 160. The more inboard area 161 of these segments 177 can be uninterrupted by the break 181. The break 181 can extend from the segment 177 to the platform portion 160. The break 181 can define a portion of a corresponding arm 332 for a portion of the insert assembly 100 (e.g., see Fig.59A ) receiving slots. These receiving slots may also be referred to as insert interface slots. The intermediate region 161 adjacent to the breakout portion 181 may be used as a catch for the flange 348 (about Fig.59A further described). Fig.21D As shown, the recess 174 in the receiving portion wall 178 can be tapered along at least a portion of its length (e.g., the portion farthest from the platform portion 160). When assembling the infusion set 102, such a tapered recess 174 can help guide the cannula subassembly 114 into place. In some embodiments, the entirety of each recess 174 can be tapered to different degrees. For example, the portion of each recess 174 farthest from the platform portion 160 can have a greater taper than the second portion of each recess 174 that is closer to the platform portion 160. Such a tapered recess 174 can be included on any of the infusion set bases 106 described or shown herein.

[0374] FIG. 21A to FIG. 21FThe example infusion set base 106 in also includes a receiving portion wall 178, which includes a cantilevered section 180 having a protuberance 182. The cantilevered section 180 can be configured to elastically deflect to not hinder when the cannula assembly 114 is introduced, but resist deflection when a force applied along the long axis of the cantilevered section 180 is applied. The cantilevered section 180 may include one or more ribs 163. The ribs 163 may protrude from the cantilevered section 180 into the receiving portion 176 and may extend along the length of the cantilevered section 180. Although ribs 163 are shown, other protrusions may be included in alternative embodiments. One or more recesses 165 may be provided on a side of the cantilevered section 180 opposite to the side from which the protuberance 182 extends. The recesses 165 may be provided opposite each of the ribs 163 or otherwise thickened areas. When the cannula assembly 114 is introduced, the ribs 163 can help position the cannula subassembly 114 within the receptacle 176. The ribs 163 can also inhibit rocking of the cannula subassembly 114 when the cannula subassembly 114 is within the receptacle 176 and coupled to the base 106.

[0375] FIG. 22A to FIG. 22CThe example infusion set base 106 shown in includes a plurality of cantilevered sections 180, each of which includes a protuberance 182. The receiving portion wall 178 includes the cantilevered section 180. The cantilevered section 180 extends away from the receiving portion wall 178 away from the platform portion 160, such that the unsupported end including the protuberance 182 is the portion of the cantilevered section 180 farthest from the platform portion 160. A pair of cantilevered sections 180 are also disposed opposite to each other adjacent to the receiving portion wall 178 on the receiving portion wall extension 179. The pair of cantilevered sections 180 extend in a direction away from the platform portion 160 (e.g., substantially perpendicular to the platform portion 160), such that the unsupported end including the corresponding protuberance 182 is the portion of the cantilevered section 180 farthest from the platform portion 60. When the cannula subassembly 114 is introduced, each cantilevered section 180 can be elastically deflected to be unobstructed to allow the cannula subassembly 116 to be transferred into the infusion set base 106. The inclined surface of the protuberance 182 can help promote this deflection. Once the cannula subassembly 114 has been advanced beyond the threshold amount into the receiving portion 176 of the infusion set base 106, the cannula subassembly 116 can be displaced away from the protuberance 182. The cantilevered sections 180 can each be restored to a state with less force or less deflection, and the protuberance 182 can each overhang a portion of the cannula subassembly 114 (e.g., the diaphragm housing 108). Therefore, the cannula subassembly 114 can be captured in the infusion set base 106. Although three cantilevered sections 180 are shown, in alternative embodiments, different numbers of cantilevered sections 180 may be included. For example, the receiving portion wall 178 may include a greater number of cantilevered sections 180. In an alternative embodiment, at least some of the cantilevered sections 180 may protrude toward the platform portion 160 such that their unsupported protuberance 182 load-bearing ends are portions of the cantilevered sections 180 that are closest to the platform portion 160 (e.g., see FIG. 21A to FIG. 21F cantilever section 180). FIG. 22A to FIG. 22C In the embodiment of the present invention, each cantilevered section 180 has a substantially equal height. In alternative embodiments, the height of at least one cantilevered section 180 may be different. The height may be selected so that the protrusion 182 overhangs and captures the cannula subassembly 114 to be installed in the receiving portion 176. The cannula subassembly 114 used with the infusion set base 106 embodiment, such as FIG. 22A to FIG. 22C The cannula subassembly shown may not include the notch 186 (see, for example, Figure 5A ) or convex corner 388 (see, for example, Fig. 8A ). The top surface 394 of the side wall 392 of the diaphragm housing 108 (see, for example, Fig.29C ) can provide an engagement surface by which the protrusion 182 retains the cannula subassembly 114 in the base 106.

[0376] Reference now FIG. 23A to FIG. 24C, depicting two exemplary infusion set base 106 embodiments. As shown, in some examples, an additional retainer member 261 may be included and may extend from the platform portion 160 of the infusion set base 106. The exemplary embodiment depicts a similar FIG. 22A to FIG. 22C The holder member 261 on the infusion set base 106 shown, however, such a holder member 261 can be included on any infusion set base 106 described herein (e.g., FIG. 21A to FIG. 21F ). The retainer member 261 is disposed adjacent the receiving portion 176 and closest to the open end of the guide channel. In the exemplary embodiment, the retainer member 261 is positioned opposite the cantilevered section 180. Such exemplary retainer member 261 may be shaped like a hook or similar to a hook. When the tubing set connector 368 is coupled to the exemplary infusion set base 106, the prong 482 (e.g., see Fig.15F ) can travel along the access path within the corresponding guide channel. The height of the retainer member 261 can be selected so as not to protrude into the access path of the prong 482, so that during the connection process of the tube set connector 368, the retainer member 262 can not block the prong 482. As shown in various embodiments described herein, the cannula subassembly 114 can include a set of notches 186 (see, for example, Figure 5A 24E). The notches 186 may be provided on opposing sections of the outer sidewall of a portion of the cannula subassembly 114.

[0377] refer to FIG. 23A to FIG. 23C , after the cannula subassembly 114 has been advanced into the receptacle 176 more than a certain distance, the cantilevered section 180 of the receptacle wall 178 can snap into a first recess in the recess 186 to retain the cannula subassembly 114 within the receptacle 176. As the cannula subassembly 114 is advanced into the receptacle 176, the retainer member 261 can deflect. When the cannula subassembly 114 has been advanced into the receptacle 176 more than a certain distance, the retainer member 261 can return to an undeflected (or at least less deflected) state and snap into a second recess in the recess 186. In various embodiments, the cantilevered section 180 and the retainer member 261 can snap into the recess 186 substantially simultaneously. FIG. 24A to FIG. 24C In the exemplary embodiment shown, the protuberance 182 of the cantilever member 180 can be clamped in place against the top surface 394 of the diaphragm housing 108 of the cannula subassembly 114. The retainer member 261 can help limit jostling of the cannula subassembly 114 within the receptacle 176 and may allow for looser tolerances. In addition, the retainer member 261 can help center the cannula subassembly 114 within the receptacle 176.

[0378] Reference now FIG. 25A to FIG. 26C, shows an example tube set connector 368, which can be used with, for example FIG. 22A to FIG. 24C The exemplary tubing set connector 368 includes pointed side protrusions 372A, 372B but does not include connector fingers 370. The exemplary tubing set connector 368 includes a set of connector latches 365. Although the combination FIG. 25A to FIG. 26C 360. The tubing set connector 368 of claim 102 may be a tubing set connector 368 having a plurality of connectors, each having a plurality of connectors, and each having a plurality of connectors. The tubing set connector 368 of claim 102 may be a tubing set connector 368 having a plurality of connectors, each having a plurality of connectors, and each having a plurality of connectors, may be a tubing set connector 368 having a plurality of connectors, each having a plurality of connectors, and each having a plurality of connectors, may be a tubing set connector 368 having a plurality of connectors, each having a plurality of connectors, and each having a plurality of connectors, may be a tubing set connector 368 having a plurality of connectors, each having a plurality of connectors, and each having a plurality of connectors, may be a tubing set connector 368 having a plurality of connectors, each having a plurality of connectors, and each having a plurality of connectors, may be a tubing set connector 368 having a plurality of connectors, each having a plurality of connectors, FIG. 22A to FIG. 24C , the connector receiver 170 can be located on an opposing portion of the base 106, between the closed and open ends of the guide channel, and laterally to the receiver wall extension 179. Portions of the body 367 that include the connector latch 365 can be attached to the flow hub 377 so as to be deflectable relative to the flow hub 377, and may be referred to herein as deflectable body segments. A compressive force applied to these segments of the body 367 toward the axis of the tip 482 can displace the connector latch 365 out of engagement with the connector receiver 170. If desired, the tubing set connector 368 can then be separated from the infusion set 102. These portions of the body 367 can include uneven, scalloped, wrinkled, etc. gripping areas 475 to assist in gripping the tubing set connector 368. In some examples (in Fig.26C ), the connector latch 365 may include a stopper body 479. The stopper body 479 may limit the deflection of the deflectable body segments because they may abut against the receiving portion wall extension 179 when the deflection exceeds a certain amount. Fig.26B As best shown in FIG. 1 , in certain exemplary tube set connectors 368, the tube set connector 368 can have an angled face 477 on each deflectable body segment. When the deflectable body segments are squeezed toward each other, the angled face 479 can displace against the connector receiver 170. When the angled face 479 is driven into the connector receiver 170 on the infusion set base 106, the angled face 479 can cause the tube set connector 368 to be pushed out of engagement. Thus, the angled face 479 can facilitate disengagement of the tube set connector 368 from the infusion set base 106.

[0379] Still refer to FIG. 22A to FIG. 26CSince the exemplary tube kit connector 368 covers the connection between the connector latch 365 and the connector receiver 170, FIG. 22A to FIG. 24C The exemplary infusion set base 106 does not include the shielding wall 169 (see, for example, Fig.21A ). When coupled together, the exemplary tube set connector 368 and base 106 can form a low-profile assembly that reduces the possibility of clothing being snagged, for example.

[0380] Still the main reference FIG. 22A to FIG. 24C , the portion of the example base 106 opposite the open end of the guide channel can be formed by a contour wall 357. The contour wall 357 can extend from the top of the receiving portion wall 178 to a portion of the periphery of the base 106 opposite the open end of the guide channel. As the proximity to the periphery of the base 106 increases, the contour wall 357 may tend to drop in the direction of the plane of the platform portion 160. The platform portion 160 may not continue below the contour wall 357. Instead, a cavity may exist on the underside of the contour wall 357, which can help facilitate molding. For example, as Fig. 22B As shown, the transition wall 349 can extend from the platform portion 160 to the edge of the contour wall 357 closest to the open end of the guide channel. In some embodiments, the transition wall 349 can be disposed generally perpendicular to the axis of the guide channel.

[0381] Now also refer to FIG. 25A to FIG. 25C , the transition wall 349 may include a passage 341 that extends through the transition wall 349 and into a cavity on the underside of the contour wall 357. When the tube set connector 368 is coupled to the infusion set base 106, the pointed side projection 372A may extend through the passage 341 in the transition wall 349. The unsupported end of the pointed side projection 372A may protrude into the cavity. The contour wall 357 of the infusion set base 106 may also be substantially flush with the outer surface of the body 367 of the tube set connector 368. The deflectable body segment of the body 367 of the tube set connector 368 may be seated against the transition wall 349 of the infusion set base 106 so that when the base 106 and the tube set connector 368 are connected, there is no significant gap between the transition wall 349 and the tube set connector 368.

[0382] exist FIG. 27A to FIG. 27B In the alternative embodiment shown, in addition to the connector latch 365, FIG. 26A to FIG. 26CThe tubing set connector 368 may also include connector fingers 370. The infusion set base 106 may include a set of additional passageways 341 in the transition wall 349. When the tubing set connector 368 is displaced into engagement with the infusion set base 106, the connector fingers 370 may deflect around the sidewalls of the corresponding additional passageways 341. When coupled to the infusion set base 106, the connector fingers 370 may snap into engagement with the back side of the transition wall 349, as shown. Fig.27B The connector latch 365 may also engage the connector interface 170. Thus, the infusion set base 106 and the tubing set connector 370 may be coupled to each other via multiple sets of coupling arrangements.

[0383] Reference now Fig.28A and Fig.28B , another example infusion set base 106 is shown. In some embodiments, the base 106 may not include a receiving portion wall 178 having a cantilevered protrusion 180 defined therein (see, e.g., Figure 4A ).like Fig.28A and Fig.28B As shown in , in some examples, the base 106 can include a retainer member 195 extending from the platform 160. The retainer member 195 can be independent and not supported by or continuous with the receiving portion wall 178. Fig.28B and Fig.28B , the retainer member 195 is depicted as a hook extending from the platform and located in the opening between two sections of the receiving portion wall 178. In other examples, a hook may not be used. Instead, a cantilevered member including a protuberance 182, such as a barb or ramp that engages with a portion of the cannula subassembly 114, may be used. The hook may include a handle region 197 attached to and continuous with the platform 160. The handle region 197 extends from the platform 160 to the bend region 199. The handle region 197 may be perpendicular to the platform 160 or may be inclined to extend toward the receiving portion 176. The hook may also include a catch segment 201 extending from the bend region 199. The catch segment may be disposed perpendicular to the handle region 197. In this example, the catch segment 201 extends at an acute angle relative to the handle 197. For example, the catch segment 201 may be disposed at an angle of 35-40° relative to the handle 197.

[0384] When the cannula subassembly 114 is introduced into the base 106, the diaphragm housing 108 (see e.g. Fig. 8A) can contact the catch segment 201 and elastically deform the retainer member 195 so that the catch segment 201 bends to avoid the obstacle. After the cannula subassembly 114 is advanced into the receptacle 176 beyond a certain point, the engagement surface of the diaphragm housing 108 can pass through the end of the catch segment 201. At this point, the catch segment 201 can be free to rebound from its deflected position. The catch segment 201 may include at least a portion that, once rebounded to its unpressurized state, cantilevers out over the engagement surface of the diaphragm housing 108. Therefore, the catch segment 201 can prevent the cannula subassembly 114 from being removed from the base 106. The engagement surface of the diaphragm housing 108 can be any suitable engagement surface on any portion of the cannula subassembly 118. For example, the engagement surface can be a recess 186 in the diaphragm housing 108 (see, for example, Figure 5A ), the wall of the opening in the diaphragm housing (see e.g. Figure 6 The connector needle passage 222 of the diaphragm housing 108, the wall of the narrow slot 390 included in the diaphragm housing 108, or the convex corner 388 included as part of the diaphragm housing 108.

[0385] Reference now FIG. 29A to FIG. 29D , various views of an example embodiment of a cannula subassembly 114 are shown. The example 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, the slot 390 being recessed into a top surface 394 of the side wall 392. When installed into the cannula subassembly 114, the septum retainer 112 can block access to the sides of the septum 110 in an area near the top surface 394 of the septum housing 108. An area of ​​the septum 110 between the septum retainer 112 and the end of the slot 390 can be exposed for inclusion of a prong 482 (e.g., see FIG. 4 ) on the tube connector 368. Fig.15D ) provides an entrance. The end of the slot 390 can be a cantilevered protrusion 180 (see, for example, Figure 4A ) or retainer member 195 (see, for example, Fig.28A ) provides an engagement surface that can capture the cannula subassembly 114 within the infusion set base 106.

[0386] As shown, the cannula 104 and the diaphragm housing 108 are FIG. 29A to FIG. 29D 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 tip guide section 216 that may be continuous with the wall of the lumen 202 of the cannula 104. During assembly, the insertion tip guide section 216 may help position the insertion tip 132 (e.g., see Figure 1A ) is guided into the lumen 202 of the cannula 104. The enlarged end region 215 can also include a septum interface region 183 on which a corresponding portion 185 of the septum 110 can be seated. The septum interface region 183 can surround the insertion tip guide section 216. The septum interface region 183 can contact the corresponding portion 185 of the septum 110 and provide a sealing surface against which the septum 110 can be pressed to form a fluid-tight seal when the cannula subassembly 114 is assembled.

[0387] Depending on the embodiment, the septum interface region 183 can have a variety of different geometric shapes. In this example, the septum interface region 183 can have a substantially straight wall portion 187 along the section farthest from the outlet of the cannula 104. The straight wall portion 187 can extend substantially parallel to the long axis of the cannula 104. The straight wall portion 187 can transition to a frustoconical shaped portion 189 that widens as the septum interface region 183 extends toward the outlet 212 of the cannula 104. In alternative embodiments, the entire septum interface region 183 can be straight-walled (e.g., see Fig.31E ), or it may be in the shape of a truncated cone.

[0388] A recess 214' may be included on the surface of the expanded portion 215 surrounding or at least partially surrounding the cannula 104. In an exemplary embodiment, the recess 214' is generally shaped in the form of a conical section (e.g., a hyperbola or a parabola) that is rotated around the central axis of the cannula 104. The diaphragm housing 108 includes a passage 399 that extends through the bottom wall 395 of the diaphragm housing 108. A cannula seat 401 may also be included in the diaphragm housing 108, which can be an elevated wall or column surrounding the passage 399. The recess 214' in the expanded portion 215 of the cannula 104 can accommodate at least a portion of the cannula seat 401 and can help position and hold the cannula 104 in place within the cannula subassembly 114. The bottom surface 217 of the expanded portion 215 (closest to the outlet 212 of the cannula 104) can be placed against the bottom wall 395. When the cannula assembly 114 is assembled, the cannula 104 can extend through the passage 399 so that the outlet 212 is located outside the diaphragm housing 108. There can be a volume between the outside of the cannula 104 and the sidewalls of the passage 399. If the infusion set 102 or a part of the patient's body causes a force to be applied to the cannula 104, this volume can provide space for the cannula 104 to shift relative to the base 106. This can minimize shearing effects on the cannula 104. In addition, this volume can be used as a volume in which a reagent can be placed. For example, a volume similar to the cannula 104 can be used. Figure 5B Any related reagents.

[0389] As shown, the diaphragm 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 spherical slice in which the relative spherical cap has been removed. In other embodiments, other rounded volumes that are generally spherical or lack straight sidewalls may be used. This shape can help ensure that a relatively large fluid introduction volume 109 is present even in the event of volume skew, which can occur when the diaphragm 110 is compressed during assembly of the cannula subassembly 114. In addition, this shape can allow for a larger fluid introduction volume 109 without changing the size of the expanded portion 215 of the cannula 104. This can cause the fluid introduction volume 109 to become a larger target for the tip 482 of the tubing kit connector 368 (e.g., see FIG. 15A to FIG. 16C ). Thus, components of the infusion set 102 or tubing set connector 368 may be constructed with looser tolerances, thereby simplifying manufacturing.

