Infusion set and inserter assembly system and method

Abstract

To provide an infusion set and an inserter assembly, and a method for using the same.SOLUTION: An inserter assembly 100 comprises: a first unit including a skin contacting face which surrounds an opening; and a second unit housed within the first unit. The second unit comprises an infusion set base disposed within the opening and having a bottom face which is substantially level with the skin contacting face and covered at least partially with adhesive and further comprises a spring biased insertion assembly. The second unit further comprises a cannula sub assembly carried by an insertion sharp of the insertion assembly. The spring biased insertion assembly and a cannula of the cannula sub assembly are driven into skin, and the cannula sub assembly is coupled into the infusion set base by an insertion spring which is released from an energy storing state after the skin has been tugged upward beyond a certain distance as the inserter assembly is withdrawn from a body.SELECTED DRAWING: Figure 39B

Description

[Technical Field]

[0001] This application relates generally to infusion sets and inserter assemblies for infusion sets, and more particularly to infusion sets and inserter assemblies and methods of using the same. [Background technology]

[0002] Many potentially valuable drugs or compounds, including biologics, are not orally active due to poor absorption, hepatic metabolism, or other pharmacokinetic factors. Furthermore, some therapeutic compounds can be administered orally, but may need to be taken so frequently that it is difficult for patients to maintain the desired schedule. In these cases, parenteral delivery is often employed or may be considered.

[0003] Effective parenteral delivery routes for drugs, other fluids, and compounds, such as subcutaneous injection, intramuscular injection, and intravenous (IV) administration, involve puncturing the skin with a needle or stylet. Insulin is one example of a therapeutic liquid that millions of diabetics self-inject. Users of parenterally delivered drugs could benefit from wearable devices that automatically deliver the required drug / compound over a period of time.

[0004] To this end, efforts have been made to design portable and wearable devices for the controlled release of therapeutic agents. Such devices have reservoirs, such as cartridges, syringes, or bags, and are known to be electronically controlled. These devices have many drawbacks, including a high rate of malfunction. Reducing the size, weight, and cost of these devices is also an ongoing challenge. Furthermore, these devices are often applied to the skin, posing the challenge of frequent repositioning for application. Summary of the Invention

[0005] According to one embodiment of the present disclosure, the inserter assembly may include a casing. The inserter assembly may further include a body including a cavity disposed within the casing. The inserter assembly may further include a sharps holder attached to the inserted sharps. The sharps holder may be at least partially disposed within the cavity. The inserter assembly may further include a bias member within the cavity. The bias member may be disposed between the sharps holder and a wall of the cavity. The inserter assembly may further include a trigger having a first state in which the bias member is maintained in an energized state and a second state in which the bias member is released from the energized state. The bias member may be configured to urge the sharps holder to move the inserted sharps from the casing when released from the energized state. The inserter assembly may further include an infusion set base that maintains engagement with the body. The infusion set base may include adhesive on a bottom surface thereof. The inserter assembly may further include a trigger actuation protrusion extending from the casing and positioned to actuate the trigger from the first state to the second state when the casing is displaced away from the body after the adhesive adheres to the skin and the skin is pulled a certain distance from the body.

[0006] In some embodiments, the casing may include a housing and a retention base coupled to the housing for movement therewith as a unit. In some embodiments, the trigger actuation protrusion may be included on the retention base. In some embodiments, the trigger may include a latch. In some embodiments, the latch may include a catch disposed on the body that engages with a shelf formed on the cantilevered arm of the sharps holder. In some embodiments, the bottom surface of the infusion set base may be substantially flush with the skin-contacting surface of the casing prior to application of the inserter assembly to the skin. In some embodiments, the inserter assembly may further include a cannula subassembly through which the insertion sharps extend. In some embodiments, the cannula subassembly may be separated from the infusion set base when the trigger is in the first state. In some embodiments, the cannula subassembly may include a cannula integral with the septum housing. In some embodiments, the cannula subassembly and the infusion set base may include cooperating coupling elements that interface to couple the cannula subassembly and the infusion set base when the cannula subassembly is moved to the infusion set base. In some embodiments, the energy storage state of the first bias member is a compressed state. In some embodiments, the inserter assembly may further include a second bias member. In some embodiments, the second bias member may be configured to be released from its energized state due to displacement of the inserted sharp from the casing. In some embodiments, the second bias member, upon release from its energized state, may urge the sharps holder and the inserted sharp to a stored position within the casing.

[0007] According to another embodiment of the present disclosure, an inserter assembly may include a first unit including a biasing member and a trigger actuation protrusion. The inserter assembly may further include a second unit housed within the first unit. The second unit may include a body including a resilient cavity and an arm. The arm may be aligned with the biasing member. The second unit may further include a sharps holder having a sharps insert thereon. The sharps holder may be at least partially disposed within the cavity. The second unit may further include a biasing member held in an energized state by the trigger. The second unit may further include an insertion set base. The insertion set base may include an adhesive. The insertion set base may be releasably coupled to the body. When the adhesive adheres to the skin and the inserter assembly is withdrawn from the body, the first and second units move together, pulling the skin away from the body until the force exerted by the elasticity of the skin overcomes the elasticity of the arm. The arm is deflected during the initial stage of actuation. In the second stage of actuation, the trigger is displaced and the energy stored in the biasing member is released, allowing the sharps holder to propel towards the skin.

[0008] In some embodiments, the first unit may include an external housing and a retaining base coupled to the external housing. In some embodiments, the biasing member and the trigger actuation protrusion may be included in the retaining base. In some embodiments, the trigger actuation protrusion may include a finger including a fin. The fin may extend from a portion of the retainer base to the second unit. In some embodiments, the trigger may include a catch on the body that engages with a shelf included in the deflectable member of the sharps holder. In some embodiments, the first unit may include a second biasing member. In some embodiments, the body of the second unit may include a second arm having a resilient second arm. In some embodiments, the second arm may be aligned with the second biasing member. In some embodiments, the infusion set base may be positioned to decouple from the body when the sharps holder is urged toward the skin. In some embodiments, the biasing member may be a compression spring. In some embodiments, the biasing member may include an angled deflection surface positioned opposite the angled arm surface on the arm. In some embodiments, the infusion set base may be releasably coupled to the body by a set of cantilevered arms. In some embodiments, the cantilevered arms can be configured to be displaced to a spread apart state to release the infusion set base with the ears of the cannula subassembly carried by the sharps insert when the sharps holder is urged by the biasing member. In some embodiments, the inserter assembly can further include a cannula subassembly carried by the insert sharp and spaced apart from the infusion set base during a first stage of actuation. In some embodiments, the cannula subassembly can be coupled to the base during a second stage of actuation.

[0009] According to another embodiment of the present disclosure, the inserter assembly may include a casing including a skin-contacting surface. The skin-contacting surface may surround an opening in the casing. The inserter assembly may further include a sharps holder including an insertion sharp. The inserter assembly may further include a cannula subassembly carried by the insertion sharp. The insertion sharp and cannula of the cannula subassembly may each have a skin-piercing tip disposed above the skin-contacting surface. The inserter assembly may further include an infusion set base disposed within the opening of the casing and having a bottom surface substantially level with the skin-contacting surface. The infusion set base may include the cannula subassembly receiving a gap sized to receive the cannula subassembly and prevent finger penetration. The inserter assembly may further include an infusion set base disposed within the opening of the casing and having a bottom surface substantially level with the skin-contacting surface. The infusion set base may include a cannula subassembly receiving gap sized to receive the cannula subassembly and prevent finger penetration. The inserter assembly may further include an insertion bias member. The sharp holder may be configured to be displaced by the insertion bias member transitioning from an insertion energy stored state to a relaxed state, pushing the insertion sharp cannula at least partially out of the casing and coupling the cannula subassembly to the infusion set base.

[0010] In some embodiments, the inserter assembly may further include a plurality of standoffs that position the infusion set base level with the skin-contacting surface prior to activation. In some embodiments, the cannula subassembly may include a cannula, a septum, a septum retainer, and a septum housing. In some embodiments, the septum housing and the cannula are formed as a continuous, monolithic, or single piece. In some embodiments, the cannula subassembly receiving cavity and the cannula subassembly include cooperating coupling elements that interact to couple the infusion set base and the cannula subassembly to one another when the cannula subassembly is advanced into the cannula subassembly receiving cavity. In some embodiments, the cooperating coupling element may include a cantilevered arm having a protrusion on the infusion set base and a receiving notch for receiving the protrusion on the cannula subassembly. In some embodiments, the inserter assembly may further include a sharps retractor and a retractor bias member configured to be released from a retracted energy-storage state in response to a protrusion on the cannula subassembly that unlatches when the sharps holder is displaced by the transition. In some embodiments, the retractor bias member may be configured to displace the sharps retractor away from the skin-contacting surface when the retractor bias member transitions from the retracted energy-storage state to the relaxed state. In some embodiments, the sharps holder may include at least one shelf, and the sharps retractor may include at least one stop. There may be a dwell distance between the at least one shelf and the stop when the retractor bias member is released from the retracted energy-storage state.

[0011] According to another embodiment of the present disclosure, the inserter assembly may include a casing. The inserter assembly may further include a sharps holder having an insertion sharp coupled thereto and a cantilevered arm having a ridge defining a shelf. The inserter assembly may further include a sharps retractor at least partially containing the sharps holder and having a cavity with a stopper therein configured to engage the shelf. The sharps retractor may further include a catch configured to engage the shelf and hold the insertion spring in a biased state. The inserter assembly may further include a cannula subassembly carried by the insertion sharp. The inserter assembly may further include an infusion set base releasably coupled to the sharps retractor and holding the retraction spring in a biased state while releasably coupled to the sharps retractor. The insertion spring may be configured to drive the sharps holder along the insertion path when the shelf disengages from the catch. The infusion set base can be decoupled from the sharps retractor, the cannula subassembly can be coupled to the infusion set base, and the ledge can be moved a dwell distance away from the stopper when the sharps holder moves to the end of the insertion path. The retraction spring can be configured to move the sharps retractor together with the sharps holder into the casing after the sharps retractor passes the dwell distance and engages the stopper with the ledge.

[0012] In some embodiments, the infusion set base can be releasably coupled to the sharps retractor by a pair of cantilevered arms extending from the sharps retractor. In some embodiments, the cannula subassembly can include a pair of ears configured to spread the pair of arms and release the infusion set base when the sharps holder moves to the end of the insertion path. In some embodiments, the sharps holder can include a second cantilevered arm having a second ridge defining a second shelf. In some embodiments, the cavity can include a second stopper configured to engage the second shelf. In some embodiments, the cannula subassembly can include a notch. The notch can be configured to mate with a ridge included in the infusion set base when the sharps holder moves to the end of the insertion path. In some embodiments, the cannula and septum housing of the cannula subassembly can be formed together as a monolithic part within a straight pull mold. In some embodiments, the casing may include an outer housing and a retaining base. The infusion set base can be placed within the opening in the retainer base and be flush with the skin-contacting surface of the retainer base prior to actuation of the inserter assembly. In some embodiments, the infusion set base can include an adhesive on its bottom surface, and the ledge can be released from the catch by lifting the inserter assembly off the patch of skin to which it is applied.

[0013] According to another embodiment of the present disclosure, the inserter assembly may include a first unit including a skin-contacting surface surrounding an opening. The inserter assembly may further include a second unit housed within the first unit. The second unit may include an infusion set base disposed within the opening, having a bottom surface substantially level with the skin-contacting surface and at least partially covered with adhesive. The second unit may further include a spring-biased insertion assembly. The second unit may further include a cannula subassembly carried by an insertion sharp of the insertion assembly. The cannula of the spring-biased insertion assembly and the cannula subassembly may be configured to be driven into the skin, and the cannula subassembly may be configured to be coupled to the infusion set base by an insertion spring, and the insertion spring may be configured to release from an energy-storing state after the skin is pulled upward by the adhesive by more than a certain distance when the inserter assembly is withdrawn.

[0014] In some embodiments, the inserter assembly may further include a sharp retractor and a retractor spring that may be configured to retract the sharp retractor along with the insertion assembly away from the skin-contacting surface. In some embodiments, the inserter assembly may include at least one latch configured to maintain the retractor spring in an energy-storing state. The latch may be released when the cannula subassembly moves to couple and engage with the infusion set base. In some embodiments, the at least one latch may include a pair of cantilever arms included in the sharp retractor. In some embodiments, each cantilever arm may include a ledge that engages a respective protrusion on the infusion set base. In some embodiments, each protrusion on the infusion set base may be part of a guide for a portion of the tubing set connector. In some embodiments, the infusion set base may include a cannula subassembly receiving cavity extending therethrough that is sized to receive the cannula subassembly but prevent finger penetration. In some embodiments, the cannula subassembly receiving cavity and the cannula subassembly include cooperating coupling elements that interact to couple the infusion set base and the cannula subassembly to one another.

[0015] According to another embodiment of the present disclosure, the inserter assembly may include a first unit. The first unit may include an infusion set base including an adhesive on its bottom surface. The first unit may further include an insertion sharp drive assembly releasably coupled to the infusion set base and including an insertion sharp, a drive spring, an elastic member, and a latch arrangement configured to engage and hold the drive spring in an energized state. The inserter assembly may further include a casing. The infusion set base may be disposed within an opening in the casing. Displacement of the inserter assembly from the body when the adhesive is in adhesive relationship with the skin initially pulls the skin from the underlying structure. In a second phase, when the force exerted by the elasticity of the skin overcomes the elasticity of the elastic member, the casing is displaced relative to the first unit, disengaging the latch arrangement. The drive spring may be configured to displace the insertion sharp from the casing when transitioning to a relaxed state.

[0016] According to another embodiment of the present disclosure, an inserter assembly for placing an infusion set at an infusion site of a body may include a casing having an actuation protrusion. The inserter assembly may further include a first unit within the casing movable relative to the casing. The first unit may include an infusion set base having an adhesive. The first unit may further include a sharps holder containing an inserted sharp. The first unit may further include a body including a drive spring and a cavity in which the sharps holder is at least partially disposed. The sharps holder may be movable from a raised state to an advanced state by the drive spring. The first unit may further include a drive spring release latch arrangement. The first unit may further include a drive spring release latch arrangement. The actuation protrusion may be configured to release the drive spring release latch arrangement after a magnitude of relative displacement between the casing and the first unit exceeds a threshold. The adhesive may be configured to secure the first unit to the body while the casing is pulled away from the body and the magnitude of relative displacement between the casing and the first unit increases.

[0017] In some embodiments, the first unit may further include a resilient member. In some embodiments, the resilient member may be aligned with a biasing member on the casing. In some embodiments, the resilient member may be configured to abut a portion of the casing to inhibit relative displacement of the casing and the first unit until a threshold force is exceeded. In some embodiments, the portion of the casing may be a biasing member, and the elastic member may be an elastic arm included in the body. In some embodiments, the force threshold may be selected such that, when the casing is pulled away from the body, the skin of the body is lifted at least a certain distance from the underlying body structure for the adhesive to adhere before the magnitude of the relative displacement exceeds the threshold. In some embodiments, the force threshold may be selected such that, when the casing is pulled away from the body, the skin of the body is lifted at least a certain distance from the underlying body structure for the adhesive to adhere before the relative displacement of the casing occurs. The first unit then begins. In some embodiments, the force threshold may be selected such that, when the casing is pulled away from the body, the skin of the body is lifted at least a certain distance from the underlying body structure for the adhesive to adhere. In some embodiments, the infusion set base may be releasably coupled to the body. In some embodiments, the infusion set base may be configured to release from the body when the sharps holder is moved to the advanced state. In some embodiments, the inserter assembly may further include a retraction spring. The sharps holder may be movable from the advanced state to the retracted state by the retraction spring. In some embodiments, the inserter assembly may further include a retraction spring release latch arrangement configured to release the sharps holder upon displacement to the advanced state via the drive spring. In some embodiments, the retraction spring release latch arrangement may releasably couple the infusion set base to the body. When the spring release latch arrangement is disengaged, the infusion set base may be released from the body. In some embodiments, the cannula subassembly may be carried on the insertion sharps.

[0018] According to one embodiment of the present disclosure, a cannula subassembly for an infusion set may include a continuous monolithic body including a cannula and a septum housing. The septum housing may have a septum receptacle with a raised region at its bottom. The cannula lumen may be continuous with a sharps guide contained in the raised region. The cannula subassembly may further include a septum including a septum recess with a centering wall section formed as a negative version of the raised region. The cannula subassembly may further include a body with latch arms extending through the septum housing, each including a latch surface that, when engaged, captures cooperating features of the septum housing to capture the septum within the septum housing.

[0019] In some embodiments, the septum housing may include a protrusion arranged to engage a latch of the infusion set base to retain the cannula subassembly within the infusion set base. In some embodiments, the top surface of the wall of the septum receptacle may include a slot recessed therein. In some embodiments, the slot may include two slots positioned opposite each other. In some embodiments, the septum retainer may further include a set of protrusions. In some embodiments, the set of protrusions is sized to be received within the slot recessed in the top surface of the wall defining the septum receptacle. In some embodiments, the set of protrusions obstruct only the top of the slot when received therein, leaving a lower segment of the slot open and exposing the side wall of the septum where at least a portion of the septum is located. In some embodiments, the raised portion of the septum receptacle has a frustoconical outer wall. In some embodiments, the septum housing may include a notch in its side wall configured to engage a latch of the infusion set base to retain the cannula subassembly within the infusion set base. In some embodiments, the monolithic body may be formed via straight-pull molding. In some embodiments, the monolithic body may lack undercut features. In some embodiments, the monolithic body may be polypropylene. In some embodiments, the monolithic body may lack undercut features. In some embodiments, the monolithic body can be polypropylene. In some embodiments, the monolithic body can be PTFE. In some embodiments, the body of the septum retainer can include a channel extending therethrough and sized to receive the nub on the face of the septum. In some embodiments, the sharp guide can be surrounded by a substantially flat peripheral edge at the top of the raised section.

[0020] According to another embodiment of the present disclosure, a cannulated housing for an infusion set may include a continuous monolithic body. The continuous monolithic body may include a cannula. The continuous monolithic body may further include a septum housing having a septum receptacle defined by a side wall and a bottom wall. The septum housing may include a raised region, and the lumen of the cannula is a continuous surface with the raised region. The side wall may have at least one guide extending the length of the septum receptacle and aligned with an opening extending through the bottom of the septum housing.

[0021] In some embodiments, the septum housing may include a protrusion on the outer surface of the sidewall configured to engage with a latch of the infusion set base to retain the cannulated housing within the infusion set base. In some embodiments, the top surface of the wall of the septum receptacle may have a recessed slot therein. In some embodiments, the slot may include two slots that may be positioned opposite each other. In some embodiments, the slots may be configured to receive a pair of protrusions included in the septum retainer to leave a lower segment of each slot open and provide a passage for the volume of the septum receptacle. In some embodiments, the raised portion of the septum receptacle may have a frustoconical outer wall. In some embodiments, the septum housing may include a notch on the outer surface of the sidewall configured to engage with a latch of the infusion set base to retain the cannulated housing assembly within the infusion set base. In some embodiments, the monolithic body may be formed via straight-pull molding. In some embodiments, the monolithic body may lack undercut features. In some embodiments, the monolithic body may be polypropylene. In some embodiments, the monolithic body may be PTFE. In some embodiments, the cannula may include a sharp guide surrounded by a substantially flat peripheral edge at the top of the raised portion. In some embodiments, the shelf may be disposed adjacent to the opening on the exterior surface of the bottom wall. In some embodiments, the wall of the opening may form a catch configured to engage with a protruding ridge on a portion of the septum retainer. In some embodiments, the guide may be recessed in the side wall.

[0022] According to one embodiment of the present disclosure, a method of placing an infusion set on a user's body may include adhering an infusion set base releasably coupled to an inserter assembly to the body, and may further include detaching the inserter assembly from the body. The method may further include lifting the skin from underlying structures of the body via the adhesion of the infusion set as the inserter assembly is pulled away from the body. The method may further include moving a trigger actuator to a trigger of the inserter assembly after the skin has been lifted at least a certain distance. The method may further include driving an insertion sharp through the skin.

[0023] In some embodiments, the method may further include releasing the bias member from an energy-storing state to drive the insertion sharp through the skin. In some embodiments, the method may further include releasing the infusion set base from the inserter assembly. In some embodiments, the method may further include removing the locking member from the inserter assembly and removing the adhesive backing from the infusion set base. In some embodiments, the method may further include releasing the anti-retraction latch to drive the insertion sharp away from the skin. In some embodiments, the method may further include driving a cannula subassembly carried by the sharp insertion into the infusion set base. In some embodiments, driving the cannula subassembly into the infusion set base may include driving a cannula of the cannula subassembly through the skin. In some embodiments, the method may further include inhibiting relative movement between a casing of the inserter assembly and a remainder of the inserter assembly at least when the skin begins to lift.

[0024] According to another embodiment of the present disclosure, a method of placing an infusion set on a user's body may include adhering an infusion set base, releasably coupled to an inserter assembly, to the body. The method may further include separating the inserter assembly from the body. The method may further include separating the inserter assembly from the body. The method may further include displacing the skin from its resting position via the infusion set adhesive as the inserter assembly is separated from the body. The method may further include inhibiting actuation of the trigger until the skin is displaced to a point where the elasticity of the skin exerts a force exceeding a threshold force against the infusion set base. The method may further include moving a trigger actuator to the trigger of the inserter assembly. The method may further include sharply driving the insertion through the skin.

[0025] In some embodiments, the method may further include releasing the bias member from an energy-storing state to sharply drive insertion through the skin. In some embodiments, the method may further include decoupling the infusion set base from the inserter assembly. In some embodiments, the method may further include removing the locking member from the inserter assembly and removing the adhesive backing from the infusion set base. In some embodiments, the method may further include driving the cannula subassembly with the sharps insert toward the skin such that the cannula subassembly is driven into the anti-retraction latch. The method may further include driving the insert sharp away from the skin. In some embodiments, the method may further include driving the cannula subassembly carried by the sharps insert into the infusion set base. In some embodiments, driving the cannula subassembly into the infusion set base can include driving a cannula of the cannula subassembly through the skin. In some embodiments, inhibiting actuation of the trigger can include inhibiting relative movement between a casing of the inserter assembly and a remainder of the inserter assembly at least when the skin begins to displace.

[0026] According to another embodiment of the present disclosure, an inserter assembly may include a first unit including a casing. The inserter assembly may further include a second unit including an infusion set base with an adhesive. The second unit may further include a sharps holder including an inserted sharp. The second unit may further include a trigger. The second unit may further include a body including a drive spring and a cavity in which the sharps holder is at least partially disposed. The sharps holder may be displaceable from a raised state to an advanced state by the drive spring upon activation of the trigger from the first state to the second state. The adhesive may be configured to secure the second unit relative to the body while the casing is separated from the body. The trigger may be prevented from being activated until the magnitude of the relative displacement between the casing and the second unit reaches a threshold.

[0027] In some embodiments, the second unit may further include a resilient member aligned with the bias on the casing. In some embodiments, the second unit may further include a resilient member configured to abut a portion of the casing to inhibit relative displacement between the casing and the second unit until a force threshold is exceeded. In some embodiments, the portion of the casing may be a biasing member, and the resilient member may be a resilient arm included in the body. In some embodiments, the force threshold may be selected so that when the casing is pulled away from the body, the skin of the body is lifted due to adhesion of the adhesive at least a certain distance from its rest position before the magnitude of the relative displacement exceeds the threshold. In some embodiments, the force threshold may be selected so that when the casing is pulled away from the body, the skin of the body is lifted due to adhesion of the adhesive at least a certain distance from its rest position before relative displacement of the casing and the first unit begins. In some embodiments, the force threshold may be selected so that when the casing is pulled away from the body, the skin of the body is lifted due to adhesion of the adhesive at least a certain distance from its rest position ... In some embodiments, the infusion set base can be configured to release from the body when the sharps holder is moved to the advanced state.

[0028] In some embodiments, the inserter assembly may further include a retraction spring. The sharps holder may be movable from the advanced state to the retracted state by a retraction spring. In some embodiments, the sharps holder may be in a different location in the retracted state than in the elevated state. In some embodiments, the inserter assembly may further include a retraction spring release latch arrangement configured to disengage when the sharps holder is displaced to the advanced state. In some embodiments, the retraction spring release latch arrangement releasably couples the infusion set base to the body. Disengagement of the spring release latch arrangement may release the infusion set base from the body. In some embodiments, the cannula subassembly may be carried on the inserter sharps.

[0029] According to another embodiment of the present disclosure, a cartridge for a reusable inserter assembly may include an outer housing. The cartridge may further include an inner housing releasably coupled to the outer housing. The cartridge may further include an infusion set base retainer having an infusion set base retained thereon. The cartridge may further include a sharps holder having an insertion sharp coupled thereto. The cartridge may further include a cannula subassembly attached to the insertion sharp such that the insertion end of the insertion sharp extends from the outlet end of the cannula of the cannula subassembly. The insertion end of the insertion sharp may be within the inner housing.

[0030] In some embodiments, the cartridge may further include a removable barrier member. In some embodiments, the barrier member may be permeable to a sterilant. In some embodiments, the outer housing may be shaped as a cup. In some embodiments, the outer housing may include at least one receptacle, and the inner housing may include at least one displaceable protrusion. In some embodiments, the inner housing may be releasably coupled to the outer housing via engagement of each of the at least one protrusion with a respective one of the at least one receptacle. In some embodiments, each of the at least one protrusion may be included on an unsupported end of a cantilever arm. In some embodiments, each cantilever arm may include an angled protrusion on its unsupported end. The angled protrusion is configured to interact with a biasing member on the reusable inserter assembly such that, when the cartridge is coupled to the reusable inserter assembly, the biasing member biases the cantilever arm and displaces the associated protrusion from engagement with the at least one receptacle. In some embodiments, the cartridge may further include a set of mating pins. In some embodiments, the mating pin may be configured to be received in a retention shoe of the reusable inserter assembly when the cartridge is coupled to the reusable inserter assembly. In some embodiments, the sharps holder may include a terminal flange extending from the internal housing. In some embodiments, the terminal flange may have a circular cross-sectional shape. In some embodiments, the infusion set base may include an adhesive on a surface thereof. The adhesive is covered with a liner or backing. In some embodiments, the internal housing may include a recess that provides a depression in which the pull tab of the liner is positioned. In some embodiments, the infusion set base retainer may include a cavity in which a majority of the inserted sharps holder is positioned. In some embodiments, the cavity may include a guide, and the inserted sharps holder may include a rail that cooperates with the guide to constrain displacement of the inserted sharps holder within the cavity to a predetermined path.

[0031] According to another embodiment of the present disclosure, a cartridge for a reusable inserter assembly may include a container. The cartridge may further include a housing releasably coupled within the container. The housing may include a bay. The cartridge may further include an infusion set base disposed within the bay. The cartridge may further include a retainer including a set of cantilever arms and a cavity. The infusion set base may be releasably coupled to the retainer body via the set of cantilever arms. The cartridge may further include a sharps holder having an insert sharp coupled thereto. The sharps holder may be configured to displace along a guide included in the cavity. The cartridge may further include a cannula subassembly attached to the insert sharp such that an end of the cannula subassembly is adjacent to a first end of the sharps holder.

[0032] In some embodiments, the cartridge further includes a barrier member that can surround the housing together with the container. In some embodiments, the cartridge further includes a set of mating pins. In some embodiments, the mating pins can be configured to be received by a retaining shoe of the reusable inserter assembly when the cartridge is coupled to the reusable inserter assembly. In some embodiments, the sharps holder can include a terminal flange extending from the housing. In some embodiments, the terminal flange can have an oval cross-sectional shape. In some embodiments, the bay can include at least one notch, and the infusion set base can include at least one tube retainer. Each tube retainer of the infusion set base can be positioned within one of the notches in the bay. In some embodiments, the cannula subassembly can include a protrusion positioned to engage a latch of the infusion set base to retain the cannula subassembly within the infusion set base when the cannula subassembly is displaced into the receiving cavity of the infusion set base. In some embodiments, the cannula subassembly may include a notch positioned to engage a latch on the infusion set base to retain the cannula subassembly within the infusion set base when the cannula subassembly is moved into the receiving cavity within the infusion set base. In some embodiments, the retainer may be coupled to the housing via a snap-fit ​​engagement. In some embodiments, the cantilever arms may be configured to be displaced to a spread-apart state when the cannula subassembly is displaced toward the infusion set base to release the infusion set base with the ears of the cannula subassembly. In some embodiments, the housing may include a recess in which an adhesive-backed pull tab is positioned to cover the adhesive on the infusion set base. In some embodiments, the housing may include at least one set of stop surfaces.

[0033] According to another embodiment of the present disclosure, a cartridge for a reusable inserter assembly may include a container. The cartridge may further include a housing including a spring-loaded tab. The housing may be coupled within the container with the spring-loaded tab in a first state and released from the container with the spring-loaded tab biased from the first state to a biased state. The cartridge may further include a retainer body including a cavity, a set of retention arms, and an end plate having a mating pin protruding therefrom. The cartridge may further include a medical instrument. At least a portion of the medical instrument may be retained by the retention arms. The cartridge may further include an insert sharp. The cartridge may further include a sharp holder configured to displace along a guide included in the cavity. The insert sharp can be coupled to the sharp holder.

[0034] In some embodiments, the spring tab may be included in a resilient cantilever arm. In some embodiments, the cartridge may further include a second spring tab opposite the spring tab. In some embodiments, the medical device may be an analyte sensor. In some embodiments, the medical device may be a physiological monitor. In some embodiments, the medical device may be an infusion set. The infusion set may include an infusion set base and a cannula subassembly. In some embodiments, the infusion set base may be held by a retaining arm, and the cannula subassembly may be placed on an insertion sharp and separated from the infusion set base. In some embodiments, the cannula subassembly may include a pair of ears. The retaining arm may be configured to be displaced to a spread-apart state so that the ears of the cannula subassembly release the infusion set base when the sharp holder is displaced toward the infusion set base. In some embodiments, the infusion set base may include an opening therethrough. In some embodiments, the infusion set base may have an adhesive bonded thereto. The adhesive may be covered with an adhesive backing. At least one of the adhesive and the adhesive backing may extend across and cover the opening. In some embodiments, the sharps holder may include a terminal flange configured to mate with an insertion driver of the reusable inserter assembly. In some embodiments, the mating pin may be configured to mate with a retention shoe included in the inserter assembly. In some embodiments, the cartridge may further include an adhesive backing that covers an adhesive on a portion of the medical device. The housing may include a recess in which a pull tab of the adhesive backing is located. In some embodiments, the housing may include a set of stop surfaces configured to interact with a locking member of the inserter assembly to lock the housing from rotational displacement when the inserter assembly and the housing are coupled. In some embodiments, the container may be configured to displace the locking member when pressed against the inserter assembly to unlock the housing from rotational displacement. In some embodiments, the spring-loaded tab can be configured to be biased to a deflected state upon coupling the cartridge to the inserter assembly. In some embodiments, the medical device can include an adhesive patch coupled thereto. The adhesive patch may be covered with a release liner.

[0035] According to another embodiment of the present disclosure, an inserter assembly may include a first unit. The inserter assembly may further include a second unit. The first unit may be displaceable relative to the second unit. The inserter assembly may further include an insertion bias member configured to transition to a stressed state when the first unit is pressed against the second unit. The inserter assembly may further include a retainer configured to engage with a first latch that maintains the insertion bias member in the stressed state when the first unit is displaced toward the second unit beyond a first threshold distance. The inserter assembly may further include an insertion driver included in the second unit and displaceable from a first position to an extended position. The inserter assembly may further include a release finger included in the first unit. The release finger may be configured to remove the insertion driver from the insertion driver latch, which releases the insertion bias member from the stressed state, when the first unit is retracted from the second unit beyond a second threshold distance. The insertion bias member, when released from a stressed state, can urge the insertion driver from the first position to the extended position. The insertion driver, when moved to the extended position, can disengage the first latch.

[0036] In some embodiments, the inserter assembly may be needleless. In some embodiments, the inserter assembly may not include an insertion sharp. In some embodiments, the inserter assembly may further include at least one retraction bias member. In some embodiments, the at least one retraction bias member may be configured to transition to a stressed state when the first unit is pressed against the second unit. In some embodiments, the at least one retraction bias member may be maintained in a stressed state when the retainer is engaged with the first latch. In some embodiments, the at least one retraction bias member may be released from the stressed state when the first latch is released when the inserter driver is advanced to the extended position. In some embodiments, the insertion driver may be displaced to the first position when the at least one retraction bias member transitions from the stressed state to the relaxed state. In some embodiments, the release finger may include a paddle body having a first side and a second side. The first side may be more medial with respect to a longitudinal axis of the inserter assembly. In some embodiments, the second unit may include a director wedge that protrudes into the displacement path and is followed by a release finger when the first unit is displaced relative to the second unit. In some embodiments, the first and second sides of the paddle body may include sloped portions. At least one of the sloped portions may be configured to contact the director wedge and deflect the release finger away from the insertion driver latch when the first unit is pushed toward the second unit. In some embodiments, the first and second sides of the paddle body may include sloped portions, and at least one of the sloped portions may be configured to contact the director wedge and deflect the release finger into the insertion driver latch when the first unit is pulled away from the second unit. In some embodiments, the insertion driver may include a port configured to mate with the insertion sharps holder. In some embodiments, the second unit may include a receptacle body coupled thereto. The receptacle body may be disposed at an end of the second unit.In some embodiments, the receptacle body may include at least one retention interface configured to mate with a mating protrusion on the disposable cartridge. In some embodiments, the first latch may include a pair of arms, each having a latch ledge. The pair of arms may be cantilevered from a main portion of the latch body. In some embodiments, the inserter driver latch may include a protrusion extending into a notch on a cantilevered arm extending from the insertion driver body. In some embodiments, the second threshold distance may be measured from a position of the first unit after the first unit has been displaced the first threshold distance. In some embodiments, the second unit may include a receptacle body configured to mate with any of an infusion set cartridge, a sensor cartridge, and a lancet cartridge.

[0037] According to one embodiment of the present disclosure, an inserter assembly may include an outer housing and a cap coupled to an end thereof. The inserter assembly may further include an inner housing. The outer housing and the cap may be displaceable relative to the inner housing. The inserter assembly may further include an insertion driver included in the inner housing and movable from a retracted position to an extended position. The inserter assembly may further include an insertion bias member housed in a portion of the insertion driver and configured to transition to a stressed state when the outer housing and the cap are displaced toward the inner housing. The inserter assembly may further include a retainer configured to engage with a first latch that maintains the insertion bias member in a stressed state when the outer housing and the cap are displaced toward the inner housing to the ready position. The inserter assembly may further include a release finger protruding from the cap configured to remove the insertion driver from an insertion driver latch that releases the insertion bias member from the stressed state when the outer housing and the cap are pulled from the ready position beyond a threshold distance. When released from the stressed state, the insertion bias member can urge the insertion driver from the first position to the extended position. When the insertion driver is moved to the extended position, it can disengage the first latch.

[0038] In some embodiments, the inserter assembly may not include an insertion sharp. In some embodiments, the inserter assembly may be needleless. In some embodiments, the inserter assembly may further include at least one retraction bias member. In some embodiments, the at least one retraction bias member may be configured to transition to a stressed state when the outer housing and the cap are pressed against the inner housing. In some embodiments, the at least one retraction bias member may be maintained in a stressed state when the retainer is engaged with the first latch. In some embodiments, the at least one retraction bias member may be released from the stressed state when the first latch is disengaged. In some embodiments, the insertion driver may move to a stowed position when the at least one retraction bias member transitions from the stressed state to the relaxed state. In some embodiments, the release finger may include a paddle body having a first side and a second side. The first side may be more medial with respect to a longitudinal axis of the inserter assembly. In some embodiments, the inner housing may include a director wedge that protrudes into a displacement path and is followed by a release finger when the outer housing and cap are displaced relative to the inner housing. In some embodiments, the first and second sides of the paddle body may include sloped portions. At least one of the sloped portions may be configured to contact the director wedge and deflect the release finger away from the insertion driver latch when the outer housing and cap are pushed toward the inner housing. In some embodiments, the first and second sides of the paddle body may include sloped portions. At least one of the sloped portions may be configured to contact the director wedge and deflect the release finger into the insertion driver latch when the outer housing and cap are pulled away from the inner housing. In some embodiments, the insertion driver may include a port configured to mate with an insertion sharps holder. In some embodiments, the inner housing may include a receptacle body coupled thereto. The receptacle body may be disposed at an end of the inner housing.In some embodiments, the receptacle body may include at least one retention interface configured to mate with a mating protrusion on the disposable cartridge. In some embodiments, the receptacle body may include at least one retention shoe configured to mate with a mating pin on the disposable cartridge. In some embodiments, the first latch may include a pair of arms, each having a latch ledge, the arms cantilevered from a main portion of the latch body. In some embodiments, the inserter driver latch includes a protrusion extending into a notch on a cantilevered arm extending from the body of the insertion driver.