[0390] Now also refer to FIG. 30A to FIG. 30B , two example cannula embodiments are shown. In some embodiments, there can be a fluid introduction volume reinforcement 107 at the end of the expanded region 215 farthest from the outlet 212 of the cannula 104. The reinforcement 107 can extend into the fluid introduction volume 109 and can abut the sidewalls of the fluid introduction volume 109. When the diaphragm 110 is compressed, the reinforcement 107 can prevent the fluid introduction volume 109 from tilting. The reinforcement 107 can include a passage 105, which can be aligned with the narrow groove 390 (e.g., see Fig.29C ) or connector pin access (see, for example, Figure 6 ) alignment. This can allow the tubing set connector 368 to be aligned with the infusion set base 106 during the process of connecting the tubing set connector 368 to the infusion set base 106. Fig. 15C ) forms a path through the reinforcing body 107 and into the fluid introduction volume 109 (for example, see Fig. 15C ). As shown, the passage 105 can be an opening (rounded in this example, but can be any suitable shape) or a slot. Such a reinforcement 107 can be included on any of the cannulas 104 described and / or shown herein.

[0391] Reference now FIG. 31A to FIG. 31G , another exemplary cannula assembly 114 is shown. FIG. 29A to FIG. 29DAs shown, the example cannula subassembly 114 includes a cannula 104 and a septum housing 108, which are separate discrete components (although in alternative embodiments, they can be integral with each other). The cannula 104 can have an enlarged region 215 that includes a septum interface region 183 surrounding an insertion tip guide 216 of the cannula 104. When assembled, a corresponding portion 185 of the septum 110 can be seated against the septum interface region 183. The enlarged region 215 can also include a flange 219 that can be disposed at the end of the enlarged region 215 that is closest to the outlet 212 of the cannula 104. As shown in FIG. Fig.31E As shown, the bottom wall 395 of the diaphragm housing 108 can include a seat for the cannula 104. In this example, the seat is shown as a receiving portion 393, and the flange 219 can be seated in the receiving portion 393. The receiving portion 393 can help center the cannula 104 within the diaphragm housing 108.

[0392] A recess 214' may be included in the face of the enlarged portion 215 surrounding or at least partially surrounding the cannula 104. In an exemplary embodiment, the recess 214' is generally shaped in the form of a conical section (e.g., a hyperbola or parabola) rotated about the central axis of the cannula 104. The diaphragm housing 108 includes a passage 399 that extends through the bottom wall 395 of the diaphragm housing 108. The walls of the passage 399 may be angled or contoured to match and form a continuation of the recess 214'. This may create a volume that may be filled with a reagent (described elsewhere herein) and / or may allow some movement of the cannula 104 relative to the infusion set base 106. The receptacle 393 (or other seat) may surround the passage 399.

[0393] The diaphragm housing 108 may include a plurality of protrusions 391 ( Fig.31F 104 ), the protuberances 391 extend from the wall of the receiving section 192 of the diaphragm housing 108 toward the elongated axis of the cannula 104. In the exemplary embodiment, these protuberances 391 are in the form of substantially straight ridges or ribs. Each protuberance 391 can have the same length, or the length of at least one of the protuberances 391 can be different from the length of at least one of the other protuberances 391. In some embodiments, the end of the protuberance 391 farthest from the outlet 212 of the cannula 104 can be sloped or curved (e.g., Fig.31F390 in the example shown). Each connector needle passage 222 (an aperture in the example shown, but in an alternative example where a slot 390 is present in the septum housing 108, it could be a slot 390) can be flanked by a protrusion 391 that can extend directly adjacent each side of the connector needle passage 222. When the septum 110 is installed in the septum housing 108, the protrusions 391 can contact the septum 110 (or, in an embodiment having multiple septa 110, contact at least one of the septa 110). The space between the protrusions 391 can provide a volume into which material of the septum 110 can be squeezed when the cannula subassembly 114 is assembled and the septum 110 is compressed. The septum retainer 112 also includes a set of protrusions 391' included on a cantilevered protrusion 188 extending from the body 206 of the septum retainer 12. When cannula subassembly 114 is fully assembled, protuberances 391, 391' can contact septum 110 and provide additional compression to septum 110 to further enhance the robustness of the fluid-tight seal formed by septum 110. These protuberances 391, 391' can also allow for less stringent tolerances to be used to help simplify manufacturing.

[0394] Reference now FIG. 32A to FIG. 32D , another example cannula subassembly 114 is shown. The example cannula subassembly 114 includes a septum holder 112 that includes a channel 218 that is substantially centrally disposed in the body 206 of the septum holder 112. A nub 220 of the septum 110 may protrude into the channel 218 and may partially extend through the channel 218. The diameter of the nub 220 of the septum 110 may be slightly larger than the diameter of the channel 218. Thus, the nub 220 may be compressed by the channel 218. In addition, the diameter of the channel 218 may extend over a majority or a major portion of the diameter of the body 206 of the septum holder 112. This may distribute the compression applied by the wall of the channel 218 over a relatively large amount of the septum 110 material. As a result, compressive stress relaxation of the septum 110 material may be reduced over the shelf life of the insert assembly 100.

[0395] Prior to using the insert assembly 100, the insertion tip 132 of the insert assembly may be extended through the nub 220 (see, e.g., Fig.74B ). The septum 110 may be completely self-sealing after the insertion tip 132 is removed and may thereafter be leak-proof. In some examples, the average width or diameter of the nub 220 may be selected such that the diameter of the insertion tip 132 is 10% smaller than the average width of the nub 220. This may further help reduce stress relaxation of the septum 110 material during storage while the insert assembly 110 awaits use.

[0396] As shown, the channel 218 may include side walls that are primarily straight and extend parallel to the elongated axis of the cannula 104. Therefore, the compression applied by the side walls of the channel 218 to the tumor 220 may be primarily perpendicular to the elongated axis of the cannula 104. This can maximize the compression applied by the channel 218 toward the puncture path of the insertion tip 132. In addition, by reducing the compressive stress relaxation of the septum 110, the septum 110 material can maintain a greater degree of elasticity. Therefore, FIG. 32A to FIG. 32D The passage 218 can help prevent leakage at pressures even exceeding those expected during use. FIG. 15A to FIG. 16C and Fig.17 Other potential benefits are described.

[0397] The exemplary diaphragm retainer 112 may also include one or more protrusions 221 that rise from an exposed surface of the diaphragm retainer 112 that at least partially surrounds the channel 218. In some embodiments, the entire channel 218 may be surrounded. In an exemplary embodiment, the protrusion 221 is included as part of a serrated wall surrounding the channel 218. In this example, only two merlons and associated crenels are shown. The merlons may be arranged relative to each other around the channel 218. In other embodiments, any suitable number of crenels may be included, and the crenels may or may not be spaced at regular angular intervals. In this example, at least one protrusion 221 extends substantially perpendicular to the body 206 of the diaphragm retainer 112. In other embodiments, the at least one protrusion 221 may extend toward the axis of the channel 218, or have a portion extending toward the axis of the channel 218.

[0398] Now also refer to FIG. 33A to FIG. 33D In some examples, the channel 218 can be completely surrounded by the protrusion 221, and at least a portion of the protrusion 221 is angled toward the axis of the channel 218. Therefore, the protrusion 221 can block all but a small portion of the tumor-shaped portion 220. FIG. 33A to FIG. 33D The protrusion 221 in the septum 212 forms a cap or cover on the protuberance 220 and may be referred to herein as a cap or cover of the septum holder 112. The portion of the protrusion 221 farthest from the outlet 212 of the cannula 104 is substantially planar and oriented perpendicular to the axis of the passage 218. In some examples, the wall adjacent to the protuberance 220 of the protrusion 221 may include one or more similar Fig.31F The protuberance 391 described in .

[0399] During assembly of the cannula subassembly 114, when the nub 220 of the septum 110 is compressed, the material may have a tendency to "mushroom" as it passes through the passage 218. The protrusions 221 can help prevent such "mushrooming" and force the septum 110 material toward the puncture path of the insertion tip 132 (e.g., see FIG. 21). Fig.74B ). This can help the cannula subassembly 114 resist leakage even under pressures exceeding those expected during use. FIG. 15A to FIG. 16C and Fig.17 Other potential benefits are described.

[0400] Reference now FIG. 34A to FIG. 34F , another example cannula subassembly 114 is shown. As shown, the cannula subassembly 114 includes a cannula 104 and a septum housing 108. FIG. 34A to FIG. 34F The illustrated embodiment does not include a diaphragm retainer 112 (see, for example, Fig.32A ). This can reduce the number of parts and help simplify the manufacture of the cannula assembly 114.

[0401] The exemplary cannula 104 includes an enlarged region 215 including a septum interface region 183 surrounding an insertion tip guide 216 of the cannula 104. When assembled, the corresponding portion 185 ( FIG. 34A to FIG. 34F The diaphragm is not shown, see e.g. Fig.32D ) can be seated against the diaphragm interface area 183. The expanded area 215 can also include a flange 219 extending outwardly. The surface of the flange 219 farthest from the cannula outlet 212 can include a recess 223 that can receive the end of the diaphragm 110. The recess 223 can also include a contoured surface that can help center or position the diaphragm 110 in the cannula subassembly 114. The opposing surface of the flange 219 can include a set of recesses 214A, 214B. The recess 214A can provide space for the portion of the cannula 104 extending from this surface to move relative to the infusion set base 106, thereby minimizing shear effects on the cannula 104. As described elsewhere herein, a reagent can be provided in either recess 214A, 214B.

[0402] A plurality of cantilever arms 231 may be included at the periphery of the flange 219. A terminal protuberance or latching member 233 may be included at the unsupported end of each cantilever arm 231. Thus, the cantilever arms 231 may be referred to as latching arms. During assembly, the latching member 233 of each cantilever arm 231 may slide within a corresponding guide 208 for the arm 231 included on the inner surface of the receiving section 192 of the diaphragm housing 108. The guide 208 shown is recessed into the inner surface of the receiving section 192 of the diaphragm housing 108. When the latching member 233 is located within the guide 208, the cantilever arm 231 may be elastically deflected toward the elongated axis of the cannula 104. When the diaphragm housing 108 and the cannula 104 are displaced toward each other over a certain distance, the latching member 233 may leave the guide 208 and pass through an orifice 235 included in the diaphragm housing 108. This can allow the cantilever arms 231 to elastically recover and spring outwardly so that the latch member 233 on each cantilever arm 231 forms a latching engagement with the catch outlet 210 defined by the holes in the aperture 235. In an exemplary embodiment, the cannula 104 includes a set of four cantilever arms 231. The cantilever arms 231 are also spaced apart from each other at substantially regular angular intervals, although this is not required in all exemplary embodiments. In other embodiments, a greater or lesser number of cantilever arms 231 may be included. The aperture 235 in this example is a recess that is recessed into the first end wall 241 of the diaphragm housing 108 and partially recessed into the side wall 243 of the diaphragm housing 108. When the cannula 104 is coupled to the diaphragm housing 108, the first end wall 241 can close one end of the diaphragm housing 108, and the flange 219 of the cannula 104 can close the second end of the diaphragm housing 108. When the cannula subassembly 114 is assembled, the septum 110 (not shown) can be captured within the septum housing 108 between the flange 219 and the first end wall 241. The first end wall 241 may include a channel 218' extending therethrough that receives the nub 220 of the septum 110 (e.g., see Fig.32D ).

[0403] As shown, the flange 219 may also include a plurality of flange members 237 that may extend outwardly from the periphery of the flange 219. When the cannula subassembly 114 is assembled, the flange members 237 may provide a retention interface that may, for example, engage with a cantilevered protrusion 180 (e.g., see FIG. 104 ) of the infusion set base 106. Figure 4A ) engages with the protrusion 182 on the flange member 237. Thus, the flange member 237 can help connect the cannula subassembly 114 to the infusion set base 106. The diaphragm housing 108 can include a recess 245 adjacent to at least one of the flange members 237.

[0404] Reference now FIG. 35A to FIG. 35F and FIG. 36A to FIG. 36E, other exemplary cannula subassembly 114 embodiments are shown. The ear 204 extending from the main portion of the exemplary diaphragm housing 108 may include a wedge-shaped body 205. Such a wedge-shaped body 205 may be included on the ear 204 of any other cannula subassembly 114 shown and described herein. The wedge-shaped body 205 may be disposed on the portion of each ear 204 farthest from the outlet 212 of the cannula 104, and may be disposed on opposite sides of the ear 204 relative to each other. The thickness of the wedge-shaped body 205 may decrease as the distance from the outlet 212 of the cannula 104 decreases. The wedge-shaped body 205 may extend from the sidewall 207 of the diaphragm housing 108.

[0405] In addition, 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 on other cannula subassemblies 114 shown and described herein. The extension 209 may be tapered so that the width of the extension 209 decreases as the outlet 212 of the cannula 104 is approached. When the cannula subassembly 114 is displaced into the infusion set base 106, the taper on the extension 209 may help guide the cannula subassembly 114 into the recess 174 of the infusion set base 106 (e.g., see Figure 4A ). In some examples, the end of the main portion 211 of the extension farthest from the ear 204 can be tapered and thus can be sacrificial. In the event that the extension 209 is too long (e.g., due to tolerances), the sacrificial portion of the extension 209 may deform when displaced into an interfering structure of the base 106. Thus, even with relatively loose tolerances, the sacrificial portion of the extension 209 can allow the cannula subassembly 114 to be coupled to the base 106 without problems. The wedge-shaped body 205 can help ensure that the cannula subassembly 114 is tightly retained within the recess 174 during assembly (e.g., see Figure 4A ), and helps center the cannula subassembly 114 within the receiving portion 176 (see, for example, Figure 4A The wedge-shaped body 205 can allow for less stringent manufacturing tolerances for the recess 174 and / or the diaphragm housing 108 while minimizing the likelihood that the cannula subassembly 114 will have wiggle room when retained within the receptacle 176 (see, e.g., Figure 4A The wedge-shaped body 205 may also help guide the cannula subassembly 114 into place during assembly into the base 106 .

[0406] Still refer to FIG. 35A to FIG. 36E and FIG. 37A to FIG. 37BIn some embodiments where the cannula 104 and the diaphragm housing 108 are separate components, a plurality of diaphragms 110A, 110B may be included. In other embodiments, a plurality of diaphragms 110 may also be included. Exemplary diaphragms 110A, 110B may each be made of the same or different materials and / or durometer materials. The cannula 104 may include, for example, a reference FIG. 31A to FIG. 31G The enlarged area 215 and the flange 219 described. The flange 219 can be captured between each diaphragm 110A, 110B in a fluid-tight manner. In an exemplary embodiment, the first diaphragm 110A can include a fluid introduction volume 109 and can include a corresponding portion 185 that seats against the diaphragm interface area 183 of the cannula 104. The second diaphragm 110B can be arranged opposite to the first diaphragm 110A. The second diaphragm 110B can include a protrusion section 113 that extends into the passage 399 of the diaphragm housing 108. The hole 115 can be included in the central area of ​​the protrusion section 113. The cannula 104 can extend through the hole 115 (at FIG. 37A to FIG. 37B 104 ) to the exterior of the cannula subassembly 114. The hole 115 can also seal the surface of the cannula 104. Since the material of the septum 110B can be an elastomer, the septum 110B can allow the cannula 104 to move relative to the infusion set base 106, thereby minimizing the shearing effect on the cannula 104.

[0407] Main references FIG. 37A to FIG. 37B , respectively showing FIG. 35A to FIG. 35F and FIG. 36A to FIG. 36E 104. At least one of the septa 110A, 110B may include a peripheral rim 117 on a side of the septa 110A, 110B that is closest to the opposing septum 110A, 110B. When the cannula subassembly 114 is assembled, the peripheral rim 117 may form a fluid-tight seal and extend near the edge of the flange 219 of the enlarged portion 215 of the cannula 104. The peripheral rim 117 may also surround a receiving area of ​​the septa 110A, 110B in which the septa 110A, 110B are included. During assembly, the receiving area may receive the flange 219 of the cannula 104.

[0408] Reference now FIG. 38A to FIG. 38E and FIG. 39A to FIG. 39E, a further exemplary cannula subassembly 114 embodiment is shown. As shown, the cannula subassembly 114 includes a plurality of diaphragms 110A, 110B. In the exemplary embodiment, the first diaphragm 110A is cup-shaped. The second diaphragm 110B is also cup-shaped, but when the diaphragms 110A, 110B are installed in the receiving portion 192 of the diaphragm housing 108, the second diaphragm 110A is inverted relative to the first diaphragm 110A. As with any other cannula assembly 114 shown and described herein, the receiving portion 192 of the diaphragm housing 108 may include a protuberance 391 (described above in conjunction with FIG. 31A to FIG. 31G Further description)

[0409] exist FIG. 38A to FIG. 39E In the example shown, the second septum 110B is sized to nest 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 with the outer wall of the second septum 110B. The second septum 110B can seal against the septum interface portion 183 of the expanded area 215 of the cannula 104. The flange 219 of the cannula 104 can be captured between the two septa 110A, 110B in a fluid-tight sealed relationship (e.g., see FIG. 38A to FIG. 38E Alternatively, the second diaphragm 110B may include a recess 119 defined on the inner wall of the cup-shaped portion of the diaphragm 110B (see, for example, FIG. 39A to FIG. 39E ). When the cannula subassembly 114 is assembled, the flange 219 of the cannula 104 can be located within the recess 119, and the recess 119 can establish a fluid-tight seal against the flange 219. The first septum 110A can include a protrusion section 113 that protrudes into the passage 399 defined in the septum housing 108. The cannula 104 can extend through the hole 115 in the protrusion section 113 and extend out of the septum housing 108. The elastic material of the septum 110A can allow displacement of the cannula 104 relative to the infusion set base 106 and minimize any potential shear on the cannula 104 during use.

[0410] Reference now FIG. 40A to FIG. 40CIn some embodiments, the flange 219 may extend from the cannula 104 in a non-radial manner and may not be substantially planar. The flange 219 may 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 non-linear in an alternative example) relationship. Thus, the flange 219 may be in the shape of a truncated cone of a hollow cone. In other embodiments, the relationship from the outlet 212 to 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 diaphragm 110A and the second diaphragm 110B may include matingly angled or contoured surfaces that mate against opposite sides of the flange 219 to form a fluid-tight seal. The second diaphragm 110B may include a raised section 113 having a hole 115 therein through which the cannula 104 may extend. The flange 219 can establish a ball-and-socket type relationship with the septum 110A, 110B to allow greater movement of the cannula 104 relative to the rest of the infusion set 102 while maintaining a secure seal. This ball-and-socket type arrangement between the cannula 104 and the septum 110A, 110B can be used in any embodiment in which the cannula 104 is not integrally formed with the septum housing 108.

[0411] Various embodiments of the infusion set base 106, the tubing set connector 368, and the cannula subassembly 114 are described herein. Although certain features of these components may be described in the context of specific example embodiments, the scope of the present disclosure is not limited in this regard. 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. In addition, any of the tubing set connectors 368 described herein may also be configured as a cap that does not include a prong 482 (e.g., see FIG. 4 ). Fig.15D ), attached infusion tube 366 (see, for example, Figure 6 ) and / or any flow passages, tube receiving portion 512 (e.g., see Fig.190 ), adhesive introduction opening 520 (see, for example, Fig.190 Such a cap may be placed on the infusion set assembly 104 when the infusion set assembly 102 is not connected to the tubing set connector 368 (e.g., when the infusion pump is disconnected during a bath).