[0039] According to one embodiment of the present disclosure, an inserter assembly may include a first portion. The inserter assembly may further include a second portion. The first portion may be displaceable relative to the second portion. The inserter assembly may further include an insertion driver included in the second portion. The inserter assembly may further include an insertion bias member included in the second portion configured to bias the insertion driver from the retracted state to the extended state when the insertion bias member is in a stressed state. The inserter assembly may further include a retainer included in the second portion. The inserter assembly may further include a first latch included in the second portion. The inserter assembly may further include an insertion driver latch included in the second portion. The insertion driver may be releasably engageable with the insertion driver latch. Displacing the first portion toward the ready position toward the second portion stresses the insertion bias member, and the retainer may engage the first latch to maintain the insertion bias member in the stressed state. Displacement of the first portion beyond a threshold distance away from the ready position can disengage the insertion driver from the insertion driver latch, releasing the insertion bias member from the stressed state.

[0040] In some embodiments, the first latch may include a set of cantilevered arms having a catch ledge. In some embodiments, the inserter driver may include a body having a width greater than the separation distance between the arms of the set of cantilevered arms. When the insertion driver is in the extended position, the body may spread the arms apart. In some embodiments, the insertion driver may include a body having a width greater than the separation distance between the arms of the set of cantilevered arms. The body may be configured to actuate the cantilevered arms from engagement with the retainer when the insertion driver is in the extended position. In some embodiments, the insertion bias member may be housed within a portion of the inserter driver. In some embodiments, the insertion driver may include a port configured to mate with an insertion sharp holder through which the insertion sharp extends. In some embodiments, the insertion driver may include at least one cantilevered arm. The at least one cantilevered arm may include a notch. In some embodiments, the inserter assembly may be without an insertion sharp. In some embodiments, the inserter assembly may not include an insertion sharp. In some embodiments, the insertion driver latch may be a protrusion extending from the housing of the second portion. The protrusion may extend into the notch. In some embodiments, the first portion may include a release finger and the second portion may include a deflection wedge. The deflection wedge may be configured to deflect the release finger against a portion of the insertion driver to disengage the insertion driver from the insertion driver latch when the first portion is displaced beyond a threshold distance. In some embodiments, the second portion may include a receptacle for one of a list consisting of a disposable infusion set cartridge, a disposable analyte sensor cartridge, and a lancet cartridge. In some embodiments, the second portion may include a receptacle including at least one mating interface for a mating protrusion of the disposable cartridge. In some embodiments, the insertion bias member may be in a relaxed state when the inserter assembly is in a storage state. In some embodiments, the insertion bias member may be a polymer spring.In some embodiments, the insertion bias member may be an injection molded spring. In some embodiments, the insertion bias member may be a compression spring. In some embodiments, the inserter assembly may further include at least one retraction bias member. In some embodiments, the at least one retraction bias member may be configured to transition to a stressed state when the first portion is displaced to the ready position. In some embodiments, the at least one retraction bias member may be maintained in a stressed state when the retainer is engaged with the first latch. In some embodiments, the at least one retraction bias member may be released from the stressed state when the first latch is disengaged. In some embodiments, the insertion driver may be displaced to the stowed state when the at least one retraction bias member transitions from a stressed state to a relaxed state.

[0041] According to one embodiment of the present disclosure, a method of placing an infusion set may include coupling an infusion set cartridge to an inserter assembly. The method may further include adhering a portion of the infusion set contained within the infusion set cartridge to an infusion site. The method may further include latching an insertion bias member of the inserter assembly in a stressed state by moving a first portion of the inserter assembly toward a second portion of the inserter assembly. The method may further include releasing the insertion bias member from the stressed state by moving the first portion of the inserter assembly away from the second portion of the inserter assembly. The method may further include propelling an insertion driver and an insertion sharp of the infusion set cartridge coupled to the insertion driver toward the infusion site. The method may further include releasing the infusion set from the infusion set cartridge.

[0042] In some embodiments, latching the insertion bias member in the stressed state can include pressing a first portion of the inserter assembly against a second portion of the inserter assembly. In some embodiments, latching the insertion bias member in the stressed state can include pressing the first portion of the inserter assembly toward the infusion site. In some embodiments, displacing the first portion of the inserter assembly toward the second portion of the inserter assembly can stress the insertion bias member. In some embodiments, releasing the insertion bias member from the stressed state can include pulling the first portion of the inserter assembly away from the infusion site. In some embodiments, the method can further include lifting skin at the infusion site from an underlying body structure before completing the driving of the insertion driver and the insertion sharp of the infusion set cartridge toward the infusion site. In some embodiments, driving the insertion driver and the insertion sharp toward the infusion site can further include driving a cannula subassembly toward the infusion site. In some embodiments, the method can further include coupling a cannula subassembly of the infusion set to a base of the infusion set. In some embodiments, adhering a portion of the infusion set to the infusion site can include adhering the base of the infusion set to the infusion site. In some embodiments, coupling the infusion set cartridge to the inserter assembly may include moving a mating protrusion included on the cartridge to a retention interface on the inserter assembly. In some embodiments, coupling the infusion set cartridge to the inserter assembly may include detaching an outer housing of the infusion set cartridge. In some embodiments, the method may further include removing the infusion set cartridge from the inserter assembly, and removing the infusion set cartridge from the inserter assembly may include recoupling the outer housing to the infusion set cartridge. In some embodiments, the method may further include detaching the infusion set cartridge from the inserter assembly after the infusion set cartridge has been used.In some embodiments, releasing the infusion set from the cartridge can include biasing a retaining arm of the infusion set cartridge out of engagement with a portion of the infusion set. In some embodiments, biasing the retaining arm can include a drive ear of a cannula subassembly of the infusion set on the retaining arm when the cannula subassembly is urged into engagement with an infusion set base of the infusion set. In some embodiments, coupling the infusion set cartridge to the inserter assembly may include rotationally locking the infusion set cartridge in place in the inserter assembly. In some embodiments, the method may further include retracting the insertion driver and the insertion sharp to a retracted state. In some embodiments, coupling the infusion set cartridge to the inserter assembly may include coupling an insertion sharp holder of the infusion set cartridge to a port of the insertion driver. In some embodiments, displacing a first portion of the inserter assembly toward a second portion of the inserter assembly may stress at least one retraction spring. In some embodiments, the method may further include releasing the at least one retraction spring from a stressed state and urging the insertion driver and the insertion sharp away from the infusion site. In some embodiments, releasing the at least one retraction spring from a stressed state may include urging the insertion driver against a portion of the latch body to unlatch.

[0043] According to one embodiment of the present disclosure, an inserter system may include an inserter assembly including a receptacle including at least one retention interface and an opening therethrough. The inserter assembly may further include an insertion driver displaceable through the opening and displaceable between a retracted position and an extended position. The inserter assembly may further include at least one spring-biased locking member displaceable from a retracted position to an extended position. The system may further include a disposable cartridge including at least one mating projection, a medical device, and at least one set of stop surfaces. Each of the at least one mating projections is configured to rotate to engage a respective one of the at least one retention interface. The at least one set of stop surfaces is configured to abut the at least one locking member when the locking member is in an extended position that inhibits rotation of the disposable cartridge.

[0044] In some embodiments, the at least one locking member may be a resiliently cantilevered member. In some embodiments, the medical device may be an infusion set. In some embodiments, the infusion set may include an infusion set base and a cannula subassembly. The cannula subassembly is separate from the infusion set base. In some embodiments, the medical device may be a lancet. In some embodiments, the medical device may be an analyte sensor. In some embodiments, each of the at least one mating projections may be a mating pin having a head portion with a larger cross-sectional area than a stem portion of the mating pin that couples the head portion to the cartridge. In some embodiments, the at least one retaining interface may be a retention shoe. In some embodiments, each of the at least one retaining interface may be configured to prevent translational displacement of a respective one of the at least one mating projections along a longitudinal axis of the inserter assembly when the respective mating projection is engaged with its retaining interface. In some embodiments, the cartridge may be configured to displace the at least one locking member to a withdrawn position when the at least one mating projection is not engaged with the at least one retaining interface and the cartridge is in contact with the receptacle. In some embodiments, the cartridge may include an inner housing including a tab disposed on the cantilevered portion of the inner housing. The housing may further include an outer housing including a receiving slot for the tab. The inner housing may be coupled to the outer housing when the tab is at least partially disposed within the receiving slot. In some embodiments, the receptacle may include a biasing member. In some embodiments, the biasing member may be configured to bias the cantilevered portion of the inner housing when the mating protrusion engages with the retention interface. When the cantilevered portion of the inner housing is in a deflected state, the outer housing is decoupled from the inner housing. In some embodiments, the at least one set of stop surfaces may be defined by edge walls on either side of at least one of the cantilevered portions. In some embodiments, the insertion driver may include a port.In some embodiments, the cartridge may include a sharps holder coupled to the inserted sharp. The sharps holder may be configured to couple to the port when each of the at least one mating projections engages with a respective one of the at least one retaining interfaces. In some embodiments, the cartridge may include a sharps holder with a terminal flange having a shape that allows it to move into the port when the cartridge is in a first orientation on the receptacle and prevents it from moving out of the port when the cartridge is in a position where each of the at least one mating projections engages with a respective one of the at least one retaining interfaces. In some embodiments, the cartridge may include a sharps holder coupled to the sharp. In some embodiments, the cartridge may include at least one guide. At least a portion of the medical device may be configured to displace along the guide when the insertion driver is displaced from the retracted position to the extended position. In some embodiments, the cartridge may include a first housing and a second housing releasably coupled to the first housing. The second housing may displace at least one locking member to a withdrawn state when the second housing contacts the receptacle. In some embodiments, the inserter assembly may further include an insertion bias member and an insertion driver latch. The insertion bias member may be configured to urge the insertion driver to the extended position when the insertion driver disengages from the insertion driver latch.

[0045] According to one embodiment of the present disclosure, an infusion set base for an infusion set may include a platform portion having a first surface and a second surface on opposite sides thereof. The infusion set base may further include a set of connector finger receptacles extending from the second surface of the platform portion. The infusion set base may further include a set of guides elevated from the second surface of the platform portion. Each guide may include a guide notch recessed therein from the surface of the guide most distal to the second surface of the platform portion. The infusion set base may further include a cannula subassembly receptacle defined by an opening in the platform portion, receptacle walls elevated from the second surface of the platform, and a portion of each guide including a guide notch. The infusion set base may further include a cannula arm included as a section of the receptacle wall, the cantilever arm having a ridge at its unsupported end.

[0046] In some embodiments, the first surface of the platform portion may include an adhesive attached thereto. In some embodiments, the adhesive may be covered by an adhesive backing. In some embodiments, the adhesive backing may extend across the opening and cover the opening. In some embodiments, the first surface of the platform portion may include two annular ridges and a plurality of radially arranged ridges around the periphery of the first surface. In some embodiments, a substrate to which the adhesive is applied may be bonded to the annular ridges and the radially arranged ridges. In some embodiments, the substrate may be welded to the annular ridges and the radially arranged ridges. In some embodiments, the platform may include a plurality of pass-throughs extending therethrough. In some embodiments, the platform portion may include at least one tubing retainer extending from the periphery of the platform portion. In some embodiments, each of the connector receptacles may include a catch for engaging a protrusion on a connector finger of the infusion tube connector. In some embodiments, at least one of the receptacle walls or portions of the guide defining the receptacle may include a tapered portion at its section most distal to the second surface of the platform portion. In some embodiments, the cantilever arm can be configured to deflect when the cannula subassembly is displaced into the cannula subassembly receptacle and can be configured to resiliently recover to a relaxed state such that the protrusion engages a ledge on a protrusion of the cannula subassembly when the cannula subassembly is in an installation orientation within the cannula subassembly receptacle. In some embodiments, the cantilever arm can be configured to deflect when the cannula subassembly is displaced into the cannula subassembly receptacle and can be configured to resiliently recover to a relaxed state such that the protrusion engages a wall of a fenestration in a housing of the cannula subassembly when the cannula subassembly is in an installation orientation within the cannula subassembly receptacle.In some embodiments, the cantilever arm may be configured to deflect when the cannula subassembly is displaced into the cannula subassembly receptacle and to elastically recover to a relaxed state such that the protrusion engages a wall of the cannula housing slot in the cannula subassembly housing when the cannula subassembly is in an installed orientation within the cannula subassembly receptacle. In some embodiments, each of the guides may define a shelf having at least a portion parallel to the second surface of the platform portion. In some embodiments, each shelf may be further proximal to the second surface of the platform portion than a portion of each notch that is most proximal to the second surface of the platform portion. In some embodiments, the cannula subassembly receptacle may be centrally disposed on the platform portion. In some embodiments, the opening may include a protrusion receiving area for receiving a protrusion of the cannula subassembly housing. In some embodiments, each of the guides may include a first portion shelf and a second portion shelf, each extending from a main portion of the respective guide. The first portion shelf can be substantially parallel to the platform portion's second surface, and the second portion shelf can be disposed at an angle relative to the first portion shelf. In some embodiments, the surface of the second portion shelf closest to the platform portion's second surface increases in distance from the platform portion's second surface as the second portion shelf extends distally relative to the first portion shelf. In some embodiments, the guides can extend parallel to each other and each can include an inner surface and an outer surface. The inner surface can be closer to the neutral plane of the infusion set base than the outer surface. In some embodiments, the guides can include a guide ledge disposed on the outer surface of each guide and an additional guide ledge on the inner surface of each guide.

[0047] According to one embodiment of the present disclosure, a tubing connector for fluidly coupling a flow lumen of an infusion tubing to a cannula of an infusion set may include a flow hub having a channel therethrough. The infusion tubing path may be coupled to a first end of the channel, and a spline may be coupled to a second, opposing end of the channel. The spline lumen of the spline may be in fluid communication with the flow lumen. The tubing connector may further include a pair of alignment channels. One of the alignment channels may be recessed into a first side of the flow hub. The other of the alignment channels may be recessed into a second, opposing side of the flow hub. The alignment channel may include a variable-width segment and a constant-width segment proximal to the second end of the channel. The tubing connector may further include a pair of cantilevered connector fingers. A first connector finger of the pair of connector fingers may be coupled to a first side via a first tubing connector body portion, and a second connector finger of the second pair of connector fingers may be coupled to a second, opposing side via a second tubing connector body portion. Each of the connector fingers may include a latching protrusion. The tubing connector may further include at least one sharp abutment protrusion extending from the flow hub parallel to the sharp axis.

[0048] In some embodiments, the at least one sharp adjacent protrusion may include a centrally located adjacent protrusion extending from the top surface of the flow hub across at least a portion of the sharp. In some embodiments, the at least one sharp adjacent protrusion may include a pair of sharp adjacent protrusions located laterally of the sharp. In some embodiments, the at least one sharp side protrusion may include a first sharp side protrusion and a second sharp side protrusion located laterally to the sharp and in the plane in which the connector finger extends. In some embodiments, the first sharp adjacent protrusion may extend parallel to the sharp axis from the first tubing connector body portion, and the second sharp adjacent protrusion may extend parallel to the sharp axis from the second tubing connector body portion. In some embodiments, the first sharp adjacent protrusion and the second sharp side protrusion may each have a protrusion tip. The protrusion tip may be distal to the flow hub from the terminal portion of each connector finger. In some embodiments, the first sharp adjacent protrusion and the second sharp side protrusion may each have a protrusion tip. The tip of the protrusion may be more distal to the flow hub than the terminal portion of each connector finger. In some embodiments, the first sharp abutting protrusion and the second sharp abutting protrusion may each include a curved end region. In some embodiments, the curved end regions may each have a curvature that spans an arc of greater than 90°. In some embodiments, the radius of curvature may be variable. In some embodiments, each curved end region may include a substantially straight extension at its end. In some embodiments, the curved end region may curve in front of and around the end portion of each connector finger of a pair of connector fingers. In some embodiments, the first sharp abutting protrusion may extend parallel to the sharp axis from a first side of the flow hub, and the second sharp abutting protrusion may extend parallel to the sharp axis from a second side of the flow hub. In some embodiments, each of the pair of alignment channels may be configured to ride along a guide ledge of the infusion set base. In some embodiments, the sharp may include a tip. The tip can be clocked in a predetermined rotational direction during assembly of the tubing connector. In some embodiments, the tip can be magnetically clocked in a predetermined rotational direction.

[0049] The details of one or more embodiments are set forth in the accompanying drawings and the description below. Other features and advantages will become apparent from the description, the drawings, and the claims. [Brief explanation of the drawings]

[0050] These and other aspects will become more apparent from the following detailed description of various embodiments of the present disclosure, taken in conjunction with the following drawings.

[0051] [Figure 1A] 1 illustrates an exploded view of an exemplary inserter assembly.

[0052] [Figure 1B] 10 illustrates an exploded view of another exemplary inserter assembly.

[0053] [Figure 1C] 10 illustrates an exploded view of another exemplary inserter assembly.

[0054] [Figure 2]10 illustrates an exploded view of another exemplary inserter assembly.

[0055] [Figure 3] 10 illustrates an exploded view of another exemplary inserter assembly.

[0056] [Figure 4A] 1 shows a perspective view of an exemplary infusion set base.

[0057] [Figure 4B] 4B shows another perspective view of the exemplary infusion set base of FIG. 4A.

[0058] [Figure 5A] 1 illustrates an exploded view of an exemplary cannula subassembly.

[0059] [Figure 5B] 5B illustrates a cross-sectional view of the exemplary cannula subassembly shown in FIG. 5A.

[0060] [Figure 6] 1 shows a perspective view of an exemplary infusion set and tubing connector.

[0061] [Figure 7A] 1 shows a perspective view of another exemplary infusion set base.

[0062] [Figure 7B] 7B shows another perspective view of the exemplary infusion set base of FIG. 7A.

[0063] [Figure 8A] 1 illustrates an exploded view of an exemplary cannula subassembly.

[0064] [Figure 8B] 8B illustrates a cross-sectional view of the exemplary cannula subassembly shown in FIG. 8A.

[0065] [Figure 9]1 shows a perspective view of another exemplary infusion set and tubing connector.

[0066] [Figure 10A] 1 shows a perspective view of an exemplary infusion set base.

[0067] [Figure 10B] 10B shows another perspective view of the infusion set base of FIG. 10A.

[0068] [Figure 11A] 1 shows a perspective view of an exemplary infusion set base.

[0069] [Figure 11B] 11B shows another perspective view of the infusion set base of FIG. 11A.

[0070] [Figure 12A] 1 shows a perspective view of an exemplary infusion set base.

[0071] [Figure 12B] 12B shows another perspective view of the infusion set base of FIG. 12A.

[0072] [Figure 13A] 1 shows a perspective view of an exemplary infusion set base.

[0073] [Figure 13B] 13B shows a bottom plan view of the infusion set base of FIG. 13A.

[0074] [Figure 14A] 1 shows a perspective view of an exemplary infusion set base.

[0075] [Figure 14B] 14B shows a bottom plan view of the infusion set base of FIG. 14A.

[0076] [Figure 15A] 1 illustrates a side view of an exemplary infusion set base.

[0077] [Figure 15B] 15B illustrates another side view of the exemplary infusion set base of FIG. 15A.

[0078] [Figure 15C] 15B shows a perspective view of the exemplary infusion set base of FIG. 15A.

[0079] [Figure 16A] 1 shows a perspective view of an exemplary infusion set.

[0080] [Figure 16B] 16B shows another perspective view of the exemplary infusion set of FIG. 16A.

[0081] [Figure 17A] 1 illustrates a side view of an exemplary inserter assembly with an exemplary locking member mounted therein.

[0082] [Figure 17B] 10 illustrates another side view of an exemplary inserter assembly with an exemplary locking member mounted therein.

[0083] [Figure 18A] 1 illustrates a top view of an exemplary inserter assembly with the outer housing removed.

[0084] [Figure 18B] 1 illustrates a perspective view of an exemplary inserter assembly with its outer housing removed.

[0085] [Figure 18C] FIG. 18B shows a detailed view of a portion of FIG. 18B.

[0086] [Figure 19] 1 illustrates a top view of an exemplary locking member.

[0087] [Figure 20A]1 illustrates a cross-sectional view of an exemplary inserter assembly with an exemplary locking member mounted therein.

[0088] [Figure 20B] 20B shows a detailed view of a portion of FIG. 20A.

[0089] [Figure 21] 1 illustrates a perspective view of an exemplary locking member.

[0090] [Figure 22] 1 shows a flowchart detailing some actions that can be used to operate the inserter assembly.

[0091] [Figure 23] 1 illustrates a top view of an exemplary inserter assembly.

[0092] [Figure 24A-B] 1 illustrates a cross-sectional view of an exemplary inserter assembly about to be applied to a user's skin.

[0093] [Figure 25] 1 shows a side view of an exemplary sharps holder.

[0094] [Figure 26] 19 illustrates another side view of the exemplary sharps holder shown in FIG. 18.

[0095] [Figure 27] 19 illustrates yet another side view of the exemplary sharps holder shown in FIG. 18.

[0096] [Figure 28] 19 shows a perspective view of the exemplary sharps holder shown in FIG. 18.

[0097] [Figure 29] A perspective view of the sharps holder, sharps, and cannula assembly is shown.

[0098] [Figure 30] 1 shows a side view of an exemplary sharps holder.

[0099] [Figure 31] 31 shows another side view of the exemplary sharps holder of FIG. 30.

[0100] [Figure 32] 31 shows a perspective view of the exemplary sharps holder of FIG. 30.

[0101] [Figure 33] FIG. 33 shows a detailed view of the indicated area of ​​FIG. 32.

[0102] [Figure 34] 1 illustrates a perspective view of an exemplary retainer base.

[0103] [Figure 35A] 1 illustrates a perspective view of an exemplary Sharp retractor.

[0104] [Figure 35B] 35B illustrates another perspective view of the exemplary Sharp retractor shown in FIG. 35A.

[0105] [Figure 35C] 35B shows a detailed view of a portion of FIG. 35A.

[0106] [Figure 36] 1 illustrates a cross-sectional view of an exemplary inserter assembly taken through an arm included in a sharp retractor of the inserter assembly.

[0107] [Figure 37] 1 illustrates a perspective view of an exemplary outer housing.

[0108] [Figure 38]38A-B show cross-sectional views of an exemplary inserter assembly including the outer housing shown in FIG.

[0109] [Figure 39A-B] 10A-10C illustrate cross-sectional views of an exemplary inserter assembly being withdrawn from a user after application to the skin.

[0110] [Figure 39C-D] 1 illustrates a cross-sectional view of an exemplary inserter assembly including an additional spring.

[0111] [Figure 40A-B] 10A-10C illustrate cross-sectional views of an exemplary inserter assembly being withdrawn from a user after application to the skin.

[0112] [Figure 41A-B] 10 illustrates a cross-sectional view of an exemplary inserter assembly after a sharp of the inserter assembly has penetrated the skin of a user.

[0113] [Figure 42A-B] 10 illustrates a cross-sectional view of an exemplary inserter assembly after the sharp retractor has been released and retracted.

[0114] [Figure 43A-B] 10A-10C illustrate cross-sectional views of an exemplary inserter assembly during retraction of a sharp retractor.

[0115] [Figure 43C] 10A-10C show cross-sectional views of an alternative embodiment of the inserter assembly.

[0116] [Figure 44A-B] 10 shows a cross-sectional view of the inserter assembly after actuation of the inserter assembly is complete.

[0117] [Figure 45] 1 illustrates a perspective view of an exemplary retainer base.

[0118] [Figure 46] FIG. 1 illustrates a bottom view of an exemplary inserter assembly.

[0119] [Figure 47] 47 shows a cross-sectional view taken at the indicated cutting plane of FIG. 46.

[0120] [Figure 48A-B] 10 illustrates a cross-sectional view of another exemplary inserter assembly about to be applied to a user's skin.

[0121] [Figure 49A] 13 shows a side view of an alternative embodiment of a sharps holder.

[0122] [Figure 49B] 49B shows a perspective view of the sharps holder shown in FIG. 49A.

[0123] [Figure 49C] 49B shows another side view of the sharps holder shown in FIG. 49A.

[0124] [Figure 50] 1 illustrates a perspective view of an exemplary retaining cap.

[0125] [Figure 51] 1 shows a cross-sectional view of an exemplary retainer cap and sharps holder.

[0126] [Figure 52] 51. FIG. 52 shows a detailed view of a portion of FIG.

[0127] [Figure 53A] 1 illustrates a perspective view of an exemplary Sharp retractor.

[0128] [Figure 53B] 53B shows another perspective view of the Sharp retractor shown in FIG. 53A.

[0129] [Figure 54] 1 illustrates a perspective view of an exemplary inserter assembly including a button.

[0130] [Figure 55A] 54 shows a top view of the inserter assembly shown in FIG. 54;

[0131] [Figure 55B] A cross-sectional view taken at section 55B-55B of FIG. 55A is shown.

[0132] [Figure 55C] 55C shows a perspective three-quarter cross-sectional view taken along 55C-55C of FIG. 55A.

[0133] [Figure 56] 1 illustrates a perspective view of an exemplary outer housing of an inserter assembly including a button.

[0134] [Figure 57] 1 illustrates a perspective view of an exemplary inserter assembly with the outer housing of the inserter assembly removed.

[0135] [Figure 58] 1 illustrates a perspective view of an exemplary inserter assembly with the outer housing of the inserter assembly removed.

[0136] [Figure 59] FIG. 59 shows a detailed view of the indicated area of ​​FIG. 58.

[0137] [Figure 60] 1 illustrates a perspective view of an exemplary sled that may be included in the inserter assembly.

[0138] [Figure 61] 1 illustrates a perspective view of an exemplary outer housing of an inserter assembly including a deformable region.

[0139] [Figure 62]10 shows a perspective view of another exemplary outer housing of an inserter assembly including ridges on the inner surface.

[0140] [Figure 63] 10 shows a flowchart detailing several actions that can be used to assemble the inserter assembly.

[0141] [Figure 64] 1A-1C illustrate side views of an example inserter assembly and an example cartridge that can be coupled to the inserter assembly.

[0142] [Figure 65A] 1 illustrates an exploded view of an exemplary cartridge.

[0143] [Figure 65B] 65B illustrates another exploded view of the exemplary cartridge shown in FIG. 65A.

[0144] [Figure 66] 1 illustrates a perspective view of an exemplary infusion set base retainer.

[0145] [Figure 67] 1 illustrates a perspective view of an exemplary inner housing of an exemplary cartridge.

[0146] [Figure 68] 1 illustrates a bottom plan view of an exemplary cartridge.

[0147] [Figure 69A] A cross-sectional view taken at section 69A-69A of FIG. 68 is shown.

[0148] [Figure 69B] 69B shows another cross-sectional view taken at section 69B-69B of FIG. 68.

[0149] [Figure 70A]1 shows an exploded view of an example inserter assembly that may be reusable.

[0150] [Figure 70B] 70B shows another exploded view of the exemplary inserter assembly of FIG. 70A.

[0151] [Figure 71A] 10 shows an exploded view of another exemplary inserter assembly that may be reusable.

[0152] [Figure 71B] 71B shows another exploded view of the exemplary inserter assembly of FIG. 71A.

[0153] [Figure 72] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0154] [Figure 73] 10A-10C illustrate views of an exemplary inserter assembly exploded away from an exemplary cartridge.

[0155] [Figure 74] FIG. 74 shows a detailed view of the indicated area of ​​FIG. 73.

[0156] [Figure 75] FIG. 74 shows a detailed view of the indicated area of ​​FIG. 73.

[0157] [Figure 76] 1 illustrates a perspective view of an exemplary inserter assembly with a cartridge coupled thereto.

[0158] [Figure 77] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0159] [Figure 78] 1 illustrates a perspective view of an exemplary locking member.

[0160] [Figure 79] FIG. 10 is a perspective view of a retractable latch body.

[0161] [Figure 80] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0162] [Figure 81] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0163] [Figure 82] 10 illustrates a view of an exemplary reset body coupled to an exemplary retraction spring retainer.

[0164] [Figure 83] 1 illustrates a top plan view of an exemplary inner housing of an exemplary inserter assembly.

[0165] [Figure 84] 84 shows a cross-sectional view taken along line 84-84 of FIG. 83.

[0166] [Figure 85] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0167] [Figure 86] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0168] [Figure 87] 1 illustrates a top view of an exemplary inserter assembly.

[0169] [Figure 88] 87. A cross-sectional view taken at 88-88 in FIG. 87 is shown.

[0170] [Figure 89] 1 illustrates a cross-sectional perspective view of an exemplary inserter assembly.

[0171] [Figure 90]FIG. 89 shows a detailed view of the indicated area of ​​FIG.

[0172] [Figure 91] 1 illustrates a perspective view of an exemplary inner housing of an exemplary inserter assembly.

[0173] [Figure 92] 1 illustrates a cross-sectional perspective view of an exemplary inserter assembly.

[0174] [Figure 93] 1 illustrates a cross-sectional view of a retaining cap of an exemplary inserter assembly.

[0175] [Figure 94] FIG. 94 shows a detailed view of the indicated area of ​​FIG. 93.

[0176] [Figure 95] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0177] [Figure 96] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0178] [Figure 97] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0179] [Figure 98] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0180] [Figure 99A] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0181] [Figure 99B] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0182] [Figure 100] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0183] [Figure 101] FIG. 10 shows a perspective view of the cartridge coupled to the inserter assembly with the outer housing of the cartridge removed.

[0184] [Figure 102] 1 illustrates a perspective view of an exemplary tubing connector.

[0185] [Figure 103A] 103 shows a bottom-up view of the tubing connector shown in FIG. 102.

[0186] [Figure 103B] A detailed view of a portion of FIG. 103A is shown.

[0187] [Figure 104] 1 shows a perspective view of the tubing connector in place on the device.

[0188] [Figure 105] 105 shows a bottom-up view of the fixture shown in FIG. 104.

[0189] [Figure 106] FIG. 1 shows a perspective view of a tube connector aligned for attachment to a fixture.

[0190] [Figure 107] 1 shows a cross-sectional view of a fixture with a tubing connector attached and a sharp introduced into the tubing connector.

[0191] [Figure 108] 10 shows a cross-sectional view of the fixture with the tubing connector attached and the sharp in place and clocked into position within the tubing connector.

[0192] [Figure 109]1 shows a flowchart detailing some exemplary actions that may be used to assemble a tubing connector. DETAILED DESCRIPTION OF THE INVENTION

[0193] In various embodiments, the infusion set may be used in combination with infusion devices, systems, and related methods, as well as in combination with an inserter assembly. In various embodiments, the exemplary infusion set can be configured to be inserted into the subcutaneous layer of a user's skin and fluidly connected to a fluid source. In various embodiments, the exemplary infusion set can be fluidly connected to a length of tubing and / or an infusion device. The infusion device can include any infusion pump, and can be described in U.S. Patent Application No. 13 / 788,260, filed March 7, 2013, entitled "Infusion Pump Assembly," now U.S. Publication No. US-2014-0107579 (Publication Date: April 17, 2014) (Attorney Docket No. K40); U.S. Patent No. 8,491,570, issued July 23, 2013, entitled "Infusion Pump Assembly," (Attorney Docket No. G75); U.S. Patent No. 8,491,570, issued April 9, 2013, entitled "Fluid Transfer System" (Attorney Docket No. G76); No. 8,414,522 (Attorney Docket No. E70), entitled "Infusion Pump Assembly," issued on September 11, 2012; U.S. Patent No. 8,262,616 (Attorney Docket No. F51), entitled "Infusion Pump Assembly," issued on December 11, 2007; and U.S. Patent No. 7,306,578 (Attorney Docket No. C54), entitled "Loading Mechanism for Infusion Pump," all of which are incorporated herein by reference in their entireties.

[0194] Various embodiments are described and illustrated herein. Each embodiment of each element of each device can be used with any other device embodiment. Each embodiment of the inserter assembly can be used with any embodiment of the infusion set.

[0195] FIG. 1A shows an exploded view of an exemplary embodiment of an inserter assembly 100. An inserter assembly such as inserter assembly 100 can be used to place an infusion set 102 at a patient's infusion site and introduce a cannula 104 of the infusion set 102 into the patient's body. In some embodiments, the inserter assembly 100 can be used to place other patient care assemblies into the patient's body. For example, a particular inserter assembly 100 can be operated to place a physiological monitor into functional relationship with the patient's body. In a particular example, an analyte sensor can be placed into the patient using the inserter assembly 100. The infusion set 102 may be used to deliver medication from an infusion pump to a specific location within a patient's body (eg, subcutaneously).

[0196] The delivered drugs may include drugs delivered as a continuous or substantially continuous infusion, although other drugs may also be used. This may include small molecules, biologics, recombinantly produced pharmaceuticals, and their analogs. Hormones such as insulin or glucagon may be administered via the infusion set 102. Other drugs, such as peptides (e.g., amylin), may be provided. Drugs affecting the cardiovascular system may also be provided via the infusion set 102. As another example, vasodilators such as treprostinil may be delivered to a patient with the infusion set 102. Chemotherapy drugs may also be used. Exemplary physiological monitors may include blood glucose monitors, such as continuous glucose monitors. Other types of body analyte monitors, such as interstitial fluid analyte monitors, may also be used.

[0197] In some embodiments, the inserter assembly 100 can position the infusion set 102 at a site and at least partially assemble the infusion set 102. For example, the infusion set 102 can be provided as several parts (e.g., separate components, subassemblies, or a combination thereof) within the inserter assembly 100. Actuation of the inserter assembly 100 can couple the parts of the infusion set 102 together to complete assembly of the infusion set 102. For example, assembly of the infusion set 102 can occur as an initial stage of actuation of the inserter assembly 100, or can occur as part of an insertion stage of actuation of the inserter assembly 100 that results in the cannula 104 being introduced into the patient.

[0198] As shown in the exploded view of FIG. 1A, the inserter assembly 100 includes the components of the infusion set 102. The inserter assembly 100 may not include the assembled infusion set 102 installed therein. The infusion set 102 may include a first portion and a second portion that are separate from each other but are coupled together to form the infusion set 102 during operation of the inserter assembly 100. The first portion may include a base 106 that is applied to the patient's skin and may be part of an infusion pump or may be coupled to a fluid pathway extending from the infusion pump (e.g., via a terminal connector on the pathway). An exemplary infusion pump may include any one or more of the components disclosed in the various references incorporated by reference above, although in various embodiments, any infusion pump may be used. The base 106 may include an adhesive (e.g., an adhesive pad) that holds the infusion set 102 in place on the patient. The adhesive may be covered with an adhesive backing 111, liner, or film that is removed to expose the adhesive before use.

[0199] The second part of the infusion set 102 may be a subassembly 114 of two or more components of the infusion set 102. The second part may include, for example, the cannula 104, the septum housing 108, the septum 110, and the septum retainer 112. In some embodiments, one or more, if not all, components of the second part may be provided integral with one another, such that the components are manufactured as a single, monolithic part, for example, during a single molding operation. Thus, attaching, fastening, bonding, mounting, or other assembly of these parts after manufacturing may be avoided. The cannula 104 and the septum housing 108 are shown in the exemplary embodiment as such a single, continuous, unitary part. This cannulated housing may be a molded part constructed of a single material, such as, for example, PTFE, Teflon, or polypropylene. Certain components may also be bonded to one another during manufacturing. For example, the septum retainer 112 may be overmolded onto the septum 110, or vice versa.

[0200] As shown in FIG. 1A , the insertion assembly 100 may include several additional components. For example, the insertion assembly 100 may include an outer housing 116. The outer housing 116 surrounds various components of the inserter assembly 100 and may serve as the portion of the inserter assembly 100 that a user grasps during operation. While the outer housing 116 in the exemplary embodiment has a circular cross-sectional shape, other embodiments may have different shapes, such as any type of polygon. In certain examples described elsewhere herein, a rectangular cross-sectional shape may be used to fit easily within a pocket. The cross-sectional area in the exemplary embodiment also varies, with the lower section of the outer housing 116 (closest to the skin during use) being wider than the upper section. The outer housing 116 may include various ergonomic features to facilitate gripping of the inserter assembly 100 in which it is contained. For example, texturing or finger or thumb recesses may be included on the exterior surface of the outer housing 116. Alternatively, or in addition, a region of the outer housing 116 may be thinner in width than the remainder of the outer housing 116. This may facilitate a firm grip on the inserter assembly 100.