[0412] Reference now Fig.41A and Fig.41B , two side views of the insert assembly 100 are shown. Fig.41B The insert component 100 in Fig.41A The orientation in is rotated 90° clockwise. The example insert assembly 100 is Figure 1A 100 . The two views can represent the appearance of the insert assembly 100 before use and after the insert assembly 100 has been removed from its shipping / storage packaging. As shown, the outer shell 116 of the insert assembly 100 is visible and the locking member 146 is in place. In addition, there is an adhesive backing 111 and covers the adhesive layer on the bottom surface 162 present on the infusion set base 106. The adhesive backing 111 can include a gripping area 224, which can be a flange, a tab or other protrusion of the backing material extending beyond the occupied area of ​​the insert assembly 100. The gripping area 224 can be gripped by the user and used to peel the adhesive backing 111 from the infusion set 106. Once the backing 111 has been removed, the insert assembly 100 can be placed against the desired infusion site using the raised ribs 118 to help align. The locking member 146 can then be pulled out of the insert assembly 100 to allow the insert assembly 100 to be actuated. When the example adhesive backing 111 is attached to the locking member 146, the extraction of the locking member 146 can complete the disassociation of the adhesive backing 111 from the insert assembly 100. If the user is not satisfied with the position where the insert assembly 100 has been placed, the user can leave the locking member 146 in the insert assembly 100 and pull the insert assembly 100 away from the body. The presence of the locking member 146 can prevent actuation when this occurs and can allow the user to select another infusion site.

[0413] Now also refer to Fig.42A and Fig.42B , showing two additional views of the insert assembly 100. The exemplary adhesive backing 111 includes a strip 225 extending from a portion of the adhesive backing 110 that covers the adhesive layer present on the bottom surface 162 of the infusion set base 106 (see, for example, Figure 43 to Figure 45 ). In some embodiments, strip 225 can extend substantially parallel to and adjacent to gripping region 224 of adhesive backing 111. Fig.42A and Fig.42BIn the example shown, the adhesive backing 111 is connected to the outer shell 116 of the insert assembly 100, rather than the locking member 146. The length of the strip 225 can be greater than the height of the insert assembly 100. Therefore, the terminal area 227 of the strip 225 can be connected to the top surface of the outer shell 116. For example, the terminal area 227 can be attached by hot melt stakes, welding (such as sonic welding) or adhesives (such as double-sided tape or other adhesives). The terminal area 227 can be connected to a spot that does not block the view of any raised alignment ribs 118 present on the top surface of the outer shell 116. In some embodiments, the strip 225 can also be attached to other parts of the insert assembly 100 (such as the side surface of the outer shell 116 and / or the locking member 146). In other embodiments, the length of the strip 225 can be different, and the terminal area 227 can be connected to another part of the insert assembly 100 (such as the side surface of the outer shell 116 or the locking member 146).

[0414] Reference now Figure 43 to Figure 45 , an exemplary adhesion component 602 is shown. Figure 43 to Figure 45 The exemplary adhesive assembly 602 shown in FIG. FIG. 42A to FIG. 42B The method shown is mounted on the insert assembly 100. Fig.43 In the example embodiment, the adhesive assembly 602 is shown with the infusion set base 106. The infusion set base 106 is not shown. Figure 44 to Figure 45 In some examples, the infusion set base 106 can be installed into the insert assembly 100, and then the adhesive assembly 602 can be coupled to the base 106.

[0415] As shown, the adhesive assembly 602 may include a liner 111 or backing. The liner 111 may cover and protect an adhesive patch 614 attached to the infusion set base 106. The liner 111 may be made of any suitable material, such as a polymer or wax paper, and may be removed from the infusion set base 106 before using the insert assembly 100 including the base 106. Optionally, the adhesive assembly 602 may include an adhesive body 616 that is separated from the adhesive patch 614 on another area of ​​the liner 111. The adhesive body 616 may be used to couple the liner 111 to a portion of the insert assembly 100, such as the outer housing 116 of the insert assembly 200 or the flange 152 of the locking member 146.

[0416] As shown, the liner 111 can have a substantially flat and elongated shape (e.g., die cut, laser cut, etc. from a larger sheet of material), but can also be flexible and bend or fold for routing, such as FIG. 42A to FIG. 42BAs shown. One end of the liner 111 may include an expanded area 604. The expanded area 604 may be an adhesive patch covering a section of the liner 111, which may cover the adhesive of the adhesive patch 614 attached to the infusion set base 106. The expanded area 604 and the adhesive patch 614 may have a footprint that is at least partially rounded, which is aesthetically preferred. The liner 111 may also include an attachment or strip portion 611, which may extend from the expanded area 604 to the opposite end of the liner 111. The strip portion 611 may be substantially straight and, although not required, may have a generally uniform width. The end opposite to the expanded area 604 may be rounded. The width of the strip portion 611 may be less than the width of the expanded area 604. The length of the strip portion 611 may be greater than the height of the insert assembly 100.

[0417] The liner 111 may also include a tab or fin 610. The fin 610 may be connected to the enlarged region 604 at a first end. The fin 610 may extend in a direction substantially parallel to the strip portion 611 to a second end opposite the first end. The fin 610 may extend directly to near the portion of the strip portion 611 closest to the rounded region 604. This may make the liner 111 appear compact and help save material during manufacturing.

[0418] The exemplary adhesive patch 614 can be composed of a substrate carrying a skin-compatible adhesive on one side thereof. The adhesive patch 614 can include a main area 620 and a protruding area 622. The main area 620 can be flat and rounded and can have a larger footprint than the infusion set base 106 to which it is attached. The protruding area 622 can extend from the periphery of the main area 620 and partially extend along the strip portion 611 of the liner 111. The segment closest to the expanded area 604 in the strip portion 611 can cover the adhesive on the protruding area 622. When the infusion set base 106 is attached to the infusion site, the protruding area 622 can be used as a removal tab, which can facilitate the adhesive patch 614 and the infusion set base 106 to be peeled off from the infusion site.

[0419] The adhesive patch 614 may be attached to the bottom surface 162 of the infusion set base 106 in any suitable manner (e.g., see Figure 4B ). In some examples, such as Fig.44 As shown, double-sided tape 606 or other adhesive may be used to couple adhesive patch 614 to base 106. In alternative embodiments, adhesive patch 614 may include a substrate that may be heat-riveted or welded (e.g., ultrasonic, RF) to bottom surface 162 of base 106. Adhesive patch 614, liner 111, and any double-sided tape 606 may include apertures extending therethrough.

[0420] Main references Fig.45, the liner 111 may include a divider that separates a portion of the liner 111. In an exemplary embodiment, a slit 608 extending through the liner 111 is included, but alternatively, perforations and / or scores may be used in place of the slit 608. In an exemplary embodiment, a single slit 608 is used that extends through a portion of the enlarged area 604. The slit 608 may be oriented to facilitate peeling of the liner 111 from the adhesive patch 614 in a single piece and limit the possibility of forming high stress areas in the liner 111 when the liner 111 is removed. The shape of the aperture 612 of the liner 111 may also be selected to facilitate this.

[0421] The orientation of the slits 608 and the shape of the orifices 612 can facilitate easy, quick, and complete removal of the liner 111 from the adhesive patch 614. This can be the case even if the user vigorously removes the liner 111 or only roughly / loosely follows the prescribed removal motion when peeling the liner 111 from the adhesive patch 614. In addition, the orientation of the slits 608 and the shape of the orifices 612 can facilitate the use of a wider range of materials for the liner 111.

[0422] As shown, the slit 608 can extend from a point between the first end of the fin 610 and the strip portion 611 of the liner 111. The slit 608 can extend to the orifice 612 in the liner 111. The slit 608 can be angled so as to be tangent to the edge wall of the orifice 612. The slit 608 can extend along a straight line. The slit 608 can be angled so that the slit 608 is tangent to the far side of the orifice 612 relative to the fin 610. The orifice 612 can be configured to have a minimum number of corners or regions in which the sidewalls of the orifice 612 otherwise extend from one direction to another different direction. As shown, the sidewalls of the orifice 612 include a first rounded span 624 and a second rounded span 626 relative to each other. These spans 624, 626 can be the only spans of the orifice 612 wall where the wall is redirected. The first rounded span 624 can have a tighter curvature (e.g., a smaller radius) than the second rounded span 626. The aperture 612 can also include two substantially straight sidewall spans 628 that connect the first and second rounded spans 624, 626. The transition between each of these spans 624, 626, 628 is gradual. The first rounded span 624 can be closer to the fin 610 than the second rounded span 626. The slit 608 can end at a point tangent to the first rounded span 624. In some embodiments, the slit 608 can be co-linear with one of the straight sidewall spans 628 of the aperture 612.

[0423] When the liner 111 is unfolded from the adhesive patch 614, the example liner 111 can be redirected around a portion of the orifice 612. In an exemplary embodiment, when the liner 111 is peeled off from the adhesive patch 614, the liner 111 can turn around the second rounded span 626 of the orifice 612. Since the second rounded span 626 has a gentler curvature (e.g., a wider radius), the turn made by the liner 111 can be relatively gentle. This can reduce the chance of high stress points in the liner 111 during the removal process. In addition, the shortest distance between the point on the second rounded span 626 and the periphery of the liner 111 can be shorter than the longest distance between the peripheral edge of the liner 111 and any other part of the orifice 612. As a result, during the removal of the liner 111, in the area where the liner 111 turns around the orifice 612, a relatively small surface area of ​​the liner 111 can be attached to the adhesive patch 614. Due to the lower surface area, the liner 111 may be least firmly or relatively weakly adhered to the adhesive patch 614 in this area. This can further help limit the stress on the liner 111 material when the liner 111 is peeled from the adhesive patch 614 around the second rounded span 626.

[0424] When the liner 111 is deployed about the orifice 612, the orientation of the slits 608 can help ensure that the only portion of the liner 111 that adheres to the adhesive patch 614 is disposed before the partition in which the liner 111 is disassociated from the adhesive patch 614. Thus, the direction of pull by a user to remove the liner 111 need not be significantly different from the direction of the lagging portion of the liner 111. This can prevent the creation of high stress points on the liner 111 material, where areas lagging behind the partition in which the liner 111 is disassociated from the adhesive patch 614 remain attached to the adhesive patch 614.

[0425] When the 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 far side of the orifice 612 may be preferred because it helps to allow the liner 111 to be easily and integrally removed. The orientation of the slit 608 can help the user to naturally peel the liner 111 along the extending direction of the slit 608. The straight-line pull of the liner 111 along this direction can substantially inhibit the formation of stress points at the edge of the liner 111 along the second rounded span 626. When the liner 111 is disassociated from the adhesive patch 614 around the second rounded span 626, the situation in which the user pulls the liner 111 in a direction that is significantly different from the direction of the adjacent downstream portion of the liner 111 can be avoided. Therefore, the area of ​​the liner 111 redirected around the second rounded span 626 can be more easily peeled off from the adhesive patch 614.

[0426] Now also refer to FIG. 46A to FIG. 47, depicting various views of the insert assembly 100 with the outer housing 116 removed and views of the locking member 146 in isolation ( Fig.47 ). As shown, when in place within the insert assembly 100, the locking member 146 can act as a safety device. The insert assembly 100 can be designed so that the insert assembly 100 cannot be started (fired) before the locking member 146 has been removed. The locking member 146 can extend across the entire width of the inner housing 120 and be located above the other components of the insert assembly 100. The locking member 146 can be directly adjacent to at least one of the other components to prevent its movement.

[0427] The locking member 146 may include a flange 152 that may be grasped to aid extraction. The locking member 146 may also include a stem 226 and attachments that protrude away from the flange 152. The stem 226 may support a plurality of arms 228, 230. In an exemplary embodiment, the arms 228, 230 are arranged in an "H"-shaped pattern, and the stem 226 is connected to the arms 228, 230 via the crosspiece of the "H". The arms 230 may be located in the opening 150 of the inner housing 120 farthest from the flange 152. The arms 230 may also include a chamfered feature 232 that may help guide the locking member 146 during installation of the locking member 146 into the insert assembly 100.

[0428] As shown, the arms 228 can be cantilevered so as to be able to deflect inwardly toward the stem 226. The distance between the outer edges of the arms 228 can be greater than the width of the opening 150 through which the outer edges of the arms 228 pass when the locking member 146 is installed in the insert assembly 100. During installation, the arms 228 can be deflected toward the stem 226 to allow the arms 228 to pass through the opening 150. Once through the opening 150, the arms 228 can spring outwardly to their unstressed state. Thus, as shown in FIG. Fig.46C As best shown, when the locking member 146 is in place, the width between the outer edges of the arms 228 can be wider than the width of the aperture 150. This can ensure that some force may be required to remove the locking member 146 from the insert assembly 100 and can prevent the locking member 146 from being inadvertently driven out. As shown, the arms 228 can include a chamfered area 234. The chamfered area 234 can abut the wall of the aperture 150 of the inner housing 120 closest to the flange 152. During extraction of the locking member 146 from the insert assembly 100, the chamfered area 234 can help deflect the arms 228 toward the stem 226. Although an angled chamfer is shown, a rounded or curved area can be included in alternative embodiments.

[0429] In various examples, at least one component of the insert assembly 100 can include at least one locking member restraining member, such as a raised bumper 238. In an example embodiment, the bumper 238 is included on the needle retractor 134 and extends from the top plate 328 of the needle retractor 134. The raised bumper 238 can be located on the side of at least a portion of the locking member 146 or positioned next to or near it. Thus, the bumper 238 can prevent any swinging or pivoting of the locking member 146 within the insert assembly 100. If the locking member 146 is introduced into the insert assembly 100 in a curved manner, the bumper 238 can also help redirect the locking member 146 during installation. The bumper 238 can also be provided to limit the depth to which the locking member 146 can be pressed into the insert assembly 100.

[0430] Reference now Fig.48 , showing FIG. 46A to FIG. 47 146 shown in the alternative embodiment of the locking member 146. As shown, the flange 152 of the locking member 146 may include an orifice 151, which may extend through the flange 152. The orifice 151 may be centrally disposed within the flange 152. The cap 153 may be coupled to the locking member 146 by a strand or strip 155 of flexible material. In an exemplary embodiment, a strip 155 of material extending from the periphery of the flange 152 to the periphery of the cap 153 is used. The flexible strand or strip 155 may allow the cap 153 to be displaced relative to the flange 152 when being tied to the flange 152. In other embodiments, the cap 153 may be a separate component. The cap 153 includes a plurality of latch fingers 157 extending from the cap 153. The latch fingers 157 may be arranged to deflect when they are introduced into the orifice 151 via the first side of the flange 152. After being displaced into the aperture 151 over a certain distance, the latch finger 157 can be elastically restored and caught on the opposite side of the flange 152. In some examples, when the cap 153 is engaged with the flange 152, the adhesive liner 111 (e.g., see FIG. 41A to FIG. 41B) can be captured between the cap 153 and the flange 152. Thus, no tape, adhesive, heat fusion, radio frequency welding, ultrasonic welding, etc., may be required to attach the liner 111 to the flange 152. In some embodiments, passages may be included in the liner 111 through which the latch fingers 157 may extend. In other embodiments, passages may not be included, and the liner 111 may be pressed into the orifice 151 when the cap 153 is coupled to the flange 152. In addition, the cap 153 and the flange 152 may include raised sections 154. The raised sections 154 may be spaced apart so as to cross each other when the cap 153 is coupled to the flange 152. This can help to securely hold the liner 111 between the cap 153 and the flange 153. Although a set of straight ridges for the raised segments 154 are shown, other embodiments may include circular raised segments (e.g., concentric circles) that may similarly capture the liner 111 between the cap 153 and the flange 152 when they are coupled. For any other locking member shown or described herein, a cap 153 and an optional strand or band 155 may be included. Any locking member 146 embodiment described herein may be modified to include a laced or separate cap 153.

[0431] Now also refer to Figures 49A to 50 , depicting various views of the insert assembly 100 with an alternative locking member 146 and views of the alternative locking member 146 alone ( Fig.50 ). As described above, when in place within the insert assembly 100, the locking member 146 can act as a safety device, preventing activation until the locking member 146 has been removed. The example locking member 146 extends across a portion of the width of the inner housing 120, but not the entire width, and is positioned above other components of the insert assembly 100 to prevent movement. Fig.49A , the exemplary locking member 146 is also directly adjacent to the arm 296 of the prong retainer 130 and mechanically interferes with displacement of the arm 296 in the general direction of the flange 152. The inner housing 120 may include only one aperture 150 rather than a set of opposing apertures 150.

[0432] The locking member 146 may include a flange 152 that may be grasped to aid extraction. The locking member 146 may also include an appendage 376 that protrudes away from the flange 152. A tine 378 may be included within the appendage 376. The tine 378 is cantilevered to the appendage 376 at a portion of the tine 378 that is farthest from the flange. The tine 378 is also configured to naturally protrude above a face 380 of the appendage 376, but is flexible when a force is applied to the unsupported end of the tine 378. As shown, the unsupported end of the tine 378 includes an inclined region 382. The end of the appendage 376 farthest from the flange 152 may also include a chamfer feature 384 that may help guide the locking member 146 during installation of the locking member 146 into the insert assembly 100. When the locking member 146 is installed into the insert assembly 100, the top wall of the opening 150 can deflect the tines 378 toward the surface of the appendage 376 so that the tines 378 can pass through the opening 150. After the introduction of the locking member 146 is completed, the tines 378 can rebound toward their initial unstressed state. Fig.49B As best shown, a portion of the tines 378 can be disposed above the top wall of the aperture 150 when the locking member 146 is in place. This can ensure that some force may be required to remove the locking member 146 from the insert assembly 100 and can prevent the locking member 146 from being inadvertently driven out. As shown, the inclined section 382 can abut the top wall of the aperture 150. The inclined section 382 can help deflect the tines 378 toward the surface 380 of the attachment 376 during extraction of the locking member 146 from the insert assembly 100. Although an inclined section 382 is shown, a rounded or curved area can be included in alternative embodiments. A similar FIG. 46A to FIG. 47 The locking member restraint feature of the raised bumper 238 shown in FIG.

[0433] Now also refer to Figure 51 to Figure 53 , showing various views of the insert assembly 100 with another alternative locking member 146 and views of the alternative locking member 46 alone ( Fig.53 ). As described above, when the locking member 146 is in place within the insert assembly 100, the locking member 146 can act as a safety device to prevent activation (fire) before the locking member 146 is removed. The exemplary locking member 146 can include a flange 152 that can be grasped to assist in extraction. The locking member 146 can also include an appendage 376 that protrudes from the flange 152. The appendage 376 can include a set of pointed teeth 277 separated by narrow slots 275 at the area of ​​the appendage 376 farthest from the flange 152. As shown in FIG. Fig.52 As shown, the pointed holder 130 (combined Figure 60 to Figure 68Further described) can be symmetrical and include two cantilevered arms 296 of substantially equal height. The slot 275 can accommodate these arms 296.

[0434] The portion of the attachment 376 closest to the flange 152 may include a set of arch members 273. The arch members 273 may be disposed on opposite sides of the attachment 376. There may be an opening 271 between each arch member 273 and the body 279 of the attachment 376. The distance between the outer sides of the arch members 273 may be greater than the width of the opening 150 through which they pass when the locking member 146 is installed in the insert assembly 100. During installation, the opening 271 may allow the arch members 273 to be resiliently deflected toward the body 279 of the attachment 279 so that the locking member 146 can pass through the opening 150. Once through the opening 150, the arch members 273 may return to their unstressed state. This may ensure that some force may be required to deflect the arch members 273 to remove the locking member 146 from the insert assembly 100, and may prevent the locking member 146 from being inadvertently displaced. Alternatively, when fully installed, the arcuate member 273 may not fully pass through the aperture 150, and the arcuate member 273 may be in a deflected state, pressing against the sidewalls of the aperture 150. This may again help ensure that some force may be required to remove the locking member 146, and help prevent inadvertent dislodging. When installed in the insert assembly 100, the edge of the slot 275 closest to the flange 152 may be directly adjacent to the arm 296 of the tine retainer 130. This may help ensure that the cantilevered arm 296 of the tine retainer 130 is securely held in place on the catch 306 of the tine retractor 134 when the locking member 146 is in place.

[0435] Reference now FIG. 54A to FIG. 54B , another example locking member 146 is shown. The example locking member 146 includes an arcuate body 351. An attachment 376 may extend from the arcuate body 351. As shown, the attachment 376 extends from the midpoint of the arcuate body 351. In an exemplary embodiment, the attachment 376 is as shown in FIG. FIG. 46A to FIG. 47100, but any of the attachments 376 shown in the embodiments herein may be used. When the locking member 146 is in place on the insert assembly 100, the attachment 376 can extend into the insert assembly and prevent the triggering of the insert assembly. The arched body 351 can be at least partially wrapped around the outer shell 116 of the insert assembly 100. The end regions 353 of the crescent-shaped body 351 can be tilted to help install the locking member 146 into the insert assembly 100. When the locking member 146 is advanced toward the insert assembly, the tilted end regions 353 can help the insert assembly 100 to be centered relative to the attachment 376. The arched body 351 can be deflected so that the end regions 353 are separated from each other during a portion of installing the locking member 146 into the insert assembly 100. The locking member 146 includes a flange 152, which can be grasped to help pull out.

[0436] The arcuate body 351 may include one or more slots 355. In the exemplary embodiment, two slots are included. The slots 355 may be disposed adjacent to the end region 353 of the arcuate body 351. The slots 355 may be sized such that a portion of the liner 111 may pass through one of the slots 355. The liner 111 may then be coupled to a portion of the insert assembly 100 (e.g., Fig.42A ). In the event that a user attempts to remove locking member 146 before removing liner 111, the portion of liner 111 that passes through slot 355 may prevent locking member 146 from being withdrawn. This may provide a prompt to the user, encouraging the user to remove liner 111 from insert assembly 100 before removing locking member 146.

[0437] Reference now Figures 55 to 56A , another example insert assembly 100 and locking member 146 are shown. As shown, the openings 148, 150 in the outer housing 116 and the inner housing 120 can be respectively configured to provide an introduction path for the locking member 146, which extends between the arms 296 of the tip holder 130. The locking member 146 can include a flange 152, and the appendage 376 extends from the flange 152. At a portion of the appendage 376 opposite the flange, at least one expansion protrusion 257 (see, for example, Figures 56B to 56E, for an example embodiment with a single expansion protrusion 257). In this exemplary embodiment, two expansion protrusions 257 are included, and the two protrusions 257 extend generally parallel to each other, so that the exemplary locking member 146 is substantially symmetrical. The symmetry of the locking member 146 can allow the locking member 146 to be installed in multiple orientations, thereby facilitating assembly. When installed in the example insert assembly 100, the lateral surface of the expansion protrusion 257 can prevent the arm 296 of the tip retainer 130 from deflecting toward the mid-plane of the insert assembly 200. Therefore, the exemplary locking member 146 can keep the arms 296 separated from each other. In some embodiments, when the locking member 146 is installed in the insert assembly 100, the expansion protrusion 257 can contact the arm 296 and press it outward from the mid-plane. This may help ensure that the arm 296 of the tip retainer 130 is held in place on the catch 306 of the tip retractor 134 when the locking member 146 is in place.

[0438] In an exemplary embodiment, the tip retractor 134 includes at least one interference body 255. In an exemplary embodiment, a plurality of interference bodies 255 are included. When the locking member 146 is installed, the interference bodies 255 can be located in the gaps between the expansion protrusions 257. The interference bodies 255 can prevent the expansion protrusions 257 from moving toward each other. In some embodiments, the interference bodies 255 can cause the expansion protrusions 257 to spread apart. The interference bodies 255 can help to securely maintain the arms 296 in engagement with the catch 306 (e.g., see FIG. 1 ). Fig.52 ).

[0439] In an exemplary embodiment, the top plate 328 of the tip retractor 134 includes a bumper 238 (about Fig.46C 146 and a passage through which a portion of the locking member 146 extends. In this example, the passage is defined by the bridge 239. When installed in the insert assembly 100, at least one expansion protrusion 257 can extend below the bridge 239. This can inhibit the tip retractor 134 from moving along the axis of the insert assembly 100 when the locking member 146 is installed, and can help prevent relative displacement of components within the insert assembly 200. In some examples, a portion of the bridge 239 can be received between the expansion protrusions 257 and double as the interference body 255.

[0440] In various examples, the expansion protrusions 257 can each include a deflectable region. In an exemplary embodiment, the expansion protrusions 257 each include a deflectable arm 263. When the locking member 146 is installed in the insert assembly 100, one of the deflectable arms 263 can contact the surface of the bridge 239. The deflectable arm 263 can include a tumor 265, so that further advancement of the locking member 146 toward the installed position can cause the deflectable arm 262 to bend toward the expansion protrusion 257 extending from it. When the locking member 146 reaches the fully installed position, the tumor 265 can be displaced away from the bridge 239, and the deflectable arm 263 can be restored to an undeflected state. When the deflectable arm 263 is restored to the undeflected state, an audible feedback (e.g., a click or a clacking sound) can be generated. When the arm 263 is restored to the non-deflected state, the user can also perceive tactile feedback. The tumor 265 can also prevent the accidental removal of the locking member 146.

[0441] Now also refer to Figures 56B to 56E , a plurality of additional locking members 146 are shown. Each locking member 146 includes a flange 152 from which an appendage 376 extends. A single expansion protrusion 257 is included in each exemplary locking member 146, which protrudes from a portion of the appendage 276 opposite the flange 152. Alternatively, each exemplary locking member 146 can be symmetrical with two substantially parallel expansion protrusions 257. The expansion protrusions 257 of the locking members 146 each include a deflectable region. Figures 56D to 56E The example shown includes a deflectable arm 263 having a nub 265, as described above with respect to Figures 55 to 56A described. FIG. 56B to FIG. 56C The expansion protrusion 257 in the illustrated example embodiment includes a slot 269. The slot 269 can allow an area of ​​the expansion protrusion 257 adjacent to the slot 269 to deflect in the direction of the slot 269. Fig.56C , when the locking member 146 is installed into the insert assembly 100, the knob 265 on the expansion protrusion 257 can contact the surface of the bridge 239. Further advancement toward the installed position can cause a portion of the expansion protrusion 257 adjacent to the slot 269 to bend or deflect inward. When the locking member 146 is in the fully installed position and the deflected portion of the expansion protrusion 257 can freely return to the undeflected state, the knob 265 can move away from the bridge 239. Fig.56B , the knob 265 may abut the arm 296 of the prong retainer 130 that engages the catch 306 (see, e.g., Fig.52 ). When in the fully installed position, the portion of the expansion protrusion 257 adjacent to the narrow slot 269 is bent or deflected inwardly, and the knob-shaped portion can press against the arm 296 to keep the arm 296 engaged with the catch 306.

[0442] Reference now Fig.57 , a flowchart 240 is shown describing a number of example actions that may be performed to place an infusion set 102 on a patient using an inserter assembly 100. Figure 1A Some of the insert components 100 shown can be placed on the skin, and some of the insert components 100 are designed to prevent actuation before the skin has been displaced from its normal static position on the body. For this reason, the insert component 100 may include an actuation limiting device (described elsewhere herein). The actuation of the insert component 100 may be excluded until a certain degree of displacement has occurred in the skin. The actuation of the insert component 100 may be prohibited until a certain amount of relative displacement has occurred between the parts of the insert component 100. When the skin is lifted and the insert component 100 is withdrawn from the body, this relative displacement can be achieved. When the user withdraws the insert component 100, the base 106 of the infusion set 102 may cause the displacement of some parts (for example, at least one part connected to the base 106) to be limited to the skin. When the insert component 100 is withdrawn, the elasticity of the skin can exert force on the base 106 (and any connected parts), pulling it toward the body or keeping it closer to the body. When insert assembly 100 is removed, at least one other component of insert assembly 100 can be freely displaced or have a greater degree of freedom of displacement. Therefore, insert assembly 100 can be divided into a first unit and a second unit, and compared with the first unit, the second unit is more restricted in its displacement capacity when insert assembly 200 is pulled away from the body. In some examples, relative motion can be suppressed until the skin applies a certain force to base 106. The user may need to pull insert assembly 100 away from the body with enough force to stretch the skin to a certain extent, thereby starting the relative movement of different parts of insert assembly 200. As the user pulls insert assembly 100 away from the infusion site, the elasticity of the skin pulls the second unit toward the infusion site in the opposite direction, and a threshold force forcing the first unit and the second unit to separate can be provided. Once this threshold force is provided, relative motion can begin.

[0443] The trigger of insert assembly 100 can be prevented from actuating until the skin is pulled away from the rest of the body by a certain distance, which is sufficient to generate the force required for starting relative motion. Before the necessary relative displacement occurs, it may not be triggered. Once triggered, the insert actuation assembly (an exemplary embodiment described below) of insert assembly 100 can be released to complete placing the infusion set 102 at the desired infusion site. The actuation assembly can include a trigger arrangement, which, once released, will cause the insertion tip 132 to be driven to the infusion site. The actuation assembly can also retract the insertion tip 132 into the insert assembly 100. The actuation assembly can connect the cannula subassembly 114 to the infusion set base 106. Once the infusion set 102 has been installed at the desired infusion site, the actuation assembly can also disconnect the infusion set 103 from the insert assembly 100.

[0444] In certain embodiments, insert assembly 100 can be placed on the skin and trigger actuation as insert assembly 100 is lifted so as to be removed. It may not be necessary for the user to excite actuation by other pressing, twisting, squeezing, etc. of the trigger, button, housing sleeve or other parts of insert assembly 100, yet actuation can still be under the control of the user. The relative motion of (one or more) free parts of insert assembly 100 with respect to (one or more) restricted parts can trigger actuation, such as by moving or driving out latches and releasing one or more biasing members to start driving actuation. Therefore, the trigger inside insert assembly 100 can be actuated as the result of the removal action of insert assembly 100 from health. The trigger can be actuated automatically, such as, when the skin of the infusion site has been lifted at least a certain distance from the anatomical structure below. From the user's perspective, this insert assembly 100 can be simply placed on the skin and then withdrawn to perform the placement of infusion set 102.

[0445] In alternative embodiments, a discrete manual triggering action can be used to trigger the actuation of the insert assembly 100. Any arrangement obvious to those skilled in the art can be used to facilitate manual triggering. The insert assembly 100 may include, for example, one or more buttons, which, when displaced, may trigger the actuation by driving out the latch in the insert assembly 100. Alternatively, a portion of the insert assembly 100 may be deformable, and squeezing the insert assembly 100 may press a protrusion that moves into the latch with the deformable section to drive out the latch. For example, in some examples, a button or a deformable section may be included on the outer housing 116. A twisting action may be used to trigger the actuation of the insert assembly 100. This twisting action of one portion (e.g., a cover portion) of the insert assembly 100 relative to another portion (e.g., the rest of the insert assembly 100) may sweep the protrusion of the insert assembly 100 into the latch to drive out the latch. In other embodiments, after the insert assembly has been pulled away from the skin to trigger actuation, a pin or similar member can be pulled out from the insert assembly 100. In an embodiment comprising a locking member 146 (e.g., referring to Figure 19), the locking member 146 can be kept in place until the user has begun to withdraw the insert assembly 100 from the skin. When the removal of the locking member 146 allows the parts of the insert assembly 100 to be displaced relative to each other so that, for example, a latch can be released, actuation can be triggered. Various combinations of manual triggering arrangements can also be used. For example, a button press or extrusion can then be twisted or vice versa to trigger actuation. Until the skin has been displaced from a stationary position and / or until a certain degree of relative motion has occurred between the free parts and the restricted parts of the insert assembly 100, a manual triggering action may be performed. Any arrangement obvious to those skilled in the art can be used to promote this locking. For example, interlocking can prevent button displacement, twisting, extrusion, etc., until the skin has been displaced or until a relative motion exceeding a threshold amplitude has occurred. Alternatively, the interlock may block access to a latch within the insert assembly 100, preventing it from being driven out until the skin has been displaced or until relative motion exceeding a threshold magnitude has occurred. In some embodiments, button displacement, twisting, squeezing, etc. may be possible, but the interlock renders them ineffective until the skin has been displaced or until relative motion exceeding a threshold magnitude has occurred. As will be appreciated by those skilled in the art, the insert assembly 100 embodiments described herein may be further modified to allow for various types of additional manual actuation schemes.

[0446] Although such a design can make trigger actuation simple, intuitive and safer, other advantages can also be achieved. For example, when the insert assembly 100 is lifted, the insert assembly 100 can be designed to pull the skin of the base 106 of the infusion set 102 away from the underlying muscles and other body structures or anatomical structures. Therefore, when inserted, the cannula 104 of the infusion set 102 can be more reliably placed in the subcutaneous layer of adipose tissue. This can alleviate the pain during insertion, help reduce bruises, increase the potential body area that can select the infusion site, and can lead to more predictable absorption of medicaments such as insulin. The skin can also be tightened to facilitate the insertion of the tip 132 to easily penetrate the skin. Since the skin is passively lifted with the insert assembly 100, it is not necessary to generate a pneumatic vacuum. This can allow the insert assembly 100 to be less complicated and made with fewer parts. In addition, the pneumatic seal against the skin or in the insert assembly 100 can be omitted. Since the body contour of the infusion site (which may bring sealing challenges) may be largely insignificant, the lifting of the skin can be more reliably completed. In addition, it may not be necessary to pinch the skin to pull the skin away from the structure below. This may help to make the insertion more comfortable, limit bruising, and more reliably pull the skin away from the structure below. The insert assembly 100 can also ensure that the insertion of the cannula 104 into the skin along the specified orientation occurs. The skin can be kept in place parallel to or perpendicular to the reference plane or axis that moves with the insert assembly 100 (for example, parallel to the bottom surface 162 of the base 106 of the infusion set 102 or perpendicular to the axis of the insertion tip 132 or the insertion tip displacement path). Therefore, the angle of the insert assembly 100 or the path along which the insert assembly 100 is pulled away relative to the body may not change the insertion angle. The example embodiment shown here depicts an insertion angle substantially perpendicular to the skin, however, by fixing the skin relative to the reference plane or axis that moves with the insert assembly 100, it can be similarly ensured that the insertion at any angle (just exceeding 0 ° to 90 °, such as 30 °, 45 °, 60 °, etc.) is inserted. Another potential benefit is that psychological issues associated with triggering the actuation may be reduced. Because the user may not have to depress, twist, squeeze, etc. certain actuators, there may be less anxiety built up in anticipation of triggering the actuation. The user may not know the exact moment of actuation when the insert assembly 100 is withdrawn. This may help limit psychological issues and may reduce perceived pain.

[0447] like Fig.57As shown, in frame 242, adhesive lining or backing 111 can be removed from the infusion set base 102 retained in the insert assembly 100. Then in frame 246, the insert assembly 100 can be placed at the desired infusion site. This may cause the adhesive on the infusion set base 102 to stick to the patient's skin. It may be desirable to press the insert assembly 100 against the skin to ensure that the adhesive is firmly attached to the skin. In frame 250, the locking member 146 can be removed from the insert assembly 100. In frame 254, the insert assembly 100 can be started to be removed from the body. In frame 258, the skin can be pulled away from the muscles and body structures below by the adhesion of the adhesive. In frame 258, the outer shell 116 and the holder base 140 can also be displaced relative to the rest of the insert assembly 100. As mentioned above, before the skin has been lifted from the anatomical structure below and the elasticity of the skin applies enough force to overcome the internal resistance to the relative displacement, the relative displacement may not occur. In frame 262, at least one latch within the insert assembly 100 may be released. As described above, this may occur automatically or as a result of some manual triggering action. In frame 266, the insertion tip 132 and the cannula subassembly 114 may be driven toward the insertion site. In frame 270, the cannula subassembly 114 may be coupled to the infusion set base 106. Additionally, in frame 270, a catch may be released from the infusion set base 106. The action of coupling the cannula subassembly 114 to the kit base 106 may result in the catch being released from the infusion set base 106. This may release the infusion set base 106 from the remainder of the insert assembly 100. When the catch is engaged with the infusion set base 106, the catch may hold the insertion tip retractor 134 in place. In frame 274, as the catch is released, the insertion tip retractor 134 can be driven through a dwell distance (described in further detail later in the specification). In frame 278, the insertion tip retractor 134 and the insertion tip 132 can be driven away from the infusion site. In frame 282, the removal of the insert assembly 100 can be completed. With the removal of the insert assembly 100 completed, the infusion set 102 can be fully assembled and in place at the infusion site. In addition, the cannula 104 can be in place in the subcutaneous layer of the skin.

[0448] Reference now Fig.58, depicts a top view of insert assembly 100 with first and second cutting planes superimposed on insert assembly 100. The first cutting plane is labeled AA. The second cutting plane is labeled BB. This figure is provided for reference purposes related to a number of upcoming figures. Some of these figures are cross-sectional views of insert assembly 100 taken at a location in one or another of these planes, and depict insert assembly 100 in different stages of operation. Unless otherwise stated, one of the following cross-sections of insert assembly 100 is given by a figure with a number followed by the letter A, which figure depicts a cross-section of insert assembly 100 at the location of plane AA. In the case where one of the following cross-sections of insert assembly 100 is given by a figure with a number followed by the letter B, the figure depicts a cross-section of insert assembly 100 at the location of plane BB.

[0449] Reference now FIG. 59A to FIG. 59B , depicting two cross-sectional views of insert assembly 100. Insert assembly 100 is depicted just as it would be applied to skin 356. FIG. 59A to FIG. 59B In the embodiment, the locking member 146 (see for example Fig.50 ) and adhesive backing 111 (see e.g. Figure 1A ) has been removed. Adhesive 374 is depicted on the bottom surface 162 of the infusion set base 106. As shown, both springs 136, 138 can be in an energy storage state, which in this particular embodiment is a compressed state. In this example, spring 136 serves as an insertion drive biasing member, while spring 138 serves as an insertion tine retraction drive biasing member. Spring 136 is held in a compressed state between the insertion tine retainer 130 and the insertion tine retractor 134, and when the spring 136 is released, the spring 136 drives the tine retainer 130 and the components carried thereon from the raised state to the forward state. Spring 138 is held in a compressed state between the inner housing 120 and the tine retractor 134. When released, the spring 138 drives the tine retractor 134 and the tine retainer 130 from the column insertion state to the retracted state.