[0201] The outer housing 116 may include markings, tabs, embossed sections, recessed sections, textured sections, ridges, color coding, appliqués, or other indicia that serve to indicate the position and / or orientation of the infusion set 102 within the insertion assembly. For example, the outer housing 116 of FIG. 1A includes raised ribs 118 on the outer surface of the outer housing 116. While the raised ribs 118 in the illustrated example extend substantially parallel to the elongation direction of the outer housing 116, in alternative embodiments, they may be disposed on any outer surface of the outer housing 116, or in part. The ribs 118 are positioned to indicate the orientation of a portion of the infusion set 102 to which a fluid conduit from an infusion device may be connected. This may allow the user to position the inserter assembly 100 in a desired orientation after the infusion set 102 is attached to the user, allowing the infusion tubing to be routed in a planned manner.

[0202] The inserter assembly 100 may also include an inner housing 120. The inner housing 120 may be disposed within the outer housing 116 when the inserter assembly 100 is assembled. Various inner housings 120 may have at least one segment designed asymmetrically. In the exemplary embodiment shown in FIG. 1A, the inner housing 120 includes a rail segment 122 including several rails 124. The rails 124 extend substantially parallel to one another and may be of at least two different widths. The inner surface of the outer housing 116 may include tracks or slots that cooperate with the rails 124. The different widths of the rails 124 may provide a keyed arrangement so that the inner housing 120 can only be nested within the outer housing 116 in a predetermined orientation. The interaction of the rails 124 within the tracks may also inhibit rotation of the inner housing 120 and the outer housing 116 relative to one another. While the rails 124 are shown on the inner housing 120 in the example, in some embodiments, the rails 124 may instead be present on the inner surface of the outer housing 116. In such an example, the track may be disposed on the inner housing 120 . Additionally, as shown, at least some of the rails 124 may also form channels or tracks in the interior surface of the inner housing 120 .

[0203] Other embodiments may not use a rail-and-track type arrangement. One of the inner housing 120 or the outer housing 116 may include at least one protrusion, such as a tab, that interfaces with a recess or guide in the other. This may similarly provide keyed engagement and prevent relative rotation. In other embodiments, the cross-sectional shapes of the inner housing 120 and the outer housing 116 may only allow the parts to be placed together in one direction and may inhibit any relative rotation. For example, the cross-sections may be teardrop-shaped or various asymmetric polygonal shapes.

[0204] Inner housing 120 may also include an infusion set base interface segment 126. This base interface segment 126 may include several protrusions 352 that may ensure that base 106 can only be inserted into inserter assembly 100 in a desired orientation. Protrusions 352 may also optionally help retain base 106 within inserter assembly 100, and there may be some friction between protrusions 128 and the surface of base 106 when base 106 is attached to inserter assembly 100. For example, the base 106 can be press-fit onto the protrusions 352. The fit can be minimally airtight so that the base 106 can be removed from the base interface segment 126 with little force. The protrusions 352 can also help maintain the base 106 horizontally within the base interface segment 126.

[0205] The inserter assembly 100 may further include a sharps holder 130 . The sharps holder 130 can hold an insert sharpener 132 thereon. The insert sharpener 132 can be glued or otherwise attached to the sharpener holder 130 so as to be fixedly positioned relative to the sharpener holder 130. Any suitable type of sharpener 132 can be used. For example, the sharpener 132 can be a hollow or solid needle, a stylet, or other pointed member, which may be made of a metallic material such as steel. A sharpener retractor 134 and several springs 136, 138 can also be included in the inserter assembly 100. A retainer base 140 can be coupled to the bottom of the inserter assembly 100 to help hold various components in place within the inserter assembly 100. In this example, the retainer base 140 includes a retention interface 142 that can snap onto a cantilevered retention arm 144 included in the outer housing 116. Other attachments are possible, such as a bayonet mount, an interference fit, a snap fit, adhesives, glue, threads, solvent bonding, welding, etc. When coupled together, outer housing 116 and retainer base 140 may form the casing of inserter assembly 100 .

[0206] As described further later in this specification, a latching arrangement may be included in the inserter assembly 100 to hold the sharps holder 130 and the sharps retractor 134 in place before and during actuation of the inserter assembly 100. The latching arrangement may include several catches. When free to move, the springs 136, 138 may displace the sharps holder 130 and the sharps retractor 134, and the components retained therein, to complete the insertion of the cannula 104 into the patient and attach the infusion set 102 to the infusion site. Retraction of the sharps 132 into the inserter assembly 100 may also occur as part of actuation, displacing the sharps 132 to a point where they are withdrawn from the infusion set 102 and protected from contact with the user.

[0207] When unpacked by a user, the inserter assembly 100 may include a locking member 146. The locking member 146 may be inserted through fenestrations 148, 150 in the outer and inner housings 116, 120, respectively, to span the width of the inserter assembly 100. While present within the inserter assembly 100, the locking member 146 can prevent actuation of the inserter assembly 100. The exemplary locking member 146 can mechanically prevent displacement of one or more components of the inserter assembly 100 and initiate actuation of the inserter assembly 100. In the exemplary embodiment, the locking member 146 includes a flange 152 that can be grasped by a user during removal of the locking member 146.

[0208] As shown, the locking member 146 may include several raised sections 154 (e.g., ridges or bumps) thereon. These raised sections 154 may provide material that can help bond to portions of the adhesive backing 111 during a welding operation. As a result, the locking member 146 may be attached to the adhesive backing 111 so that the user has a visual cue if either the locking member 146 or the adhesive backing 111 is removed while still in place. This may help facilitate removal of both components before actuating the inserter assembly 100 and making the device more intuitive.

[0209] As shown in FIGS. 1B and 1C, in some examples, the inserter assembly 100 may include one or more additional springs 156, 158. As shown in FIG. 1C, the additional spring 158 may be a conventional metal spring. Alternatively, as shown in FIG. 1B, a plastic spring 156 may be used. In certain embodiments, the plastic spring 156 may be injection molded, cut from a tube of material (e.g., by laser cutting), made by a material additive process, or by any other suitable method. Such springs 156, 158 are described further later in this specification.

[0210] Referring now to FIG. 2, another inserter assembly 100 is shown. The inserter assembly 100 of FIG. 2 includes an outer housing 116 that encloses various components of the inserter assembly 100 and can serve as the portion of the inserter assembly 100 that a user grips during operation. While depicted as circular, the outer housing 116 can have other cross-sectional shapes or various ergonomic features, as described above. The outer housing 116 includes a position indicator in the form of a raised rib 118 extending from an outer surface of the outer housing 116. The rib 118 can be positioned to indicate the orientation of a portion of the infusion set 102 contained within the inserter assembly 100.

[0211] The inner housing 120, also included in FIG. 2, can be keyed to ensure secure assembly to the inserter assembly 100 in a predetermined orientation and prevent relative rotation. As shown in FIG. 2, the inner housing 120 can be made asymmetrical by including at least one protrusion 400, such as a tab, that interfaces with a recess or guide 402 in the outer housing 116. In this example, the guide 402 is provided by a channel formed by a raised rib 118 on the inner surface of the outer housing 116. The protrusion 400 on the inserter assembly 100 of FIG. 2 is included in a spacing plate 404 that ensures the inner housing 120 fits snugly within the outer housing 116. An infusion set base interface segment 126 is also included in the exemplary inner housing shown in FIG. 2.

[0212] In the exemplary embodiment, a sharps holder 130 is shown that can be attached to an insertion sharps 132. Additionally, a sharps retractor 134 and several springs 136, 138 can also be included. A retainer cap 406 can be coupled to the top of the inserter assembly 100 to help hold various components in place within the inserter assembly 100. In the example, the retainer cap 406 includes a cantilevered retention arm 408 that can snap into a retention interface 411. Other attachments are possible, such as a bayonet mount, interference fit, snap fit, adhesive, glue, threads, solvent bonding, welding, etc. When coupled together, the outer housing 116 and the retention cap 406 can form the casing of the inserter assembly 100.

[0213] As described in detail elsewhere herein, a latching arrangement may be included in the inserter assembly 100 that can hold the sharps holder 130 and the sharps retractor 134 in place before and during actuation of the inserter assembly 100. The latching arrangement may include several catches. When free to move, the springs 136, 138 can displace the sharps holder 130 and the sharps retractor 134, and the components retained therein, to complete the insertion of the cannula 104 into the patient and attach the infusion set 102 to the infusion site. Retraction of the sharps 132 into the inserter assembly 100 may also occur as part of actuation.

[0214] In the exemplary embodiment shown in FIG. 2, the inserter assembly 100 does not include a locking member 146. However, in various embodiments, the outer housing 116 and the inner housing 120 can include fenestrations similar to the fenestrations 148, 150 of FIGS. 1A-1C to accommodate the locking member 146. In these embodiments, the adhesive backing 111 can be adhered to the locking member 146. However, in embodiments, the adhesive backing 111 includes two pull tabs 410 (although any suitable number may be included). These pull tabs 410 can be grasped by a user to facilitate removal of the adhesive backing 111. An additional spring 158, shown in FIG. 1C, is included in FIG. 2.

[0215] Referring now to FIG. 3 , another exemplary embodiment of an inserter assembly 100 is shown. As shown, the inserter assembly 100 of FIG. 3 includes an outer housing 116 and an inner housing 120 similar to those shown in the example shown in FIG. 2 . The sharps holder 130 and sharps retractor 134 are different from those shown in FIGS. 1A and 2 . A retaining cap 406 may couple to the top of the inserter assembly 100 to hold various components in place within the inserter assembly 100 and function to form the casing of the inserter assembly 100. The retaining cap 406 couples to the outer housing 116 in a manner similar to the embodiment described in connection with FIG. 2 . However, any other type of coupling may be used in alternative embodiments. The retaining cap 406 also includes a protrusion 412 that may fit within a portion of the sharps holder 130 when the inserter assembly 100 is fully assembled and ready for operation.

[0216] As described in detail elsewhere herein, a latching arrangement may be included in the inserter assembly 100 that can hold the sharps holder 130 and the sharps retractor 134 in place before and during actuation of the inserter assembly 100. The latching arrangement may include several catches. When free to move, the springs 136, 138 can displace the sharps holder 130 and the sharps retractor 134, and the components retained therein, to complete the insertion of the cannula 104 into the patient and attach the infusion set 102 to the infusion site. Retraction of the sharps 132 into the inserter assembly 100 may also occur as part of actuation.

[0217] In the exemplary embodiment shown in FIG. 3, the inserter assembly 100 does not include a locking member 146. However, in various embodiments, fenestrations similar to the fenestrations 148, 150 of FIGS. 1A-1C may be included in the outer housing 116 and the inner housing 120 to accommodate the locking member 146. In these various embodiments, the adhesive backing 111 may be adhered to the locking member 146. However, in embodiments, the adhesive backing 111 includes two pull tabs 410. These pull tabs 410 may be grasped by a user to facilitate removal of the adhesive backing 111. The additional spring 148 shown in FIG. 1C may also be included in FIG. 3.

[0218] 4A-B, top and bottom perspective views, respectively, of the infusion set base 106 are shown. As shown, the base 106 may have a platform portion 160. The platform portion 160 may be placed against the patient's skin while the infusion set 102 is in place at the infusion site. In an exemplary embodiment, the platform portion 160 is substantially circular, in this case having a generally circular, disk-shaped footprint. Platform portion 160 is also substantially flat, although this need not be the case in all embodiments.

[0219] In various embodiments, adhesive may be applied to the bottom surface 162 of the platform portion 160. An adhesive backing 111 (see, e.g., FIG. 1A ) may cover the adhesive. In an exemplary embodiment, the bottom surface 162 of the platform portion 160 includes several raised segments 164. The exemplary raised segments 164 are shown as radially arranged ridges spaced at substantially regular angular intervals across a portion of the bottom surface 162. There are also two concentric raised rings around the periphery of the bottom surface 162. In other embodiments, raised segments other than ridges may be included, and / or the raised features may not be radially arranged or regularly spaced. The raised segments 154 may allow for bonding (e.g., ultrasonic or radio frequency welding) of the adhesive to the bottom surface 162. For example, the adhesive may be included on a substrate, which may be a plastic such as polypropylene or any other plastic suitable for welding operations. The raised segments 164 and the substrate can be fused together during a welding operation to create a bond that holds the adhesive on the bottom surface 162 of the infusion set base 106 .

[0220] In various embodiments, the platform portion 160 may include several pass-throughs 166. Three circular pass-throughs 166 are shown in FIGS. 4A-B . However, other examples may include any number, and their shapes may vary. The pass-throughs 166 may be provided to facilitate manufacturing by allowing protrusions on a portion of an assembly line to interface with them. This interface can aid in orienting or centering the base 106 or any infusion set 102 subassembly that includes the base 106 during manufacturing operations. If the pass-throughs 166 aid in orientation, it may be desirable for the pass-throughs 166 to be positioned asymmetrically (although symmetric pass-through 166 positions are also possible). In this example, the pass-throughs 166 are arranged in a triangular-type layout so that the base 106 only mates with a corresponding set of protrusions in one direction. Additionally, in some embodiments, any adhesive and adhesive liner 111 may include holes that align with the locations of the pass-throughs 166. Thus, even when the inserter assembly 100 is fully assembled and ready to be triggered, the pass-through 166 can be used to assist in the manufacturing process. The pass-through 166 can also be engaged by part of any packaging in which the inserter assembly 100 is provided to help hold the inserter assembly 100 in place.

[0221] While the pass-through 166 may be useful during manufacturing, it may also provide other benefits. For example, the pass-through 166 may provide a window for observing the skin around the infusion site. As a result, the user may be able to assess the skin for signs of irritation (such as flushing or redness). Additionally, the pass-through 166 may provide a path by which ambient air may communicate with the space between any raised segments 164 on the bottom surface 162 of the infusion set base 106. This may help the area below the infusion set 102 breathe while the infusion set 102 is attached to the skin.

[0222] Extending from the periphery of the platform portion 160 may be a number of tubing retainers 184. The tubing retainers 184 may allow the infusion tube 366 to be wrapped around a portion of the infusion set 102 and held in place. This may help to inhibit kinking of the tubing 366 and may help the user conveniently route the infusion tube 366 as needed.

[0223] As shown in FIG. 6 , the top surface 168 of the platform portion 160 may include various receiving features extending therefrom that may mate or interface with a connector 368 included at the end of an infusion tube 366 extending from the infusion pump. Infusion tube 366 may, in various embodiments, be coupled to an infusion pump reservoir, such as a syringe or an infusion pump outlet. Infusion tube 366 may be coupled to the infusion pump via a luer lock, other mechanical bond, adhesive, solvent bond, or any other suitable method. The base 106 may include a connector receiver 170 about which a cantilevered finger 370 on the tubing set connector 368 can deflect when the connector 368 is slid onto the base 106. Once past the connector receiver 170, the cantilevered finger 370 can return to an undeflected position. A bump or catch protrusion on the cantilevered finger 370 may be displaced into latching engagement with a cooperating feature of the connector receiver 170. Sharp abutment protrusions 372 may also be present on connector 368. These abutment protrusions 372 may extend substantially parallel to the sharps included on connector 368 and may present an obstacle to help prevent accidental contact between the sharps and a user. Shielding walls 169 may be provided on base 106 to help prevent fingers or objects from inadvertently disengaging cantilevered fingers 370 from engagement with connector receiver 170. Shielding walls 169 may be continuous with connector receiver 170.

[0224] Respective guides 172 for the connector fingers 370 and adjacent protrusions 372 may also be included and, in the exemplary embodiment, define several slots along which the connector fingers 370 and adjacent protrusions 372 can slide as the connector 368 is displaced. The guides 172 can make it easier for a user to couple the infusion set 102 and the connector 368 together. Additionally, the guides 172 can help ensure that sharps on the connector 368 are introduced into the infusion set 102 along or near the desired insertion axis. In this example, the guides 172 include notches 174. Each notch 174 may be sized to receive a protrusion on a component of the inserter assembly 100. The notches 174 may also be sized to receive at least a portion of a protrusion included on the cannula subassembly 114 (see, e.g., FIG. 5A ). The adjacent protrusions 372 may be sized to extend a shorter distance from the connector 368 than the location of the notches 174 when the connector 368 is attached to the infusion set 102. As will be described below, the notch 174 can help facilitate release of the base 106 from the inserter assembly 100 during actuation.

[0225] In various embodiments, the base 106 may also include a receptacle 176 for mating with the cannula subassembly 114 (see, eg, FIG. 5A) of the infusion set 102. In this example, the receptacle 176 generally includes a base 106 and a receptacle 176 flanked on either side by a guide 172. The receptacle 176 may be at least partially surrounded by a receptacle wall 178 that projects upward from the top surface 168 of the platform portion 160. Thus, the receptacle wall 178 and the portion of the guide 172 including the notch 174 may define the receptacle 176. A portion of the receptacle wall 178 may include a cantilever portion 180. The cantilever portion 180 may include a protrusion (e.g., a barb or ramp) 182. The receptacle wall 178 and / or a portion of the guide 172 may include a tapered section (see, for example, the embodiment shown in FIGS. 10A-10B ). A tapered section may be included in the distal-most receptacle wall 178 of the platform 160 and / or in the portion of the guide 172. 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 receptacle 176.

[0226] 5A , an exemplary cannula subassembly 114 is shown. As shown, septum housing 108 may include a notch 186. Notch 186 may be recessed in the exterior surface of septum housing 108. While moving cannula subassembly 114 into receptacle 176 of base 106, base 106 may deflect around septum housing 108 until ridge 182 freely springs back into notch 186. Once cantilevered projection 180 returns to its undeflected state and ridge 182 is positioned within notch 186, cannula subassembly 114 may be retained within base 106. In the retained state, ear or nub 204 of septum housing 108 may reside at least partially within notch 186 of base 106 (shown in FIG. 6 ).

[0227] Referring now to FIG. 5B, which shows a cross-sectional view of assembled cannula subassembly 114, cannula subassembly 114 may, in certain embodiments, further include septum 110 and septum retainer 112. Septum housing 108 may include a cup-like receiving section or receptacle 192 into which septum 110 may be introduced. Receptacle 192 may include a raised region 194 at its center. In this example, raised region 194 may have a frusto-conical shape, although other shapes are possible. Septum 110 may also include a cup-like septum recess 196 included in its bottom surface. Septum recess 196 may include an enlarged or flared-out section 198. Septum recess 196 may include an enlarged or flared-out section 198 formed as a negative version of raised region 194 in receiving section 192 of septum housing 108. Thus, the enlarged section of the septum recess 196, as the septum 110, is introduced into the receiving section 192 and may be referred to herein as the centering wall of the septum recess 196. The second section 200 of the septum recess 196, which is most distal from the bottom surface of the septum 110, defines, at least in part, a fluid introduction volume through which a needle or sharp included in the tubing connector 368 can penetrate to deliver fluid to the infusion set 102. Fluid passes from the fluid introduction volume into the lumen 202 of the cannula 104 and then to the patient. The second section 200 of the septum recess 196 may have any suitable cross-section, but in this example has a circular, approximately circular cross-section. The septum housing 108 may include a connector needle passage 122 in its sidewall (as shown in FIG. 6 ), which may allow the needle or sharp of the connector 368 to access the fluid introduction volume. In the exemplary embodiment, connector needle passage 122 is shown as a fenestration extending through septum housing 108. Connector needle passage 222 and notch 186 may (but need not) be on opposite sides of septum housing 108, allowing cannula subassembly 114 to be attached to base 106 in two orientations. This may make assembly of the inserter assembly 100 easier.

[0228] The receiving section 192 of the septum housing 108 may also receive a portion of the septum retainer 112. The septum retainer 112 may be constructed with a body 206 having at least one cantilevered projection 188 extending therefrom, the cantilevered projection 188 comprising a terminal ridge or latch member. In this example, the body 206 is substantially planar. Additionally, there are two cantilevered projections 188 positioned opposite each other and extending generally perpendicular to the body 206. These cantilevered projections 188 may fit within guides 208 included on the inner surface of the receiving section 192 of the septum housing 108. The illustrated guide 208 is recessed into the inner surface of the receiving section and is substantially flush with the ears 204. The guides 208 are angled such that the distance between the two guides 208 decreases as the distance from the cannula 104 decreases. This can deflect the cantilevered projections 188 of the septum retainer 112 toward the extension axis of the cannula 104 as the septum retainer 112 advances into the receiving section 192. Once the septum retainer 112 advances a certain distance into the septum housing 108, the cantilevered projections 188 can spring outward such that a ridge 190 on each cantilevered projection 188 latches into engagement with a catch 210 on the septum housing 108, as shown in FIG. 5B . In some embodiments, a portion of the cantilevered projections 188 can extend into or through an opening included in the bottom of the septum housing 108 and latch into engagement with a catch adjacent to or formed by the wall of the opening. With the septum retainer 112 latched in place within the cannula subassembly 114, the septum 110 can be placed in sealing relationship with the septum housing 108. Thus, fluid contained in the fluid introduction volume of septum 110 can be provided with a sealed fluid flow path to outlet 212 of cannula 104 .

[0229] As shown, the septum retainer 112 includes a channel 218 extending therethrough. The illustrative channel 218 is located substantially centrally in the body 206. When the septum retainer 112 is locked in place within the cannula subassembly 114, a nub or protrusion 220 of the septum 110 can extend into the channel 218. An access path can be provided for the insertion acute 132 of the inserter assembly 100 to extend from the outlet 212 of the cannula 212 through the infusion set 102.

[0230] The cannula 104 may include an insertion sharp guide section 216 that can help direct the insertion sharp 132 into the lumen 202 of the cannula 104. In an exemplary embodiment, the insertion sharp guide section 216 includes relatively steep sides and is surrounded by a flat (or perhaps chamfered or rounded) peripheral edge that forms the wall of a fluid introduction volume within the infusion set 102. In some embodiments, this peripheral edge may be the top surface of the raised section 192. The insertion sharp guide section 216 may be continuous with the wall of the lumen 202 of the cannula 104 and may be wetted by any fluid delivered through the infusion set 102. The insertion sharp guide section 216 may also be continuous with the raised region 194. The insertion sharp guide section 216 may be continuous with the wall of the lumen 202 of the cannula 104 and may be wetted by any fluid delivered through the infusion set 102. The insertion sharp guide section 216 may also be contiguous with the raised area 194 in the receiving section 192 of the septum housing 108 .

[0231] 5B, a recess 214 may be included in the septum housing 108 that surrounds or at least partially surrounds the cannula 104. This recess 214 may not be covered by the adhesive when the adhesive is placed on the infusion set base 106. The recess 214 may provide room for the cannula 104 to move relative to the base 106 if the infusion set 102 or a portion of the patient's body causes force to be applied to the cannula 104. This may minimize shearing effects on the cannula 104. The recess 214 may function as a volume into which a medication may be placed. For example, an antiseptic, disinfectant, anti-inflammatory, anesthetic, or other topical medication, such as an ointment, may be contained in the recess 214. The medication may be medicinal, nutritional, or some other type of medication. Thus, upon application of the infusion set 102, the medication may be introduced to and held in contact with the patient's skin. In some instances, the medication may remain in contact with the recess 214. This may be beneficial for many reasons, including potentially helping to prevent infection, inflammation, or pain, and may provide a convenient method of applying the medication. In an exemplary embodiment, the recess 214 is shaped as a conical section (e.g., a hyperbola or parabola) that rotates around the central axis of the cannula 104.

[0232] In various embodiments, cannula 104 can be tapered or non-tapered. In some embodiments, cannula 104 can include one or more tapered sections and one or more non-tapered or straight sections. Any tapered section can extend at an angle relative to the longitudinal axis of cannula 104. In some embodiments, instead of being at a constant angle relative to this axis, there can be a curvature. The angle or degree of curvature of the tapered section can also vary over the extent of the tapered section.

[0233] In some embodiments, the first portion of the cannula 104 proximal to the outlet 212 is tapered. The taper present in this section reduces the wall thickness as the cannula 104 approaches the outlet 212. Additionally, the second portion of the cannula 104 tapers adjacent the point on the septum housing 108 from which it extends. The angle of the taper of the second portion may, in certain embodiments, be substantially equal to the angle of the insertion sharp guide section 216. The taper of the second portion reduces the width of the cannula 104 in this section without substantially reducing the wall thickness of the cannula 104 surrounding the lumen 202. In exemplary embodiments, a straight section may be located intermediate the first and second portions of the cannula 104. Alternatively, a slightly tapered section may be used as the intermediate segment. This section may be tapered to a lesser extent than the first and second portions of the cannula and may or may not be tapered in a manner that maintains a constant wall thickness along the length of the intermediate segment.

[0234] 7A-9, another exemplary infusion set 102 is shown. As shown, the cannula subassembly 114 of the exemplary infusion set 102 is designed to allow for manufacturing by straight pull molding. Features that may require a mold with side action or other special characteristics are not present in the exemplary cannula subassembly 114. For example, in some embodiments, undercut features may not be present. This may allow the cannula subassembly 114, or its components, to be constructed from a wider array of different materials.

[0235] As shown, cannula subassembly 114 includes a septum 110 similar to that shown in FIGS. 5A and 5B. Septum housing 108 does not include notches 186. Instead, septum housing 108 includes protrusions 388 extending outward from the exterior surface of septum housing 108. During mating of cannula assembly 104 to infusion set base 106, one of protrusions 388 can deflect cantilevered portion 180 of base 106 until protrusion 182 is free to spring back into a position that protrudes protrusion 388. When cantilevered protrusion 180 returns to its undeflected state and ridge 182 terminates in the protrusion, protrusion cannula subassembly 114 can be retained within base 106. In the retained state (see, e.g., FIG. 9), ears or nubs 204 of septum housing 108 can reside at least partially within notches 186 of base 106. 4A-B to accommodate the larger footprint of the cannula subassembly 114. Additionally, the receptacle 176 includes a protrusion receiving area 398 opposite the cantilevered projection 180 to receive the protrusion 388 not engaged by the ridge 182. The cannula subassembly 114 is made symmetrical, allowing it to be installed on the infusion set base 106 in two orientations. This may help simplify manufacturing and assembly. In other embodiments, protrusion 388 may be included on only one side of cannula subassembly 114, and protrusion receiving area 398 on base 106 may be omitted.

[0236] Further, in the exemplary embodiment, the septum housing 108 does not include a fenestration in its side wall that forms the connector needle passageway 122 (see, e.g., FIG. 6 ). The septum housing 108 of FIGS. 8A-9 includes a slot 390 in the side wall 392 of the septum housing 108 that is recessed into the top surface 394 of the side wall 392. The septum retainer 112 may include a protrusion 396 that aligns with the slot 390 when the cantilevered protrusion 188 is mounted within a guide 208 included within the inner surface of the receiving section 192 of the septum housing 108. When the cannula subassembly 114 is coupled together (see, e.g., FIG. 8B ), the protrusion 396 is mounted within a guide 208 included within the inner surface of the receiving section 192 of the septum housing 108. Thus, an access hole for a sharp or needle included in the tubing connector 368 may be provided in the cannula subassembly 114. The septum retainer 112 also includes several pass-throughs 397. The pass-through 397 may aid in assembly and manufacturing similar to the pass-through 166 in the infusion set base 106 .

[0237] In some embodiments, a slot 390 in a side wall 392 of the septum housing 108 may be used in place of the protrusion 388 as a retention feature that cooperates with a ridge included as part of the base 106. The ridge can hook against or engage with one wall of the slot 390 inhibiting removal of the cannula subassembly 114. In such embodiments, the protrusion 388 may not be included in the septum housing 108. This may help to further simplify the manufacture of cannula subassembly 114.

[0238] 10A and 10B , another exemplary base 106 is shown. As shown in FIG. 6 , the top surface 168 of the platform portion 160 may include various receiving features extending therefrom that may mate or interface with a connector 368. The base 106 may include a connector receiver 170 that may allow the base 106 to mate with cantilevered fingers 370 on a tubing set connector 368, as described above (see, e.g., the description of FIG. 6 ). Guides 172 for each of the connector fingers 370 may also be included in the exemplary embodiment. As shown, the exemplary guides 172 include a first section 171 and a second section 173. The first section 171 of each guide 172 may be positioned to have a portion that extends substantially parallel to the plane of the platform 160. The second section 173 of each guide 172 may include a portion that is positioned at an angle relative to the first section 171. In this example, the first and second portions 171, 173 each include a ledge that projects from the main portion of the guide. The distance between the platform 160 and the proximal surface of the ledge of the second section 173 of the guide 172 can increase as the second section 173 extends distally from the ledge of the first portion of the guide 172. This allows the tubing set connector 368 to initially be introduced at a substantial angle relative to the plane of the platform 160 of the base 106. With further introduction, the connector fingers 370 can contact the platform 160 and be redirected to the appropriate displacement path for mating of the tubing set connector 368. Thus, the guide 172 can help enable a user to blindly insert the connector fingers 370 into the connector receiver 170 when mating of the base 106 and the tubing set connector 368 is performed. As shown, a second set of additional guide ledges 175 can be included on the receptacle wall extension 179. These additional guide ledges 175 can extend to the periphery of the base 106. In the exemplary embodiment, the second set of guide ledges 175 extend substantially perpendicularly from the inner surface 179 of the guide 172 toward the axis along which the sharps 482 of the tubing set connector 368 (see, e.g., Figures 102-106) are inserted into the cannula subassembly 114. The face of each of a second set of guide ledges 175 located near the end of each guide 172 most proximal to the periphery of base 106 may include a sloped region.

[0239] 11A-11B, the tubing set connector 368 can include a flow hub 377 to which the tubing 366 and the sharps 482 (see, e.g., FIGS. 102-106) can be coupled. Fluid flowing through the connector 368 can pass through lumens 514 and 516 (see, e.g., FIGS. 102-106) of the tubing 366 and the sharps 482, respectively, within the flow hub 377. As shown in FIGS. 11A-11B, the flow hub 377 can include an alignment channel 375 embedded therein. As shown, the alignment channel includes a constant-width segment 373 and a variable-width segment 379. Upon coupling of the tubing set connector 368 and the infusion set 102, the alignment channel 375 can interact with a second set of guide ledges 175 on the base 106. The angled section of each of the second set of guide ledges 175 and the variable width section 379 of the alignment channels 375 may allow the tubing set connector 368 to be initially introduced at a substantial angle relative to the plane of the platform 160 of the base 106. Upon further introduction, the second set of guide ledges 175 may contact the walls of the respective alignment channels 375, redirecting the tubing set connector 368 toward the appropriate displacement path for coupling the tubing set connector 368 to the base 106. Thus, the set of guide ledges 175 in conjunction with the alignment channels 375 may help enable a user to blindly couple the base 106 and the tubing set connector 368.

[0240] 12A-12B and 13A-13B, in some embodiments, a sharp-adjacent protrusion 372 may be included as part of the tubing set connector 368. As shown, the sharp-adjacent protrusion 372 can extend parallel to the axis of the sharp 482 (see, e.g., FIGS. 102-106). This may be included in the tubing set connector 368. The sharp-adjacent protrusion 372 can help prevent user contact with the sharp 482 by providing an obstacle that blocks a finger from reaching the sharp 482. The sharp-adjacent protrusion 372 includes a centrally located protrusion 372 that extends from the top surface of the tubing set connector 368 above the sharp 482. The sharp-adjacent protrusion 372 may also include a set of protrusions that are in the same plane as, but positioned inward from, the connector fingers 370 of the tubing set connector 368. In an exemplary embodiment, the connector fingers 370 and this set of protrusions 372 are aligned with the bottom surface of the tubing set connector 368. Each protrusion 372 in the set of protrusions 372 can be positioned to extend from a point on the body of the tubing set connector 368 that is intermediate the flow hub 377 and the connector fingers 370. These protrusions 372 can be positioned to interact with guides 172 on the base 106 during coupling of the tubing set connector 368 to a corresponding base 106. In such an embodiment, the connector fingers 370 may not interact with guides 172 on the base 106.

[0241] 13A-13B, a pair of sharp adjacent protrusions 372 in the plane of the connector fingers 370 can extend beyond the tips 381 of the connector fingers 370. These protrusions 372 can include a curved end region 383 at the end of the protrusions 372 opposite that attached to the body of the tubing set connector 368. The curved end region 383 can be curved transversely to the axis of the sharps 482 (see, e.g., FIGS. 102-106) of the tubing set connector 368. In this example, the curved end region 383 may have a curvature that exceeds a 90° arc. In this example, the curved end region 383 has a curvature such that the curved end region 383 begins to extend rearward toward the body of the tubing set connector 368. The radius of the curved end region 383 may or may not be constant. Additionally, the curved end region 383 may include one or more straight sections. As best shown in FIG. 13B , the portion of the curved end region that terminates in the prongs may be substantially straight. In this example, the curved end region 383 curves around and in front of a portion of each connector finger 370. The distance between the prongs 372 may be slightly smaller than the spacing between the corresponding guides 172 on the base 106. However, the prongs 372 at the curved end region 383 may be slightly larger to facilitate maneuvering the prongs 372 into their respective guides 172. Once the protrusions 372 are positioned within the guide 172, advancement of the tubing set connector 368 causes the protrusions 372 to resiliently spread apart. Due to the resiliency of the protrusions 372, the protrusions 372 press against the surface of the guide 172, ensuring a tight and substantially wiggle-free fit. This can help further limit the displacement of the tubing set connector 368 along a desired path when coupling of the tubing set connector 368 to the base 106 is complete.

[0242] 14A-14B, a set of sharp-side protrusions 372 along the connector fingers 370 can extend from the flow hub 377. This can help reduce the gap between the sharp-side protrusions 372 of the tubing set connector 368, further minimizing a user's ability to access the space near the sharps 482 (see, e.g., FIGS. 102-106) with their fingers. In the embodiment shown in FIGS. 14A-14B, a set of sharp-adjacent protrusions 372 are included extending along and from opposing faces of the flow hub 377 transverse to the axis of the sharps 482. These protrusions 472 can each include a support segment 385. These support segments 385 can be positioned in a region of the sharp-adjacent protrusion 372 that extends beyond the face 387 of the flow hub 377 from which the sharps 482 extend. As shown, the support segment 385 is positioned in the portion of this region most proximal to the flow hub 377. The support segment 385 in the exemplary embodiment includes an arched surface that can provide additional rigidity to the set of sharps adjacent protrusions 372. The surface 387 of the flow hub 377 from which the sharps 482 extend can also be arched, which can add further robustness to the protrusions 372.

[0243] Another exemplary base 106 is shown in Figures 15A-15C. The exemplary base 106 can be coupled to a tubing set connector 368 such as that shown in Figures 14A and 14B. The base 106 can include a connector receiver 170, which can enable the base 106 to mate with cantilevered fingers 370 on the tubing set connector 368, as described elsewhere herein. Although not shown in the exemplary embodiment, guides 172 for each of the connector fingers 370 can be included, as shown in Figures 6 and 10A. As shown, the base 106 can define a receiver track 189 that can receive a pair of sharp adjacent protrusions 372 that lie in the plane of the connector fingers 370. As shown, the receptacle wall extension 179 and the portion of the receptacle wall 178 that extend parallel to one another can be separated from one another by a channel. The receiver tracks 189 are recessed in portions of the receptacle wall 178 that extend parallel to and adjacent the receptacle wall extension 179 and the platform 160. Thus, the width of the channel between the receptacle wall extension 179 and the portion of the receptacle wall 178 may be greatest adjacent the platform 160. The width of the channel may decrease as the distance from the platform 160 increases. As shown, the receiver tracks 189 may each include a sloped wall 191. The sloped wall 191 can aid in locating the sharp-sided protrusion 372 of the tubing set connector 368 within the receiver track 189. Additionally, the base 106 may include a sloped section 193 disposed at the open end of the receiver track 189. The sloped section 193, similar to the second section 173 of the guide 172 in FIGS. 10A-10B , allows the tubing set connector 368 to be initially introduced at a substantial angle relative to the plane of the platform 160. Further introduction may redirect the adjacent protrusion 372 toward the receiver track 189. Thus, the angled wall 191 and angled section 193 may facilitate blind insertion of the tubing set connector 368 into mating relationship with the base 106.

[0244] 16A and 16B, in certain embodiments, the base 106 may not include the receptacle wall 178 having the cantilevered protrusion 180 defined therein (see, for example, FIG. 4A). As shown in FIGS. 16A and 16B, in some examples, the base 106 may include a retaining member 195 extending from the platform 160. The retaining member 195 is freestanding and not supported by or continuous with the receptacle wall 178. In FIGS. 16A and 16B, the retaining member 195 is shown as a hooked body extending from the platform and positioned in an opening between two sections of the receptacle wall 178. In other examples, a hooked body 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 hooked body may include a shank region 197 that is attached to and continuous with the platform 160. The shank region 197 can extend from the platform 160 to the bend region 199. The shank region 197 can be perpendicular to the platform 160 or angled to extend toward the receptacle 176. The hook body can also include a catch segment 201 extending from the bend region 199. The catch segment can be positioned perpendicular to the shank region 197. In this example, the catch segment 201 extends at an acute angle relative to the shank 197. For example, the catch segment 201 can be positioned at a 35-40° angle relative to the shank 197.