[0450] Now also refer to Figure 60 to Figure 64 , depicting multiple views of the tip holder 130. The tip holder 130 may include a biasing member receiving compartment 290 in which the spring 136 may be disposed. The tip holder 130 may also include a wall 292 surrounding the biasing member receiving compartment 290. The wall 292 may include two protrusions 294 on its outer face. The two protrusions 294 in the exemplary embodiment are rails that are disposed on the tip holder 130 relative to each other. These rails may be arranged along the guide 354 (see, e.g. FIG. 70A to FIG. 70B) rides on a portion of the cusp retractor 134. The protrusion 294 can extend from the cusp retainer 130 to match the width of the cannula subassembly 114 at the plane of the cannula subassembly 114 including the ear 204 of the septum housing 108.

[0451] In various embodiments, the wall 292 may also include an interrupted area that creates one or more cantilever arms 296. In an exemplary embodiment, the cantilever arms 296 are disposed opposite each other on the tip holder 130. One of the cantilever arms 296 may be longer than the other of the cantilever arms 296. In other embodiments, the two cantilever arms 296 may be identical mirror images (see, e.g., FIG. 78C ) to allow for easier assembly of the insert assembly 100. Both cantilever arms 296 may extend above the top surface 298 of the remainder of the wall 292. Each of the cantilever arms 296 may include a protuberance 300 disposed at its non-supported end or terminal end. A flange section 302 may be defined by a portion of each protuberance 300. At least one of the flanges 302 may extend substantially perpendicular to the cantilever arms 296. At least one of the flanges 302 may be angled relative to the cantilever arm 296 containing it so that the undercut area has a triangular cross-section. In an exemplary embodiment, the flange 302 on the longer of the two cantilever arms 296 is undercut as such. The tip bracket 130 may also include a port 304. The port 304 may be used to supply glue or adhesive into the tip holder 130 to securely hold the insertion tip 132 therein.

[0452] Figure 65 to Figure 68 , an alternative embodiment of a tip retainer 130 is shown in FIG. As shown, the longer of the two cantilever arms 296 of the tip retainer 130 includes a protuberance 300 having a ridge 301. The ridge 301 can be located in the middle of the protuberance 300, but can also be located in other locations in alternative embodiments. As shown, the protuberance 300 can be double-beveled. The portion of the protuberance 300 near the flange section 302 can have a steeper slope than the portion of the protuberance 300 away from the flange section 302. The ridge 301 can be formed on the portion of the protuberance near the flange section 302. In this example, the ridge 301 is formed as an oblique extension extending from the portion of the protuberance 300 away from the flange section 302 to the portion of the protuberance 300 adjacent to the flange section 302. Any of the tip retainer 130 embodiments described herein may include such a ridge 301.

[0453] like Fig.59BAs best shown in FIG. 1 , the flange 302 on the longer of the cantilever arms 296 can rest on a catch 306. The catch 306 in the example embodiment is included on the tip retractor 134. In the example embodiment, this can inhibit the release of energy stored in the spring 136 and maintain the spring 136 in a compressed state. The catch 306 can have an angle that cooperates with any angle of the flange 302 to securely hold the flange 302 on the catch 306. The finger 308 extending from the base retainer 140 of the insertion assembly 100 can extend through a gap 322 adjacent to the catch 306 (see, e.g., FIG. 1 ). Fig.70C ). Displacement of the finger 308 relative to the catch 306 may cause the flange 302 to disengage from the catch 306. This may trigger the release of the prong retainer 130 and free the spring 136 from its energy storage state. Although illustrated as an upright 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 insert 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 catch 306 and the flange 302 is an example of a trigger (e.g., see Fig.57 ), the trigger can be operated to initiate actuation of the insert assembly 100.

[0454] Now also refer to Figures 69 to 70C , depicting multiple views of the holder base 140 and the pointed retractor 134. As shown, the finger-like portion 308 ( Fig.69 ) is formed as a continuous portion of the holder base 140. The exemplary holder 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 are connected by a middle region 314 and can be concentric with each other. The middle region 314 can be generally flat and can serve as a skin contacting portion of the insert assembly 100 that is substantially flush with the bottom surface 162 of the infusion set base 106. The finger portion 308 extends from the second ring portion 312. As shown, the finger portion 308 includes an upright segment 316 and a fin 318.

[0455] In various embodiments, the tip retractor 134 can include a guide 320 along which the fin 318 can slide during assembly. In some embodiments, the guide 320 can also ride along the fin 318 during at least a portion of the retraction of the tip retractor 134. The example guide 320 is formed as two raised parallel ribs. The catch 306 includes two supports 324 with which the flange 302 of the cantilever arm 296 can engage. The supports 324 can include a gap 326 therebetween. The width of the gap 326 can be equal to or wider than the width of the fin 318. During the lifting of the insert assembly 100 from the skin 356, the fin 318 can be pushed through the gap 326. This can cause the fin 318 to come into abutment with the protuberance 300 on the cantilever arm 296 and force the cantilever arm 296 to bend inward. Once the fin 318 has advanced a certain distance, the cantilevered arm 296 can be deflected to a point where the flange 302 is no longer engaged with the catch 306 and the spring 136 can be released and the actuation can be triggered. The position of the fin 318 on the finger 308 and / or the height of the finger 308 can be adjusted to change the displacement distance at which the flange 302 is released from the catch 306. In embodiments where the protuberance 300 includes a ridge 301 (see, e.g., Figure 65 to Figure 68 ), the ridge 301 can be sized to fit through the gap 326. Thus, the ridge 301 can increase the amount that the cantilevered arm 296 can be deflected by the fin 318 and provide additional assurance that the flange 302 is fully removed from the catch 306. As a result, the acceptable tolerance range for various features associated with the catch 306 and the prong holder 130 can be greater.

[0456] Still combined Figures 69 to 70B refer to FIG. 59A to FIG. 59B, the spring 138 may also be held in the energy storage state by at least one latch engagement. As shown, the apex retractor 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 the top plate 328 of the apex retractor 134. These arms 330 may extend substantially parallel to each other and may be disposed on the apex retractor 134 in an opposing manner. Additionally, the first set of arms 330 may extend laterally to the central cavity 334 of the apex retractor 134. In some embodiments, the first set of arms 330 may be attached to the top plate 328 of the apex retractor 134 at an exposed region 336 of the top plate 328. The arms 330 may thus fit within a channel formed by the guide rails 124 of the inner housing 120 to prevent rotation and guide any displacement of the apex retractor 134 during actuation. In addition, the tip retractor 134 may include an exposed area 336 in an asymmetrical manner to ensure that the tip retractor 134 is assembled into the insert assembly 100 in a prescribed orientation. The first set of arms 330 can be cantilevered and attached to the tip retractor 134 at the top plate and the second plate 338, which can extend parallel to and below the top plate 328. Thus, the arms 330 can form resilient protrusions or members that may deflect if sufficient force is applied to them. The non-supporting end of the arm 330 can include a curved or inclined section 340. The section 340 can abut against a complementary contoured surface of the deflector member 358 to facilitate and / or guide such deflection. There can also be one or a pair of notches 342 on each of the first set of arms 330. In this example, each arm 330 includes a pair of notches 342 located near the non-supporting end of the arm 330.

[0457] Fig.71 A cross section of the insert assembly 100 is depicted, taken through a plane in one of the arms 330, the plane extending along the length of the arm 330. As shown, each of the one or more notches 342 can engage with a cooperating protrusion 344. The cooperating protrusion 344 can be included on the inner housing 120. Thus, the interaction of the notches 342 (one or more) and the cooperating protrusions 344 (one or more) can hold the spring 138 in a compressed state and act as a latch to prevent retraction. This can be particularly helpful during assembly because the infusion set base 106 may not be in place, otherwise the spring 138 may be free to relax. In addition, the engagement can ensure that the top plate 328 of the tip retractor 134 is disposed slightly below the openings 148, 150 to allow the introduction of the locking member 146. Although the notches 342 are shown, the arm 330 and the inner housing 120 can be engaged in other ways. For example, the arm 330 or the inner housing 120 can include a protrusion that forms a flange. The flange may engage with a catch recess in the other of the arm 330 or the inner housing 120 .

[0458] Now again mainly combined Figures 69 to 70B refer to FIG. 59A to FIG. 59B In some embodiments, an additional latch may be included in the insert assembly 100 that helps to retain one of the springs 136, 138 in the energy storage state. In an example embodiment, the spring 138 is retained in the energy storage state by an additional latch arrangement. As shown, the second set of arms 332 of the cusp retractor 134 extends from the bottom of the wall defining the central cavity 334. The second set of arms 332 may be disposed in an opposing relationship to each other and may be cantilevered. Each of the second set of arms 332 may include a protuberance 346 disposed at its non-supported end. Each protuberance 346 may form a flange 348 on the arm 332 including the protuberance. In addition, the arm 332 may include a knob 350 or an elevated slope that increases in thickness as the distance from the cavity 334 increases. The knob 350 may be disposed intermediate the non-supported end of the arm 332 and its attachment point to the rest of the cusp retractor 134.

[0459] like Fig.59A As best shown, the flange 348 can capture a portion of the infusion set base 106. Specifically, the flange 348 can capture on an exposed portion of the infusion set base 106. The base 106 can include rails, step features, knobs, or any other suitable protrusions to provide a complementary capture surface for the flange 348. In some embodiments, the lobes 348 can capture on the guides 172 of the infusion set base 106 (see, e.g., Figure 4A ). Thus, the infusion set base 106 can be retained within the insert assembly 100. In alternative embodiments, for example, where FIG. 21A to FIG. 21F In those embodiments of the infusion set base 106 of the type shown in , a portion of each arm 332 can extend at least partially into a corresponding receiving slot defined in the base 106. The flange 348 can engage with a catch present at the end of the corresponding receiving slot to retain the base 106 within the insert assembly 100.

[0460] The flange 348 can be angled relative to the cantilevered arm 332 including the flange so that the undercut has a triangular cross-section. For example, the portion of each flange 348 of the guide 172 (or any other snap feature) onto which it snaps can be angled in a cooperative manner to help ensure a secure engagement. The retainer base 140 (or in a similar manner to the FIG. 73A to FIG. 73B The outer housing 116 in the illustrated embodiment may include a retaining protrusion 359 that may abut or nearly abut the arm 332 and retain the arm 332 from moving out of engagement with the infusion set base 106 prior to actuation of the insert assembly 100. This may help prevent any accidental activation of the insert assembly 100.

[0461] In some embodiments, only one arm 332 may be included. In some embodiments, the arm 332 on the tine retractor 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 tine retractor 134. The inner housing 120 may also include a latch 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.

[0462] A plurality of latches or alignment protrusions 352 may be included in the insert assembly 100 to help ensure that the infusion set base 106 is assembled into the insert assembly 100 in a desired orientation. As shown, the latches 352 may be disposed on the inner housing 120 of the insert assembly 100. When the infusion set base 106 is held by the arms 332 of the prong retractor 134, the infusion set base 106 may be held so that the surface of the infusion set base 106 is adjacent to the latches 352. This may prevent the infusion set base 106 and the prong retractor 134 holding it from being displaced into the insert assembly 100 due to mechanical interference of the latches 352. Thus, the latching of the flange 348 of the arm 332 on the infusion set base 106 may also help maintain the spring 138 in an energy storage state. The latches 352 may also ensure that the infusion set base 106 is located within the insert assembly 100 so that the adhesive 374 may be pressed against the skin 356. In this example, the post 352 ensures that the infusion set base 106 is substantially flush with the skin contacting surface on the retaining base 140 .

[0463] With the infusion set base 106 so positioned, the infusion set base 106 can also be used as a protective barrier. Since the cannula subassembly 114 and the insertion tip 132 can be inside the insert assembly 100, when the infusion set base 106 is in the initial holding position, the user can be protected from accidentally contacting the insertion tip 132. This can additionally help prevent the cannula 104 or the insertion tip 132 from contacting with contaminants. Although the space for receiving the cannula subassembly 114 can extend through the entire infusion set base 106, the space can be sized to prevent fingers from entering (e.g., the cross-section of the space is smaller than the cross-section of the finger). Therefore, the infusion set base 106 can have a barrier that blocks the unintentional approach of the insertion tip 132 and the cannula 104. In addition, since the cannula subassembly 114 is inside the insert assembly 100, any adhesive backing 111 provided on the infusion set base 106 does not need to include an interruption that allows the cannula 104 to pass. Thus, the void in the infusion set base 106 for the cannula subassembly 114 may be blocked by the adhesive backing 111 until just prior to use. This may further prevent finger entry and may mitigate the possibility of debris entering the insert assembly 100. In some examples, the adhesive 374 may also extend over the opening and may be pierced during insertion of the cannula 104 into the skin 356.

[0464] Reference now Fig.72 , showing Figure 2 100 is an isolated view of an alternative outer housing 116 depicted in an embodiment of an insert assembly 100. As shown, in place of a retainer base 140, various features of the retainer base 140 can be included in the outer housing 116. For example, during a molding operation, these features can all be integrally formed and integrally formed with each other as a single, unitary component. As shown, the fingers 308 and fins 318 are included as part of the outer housing 116. The fingers 308 can extend from a center ring portion 313 connected to the remainder of the outer housing 116 through an intermediate region 314. Similarly, the deflector member 358 is included as part of the outer housing 116.

[0465] FIG. 73A to FIG. 73B It is shown in Figure 2 FIG. 1 is a cross-sectional view of an exemplary embodiment of an insert assembly 100. The insert assembly 100 includes Fig.72 The outer housing 116 is shown in FIG. FIG. 73A to FIG. 73B The view in Figure 2 shows the FIG. 59A to FIG. 59B and Fig.71 1 and 2. This alternative embodiment of insert assembly 100 shows insert assembly 100 in the same state as shown in FIG. FIG. 73A to FIG. 73B The insert assembly 100 shown in FIG. FIG. 59A to FIG. 59B and Fig.71The insert assembly 100 shown in FIG. 1 operates similarly. For the sake of brevity, the following description FIG. 59A to FIG. 59B and Fig.71 Various operating states of insert assembly 100 are shown in FIG.

[0466] Reference now FIG. 74A to FIG. 74B , two cross-sectional views of the insert assembly 100 are shown. FIG. 74A to FIG. 74B In the embodiment of the present invention, exemplary insert assembly 100 has been placed against skin 356 at the desired infusion position and begins to be withdrawn 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, causing the skin 356 to be pulled upwards by the insert assembly 100 as the insert assembly 100 is pulled away from the body by the user. Adhesive 374 can be selected to have enough erosion, to keep adhesion with skin 356 when skin 356 is lifted from the anatomical structure below. When the user removes the insert assembly 100 from their body, the outer shell 116 and the retainer base 140 (it can form the cover of the insert assembly 100) can be displaced with the user's hand. Other parts of the insert assembly 100 may not be limited to be displaced as a unit with the outer shell 116 and the retainer base 140 (at least during a part of the removal action of the insert assembly 100). Because the infusion set base 106 is latchingly engaged with the tip retractor 134 and the tip retractor 134 is in latching engagement with the inner housing 120 and the tip retainer 130, these components can be retained at the rear. Therefore, these components can form a first unit of the insert assembly 100, which is more limited in displacement capacity than the second cover unit of the insert assembly 200. As described elsewhere herein, at least in the initial portion of the removal movement of the insert assembly 100, these components can be displaced in cooperation with the cover. For this portion of the removal action, the first unit and the second unit can be releasably engaged with each other. For example, there may be an interference or interfering relationship between the first unit and the second unit. This interference may prevent relative movement of the first unit and the second unit until the applied force exceeds a threshold value. When the applied force exceeds the threshold value, the interference can be overcome, and the first unit and the second unit can begin to shift relative to each other.

[0467] Still refer to FIG. 74A to FIG. 74B During removal, the outer housing 116 and the holder base 140 can be displaced away from the skin 356 substantially along the axis of the insertion tip 132 relative to the components of the second unit. This can cause the deflector member 358 included on the holder base 140 to bend the resilient member or arm 330 inwardly. It can also cause the finger 308 on the holder base 140 to advance into the void 322 (see, e.g. Fig.70C). Thus, the finger 308 can eventually be displaced a distance sufficient to trigger actuation of the insert assembly 100. The elasticity of the arm 330 and the interference presented by the biasing member 358 can cause the entire insert assembly 100 to move as a unit for the withdrawal movement of at least a portion of the insert assembly 100 from the body. The deflector member 358 can bend or deflect the arm 330 to disengage it from the interfering relationship with the deflector member 358. Once the force applied by the elasticity of the skin exceeds the force threshold, the portions of the insert assembly 100 can be displaced relative to each other. Thus, by deflecting at least a portion of one of the first and second units to disengage it from the interfering relationship with the other of the first and second units, the interference between the units that prevents their relative displacement can be overcome. This may occur after a threshold holding force is applied to pull the first and second units apart. The separation force can be generated by the user moving the hood away from the body and the elasticity of the pulled or lifted skin 356 pulling the first unit in opposite directions.

[0468] In various embodiments, the elasticity of the elastic member or arm 330 can at least partially control the distance that the skin 356 of a given user is pulled away from the body before actuation of the insert assembly 100 occurs. When the skin 356 is pulled away from the body, the elasticity of the skin 356 can apply a pulling force that presses the arm 330 against the deflector member 358. The type, quantity and / or arrangement of the adhesive 374 on the infusion set base 106 can be selected to withstand such forces while maintaining adhesion to and compatibility with the skin 356. Once the force overcomes the elasticity of the arm 330 and the components of the insert assembly 100 described above begin to move relative to each other, the finger 308 can begin to advance into the gap 322. Prior to this, trigger actuation can be prohibited. Therefore, the releasable engagement between the first and second units and the trigger can form an actuation limiting arrangement that can ensure that the skin is lifted before the insert assembly is triggered. The elasticity can be selected so that the insert assembly 100 can be used for a wide range of individuals with different skin 356 properties (e.g., elasticity), while still ensuring that the skin 356 is pulled at least some minimum distance before triggering actuation. In some embodiments, the insert assembly 100 can be manufactured with different arm 330 elasticities, which can be suitable for different user groups. For example, an arm 330 with less elasticity (e.g., elderly elasticity) can be used for an elderly user group whose skin 356 tends to have less elasticity.

[0469] The steepness of the inclined section 340 on each arm 330 can be modified to change the magnitude of the force applied before relative motion occurs. In the case where a greater force is required before relative motion occurs, a shallower angle can be adopted on the inclined section 340. In the case where a smaller force may be required, a steeper angle on the inclined section 340 can be used. In some embodiments, there may be high (e.g., teenagers), medium (e.g., adults), and low (e.g., elderly) skin elasticity ramp angles. In addition, the thickness of the arm 330 can be changed to change their elasticity. Thinner arms can be used where less force is required, and thicker arms can be used where greater force is required. Various support features such as buttresses can also be included, and various support features can support the arm 330 against deflection at a point near the supported end of the arm 330. In some examples, the position of the second plate 338 can also be modified to change the length of the deflectable portion of the arm 330 so that they are more or less elastic. The material used to form the arm can also be selected based on its elastic properties.

[0470] The length of the finger 308 and the position of the fin 318 on the finger 308 can at least partially control the distance that the user's skin 356 is pulled away from the body. These parameters can be modified to change the distance.

[0471] Now refer to 74C to Fig.74D , showing two additional cross-sections of the example insert assembly 100. Each of the example insert assemblies 100 includes an additional spring 156, 158. Figures 1A to 1C These springs 156, 158 are described. Additional springs 156, 158 may be used to adjust the amount of force that is established before the fin 318 triggers the insert assembly 100 to begin actuation (e.g., by disengaging the catch 306 and flange 302, see e.g., Fig.59B ). Springs 156, 158 can also help remove any mechanical overflow that may exist due to tolerances of the various components of insert assembly 100. Varying the features described in the above paragraphs can allow one to empirically determine appropriate designs for various patient populations (e.g., adolescents, adults, elderly, or those with high skin elasticity, medium skin elasticity, or low skin elasticity). Skin expansion tests, elastomer or other tests can be used to match the appropriate type of insert assembly 100 to a particular patient.

[0472] Reference now FIG. 75A to FIG. 75B , two cross-sectional views of the insert assembly 100 are shown. FIG. 75A to FIG. 75B, the example insert assembly 100 has been further withdrawn from the skin 356. The outer housing 116 and the retainer base 140 have continued to be displaced away from the skin 356 relative to the remainder of the insert assembly 100. The deflector member 358 included on the retainer base 140 has continued to bend or deflect the arm 330 inwardly. The finger 308 on the retainer base 140 has advanced into the gap 322 (see, e.g., Fig.70C ), such that the fins 318 of the finger 308 have driven the cantilevered arms 296 of the tip holder 130 away from the catch 306 (see e.g. Fig.70C ). Thus, movement of the outer housing 116 and the retainer base 140 has advanced the insert assembly 100 to FIG. 75A to FIG. 75B As the cantilevered arm 296 disengages from the catch 306, the spring 136 is free to release its stored energy and begin to drive actuation of the insert assembly 100.

[0473] Before the relative displacement between the parts of insert assembly 100 increases to the insertion release point threshold, insert assembly 100 can be prevented from triggering actuation. This can ensure that before actuation of the trigger arrangement of insert assembly 100 can occur (e.g., catch 306 and flange 302 are disengaged, see, e.g., Fig.59B )Lift the skin a certain distance.

[0474] Reference now FIG. 76A to FIG. 76B , two cross-sectional views of the insert assembly 100 are shown. FIG. 76A to FIG. 76B , the example insert assembly 100 has been further withdrawn from the skin 356. As shown, the restoring action of the spring 136 can drive the tip retainer 130, the insertion tip 132 and the cannula subassembly 114 along the insertion path toward the skin 356. In the exemplary embodiment, the tip retainer 130 extends at least partially from the cavity 334 of the tip retractor 130. As shown, the insertion tip 132 and the cannula 104 have just pierced the skin 356. During the piercing, the skin 356 may still be in a state of being pulled away from the muscle and other underlying body structures. The cannula subassembly 114 has also begun to advance toward the infusion set base 106. It should be noted that the spring 136 is still depicted as being in a compressed state in the following figures. This is for ease of illustration. Those skilled in the art will understand that the example spring 136 will expand during the insertion movement. As also shown, the holder base 140 of the insert assembly 100 can include a stop 364 that prevents relative movement beyond a certain point between the inner housing 120 and the cover formed by the outer housing 116 and the holder base 140 (which can be connected to each other). The stop 364 can be included as part of the second ring 312 of the holder base 140.

[0475] Reference now FIG. 77A to FIG. 77B , two cross-sectional views of the insert assembly 100 are shown. As shown, the spring 136 has returned to a relaxed state and the insertion movement of the tip holder 130, the insertion tip 132, and the cannula subassembly 114 toward the skin 356 is completed. The relaxed state can be a completely relaxed state or a relatively relaxed state, in which the spring 136 still applies a certain pressure to the tip holder 130 to prevent it from shaking. The notch 186 of the cannula subassembly 114 is shown to engage with the protuberance 182 of the infusion set base 106, thereby locking the cannula subassembly 114 in place and completing the assembly of the infusion set 102. As shown, when the cannula subassembly 114 is latched into the base 106, the ear 204 on the cannula subassembly 114 can be pressed against the tumor 350 included on the arm 332. This can cause the arm 332 to open, causing the arm 332 to disengage from the infusion set base 106. This, in turn, releases the spring 138 to begin releasing the stored energy. FIG. 77A to FIG. 77B The insertion assembly 100 is depicted in a retracted release state, and the arm 332 may function as a retraction prevention latch.

[0476] Reference now FIG. 78A to FIG. 78B In some examples, the arms 332 of the needle retractor 134 can be provided with ribs 333. The ribs 333 can strengthen the arms 332 while still allowing the arms 332 to deflect when the ears 204 of the cannula subassembly 114 are driven into the nubs 350 by the springs 136. The ribs 333 can help prevent and / or guide the deflection of the arms 332 when the insert assembly 100 is mishandled (e.g., if the insert assembly 200 is dropped or otherwise subjected to a severe impact). This can help to ensure that the base 106 is not accidentally dislodged. The ribs 333 can include an inclined surface 335, in which case the inclined surface 335 can collide with the end of the wall 337 of the inner housing 120 if the tip retractor 134 is slightly displaced toward the open end of the insert assembly 100. The ends of the walls 337 are angled and the ribs 333 can tighten the arms 332 against the base 106 when such displacement occurs, which further helps to ensure that the base 106 remains in place within the insert assembly 100. In addition, as shown, at least one of the first set of arms 330 of the tip retractor 134 can be molded in an outwardly deflected state. Although in Fig.78A 10 is shown in its molded state, but when engaging with the protrusion 344 on the inner housing 120, the arm 330 may be in an inwardly deflected state (about Fig.71 34. As such, arm 330 may be biased into engagement with protrusion 344. This may further increase the resistance of insert assembly 100 to abuse.

[0477] In certain other embodiments, reference is now made to Figures 79A to 82C, a set of retaining supports, such as yoke 311, may be included in insert assembly 100. The exemplary supports may help to reliably hold infusion set base 106 in place within insert assembly 100 even if insert assembly 100 is mishandled. Although the following embodiments are described with respect to infusion set base 106, in alternative examples, supports may be included to help hold other patient care component bases. The supports may contact arm 332 and increase the force required to deflect arm 332 to release infusion set base 106. Various support embodiments may abut against arm 332 or be disposed adjacent to arm 332 to limit the ability of arm 332 to shift at least prior to insert assembly 100 being activated.

[0478] Main reference FIG. 79A to FIG. 79B For example, the yoke 311 can be disposed around the arms 332. The arms 332 can be created (e.g., molded) such that there is a preload applied to the yoke 311 to help hold the yoke 311 in place. Although the yoke 311 is illustrated as a discrete component, in alternative embodiments, the yoke 311 can be integrated into another component of the insert assembly 100 (e.g., the inner housing 120). The yoke 311 can separate each of the arms 332 into a constrained portion that can be prevented from deflecting and a deflectable portion. The deflectable portion can be disposed closer to the open end of the insert assembly 100 than the yoke 311, with the remainder of each arm 332 forming the constrained portion. As FIG. 77A to FIG. 77B As shown, when the spring 136 returns to a relaxed state, the ear 204 on the cannula subassembly 114 can be pressed against the nub 350 included on the arm 332. When this occurs, the force provided by the spring 136 can be sufficient to deflect the deflectable portion of the arm 332 to release the infusion set base 106 (e.g., see Fig.77A , 77B ) and free spring 138 (see, for example, Fig.77B ). However, the yoke 311 can help ensure that the infusion set base 106 is securely retained when the insert assembly 100 is mishandled.

[0479] In an alternative embodiment including a yoke 311, and referring now to FIG. 80A to FIG. 80B, when the insert assembly 100 is activated, the yoke 311 can transition between a constrained state and a disengaged state. For example, when the cannula subassembly 114 is advanced toward the infusion set base 106, the yoke 311 can be disengaged from the arm 332. As shown, in some such embodiments, the yoke 311 can be defined as a ring 315 having a split 317. The inner periphery of the ring can include a protuberance 319. In the example shown, each of the arms 332 is flanked by the protuberance 319. When the tip retainer 130 is advanced toward the open end of the insert assembly 100, the protuberance 319 can be disposed in the displacement path of a portion of the tip retainer 30. In the example shown, the tip retainer 130 includes a wing 327 that collides with the protuberance 319 when the tip retainer 30 is driven by the spring 136.

[0480] The arm 332 may include a bottom beam 339 on which the yoke 311 may rest when the insert assembly 100 is in the storage state. In addition, the inner sidewalls of the yoke 311 may abut against the lateral surfaces of the arm 332. In some embodiments, the yoke 311 may be held in place by a slight interference fit engagement with the arm 332. Thus, when the insert assembly 100 is in the storage state, the yoke 311 may constrain the arm 332, and the yoke 311 may inhibit release of the infusion set base 106 in the event of mishandling. When the prong retainer 130 collides with the yoke 311, the yoke 311 may be driven into the bottom beam 339. The joint 317 may facilitate the skewing of the yoke 311 so that the yoke 311 may pass through the bottom beam 339 toward the open end of the insert assembly 100 and enter the disengaged state. With the yoke 311 in the released state, during operation, the ear 204 on the cannula subassembly 114 can be pressed against the knob 350 included on the arm 332 to release the infusion set base 106, as described above (see, e.g. Fig.77A , 7B ). As shown, the arm 332 can be thickened near the bottom beam 339. This can allow a wider yoke 311 to be used. When in the disengaged state, the large aperture of the yoke 311 can provide sufficient clearance for the arm 332 to open to release the infusion set base 106. Although not shown, in some examples, a stopper (e.g., included on the retainer base 140) can be included that can retain the yoke 311 in the disengaged state to prevent the yoke 311 from falling out of the insert assembly 100.

[0481] Reference now FIG. 81A to FIG. 81B In an alternative embodiment, the yoke 311 may be included as a set of pads 389 that may be coupled to another component of the insert assembly 100 via corresponding flexures 303. Fig.81AAs best shown in FIG. 1 , the shoe 389 may be coupled to the example inner housing 120 via the flexure 303. Although in FIG. Fig.81A In the cross-sectional view shown in FIG. 1 , half of the inner housing 120 is removed, but the opposite side of the inner housing 120 is constructed as a mirror image as shown and also includes the cushion seat 389. Fig.81B , each pad 389 can abut a corresponding arm 332 of the cusp retractor 134. The pads 389 can inhibit displacement of the arms 332 and help maintain the infusion set base 106 engaged with the arms 332 during improper operation.

[0482] When the insert assembly 100 is activated, the yoke 311 can transition between the restrained state and the disengaged state via the deflection of the flexure 303 that couples each pad 389 to the inner housing 120. When the spring 136 relaxes, as the prong retainer 130 is pushed by the open end of the insert assembly 100, portions of the prong retainer 130 can collide with the pads 389. As shown, each of the pads 389 includes a leg 305 that can extend into the displacement path of the prong retainer 130. FIG. 81A to FIG. 81B As shown, the leg 305 can be positioned, for example...

Claims

1. An insert assembly comprising: a housing having an insert driver latch defined thereon; an insertion driver displaceable between a home position in which the insertion driver is engaged with the insertion driver latch and a forward position; a release finger displaceable relative to the housing from a first position to a ready position and from the ready position to a triggered position; The release finger is configured to: when the release finger is displaced from the first position to the ready position, the release finger presses a portion of the insertion drive in a set direction, thereby retaining the insertion drive in engagement with the insertion drive latch, and the release finger is configured to: when the release finger is displaced from the ready position to the triggered position, the release finger displaces a portion of the insertion drive in a release direction, thereby driving the insertion drive out of the insertion drive latch; Latch arrangement; and an insertion biasing member configured to be maintained in a skewed state by the latch arrangement 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 skewed state when the insertion driver is driven out of the insertion driver latch.

2. The insert assembly according to claim 1, wherein: The latch arrangement includes a set of opposing keeper arms and a keeper displaceable between the set of opposing keeper arms, the keeper arms defining a flange that overhangs the keeper when the latch arrangement is engaged.

3. The insert assembly of claim 2, wherein: The retainer is configured to be displaced when the release finger is displaced from the first position to the ready position, and the latch arrangement is engaged when the release finger is displaced to the ready position.

4. The insert assembly of claim 1, wherein: The insert assembly also includes a retraction biasing member configured to deflect when the release finger is displaced to the ready position and configured to be retained in the deflected state by the latch arrangement.

5. The insert assembly of claim 1, wherein: The insertion drive is configured to disengage the latch arrangement when displaced from the starting position to the forward position, and the retraction biasing member is configured to displace the insertion drive to the starting position when the latch arrangement is disengaged.

6. The insert assembly of claim 1, wherein: The insertion driver includes a port configured to couple to an insertion tip carrier body.

7. The insert assembly of claim 1, wherein: The housing includes a receiving portion configured to couple to a treatment component cartridge.

8. The insert assembly of claim 1, wherein: The housing comprises a housing including a set of receiving shoes for holder pins of a care set cartridge.

9. The insert assembly of claim 1, wherein: The release finger is configured to collide with and deflect about a portion of the insertion actuator when the release finger is displaced to the ready position.

10. The insert assembly of claim 9, wherein: The housing blocks deflection of the release finger in a direction toward the housing when the release finger is displaced from the ready position to the trigger position.

11. The insert of claim 1, wherein: The insertion actuator includes a cantilevered arm including a catch body configured to engage the insertion actuator latch, the housing resisting deflection of the cantilevered arm in a direction toward the housing.

12. The insert assembly of claim 11, wherein: The release finger is configured to collide with a portion of the cantilevered arm when the release finger is displaced from the ready position to the trigger position, causing the cantilevered arm to deflect out of the path of the release finger, the deflection of the cantilevered arm driving the catch body out of the insert driver latch.

13. An insert assembly comprising: a cover portion, the cover portion comprising an outer shell and an end cap; inner shell; an insertion driver included in the inner housing and displaceable from a starting position to a forward position in which the insertion driver is engaged with an insertion driver latch defined on an inner side wall of the inner housing; an insertion biasing member between the insertion driver and the end cap; a retainer configured to engage with a first latch when the cover portion is displaced in a first direction to a ready position, the insertion biasing member being held in a skewed state when the retainer is engaged with the first latch and the insertion actuator is engaged with the insertion actuator latch; and a release finger included on the cover portion and configured to: retain the insertion driver in engagement with the insertion driver latch when the cover portion is displaced to the ready position, and configured to: urge the insertion driver out of the insertion driver latch when the cover portion is displaced in a second direction from the ready position to a trigger position, the insertion biasing member configured to urge the insertion driver to the forward position when the insertion driver latch is released; and Wherein, when the insertion driver is displaced toward the forward position, the insertion driver disengages the retainer from the first latch.

14. The insert of claim 13, wherein: The insert assembly also includes a retraction biasing member configured to skew when the cover portion is displaced to a ready state, the retraction biasing member configured to be retained in the skewed state when the retainer is engaged with the first latch.

15. The insert of claim 14, wherein: The retraction biasing member is released from the skewed state when the retainer is disengaged from the first latch, and the retraction biasing member is configured to displace the retainer away from the first latch and displace the insertion driver to the starting position when the retainer is disengaged from the first latch.

16. The insert of claim 13, wherein: The insertion driver includes a port configured to couple to an insertion tip holder carrying an insertion tip.

17. The insert of claim 13, wherein: The inner housing includes a receiving portion opposite the end cap, the receiving portion being configured to couple to a treatment component cartridge.

18. The insert of claim 13, wherein: The release finger is configured to collide with and deflect about a portion of the insertion actuator when the cover portion is displaced to the ready position.

19. The insert of claim 13, wherein: The inner housing blocks deflection of the release finger in a direction toward the inner housing when the cover portion is displaced from the ready position to the trigger position.

20. The insert of claim 13, wherein: The insertion actuator includes a cantilevered arm including a catch body configured to engage the insertion actuator latch, and the inner housing blocks deflection of the cantilevered arm in a direction toward the inner housing.

21. The insert of claim 20, wherein: The release finger is configured to collide with a portion of the cantilevered arm when the cover portion is displaced from the ready position to the trigger position, causing the cantilevered arm to deflect out of the path of the release finger, the deflection of the cantilevered arm driving the catch body out of the insert driver latch.

22. The insert assembly of claim 13, wherein: The retainer includes a reset body and a retraction spring retainer, a portion of the insertion driver is disposed between the retraction spring retainer and the reset body, and the insertion biasing member is captured between the portion of the insertion driver and the reset body.

23. The insert assembly of claim 22, wherein: The end cap includes a post extending into a passage defined in the reset body, the end cap being configured to push against the reset body when the cover portion is displaced to the ready position.

24. An insert assembly comprising: a cover portion, the cover portion comprising an outer shell and an end cap; an inner housing, the cover portion being displaceable relative to the inner housing; a retainer configured to engage a first latch when the cover portion is displaced in a first direction toward the inner housing by more than a first threshold distance; an insertion driver included in the inner housing and displaceable from a first position to a second position and including a routing body; a release finger included on the cover portion, the release finger being configured to: when the cover portion is displaced in the first direction, the release finger is pressed against the routing body in a set direction to reinforce the engagement of the insertion drive with the insertion drive latch, and the release finger is configured to: when the cover portion is pulled in a second direction opposite to the first direction beyond a second threshold distance, the release finger displaces the routing body in a release direction to drive the insertion drive out of the insertion drive latch; and a first biasing member, the first biasing member being maintained in a skewed state when the retainer is engaged to the first latch and the insertion driver is engaged with the insertion driver latch, the first biasing member urging the insertion driver toward the second position when the insertion driver is driven out of the insertion driver latch; and Wherein, when the insertion actuator is displaced toward the second position, the insertion actuator disengages the retainer from the first latch.

25. The insert of claim 24, wherein: The insertion driver includes a cantilevered arm including a catch body that latches into engagement with the insertion driver.

26. The insert of claim 25, wherein: The routing body is arranged on the cantilever arm.

27. The insert of claim 26, wherein: The routing body includes a first surface and a second surface opposite to each other, and the first surface and the second surface each include an inclined portion.

28. The insert of claim 27, wherein: The release finger includes a paddle-shaped body, and the paddle-shaped body has opposite first and second paddle-shaped body sides, and the first and second paddle-shaped body sides each include an inclined portion, and the inclined portion of the first paddle-shaped body side is configured to be pushed into the inclined portion of the second surface of the routing body when the cover portion is displaced in the first direction, and the release finger deflects around the second surface of the routing body when the cover portion is further advanced in the first direction, and the inclined portion of the second paddle-shaped body side is configured to: when the cover portion is displaced in the second direction, the inclined portion of the second paddle-shaped body side is pushed into the inclined portion of the first surface of the routing body, and the cantilever arm is displaced out of the path of the paddle-shaped body in the release direction when the cover portion is further advanced in the second direction.

29. The insert of claim 25, wherein: The cantilever arm extends along an axis, and the routing body protrudes from the cantilever arm in a direction substantially perpendicular to the axis.

30. The insert of claim 24, wherein: The insertion drive latch is provided by at least one shelf defined on an inner surface of the inner housing.