[0245] When cannula subassembly 114 is introduced into base 106, septum housing 108 (see, e.g., FIG. 8A ) contacts catch segment 201 and can elastically deform retaining member 195 so that catch segment 201 is bent out of the way. After cannula subassembly 114 is advanced into receptacle 176 beyond a certain point, the engagement surface of septum housing 108 can pass the end of catch segment 201. At this time, catch segment 201 can include at least a portion that overhangs the engagement surface of septum housing 108 after springing back to its unstressed state. Thus, catch segment 201 can inhibit removal of cannula subassembly 114 from base 106. The engagement surface of septum housing 108 can be any suitable engagement surface on any portion of cannula subassembly 118. For example, the engagement surface may be a notch 186 in the septum housing 108 (see, e.g., FIG. 5A), a wall of a fenestration in the septum housing 108 (see, e.g., connector needle passageway 122 in FIG. 6), a wall of a slot 390 included in the septum housing 108, or a protrusion 388 included as part of the septum housing 108.

[0246] Two side views of the inserter assembly 100 are shown in FIGS. 17A and 17B. The inserter assembly 100 in FIG. 17B is rotated 90 degrees clockwise from its orientation in FIG. 17A. The exemplary inserter assembly 100 is an assembled version of the exploded view shown in FIG. 1A. The two views may represent the appearance of the inserter assembly 100 before use and after the inserter assembly 100 has been removed from its shipping / storage package. As shown, the outer housing 116 of the inserter assembly 100 is visible, with the locking member 146 in place. Additionally, an adhesive backing 111 is present and covers the adhesive layer present on the bottom surface 162 of the infusion set base 106. The adhesive backing 111 may include a gripping area 224, which may be a backing material in the form of a flange, tab, or other protrusion, that extends beyond the footprint of the inserter assembly 100. This gripping area 224 can be grasped by a user and used to peel the adhesive backing 111 from the infusion set 106. Once the backing 111 is removed, the inserter assembly 100 can be positioned relative to the desired injection site, using the raised ribs 118 to aid in alignment. The locking member 146 can then be pulled from the inserter assembly 100 to actuate the inserter assembly 100. Because the exemplary adhesive backing 111 is attached to the locking member 146, extraction of the locking member 146 can complete the separation of the adhesive backing 111 from the inserter assembly 100. If the user is dissatisfied with the position of the inserter assembly 100, the user can leave the locking member 146 on the inserter assembly 100 and pull the inserter assembly 100 from the body. The presence of the locking member 146 can prevent actuation when this occurs and may allow the user to select a different injection site.

[0247] 18A-19 show various views of the inserter assembly 100 with the outer housing 116 removed and a view of the isolated locking member (FIG. 19). As shown, when in place within the inserter assembly 100, the locking member 146 can function as a safety. The inserter assembly 100 can be designed so that it cannot be fired until the locking member 146 is removed. The locking member 146 extends the entire width of the inner housing 120 and may overlie other components of the inserter assembly 100. The locking member 146 may be directly adjacent to at least one of the other components to prevent its movement.

[0248] The locking member 146 may include a flange 152 that may be gripped to aid in withdrawal. The locking member 146 may also include a stem portion 226 that protrudes from the flange 152. Stem portion 226 may support a number of arms 228, 230. In the exemplary embodiment, arms 228, 230 are arranged in an "H"-like pattern, with stem portion 226 connected to arms 228, 230 via a crosspiece of the "H." Arms 230 may reside within fenestrations 150 in inner housing 120 distal-most to flange 152. Arms 230 may also include chamfered features 232 that can help guide locking member 146 during installation into inserter assembly 100.

[0249] As shown, the arms 228 can be cantilevered to allow them to deflect inward toward the stem portion 226. The distance between the outer edges of the arms 228 can be greater than the width of the fenestration 150 through which they pass when the locking member 146 is attached to the inserter assembly 100. During attachment, the arms 228 can deflect toward the stem portion 226 to allow them to pass through the fenestration 150. Once past the fenestration 150, the arms 228 can spring outward to an unstressed state. Thus, as shown in FIG. 18C , the width between the outer edges of the arms 228 can be wider than the width of the fenestration 150 when the locking member 146 is in place. This may require some force to remove the locking member 146 from the inserter assembly 100 and may prevent the locking member 146 from inadvertently becoming dislodged. As shown, the arms 228 can include a chamfered region 234. A chamfered region 234 may abut the wall of the fenestration 150 of the inner housing 120 most proximal to the flange 152. The chamfered region 234 may aid in the deflection of the arm 228 toward the stem portion 226 during withdrawal of the locking member 146 from the inserter assembly 100. While an angled chamfer is shown, a rounded or curved region may be included in alternative embodiments.

[0250] In various examples, at least one component of inserter assembly 100 may include at least one locking member restraining member, such as raised bumper 238. In an exemplary embodiment, bumper 238 is included on needle retractor 134 and extends from its top plate 328. Raised bumper 238 may be adjacent to, disposed beside, or disposed adjacent to at least a portion of locking member 146. Thus, bumper 238 may prevent wobbling or pivoting of locking member 146 within inserter assembly 100. A bumper 238 may also be provided to limit the depth to which the locking member 146 can be forced into the inserter assembly 100.

[0251] 20A-21, various views of the inserter assembly 100 with an alternative locking member 146 are shown, as well as a view of the alternative locking member 146 in isolation (FIG. 21). As noted above, when in place within the inserter assembly 100, the locking member 146 functions as a safety device, preventing fire until the locking member 146 is removed. The exemplary 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 inserter assembly 100 to prevent movement. The inner housing 120 may include only one fenestration 150, instead of a pair of opposing fenestrations 150.

[0252] The locking member 146 may include a flange 152 that can be gripped to assist in extraction. The locking member 146 may also include an appendage 376 that protrudes from the flange 152. Tines 378 may be contained within the appendage 376. The tines 378 are cantilevered to the appendage 376 at the portions of the tines 378 most distal from the flange. The tines 378 are also constructed to naturally protrude above a face 380 of the appendage 376, yet are flexible when force is applied to the unsupported ends of the tines 378. As shown, the unsupported ends of the tines 378 include a sloped region 382. The end of the appendage 376 most distal to the flange 152 may also include a chamfered feature 384 that can help guide the locking member 146 during installation on the inserter assembly 100. When the locking member 146 is attached to the inserter assembly 100, the upper wall of the fenestration 150 can bias the tines 378 toward the surface of the appendage 376 to allow the tines 378 to pass through the fenestration 150. After installation of the locking member 146 is complete, the tines 378 can spring back toward their initial, unstressed state. Thus, as best shown in FIG. 20B , a portion of the tines 378 can be disposed above the upper wall of the fenestration 150 when the locking member 146 is in place. This may require some force to remove the locking member 146 from the inserter assembly 100 and may prevent the locking member 146 from inadvertently disengaging. As shown, a ramp 382 may abut the upper wall of the fenestration 150. The ramp 382 can help bias the tines 378 toward the surface 380 of the appendage 376 during withdrawal of the locking member 146 from the inserter assembly 100. Although an angled section 382 is shown, rounded or curved areas may be included in alternative embodiments. A locking member restraining feature similar to the raised bumper 238 shown in Figures 18A-19 may also be included.

[0253] Referring now to FIG. 22 , a flowchart 240 is shown illustrating some exemplary actions that may be performed to place an infusion set 102 in a patient with an inserter assembly 100. Certain inserter assemblies 100, such as the one shown in FIG. 1A , may be designed to be placed on the skin and prevent actuation until the skin is displaced from its normal resting position on the body. Actuation of the inserter assembly 100 may be precluded until some degree of skin displacement occurs. Actuation of the inserter assembly 100 may be inhibited until a certain amount of relative displacement occurs between components of the inserter assembly 100. This relative displacement may occur when the skin is lifted and the inserter assembly 100 is pulled away from the body. Adhesion of the base 106 of the infusion set 102 to the skin may cause displacement of certain components (e.g., at least one component coupled to the base 106) to be limited when the user withdraws the inserter assembly 100. When pulled, the elasticity of the skin can apply a force to the base 106 (and any coupled components) to pull it toward or close to the body. At least one other component of the inserter assembly 100 can be free to displace or have greater freedom to displace when the inserter assembly 100 is removed. Relative movement can, in certain instances, be inhibited until a certain force is exerted by the skin against the base 106. The trigger of the inserter assembly 100 can be held inactive until the skin is pulled away from the rest of the body a sufficient distance to generate the force necessary to initiate relative movement. The trigger may not be activated until the required amount of relative displacement occurs.

[0254] In some embodiments, the inserter assembly 100 may be placed on the skin and trigger actuation when the inserter assembly 100 is lifted and removed. No trigger, button, housing sleeve, or other pressing, twisting, squeezing, or the like of a trigger, button, housing sleeve, or other part of the inserter assembly 100 is required to trigger actuation, although actuation may still be under the control of the user. Relative movement of a free component of the inserter assembly 100 relative to a restricted component can trigger actuation, for example, by moving or removing a latch and releasing one or more biasing members to begin driving actuation. Thus, a trigger internal to the inserter assembly 100 may be actuated as a result of the act of removing the inserter assembly 100 from the body. From the user's perspective, such an inserter assembly 100 can simply be placed on the skin and then withdrawn to perform placement of the infusion set 102.

[0255] In alternative embodiments, a separate manual trigger action can be used to trigger actuation of the inserter assembly 100. Any configuration apparent to one skilled in the art can be used to facilitate manual triggering. The inserter assembly 100 can include one or more buttons that, when displaced, can trigger actuation by disengaging a latch within the inserter assembly 100. Alternatively, a portion of the inserter assembly 100 can be deformable, and compression of the inserter assembly 100 can cause a protrusion that moves with the deformable section to move into the latch to disengage the latch. The button or deformable section can be included in the outer housing 116, for example, in certain instances. A twisting action can be used to trigger actuation of the inserter assembly 100. Such a twisting action of one portion of the inserter assembly 100 (e.g., the casing) relative to another portion (e.g., the remainder of the inserter assembly 100) can sweep the protrusion of the inserter assembly 100 against the latch, disengaging the latch. In other embodiments, a pin or similar member may be withdrawn from the inserter assembly 100 after the inserter assembly is pulled away from the skin to trigger actuation. In embodiments including a locking member 146 (see, e.g., FIG. 19 ), the locking member 146 may be held in place until the user begins to pull the inserter assembly 100 away from the skin. Actuation may be triggered when removal of the locking member 146 allows components of the inserter assembly 100 to displace relative to one another, for example, so that a latch may be released. Various combinations of manual trigger devices may also be used. For example, actuation may be triggered by pressing or pushing a button and then twisting it, or vice versa. Manual triggering may be impossible after the skin is displaced from a resting position and / or until some degree of relative movement between the free and restrictive components of the inserter assembly 100 occurs. Any arrangement apparent to one skilled in the art may be used to facilitate such lockout. For example, an interlock may prevent displacement, twisting, squeezing, etc. of a button until the skin is displaced or until relative movement above a threshold amount occurs. Alternatively, the interlock may block access to a latch within the inserter assembly 100, preventing the latch from disengaging until the skin is displaced or until relative movement above a threshold amount occurs. In some embodiments, displacement, twisting, squeezing, etc. of the button is possible but is disabled by the interlock until the skin is displaced or until relative movement above a threshold amount occurs. As one skilled in the art will appreciate, the embodiments of the inserter assembly 100 described herein may be modified in other ways to enable various types of additional manual actuation schemes.

[0256] Such a design can make trigger actuation simple, intuitive, and more reliable, but other advantages can also be realized. For example, when the inserter assembly 100 is lifted, the inserter assembly 100 can be designed to pull the skin to which the base 106 of the infusion set 102 is attached, away from underlying muscle and other body structures. Thus, upon insertion, the cannula 104 of the infusion set 102 can be more securely positioned within the subcutaneous layer of fatty tissue. This can reduce pain during insertion, minimize bruising, increase the potential body area for injection site selection, and lead to more predictable absorption of medications such as insulin. The skin can also be pulled taut to facilitate easy penetration of the insertion sharp 132 through the skin. Because the skin is passively lifted with the inserter assembly 100, there is no need to generate a pneumatic vacuum. This allows the inserter assembly 100 to be manufactured with less complexity and fewer parts. Furthermore, pneumatic seals, either against the skin or within the inserter assembly 100, may be omitted. Skin lifting may be achieved more reliably because the contours of the body at the injection site (which may present sealing challenges) may be largely irrelevant. Furthermore, pinching the skin to separate it from the underlying structures may not be necessary. This may help make insertion more comfortable, may limit bruising, and may more reliably separate the skin from the underlying structures. The inserter assembly 100 may also ensure that the insertion of the cannula 104 into the skin occurs in a predetermined direction. The skin may be held in place so that it is parallel or perpendicular to a reference plane or axis (e.g., parallel to the bottom surface 162 of the base 106 of the infusion set 102 or perpendicular to the insertion sharp 132 or the axis of the insertion sharp). Therefore, the angle of the inserter assembly 100, or the path along which the inserter assembly 100 is separated from the body, should not change the insertion angle.While the exemplary embodiments shown herein depict an insertion angle substantially perpendicular to the skin, insertion at any angle (greater than 0° up to 90°, e.g., 30°, 45°, 60°, etc.) may similarly be ensured by anchoring the skin relative to a reference plane or axis that moves with the inserter assembly 100. Another potential advantage is that psychological concerns associated with triggering actuation may be reduced. Because the user may not need to depress, twist, squeeze, etc., some actuators, less anxiety may build up in anticipation of triggering actuation. The exact moment of actuation as the inserter assembly 100 is withdrawn may be unknown to the user. This may help limit psychological concerns and may reduce perceived pain.

[0257] 22 , in block 242, the adhesive liner or backing 111 may be removed from the infusion set base 102 held within the inserter assembly 100. The inserter assembly 100 may then be placed at the desired infusion site in block 246, causing the adhesive on the infusion set base 102 to adhere to the patient's skin. It may be desirable to press the inserter assembly 100 against the skin to ensure that the adhesive firmly adheres to the skin. The locking member 146 may be removed from the inserter assembly 100 in block 250. The inserter assembly 100 may begin to be removed from the body at block 254. At block 258, the skin may be pulled away from the underlying muscle and body structures via adhesive bonding. The outer housing 116 and retainer base 140 may also be displaced relative to the remainder of the inserter assembly 100 at block 258. At least one latch within the inserter assembly 100 may be released at block 262. As described above, this may occur automatically or as a result of a manually triggered action. The insertion sharp 132 and cannula subassembly 114 may be driven toward the insertion site at block 266. The cannula subassembly 114 may be coupled to the infusion set base 106 at block 270. Additionally, the catch may be released from the infusion set base 106 at block 270. The act of coupling the cannula subassembly 114 to the set base 106 may cause the catch to be released from the infusion set base 106. The insertion sharp retractor 134 may be driven through a dwell distance (described below) at block 274. The insertion sharp retractor 134 and the insertion sharp 132 may be driven away from the injection site at block 278. Removal of the inserter assembly 100 may be completed at block 282. With removal of the inserter assembly 100 complete, the infusion set 102 is fully assembled and positioned at the injection site. Additionally, the cannula 104 may be positioned in the subcutaneous layer of the skin.

[0258] Referring to FIG. 23 , a top view of the inserter assembly 100 is shown with first and second cross-sectional planes superimposed. The first cross-sectional plane is labeled AA. The second cross-sectional plane is labeled BB. This view is provided for reference purposes in connection with several subsequent views, some of which are cross-sectional views of the inserter assembly 100 taken at either of these planes, showing the inserter assembly 100 in various stages of operation. Unless otherwise noted, if one of the cross-sections of the inserter assembly 100 below is designated by the figure number followed by the letter A, the view shows the cross-section of the inserter assembly 100 at plane AA. If one of the cross-sections of the inserter assembly 100 below is designated by the figure number followed by the letter B, the view shows the cross-section of the inserter assembly 100 at plane BB.

[0259] Two cross-sectional views of the inserter assembly 100 are shown in Figures 24A-B. The inserter assembly 100 is depicted as if about to be applied to the skin 356. The locking member 146 (see, e.g., Figure 21) and adhesive backing 111 (see, e.g., Figure 1A) have been removed in Figures 24A-B. Adhesive 374 is shown on the bottom surface 162 of the infusion set base 106. As shown, both springs 136, 138 may be in an energy storage state, which in this particular embodiment is in a compressed state. In this example, spring 136 functions as an insertion drive bias member, and spring 138 functions as an insertion sharps retraction drive bias member. Spring 136 is held in a compressed state between the insertion sharps holder 130 and the insertion sharps retractor 134, and when released, drives the sharps holder 130 and the components carried therein from a raised state to an advanced state. Spring 138 is held in a compressed state between the inner housing 120 and the sharps retractor 134. When released, spring 138 drives sharps retractor 134 and sharps holder 130 from the post-insertion state to the retracted state.

[0260] 25-29 depict several views of the sharps holder 130. The sharps holder 130 may include a biasing member that receives a bay 290 in which the spring 136 may be positioned. The sharps holder 130 may also include a wall 292 that surrounds the biasing member that receives the bay 290. The wall 292 may include two protrusions 294 on its outer surface. In the exemplary embodiment, the two protrusions 294 are rails positioned opposite each other on the sharps holder 130. These rails can ride along guides 354 (see, for example, FIGS. 35A and 35B) on a portion of the sharps retractor 134. The protrusions 294 can extend from the sharps holder 130 to match the width of the cannula subassembly 114 in the plane of the cannula subassembly 114, including the ears 204 of the septum housing 108.

[0261] In various embodiments, the wall 292 may also include an interrupted area creating one or more cantilevered arms 296. In an exemplary embodiment, the cantilevered arms 296 are positioned opposite one another on the sharps holder 130. One of the cantilevered arms 296 may have a longer length than the other of the cantilevered arms 296. In other embodiments, both cantilevered arms 296 may be identical mirror images (see, for example, FIG. 43C ) to allow easier assembly of the inserter assembly 100. The cantilevered arms 296 may extend above the remaining top surface 298 of the wall 292. Each of the cantilevered arms 296 may include a ridge 300 located at its unsupported or distal end. A ledge 302 may be defined by a portion of each of the ridges 300. At least one of the ledges 302 may extend substantially perpendicular to the cantilevered arms 296. At least one of the shelves 302 may be angled relative to the cantilevered arms 296 that include the undercut area such that the undercut area has a triangular cross-section. In the exemplary embodiment, the shelf 302 of the longer of the two cantilevers 296 is so undercut. The sharps holder 130 may also include a port 304. The port 304 may be used to supply adhesive or glue to the sharps holder 130 to securely hold the inserted sharps 132 in the sharps holder 130.

[0262] An alternative embodiment of the sharps holder 130 is shown in FIGS. 30-33. As shown, the longer of the two cantilevered arms 296 of the sharps holder 130 includes a ridge 300 and a ridge 301. The ridge 301 may be located inside the ridge 300, but may be located on the inside of the ridge 300. As shown, the ridge 300 may be double-beveled. The portion of the ridge 300 adjacent the ledge section 302 may have a steeper bevel than the portion of the ridge 300 distal to the ledge section 302. The ridge 301 may be formed on the portion of the ridge adjacent to the ledge section 302. For example, the ridge 301 is formed as a beveled extension from the portion of the ridge 300 distal to the ledge section 302, extending to the portion of the ridge 300 adjacent to the ledge section 302. Such a ridge 301 may be included in any of the embodiments of the sharps holder 130 shown herein.

[0263] As best shown in FIG. 24B , the longer shelf 302 of the cantilevered arm 296 can rest on a catch 306. The catch 306 in the exemplary embodiment is included in the sharp retractor 134. This can inhibit the release of energy stored in the spring 136 and hold the spring 136 under compression in the exemplary embodiment. The catch 306 can be angled to cooperate with any angle of the ledge 302 to securely hold the ledge 302 on the catch 306. A finger 308 extending from the base retainer 140 of the insertion assembly 100 can extend through a gap 322 adjacent the catch 306 (see, for example, FIG. 35C ). Displacement of the finger 308 relative to the catch 306 can cause the ledge 302 to disengage from the catch 306. While shown as an upright finger 308, other types of actuation protrusions can be used. Additionally, in some embodiments, the fingers 308 or other actuation protrusions may be included on another portion of the inserter assembly 100. For example, the fingers 308 may protrude from the inner surface of the top surface of the outer housing 116.

[0264] 34-35C show several views of the retainer base 140 and the sharp retractor 134. As shown, the fingers 308 of the retainer base 140 (FIG. 34) are formed as a continuous portion of the retainer base 140. The exemplary retainer base 140 includes a first ring portion 310 and a second ring portion 312. The first ring portion 310 and the second ring portion 312 may be connected by an intermediate region 314 and may be concentric with one another. The intermediate region 314 may be generally flat and may serve as a skin-contacting portion of the inserter assembly 100 that is substantially level with the bottom surface 162 of the infusion set base 106. The fingers 308 extend from the second ring portion 312. As shown, the fingers 308 include an upstanding segment 316 and a fin 318.

[0265] In various embodiments, the sharp retractor 134 can include a guide 320 along which the fin 318 can slide during assembly. The guide 320 can also, in certain embodiments, ride along the fin 318 during at least a portion of the retraction of the sharp retractor 134. An exemplary guide 320 is formed as two raised parallel ribs. The catch 306 includes two supports 324 with which the shelves 302 of the cantilevered arm 296 can engage. The supports 324 can include a gap 326 between them. The gap 326 can have a width equal to or greater than the width of the fin 318. The fin 318 can advance through the gap 326 while lifting the inserter assembly 100 from the skin 356, which can cause the fin 318 to become wedged. The guide 320 abuts the ridge 300 of the cantilevered arm 296, forcing the cantilevered arm 296 to bend inward. Once the fin 318 advances a certain distance, the cantilevered arm 296 may be deflected to a point where the ledge 302 no longer engages the catch 306 and the spring 136 may be released. The position of the fin 318 on the finger 308 and / or the height of the finger 308 may be adjusted to change the displacement distance at which release of the ledge 302 from the catch 306 occurs. In embodiments in which the protuberance 300 includes a ridge 302 (see, e.g., FIGS. 30-33 ), the ridge 302 may be sized to fit through the gap 326. Thus, the ridge 302 may increase the total amount of cantilevering. The arm 296 may be deflected by the fin 318, providing additional assurance that the ledge 302 will fully displace from the catch 306. As a result, greater tolerances may be tolerated for various features associated with the catch 306 and the sharps holder 130.

[0266] 24A-B in conjunction with FIGS. 34-35B, spring 138 may also be held in an energy-storing state by at least one latching engagement. As shown, sharp retractor 134 may include a first set of arms 330 and a second set of arms 332. First set of arms 330 may extend from top plate 328 of sharp retractor 134. Further, first set of arms 330 may extend transversely relative to central cavity 334 of sharp retractor 134. In some embodiments, first set of arms 330 may be attached to top plate 328 of sharp retractor 134 at cutout region 336 of top plate 328. Thus, arms 330 may fit within channels formed by rails 124 of inner housing 120 to prevent rotation and guide displacement of sharp retractor 134 during actuation. Additionally, the cutout regions 336 may be asymmetrically included on the sharp retractor 134 to ensure that the sharp retractor 134 is assembled to the inserter assembly 100 in a predetermined orientation. The first set of arms 330 may be cantilevered and attached to a second plate 338 that may extend parallel to and below the top plate 328 and the sharp retractor 134. Thus, the arms 330 may form resilient protrusions that can deflect when sufficient force is applied against them. The unsupported ends of the arms 330 may include a curved or angled section 340. This section 340 may abut a complementary contoured surface of the deflection member 358 to facilitate and / or direct such deflection. A notch or pair of notches 342 may also be present on each of the first set of arms 330. In this example, each arm 330 includes a pair of notches 342 positioned near the unsupported end of the arm 330.

[0267] FIG. 36 shows a cross-section of the inserter assembly 100 taken through one plane of the arm 330 extending along its length. As shown, each of the one or more notches 342 may engage with a cooperating protrusion 344. The cooperating protrusions 344 may be included on the inner housing 120. Thus, the interaction of the notches 342 with the cooperating protrusions 344 may keep the spring 138 under compression and act as an anti-retraction latch. This may be particularly useful during assembly, as the infusion set base 106 may not be in place, otherwise allowing the spring 138 to relax freely. Furthermore, this engagement may ensure that the top plate 328 of the sharp retractor 134 is positioned slightly below the fenestrations 148, 150 to allow for the introduction of the locking member 146. While notches 342 are shown, the arm 330 and inner housing 120 may engage in other ways. For example, the arm 330 or inner housing 120 may include a protrusion forming a ledge. The shelf can engage with a capture recess on the arm 330 or the other of the inner housing 120 .

[0268] 24A-B in conjunction with FIGS. 34-35B, in some embodiments, an additional latch may be included in the inserter assembly 100 to help maintain one of the springs 136, 138 in an energized state. In an exemplary embodiment, the spring 138 is held in an energized state by an additional latch configuration. As shown, the second set of arms 332 of the sharp retractor 134 extend from the bottom of the wall defining the central cavity 334. The second set of arms 332 may be positioned in an opposed relationship to one another and may be cantilevered. Each of the second set of arms 332 may include a ridge 346 disposed on its unsupported end. Each ridge 346 may form a ledge 348 on the arm 332 to which it is attached. Additionally, the arms 332 may include nubs 350 or raised ramps that increase in thickness as the distance from the cavity 334 increases. A nub 350 may be located intermediate the unsupported end of arm 332 and its attachment point to the remainder of the Sharp retractor 134 .

[0269] As best shown in FIG. 24 , the ledge 348 can capture a portion of the infusion set base 106. Specifically, the ledge 348 can hook onto a cutout portion of the infusion set base 106, providing a complementary catch surface for the ledge 348. In certain embodiments, the ledge can hook onto a guide 172 (see, e.g., FIG. 4A ) on the infusion set base 106. Thus, the infusion set base 106 can be retained within the inserter assembly. The ledge 348 can be angled relative to the cantilevered arm 332 within which it is contained so that the undercut has a triangular cross-section. For example, the portion of the guide 172 (or any other catch feature) that each ledge 348 catches can be cooperatively angled to help ensure a secure engagement. The retention base 140 (or the outer housing 116 in the embodiment shown in FIGS. 38A-B) may include a retention protrusion 359 adjacent or nearly adjacent the arm 332, which may retain the arm 332 from displacement out of engagement with the infusion set base 106 before the inserter assembly 100 is actuated. This may help prevent accidental firing of the inserter assembly 100.

[0270] In certain embodiments, only one arm 332 may be included. In some embodiments, the arm 332 on the sharp 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 sharp retractor 134. A latch may also be included that may interface with the guide 172 or another cooperating portion of the infusion set base 106 to hold the infusion set base 106 in place.

[0271] To help ensure that the infusion set base 106 is securely assembled to the inserter assembly 100 in the desired orientation, several standoffs or alignment protrusions 352 may be included in the inserter assembly 100. The standoffs 352 may be located on the inner housing 120 of the inserter assembly 100, as shown. While held by the arms 332 of the sharp retractor 134, the infusion set base 106 may be held so that a surface of the infusion set base 106 is adjacent the standoffs 352. It is prevented from moving within the inserter assembly 100 due to the mechanical interference presented by the standoffs 352. As a result, the capture of the ledges 348 of the arms 332 on the infusion set base 106 can also help retain the energized spring 138. The standoffs 352 may also ensure that the infusion set base 106 is positioned within the inserter assembly 100 so that the adhesive 374 is pressed against the skin 356. In this example, the standoffs 352 ensure that the infusion set base 106 is substantially even with the skin-contacting surface on the retention base 140 .

[0272] With the infusion set base 106 so positioned, it can also function as a protective barrier. Because the cannula subassembly 114 and the insertion sharp 132 can be internal to the inserter assembly 100, the user can be protected from accidental contact with the insertion sharp 132 when the infusion set base 106 is in the initial holding position, preventing contact of the cannula 104 or the insertion sharp 132 with contaminants. The gap for receiving the cannula subassembly 114 can extend throughout the infusion set base 106, but the gap can be sized to prevent finger penetration (e.g., have a cross-section smaller than that of the finger). Thus, the infusion set base 106 can present an obstacle that prevents unintended access to the insertion sharp 132 and the cannula 104. Furthermore, because the cannula subassembly 114 is internal to the inserter assembly 100, the adhesive backing 111 provided on the infusion set base 106 does not include an interruption to allow the cannula 104 to pass through. Thus, the void within the infusion set base 106 of the cannula subassembly 114 may be blocked by the adhesive backing 111 until immediately prior to use. This may further prevent finger penetration and reduce the likelihood of debris entering the inserter assembly 100. In some instances, the adhesive 374 may also extend beyond this opening and be punctured during insertion of the cannula 104 into the skin 356.

[0273] FIG. 37 illustrates an exploded view of the alternative outer housing 116 shown in the embodiment of the inserter assembly 100 of FIG. 2. As shown, instead of the retainer base 140, various features of the retainer base 140 may be included in the outer housing 116. All of these features may be integrally and unitarily formed with one another as a single monolithic component, for example, during a molding operation. As shown, fingers 308 and fins 318 are included as part of the outer housing 116. Fingers 308 may extend from a central ring portion 313 connected by a mid-region 314 to the remainder of the outer housing 116. A biasing member 358 is likewise included as part of the outer housing 116.

[0274] A cross-sectional view of the exemplary embodiment of the inserter assembly 100 of Figure 2 is shown in Figures 38A-B. This inserter assembly 100 includes the outer housing 116 shown in Figure 37. The views of Figures 38A-B show this alternative embodiment of the inserter assembly 100 in the same state as the inserter assembly 100 shown in Figures 24A-B and 36. The inserter assembly 100 shown in Figures 38A-B can operate similarly to the inserter assembly 100 shown in Figures 24A-B and 36. For brevity, the following describes various operational states of the inserter assembly 100 shown in Figures 24A-B and 36.

[0275] 39A-B show two cross-sectional views of the inserter assembly 100. In FIGS. 39A-B, the exemplary inserter assembly 100 is positioned against the skin 356 at the desired injection site and is beginning to be pulled by the user. As shown, the adhesive 374 on the bottom surface 162 of the infusion set base 106 can adhere to the skin 356, such that when the inserter assembly 100 is pulled away from the body by the user, the skin 356 is pulled upward with the inserter assembly 100. The outer housing 116 and retainer base 140 can displace along with the user's hand when the user removes the inserter assembly 100 from the body. Other components of the inserter assembly 100 should not be constrained to displace as a unit with the outer housing 116 and retainer base 140. The infusion set base 106 is in latching engagement with the sharp retractor 134, and the sharp retractor 134 is latched. Engagement with the inner housing 120 and sharps holder 130 allows these components to be held back. During removal, the outer housing 116 and the retainer base 140 may be displaced relative to these components away from the skin 356 substantially along the axis of the insertion acute angle 132. This allows the biasing members 358 included in the retainer base 140 to bend the arms 330 inward, which may also advance the fingers 308 on the retaining ring 140 into the gaps 322 (see, e.g., FIG. 35C ). The resilience of the arms 330 allows the entire inserter assembly 100 to move as a unit for at least part of the withdrawal motion of the inserter assembly 100 from the body. Portions of the inserter assembly 100 may be displaced relative to one another when the force exerted by the elasticity of the skin exceeds a force threshold.

[0276] In various embodiments, the resilience of the arms 330 can at least partially control the distance that a given user's skin 356 is pulled away from the body before actuation of the inserter assembly 100 occurs. As the skin 356 is pulled away from the body, the resilience of the skin 356 can exert a pulling force that presses the arms 330 against the biasing member 358. The type, amount, and / or placement of adhesive 374 on the infusion set base 106 may be selected to withstand this force while maintaining adhesion to and compatibility with the skin 356. If this force overcomes the resilience of the arms 330, the components of the inserter assembly 100 described above may begin to move relative to one another. Alternatively, the fingers 308 may begin to advance into the gap 322. Triggering of actuation may be inhibited prior to this. The resilience may be selected to allow the inserter assembly 100 to be used by a wide range of individuals with different skin 356 characteristics (e.g., elasticity), while ensuring that the skin 356 is pulled at least a minimum distance before actuation is triggered. In some embodiments, the inserter assembly 100 may be manufactured with different arm 330 resiliences that may be suitable for different user groups. For example, arms 330 with less resilience (e.g., geriatric resilience) may be used for older users, whose skin 356 tends to be less resilient.

[0277] The steepness of the sloped section 340 of each arm 330 can be modified to change the amount of force applied before relative movement occurs. A shallower angle of the sloped section 340 can be used when more force is desired before relative movement occurs. A sharper angle on the sloped section 340 can be used when less force is desired. In certain implementations, there may be high (e.g., young), medium (e.g., adult), and low (e.g., elderly) skin elasticity slope angles. Additionally, the thickness of the arms 330 can be varied to alter their elasticity. Thinner arms can be used when less force is desired, and thicker arms can be used when more force is desired. Various support features, such as buttresses, can also be included to support the arms 330 against deflection at points near the supported ends of the arms 330. The location of the second plate 338, in certain instances, can also make the deflectable portions of the arms 330 more or less elastic. The material used to form the arms can also be selected based on its elasticity characteristics.

[0278] The length of the fingers 308 and the position of the fins 318 on the fingers 308 can play a role in controlling, at least in part, the distance that the user's skin 356 is pulled away from the body. These parameters can be altered to change this distance.

[0279] Referring now to Figures 27C-D, two additional cross sections of an exemplary inserter assembly 100 are shown. Each of the exemplary inserter assemblies 100 includes additional springs 156, 158. These springs 156, 158 are described above in connection with Figures 1A-1B. The additional springs 156, 158 can be used to adjust the amount of force accumulated before the fin 318 triggers the initiation of actuation of the inserter assembly 100. The springs 156, 158 can also help eliminate mechanical bias that may exist due to the tolerances of various components of the inserter assembly 100. By varying the characteristics described in the preceding paragraphs, appropriate designs for various patient populations (e.g., young, adult, elderly, or those with high, medium, or low skin elasticity) can be empirically determined. Skin turgor testing, elastomer, or other testing can be used to match the appropriate inserter assembly 100 type to a specific patient.

[0280] 40A-B show two cross-sectional views of the inserter assembly 100. In FIGS. 40A-B, the exemplary inserter assembly 100 has been further withdrawn from the skin 356. The outer housing 116 and retainer base 140 continue to be displaced away from the skin 356 relative to the remainder of the inserter assembly 100. The arms 330 on the retainer base 140 continue to bend inward. The fingers 308 on the retainer ring 140 advance into the gaps 322 (see, e.g., FIG. 35C), causing the fins 318 of the fingers 308 to disengage the cantilevered arms 296 of the sharps holder 130 from the catches 306 (see, e.g., FIG. 35C). Thus, movement of the outer housing 116 and retainer base 140 has advanced the inserter assembly 100 to the insertion release point of FIGS. 40A-B. Once the cantilevered arm 296 disengages from the catch 306 , the spring 136 is free to release its stored energy and begin actuating the inserter assembly 100 .

[0281] Before the magnitude of relative displacement between portions of the inserter assembly 100 increases to this insertion release point threshold, the inserter assembly 100 may be removed from triggering actuation. This may ensure that some skin lift occurs before actuation of the trigger arrangement of the inserter assembly 100 can occur.

[0282] 41A-B show two cross-sectional views of the inserter assembly 100. In FIGS. 41A-B, the illustrative inserter assembly 100 has been further withdrawn from the skin 356. As shown, the restoring action of the spring 136 can drive the sharps holder 130, the insertion sharp 132, and the cannula subassembly 114 along the insertion path toward the skin 356. In the illustrative embodiment, the sharps holder 130 extends at least partially from the cavity 334 of the sharps retractor 130. As shown, the insertion sharp 132 and the cannula 104 have just pierced the skin 356. Upon piercing, the skin 356 may be pulled away from muscle or other underlying body structures. The cannula subassembly 114 has also begun to advance toward the infusion set base 106. Note that the spring 136 is still depicted in a compressed state in the following figures. This is for ease of illustration. As will be appreciated by those skilled in the art, the exemplary spring 136 will expand over the course of the insertion movement. Also, as shown, the retainer base 140 of the inserter assembly 100 may include a stop 364 that prevents relative movement between the inner housing 120 and the casing formed by the outer housing 116 and the retainer base 140 (which may be connected to one another) beyond a certain point. This stop 364 may be included as part of the second ring 312 of the retainer base 140.

[0283] 42A-B show two cross-sectional views of the inserter assembly 100. As shown, the spring 136 has returned to a relaxed state, completing the insertion movement of the sharps holder 130, the insertion sharp 132, and the cannula subassembly 114 into the skin 356. The relaxed state can be a fully relaxed state or a relatively relaxed state. Here, the spring 136 still exerts some pressure on the sharps holder 130 to prevent it from swinging around. The notch 186 on the cannula subassembly 114 is shown engaging with the ridge 182 on the infusion set base 106, locking the cannula subassembly 114 and completing assembly of the infusion set 102. As shown, the ear 204 on the cannula subassembly 114 can press against the nub 350 included in the arm 332 when the cannula subassembly 114 latches to the base 106. This spreads the arms 332, allowing them to disengage from the infusion set base 106. This, in turn, releases the spring 138, initiating the release of stored energy. Thus, Figures 42A-B show the insertion assembly 100 in a retracted, released state, where the arms 332 can function as an anti-retraction latch.

[0284] In certain embodiments, retraction may not be automatic and / or spring-biased. For example, the insertion sharp 132 may remain in the advanced position, and a user removal motion may manually withdraw the insertion sharp 132 from the cannula 104. In such embodiments, the spring 138 may be omitted. In some embodiments, release of the arm 332 from the infusion set base 106 may not be automatic. Any arrangement apparent to one of ordinary skill in the art may be used to facilitate manual separation of the arm 332 from the infusion set base 106. A twisting motion may be used to release the arm 332 from the infusion set base 106, allowing the insertion sharp 132 to subsequently retract automatically or be manually withdrawn. In alternative embodiments, one or more buttons may be included. Displacement of the one or more buttons may disengage the arm 332 from the infusion set base 106 and manually or automatically withdraw the insertion sharp 132 from the cannula 104. Squeezing a deformable portion of the inserter assembly 100 may similarly cause separation. As will be appreciated by those skilled in the art, the embodiments of the inserter assembly 100 described herein can be modified in other ways to allow for various types of other manual arm 332 release schemes.

[0285] In an alternative embodiment in which the infusion set base 106 is held by a portion of the inner housing 120 and the arms 332 engage with the portion of the inner housing 120, displacement of the sharps holder 130 similarly causes release of the infusion set 102 and triggers retraction. For example, the ears 204 may collide with and cause displacement of catch features on the inner housing 120 (e.g., spreading them away from the infusion set 102), thereby disconnecting them from the infusion set 102. Additional ears 204 or other protrusions on the cannula subassembly 114 may be included to cause release of the arms 332 from the inner housing 120 (e.g., via spreading of the arms 332) to enable retraction.

[0286] In certain embodiments, there may be a dwell period during actuation of the inserter assembly 100 during which retraction of the insertion sharp 132 is triggered and the sharps retractor 134 is displaced, but the insertion sharp 132 remains substantially stationary. During this dwell period, the spring 136 may continue to apply pressure to the cannula subassembly 114 through the sharps holder 130. This may block and ensure any tendency for the cannula subassembly 114 to bounce or recoil as it is propelled into the infusion set base 106. As shown, upon completion of the insertion operation, a dwell gap 360 may exist between the stop 362 of the sharps retractor 134 and the shelf 302 of each cantilever arm 296 of the sharps holder 130. The spring 136 may still have energy stored therein and continue to press against the sharps holder 130. The dwell gap 360 on each side may be the same size.

[0287] In FIGS. 43A-B, which show two cross-sectional views of the inserter assembly 100, the retention gap 360 can decrease until the stop 362 on the sharps retractor 134 contacts the ledge 302 of the cantilevered arm 296 on the sharps holder 130. The restoring action of the spring 138 can begin to displace the sharps holder 130 and the insertion sharp 132 mounted thereon, along with the sharps retractor 134. This displacement can retract the insertion sharp 132 from the cannula 104 and infusion set 102. An alternative embodiment of the inserter assembly 100 at this stage of operation is shown in FIG. 43C. In FIG. 43C, the cantilevered arms 296 are mirror images of each other and of equal length. In such an embodiment, the stops 362 on the sharps retractor 134 can be of uniform height relative to each other.

[0288] As shown in FIGS. 44A-B , once retraction is complete, the sharps retractor 134 may be pressed against the outer housing 116 by the spring 138. For ease of illustration, the spring 138 is depicted still in a compressed state, but as will be understood by those skilled in the art, it will uncompress to a relaxed state while retraction is in progress. Similar to the spring 136, the relaxed state may be a fully relaxed state or a relatively relaxed state in which the spring 138 still exerts some pressure on the sharps retractor 134, preventing it from swinging around. After retraction, the insertion sharp 132 may be housed within the inserter assembly 100 to help protect against unintentional finger sticks and the like. In an exemplary embodiment, the insertion sharp 132 is further housed within the inserter assembly 100 after retraction when compared to its starting position. In other embodiments, the retracted position of the insertion angle 132 may be different, but may be housed at least as deep within the inserter assembly 132 as its initial starting position. The infusion set 102 may be held in place on the skin 356 with the cannula 104 remaining in place in the patient.

[0289] 45-47 , in certain embodiments, certain components of the inserter assembly 100 can be locked in place after actuation. Alternatively, certain components can prevent displacement in certain directions or beyond a predefined distance in certain directions. This can inhibit reuse of the inserter assembly 100 and can help protect users from unintentional finger pricks. Some embodiments of the retainer base 140 can include one or more locking members 141. As shown, two locking members 141 are included, but other embodiments can include a greater or lesser number (e.g., three or four). The locking members 141 in the exemplary embodiment are positioned opposite each other on the retainer base 140.

[0290] The exemplary locking member 141 in the exemplary embodiment is shown as a cantilevered locking tab. Each cantilevered tab includes a ridge 143 located on a portion of the locking member 141 most distal to the skin that contacts the intermediate region 314 of the retention base 140. The ridge 143 may be sloped to define a shelf region 145. A portion of the inner housing 120 may contact the sloped portion of the ridge 143 while the inserter assembly 100 is being withdrawn from the skin 356. As shown, the inner housing 120 includes a radial flange 121 that separates the infusion set base interface segment 126 of the inner housing 120 from the rail segment 122 (see FIG. 1A ) of the inner housing 120. This radial flange 121 may be a portion of the inner housing 120 that contacts the ridge 143 of the locking member 141. Further relative displacement may cause deflection of the locking member 141, allowing the radial flange 121 of the inner housing 120 to pass over the ridge. As shown, when radial flange 121 is displaced beyond ridge 143, locking members 141 may resiliently return to their unstressed state, as shown in FIG. 47 . If a user presses inner housing 120 after activation, radial flange 121 may abut ledge 145 of locking member 141 and may be unable to displace further into outer housing 116. Thus, inner housing 120 is restrained after activation, such portion of inner housing 120 being held a predetermined distance from the tip of insertion sharp 132. This portion may present an obstacle that can help prevent inadvertent contact with the user of insertion sharp 132 after activation.

[0291] As shown in FIGS. 48A-B, two cross-sectional views of the exemplary inserter assembly 100 shown in FIG. 3 are shown. The inserter assembly 100 is depicted as if about to be applied to the skin 356. The adhesive backing 111 can be removed to expose the adhesive on the infusion set base 106. As shown, both springs 136, 138 can be in an energized state (in this particular embodiment, a compressed state). In this example, spring 136 functions as an insertion drive bias member, and spring 138 functions as a retraction drive bias member for the insertion sharp 132. Spring 136 is held in a compressed state between the insertion sharp holder 130 and the insertion sharp retractor 134, and when released, drives the sharp holder 130 and the components carried therein from an elevated state to an advanced state. Spring 138 is held in a compressed state between the inner housing 120 and the sharp retractor 134. When released, spring 138 drives sharps retractor 134 and sharps holder 130 from the post-insertion state to the retracted state. Additional spring 158, while optional, is included in the exemplary embodiment. Additional spring 158 can vary the amount of force that builds up before actuation of inserter assembly 100 is triggered and can help eliminate mechanical bias that may exist due to tolerances of various components of inserter assembly 100.

[0292] 49A-52 show several views of sharps holder 130 and retainer cap 406. Sharps holder 130 can include a biasing member that receives a shelf 420 on which spring 136 is retained. Shelf 420 can include two protrusions 422 on its sides. In the exemplary embodiment, the two protrusions 422 are rails positioned opposite each other on sharps holder 130. These rails can ride along guides 354 (see, for example, FIGS. 53A-B) on a portion of sharps retractor 134. Protrusion 422 can extend from sharps holder 130 to match the width of cannula subassembly 114 in the plane of cannula subassembly 114, including ears 204 of septum housing 108.

[0293] The wall 426 can extend upward from the shelf 420. Figures 49A-C include interrupted areas that create one or more wall sections 428. The wall sections 428 can be crescent-shaped as shown, separated by interrupted areas formed by U-shaped recesses that extend from the top surface 430 of the sharps holder 130 to near the shelf 420. The recesses can extend at least 90-95% of the distance from the top surface 430 to the shelf 420. The recesses can allow deflection of the wall sections 428. The wall sections 428 can be positioned opposite each other on the sharps holder 130 and can be the same length. In other embodiments, the wall sections 428 may not be identical mirror images. Each of the wall sections 428 can include a ridge 432 at the end of the wall section 428 opposite the shelf 420. The ridge 432 has a generally pileus-type shape that widens as the distance from the shelf 420 decreases. During assembly, this can facilitate attaching the sharps holder 130 to the insertion assembly 100 via the side of the sharps retractor 134 from which the arms 330, 332 (see, e.g., FIG. 48A ) extend. A ledge section 434 can be defined by a portion of each of the ridges 432. At least one of the ledges 434 can extend substantially perpendicular to the wall section 428. At least one of the ledges 434 can be angled relative to the included wall section 428 such that the undercut region has a triangular cross-section.

[0294] Further, each wall section 428 may include a first section 436 and a second section 438. The first section 436 may have a narrower width than the second section 438 and may be more proximal in area to the shelf 420. The first section 436 and the second section 438 may be connected by an intermediate region 440. The intermediate region 440 may be angled or curved to transition between the different widths of the first section 436 and the second section 438. A nub 442 may be included protruding from the intermediate section 440 or protruding from a portion of the first section 436 and the second section 438 adjacent to the intermediate section 440. Although not shown, a glue or adhesive supply port similar to port 304 of FIG. 26 may be included.

[0295] As shown in FIGS. 50-52 , a protrusion 412, which may be referred to herein as a spreader pin 412, extending from the cap retainer 406 of the insert assembly 100 may protrude into a receiving cavity 444 between the wall sections 428. A tapered region 446 at its end may be hollow or solid. The tapered region 446 may abut an inner surface 448 of the wall section 428 when the spreader pin 412 advances into the sharps holder 130 beyond a certain distance, helping to guide the spreader pin 412 as it displaces into the sharps holder 130. Further displacement of the spreader pin 412 into the sharps holder 130 may cause the wall sections 428 to elastically deflect or spread apart from one another, thus widening the sharps holder 130 to receive the spreader pin 412 therein. This may also increase the distance between the outwardly facing surfaces of the nubs 442 when the spreader pin 412 is present.

[0296] Reference is now made primarily to Figure 1. Figure 48B and Figure 48B and Figure 48B and Figure 48B. 53A-B, nub 442 can interact with another component of inserter assembly 100 to prevent the force exerted by spring 136 against shelf 420 from moving sharps holder 130 to the forward position. In the example shown, nub 442 is sized such that it does not fit into cavity 334 contained in sharps retractor 134 when spreader pin 412 is in place within sharps holder 130. The inner surface of top plate 328 of sharps holder 130 and sharps retractor 134, nub 442, can inhibit the release of energy stored in spring 136.

[0297] 48A-B in conjunction with FIG. 53A-B, spring 138 may also be held in an energy-storing state by at least one latching engagement. As shown, sharp retractor 134 may include a first set of arms 330 and a second set of arms 332. These arms 330, 332 may be as described above in conjunction with FIG. 35A-B. Sharp retractor 134 in this embodiment is shown as having a symmetrical design to allow sharp retractor 134 to be assembled to inserter assembly 100 in multiple orientations. This may help simplify assembly. Sharp retractor 134 in FIG. 35A-B may be constructed symmetrically by including voids 322 (see, e.g., FIG. 35C) on opposite sides of cavity 334.

[0298] One or more notches 342 or arms 330, respectively, can engage with cooperating protrusions 344 on the inner housing 120 (see, e.g., FIG. 36 ). Thus, the interaction of the notches 342 with the cooperating protrusions 344 can keep the spring 138 under compression and act as an anti-retraction latch, which can be particularly useful during assembly. While notches 342 are shown, the arms 330 and inner housing 120 can engage in other ways, as described elsewhere herein.

[0299] 48A-B in conjunction with FIGS. 53A-B, in some embodiments, an additional latch may be included in the inserter assembly 100 to help maintain one or more of the springs 136, 138 in an energized state. In an exemplary embodiment, the spring 138 is held in the energized state by an additional latching engagement provided by features of the arm 332 that interact with features of the infusion set base 106. This latching arrangement may be similar to that described above in conjunction with FIGS. 24A-B. While held by the arm 332 of the sharp retractor 134, the infusion set base 106 may be held such that a surface of the infusion set base 106 is adjacent the standoff 352. This prevents movement within the inserter assembly 100 due to mechanical interference presented by the standoff 352. As a result, the engagement of the arm 332 with the infusion set base 106 may also help to hold the spring 138 in an energized state. The standoffs 352 may also ensure that the infusion set base 106 is positioned within the inserter assembly 100 so that the adhesive 374 is pressed against the skin 356. In this example, the standoffs 352 ensure that the infusion set base 106 is substantially even with the skin-contacting surface on the retention base 140. With the infusion set base 106 so positioned, the infusion set base 106 and / or adhesive liner 111 may also function as a protective barrier, as described elsewhere herein.

[0300] As shown in FIGS. 48A-B, when the retaining pin 412 is withdrawn from the sharps holder 130, the wall section 428 can return to its undeflected state. This can decrease the distance between the nubs 442, allowing the nubs 442 to pass into the cavity 334 in the sharps retractor 134. This, in turn, can cause the spring 136 to begin to release energy and displace the sharps holder 130 to its forward position. As shown in FIGS. 48A-B, the exemplary inserter assembly 100 is configured to allow the entire inserter assembly 100 to move as a unit for at least part of the withdrawal motion from the body of the inserter assembly 100. This allows the skin 356 to be lifted a certain distance before the retaining pin 412 begins to be withdrawn, triggering an actuation. The amount the skin 356 is lifted, or the force applied before portions of the inserter assembly 100 are displaced relative to one another, can be modified as described in connection with the description of FIGS. 39A-B.

[0301] In various embodiments, the ledge section 434 of the sharps holder 130 can prevent the sharps holder 130 from being displaced beyond a certain amount. Alternatively, the ledge section 434 can be positioned on the sharps holder 130 such that a retention gap 360 (see, for example, FIG. 42B) exists after the sharps holder 130 is propelled to the forward position. As described elsewhere herein, retention gap 360 can help ensure that cannula subassembly 114 is securely held within base 106 .

[0302] In various embodiments, when the sharps holder 130 is displaced, the cannula subassembly 114 can be coupled to the infusion set 106 as described elsewhere herein. Additionally, the ears 204 of the cannula subassembly 114 can spread the arms 332 as the sharps holder 130 is displaced, releasing the infusion set base 106 from the arms 332. This can release the spring 138 and begin retraction of the inserted sharp 132. During retraction, the retention gap 360 can decrease (if present) until the top plate 328 of the sharps retractor 134 contacts the shelf 434 of the sharps holder 130. When this occurs, the restoring action of the spring 138 can begin to displace the inserted sharp 132 mounted thereon along with the sharps holder 130 and sharps retractor 134. This displacement can retract the inserted sharp 132 from the cannula 104 and infusion set 102. Once retraction is complete, the sharps retractor 134 is biased against the outer housing 116 by the spring 138, and the insertion sharps 132 may be housed within the inserter assembly 100 to help protect against unintentional finger pricks and the like. The infusion set 102 may be held in place on the skin 356 with the cannula 104 remaining in place in the patient.

[0303] 54 illustrates another embodiment of an inserter assembly 100 that includes a manual trigger. The exemplary inserter assembly 100 includes a button 550 that can trigger actuation when displaced. The button 550 can be included as a separate component assembled to the inserter assembly 100. Alternatively, as shown, the button 550 can be integrally formed with another portion of the inserter assembly 100. In the exemplary embodiment, the button 550 is formed as a continuous portion of the outer housing 116. In the exemplary embodiment, the button 550 includes an enlarged region that can include a recess 552 that can be substantially centrally located. The recess 552 may facilitate interaction with a user's finger. The button 550 may also include a cantilever portion 554 connecting the button 550 to the remainder of the outer housing 116. In the exemplary embodiment, the enlarged portion of the button 550 is located at the distal, unsupported end of the cantilever portion 554. However, in other embodiments, the enlarged portion may be located anywhere along the length of the cantilever portion 554. In the exemplary embodiment, the cantilever 554 extends toward the top of the inserter assembly 100 in a direction substantially parallel to the longitudinal axis of the inserter assembly 100. In other embodiments, the cantilever section 554 may extend in any direction. The cantilever portion 554 may include a curvature that matches the curvature of the outer housing 116. A gap 556 surrounding the button 550 may be included to provide clearance for displacement or deflection of the button 550 during use. During actuation, the button 550 may be moved at least partially within the inserter assembly 100 to trigger insertion.

[0304] In some embodiments, the button 550 may not include the cantilevered section 554 and may instead be formed as a strip of material defined by cutouts adjacent both sides of the strip. The enlarged section may be located at or near the center of the strip. The strip may be deflected inward toward the interior of the inserter assembly 100 by applying pressure to trigger insertion.

[0305] As shown in FIGS. 55A-C and 56, an interlock can be included that prevents the button 550 from actuating the inserter assembly 100 until the skin is displaced or a relative movement exceeding a threshold amount occurs. As shown, the button 550 can include a ridge 558 (best seen in FIG. 56) on its inner surface. The ridge 558 can be located opposite the depression 552 in the enlarged area of ​​the button 550, as shown. Initially, the ridge 558 may not be aligned with the sled member 560, as shown in FIG. 55B, for example. As the inserter assembly 100 is withdrawn from the body, the skin is lifted, and relative displacement of a portion of the inserter assembly 100 occurs, the ridge 558 can be aligned with the sled 560. At this point, the portion of the inserter assembly 100 can be positioned similarly to that shown in FIG. 40B. Once aligned, the button 550 can be displaced into contact with the sled 560. Displacement of button 550 may then drive sled 560 into bump 300 located at the end of cantilevered arm 296 on the sharps holder. As sled 560 continues to move forward, bump 300 may displace from catch 306 to release bias member 136.

[0306] Referring primarily to Figures 56-59, initially, the sled 560 may be positioned within a receiving cavity 564 contained within the inner housing 120. The sled 560 may initially have a curved wall 566 that is substantially flush with the outer surface of the inner housing 120. As shown, the receiving cavity 564 is shaped to receive the bump 558 of the button 550. In the exemplary embodiment, the bump 558 is cross-shaped, and the receiving cavity 564 mimics this shape. Until the inserter assembly 100 is aligned, the walls of the inner housing 120 present a mechanical interference that prevents the button 550 from being pressed. Once aligned, the bump 558 can enter the receiving cavity 564 and the sled 560. While a cross-shaped shape is used, any other type of shape can be used. For example, a star-shaped or asterisk-shaped shape can be used in alternative embodiments. 56, the selected shape may include an angled portion or portions that extend substantially parallel to the longitudinal axis of the inserter assembly 100. This may allow for increased tolerance of the threads 560 and ridges 558, which may help ensure smooth operation as the inserter assembly 100 is withdrawn from the body.

[0307] Referring primarily to FIGS. 59-60 , the sled 560 can include a cantilevered member 568 including a sled ridge 570 at its unsupported end. The cantilevered member 568 can be included within an actuation projection 576 of the sled 560. The sled ridge 570 can form a ledge 572 that can hook onto a component of the insertion assembly 100 and retain the sled 560 within the insertion assembly 100. As shown, the top plate 328 of the Sharp retractor 134 includes a bridge 574. The bridge 574 forms an underpass that is aligned with the receiving cavity 564 of the inner housing 120 when the inserter assembly 100 is assembled. During assembly, the sled 560 can pass through the receiving cavity 564, and the actuation projection 576 of the sled 560 can move through the underpass formed by the bridge 574. The ledge 572 of the cantilevered member 568 hooks onto a surface of the bridge 574, retaining the sled 560 within the inserter assembly 100. Sled ridge 570 on cantilevered member 568 can be angled to facilitate deflection of cantilevered member 568 around bridge 574 during installation of sled 560. Bridge 574 can also act as a guide, providing a displacement channel for sled 560 as it is driven into ridge 300 of cantilevered arm 296.

[0308] As shown in FIG. 61 , in some embodiments, button 550 may not be included, but a section of outer housing 116 may be deformable. In the example shown in FIG. 61 , outer housing 116 includes a deformable region 580 including a ridge 558 thereon. Deformable region 580 may, in certain examples, be coupled (e.g., overmolded or otherwise adhered) to outer housing 116. In embodiments including a deformable region, once inserter assembly 100 is aligned, a user may squeeze outer housing 116 at deformable region 580 to drive ridge 558 into sled 560 (see, e.g., FIG. 59 ) to trigger actuation.

[0309] 62, the inner surface of the outer housing 116 may include a ridge 558. The button 550 or the deformable region 580 may not be included. During the withdrawal of inserter assembly 100 from the body, relative displacement of the components of inserter assembly 100 can automatically trigger inserter assembly 100. The relative displacement can bring bump 558 into contact with sled 560 (see, e.g., FIG. 59), forcing sled 560 onto bump 300 (see, e.g., FIG. 55B) on cantilever arm 296 (see, e.g., FIG. 55B), which is then displaced from catch 306 (see, e.g., FIG. 55B), releasing bias member 136 (see, e.g., FIG. 55B). Inner housing 120 can include an appropriately sized channel to accommodate bump 558.

[0310] Referring to FIG. 63, a flowchart 450 is shown illustrating several exemplary actions that may be performed to assemble an inserter assembly 100 such as that shown in FIGS. 24A-B. In block 452, a first bias member, such as spring 136, may be placed in cavity 334 in sharps retractor 134. Cannula subassembly 114 may be placed on sharps 132 attached to sharps holder 130 in block 454. Sharps holder 130 may be placed in cavity 334 of sharps retractor 134 in block 456. In block 458, sharps holder 130 is latched in a position where the first bias member is in an energized state. This may be a compressed state in various examples. A second bias member, such as spring 138, may be sandwiched between sharps retractor 134 and inner housing 120 in block 460. Sharps retractor 134 may be latched in a position where the second bias member is in an energized state in block 462. This may be in a compressed state in various embodiments. At block 464, the casing (which may be formed from the outer housing 116 and the retention base 140) may be coupled together around the inner housing 120. The infusion set base 106 may be releasably coupled to the sharp retractor 134 at block 466. The locking member 146 may be installed on the inserter assembly 100 at block 468. As described elsewhere herein, the locking member may be welded to the adhesive liner 111 coving adhesive on the infusion set base 106 in certain embodiments. During assembly of the components, rails, guides, keyed features, fingers, etc. included on the components may be aligned with cooperating features on the components in which they are located. Latching the various components of the inserter assembly 100 together can simplify assembly of the inserter assembly 100 because the components can hold themselves in the proper orientation or position against any spring bias. Thus, an assembler (human or robotic) can simply latch the components together and then release the components.This allows partially assembled portions of the inserter assembly 100 to be moved around the production facility or shipped to other facilities, simplifying the fixtures used during assembly.

[0311] As shown in FIG. 64 , in some examples, the inserter assembly 1000 may be reusable. After activation, a particular inserter assembly 1000 embodiment may be reset and used to install a next infusion set 102 (or, in certain examples, an analyte sensor). Thus, the same inserter assembly 1000 may be used to install multiple different infusion sets 102. For example, a container of infusion sets 102 may include a single inserter assembly 1000 (or a number of inserter assemblies 1000 fewer than the number of infusion sets 102). The single inserter assembly 1000 may be intended for use to attach each of the infusion sets 102 in the container to a patient. Thus, waste and costs associated with site changeovers may be reduced. In embodiments in which the inserter assembly 1000 is a multi-purpose device, the infusion sets 102 may be provided in separate set cartridges 1002. Similarly, if the inserter assembly 100 is configured to apply sensors to a patient, the sensors may be provided in a sensor cartridge. As with other embodiments described herein, the infusion set 102 may be provided partially assembled within a set cartridge 1002. The set cartridge 1002 is shown separate from the inserter assembly 1000 in FIG. 1 . The set cartridge 1002 may be coupled to the inserter assembly 1000. Once coupled, the inserter assembly 1000 may be actuated to place the infusion set 102 at a desired infusion site. After actuation, the used cartridge 1002 may be separated from the inserter assembly 1000 and discarded. The inserter assembly 1000 may be reset when another set cartridge 1002 is coupled to it and used to place another infusion set 102.

[0312] Depending on the embodiment, actuation of the inserter assembly 1000 can also complete the assembly of the infusion set 102. The infusion set 102 may be provided as several parts (e.g., separate components, subassemblies, or a combination thereof) within the set cartridge 1002. Actuation of the inserter assembly 1000 can couple the parts of the infusion set 102 together to complete the assembly of the infusion set 102. For example, assembly of the infusion set 102 can occur as an initial stage of actuation of the inserter assembly 1000, or can occur as part of the insertion stage of actuation of the inserter assembly 1000, which results in the introduction of the cannula 104 into the patient.

[0313] 65A-65B show exploded views of an exemplary set cartridge 1002. As shown, the set cartridge 1002 may include an outer housing 1004. When the set cartridge 1002 is assembled, the outer housing 1004 may contain the other components of the set cartridge 1002. Accordingly, the outer housing 1004 is also referred to herein as a "container." In this example, the outer housing 1004 is shown as a cup and includes an open top. Depending on the embodiment, when fully assembled, the open top of the outer housing 1004 may be covered by a barrier member to completely enclose the components of the set cartridge 1002. This barrier member may be permeable to a sterilant, allowing sterilization of the set cartridge 1002 after assembly. The barrier member may also help minimize contact between the components within the outer housing 1004 and the surrounding environment or a user.

[0314] As shown, the infusion set 102 may be contained within the set cartridge 1002 as a first and second portion that are separate from one another but are coupled together to form the infusion set 102 during operation of the inserter assembly 1000. The first portion may include a base 106 that may be applied to the patient's skin and may be part of the infusion pump or coupled to a fluid pathway extending from the infusion pump (e.g., via a terminal connector on the pathway). An adhesive backing, film, or liner 111 may be included and applied over an adhesive 374 included on the infusion set base 106. The infusion set base 106 may seat within a receiving bay 1006 of the internal housing 1008 of the set cartridge 1002. The receiving bay 1006 may include a notch 1010 that can receive a tube retainer 184 included on the infusion set base 106. In an exemplary embodiment, the notch 1010 may also help ensure that the base 106 can only be placed within the receiving bay 1006 in a desired orientation. As shown, the inner housing 1008 may include a recess 1012. The recess 1012 may be sized to receive the pull tab 410 included in the adhesive liner 111. Because the recess 1012 may be visible to a user, the recess 1012 may be used as a directional indicator. This may assist the user in placing the infusion set 102 in a manner that corresponds to the planned path for the infusion tubing to be coupled to the infusion set 102. An indicator showing the orientation of the infusion set 102 may also be included as part of the inserter assembly 1000. This may be particularly true in embodiments in which the set cartridge 1002 may only be coupled to the inserter assembly 1000 in a single orientation.

[0315] The second part of the infusion set 102 can be a subassembly 114 of two or more components of the infusion set 102. The second part can include, for example, a cannula 104, a septum housing 108, a septum 110, and a septum retainer 112 (an exemplary cannula subassembly 114 is shown exploded in FIG. 1A). Any of the cannula subassemblies 114 described herein can be used. The cannula 104 and septum housing 108 are shown in the exemplary embodiment as a single, continuous, single piece. This cannulated housing can be a molded part constructed of a single material, such as PTFE, Teflon, or polypropylene. When the set cartridge 1002 is assembled, the insert sharps 132 can extend through the cannula subassembly 114, and the cannula subassembly 114 can be positioned relative to the sharps holder 130. In a sensor cartridge embodiment, the cannula subassembly 114 and the infusion set base 106 can be replaced with a sensor assembly.

[0316] The set cartridge 1002 may further include a sharps holder 130 . The sharps holder 130 can hold a sharpener insert 132 thereon. The sharpener insert 132 can be glued or otherwise attached to the sharps holder 130 so as to be fixedly disposed relative to the sharps holder 130. Alternatively, the sharpener insert 132 can be press-fit into the sharps holder 130, or the sharps holder 130 and the sharpener insert 132 can be joined by an overmolding process. Any suitable type of sharpener 132 can be used. For example, the sharpener 132 can be a hollow or solid needle, stylet, or other pointed member that may be made of a metallic material such as steel.

[0317] As shown primarily in FIG. 66 , an infusion base retainer 1014 may also be included in the set cartridge 1002. The infusion base retainer 1014 may include a set of retention arms 1016. The retention arms 1016 may extend from an end plate 1028 of the infusion base retainer 1014. The arms 1016 may be separated from the wall 1018 defining the central cavity 1020 of the infusion base retainer 1014 by a blocking region included in the wall 1018. The wall 1018 may also include a pair of ridges 1030. The ridges 1030 may be positioned opposite one another and may be spaced approximately 90° apart from the arms 1016 on the wall 1018. The ridges 1030 may include a sloped surface 1032 at the distal-most portion of each ridge 1032 of the end plate 1028. The ridge 1030 may also define a catch surface 1034 on the portion of the ridge 1030 most proximal to the endplate 1028 .

[0318] As shown in FIG. 67 , during assembly of the injection base retainer 1014 to the inner housing 1008, the ridges 1030 can move along respective channels 1036 defined in the inner housing 1008. As shown, ends of the channels 1036 can be closed by stop walls 1038. As shown, ends of the channels 1036 can be closed by stop walls 1038. When the ridges 1030 are driven into the stop walls 1038, the portion of the wall 1018 containing the ridges 1030 resiliently deflects inward to allow passage of the ridges 1030 past the stop walls 1038. The angled surfaces 1032 can facilitate this deflection. Once the ridges 1030 have cleared the stop walls 1038, the portion of the wall 1018 can return to its unstressed state. When the portion of wall 1018 is in an unstressed state, catch surface 1034 of ridge 1030 may latch against stop wall 1038 of channel 1036, preventing infusion base retainer 1014 from being pushed out of inner housing 1008. End plate 1028 of infusion base retainer 1014 may abut rim 1040 that prevents infusion base retainer 1014 from being displaced further into inner housing 1008. Thus, infusion base retainer 1014 may be secured in place within inner housing 1008.

[0319] As shown in FIG. 66, the set of arms 1016 of the injection base retainer 1014 may be arranged in opposing relation to one another and cantilevered from an end plate 1028. Each of the arms 1016 may include a ridge 1022 disposed on its unsupported end. Each ridge 1022 may form a ledge 1024 on the arm 1016 to which it is attached. Additionally, the arms 1016 may include nubs 1026 or raised ramps that increase in thickness as the distance from the cavity 1020 increases (see, for example, FIG. 65A ). The nub 1026 may be located intermediate the unsupported end of the arm 1016 and its attachment point to the remainder of the infusion base retainer 1014 .

[0320] As shown in FIGS. 68-69B, as best shown in FIGS. 68-69B, each ledge 1024 can capture a portion of the infusion set base 106. Specifically, the ledge 1024 can hook onto a cutout portion of the infusion set base 106. The base 106 may include rails, step features, nubs, or any other suitable protrusions. In certain embodiments, the ledge 1024 can hook onto a guide 172 on the infusion set base 106. Thus, the infusion set base 106 can be retained within the set cartridge 1002. The ledges 1024 can be angled with respect to the cantilevered arm 1016 on which they are contained such that the undercut has a triangular cross-section. For example, the portion of the guide 172 (or any other catch feature) that each ledge 1024 catches can be cooperatively angled to help ensure a secure engagement.

[0321] In certain embodiments, only one arm 1016 may be included. In some embodiments, the inner housing 1008 may also, or instead, include a latch that can interface with the guide 172 or another cooperating portion of the infusion set base 106 to hold the infusion set base 106 in place.

[0322] With the infusion set base 106 held by the arms 1016, the infusion set base 106 can also function as a protective barrier. Because the cannula subassembly 114 and the insertion sharp 132 can be inside the set cartridge 1002, the user can be protected from accidental contact with the insertion sharp 132 when the infusion set base 106 is in the initial holding position. This further prevents the cannula 104 or the insertion sharp 132 from coming into contact with contaminants. The cavity for receiving the cannula subassembly 114 can extend throughout the infusion set base 106, but the cavity can be sized to prevent finger penetration (e.g., have a cross-section smaller than that of the fingers). Thus, the infusion set base 106 can present an obstacle that prevents unintended access to the insertion sharp 132 and the cannula 104. Additionally, because the cannula subassembly 114 is internal to the set cartridge 1002, the adhesive backing 111 provided on the infusion set base 106 does not need to include interruptions to allow the cannula 104 to pass through. Thus, the gap within the infusion set base 106 for the cannula subassembly 114 may be blocked by the adhesive backing 111 until immediately prior to use. This may further prevent finger penetration and reduce the likelihood of debris entering the set cartridge 1002. The outer housing 1004 may also present a barrier that prevents a user from interacting with the insertion sharp 132 and / or the cannula 104.

[0323] As shown in FIGS. 69A-69B, the infusion base retainer 1014 can include at least one guide in various embodiments. In an exemplary embodiment, the infusion base retainer 1014 includes a pair of sharps holder guides 1042 (see FIG. 69A). The sharps holder guides 1042 can be embedded in the cavity-facing side of the wall 1018 of the infusion base retainer 1014. The sharps holder 130 can include fins 1044 that can ride within the sharps holder guides 1042 during displacement of the sharps holder 130 within the set cartridge 1002. In an alternative embodiment, the sharps holder 130 can include a recess, and the wall can include rails protruding from the cavity-facing side of the wall 1018. The rails are received within the recesses of the sharps holder 130 and guide the displacement of the sharps holder 130 as it is displaced within the set cartridge 1002.

[0324] The infusion base retainer 1014 may also include a set of septum housing guides 1046. The septum housing guides 1046 (see FIG. 69B ) may be recessed within cavities facing the sides of the arms 1016. The ears 204 of the septum housing 108 may ride within the septum housing guides 1046 during displacement of the cannula subassembly 114 within the set cartridge 1002. As shown, the sharps holder 130 may also include fins 1048 that are aligned with the ears 204 and that may also ride within the septum housing guides 1046. When the cannula subassembly 114 latches to the base 106, the ears 204 on the cannula subassembly 114 may press against nubs 1026 included on the arms 1016. This spreads the arms 1016, moving them away from the infusion set base 106. This, in turn, may release the now-assembled infusion set 102 from the set cartridge 1002.

[0325] 70A-70B and 71A-71B show exploded views of two exemplary embodiments of an inserter assembly 1000. An inserter assembly such as the inserter assembly 1000 can be coupled to a set cartridge 1002 and then used to place the infusion set 102 at a patient's infusion site and introduce the cannula 104 of the infusion set 102 into the patient's body. As noted elsewhere, some inserter assemblies 1000 can be used to place other patient care assemblies on a patient's body. For example, certain inserter assemblies 1000 can be operated to place a physiological monitor or an analyte sensor in functional relationship with the patient's body. A blood glucose monitor, such as a continuous glucose sensor, can be placed using the inserter assembly 1000. In certain embodiments, the same inserter assembly 1000 can be combined with a set cartridge 1002 or a sensor cartridge, depending on the type of device the patient is seeking to place. In some embodiments, the inserter assembly 1000 may also be coupled to a lancet cartridge (e.g., a set cartridge 1002 without a cannula subassembly and an infusion set base 106) to create a skin puncture for collecting a body sample with an analyte test strip.

[0326] As shown in FIGS. 70A-71B, the insertion assembly 1000 may include an outer housing 116. The outer housing 116 encloses various components of the inserter assembly 1000 and may serve as the portion of the inserter assembly 1000 that a user grasps during operation. While the outer housing 116 in the exemplary embodiment of FIGS. 70A-70B has a circular cross-sectional shape, other embodiments may have a different shape, such as any type of polygon. In certain instances, a rectangular or oblong cross-sectional shape, as shown in FIGS. 71A-71B, may be used. Such a shape may fit more easily within a pocket or into a smaller pocket that may be more typical of women's clothing, for example. The cross-sectional area in the exemplary embodiment also varies, with the lower section of the outer housing 116 (closest to the skin during use) being wider or having a larger cross-sectional area than the upper portion. The outer housing 116 may include various ergonomic features that facilitate gripping the inserter assembly 1000 in which it is contained. For example, texturing or finger or thumb indentations may be included on the exterior surface of the outer housing 116. Alternatively, or in addition, an area of ​​the outer housing 116 may be thinner in width than the remainder of the outer housing 116, which may facilitate a firm grip on the inserter assembly 1000.