31. The insert of claim 24, wherein: When the cover portion is displaced in the second direction, the inner housing prevents the release finger from deflecting in a direction opposite to the release direction.

32. The insert of claim 24, wherein: The insertion driver includes a port configured to mate with an insertion tip holder.

33. The insert of claim 24, wherein: The insert also includes a second biasing member.

34. The insert of claim 33, wherein: The second biasing member is configured to transition to a skewed state when the cover portion is displaced in the first direction, and the second biasing member is retained in the skewed state when the retainer is engaged with the first latch.

35. The insert of claim 34, wherein: The second biasing member is configured to urge the retainer away from the first latch and urge the insertion driver toward a first position and into engagement with the insertion driver latch when the first latch is disengaged.

36. The insert assembly of claim 33, wherein: The shaft of the insertion driver extends through the second biasing member.

37. A cartridge for a reusable insert assembly, the cartridge comprising: a housing having a compartment recessed into an end of the housing, the housing including a set of retaining members projecting into the compartment; a retainer including a flange captured between a rim at an end of the compartment and a corresponding end of the retaining member, a set of cantilevered arms projecting from a first face of the flange; a first patient care assembly portion coupled to the retaining member via the set of cantilevered arms; a tine holder having an insertion tine coupled to the tine holder; and A second patient care assembly portion is carried on the insertion tip.

38. The cartridge of claim 37, wherein: The cartridge further comprises a set of matching bodies extending beyond a surface of the rim furthest from the flange.

39. The cartridge of claim 38, wherein: The mating body is a mating pin.

40. The cartridge of claim 38, wherein: The mating body protrudes from a second face of the flange opposite the first face.

41. The cartridge of claim 37, wherein: The retaining member is a cantilevered section of a side wall of the compartment.

42. The cartridge of claim 37, wherein: The cantilevered arm defines a guide along which the tip holder is configured to be displaced.

43. The cartridge of claim 42, wherein: The edge forms a stop that limits the range of displacement of the tip holder in the first direction.

44. The cartridge of claim 42, wherein: The guide is formed by a slot extending through each of the cantilevered arms.

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

46. ​​The cartridge of claim 37, wherein: The housing is disposed within a container and is releasably coupled to the container.

47. A cartridge for a reusable insert assembly, the cartridge comprising: a housing having a compartment recessed into an end of the housing, the housing including a set of retaining members projecting into the compartment; a retainer including a flange captured between a rim at an end of the compartment and a corresponding end of the retaining member, a set of cantilevered arms projecting from a first face of the flange, the cantilevered arms each including a guide passage along a section of the cantilevered arm, the guide passage extending through the cantilevered arm; a first patient care assembly portion coupled to the retaining member via the set of cantilevered arms; a tine holder having an insertion tine coupled to the tine holder, the tine holder including a fin extending from a main portion of the tine holder through the guide passage; and A second patient care assembly portion is carried on the insertion tip.

48. The cartridge of claim 47, wherein The cartridge further comprises a set of matching bodies extending beyond a surface of the rim furthest from the flange.

49. The cartridge of claim 48, wherein The mating body is a mating pin.

50. The cartridge of claim 48, wherein: The mating body protrudes from a second face of the flange opposite the first face.

51. The cartridge of claim 47, wherein: The retaining member is a cantilevered section of a side wall of the compartment.

52. The cartridge of claim 47, wherein: The section of each cantilever arm including the guide passage extends from the supported end of each cantilever arm to a point approaching but not reaching the unsupported end of each cantilever arm.

53. The cartridge of claim 47, wherein: The edge forms a stop that limits the displacement range of the tip holder along the guide path in the first direction.

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

55. The cartridge of claim 47, wherein: The housing is disposed within a container and is releasably coupled to the container.

56. The cartridge of claim 55, wherein: A barrier is attached to the container, and the barrier and the container completely surround the housing, the retainer, the first patient-care assembly portion, the second patient-care assembly portion, and the prong retainer.

57. A method of assembling a cartridge for a reusable insert assembly, the method comprising: placing an insertion tip extending from a tip holder through the first percutaneous access assembly portion; positioning the pointed holder in a set of guides of a holder; Advancing the retainer into the compartment of the housing through a first range of displacement in which a flange of the retainer deflects a set of retaining members and into a retaining position in which the flange is urged against an edge at an end of the compartment and away from the retaining member, the retaining member returning to a resting state while blocking movement of the retainer to a position in the first range of displacement; and A second percutaneous access assembly portion is releasably coupled to a set of cantilevered arms included in the retainer.

58. The method of claim 57, wherein: Advancing the retainer into the compartment further includes blocking displacement of the pointed retainer along a portion of the guide with the rim.

59. The method of claim 57, wherein: The method also includes passing a set of mating bodies defined on the retainer through at least one opening in the rim.

60. The method of claim 57, wherein: The method also includes placing the housing into a container.

61. The method of claim 60, wherein: The method also includes releasably coupling the housing to the container.

62. The method of claim 60, wherein: The method also includes sealing the opening in the container with a barrier, the barrier and the container together completely surrounding the housing.

63. The method of claim 57, wherein: Positioning the prong holder within the guide includes placing a fin on the prong holder within a slot defined by the cantilevered arm.

64. The method of claim 57, wherein: Positioning the pointed retainer within the guide includes introducing a portion of the pointed retainer into a slot extending through the cantilever arm, the portion of the pointed retainer being introduced into a section of the slot farthest from the non-supported end of the cantilever arm.

65. An insert assembly comprising: a hood portion having an open end and an opposite closed end; a care component base holder having a care component base releasably coupled to the care component base holder; a trigger body held in place relative to the nursing component base holder via an insertion latch arrangement; a prong shuttle carrying an insertion prong, the prong shuttle being coupled to the trigger body via a retract latch arrangement; a first biasing member configured to: urge the trigger body, the prong shuttle, and the insertion prong toward the open end of the cover portion when the insertion latch arrangement transitions to a released state; and A second biasing member configured to urge the pointed shuttle and the insertion pointed tip toward the closed end when the retraction latch arrangement is displaced into the trigger when the trigger body and the pointed shuttle are displaced to a retracted release position by the first biasing member.

66. The insert assembly of claim 65, wherein: The insertion latch arrangement is configured to transition to the insertion release state when a force pressing a portion of the trigger body and a portion of the cover against each other exceeds a threshold value.

67. The insert assembly of claim 65, wherein: The insertion latch arrangement includes a flange of the trigger body that releasably engages a catch defined on the care component base retainer.

68. The insert assembly of claim 65, wherein: The trigger body includes an arm having a flange defined thereon, the insertion latch arrangement being formed by engagement of the flange with a catch defined on the care component base retainer.

69. The insert assembly of claim 68, wherein: The treatment component base holder includes an aperture through which the terminal portion of the arm extends.

70. The insert assembly of claim 69, wherein: The terminal portion of the arm is aligned with the trigger protrusion on the cover portion, and abutment of the terminal portion with the trigger protrusion prevents displacement of the cover portion relative to the trigger body.

71. The insert assembly of claim 70, wherein: The arm is configured to deflect to a deflected state when the force pressing the trigger protrusion and the terminal portion of the arm against each other exceeds a threshold value, and when the arm is in the deflected state, the flange is displaced out of engagement with the catch member, causing the insertion latch arrangement to transition to the released state.

72. The insert assembly of claim 65, wherein: The trigger is defined on the care component base holder.

73. The insert assembly of claim 65, wherein: The retract latch arrangement includes a flange of the pointed shuttle that releasably engages a catch defined on the trigger body.

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

75. The insert assembly of claim 65, wherein: The retracted release position is located at a midpoint in the displacement range of the trigger body, and the first biasing member is configured to continue to push the trigger body in the insertion direction toward the open end through the terminal portion of the displacement range of the trigger body after the trigger body reaches the midpoint.

76. The insert assembly of claim 75, wherein: A cannula subassembly is carried by the insertion tip, and the trigger body is configured to displace the cannula subassembly in the insertion direction within the terminal portion of the displacement range of the trigger body.

77. The insert assembly of claim 65, wherein: A cannula subassembly is carried by the insertion tip.

78. The insert assembly of claim 65, wherein: The insertion latch arrangement is configured to be transitioned to the release state by displacement of the cover portion relative to at least the care component base in a direction away from the care component base.

79. The insert assembly of claim 78, wherein: An adhesive is coupled to the care component base, the adhesive being configured to anchor the care component base to a bio-barrier that is lifted from a resting position when the cover portion is displaced relative to the care component base.

80. An insert assembly comprising: Hood; a care component base holder having a care component base releasably coupled to the care component base holder; an insert unit, the insert unit being held in place relative to the care component base holder via an insert latch arrangement, the insert unit comprising: a trigger body; and a retraction unit including an insertion prong, the retraction unit being releasably coupled to the trigger body via a retraction latch arrangement; a first biasing member configured to: urge the insertion unit to be displaced in an insertion direction when the insertion latch arrangement is transformed to a first release state; and A second biasing member configured to, when the insertion unit is displaced to a retraction release position by the first biasing member, urge the retraction unit to be displaced in a retraction direction when the retraction latch arrangement is displaced into a trigger.

81. The insert assembly of claim 80, wherein: The second biasing member is maintained in a skewed state between the trigger body and a portion of the retraction unit when the retraction latch arrangement is in an engaged state.

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

83. The insert assembly of claim 80, wherein: The retraction release position is at an intermediate point in the range of displacement of the trigger body, and the first biasing member is configured to urge the trigger body toward the open end beyond the retraction release point.

84. The insert assembly of claim 80, wherein: A cannula subassembly is carried by the insertion tip, and the trigger body is configured to urge the cannula subassembly in the insertion direction when the trigger body is displaced in the insertion direction by the first biasing member.

85. The insert assembly of claim 80, wherein: A portion of the care component that is separate from the care component base is carried by the insertion tip.

86. The insert assembly of claim 80, wherein: The insertion unit is configured to be displaced together with the cover portion until a force exceeding a threshold force is applied to pull the cover portion and the insertion unit apart.

87. The insert assembly of claim 86, wherein: The treatment component base is coupled to an adhesive, and when the adhesive adheres to a patch of a biological barrier, withdrawing the cover from the patch generates a threshold force and lifts the patch from a resting state.

88. The insert assembly of claim 80, wherein: The insertion latch arrangement includes an elastic member that is releasably engaged with a catch, and the cover portion is configured to: when the cover portion is pulled in a direction away from the care component base, the cover portion deflects the elastic member out of engagement with the catch, thereby transitioning the insertion latch arrangement to the released state.

89. The insert assembly of claim 80, wherein: The retraction release arrangement includes a resilient member of the retraction unit releasably engaging a catch defined on the trigger body.

90. An insert assembly comprising: an insertion unit, the insertion latch arrangement restraining said insertion unit from displacement in the insertion direction, a retraction unit, the retraction unit comprising an insertion prong, the retraction unit being releasably coupled to the insertion unit by a retraction latch arrangement; a first biasing member configured to urge the insertion unit and the retraction unit to be displaced in an insertion direction when the insertion latch arrangement is released; and a second biasing member configured to urge the retracting unit to shift in a retracting direction; and A retraction trigger is provided, the retraction latch arrangement being configured to transition to a disengaged state when displaced into the retraction trigger at an intermediate point of a displacement path of the plug-in unit.

91. The insert assembly of claim 90, wherein: A percutaneous access assembly is carried by the insertion tip.

92. The insert assembly of claim 90, wherein: The infusion cannula assembly is carried by the insertion tip.

93. The insert assembly of claim 90, wherein: The insertion unit is configured to drive the percutaneous access assembly carried by the insertion tip in an insertion direction after passing through the intermediate point.

94. The insert assembly of claim 90, wherein: The insertion unit is configured to press the percutaneous access assembly carried by the insertion tip in the insertion direction after passing through the intermediate point.

95. The insert assembly of claim 90, wherein: The inserter assembly also includes a retainer and a first patient-care assembly portion coupled to the retainer, the inserter assembly also including a second patient-care assembly portion carried by the insertion tip.

96. The insert assembly of claim 95, wherein: The second patient care assembly portion is coupled to the first patient care assembly portion when the insertion unit is displaced along the displacement path.

97. The insert assembly of claim 95, wherein: Once the insertion unit is displaced beyond the midpoint, the second patient care assembly portion is coupled to the first patient care assembly portion.

98. The insert assembly of claim 90, wherein: The inserter assembly includes an entry assembly carried by the insertion tip, the insertion tip having a leading length extending beyond the entry assembly.

99. The insert assembly of claim 98, wherein: The entry assembly is positioned in the displacement path of the insertion unit, and the intermediate point is selected such that after passing through the intermediate point, the insertion unit drives the entry assembly in the insertion direction by a distance at least equal to the leading length.

100. An insert for placing a device, comprising: Hood; a device base having an adhesive thereon for anchoring the base to a portion of the barrier; and a spring-biased insertion unit maintained in a starting state by an insertion latch arrangement, the base being releasably coupled to the insertion unit and anchoring the insertion unit to prevent displacement of the insertion unit relative to the portion of the barrier when the base is anchored to the portion of the barrier by the adhesive; and wherein the cover portion is capable of shifting from a starting position to a trigger position in a direction opposite to the insertion displacement direction of the insertion unit, the cover portion is configured to transition the insertion latch arrangement to a disengaged state when the cover portion is shifted to the trigger position, and wherein the insertion latch arrangement prevents relative movement between the cover portion and the insertion unit until a force threshold is exceeded.

101. The insert assembly of claim 100, wherein: The force threshold is greater than a threshold required to lift the portion of the barrier from a resting position when the base is anchored to the portion of the barrier via the adhesive.

102. The insert assembly of claim 100, wherein: The inserter assembly further includes a percutaneous access assembly, the insertion unit being spring biased to displace in the insertion direction and couple the percutaneous access assembly into the base upon release of the insertion latch arrangement.

103. The insert assembly of claim 100, wherein: The insertion unit includes a spring-biased retraction unit including an insertion tip, which is releasably connected to the rest of the insertion unit by a retraction latch arrangement and is constrained to be displaced in cooperation with the rest of the insertion unit when the retraction latch arrangement is in an engaged state.

104. The insert assembly of claim 103, wherein: The insertion unit is spring biased to be displaced along a displacement path in the insertion direction, the retracting latch arrangement being configured to be displaced into the triggering protrusion when the insertion unit is displaced along the displacement path.

105. The insert assembly of claim 104, wherein: The retracting latch arrangement is configured to be displaced into the triggering projection when the plug-in unit reaches an intermediate point in the displacement path.

106. The insert assembly of claim 103, wherein: The retracting unit is spring-biased to be displaced in a retracting direction opposite to the inserting direction.

107. The insert assembly of claim 103, wherein: The retracting unit includes an inclined protrusion.

108. A method of placing a care component on a biological barrier, comprising: adhering a portion of the treatment component coupled to the insert component to the barrier; pulling the insert assembly away from the barrier; raising the barrier from a rest position to a raised position via adhesion of the portion of the grooming component; After lifting the barrier, disengaging the insertion latch arrangement and pushing the insertion unit and the access assembly in the insertion direction; as well as Once the insertion unit reaches the retraction release position, disengaging the retraction latch arrangement and pushing the retraction unit including the insertion prong in a retraction direction; Therein, the displacement of the entry assembly in the insertion direction and the displacement of the retraction unit in the retraction direction at least partially overlap in time.

109. The method of claim 108, wherein: The method also includes coupling the access assembly to the portion of the patient-care assembly.

110. The method of claim 108, wherein: Pushing the retracting unit in the retracting direction further includes tilting the insertion tip.

111. The method of claim 108, wherein: Disengaging the insert latch arrangement includes displacing a portion of a cover portion of the insert assembly into a portion of the insert latch arrangement and deflecting the portion of the insert latch arrangement.

112. The method of claim 108, wherein: Disengaging the retraction latch arrangement comprises driving the retraction unit in the insertion direction and driving the retraction unit into a trigger.

113. The method according to claim 112, wherein: Driving the retraction unit in the insertion direction and into the trigger comprises cooperatively displacing the retraction unit and the insertion unit with each other when the insertion latch arrangement is disengaged.

114. The method of claim 108, wherein: Disengaging the retraction latch arrangement comprises decoupling the retraction unit from the insertion unit when the insertion unit is displaced in the insertion direction.

115. The method of claim 108, wherein: Disengaging the insertion latch arrangement includes releasing a first biasing member held in a first skewed state when the insertion latch arrangement is in an engaged state, and disengaging the retracting latch arrangement includes releasing a second biasing member held in a second skewed state when the retracting latch arrangement is in an engaged state.

116. The method of claim 108, wherein: The method also includes removing a locking member from the insert assembly.

117. A method of placing an access device through an insert assembly, comprising: coupling the insert assembly to the biobarrier; raising the bio-barrier coupled to the insert component from a rest state to a raised state by displacing the insert component in a direction away from the barrier; automatically disengaging the insertion latch arrangement and pushing the insertion unit including the retraction unit with the insertion prong in the insertion direction after the skin has been lifted at least a certain distance; automatically disengaging a retraction latch arrangement coupling the retraction unit to the remainder of the insertion unit and pushing the retraction unit in a retraction direction once the insertion unit is displaced to the retraction release position; and The remaining portion of the plug-in unit is urged from the retracted release position to a forward position in the insertion direction.

118. The method of claim 117, wherein: The method further includes blocking displacement of the insertion unit in the retracting direction after the insertion unit reaches the forward position.

119. The method of claim 117, wherein: The method further includes tilting the retracting unit while pushing the retracting unit in the retracting direction.

120. The method of claim 117, wherein: The method further includes coupling an access assembly to an access assembly base while at least the remaining portion of the insertion unit is displaced in the insertion direction.

121. The method of claim 120, wherein: Before the access assembly is coupled to the access assembly base, a retraction release point is reached.

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

123. The method of claim 117, wherein: Coupling the insert assembly to the bio-barrier includes adhering an access assembly base to the bio-barrier.

124. The method of claim 123, wherein: The method also includes releasing the entry assembly base from the insert assembly.

125. An insert assembly comprising: a cover portion, the cover portion comprising an outer shell and an end cap; inner shell; an insertion driver included in the inner housing and displaceable from a starting position to a forward position in which the insertion driver is engaged with an insertion driver latch defined on an inner side wall of the inner housing; an insertion biasing member between the insertion driver and the end cap; a retainer configured to engage with a first latch when the cover portion is displaced in a first direction to a ready position, the insertion biasing member being held in a skewed state when the retainer is engaged with the first latch and the insertion driver is engaged with the insertion driver latch, the insertion biasing member being configured to urge the insertion driver to the forward position when the insertion driver latch is released; and A release lock is configured to shift between an inactive position and an active position in which the release lock blocks release of the insertion drive latch.

126. The insert of claim 125, wherein: The insertion driver disengages the retainer from the first latch when displaced toward the forward position.

127. The insert of claim 125, wherein: The insertion actuator includes a cantilevered arm including a catch body configured to engage the insertion actuator latch, and the inner housing blocks deflection of the cantilevered arm in a direction toward the inner housing.

128. The insert of claim 127, wherein: The release lock includes a body that blocks deflection of the cantilevered arm in a direction away from the inner housing when the release lock is in the active position.