[0327] The exemplary outer housing 116 may include markings, tabs, embossed sections, recessed sections, textured sections, ridges, color coding, appliqués, or other indicia that help indicate the location and / or orientation of the infusion set 102 within the inserter assembly 1000. Raised ribs 118, as shown in FIG. 1A, may be included. This allows the user to position the inserter assembly 1000 in a desired orientation so as to allow the run of the infusion tube 366 (see, e.g., FIG. 6) to be routed in a planned manner once the infusion set 102 is attached to the user.

[0328] A retaining cap 406 can be coupled to the top of the inserter assembly 1000 to help hold various components in place within the inserter assembly 1000. In the example shown in FIGS. 70A-71B, the retainer cap 406 includes a cantilevered retainer body 408 that can snap into a retention interface 411 included in the outer housing 116 (see, for example, FIG. 70A). Other couplings are possible, such as a bayonet mount, interference fit, snap fit, adhesive, glue, threads, solvent bonding, welding, etc. When coupled together, the outer housing 116 and the retaining cap 406 can form the casing of the inserter assembly. Together, the outer housing 116 and the retaining cap 406 can form a first unit of the inserter assembly 1000. The remaining components of the inserter assembly 1000 can be referred to as a second unit of the inserter assembly 1000.

[0329] 70A-71B, the inserter assembly 1000 may also include an inner housing 120. The inner housing 120 may be disposed inside the outer housing 116 when the inserter assembly 1000 is assembled. The first unit of the inserter assembly 1000 may be displaceable relative to the inner housing 120 and other components of the second unit of the insector assembly 1000 contained therein. Various outer housings 116 may have at least one keying feature that constrains the inner housing 120 so that it can be installed in only a limited number of orientations within the outer housing 116. The cross-sectional shape may be selected to define such constraints (see, e.g., FIGS. 71A-71B). Alternatively, the outer housing 116 may include at least one rail 1090 (see, e.g., FIGS. 70A-70B). In the exemplary embodiment shown in FIGS. 70A-70B, two rails 1090 are included directly opposite each other (only one is visible) on the inward-facing surface of the outer housing 116. The rails 1090 extend substantially parallel to one another. The rails 1090 can be of different widths if it is desired to restrict the inner housing 116 to a single installation orientation. The outer surface of the inner housing 120 can include tracks 1092 that cooperate with the rails 1090. The inner housing 120 can be restrained from moving within the outer housing 116 until the rails 1090 are aligned with the tracks 1092. Within the interacting tracks 1092 of the rails 1090, the inner housing 120 and the outer housing 116 can also be inhibited from rotating relative to one another. While the rails 1090 are shown on the outer housing 116 in the examples, in some embodiments, the rails 1090 can instead be on the outer surface of the inner housing 120. In such examples, the tracks 1092 can be located on the outer housing 116.

[0330] As shown in FIGS. 70A-70B , the outer housing 116 may also include a stop protrusion 1094 on the inner surface of the outer housing 116. The stop protrusion 1094 may be a nub, a pin, a rail, or any suitable feature. The stop protrusion 1094 may limit the movement of the inner housing 120 along the axis of the outer housing 116. In an exemplary embodiment, the stop protrusion 1094 extends from the end of the outer housing 116 in a direction parallel to the rail 1090. In certain examples, the retaining arm 408 of the retainer cap 406 may also function as a stop that limits the movement of the inner housing 120 relative to the outer housing 116.

[0331] A receptacle body 1060 (described in more detail with respect to Figures 73-75 and 77) may couple to the bottom of the inserter assembly 1000 and function to hold various components in place within the inserter assembly. In the example shown in Figures 70A-71B, the receptacle body 1060 includes a cantilevered retention arm 1096 that can snap into a retention interface 1098 included in the inner housing 116. Other attachments are possible, such as a bayonet mount, interference fit, snap fit, adhesive, glue, threads, etc. Locking members 1112A, B, which may be part of a separate component (e.g., retractable latch body 1102 in Figures 70A-70B) or as separate, distinct components (e.g., see Figures 71A-71B), may be included and protrude through the receptacle body 1060.

[0332] A retraction latch body 1100 and a retraction spring retainer 1102 may also be included. As described further later in this specification, the storage latch body 1100 and the storage spring retainer 1102 may engage with one another to retain a biasing member, such as spring 1104 (or springs 1104A, B in FIGS. 71A-71B) and spring 1108, in an energy-storing state during a portion of the actuation of the inserter assembly 1000. The retraction latch body 1100 may be coupled into position on the receptacle body 1060 via interaction between a latch finger 1097 on the receptacle body 1060 and a catch body 1099 on the retraction latch body 1100.

[0333] An insertion driver 1062 may also be included in the inserter assembly 1000. As described further herein, the insertion driver 1062 may have a plunger 1106 and a spring 1108 housed within a portion of the insertion driver 1062. An assembly reset body 1110 may be included. As described further herein, the reset body 1110 may act on various components of the inserter assembly 1000 to place the components in an armed state in preparation for actuation. Upon being released from the energized state to the relaxed state, the spring 1108 may displace the insertion driver 1062 to insert the cannula 104 from the attached set cartridge 1002 and fully assemble the infusion set 102 of the set cartridge 1002. Retraction of the sharps 132 into the set cartridge 1002 may also occur when the spring 1104 (or springs 1104A, B in FIGS. 71A-71B ) is released to transition from the energized state to the relaxed state. During this transition, in some embodiments, the spring 1104 can drive the retraction spring retainer 1102 toward a stored state within the inserter assembly 1000. This drives the insertion driver 1062 (which may be attached to the sharps holder 130, see, e.g., FIG. 73) toward the stored state.

[0334] 72 shows a cross-sectional view of the inserter assembly 1000 of FIGS. 71A-71B. The inserter assembly 1000 is shown in a relaxed or storage state. As shown, the set cartridge 1002 is not attached to the inserter assembly 1000. In some embodiments, an end cover may be included for storage purposes and may be placed on the end of the inserter assembly 1000 to which the cartridge 1002 may be coupled. Further, with reference to FIG. 72 , all of the bias members 1108, 1104A, B are shown in a relaxed or unstressed state. The inserter assembly 1000 may be in a relaxed state during use of the inserter assembly 1000. Because the inserter assembly 1000 may typically only be used during site changes (e.g., every three days), the inserter assembly 1000 may be in a relaxed state for the majority of its useful life. Therefore, the bias members 1108, 1104A, B may only need to be in an energy storage state or stressed state (compressed in the exemplary embodiment) for short periods of time. The bias members 1108 and 1104 of the inserter assembly 1000 of FIGS. 70A-70B may similarly be in a substantially unstressed state when the inserter assembly 1000 is in its storage state.

[0335] The storage state, in which the bias members 1108, 1104A,B are in an unstressed state, may facilitate the use of a wider variety of different bias members 1108, 1104A,B or bias member 1108, 1104A,B materials. For example, spring relaxation and / or creep may be less of a concern, allowing materials such as various polymers to be more easily utilized in the construction of the bias members 1108, 1104A,B. Furthermore, other components of the inserter assembly 1000 are not subjected to the sustained stress exerted by the bias members of the inserter assembly 1000 in a stressed state when the inserter assembly 1000 is stored (e.g., during transport or in inventory). As a result, any creep caused by this sustained stress may be eliminated. This allows for greater flexibility in the design of other components of the inserter assembly 1000. For example, a greater variety of materials may be used, or certain components may be smaller. It should be noted that in certain examples, the set cartridge 1002 (or sensor cartridge or lancet cartridge) may not include a biasing member. Instead, all biasing members may be included in the inserter assembly. As a result, the components of the set cartridge 1002 may also be stored in a state where they are not exposed to sustained stress. This, in turn, may help provide greater design flexibility for the components of the cartridge 1002.

[0336] Referring to FIG. 73 , a view of the exemplary cartridge 1002 exploded away from the exemplary inserter assembly 1000 is shown. As shown, the end plate 1028 of the injection base retainer 1014 (see, for example, FIG. 66 ) can include at least one mating pin 1050. In the exemplary embodiment, two mating pins 1050 are included. The mating pins 1050 can be positioned opposite each other on the top plate 1028 and are shown 180° apart from each other in this example. The mating pin 1050 can include an enlarged head portion 1052 connected to the end plate 1028 via a pin body 1054. A portion of the sharps holder 130 can also be seen in FIG. 73 . As best shown in the detailed view of FIG. 74 , the sharps holder 130 can include a mating section 1056. The mating section 1056 can include a thinned region 1058 adjacent to an end flange 1059 that forms the end of the sharps holder 130. The end flange 1059 can have a longer dimension than a wider dimension. In an exemplary embodiment, the upper flange 1059 is oval in shape.

[0337] To couple the cartridge 1002 to the inserter assembly 1000, the cartridge 1002 can be positioned relative to a receptacle body 1060 included within the inserter assembly 1000. A sharps driver 1062, including a port 1064 for a mating section 1056 of the sharps holder 130, can be accessed through the receptacle body 1060. In an initially coupled state, the mating section 1056 can be oriented in alignment with the port 1064 such that the mating section 1056 can enter the port 1064. The mating pin 1050 may function as a standoff that limits the amount that the mating section 1056 can be displaced into the port 1064. In an exemplary embodiment, the mating pin 1050 may limit the displacement of the mating section 1056 into the port 1064 so that the thinned section 1058 is aligned with the port 1064. The cartridge 1002 may then be rotated from the initial mated state to the fully mated state. Because the thinned section 1058 is aligned with the rim 1066, the mating section 1056 is free to rotate. During mating, the terminal flange 1059 may be swept over the inner surface of the rim 1066 in a direction that no longer passes through the port 1064. The upper flange 1059 may be biased against the inner surface of the rim 1066 by at least one biasing member 1108 (see, for example, FIG. 77 ). This can help inhibit additional rotation of the terminal flange 1059. The mating pin 1050 can also move into a mating interface, such as a retention shoe 1068 included in the receptacle body 1060. The retention shoe 1068 can be formed as a "U" shaped body. They are elevated above the receptacle body 1060. The "U" shaped body can have a graduated width as the distance from the receptacle body 1060 increases. Adjacent to the receptacle body 1060, the width can be sized to receive the head 1052 of the mating pin 1050. The distal-most portion of the shoe 1068 on the receptacle body 1060 can have a width sized to receive the pin body 1054 of the mating pin. Thus, when the cartridge 1002 is rotated to a fully coupled state, the head 1052 of the mating pin 1050 may be overhanging by a portion of the shoe 1068 such that the mating pin 1050 is not translationally displaced from the shoe 1068 in a direction parallel to the longitudinal axis of the inserter assembly 1000. In alternative embodiments, the mating pin 1050 (or another mating protrusion) may be included on the receptacle body 1060. The retention shoe 1068 (or another mating interface) may be included as part of the cartridge 1002.

[0338] As shown in FIG. 75 , in some embodiments, rotation of the cartridge 1002 to a fully mated state can actuate housing tabs 1070 of the inner housing 1008 from engagement with receiving slots 1072 of the outer housing 1004 (see also, e.g., FIG. 69B ). In an exemplary embodiment, the housing tabs 1070 each include an angled protrusion 1074 that can be disposed on an inner portion of the housing tab 1070. As shown in FIG. 67 , each housing tab 1070 can be disposed on a cantilever arm 1076. During mating of the cartridge 1002 to the inserter assembly 1000, a portion of the receptacle body 1060 can interact with the housing tab 1070 and deflect the cantilever arm 1076 toward the center. This deflection can displace the housing tab 1070 from the receiving slot 1072 of the outer housing 1004 (best shown in FIG. 69B ). In an exemplary embodiment, the receptacle body 1060 includes a set of deflections. The biasing member 1078 can include an angled portion 1080. When the cartridge 1002 is rotated to a fully coupled position, the angled portion 1080 of the biasing member 1078 can displace and contact the angled protrusion 1074 of the housing tab 1070. Upon further rotation, the biasing member 1078 can push the angled protrusion 1074 out of the displacement path of the biasing member 1002. This can then actuate the housing tab 1070 from the receiving slot 1072. The outer housing 1004 can then be separated from the set cartridge 1002.

[0339] As shown in FIG. 73 , the inserter assembly 1000 can include one or more locking members 1112A, B. In the exemplary embodiment, the inserter assembly 1000 includes two locking members 1112A, B that are diametrically opposed to each other or spaced 180° apart. When the cartridge 1002 is coupled to the inserter assembly 1000 and the outer housing 1004 is removed, the locking members 1112A, B can be in a state in which they protrude from the receptacle body 1060. When in the protruding state, the locking members 1112A, B can be disposed between portions of the edge walls 1084 on either side of the cantilever 1076. This can inhibit rotation of the inner housing 1008 of the cartridge 1002. The edge walls 1084 of the inserter assembly 1000 can function as stop surfaces that present mechanical interference that blocks displacement of the locking members 1112A, B. Thus, the inserter assembly 1000 and inner housing 1008 can be locked together in a fully coupled orientation as rotational displacement of the mating pin 1050 from the retention shoe 1068 is prevented. A sensor cartridge or lancet cartridge can be similarly coupled to the inserter assembly 1000.

[0340] 76 , in certain embodiments, cartridge 1002 (or other cartridges) may couple to inserter assembly 1000 in the same manner but may not have the same cross-sectional shape as inserter assembly 1000. As shown in FIG. 76 , inserter assembly 1000 has a generally circular cross-sectional shape, and set cartridge 1002 has a substantially circular shape. In some examples, various different types of cartridges may have different cross-sectional shapes so that they are easily distinguishable upon visual inspection. Different types of cartridges may also be different colors or have different textures, surface finishes, indicia, labeling, etc.

[0341] FIG. 77 shows another cross-sectional view of the inserter assembly 1000 of FIGS. 71A-71B. The inserter assembly 1000 is coupled to the exemplary set cartridge 1002 of FIG. 77. The mating pin 1050 of the set cartridge 1002 can be retained within the retention shoe 1068 of the receptacle body 1060 of the inserter assembly 1000. The biasing member 1078 of the receptacle body 1060 has biased the cantilever arm 1076 of the inner housing 1008, which in turn disengages the housing tab 1070 from the receiving slot 1072 of the outer housing 1004. Thus, the outer housing 1004 of the set cartridge 1002 can be separated from the set cartridge 1002 to expose the infusion set base 106.

[0342] 77, during coupling of the set cartridge 1002 to the inserter assembly 1000, a portion of the set cartridge 1002 can displace the locking members 1112A, B from the extended state to the retracted state. As shown in FIG. 77, the outer housing 1004 of the set cartridge 1002 can force the locking members 1112A, B to the retracted state when the set cartridge 1002 is docked with the inserter assembly 1000. When in the retracted state, the locking members 1112A, B can permit rotation of the set cartridge 1002.

[0343] FIG. 78 shows the locking member 1112A of the inserter assembly 1000 of FIG. 77 in isolation. As shown, the locking member 1112A may include a locking protrusion 1114, which may be a portion of the locking member 1112A extending from the receptacle body 1060. The locking protrusion 1114 may extend from a first end 1124 of the positioning plate 1116 at a substantially perpendicular angle to the positioning plate 1116. The positioning plate 1116 may include one or more orifices 1118, 1120 that allow the positioning plate 1116 to slide over a portion of another component of the inserter assembly 1000 to hold the positioning plate 1116 in place within the inserter assembly 1000. The positioning plate 1116 may slide over a portion of the retractable latch body 1100, for example, as shown in FIG. 77A . A second end 1126 of the positioning plate 1116 opposite the attachment point of the locking projection 1114 may be rounded.

[0344] As shown, the positioning plate 1116 may include ridges 1122 that may be located on the sides of the positioning plate 1116. Other components of the inserter assembly 1000 may also include ridges along their side edges (see, for example, the exploded views of FIGS. 71A-B). These ridges 1122 may be provided as reinforcements to add rigidity to the locking members 1112A, B and any other components in which they are included. In some embodiments, the ridges 1122 may also help guide or position other components as they are displaced within the inserter assembly 1000.

[0345] As shown in FIG. 77 , the locking members 1112A, B can be biased toward the extended state. In this example, the locking members 1112A, B are disposed between the respective biasing members 1104A, B and the surface of the storage latch body 1100. The rounded end 1126 of each locking member 1112A, B pivots the locking members 1112A, B when they are actuated to the retracted state. The orifices 1118, 1120 can also be dimensioned to allow such pivoting. Upon pivoting, the locking members 1112A, B can apply stress to their associated biasing members 1104A, B. Thus, when the outer housing 1004 of the set cartridge 1002 is discarded, the locking members 1112A, B can automatically displace back to the extended state. The biasing members 1104A, B recover to their unstressed state (see, for example, FIG. 80 ). This can, for example, lock the inner housing 1008 of the set cartridge 1002 into place in the inserter assembly 1000.

[0346] As shown in FIG. 79 , in certain alternative embodiments (see, for example, FIGS. 70A-70B ), the locking members 1112A, B may be integrated into a separate component. As shown, the locking members 1112A, B are formed as protrusions extending from an arcuate member 1128, which may be cantilevered, for example, to the retractable latch body 1100. When the inserter assembly 1000 including such locking members 1112A, B is assembled, the locking members 1112A, B may extend from the receptacle body 1060, as shown in FIG. 73 . When the locking members 1112A, B are displaced to the retracted state, the cantilevered arcuate member 1128 may resiliently deflect. The cantilevered arcuate member 1128 may resiliently return to its unstressed state, for example, when the outer housing 1004 is removed. This allows the locking members 1112A,B to return to their extended state, locking the inner housing 1008 in place on the inserter assembly 1000.

[0347] As shown in FIG. 80 , after removing the adhesive backing 111 by pulling the pull tab 410 (see, e.g., FIG. 65A ), the set cartridge 1002 can be placed against the skin 356. The inserter assembly 1000 can then be actuated to a ready state. Because the storage state of the exemplary inserter assembly 1000 is a state in which all of the bias members 1104A,B, 1108 are in a relaxed or unstressed state, the inserter assembly 1000 can be actuated through a set phase to place the inserter assembly 1000 in a ready state. During the set phase, the bias members 1104A,B, 1108 of the inserter assembly 1000 can transition (e.g., be compressed) to a stressed state. To accomplish this, the user can press the first unit of the inserter assembly 1000 (e.g., the outer housing 116 and retaining cap 406) toward the rest of the inserter assembly 1000 (or a second unit of the inserter assembly 1000) and the skin 356. In addition to actuating the inserter assembly 1000 to the ready state, the pressure applied by the user can help ensure that the adhesive 374 on the infusion set base 106 is firmly adhered to the skin 356. FIG. 80 illustrates the inserter assembly 1000 shown in FIGS. 71A-71B, however, the exemplary inserter assembly 1000 of FIGS. 70A-70B can progress through the set stage by pressing its outer housing 116 and retainer cap 406. The inserter assembly 1000 can be considered to have passed the set stage and progressed to the ready state once the first unit of the inserter assembly 1000 has been displaced at least a threshold distance to the ready position. Upon progressing through the set stage, the retainers may engage latches to hold the bias members 1104A,B, 1108 in a stressed state, as described in more detail elsewhere herein.

[0348] As shown in FIG. 81 , in an exemplary embodiment, as a user displaces the outer housing 116 toward the skin 356, the bias members 1108, 1104A,B (or the bias member 1104 in the example shown in FIGS. 70A-70B ) can begin to compress. As shown, the retaining cap 406 can include a set of standoffs 1130. The standoffs 1130 can surround the barrel 1132 of the reset body 1110 of the inserter assembly 1000. As the outer housing 116 is displaced, the standoffs 1130 can be driven into contact. In the exemplary embodiment, a flange 1134 is disposed in a central region of the barrel 1132 and extends substantially perpendicular thereto. Further displacement of the outer housing 116 can press the standoffs 1130 against the flange 1134, causing the reset body 1110 to move with the outer housing 116. This causes the barrel 1132 to advance along the plunger 1106, disposing the plunger 1106 in an increment within the bore of the barrel 1132. Because the bias member 1108 is captured between the end of the barrel 1132 and the flange 1136 of the plunger 1106, the advancement of the barrel 1132 on the plunger 1106 may compress the bias member 1108.

[0349] As the reset body 1110 is displaced, the bias members 1104A, B (or bias member 1104 in the example shown in FIGS. 70A-70B) may also be compressed. In an exemplary embodiment, the retraction spring retainer 1102 may be coupled to the reset body 1110 such that the reset body 1110 and the retraction spring retainer 1102 are displaced together as a unit. To illustrate this, the exemplary reset body 1110 and retraction spring retainer 1102 are shown coupled together and separated from the rest of the inserter assembly 1000 in FIG. 82. In both FIGS. 81 and 82, in an exemplary embodiment, the retraction spring retainer 1102 includes a pair of retention arms 1138. The retention arms 1138 may be cantilevered off a base 1140 of the retraction spring retainer 1102, which in the exemplary embodiment is shown as a planar body. Each of the retention arms 1138 may include a ridge 1142 located at its unsupported or distal end. A ledge section 1144 may be defined by a portion of each ridge 1142. The flange 1134 of the reset body may include a passage 1146 through which the ridge 1142 may be displaced to couple the reset body 1110 and the retention arms 1138 via a snap-fit ​​engagement. The ridge 1142 may include a sloped portion to facilitate deflection of the retention arms 1138 when the reset body 1110 and the retraction spring retainer 1102 are coupled together. When coupled together, the bottom surface of the flange 1134 may rest against at least one step 1148 included in each retention arm 1138. The width of the retention arms 1138 may vary with the step 1148. The portion of the retention arm 1138 proximal to the base 1140 relative to the step 1148 may have a width greater than the width of the passage 1146. Thus, the flanges 1136 are captured between the respective ledges 1144 and steps 1148 of each retainer 1138 and cannot be substantially displaced relative to the ledges 1144 and steps 1148. With the reset body 1110 and retraction spring retainer 1102 coupled together, they can be displaced as a unit.

[0350] As shown in FIG. 81 , the bias members 1104A, B may be captured between the retraction spring retainer 1102 and the retraction latch body 1100. One end of the bias members 1104A, B may contact the retraction spring retainer 1102, and the other end may contact the locking members 1112A, B. In an exemplary embodiment, the bias members 1104A, B are disposed around a guide protrusion 1150 included in the storage latch body 1100. The guide protrusion 1150 may thus function as a locator protrusion that holds the bias members 1104A, B in place within the inserter assembly. The retraction spring retainer 1102 and the insertion driver 1062 may include a guide opening 1152 through which the guide protrusion 1150 can extend. When a user presses down on the outer housing 116, the retraction spring retainer 1102 may be displaced along the guide protrusion 1150 toward the retraction latch body 1100. The bias members 1104A,B are captured between the retraction spring retainer 1102 and the retraction latch body. As shown in FIG. 1100, advancement of the retraction spring retainer 1102 can cause the bias members 1104A,B to compress.

[0351] As shown in FIGS. 83-84 , in some embodiments, additional guide protrusions 1150 may be included, or the guide protrusions 1150 may be included in another component of the inserter assembly 1000. FIG. 84 shows a three-quarter cross-sectional view (taken along line 84-84 in FIG. 83 ) of the exemplary inner housing 120 of the inserter assembly 1000 shown in FIGS. 70A-70B . As shown, the inner housing 120 may include four guide protrusions 1150 (one cut away) extending from the top of the inner housing 120. The guide protrusions 1150 may be equiangularly spaced from one another by spacing and number. The guide protrusions 1150 may vary in alternative embodiments. The retraction spring retainer 1102 and the insertion driver 1062 may have cooperating guide openings 1152 (see FIGS. 70A-70B ) and may be displaced along the guide protrusions 1150.

[0352] As shown in FIG. 85 , as the outer housing 116 of the inserter assembly 1000 continues to be displaced and the bias members 1104A,B, 1108 continue to compress, the base 1140 of the retraction spring retainer 1102 may contact the latch arms 1190 of the retractable latch body 1100. As shown, the latch arms 1190 may be cantilevered from the base 1192 of the retractable latch body 1100. The latch arms 1190 may each include a first portion 1194 proximal to the base 1192. The first portions 1194 extend substantially perpendicular from the base 1192 and parallel to each other when unstressed. Each latch arm 1190 may also include a second portion 1196 distal to the base 1192, which may be angled relative to the first portion 1194. In this example, the second portions 1194 are angled so that the distance between the latch arms 1190 increases with distance from the base 1192. A catch 1198 may be included where the second portions 1194 meet the first portions 1192 of each latch arm 1190. When the retraction spring retainer 1102 is actuated into contact with the second portions 1194 of each latch arm 1190, the latch arms 1190 may be spread apart as shown in FIG.

[0353] 86-88, a view of the exemplary inserter assembly 1000 of FIGS. 70A-70B and 71A-71B is shown in a ready state. When the retraction spring retainer 1102 is displaced under the second portion 1194 of each latch arm 1190, the latch arms 1190 can resiliently recover from their expanded state. When the latch arms 1190 return to their unstressed state, the catch 1198 can overhang the base 1140 of the retraction spring retainer 1102. Thus, the catch 1198 can hold the retraction spring retainer 1102 in place with the bias members 1104A,B, 1108 compressed. The inserter assembly 1000 may then be ready to be actuated to drive placement of the infusion set 102 at the selected infusion site on the patient. The outer housing 116 and retainer cap 406 can be seen in the ready position in Figures 86-88.

[0354] 89 and 90, a cross-sectional view (FIG. 89) of the exemplary inserter assembly 1000 and a detailed view of the indicated area thereof (FIG. 90) are shown. When the outer housing 116 of the exemplary inserter assembly 1000 is pressed toward the skin 356 during the setup phase (see, for example, FIG. 81), the release fingers 1154 extending from the retaining cap 406 may deflect around a director wedge 1156 included in the inner housing. Each of the release fingers 1154 may be connected to the base portion 1174 of the retaining cap 406 in a cantilevered manner. The unsupported end 1162 of each release finger 1154 may include a paddle body 1164 having a protrusion 1166. The paddle body 1164 may have a width greater than the remainder of the release finger 1154. In some embodiments, the width can be 2-3 times (e.g., 2.15-2.30 times, or in some instances, 2.25 times) the width of the remainder of the release finger 1154. The paddle body 1164 can be positioned such that a central region of the paddle body 1164 is connected to the remainder of the associated release finger 1154. Thus, the paddle body 1164 can include two equally sized portions adjacent to the release finger 1154 (only one is visible in the cross-sectional view of FIG. 89).

[0355] Each paddle body 1164 may include an inner surface 1168 proximal to the longitudinal axis or neutral plane of the inserter assembly 1000 and a side surface 1170 on a side of the paddle body 1164 opposite the inner surface 1168. A protrusion 1166 may be disposed on the side surface 1170 of each paddle body 1164. The protrusion 1166 may be centrally disposed in each paddle body 1164 so that the protrusion 1166 can be displaced during actuation without contacting the director wedge 1156. The side surface 1170 of each paddle body 1164 may include a laterally angled portion 1172 adjacent to the paddle body 1164. The laterally angled portion 1172 may be included in a portion of the paddle body 1164 most distal to the base portion 1174 of the retainer cap 406. As the distance from the base portion 1174 of the retainer cap 406 increases, the outer ramp portion 1172 may slope toward the inner surface 1168. The inner surface 1168 of the paddle body 1164 may also include an inner sloped portion 1176 adjacent the paddle body 1164. The inner sloped portion 1176 may be included in the portion of the paddle body 1164 most proximal to the base portion 1174. As the distance to the base portion 1174 of the retainer cap 406 decreases, the inner sloped portion 1176 may slope toward the outer surface 1170.

[0356] As shown in FIG. 91 , in the exemplary embodiment, director wedges 1156 extend from side walls 1160 of passageways 1158 through the top of inner housing 120 (shown alone in FIG. 91 ). The director wedges 1156 are included in pairs. The director wedges 1156 of each pair extend toward each other from opposing side walls 1160 of the passageways. The director wedges 1156 include upper surfaces 1180 that slope toward the neutral plane of the inserter assembly 1000 as the distance from the top of inner housing 120 increases. The director wedges 1156 also include bottom surfaces 1182 that are parallel to the upper surfaces 1180. The ends of the upper and lower surfaces 1182 most distal from the top of inner housing 120 can be rounded or chamfered to form a point (as shown in FIGS. 89-91 ). As the outer housing 116 is displaced toward the body during the set stage, the release fingers 1154 and paddle bodies 1164 can displace along a displacement path along which the director wedges 1156 extend. The laterally angled portions 1172 of the paddle bodies 1164 of each release finger 1154 can contact the top surfaces 1180 of the paired director wedges 1156 during this displacement. Further displacement can cause the laterally angled portions 1172 to slide along the top surfaces 1180 of the director wedges 1156. This can produce deflection of the associated release fingers 1154 and movement of the protrusions 1166 of the paddle bodies 1164 toward the neutral plane of the inserter assembly 1000 (see, for example, FIG. 81 ). The protrusions 1166 of the paddle bodies 1164 can pass through the gap between the associated pair of director wedges 1156 as this displacement occurs. Once the paddle body 1164 is displaced beneath the director wedge 1156, the release finger 1154 is free to resiliently return to its undeflected state (see, eg, FIG. 85).

[0357] As described in more detail later herein, the outer housing 116 can be displaced in the opposite direction relative to the inner housing 120 to fire the inserter assembly 1000. As this occurs, the paddle body 1164 of each release finger 1154 can contact the bottom or lower surface 1182 of the associated director wedge 1156. Further displacement can cause the inner angled portion 1176 to slide along the underside 1182 of the director wedge 1156. The protrusion 1166 of the paddle body 1164 can pass through the gap between the associated pair of director wedges 1156 as the outer housing 116 is displaced.

[0358] When the release finger 1154 is deflected away from the neutral plane of the inserter assembly 1000, the protrusion 1166 can deflect toward a cantilevered arm 1184 on the insertion driver 1062. The arm 1184 can form a resilient protrusion that can deflect when sufficient force is applied thereto. The unsupported end of the arm 1184 can include a curved or angled section. A notch or pair of notches 1188 can also be present on each of the cantilevered arms 1184. In this example, each arm 1184 includes a pair of notches 1188 positioned near the unsupported end of the arm 1184. The notches 1188 can be positioned, for example, similar to the notch 342 shown in FIG. 36 . Each of the one or more notches 1188 can engage with a cooperating protrusion 1200. The cooperating protrusion 1200 can be included in the inner housing 120 and can protrude from the side wall 1160 of the passageway 1158 through the top of the inner housing 120. The interaction of the notch 1188 and the cooperating protrusion 1200 keeps the biasing member 1108 under compression and may function as an insertion prevention latch or an insertion driver latch.

[0359] With the release finger 1154 biased toward the arm 1184, further displacement of the outer housing 116 from the skin 356 may cause the protrusion 1166 of the paddle body 1164 to collide with the protrusion 1202 of the cantilever arm 1184. This may disengage the notch 1188 of the cantilever arm 1184 from the cooperating protrusion 1200 of the inner housing 120. Thus, when the first unit of the inserter assembly 1000 (e.g., the outer housing 116 and the retainer cap 406) is pulled away from the remainder of the inserter assembly (the second unit of the inserter assembly 1000) beyond a threshold distance (which may be measured from the ready position), the insertion driver 1062 may disengage from the insertion driver latch. This releases the spring 1108 and transitions it to its unstressed state, allowing the insertion driver 1062 to be displaced toward the skin 356. As the spring transitions from its stressed state to its relaxed state, the inserter driver 1062 can be displaced from its stowed state to an extended position. In the extended position, at least a portion of the inserter driver 1062 protrudes from the inserter assembly 1000 into the cartridge 1002. As shown in FIG. 91 , a ridge 1201 that blocks displacement of the cantilevered arm 1184 can be included on the inside of each of the cooperating protrusions 1200. This can help ensure that the cantilevered arm 1184 can be released from the cooperating protrusion 1200 only when intended by the user.

[0360] 92, a cross-sectional view of the inserter assembly 1000 shown in FIGS. 70A-70B is shown. In some embodiments, and as shown in FIG. 92, the release fingers 1154 may be positioned on the outside (with respect to the neutral plane) of the cantilevered arms 1184 of the insertion driver 1062, as opposed to on the inside (see, for example, the embodiment in FIGS. 71A-71B). Away from their respective cooperating protrusions 1200 of the inner housing 120, they may be displaced toward the neutral plane of the inserter assembly 1000. In such embodiments, the standoffs 1130 included in the retaining cap 406 may include an enlarged section 1131 that blocks the cantilevered arms 1184 from disengaging until the inserter assembly 1000 is withdrawn from the skin 356 beyond a certain amount.

[0361] As shown in FIG. 94 , a detail view of the indicated area of ​​FIG. 93 , the release fingers 1154 can have paddle bodies 1164 configured to deflect the release fingers 1154 in a direction opposite to that described in connection with FIGS. 89-91 . Each paddle body 1164 can include an inner surface 1168 proximal to the longitudinal axis or neutral plane of the inserter assembly 1000 and an outer surface 1170 on a side of the paddle body 1164 opposite the mid-plane 1168. A protrusion 1166 can be disposed on the neutral surface 1170 of each paddle body 1164. The protrusion 1166 can be centrally disposed on each paddle body 1164 so that the protrusion 1166 can be displaced without contacting the director wedge 1156 during actuation. The side surface 1170 of each paddle body 1164 can include a laterally angled portion 1172 adjacent to the paddle body 1164. The lateral sloped portion 1172 may be included in a section of the paddle body 1164 most proximal to the base portion 1174 of the retainer cap 406 (see, e.g., FIG. 93 ). As the distance from the base portion 1174 of the retainer cap 406 decreases, the lateral sloped portion 1172 may slope toward the neutral plane 1168. The intermediate plane 1168 of the paddle body 1164 may also include an inner sloped portion 1176 adjacent to the paddle body 1164. The inner sloped portion 1176 may be included in a portion of the paddle body 1164 most distal from the base portion 1174 of the retainer cap 406. As the distance to the base portion 1174 of the retainer cap 406 increases, the inner sloped portion 1176 may slope toward the side surface 1170.

[0362] When the outer housing 116 is pressed toward the skin 356 during the set up phase, the inner angled portion 1176 can deflect the paddle body 1164 of the release finger 1154 outwardly around the director wedge 1158. When the inserter assembly 1000 is lifted off the skin 356 to trigger insertion, the lateral angled portion 1172 can deflect the release finger 1154 inwardly around the deflector wedge 1158 and toward the cantilever arm 1184. As the release finger 1154 is deflected toward the arm 1184, further deflection of the paddle body 1164 from the skin 356 can cause the protrusion 1166 of the paddle body 1164 to collide with the protrusion 1202 of the cantilever arm 1184. This can cause the notch 1188 (described above) on the cantilevered arm 1184 to disengage from the cooperating protrusion 1200 (described above) on the inner housing 120. This can release the spring 1108 and move it to its unstressed state, displacing the insertion driver 1062 toward the skin 356.

[0363] As shown in FIG. 95 , actuation of the inserter assembly 1000 can be triggered when the inserter assembly 1000 is lifted from the skin 356 and removed from the patient. No other pressing, twisting, squeezing, etc. of a trigger, button, housing sleeve, or other part of the inserter assembly 1000 is required to trigger actuation, although actuation can still be under the control of the user. In alternative embodiments, and as described elsewhere herein, a separate manual trigger action can be used to trigger actuation of the inserter assembly 1000. While the trigger occurs automatically when the inserter assembly 1000 is withdrawn from the skin 356, relative movement of a free component of the inserter assembly 1000 relative to a restricted component can cause actuation. As described above, actuation can be triggered, for example, by moving or disengaging a latch and releasing one or more biasing members to begin driving actuation. Thus, one or more triggers internal to the inserter assembly 1000 can be actuated as a result of the act of removing the inserter assembly 1000 from the body. From the user's perspective, such an inserter assembly 1000 can simply be placed on the skin 356 and then removed to perform placement of the infusion set 102. This can be advantageous for several reasons detailed elsewhere herein.

[0364] FIG. 95 shows the exemplary inserter assembly 1000 of FIGS. 71A-71B coupled to the set cartridge 102 and being removed from the skin 356. As shown, the adhesive 374 on the infusion set base 106 may adhere to the skin 356, causing the skin 356 to pull the inserter assembly 1000 and set cartridge 1002. The outer housing 116 and retainer cap 406 can be displaced together as a unit with the user's hand when the user removes the inserter assembly 1000 from the body. This may also be true for the outer housing 116 and retainer cap 406 of the exemplary inserter assembly 1000 shown in FIGS. 70A-70B. Other components of the exemplary inserter assembly 1000 and set cartridge 1002 may not be constrained to displace as a unit with the outer housing 116 and retainer cap 406. These components may form a second unit that cannot be displaced and may be held back relative to the patch of skin 356 adhered to the adhesive 374 .

[0365] During removal of the inserter assembly 1000 and set cartridge 1002, the outer housing 116 and retainer cap 406 may be displaced away from the skin 356 substantially along the axis of the insertion sharp 132. This displacement relative to the other components releases the fingers 1154, causing them to deflect toward the cantilevered arms 1184 of the insertion drive 1062, as described above. The resilience of the release fingers 1154 allows the entire inserter assembly 1000 and set cartridge 1002 to move together for at least part of the insertion assembly 1000's withdrawal from the skin 356. During this portion of the inserter assembly 1000's removal operation, the skin 356 may lift from the underlying body structure. The portions of the inserter assembly 1000 may again be displaced relative to one another once the force exerted by the skin's elasticity exceeds a force threshold and the release fingers 1154 fully deflect about the deflection wedges 1158.

[0366] 96 , as the outer housing 116 and retainer cap 406 continue to be displaced relative to the rest of the inserter assembly 1000 and set cartridge 1002, the cantilevered arm 1184 of the insertion driver 1062 may disengage from the associated cooperating protrusion 1200 on the inner housing 120. As described above with respect to FIGS. 89-91 or 92-94 , this may be caused by the protrusion 1166 of the paddle body 1164 on the release finger 1154 colliding with the protrusion 1202 on the unsupported end of the cantilevered arm 1184.

[0367] As shown in FIG. 97, this may allow the bias member 1108 between the reset body 1110 and the plunger 1106 to transition to its uncompressed state. As the bias member 1108 transitions to its relaxed state, the plunger 1106 and insertion driver 1062 may be urged toward the skin 356. When the sharps holder 130 is coupled to the port 1064 of the insertion driver 1062, the sharps holder 130 and the cannula subassembly 114 coupled thereto may also be launched toward the skin 356 along the insertion path. As shown in FIG. 97, which illustrates the inserter assembly 1000 of FIGS. 71A-71B by way of example, the insertion sharps 132 and cannula 104 have just penetrated the skin 356. During puncture, the skin 356 may remain pulled away from muscle and other underlying body structures. The cannula subassembly 114 has also begun to advance toward the infusion set base 106. Also, as shown, the retaining cap 406 of the inserter assembly 100 may include one or more stop arms 1204 that prevent relative movement between the inner housing 120 and the casing formed by the outer housing 116 and the retainer cap 406 beyond a certain point. The stop arms 1204 can hook onto a portion of the top of the inner housing 120 to inhibit further relative displacement. The stop arms 1204 can be engaged as the insertion of the cannula 104 begins or progresses. Thus, additional lifting of the skin 356 can occur during the insertion movement of the cannula 104.

[0368] In some embodiments, a biasing member can be included so that the stop arm 1204 must compress the biasing member before the cantilever arm 1184 of the insertion driver 1062 disengages from the cooperating protrusion 1200. This aids in further lifting of the skin 356 before insertion is triggered. In some embodiments, the portion of the inner housing 120 that the stop arm 1204 contacts can be resiliently cantilevered in the path of the stop arm 1204. Thus, as the inserter assembly 1000 is withdrawn, the cantilevered portion of the inner housing 120 is deflected by the stop arm 1204 before the cantilever arm 1184 disengages from the cooperating protrusion 1200. The resiliency of these cantilevered portions can be selected to ensure that the skin is lifted at least a certain amount. In other embodiments, springs (e.g., compression springs, leaf-type springs, etc.) can be placed in the path of the stop arm 1204. These springs may need to be placed in a stressed state via displacement of the stop arm 1204 before the cantilever arm is released. Again, the spring can be selected to allow at least the desired amount of skin lift to occur before the cantilevered arm 1184 releases from the cooperating projection 1200 .

[0369] FIG. 98 shows another cross-sectional view of the exemplary inserter assembly 1000 and set cartridge 1002. As shown, the spring 1108 has returned to a relaxed state, completing the insertion movement of the sharps holder 130, the insertion sharps 132, and the cannula subassembly 114 into the skin 356. The relaxed state can be a fully relaxed state or a relatively relaxed state. Here, the spring 1108 still exerts some pressure on the sharps holder 130 to prevent it from hitting it. Similar to FIG. 42B , the notch 184 on the cannula subassembly 114 engages with the ridge 182 on the infusion set base 106 to lock the cannula subassembly 114 in place and complete the assembly of the infusion set 102. As shown, when the cannula subassembly 114 latches to the base 106, the ear 204 included on the cannula subassembly 114 can press against the nub 1026 included on the retaining arm 1016. This spreads the retention arms 1016, allowing the retention arms 1016 to disengage from the infusion set base 106. The assembled infusion set 102 can then be placed at the infusion site and released from the set cartridge 1002.

[0370] As shown in FIG. 98, the insertion driver 1062 may collide with the latch arms 1190 of the retraction latch body 1100 when the now-assembled infusion set 102 is released. This collision may cause the latch arms 1190 to spread apart, releasing the retraction spring retainer 1102 from engaging the catches 1198 of the latch arms 1190. FIG. 98 shows the insertion assembly 1000 in a retracted, released state. The exemplary inserter assembly 1000 of FIGS. 70A-70B is shown in a retracted, released state in FIGS. 99A-99B.

[0371] As shown in FIG. 100 , when the retraction spring retainer 1102 is released from the catch 1198, the bias members 1104A, B (or bias member 1104 in the case of the inserter assembly 1000 of FIGS. 70A-70B ) may transition to their unstressed state, driving the retraction spring retainer 1102 toward the retainer cap 406 of the outer housing 116. Because a portion of the insertion driver 1062 is between the retraction spring retainer 1102 and the retainer cap 406, the insertion driver 1062 may also be displaced along with the retraction spring retainer 1102 as the bias members 1104A, B are released. Because the sharps holder 130 is coupled to the insertion driver 1062, displacement of the insertion driver 1062 may remove the insertion sharps 132 from the skin 356 and retract them back into the set cartridge 1002.

[0372] In certain alternative embodiments, retraction of the insertion sharp 132 may not be automatic and / or spring biased. For example, the insertion sharp 132 may remain in an advanced position, and a user removal action may manually withdraw the insertion sharp 132 from the cannula 104. In such embodiments, the biasing members 1104A, B may be omitted. In some embodiments, a button press or similar interaction may be required to trigger the spring-biased retraction of the insertion sharp 132.

[0373] As shown in FIG. 101 , the outer housing 1004 is shown separate from the rest of the used-set cartridge 1002 attached to the inserter assembly 1000. Once the infusion set 102 is attached to the desired infusion site, the outer housing 1004 can be used as a removable replacement. As shown, the cantilevered arms 1076 of the inner housing 1008 may be recessed relative to the outer surface 1082 of the inner housing 1008. A recessed edge wall 1084 may be present on each side. The outer housing 1004 may include a pair of stoppers 1086 that may fit within recesses formed in the inner housing 1008. After insertion of the infusion set 102, the outer housing 1004 may be slid onto the inner housing 1008. The used-set cartridge 1002 may be rotated to an uncoupled state. The stoppers 1086 may hook into the recessed edge walls 1084, ensuring that the inner housing 1008 rotates in tandem with the outer housing 1004. 73 , this can displace the angled protrusion 1074 of the housing tab 1070 from abutment with the biasing member 1078 of the receptacle body 1060. The resilience of the cantilever arm 1076 allows the housing tab 1070 to return to engagement with the receiving slot 1072 in the outer housing 1004. The spent-set cartridge 1002 can then be removed from the inserter assembly 1000.

[0374] After use, the outer housing 1004 may serve as a storage container for the remaining components of the used set cartridge 1002. This may securely seal the used insertion sharps 132 within the set cartridge 1002. Thus, the insertion sharps 132 may not be accessible to the user. Engagement of the housing tab 1070 with the storage slot 1072 may lock the insertion sharps 132 within the used set cartridge 1002. In certain embodiments, placement of the infusion set 102 at the infusion site via the inserter assembly 1000 may be performed with one hand. Thus, after removing the outer housing 1004, the user may be prompted to hold the outer housing 1004 with their free hand as the infusion set 102 is applied with the inserter assembly 1000. The user may then remove the used set cartridge 1002 by reattaching it. The user may then remove the used set cartridge 1002 by connecting the outer housing 1004 to the inner housing 1008 and separating the set cartridge 1002 from the inserter 1000. Occupying the user's hands during the process may help limit the opportunity for the user to inadvertently come into contact with the inserted sharps 132.

[0375] 102-106 illustrate an exemplary tubing connector 368 (FIGS. 102-103B) and a fixture 480 (FIGS. 104-105) for assembling the tubing connector 368. The fixture 480 can assist in assembling the sharp 482 and infusion tube 366 (see, e.g., FIG. 6) to the tubing connector 368. The fixture 480 can ensure that the sharp 482 is positioned to have a predetermined length of exposed portion. In various embodiments, this can help ensure that the sharp 482 extends a desired distance into the septum 110 (see, e.g., FIG. 5B) when the tubing connector 368 is coupled to the infusion set 102 (see, e.g., FIG. 6). For example, the length of the exposed portion 484 can be sized to extend into the fluid introduction volume of the cannula subassembly 114, as described elsewhere herein.

[0376] In the example, the sharp 482 is depicted as a lancet tip, although other types of sharps can be used. For example, in certain embodiments, a sharp 482 with a trailing bevel can be used. The exemplary sharp 482 (see FIG. 103B) includes a primary grinding region 487 that is at an angle (e.g., an angle between 10-20 degrees, such as 15.5 degrees) relative to the longitudinal axis of the sharp 482. A grinding 489 is also included, forming a point 485 of the acute angle 482.

[0377] Additionally, the fixture 480 can ensure that the sharpener 482 is oriented in a predetermined rotational direction. This can be achieved using magnetism. Thus, the tip 486 of the sharpener 482 of the tubing connector 368 can be uniformly oriented across the tubing connector 368. This may be desirable for a variety of reasons. For example, during a typical service life of the infusion set 102, the tubing connector 368 may be disconnected and reconnected many times. When the tip 486 is angled, the sharpener 482 may tend to deviate from the insertion axis as the tubing connector 368 advances to engage with the infusion set base 106. This tendency may be exaggerated by repeated connection and disconnection. By ensuring that the tip 486 is always oriented in a specific direction, any deflection of the sharpener 482 can occur in a predictable direction, and the septum 110 can be designed to accommodate such deflection. This may allow the septum 110 to be smaller in areas where deflection of the sharpener 482 is not expected to occur. The septum 110 can have a smaller footprint or height and can be made with less material. Additionally, the fluid introduction volume formed by the septum recess 196 (see, e.g., FIG. 5B) can be smaller. This will minimize the holdup volume within the infusion set 102 and the amount of drug or agent expended to fill this volume. Such rotational alignment of the sharp 482 may allow for the use of a greater variety of tip 486 bevels. It may also minimize the possibility of blockage because the tip 486 is completely surrounded by the septum 110 material after the connection is made, or it may allow the connection between the infusion set 102 and the tubing connector 368 to be made in a more forgiving manner. As a result, greater tolerances may be allowed for various features of the infusion set 102 and the tubing connector 368. Similarly, the amount of material required to form the guide 172 (see, e.g., FIG. 6) or the adjacent protrusion 372 of the tubing connector 368 may be reduced.

[0378] 106, the fixture 480 may include a dock 490 for the tubing connector 368. The dock 490 may mimic the mating interface of the infusion set base 106 (see, e.g., FIG. 6) and may include, for example, the guide 172′ and the connector receiver 170. Thus, the tubing connector 368 may engage with and be retained within the fixture 480. The dock 490 may also position the tubing connector 368 in a desired position and orientation on the fixture 480.

[0379] The fixture 480 may include an adhesive port 510 (best shown in FIG. 105) that allows glue, epoxy, or adhesive to be introduced into the tubing connector 368 to hold the sharp 482 to the tubing connector 368 once properly positioned. In certain embodiments, a UV-curable adhesive may be used.

[0380] 107-108 show two cross-sectional views of the tubing connector 368 attached to the dock 490. A sharpener 482 is shown attached to the tubing connector 368 in FIG. 107. The sharpener 482 is in a predetermined position within the tubing connector 368 and is clocked so that a point 485 of the sharpener 482 is at a specific position, which in the exemplary embodiment is the 12 o'clock position. In the exemplary embodiment, the point 485 of the tip 486 of the sharpener 482 is positioned to be substantially aligned with and perpendicular to the axis of the lumen 202 of the cannula 104 of the infusion set 102 when the tubing connector 368 is connected thereto. The primary grind 487 and secondary grind 489 on the tip 486 are also in a downward position.

[0381] As shown, the fixture 480 includes a first body 498 and a second body 500. The bodies 498, 500 may be joined together via any suitable method, including bonding, welding, adhesives, fasteners, etc. A clamping element is used to join the second body 498 and the second body 500. The second body 500 may fit within a cavity or slot 504 in the first body 498, which can help position the second body 500 relative to the first body 498. The second body 500 may include a sloped surface 506. The sloped surface 506 may have an angle relative to the axis of the sharp 482 that is substantially equal to the angle of one of the grinds 487, 489 on the sharp 482. For example, the angle is approximately 15.5°, which is the angle of the primary grind 487 of the sharp 482. The sloped surface 506 may include a portion that is aligned with the sharp receiving hole 508 in the first body 498. This portion may be operative. As a support surface for the primary grinding 487 of the sharpening 482. The second body 500 may be constructed of a hard non-metallic material.

[0382] As shown, fixture 480 may include a first magnet 492 and a second magnet 494. First magnet 492 may be larger than second magnet 494. The dimensions of each edge of second magnet 494 are as follows: In some embodiments, first magnet 492 may be a 1 / 8 inch x 1 / 8 inch x 1 / 2 inch NdFeB magnet. Second magnet 494 may be a 1 / 16 inch x 1 / 16 inch x 1 / 4 inch NdFeB magnet. Alternative embodiments may use electromagnets, which may be equivalent to the permanent magnets just described. First magnet 492 and second magnet 494 may be positioned within a channel 496 included in fixture 480. Channel 496 of second magnet 494 may be at an angle relative to channel 496 of first magnet 492. The angle is approximately 15.5°. The angle may reflect the angle of one of the grinds 487, 489 of sharp 482. The angle can be the same as the angle of the angled surface 506 of the second body 500. The first magnet 492 is oriented so that each pole is closest to the opposing pole of the second magnet 494. The ends of the magnets 492, 494 are set back from the support surface portion of the angled surface 506. In the exemplary embodiment, the ends of the magnets 492, 494 are set back approximately 0.060 inches.

[0383] When the sharpener 482 is introduced into the tubing connector 368, the magnetic field generated by the magnets 492, 494 rotates and can steer the sharpener 482 in a desired rotational direction. The magnetic field may also draw the sharp 482 into contact with the inclined surface 506, setting the length of the exposed portion 484 of the sharp 482. During introduction of the sharp 482, the sharp 482 may be displaced to a desired position and direction with no or minimal contact between the point 485 or secondary grinding 489 and any material of the tubing connector 368 or fixture 480. Only the primary grinding 487 of the sharp 482 may rest against the inclined surface 506. Also, the bevel section formed by the point 485 and secondary grinding 489 may not be in contact with the inclined surface 506. This may help ensure that the tip 486 remains sharp and may help prevent weakening of the tip 486's penetration ability.

[0384] With the sharpener 482 in place, the injection tube 366 can be coupled to the tubing connector 368. The tubing 366 can be introduced into the tubing receptacle 512 of the tubing connector 368. The lumen 514 of the tubing 366 can be positioned in fluid communication with the lumen 516 of the sharpener 482. The tubing receptacle 512 of the tubing connector 368 can include at least one tapered region 518, which can aid in funneling the tubing 366 into the tubing receptacle 512. The tubing 366 can be slid into place and transferred to the beveled surface 506 via the primary grind 487 of the sharpener 482. This can help ensure that the tip 486 of the sharpener 482 is protected when the tubing 366 is assembled to the tubing connector 368.

[0385] Once the tubing 366 is in place, the applicator can be advanced into the port 510. An adhesive or glue can be dispensed into the opening 520 of the tubing connector 368. In some embodiments, a UV-curable adhesive can be used. UV light can be directed toward the tubing connector 368 to cure the glue and securely hold the sharp 482 and tubing 366 onto the tubing connector 368. However, an external light source can also be utilized. The tubing connector 368 can then be removed from the fixture 480.

[0386] Referring to FIG. 109 , a flowchart 530 is shown illustrating some example actions that may be performed to assemble a tubing connector 368. In block 532, the tubing connector 368 may be coupled to a fixture 480. A sharpener 482 may be introduced to the tubing connector 368 in block 534. The fixture 480 may be oriented so that the sharpener 482 is introduced to the tubing connector 368 along the direction of acceleration due to gravity (aiding introduction). Magnets 492, 494 within the fixture 480 may orient the sharpener 482 to a desired position as it is introduced. In block 536, the injection tube 366 may be inserted into the tubing receptacle 512 of the tubing connector 368. Adhesive may be applied to the tubing connector 540 in block 538. The adhesive may be cured in block 540. In block 542, the completed tubing connector 368 may be removed from the fixture 480.

[0387] Various alternatives and modifications may be devised by those skilled in the art without departing from the present disclosure. Accordingly, the present disclosure is intended to encompass all such alternatives, modifications, and variations. Moreover, while several embodiments of the present disclosure have been shown in the drawings and / or discussed herein, it is intended that the disclosure be as broad as the art will permit, and that the specification be read accordingly. Accordingly, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto. Other elements, steps, methods, and techniques that differ substantially from those described above and / or in the appended claims are also intended to be within the scope of the present disclosure.

[0388] The embodiments illustrated in the drawings are presented only to demonstrate certain examples of the present disclosure. The drawings described are for illustration purposes only and are not limiting. In the drawings, the size of some of the elements may be exaggerated and not drawn to scale for illustrative purposes. Furthermore, like-numbered elements shown in the drawings may be identical or similar elements, depending on the context.

[0389] When the term "comprising" is used in the specification and claims, it does not exclude other elements or steps. Where an indefinite or definite article is used when referring to a singular noun, this includes the plural of that noun unless otherwise specified. Thus, the term "comprising" should not be construed as being limited to the items listed thereafter. Because it does not exclude other elements or steps, the scope of the expression "a device comprising items A and B" should not be limited to a device containing only components A and B.

[0390] Furthermore, terms such as "first," "second," "third," etc., whether used in the description or the claims, are provided to distinguish between similar elements and do not necessarily describe a sequential or chronological order. Terms so used are interchangeable under appropriate circumstances (unless expressly disclosed otherwise), and it is un...

Claims

1. 1. An inserter assembly comprising: A casing; a body including a cavity disposed within the casing; a sharps holder attached to the inserted sharps, the sharps holder being at least partially disposed within the cavity; a bias member disposed within the cavity and between the sharps holder and a wall of the cavity; a trigger having a first state in which a biasing member is maintained in an energized state and a second state in which the biasing member is released from the energized state, the biasing member being configured to urge the sharps holder to displace the inserted sharps from the casing when released from the energized state; an infusion set base that retains engagement with the body and includes an adhesive on a bottom surface thereof; a trigger actuation protrusion extending from the casing and positioned to actuate the trigger from the first state to the second state when the adhesive adheres to skin and the skin is pulled away from the body, separating the casing from the body; and An inserter assembly comprising:

2. The inserter assembly of claim 1 , wherein the casing comprises the housing and a retaining base coupled to the housing for movement therewith as a unit.

3. The inserter assembly of claim 2 , wherein the trigger actuation projection is included on the retention base.

4. The inserter assembly of claim 1 , wherein the trigger includes a latch.

5. The inserter assembly of claim 4 , wherein the latch includes a catch disposed on the body that engages a ledge formed on a cantilevered arm of the sharps holder.

6. The inserter assembly of claim 1 , wherein a bottom surface of the infusion set base is substantially level with the skin-contacting surface of the casing prior to application of the inserter assembly to the skin.

7. 2. The inserter assembly of claim 1, further comprising a cannula subassembly through which the insertion sharp extends, the cannula subassembly separating from the infusion set base when the trigger is in the first position.

8. The inserter assembly of claim 7 , wherein the cannula subassembly includes a cannula that is integral with a septum housing.

9. 8. The inserter assembly of claim 7, wherein the cannula subassembly and the infusion set base include cooperating coupling elements that interface to couple the cannula subassembly and the infusion set base when the cannula subassembly is moved to the infusion set base.

10. The inserter assembly of claim 1 , wherein the energy stored state of the first bias member is a compressed state.

11. 2. The inserter assembly of claim 1, further comprising a second bias member configured such that displacement of the insert sharp from the casing releases the second bias member from its energized state, the second bias member urging the sharps holder and the insert sharp to a stored state within the casing when released from its energized state.

12. 1. An inserter assembly comprising: a first unit including a biasing member and a trigger actuation protrusion; a second unit housed within the first unit, a body including a cavity and a resilient arm, the arm aligned with the biasing member; a sharps holder having a sharps insert at least partially disposed within the cavity; a biasing member held in an energized state by the trigger; an insert set base including an adhesive releasably coupled to the body; a second unit including: when the adhesive adheres to the skin and the inserter assembly is withdrawn from the user, in a first stage of actuation, the first unit and the second unit move together by forcing the arm into the bias, pulling the skin away from the user until a force applied by the elasticity of the skin overcomes the elasticity of the arm, and in a second stage of actuation, the trigger is displaced and energy stored in the bias member is released, urging the sharps holder toward the skin.

13. The inserter assembly of claim 12 , wherein the first unit includes the outer housing and the retention base coupled to the outer housing.

14. The inserter assembly of claim 13 , wherein the biasing member and trigger actuation projection are included on the retainer base.

15. The inserter assembly of claim 13 , wherein the trigger actuation projection includes a finger including a fin extending from a portion of the retainer base to the second unit.

16. The inserter assembly of claim 12 , wherein the trigger includes a catch on the body that engages with a ledge included in the biasing member of the sharps holder.

17. 13. The inserter assembly of claim 12, wherein the first unit includes the second biasing member, and the body of the second unit includes a second arm having a second arm resilience, the second arm aligned with the second biasing member.

18. The inserter assembly of claim 12, wherein the infusion set base is arranged to be detached from the body when the sharps holder is urged toward the skin.

19. The inserter assembly of claim 12 , wherein the biasing member is a compression spring.

20. The inserter assembly of claim 12 , wherein the deflection member includes an angled deflection surface disposed opposite an angled arm surface included on the arm.

21. 13. The inserter assembly of claim 12, wherein the infusion set base is releasably coupled to the body by a pair of cantilever arms, and when the sharps holder is urged by the biasing member, the cantilever arms are configured to be displaced to a spread-apart state to release the infusion set base by ears of a cannula subassembly carried with the insertion sharps.

22. 13. The inserter assembly of claim 12, further comprising a cannula subassembly carried by an insertion sharp and spaced apart from the infusion set base during a first stage of operation, the cannula subassembly being coupled to the base during a second stage of operation.

23. 1. An inserter assembly comprising: a casing including a skin-contacting surface surrounding the casing opening; a sharps holder including an insert sharps; a cannula subassembly carried by an insertion sharp, the insertion sharp and the cannula of the cannula subassembly each having a skin-piercing tip disposed on a skin-contacting surface; an infusion set base disposed within the opening of the casing and having a bottom surface substantially level with the skin-contacting surface, the infusion set base including a cannula subassembly receiving cavity sized to receive the cannula subassembly and prevent finger penetration; an insertion bias member; the sharps holder is configured for displacement upon transition of the insertion bias member from an insertion energy stored state to a relaxed state to push the insertion sharps and the cannula at least partially out of the casing and couple the cannula subassembly to the infusion set base.

24. 24. The inserter assembly of claim 23, further comprising a plurality of standoffs that position the infusion set base flush with the skin-contacting surface prior to activation.

25. The inserter assembly of claim 23, wherein the cannula subassembly includes a cannula, a septum, a septum retainer, and a septum housing.

26. The inserter assembly of claim 25, wherein the septum housing and the cannula are formed as a continuous piece.

27. 24. The inserter assembly of claim 23, wherein the cannula subassembly receiving cavity and the cannula subassembly include cooperating coupling elements that interact to couple the infusion set base and the cannula subassembly together when the cannula subassembly is advanced into the cavity receiving the cannula subassembly.

28. 28. The inserter assembly of claim 27, wherein the cooperating coupling element includes a cantilevered arm having a ridge on the infusion set base and a receiving notch for receiving a ridge on the cannula subassembly.

29. 24. The inserter assembly of claim 23, further comprising a sharps retractor and a retractor biasing member configured to be released from a retracted energy stored state and unlatched in response to a protrusion on the cannula subassembly when the sharps holder is displaced by a transition of the insertion biasing member.

30. 30. The inserter assembly of claim 29, wherein the retractor biasing member is configured to displace the sharp retractor away from the skin-contacting surface when the retractor biasing member transitions from the retracted energy stored state to the relaxed state.

31. 31. The inserter assembly of claim 30, wherein the sharps holder includes at least one shelf and the sharps retractor includes at least one stop, and wherein a dwell distance exists between the at least one shelf and the stop when the retractor biasing member is released from the retracted energy stored state.

32. 1. An inserter assembly comprising: A casing; a sharps holder comprising: an insert sharp coupled to the sharps holder; and a cantilevered arm having a ridge defining a shelf; a sharps retractor at least partially containing the sharps holder and having a cavity with a stopper therein configured to engage the ledge, the sharps retractor further having a catch configured to engage the ledge and hold the insertion spring in a biased state; a cannula subassembly carried by the insertion sharp; an infusion set base releasably coupled to the Sharp retractor and configured to maintain a retraction spring in a biased state while releasably coupled to the Sharp retractor; the insertion spring is configured to drive the sharps holder along an insertion path when the shelf disengages from the catch, the infusion set base is decoupled from the sharps retractor, the cannula subassembly is coupled to the infusion set base, the shelf is spaced a retention distance from the stopper when the sharps holder moves to an end of the insertion path, and the retraction spring is configured to displace the sharps retractor together with the sharps holder into the casing after the sharps retractor moves the retention distance to engage the stopper with the shelf.

33. 33. The inserter assembly of claim 32, wherein the infusion set base is releasably coupled to the Sharp retractor by a pair of cantilevered arms extending from the Sharp retractor.

34. 34. The inserter assembly of claim 33, wherein the cannula subassembly includes a pair of ears configured to spread the set of arms apart and release the infusion set base when the sharps holder moves to the end of the insertion path.

35. 33. The inserter assembly of claim 32, wherein the sharps holder includes a second cantilevered arm having the second ridge defining the second shelf.

36. 36. The inserter assembly of claim 35, wherein the cavity includes a second stop configured to engage the second shelf.

37. 33. The inserter assembly of claim 32, wherein the cannula subassembly includes a notch configured to mate with a protuberance included in the infusion set base when the sharps holder is moved to the end of the insertion path.

38. 33. The inserter assembly of claim 32, wherein the cannula subassembly includes a protrusion configured to mate with a ridge included in the infusion set base when the sharps holder is moved to the end of the insertion path.

39. 33. The inserter assembly of claim 32, wherein the cannula and septum housing of the cannula subassembly are formed together as a monolithic piece in a straight pull mold.

40. 33. The inserter assembly of claim 32, wherein the casing includes an outer housing and a retainer base, and the infusion set base is positioned within an opening in the retainer base and is level with a skin-contacting surface of the retainer base prior to actuation of the inserter assembly.

41. 33. The inserter assembly of claim 32, wherein the infusion set base includes an adhesive on its bottom surface, and the ledge disengages from the catch by lifting the inserter assembly from a patch of skin to which it has been applied.

42. 1. An inserter assembly comprising: a first unit including a skin-contacting surface surrounding the opening; a second unit housed within the first unit, an infusion set base positioned within the opening, the infusion set base having a bottom surface substantially level with the skin-contacting surface and at least partially covered with adhesive; a spring bias insert assembly; and a second unit including a cannula subassembly carried by the insertion sharp of the insertion assembly; wherein the spring-biased insertion assembly and a cannula of the cannula subassembly are configured to be driven into the skin, and the cannula subassembly is configured to be coupled to the infusion set base by an insertion spring configured to be released from an energy-storing state after an adhesive pulls the skin upward beyond a specified distance when the inserter assembly is withdrawn.

43. 43. The inserter assembly of claim 42, further comprising a sharp retractor and a retractor spring configured to retract the sharp retractor along with the insertion assembly away from the skin-contacting surface.

44. 44. The inserter assembly of claim 43, wherein the inserter assembly includes at least one latch configured to maintain a retractor spring in an energy-storing state, the latch being released when the cannula subassembly is displaced into mating engagement with the infusion set base.

45. The inserter assembly of claim 44, wherein the at least one latch comprises a pair of cantilevered arms included in the Sharp retractor.

46. 46. ​​The inserter assembly of claim 45, wherein the cantilevered arms each include a ledge that engages a respective protrusion on the infusion set base.

47. 46. ​​The inserter assembly of claim 45, wherein each protrusion on the infusion set base is part of a guide for a portion of the tubing set connector.

48. 43. The inserter assembly of claim 42, wherein the infusion set base includes a cannula subassembly receiving cavity extending therethrough and sized to receive the cannula subassembly but prevent finger penetration.

49. 49. The inserter assembly of claim 48, wherein the cannula subassembly and the cannula subassembly receiving cavity include cooperating coupling elements that interact to couple the infusion set base and the cannula subassembly to one another.

50. 1. An inserter assembly comprising: A first unit; an infusion set base including an adhesive on a bottom surface thereof; an insertion sharp drive assembly releasably coupled to the infusion set base, the insertion sharp drive assembly including an insertion sharp, a drive spring, a resilient member, and a latch arrangement configured to engage and hold the drive spring in an energized state; A casing; the infusion set base is disposed within the opening of the casing, and displacement of the inserter assembly from the body when the adhesive is in adhesive relation to the skin in a first stage pulls the skin from the underlying structure and forces exerted by the skin's elasticity overcome the skin's elasticity in a second stage, the elastic member displaces the casing relative to the first unit and disengages the latching arrangement, and the drive spring is arranged to displace the insertion sharp from the casing when transitioned to a relaxed state.

51. 1. An inserter assembly for placing an infusion set at an infusion site on a body, comprising: a casing having an actuation protrusion; a first unit within the casing movable relative to the casing, an infusion set base having an adhesive; a sharps holder including an insert sharps; a body including a cavity in which a drive spring and the sharps holder are at least partially disposed, the sharps holder being displaceable from a raised state to an advanced state by the drive spring; a drive spring release latch arrangement, wherein the actuation protrusion is configured to release the drive spring release latch arrangement after a magnitude of relative displacement between the casing and the first unit exceeds a threshold; and Including, The adhesive is configured to secure the first unit relative to the body while the casing is pulled away from the body and the magnitude of relative displacement between the casing and the first unit is increased, and an inserter assembly.

52. 52. The inserter assembly of claim 51, wherein the first unit further comprises a resilient member.

53. 53. The inserter assembly of claim 52, wherein the resilient member is aligned with the bias on the casing.

54. 53. The inserter assembly of claim 52, wherein the resilient member is configured to abut a portion of the casing to inhibit relative displacement of the casing and the first unit until the force threshold is exceeded.

55. 55. The inserter assembly of claim 54, wherein the portion of the casing is the biasing member and the resilient member is the resilient arm included in the body.

56. 55. The inserter assembly of claim 54, wherein the adhesive bond is selected to lift the skin of the body at least a specified distance from an underlying body structure before the magnitude of the relative displacement exceeds a threshold when the casing is pulled away from the body.

57. 55. The inserter assembly of claim 54, wherein a force threshold is selected such that, when the casing is pulled away from the body, the adhesive bond lifts the body skin at least a specified distance from underlying body structure before relative displacement of the casing and the first unit begins.

58. 55. The inserter assembly of claim 54, wherein a force threshold is selected such that when the casing is pulled away from the body, adhesion of the adhesive lifts the skin of the body at least a specified distance from underlying body structures.

59. 52. The inserter assembly of claim 51, wherein the infusion set base is releasably coupled to the body.

60. 52. The inserter assembly of claim 51, wherein the infusion set base is arranged to release from the body when the sharps holder is displaced to an advanced state.

61. 52. The inserter assembly of claim 51, further comprising a retraction spring, the sharps holder being displaceable from an advanced state to a retracted state by the retraction spring.

62. 62. The inserter assembly of claim 61, further comprising a retraction spring release latch arrangement configured to release upon displacement of the sharps holder to an advanced state via a drive spring.

63. 63. The inserter assembly of claim 62, wherein the retraction spring release latch arrangement releasably couples the infusion set base to the body, and the infusion set base is released from the body when the spring release latch arrangement is released.

64. 52. The inserter assembly of claim 51, wherein the cannula subassembly is carried on the insertion sharp.

65. 1. A cannula subassembly for an infusion set, comprising: a continuous monolithic body including a cannula and a septum housing having a septum receptacle with a raised area at its bottom, the lumen of the cannula being continuous with a sharps guide contained in the raised area; a septum including a septum recess having a centering wall section formed as a negative version of the raised region; a bulkhead retainer including a body having latch arms extending through the bulkhead housing, each including a latch surface that, in engagement, captures a cooperating element of the bulkhead housing to capture a bulkhead within the bulkhead housing; a cannula subassembly including:

66. 66. The cannula subassembly of claim 65, wherein the septum housing includes a protrusion positioned to engage a latch of an infusion set base to retain the cannula subassembly within the infusion set base.

67. 66. The cannula subassembly of claim 65, wherein an upper surface of the wall of the septum receptacle has a recessed slot therein.

68. 68. The cannula subassembly of claim 67, wherein the slot comprises two slots disposed opposite one another.

69. 66. The cannula subassembly of claim 65, wherein the septum retainer further includes a set of protrusions.

70. 70. The cannula subassembly of claim 69, wherein the set of protrusions are sized to be received within slots recessed in an upper surface of a wall defining the septum receptacle.

71. 71. The cannula subassembly of claim 70, wherein the set of protrusions, when received in the slot, obstruct only the upper portion of the slot, leaving a lower segment of the slot open and exposing a side wall of the septum at a position level with at least a portion of the recess in the septum.

72. 66. The cannula subassembly of claim 65, wherein the raised portion of the septum receptacle has the frustoconical outer wall.

73. 66. The cannula subassembly of claim 65, wherein the septum housing includes a notch in a side wall thereof configured to engage a latch on the infusion set base to retain the cannula subassembly within the infusion set base.

74. 66. The cannula subassembly of claim 65, wherein the monolithic body is formed by straight pull molding.

75. 66. The cannula subassembly of claim 65, wherein the monolithic body is devoid of undercut features.

76. 66. The cannula subassembly of claim 65, wherein the monolithic body is polypropylene.

77. 66. The cannula subassembly of claim 65, wherein the monolithic body is PTFE.

78. 66. The cannula subassembly of claim 65, wherein the body of the septum retainer includes a channel extending therethrough and sized to receive a nub on a face of the septum.

79. 66. The cannula subassembly of claim 65, wherein the sharp guide is surrounded by a substantially flat peripheral edge at the top of the raised portion.

80. 1. A cannulated housing for an infusion set comprising a continuous monolithic body, The continuous monolithic body comprises: A cannula and a septum housing having a septum receptacle defined by a side wall and a bottom wall having a raised region, wherein the cannula lumen is a continuous surface having the raised region, and the side wall extends the length of the septum receptacle and has at least one guide aligned with an opening extending through the bottom of the septum housing.

81. 81. The cannulated housing of claim 80, wherein the septum housing includes a protrusion on an exterior surface of a sidewall positioned to engage a latch of the infusion set base to retain the cannula housing within the infusion set base.

82. 81. The cannulated housing of claim 80, wherein an upper surface of the wall of the septum receptacle has a recessed slot therein.

83. 83. The cannulated housing of claim 82, wherein the slot comprises two slots disposed opposite one another.

83. 83. The cannulated housing of claim 82, wherein the slots are configured to receive a set of protrusions included in the septum retainer to leave a bottom segment of each slot open and provide a passageway for the volume of the septum receptacle.

84. 81. The cannulated housing of claim 80, wherein the raised portion of the septum receptacle has a frustoconical outer wall.

85. 81. The cannulated housing of claim 80, wherein the septum housing includes a notch on an outer surface of the side wall configured to engage with a latch on an infusion set base to retain the cannulated housing assembly within the infusion set base.

86. 81. The cannulated housing of claim 80, wherein the monolithic body is formed by straight pull molding.

87. 81. The cannulated housing of claim 80, wherein the monolithic body is devoid of undercut features.

88. 81. The cannulated housing of claim 80, wherein the monolithic body is polypropylene.

89. 81. The cannulated housing of claim 80, wherein the monolithic body is PTFE.