129. The insert of claim 125, wherein: The release latch includes a base portion from which a set of barrier bodies protrude, the barrier bodies being configured to extend through a passageway in the end cap.

130. The insert of claim 125, wherein: The release lock is configured to be rotationally displaced between the inoperative position and the operative position.

131. The insert of claim 125, wherein: The insert assembly also includes a retraction biasing member configured to skew when the cover portion is displaced to the ready state, the retraction biasing member configured to be retained in the skewed state when the retainer is engaged with the first latch.

132. The insert of claim 131, wherein: The insertion drive disengages the retaining member from the first latch when it is displaced toward the forward position, and wherein the retraction biasing member is released from the skewed state when the retaining member is disengaged from the first latch, and the retraction biasing member is configured to displace the retaining member away from the first latch and displace the insertion drive to the starting position when the retaining member is disengaged from the first latch.

133. The insert of claim 125, wherein: The insertion driver includes a port configured to couple to an insertion tip holder carrying an insertion tip.

134. The insert of claim 125, wherein: The inner housing includes a receiving portion opposite the end cap, the receiving portion being configured to couple to a treatment component cartridge.

135. An insert assembly comprising: Hood; a release lock, the release lock being displaceable between an inoperative position and a release position; an inner housing, the cover portion being displaceable relative to the inner housing when the release lock is in the inoperative position, and the cover portion being blocked from displacement relative to the inner housing when the release lock is in the release position; a retainer configured to engage a first latch when the cover portion is displaced in a first direction toward the inner housing; an insertion driver included within the inner housing and displaceable from a first position to a second position and including a routing body; a release finger included on the cover portion, the release finger configured to deflect about the routing body when the cover portion is displaced in the first direction, and the release finger configured to displace the routing body in a release direction when the cover portion is pulled in a second direction, thereby disengaging the insertion drive from the insertion drive latch; and A first biasing member is maintained in a skewed state when the retaining member is engaged to the first latch and the insertion driver is engaged with the insertion driver latch, and the first biasing member urges the insertion driver toward the second position when the insertion driver is disengaged from the insertion driver latch.

136. The insert of claim 135, wherein: The release lock and the outer housing are a continuous, one-piece component.

137. The insert of claim 135, wherein: The release lock is deflectable relative to the outer housing to shift the release lock between the inoperative position and the operative position.

138. The insert of claim 135, wherein: At least a portion of the release latch is disposed within a window defined in the inner housing when the release latch is in the release position.

139. The insert of claim 135, wherein: The insertion actuator includes a cantilevered arm including a catcher body that latches with the insertion actuator, the routing body being disposed on the cantilevered arm.

140. The insert of claim 135, wherein: The insertion drive latch is provided by at least one shelf defined on an inner surface of the inner housing.

141. The insert of claim 135, wherein: The insertion driver includes a port configured to mate with an insertion tip holder.

142. The insert of claim 135, wherein: The insert assembly also includes a second biasing member.

143. The insert of claim 142, wherein: The second biasing member is configured to transition to a skewed state when the cover portion is displaced in the first direction, and the second biasing member is retained in the skewed state when the retainer is engaged with the first latch.

144. The insert of claim 143, wherein: The second biasing member is configured to urge the retainer away from the first latch and urge the insertion driver toward the first position and into engagement with the insertion driver latch when the first latch is disengaged.

145. An insert assembly comprising: a cover portion, the cover portion comprising an outer shell and an end cap; inner shell; an insertion driver included in the inner housing and displaceable from a starting position to a forward position in which the insertion driver is engaged with an insertion driver latch defined on an inner side wall of the inner housing; an insertion biasing member between the insertion driver and the end cap; a retainer configured to skew a second biasing member and engage a first latch when the retainer is displaced in a first direction with the cover portion from a released state to a ready state, the insertion biasing member being held in a skewed state when the retainer is engaged with the first latch and the insertion driver is engaged with the insertion driver latch, the insertion biasing member being configured to urge the insertion driver to the forward position when the insertion driver latch is released; and a release actuator configured to disengage the retainer from the first latch when displaced from an inactive state to an actuated state; and The second biasing member is configured to push the cover and the retaining member to the released state when the retaining member is disengaged from the first latch.

146. The insert assembly of claim 145, wherein: The first biasing member abuts the insertion driver and faces of the retainer abutting the cover portion, and is configured to urge the retainer and the cover portion to the released state when the retainer is disengaged from the first latch.

147. The insert assembly of claim 145, wherein: The insertion driver includes a cantilevered arm including a catch body that latches into engagement with the insertion driver.

148. The insert of claim 145, wherein: The insertion drive latch is provided by at least one shelf defined on an inner surface of the inner housing.

149. The insert of claim 145, wherein: The insertion driver includes a port configured to mate with an insertion tip holder.

150. The insert of claim 145, wherein: The inner housing includes a receiving portion opposite the end cap, the receiving portion being configured to couple to a treatment component cartridge.

151. The insert of claim 145, wherein: A release finger is defined on the cover portion and is configured to retain the insertion drive in latching engagement with the insertion drive when the cover portion is displaced toward the ready state.

152. The insert of claim 151, wherein: The release finger is further configured to drive the insertion driver out of the insertion driver latch when the cover portion is displaced from the ready state to a trigger position in a second direction opposite to the first direction when the release actuator is in the inactive state.

153. The insert of claim 152, wherein: The release actuator is configured to deflect the release finger to a deflected state when transitioning from the inactive state to the active state.

154. The insert of claim 153, wherein: When the cover is displaced from the ready state to the trigger position and the release finger is in the deflected state, the release finger does not contact the insertion driver.

155. The insert of claim 151, wherein The release finger is configured to urge the insertion driver out of the insertion driver latch when the cover portion is displaced from the ready state to a trigger position in a second direction opposite the first direction.

156. The insert of claim 155, wherein: When the second biasing member pushes the retainer and the cover toward the released state and the cover is displaced through the trigger position, the retainer is configured to collide with the insertion driver and reverse the advancement of the insertion driver toward the forward state caused by the release of the insertion driver latch.

157. An insert assembly comprising: a cover portion, the cover portion comprising an outer shell and an end cap; inner shell; an insertion driver included in the inner housing and displaceable from a starting position to a forward position in which the insertion driver is engaged with an insertion driver latch defined on an inner side wall of the inner housing; an insertion biasing member between the insertion driver and the end cap; a retainer configured to skew a second biasing member and engage a first latch when the retainer is displaced in a first direction with the cover portion from a released state to a ready state, the insertion biasing member being held in a skewed state when the retainer is engaged with the first latch and the insertion driver is engaged with the insertion driver latch, the insertion biasing member being configured to urge the insertion driver to the forward position when the insertion driver latch is released; and a release actuator configured to disengage the retainer from the first latch when displaced from an inactive state to an actuated state; and Wherein, the second biasing member is configured to: when the retaining member is disengaged from the first latch, the second biasing member pushes the cover portion and the retaining member through a retraction stroke in a second direction opposite to the first direction.

158. The insert assembly of claim 157, wherein: The first biasing member abuts the insertion driver and faces of the retainer abutting the cover portion, and is configured to urge the retainer and the cover portion through the retraction stroke when the retainer is disengaged from the first latch.

159. The insert assembly of claim 157, wherein: The insertion actuator includes a cantilevered arm including a flange that engages the insertion actuator latch.

160. The insert of claim 157, wherein: The insertion drive latch includes a shelf defined on the inner housing.

161. The insert of claim 157, wherein: The insertion driver includes a port configured to mate with an insertion tip holder.

162. The insert of claim 157, wherein: The inner housing includes a receiving portion opposite the end cap, the receiving portion being configured to couple to a treatment component cartridge.

163. The insert of claim 157, wherein: A release finger is defined on the cover portion and is configured to reinforce engagement of the insertion drive with the insertion drive latch when the cover portion is displaced toward the ready state.

164. The insert of claim 163, wherein: The release finger is further configured to drive the insertion driver out of the insertion driver latch when the cover is displaced in the second direction from the ready state to the trigger position and the release actuator is in the inactive state.

165. The insert of claim 164, wherein: The release actuator is configured to deflect the release finger to a deflected state when transitioning from the inactive state to the active state.

166. The insert of claim 165, wherein: When the cover portion is displaced through the retraction stroke, the release finger is in the deflected state and is maintained out of contact with the insertion driver.

167. The insert of claim 163, wherein: The release finger is configured to urge the insertion driver out of the insertion driver latch as the cover portion is displaced through the retraction stroke.

168. The insert of claim 167, wherein: As the hood and retainer are displaced through the retraction stroke, the retainer is configured to collide with the insertion driver and reverse advancement of the insertion driver toward the forward condition caused by release of the insertion driver latch.

169. A method of releasing an inserter having a spring-loaded insertion driver and a spring-loaded retractor, the method comprising: adhering a portion of the patient care component to the barrier; shifting a release actuator of the insert from an inactive state to an active state; disengaging a first latch holding the retractor in place when the release actuator is displaced to the active state; releasing a spring of the spring-loaded retractor and driving the spring-loaded retractor and the cover portion of the inserter through a retraction stroke; as well as The portion of the patient-care component is disassociated from the barrier.

170. The method of claim 169, wherein: The method further includes maintaining a second latch retaining the spring loaded insertion driver in place as the spring loaded retractor and the cover portion are driven through the retraction stroke.

171. The method of claim 169, wherein: The method further includes releasing a spring of the spring-loaded insertion driver during the retraction stroke, the spring of the spring-loaded insertion driver urging the insertion driver in a forward direction.

172. The method of claim 171, wherein: The method further includes bumping the spring loaded insertion driver with the spring loaded retractor as the spring loaded retractor is displaced through the retraction stroke and reversing advancement of the insertion driver toward the forward direction.

173. The method of claim 169, wherein: Displacing the release actuator includes depressing a button.

174. The method of claim 169, wherein: Displacing the release actuator includes depressing at least one tab coupled to the first latch.

175. The method of claim 169, wherein: Unlatching the first latch includes deflecting a latch arm out of engagement with the spring-loaded retractor.

176. The method of claim 169, wherein: The method further includes deflecting a release finger of the cover portion out of alignment with a fin on a cantilevered arm of the insertion drive when the release actuator is displaced from the inactive state to the active state.

177. The method of claim 169, wherein: The method also includes automatically returning the release actuator to the inactive state during the retraction stroke.

178. The method of claim 169, wherein: Automatically returning the release actuator to the inactive state includes displacing an inclined surface on the release actuator into the insertion drive.

179. The method of claim 169, wherein: The method also includes driving the release actuator together with the retainer and the cover portion through the retraction stroke.

180. An insert assembly comprising: Hood; a body comprising a cavity flanked by a set of arms; a patient care assembly comprising a base and a second portion, the base releasably engaging the set of arms; a spring biasing unit including a tine holder on which an insertion tine and the second portion of the patient-care assembly are carried; a spring for the spring biasing unit; a trigger having a first state and a second state, wherein the spring is maintained in an energy storage state in the first state and the spring is released from the energy storage state in the second state, and when the trigger is actuated, the spring pushes the spring biasing unit toward the base; a yoke having at least a portion adjacent to each of the set of arms, the yoke restraining at least a portion of each of the set of arms from deflection; Wherein, the arms include a set of knobs, and when the insertion tip and the second portion of the patient-care assembly are displaced toward the base, a portion of the spring biasing unit collides with the knobs and causes the set of arms to open to release the base.

181. The insert assembly of claim 180, wherein: The yoke is an open centering member surrounding the arm.

182. The insert assembly of claim 181, wherein: The yoke includes split sections and is seated on a bottom beam defined on the set of arms.

183. The insert assembly of claim 181, wherein: The yoke is seated on a bottom beam defined on the set of arms, and a portion of the spring biasing unit includes a set of protrusions that impact the yoke and deflect the yoke around the bottom beam when the spring pushes the spring biasing unit toward the base.

184. The insert assembly of claim 180, wherein: The yoke includes a set of pads, each of which is adjacent to a respective arm of the set of arms, the pads being connected to a section of the body via a flexure.

185. The insert assembly of claim 184, wherein: The portion of the spring biasing unit collides with a respective shoe when the spring biasing unit is urged toward the base and the spring biasing unit applies a force causing the flexure to yield.

186. The insert assembly of claim 180, wherein: The yoke is provided by a set of lugs on the pointed retainer through which the arms extend, each arm in the set of arms having a thick region and a thin region, each lug blocking deflection of a corresponding arm in the set of arms when the lug is adjacent to the thick region of the corresponding arm, and the lug being sized to allow deflection of the corresponding arm when adjacent to the thin region of the corresponding arm.

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

188. The insert assembly of claim 180, wherein: The patient care component is an analyte sensor.

189. The insert assembly of claim 180, wherein: When the spring biasing unit is urged toward the base, the base and the second portion of the patient-care assembly are coupled together.

190. A patient care component placement system comprising: an insert assembly including a port having a central slot flanked on opposite sides by segments of a port rim, and a receiver body including a set of shoes each sweeping around a portion of the port from a closed shoe end to an open shoe end, the shoes each having an overhang region farthest from a main segment of the receiver body; a drug cartridge comprising a holder, a patient care assembly coupled to the holder, and a prong-carrying body from which an insertion prong protrudes, the holder comprising a set of mating pins each having a stem and a wider head, the prong-carrying body comprising a first end opposite a second end from which the insertion prong protrudes, the prong-carrying body comprising a tapered region intermediate the first end and the second end; wherein, when the cartridge is placed in an aligned position relative to the accommodating body and rotated to a coupled state, each matching pin is displaced from the open boot end of the corresponding boot to the closed boot end, the cartridge is translationally displaced to a position in which the first end of the pointed carrier body is pushed into the port to a depth in which the tapered region is aligned with the port edge over the matching pin capture displacement range, the head of each matching pin is displaced along the slope of the overhanging region of the corresponding boot over the matching pin capture displacement range, and the first end of the pointed carrier body is subsequently rotated on the port edge over the pointed carrier body capture displacement range.

191. A patient care component placement system comprising: an insert assembly comprising: a port flanked on opposite sides by shelves; and a receiver body including a set of mating tracks that sweep partially around an axis of the port; a drug cartridge comprising a retainer, a patient care assembly coupled to the retainer, and a prong retainer from which an insertion prong protrudes, the retainer comprising a set of mating projections, the prong retainer comprising a tapered region intermediate a first end and an opposite second end from which the insertion prong protrudes; Wherein, when the cartridge is in an aligned position relative to the accommodating portion body and is rotated to a connected state, the matching protrusion is displaced along the inclined area of ​​the corresponding matching track within the matching protrusion capture displacement range, thereby driving the cartridge translationally to a position in which the first end of the pointed retainer is advanced into the port to a depth where the tapered area is aligned with the shelf, and the first end of the pointed retainer is subsequently rotated on the shelf within the pointed retainer capture displacement range of the cartridge.

192. The system of claim 191, wherein: The mating rails include a shoe having a cantilevered shoulder section at a portion of each mating rail farthest from a main section of the receiver body.

193. The system of claim 191, wherein: The mating projections are each a mating pin having a head and a relatively thin stem connecting the head to the remainder of the retainer.

194. The system of claim 191, wherein: The port is shaped to receive the first end of the pointed retainer when the cartridge is in a rotational position within the mating protrusion capture displacement range.

195. The system of claim 191, wherein: The first end of the pointed retainer has an elongated cross-sectional shape, and the cross-sectional shape of the first end is more elongated than the cross-sectional shape of the thinned region.

196. The system of claim 191, wherein: The tapered region is formed by a notch recessed into the tip holder at an angle substantially perpendicular to the axis of the insertion tip.

197. The system of claim 196, wherein: The thickness of the shelf is sufficient to substantially fill the recess when the cartridge has been rotated through the tip holder capture displacement range.

198. The system of claim 191, wherein: The inclined region of each corresponding matching track starts from an open end of the matching track, and when the cartridge is rotated to the coupled state, the matching protrusion is located at a closed end of the corresponding matching track.

199. The system of claim 198, wherein: The inclined region of each respective mating rail includes a steepest portion along a segment of the inclined region closest to the open end.

200. The system of claim 191, wherein: The patient care component is selected from the list consisting of an infusion set and an analyte sensor.

201. The system of claim 191, wherein: The patient care assembly includes a first portion within the cartridge and a second portion separate from the first portion.

202. A patient care component placement system comprising: An insert assembly comprising: a port having a port coupling interface; and a receiver body including a set of mating tracks that sweep partially around an axis of the port; a cartridge comprising a holder, a patient care assembly coupled to the holder, and a prong holder from which an insertion prong protrudes, the holder comprising a set of protrusions, the prong holder comprising a prong holder coupling interface disposed opposite a first end of the prong holder from which the insertion prong protrudes; Wherein, when the cartridge is placed in an aligned position relative to the accommodating body and rotated to a connected state, the protrusion is displaced along the inclined area of ​​the corresponding matching track within a first displacement range to drive the cartridge translationally to a position where the pointed retainer coupling interface is aligned with the port coupling interface, and the pointed retainer coupling interface is rotated within a second displacement range of the cartridge to engage with the port coupling interface.

203. The system of claim 202, wherein: The port coupling interface and the tip retainer coupling interface are threaded interfaces.

204. The system of claim 202, wherein: The port coupling interface includes a set of shelves arranged on opposite sides of the port, and the pointed retainer coupling interface includes a protrusion having a tapered region arranged between the first end and a second end of the pointed retainer opposite the first end.

205. The system of claim 204, wherein: The second end of the tip holder rotates on the set of shelves as the cartridge rotates through the second range of displacement.

206. The system of claim 205, wherein: When the cartridge has been rotated through the second range of displacement, the thickness of the shelf is sufficient to substantially fill the recess.

207. The system of claim 202, wherein: The cartridge also includes a housing and a container, the holder, the patient-care component, and the prong holder being at least partially disposed within the housing.

208. The system of claim 207, wherein: The housing comprises a set of arms which are deflectable from a container engaged state to a container released state, wherein a portion of each arm in the set of arms is disposed in a corresponding recess in the container, and in the container released state, the portion of each arm in the set of arms is displaced out of the corresponding recess, wherein the container is disassociated from the rest of the cartridge when the set of arms is in the container released state.

209. The system of claim 208, wherein: The receptacle body includes a set of angled deflectors positioned to collide with the set of arms and deflect the set of arms from the container engaging state to the container releasing state when the cartridge is rotated from the aligned position to the coupled state.

210. The system of claim 209, wherein: The receiving body includes a set of protrusions, which protrude from the main surface of the receiving body and are connected to the rest of the receiving body via corresponding flexures, and the flexures are configured to allow the protrusions to be depressed by the container when the cartridge is rotated from the aligned position to the coupled state, and the flexures recover between the set of stop surfaces of the housing when the container is disassociated from the rest of the cartridge and the cartridge is in the coupled state.

211. The system of claim 202, wherein: The inclined region of each corresponding matching track starts from an open end of the matching track, and when the cartridge is rotated to the coupled state, the matching protrusion is located at a closed end of the corresponding matching track.

212. The system of claim 209, wherein: The inclined region of each respective mating rail includes a steepest portion along a segment of the inclined region closest to the open end.

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

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