90. 81. The cannulated housing of claim 80, wherein the cannula includes a sharp guide surrounded by a substantially flat peripheral edge at the top of the raised portion.

91. 81. The cannulated housing of claim 80, wherein the shelf is disposed adjacent the opening on an exterior surface of the bottom wall.

92. 81. The cannulated housing of claim 80, wherein a wall of the opening forms a catch configured to engage a protuberance on a projection of a portion of the septum retainer.

93. 81. The cannulated housing of claim 80, wherein the guide is embedded in the side wall.

94. 1. A method of placing an infusion set on a user's body, comprising: adhering an infusion set base releasably coupled to an inserter assembly to the body; pulling the inserter assembly away from the body; elevating the skin from underlying structures of the body via the adhesive of the infusion set as the inserter assembly is pulled away from the body; After the skin has been lifted at least a specified distance, moving a trigger actuator to a trigger of the inserter assembly; driving an insertion sharp through the skin; A method comprising:

95. 95. The method of claim 94, wherein the method further comprises releasing a bias member from an energized state to drive the insertion sharp through the skin.

96. 95. The method of claim 94, further comprising releasing the infusion set base from the inserter assembly.

97. 95. The method of claim 94, wherein the method further comprises removing a locking member from the inserter assembly and removing an adhesive backing from the infusion set base.

98. 95. The method of claim 94, wherein the method further comprises releasing an anti-retraction latch and sharply driving the insertion sharp away from the skin.

99. 95. The method of claim 94, further comprising driving a cannula subassembly carried by sharp insertion into the infusion set base.

100. 100. The method of claim 99, wherein driving the cannula subassembly into the infusion set base comprises driving a cannula of the cannula subassembly through the skin.

101. 95. The method of claim 94, further comprising: inhibiting relative movement between a casing of the inserter assembly and a remainder of the inserter assembly at least when the skin begins to lift.

102. 1. A method of placing an infusion set on a user's body, comprising: adhering an infusion set base releasably coupled to an inserter assembly to the body; pulling the inserter assembly away from the body; displacing the skin from its resting position via the infusion set adhesive as the inserter assembly is pulled away from the body; inhibiting actuation of the trigger until the skin is displaced to a point where the elasticity of the skin exerts a force against the infusion set base that exceeds a threshold force; displacing a trigger actuator onto a trigger of the inserter assembly; driving an insertion sharp through the skin; A method comprising:

103. 103. The method of claim 102, wherein the method further comprises releasing a bias member from an energized state to drive the insertion sharp through the skin.

104. 103. The method of claim 102, wherein the method further comprises disconnecting the infusion set base from the inserter assembly.

105. 103. The method of claim 102, wherein the method further comprises removing a locking member from the inserter assembly and removing an adhesive backing from the infusion set base.

106. 95. The method of claim 94, further comprising driving the cannula subassembly together with the insertion sharp toward the skin so that the cannula subassembly is driven into an anti-retraction latch, and driving the insertion sharp away from the skin.

107. 103. The method of claim 102, further comprising driving a cannula subassembly carried by the insertion sharp into the infusion set base.

108. 108. The method of claim 107, wherein driving the cannula subassembly into the infusion set base comprises driving a cannula of the cannula subassembly through the skin.

109. 103. The method of claim 102, wherein inhibiting actuation of a trigger comprises inhibiting relative movement between a casing of the inserter assembly and a remainder of the inserter assembly at least when the skin begins to displace.

110. 1. An inserter assembly comprising: a first unit including a casing; a second unit, an infusion set base having an adhesive; Sharps holder, including insert sharps triggers, and a body including a cavity in which a drive spring and a sharps holder are at least partially disposed; a second unit including: wherein the sharps holder is displaceable from a raised state to an advanced state by the drive spring upon actuation of a trigger from a first state to a second state, and the adhesive is configured to fix the second unit to the body while the casing is pulled away from the body, and actuation of the trigger is prevented until a magnitude of relative displacement between the casing and the second unit reaches a threshold.

111. 111. The inserter assembly of claim 110, wherein the second unit further includes a resilient member aligned with a biasing member on the casing.

112. 111. The inserter assembly of claim 110, wherein the second unit further comprises a resilient member configured to abut a portion of the casing to inhibit relative displacement of the casing and the second unit until a threshold force is exceeded.

113. 113. The inserter assembly of claim 112, wherein the casing portion is a biasing member and the resilient member is a resilient arm included in the body.

114. 113. The inserter assembly of claim 112, wherein the force threshold is selected such that, when the casing is pulled away from the body, the adhesive bond causes the skin of the body to lift at least a certain distance from its rest position before the magnitude of the relative displacement exceeds the threshold.

115. 113. The inserter assembly of claim 112, wherein the force threshold is selected such that, when the casing is pulled away from the body, adhesion of the adhesive causes the skin of the body to lift at least a certain distance from its rest position before relative displacement of the casing and the first unit begins.

116. 113. The inserter assembly of claim 112, wherein the force threshold is selected such that when the casing is pulled away from the body, the adhesive adheres at least a certain distance from its rest position, thereby lifting the skin of the body.

117. 111. The inserter assembly of claim 110, wherein the infusion set base is releasably coupled to the body.

118. 111. The inserter assembly of claim 110, wherein the infusion set base is arranged to be released from the body when the sharps holder is displaced to an advanced state.

119. 111. The inserter assembly of claim 110, further comprising a retraction spring, the sharps holder being displaceable from the advanced state to the retracted state by the retraction spring.

120. 120. The inserter assembly of claim 119, wherein the sharps holder is in a different position in the stowed state than in the raised state.

121. 120. The inserter assembly of claim 119, further comprising a retraction spring release latch arrangement configured to release when the sharps holder is displaced to the advanced state.

122. 122. The inserter assembly of claim 121, wherein the retraction spring release latch arrangement releasably couples the infusion set base to the body, and the infusion set base is released from the body when the spring release latch arrangement is released.

123. 111. The inserter assembly of claim 110, wherein a cannula subassembly is carried on the insertion sharp.

124. 1. A cartridge for a reusable inserter assembly, comprising: an outer housing; an inner housing releasably coupled to the outer housing; an infusion set base retainer on which the infusion set base is held; a sharps holder to which an insert sharps is attached; a cannula subassembly attached to the insertion sharp such that an insertion end of the insertion sharp extends from an outlet end of a cannula of the cannula subassembly; wherein an insertion end of the insertion sharp is within the inner housing.

125. 125. The cartridge of claim 124, wherein the cartridge further comprises a removable barrier member.

126. 126. The cartridge of claim 125, wherein the barrier member is permeable to a sterilant.

127. 125. The cartridge of claim 124, wherein the outer housing is shaped as a cup.

128. 125. The cartridge of claim 124, wherein the outer housing includes at least one receptacle and the inner housing includes at least one displaceable protrusion, the inner housing being releasably coupled to the outer housing via engagement of each of the at least one protrusion with a respective one of the at least one receptacle.

129. 129. The cartridge of claim 128, wherein each of the at least one protrusion is included on the unsupported end of a cantilevered arm.

130. 130. The cartridge of claim 129, wherein each cantilever arm includes an angled protrusion at its unsupported end, the angled protrusion configured to interact with a biasing member on a reusable inserter assembly such that, upon coupling of the associated cartridge to the reusable inserter assembly, the biasing member biases the cantilever arm and removes the associated protrusion from engagement with the receptacle of the at least one receptacle.

131. 125. The cartridge of claim 124, wherein the cartridge further comprises a set of mating pins.

132. 132. The cartridge of claim 131, wherein the mating pin is configured to be received in a retaining shoe of a reusable inserter assembly when the cartridge is coupled to the reusable inserter assembly.

133. 125. The cartridge of claim 124, wherein the sharps holder includes a terminal flange extending from the inner housing.

134. 125. The cartridge of claim 124, wherein the infusion set base includes an adhesive on a surface thereof, the adhesive being covered by a liner.

135. 135. The cartridge of claim 134, wherein the inner housing includes a recess providing a recess in which a pull tab of the liner is positioned.

136. 125. The cartridge of claim 124, wherein the infusion set base retainer includes a cavity into which a majority of the inserted sharps holder is disposed.

137. 137. A cartridge as described in claim 136, wherein the cavity includes a guide and the inserted sharps holder includes a rail that cooperates with the guide to constrain displacement of the inserted sharps holder within the cavity to a predetermined path.

138. 1. A cartridge for a reusable inserter assembly, comprising: A container and a housing releasably coupled within the container and including a bay; an infusion set base positioned within the bay; a retainer body including a set of cantilever arms and a cavity, the infusion set base being releasably coupled to the retainer body via the set of cantilever arms; a sharps holder coupled to an insert sharp, the sharps holder configured to be displaced along a guide included in the cavity; a cannula subassembly attached to the insertion sharp such that an end of the cannula subassembly is adjacent to a first end of the sharp holder; Including, cartridge.

139. 139. The cartridge of claim 138, wherein the cartridge further comprises a barrier member enclosing the housing together with the container.

140. 139. The cartridge of claim 138, wherein the cartridge further comprises a set of mating pins.

141. 141. The cartridge of claim 140, wherein the mating pin is configured to be received in a retaining shoe of a reusable inserter assembly when the cartridge is coupled to the reusable inserter assembly.

142. 139. The cartridge of claim 138, wherein the sharps holder includes a terminal flange extending from the housing.

143. 144. The cartridge of claim 143, wherein the terminal flange has a rectangular cross-sectional shape.

144. 139. The cartridge of claim 138, wherein the bay includes at least one notch, the infusion set base includes at least one tube retainer, and each tube retainer of the infusion set base is positioned within one of the notches of the bay.

145. The cartridge of claim 138, wherein the cannula subassembly includes a notch arranged to engage with a latch of the infusion set base to retain the cannula subassembly within the infusion set base when the cannula subassembly is displaced into a receiving cavity within the infusion set base.

146. 139. The cartridge of claim 138, wherein the cannula subassembly includes a notch positioned to engage a latch of the infusion set base to retain the cannula subassembly within the infusion set base when the cannula subassembly is displaced into a receiving cavity in the infusion set base.

147. 139. The cartridge of claim 138, wherein the retainer body is coupled to the housing via a snap fit engagement.

148. The cartridge of claim 138, wherein the cantilever arms are configured to be displaced to a spread apart state so as to release the infusion set base with the ears of the cannula subassembly when the cannula subassembly is displaced toward the infusion set base.

149. 139. The cartridge of claim 138, wherein the housing includes a recess in which an adhesive-backed pull tab is positioned to cover the adhesive on the infusion set base.

150. 139. The cartridge of claim 138, wherein the housing includes at least one set of stop surfaces.

151. 1. A cartridge for a reusable inserter assembly, comprising: A container and a housing including a spring-loaded tab, the housing being coupled within the container with the spring-loaded tab in a first state and released from the container with the spring-loaded tab biased from the first state to a biased state; a retainer body including an end plate having a cavity, a pair of retention arms, and a mating pin projecting therefrom; a medical device, at least a portion of which is held by the holding arm; and Insert sharp insert and a sharps holder configured to be displaced along a guide included in the cavity, the sharps holder being coupled to the sharps holder; Including, cartridge.

152. 152. The cartridge of claim 151, wherein the spring-loaded tab is included in a resilient cantilever arm.

153. 152. The cartridge of claim 151, wherein the cartridge further comprises a second spring-loaded tab opposite the spring-loaded tab.

154. 152. The cartridge of claim 151, wherein the medical device is an analyte sensor.

155. 152. The cartridge of claim 151, wherein the medical device is a physiological monitor.

156. 152. The cartridge of claim 151, wherein the medical device is an infusion set, the infusion set including an infusion set base and a cannula subassembly.

157. 157. The cartridge of claim 156, wherein the infusion set base is held by a holding arm and the cannula subassembly is positioned on the insertion sharp and separated from the infusion set base.

158. 158. The cartridge of claim 157, wherein the cannula subassembly includes a pair of ears, and the retaining arms are configured to be displaced to a spread apart state so as to release the infusion set base by the ears of the cannula subassembly when the sharps holder is displaced toward the infusion set base.

159. 152. The cartridge of claim 151, wherein the sharps holder includes a terminal flange configured to mate with an insertion driver of the reusable inserter assembly.

160. 152. The cartridge of claim 151, wherein the mating pin is configured to mate with a retention shoe included in the inserter assembly.

161. 152. The cartridge of claim 151, wherein the cartridge further comprises an adhesive backing that covers an adhesive on a portion of the medical device, and the housing comprises a recess in which a pull tab of the adhesive backing is positioned.

162. 152. The cartridge of claim 151, wherein the housing includes a set of stop surfaces configured to interact with a locking member of the inserter assembly to lock the housing from rotational displacement when the inserter assembly and the housing are coupled.

163. 163. The cartridge of claim 162, wherein the container is configured to displace the locking member when pressed against the inserter assembly to unlock rotational displacement of the housing.

164. 152. The cartridge of claim 151, wherein the spring-loaded tab is configured to be biased to a deflected state when the cartridge is coupled to the inserter assembly.

165. 1. An inserter assembly comprising: A first unit; A second unit; an insertion bias member configured to transition to a stressed state when the first unit is pressed against the second unit; a retainer configured to engage a first latch that maintains the insertion bias member in a stressed state when the first unit is displaced toward the second unit beyond a first threshold distance; and an insertion driver included in the second unit, displaceable from a first position to an extended position; and a release finger included in the first unit, wherein when the first unit is pulled away from the second position beyond the second threshold, the release finger disengages the insertion driver from an insertion driver latch, releasing the insertion vial member from a stressed state and urging the insertion bias member from the first position to an extended position. wherein the first unit is displaceable relative to the second unit, and the insertion driver disengages the first latch when displaced to an extended position.

166. 166. The inserter assembly of claim 165, further comprising at least one retraction bias member.

167. 167. The inserter assembly of claim 166, wherein at least one retraction bias member is configured to transition to a stressed state when the first unit is pressed against the second unit.

168. 168. The inserter assembly of claim 167, wherein the at least one retraction bias member is maintained in a stressed state when the retainer is engaged with the first latch.

169. 169. The inserter assembly of claim 168, wherein the at least one retraction bias member is released from the stressed state when the first latch is disengaged as the inserter driver is urged to an extended position.

170. 169. The inserter assembly of claim 168, wherein the insertion driver is displaced to the first position when the at least one retraction bias member transitions from the stressed state to the relaxed state.

171. 166. The inserter assembly of claim 165, wherein the release finger includes a paddle body having a first side and a second side, the first side being more inward relative to a longitudinal axis of the inserter assembly.

172. 172. The inserter assembly of claim 171, wherein the second unit includes a director wedge that projects into a displacement path followed by the release finger when the first unit is displaced relative to the second unit.

173. 173. The inserter assembly of claim 172, wherein the first and second sides of the paddle body include angled portions, one of the angled portions contacting the director wedge and deflecting the release finger away from the insertion driver latch when the first unit is pressed toward the second unit.

174. 173. The inserter assembly of claim 172, wherein the first and second sides of the paddle body include sloped portions, one of the sloped portions contacting the director wedge and deflecting the release finger toward the insertion driver latch when the first unit is pulled away from the second unit.

175. 166. The inserter assembly of claim 165, wherein the insertion driver includes a port configured to mate with an insertion sharps holder.

176. 166. The inserter assembly of claim 165, wherein the second unit includes a receptacle body coupled thereto, the receptacle body being disposed at an end of the second unit.

177. 177. The inserter assembly of claim 176, wherein the receptacle body includes at least one retaining interface configured to mate with a mating protrusion of a disposable cartridge.

178. 166. An inserter assembly as described in claim 165, wherein the first latch includes a pair of arms each having a latch ledge, the arms cantilevered from a main portion of a latch body.

179. 166. The inserter assembly of claim 165, wherein the inserter driver latch includes a protrusion that extends into a notch in a cantilevered arm that extends from a body of the insertion driver.

180. 166. The inserter assembly of claim 165, wherein the second threshold distance is measured from a position of the first unit after the first unit has been displaced the first threshold distance.

181. 1. An inserter assembly comprising: a cap coupled to an outer housing and an end thereof; an inner housing, wherein the outer housing and the cap are displaceable relative to the inner housing; an insertion driver contained in the inner housing and movable from a retracted position to an extended position; an insertion bias member received in a portion of the insertion driver and configured to transition to a stressed state when the outer housing and the cap are displaced toward the inner housing; a retainer configured to engage a first latch to maintain the insertion bias member in the stressed state when the outer housing and the cap are displaced toward the inner housing to a ready position; a release finger protruding from the cap configured to disengage the insertion driver from the insertion driver latch and release the insertion bias member from the stressed state when the outer housing and the cap are pulled beyond a threshold distance from the ready position, the insertion bias member urging the insertion driver from the first position to the extended position; and wherein the insertion bias disengages the first latch when displaced to the extended position.

182. 182. The inserter assembly of claim 181, wherein the inserter assembly further comprises at least one retraction bias member.

183. 183. The inserter assembly of claim 182, wherein the at least one retraction bias member is configured to transition to a stressed state when the outer housing and the cap are pressed against the inner housing.

184. 184. The inserter assembly of claim 183, wherein the at least one retraction bias member is maintained in a stressed state when the retainer is engaged with the first latch.

185. 185. The inserter assembly of claim 184, wherein the at least one retraction bias member is released from the stressed state when the first latch is disengaged.

186. 185. The inserter assembly of claim 184, wherein the insertion driver is displaced to the stowed position when the at least one retraction bias member transitions from the stressed state to the relaxed state.

187. 182. The inserter assembly of claim 181, wherein the release finger includes a paddle body having a first side and a second side, the first side being more inward relative to a longitudinal axis of the inserter assembly.

188. 188. The inserter assembly of claim 187, wherein the inner housing includes a director wedge that projects into a displacement path followed by the release finger when the outer housing and the cap are displaced relative to the inner housing.

189. 189. The inserter assembly of claim 188, wherein the first and second sides of the paddle body include angled portions, at least one of the angled portions configured to contact the director wedge and deflect the release finger away from the insertion driver latch when the outer housing and the cap are pressed toward the inner housing.

190. 189. The inserter assembly of claim 188, wherein the first and second sides of the paddle body include sloped portions, at least one of the sloped portions configured to contact the director wedge and bias a release finger toward the insertion driver latch when the outer housing and the cap are pulled away from the inner housing.

191. 182. The inserter assembly of claim 181, wherein the insertion driver includes a port configured to mate with the insertion sharps holder.

192. 182. The inserter assembly of claim 181, wherein the inner housing includes a receptacle body coupled thereto, the receptacle body being disposed at an end of the inner housing.

193. 193. An inserter assembly as described in claim 192, wherein the receptacle body includes at least one retaining interface configured to mate with a mating protrusion of a disposable cartridge.

194. 193. An inserter assembly as described in claim 192, wherein the receptacle body includes at least one retention shoe configured to mate with a mating pin of a disposable cartridge.

195. 182. An inserter assembly as described in claim 181, wherein the first latch includes a pair of arms each having a latch ledge, the arms cantilevered from a main portion of a latch body.

196. 182. The inserter assembly of claim 181, wherein the inserter driver latch includes a protrusion that extends into a notch in a cantilevered arm extending from a body of the insertion driver.

197. 1. An inserter assembly comprising: a first portion; and a second part; and an insertion driver included in the second portion; an insertion bias member included in the second portion configured to bias the insertion driver from a retracted state to an extended state when the insertion bias member is in a stressed state; a retainer included in the second portion; a first latch included in the second portion; and an insert driver latch included in the second portion, the insert driver releasably engaging the insert driver latch; the first portion is displaceable relative to the second portion, wherein displacement of the first portion toward the second portion and to a ready position stresses the insertion bias member and engages the retainer with the first latch to maintain the insertion bias member in a stressed state, and displacement of the first portion away from the ready position beyond a threshold distance disengages the insertion driver from the insertion driver latch to release the insertion driver member from the stressed state.

198. 198. An inserter assembly as described in claim 197, wherein the first latch includes a pair of cantilevered arms having a catch ledge.

199. 200. An inserter assembly as described in claim 198, wherein the inserter driver includes a body having a width greater than the separation distance between the arms of the pair of cantilevered arms, the body spreading the arms apart when the inserter driver is in the extended position.

200. 200. An inserter assembly as described in claim 198, wherein the insertion driver includes a body having a width greater than a separation distance between the pair of cantilever arms, the body being configured to actuate the cantilever arms to disengage from the retainer when the insertion driver is in the extended position.

201. 198. The inserter assembly of claim 197, wherein the insertion bias member is housed within a portion of the inserter driver.

202. 200. An inserter assembly as described in claim 197, wherein the insertion driver includes a port configured to mate with an insertion sharp holder from which the insertion sharp extends.

203. 198. The inserter assembly of claim 197, wherein the insertion driver includes at least one cantilevered arm, the arm including a notch.

204. 198. The inserter assembly of claim 197, wherein the insertion driver latch is a protrusion extending from the second portion housing, the protrusion extending into the notch.

205. 200. The inserter assembly of claim 197, wherein the first portion includes the release finger and the second portion includes a deflection wedge configured to deflect the release finger against a portion of the insertion driver to disengage the insertion driver from the insertion driver latch when displacement of the first portion exceeds the threshold distance.

206. 200. The inserter assembly of claim 197, wherein the second portion includes a receptacle for one of the following: a disposable infusion set cartridge, a disposable analyte sensor cartridge, and a lancet cartridge.

207. 200. An inserter assembly as described in claim 197, wherein the second portion includes a receptacle including at least one mating interface for a mating protrusion of a disposable cartridge.

208. 198. The inserter assembly of claim 197, wherein the insertion bias member is in a relaxed state when the inserter assembly is in the storage state.

209. 198. The inserter assembly of claim 197, wherein the insertion bias member is a polymer spring.

210. 198. The inserter assembly of claim 197, wherein the insertion bias member is an injection molded spring.

211. 198. The inserter assembly of claim 197, wherein the insertion bias member is a compression spring.

212. 198. An inserter assembly as described in claim 197, wherein the inserter assembly further comprises at least one retraction bias member.

213. 213. The inserter assembly of claim 212, wherein the at least one retraction bias member is configured to transition to a stressed state when the first portion is displaced to the ready position.

214. 214. The inserter assembly of claim 213, wherein the at least one retraction bias member is maintained in a stressed state when the retainer is engaged with the first latch.

215. 215. The inserter assembly of claim 214, wherein at least one retraction bias member is released from a stressed state when the first latch is released.

216. 215. The inserter assembly of claim 214, wherein the insertion driver is displaced to the stowed state when the at least one retraction bias member transitions from the stressed state to the relaxed state.

217. 1. A method of placing an infusion set, comprising: coupling an infusion set cartridge to an inserter assembly; attaching a portion of an infusion set contained within the infusion set cartridge to an infusion site; latching an insertion bias member of the inserter assembly in a stressed state by displacing a first portion of the inserter assembly toward a second portion of the inserter assembly; releasing the insertion bias member from the stressed state by moving the first portion of the inserter assembly away from the second portion of the inserter assembly; urging an insertion driver and an insertion sharp of the infusion set cartridge coupled to the insertion driver toward the infusion site; releasing the infusion set from the infusion set cartridge; A method comprising:

218. 218. The method of claim 217, wherein latching the insertion bias member in the stressed state comprises pressing the first portion of the inserter assembly against the second portion of the inserter assembly.

219. 218. The method of claim 217, wherein latching the insertion bias member in the stressed state comprises urging the first portion of the inserter assembly toward the injection site.

220. 218. The method of claim 217, wherein displacing the first portion of the inserter assembly toward the second portion of the inserter assembly applies stress to the insertion bias member.

221. 218. The method of claim 217, wherein releasing the insertion bias member from the stressed state comprises pulling the first portion of the inserter assembly away from the injection site.

222. 218. The method of claim 217, further comprising lifting the skin at the injection site from an underlying body structure before completing the driving of the insertion driver and the insertion sharp of the infusion set cartridge toward the injection site.

223. 218. The method of claim 217, wherein advancing the insertion driver and the insertion sharp toward the injection site further comprises advancing a cannula subassembly toward the injection site.

224. 218. The method of claim 217, wherein the method further comprises coupling a cannula subassembly of the infusion set to a base of the infusion set.

225. 225. The method of claim 224, wherein adhering a portion of the infusion set to the infusion site comprises adhering a base of the infusion set to the infusion site.

226. 218. The method of claim 217, wherein coupling the infusion set cartridge to the inserter assembly includes moving a mating protrusion included on the cartridge into a retaining interface on the inserter assembly.

227. 218. The method of claim 217, wherein coupling the infusion set cartridge to the inserter assembly includes removing an outer housing of the infusion set cartridge.

228. The method of claim 227, wherein the method further includes removing the infusion set cartridge from the inserter assembly, and removing the infusion set cartridge from the inserter assembly includes reconnecting the outer housing to the infusion set cartridge.

228. 228. The method of claim 227, further comprising removing the infusion set cartridge from the inserter assembly once the infusion set cartridge has been used.

229. 218. The method of claim 217, wherein releasing the infusion set from the cartridge comprises deflecting a retaining arm of the infusion set cartridge out of engagement with a portion of the infusion set.

230. The method of claim 229, wherein deflecting the retaining arm includes driving ears of the cannula subassembly of the infusion set into the retaining arm when the cannula subassembly is propelled into engagement with the infusion set base of the infusion set.

231. 218. The method of claim 217, wherein coupling the infusion set cartridge to the inserter assembly includes rotationally locking the infusion set cartridge in position on the inserter assembly.

232. 218. The method of claim 217, wherein the method further comprises retracting the insertion driver and the insertion sharp to a stored state.

233. 218. The method of claim 217, wherein coupling the infusion set cartridge to the inserter assembly includes coupling an insertion sharps holder of the infusion set cartridge to a port of the insertion driver.

234. 218. The method of claim 217, wherein displacing the first portion of the inserter assembly toward the second portion of the inserter assembly stresses at least one retraction spring.

235. 235. The method of claim 234, wherein the method further comprises releasing at least one retraction spring from a stressed state and propelling the insertion driver and the insertion sharp away from the injection site.

236. 236. The method of claim 235, wherein releasing the at least one retraction spring from the stressed state includes urging the insertion driver into a portion of the latch body to unlatch.

237. 1. An insertion system including an inserter assembly, The inserter assembly includes: a receptacle including at least one retention interface and an opening therethrough; an insertion driver displaceable through the opening between a retracted position and an extended position; at least one spring bias locking member displaceable from a retracted position to an extended position; at least one disposable cartridge including at least one mating projection, a medical device, and at least one set of stop surfaces, each of the at least one mating projection configured to rotate to engage a respective one of the at least one retention interfaces, and the at least one set of stop surfaces configured to abut the at least one locking member when the locking member is in the extended position inhibiting rotation of the disposable cartridge; an inserter system, including:

238. 238. The system of claim 237, wherein the at least one locking member is a resiliently cantilevered member.

239. The system of claim 237, wherein the medical device is an infusion set.

240. 240. The system of claim 239, wherein the infusion set includes the infusion set base and a cannula subassembly, the cannula subassembly being separate from the infusion set base.

241. The system of claim 237, wherein the medical device is a lancet.

242. The system of claim 237, wherein the medical device is an analyte sensor.

243. 238. The system of claim 237, wherein each of the at least one mating projections is a mating pin having a head portion with a larger cross-sectional area than a stem portion that connects the head portion to the cartridge.

244. The system of claim 237, wherein at least one holding interface is a holding shoe.

245. 238. The system of claim 237, wherein each of the at least one retaining interface is configured to prevent translational displacement of a respective one of the at least one mating projections along the axis of the inserter assembly when the respective mating projection is engaged with its retaining interface.

246. 238. The system of claim 237, wherein the cartridge is configured to displace the at least one locking member to a withdrawn position when the at least one mating projection is not engaged with the at least one retaining interface and the cartridge is facing the receptacle.

247. The cartridge an inner housing including a tab disposed on a cantilevered portion of the inner housing; an outer housing including receiving slots for the tabs; 238. The system of claim 237, comprising: the inner housing coupled to the outer housing when the tab is at least partially disposed within the receiving slot.

248. The system of claim 247, wherein the receptacle includes a deflectable member.

249. 249. The system of claim 248, wherein the deflection member is configured to deflect the cantilevered portion of the inner housing when the mating protrusion is engaged with the retention interface, and the outer housing is decoupled from the inner housing when the cantilevered portion of the cantilevered portion is in a deflected state.

250. 248. The system of claim 247, wherein the at least one set of stop surfaces are defined by an edge wall on at least one side of the cantilevered portion.

251. 238. The system of claim 237, wherein the insertion driver comprises a port.

252. The system of claim 251, wherein the cartridge includes a sharps holder coupled to the inserted sharps, the sharps holder configured to couple to the port when each of the at least one mating protrusions engages with a respective one of the at least one holding interface.

253. The system described in claim 251, wherein the cartridge includes a sharps holder having an end flange having a shape that can be displaced into the port when the cartridge is in a first orientation on the receptacle and cannot be displaced from the port when the cartridge is in a position in which each of the at least one mating protrusions is engaged with a respective one of the at least one retaining interface.

254. The system of claim 237, wherein the cartridge includes a sharps holder coupled to the sharps.

255. The system of claim 237, wherein the cartridge includes at least one guide and at least a portion of the medical device configured to displace along the guide when the insertion driver is displaced from the storage position to the extended position.

256. 238. The system of claim 237, wherein the cartridge includes a first housing and a second housing releasably coupled to the first housing, the second housing displacing at least one locking member to a withdrawn state when the second housing faces the receptacle.

257. 238. The system of claim 237, wherein the inserter assembly further includes an insertion bias member and an insertion driver latch, the insertion bias member configured to bias the insertion driver to the extended position when the insertion driver disengages from the insertion driver latch.

258. 1. An infusion set base for an infusion set, comprising: a platform portion having a first surface and a second surface opposite thereto; a pair of connector finger receptacles extending from the second surface of the platform portion; a set of guides elevated from the second surface of the platform portion, each guide including a guide notch recessed therein from a surface of the guide that is distal-most from the second surface of the platform portion; a cannula subassembly receptacle defined by an opening in the platform portion, a receptacle wall raised from the second surface of the platform, and a portion of each guide including the guide notch; a cantilevered arm included as a section of the receptacle wall, the cantilevered arm having a ridge at its unsupported end; Includes an infusion set base.

259. The infusion set base of claim 258, wherein the first surface of the platform portion includes an adhesive attached thereto.

260. The infusion set base of claim 259, wherein the adhesive is covered by an adhesive backing.

261. 259. The infusion set base of claim 258, wherein the first surface of the platform portion includes two annular ridges and a plurality of radially arranged ridges around the periphery of the first surface.

262. 260. The infusion set base of claim 259, wherein the substrate to which the adhesive is applied is bonded to the annular ridge and the radially arranged ridges.

263. The infusion set base of claim 262, wherein the substrate is welded to the annular ridge and the radially arranged ridges.

264. 259. The infusion set base of claim 258, wherein the platform includes a plurality of pass-throughs extending therethrough.

265. The infusion set base of claim 258, wherein the platform portion includes at least one tubing retainer extending from a periphery of the platform portion.

266. 259. The infusion set base of claim 258, wherein each of the connector receptacles includes a catch for engaging a protrusion on a connector finger of an infusion tube connector.

267. 259. The infusion set base of claim 258, wherein at least one of the receptacle walls or portions of the guide defining the receptacle includes a tapered portion at a section most distal from the second surface of the platform portion.

268. The infusion set base of claim 258, wherein the cantilever arm is configured to deflect when the cannula subassembly is displaced into the cannula subassembly receptacle and is configured to elastically recover to a relaxed state so that the protrusion engages a ledge on a protrusion of the cannula subassembly when the cannula subassembly is in an installation orientation within the cannula subassembly receptacle.

269. The infusion set base of claim 258, wherein the cantilever arm is configured to deflect when the cannula subassembly is displaced into the cannula subassembly receptacle and to elastically recover to a relaxed state so that the protrusion engages with the wall of a fenestration in the housing of the cannula subassembly when the cannula subassembly is in an installation orientation within the cannula subassembly receptacle.

270. The infusion set base of claim 258, wherein the cantilever arm is configured to deflect when the cannula subassembly is displaced into the cannula subassembly receptacle and to elastically recover to a relaxed state so that the protrusion engages with a wall of a cannula housing slot in the housing of the cannula subassembly when the cannula subassembly is in an installation orientation within the cannula subassembly receptacle.

271. 259. The infusion set base of claim 258, wherein each of the guides defines a shelf having at least a portion parallel to the second surface of the platform portion.

272. 272. The infusion set base of claim 271, wherein each shelf includes a portion that is more proximal to the second surface of the platform portion than the portion of each notch that is most proximal to the second surface of the platform portion.

273. The infusion set base of claim 258, wherein the cannula subassembly receptacle is centrally located on the platform portion.

274. 259. The infusion set base of claim 258, wherein the opening includes a protrusion receiving area for receiving a protrusion on a housing of a cannula subassembly.

275. The infusion set base of claim 258, wherein each of the guides includes a first partial ridge and a second partial ridge extending from a main portion of the respective guide, the first partial ridge being substantially parallel to the second surface of the platform portion, and the second partial ridge being arranged at an angle relative to the first partial ridge.

276. The surface of the second portion ridge closest to the second face of the platform portion comprises:

276. The infusion set base of claim 275, wherein the distance of the platform portion from the second surface increases as the second partial ridge extends distally relative to the first partial ridge.

277. The infusion set base of claim 258, wherein the guides extend parallel to one another and each include an inner surface and an outer surface, the inner surface being closer to the medial surface of the infusion set base than the outer surface.

278. 259. The infusion set base of claim 258, wherein the guides include a guide ledge disposed on an outer surface of each guide and an additional guide ledge disposed on an inner surface of each guide.

279. 1. A tubing connector for fluidly coupling a flow lumen of an infusion tubing pathway to a cannula of an infusion set, comprising: a flow hub having a channel therethrough, the inlet tube path being coupled to a first end of the channel and the sharp being coupled to a second opposite end of the channel, the sharp lumen of the sharp being in fluid communication with the flow lumen; a pair of alignment channels, one alignment channel embedded in a first side of the flow hub and the other alignment channel embedded in a second opposing side of the flow hub, the alignment channels including a variable width segment proximate a second end of the channel and a constant width segment; a pair of cantilevered connector fingers, a first connector finger of the pair coupled to the first side via a first tubing connector body portion and a second connector finger of the pair coupled to the second opposing side via a second tubing connector body portion, each connector finger including a latch protrusion; at least one sharp abutment projection extending from said flow hub parallel to the axis of said sharp; A tubing connector comprising:

280. 280. A tubing connector as described in claim 279, wherein the at least one sharp adjacent projection includes a centrally located adjacent projection extending from a top surface of the flow hub across at least a portion of the sharp.

281. 280. A tubing connector as described in claim 279, wherein the at least one sharp adjacent protrusion includes a pair of sharp adjacent protrusions arranged laterally relative to the sharp.

282. 280. A tubing connector as described in claim 279, wherein the at least one sharp adjacent projection includes a first sharp adjacent projection and a second sharp adjacent projection arranged transverse to the sharp and in a plane in which the connector fingers extend.

283. 283. A tubing connector as described in claim 282, wherein the first sharp adjacent protrusion extends from the first tubing connector body portion parallel to the axis of the sharp, and the second sharp adjacent protrusion extends from the second tubing connector body portion parallel to the axis of the sharp.

284. 283. A tubing connector as described in claim 282, wherein the first sharp adjacent protrusion and the second sharp adjacent protrusion each have a protrusion tip that is more distal to the flow hub than the terminal portion of each connector finger.

285. 283. A tubing connector as described in claim 282, wherein the first sharp abutting projection and the second sharp abutting projection each include a curved end region.

286. 286. A tubing connector as described in claim 285, wherein each of the curved end regions has a curvature that is greater than 90 degrees.

287. 287. The tubing connector of claim 286, wherein the radius of curvature is variable.

288. 286. A tubing connector as described in claim 285, wherein each of the curved end regions includes a substantially straight expanse at its terminal end.

289. 286. A tubing connector as described in claim 285, wherein the curved end region is curved in front of and around a terminal portion of each connector finger of the pair of connector fingers.

290. 283. The tubing connector of claim 282, wherein the first sharp adjacent protrusion extends from the first side of the flow hub parallel to the axis of the sharp, and the second sharp adjacent protrusion extends from the second side of the flow hub parallel to the axis of the sharp.

291. 280. The tubing connector of claim 279, wherein each of the pair of alignment channels is configured to ride along a guide ledge of an infusion set base.

292. 273. A tubing connector as described in claim 272, wherein the sharp includes a tip, and the tip is clocked in a predetermined rotational direction during assembly of the tubing connector.

293. 293. A tubing connector as described in claim 292, wherein the tip is magnetically clocked in the predetermined rotational direction.

294. All device, system, and method embodiments shown and described herein.

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