Infusion set, inserter assembly device, system, and method

Abstract

The inserter assembly may include a casing having an open end and a closed end. The inserter assembly may further include a first unit at least partially within the casing, movable relative to the casing. The first unit may include a device base. The first unit may further include a sharp. The first unit may further include a body configured to displace in conjunction with the sharp at least during displacement of the sharp from the forward state to the retracted state. The first unit may further include a biasing member configured to displace the body toward the closed end and displace the sharp to the stored state when the opening latch transitions from the engaged state to the released state. One of the casing and the body may include a protrusion that causes a tilt of the body when the body and the sharp are displaced by the biasing member.

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 fluid that millions of diabetic patients self-inject. Users of parenterally delivered drugs could benefit from wearable devices that automatically deliver the required drug / compound over a period of time.

[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 an exemplary embodiment of the present disclosure, there is provided an inserter assembly including: a casing having an open end and a closed end; a first unit movable at least partially within and relative to the casing, the first unit comprising: a device base; an insertion sharp displaceable between a raised state, a forward state, and a retracted state; a body configured to displace in conjunction with the insertion sharp at least during displacement of the insertion sharp from the forward state to the retracted state; a first biasing member configured to bias the body toward the closed end of the casing; and a biasing member release latch having an engaged state and a disengaged state, the first biasing member configured to displace the body toward the closed end and displace the insertion sharp to the retracted state when the release latch transitions from the engaged state to the released state, wherein one of the casing and the body includes a sloped protrusion that prevents displacement of a portion of the body and causes the body and the insertion sharp to slope when the first biasing member is displaced.

[0006] The inserter assembly may include at least one guide. When the body is displaced toward the closed end by the first biasing member, the body may be displaced along the at least one guide and then disengage from the at least one guide. The first unit may further include a second biasing member configured to urge the insertion sharp from a raised state to a forward state. The inserter assembly may further include a release latch for the second biasing member configured to transition from an engaged state to a disengaged state after a magnitude of displacement of the casing relative to the first unit exceeds a threshold. The device base may be bonded with an adhesive, the adhesive configured to secure the first unit to the patient while the casing is pulled away from the patient, and the magnitude of displacement of the casing relative to the first unit may increase. The first unit may further include a cannula assembly carried by the insertion sharp. The cannula assembly may be configured to couple to the device base and transition the biasing member release latch to the released state when the insertion sharp reaches the forward position. The inserter assembly includes an inner housing within the casing, the inner housing including a guard, and at least the tip of the insertion sharp can be displaced into the guard when the insertion sharp is displaced to the retracted state. The guard can function as a guide to direct displacement of the body as the body is displaced toward the closed end.

[0007] According to another exemplary embodiment of the present disclosure, there is provided an inserter assembly comprising: a casing having an open end and a closed end; a first unit movable relative to and at least partially within the casing, the first unit comprising: a device base; a sharps holder including an insertion sharp; the sharps holder being displaceable between a raised state, a forward state, and a retracted state; a retractor, the sharps holder being at least partially disposed within the retractor; and a first biasing member configured to displace the retractor from an initial position to a retracted position; An inserter assembly is provided that includes a biasing member release latch having an engaged state and a released state, the first biasing member being configured to displace the retractor and the insertion sharp to the retracted state when the release latch transitions from the engaged state to the released state, and one of the casing and the retractor including a ramp protrusion that prevents displacement of a portion of the sharp retractor and causes the retractor to ramp when the retractor and insertion sharp are displaced to the retracted state.

[0008] In some embodiments, the inserter assembly includes an internal housing within the casing defining at least one retractor guide, and as the retractor and insertion sharp are displaced to the retracted state, the retractor may displace along and subsequently disengage from the at least one guide. The retractor and sharps holder may move as a unit during at least a portion of the displacement of the retractor and insertion sharp to the retracted state. The first unit may further include a second biasing member configured to urge the sharps holder from the raised state to the forward state. The inserter assembly may further include a release latch for the second biasing member configured to transition from an engaged state to a disengaged state after a magnitude of displacement of the casing relative to the first unit exceeds a threshold. The device base is bonded with an adhesive configured to secure the first unit to the patient while the casing is pulled away from the patient, and the magnitude of displacement of the casing relative to the first unit may increase. The first unit may further include a cannula assembly carried by the insertion sharp, the cannula assembly coupled to the device base and configured to transition the biasing member release latch to the released state when the sharp holder is in the forward state. The inserter assembly may include an internal housing within the casing, the internal housing including a guard, and the insertion sharp may tilt at least partially into the guard as the retractor and the insertion sharp are displaced to the retracted state. The guard may serve as a retractor guide to direct displacement of the retractor as the retractor is displaced to the retracted state.

[0009] According to another exemplary embodiment of the present disclosure, an inserter assembly includes a casing having an open end and a closed end, the casing having an angled protrusion disposed at the closed end; a guide body disposed within the casing and including at least one guide; a patient-care assembly base; a sharps holder including an insertion sharp, the sharps holder being displaceable between a raised position, a forward position, and a retracted position; a sharps retractor, the sharps holder at least partially disposed within the sharps retractor; and a drive mechanism configured to drive the sharps retractor from an initial position to a stored position. An inserter assembly is provided comprising: a retraction spring; and a retraction spring release latch having an engaged state and a released state, the retraction spring configured to displace a sharps retractor and the insertion sharp along a retraction stroke when a release latch transitions from the engaged state to the released state, wherein the sharps retractor is displaced along at least one guide during a first portion of the retraction stroke and is unguided during a second portion of the retraction stroke, and the angled protrusion is configured to prevent displacement of a portion of the sharp during at least a portion of the second portion of the retraction stroke.

[0010] In some embodiments, the sharps retractor and insertion sharp may be non-parallel to the axis of the casing at the end of the retraction stroke. The guide body may include a guard, and at least a tip of the insertion sharp may be displaced within the guard during a second portion of the retraction stroke. The sharps retractor and sharps holder may also move as a unit during at least a portion of the retraction stroke. The patient-care assembly base may be an infusion set base, and the inserter assembly may further include a cannula assembly carried by the insertion sharp. When the sharps holder is displaced to the forward state, the cannula assembly may be coupled to the infusion set base. When the retraction spring release latch is in an engaged state, the retraction spring release latch may couple the patient-care assembly to the sharps retractor. The insertion sharp may be closer to the closed end of the casing when in the retracted state compared to the raised state.

[0011] According to another embodiment of the present disclosure, there is provided a method of positioning a patient-care assembly into an inserter assembly, the method including: releasing a first latch of the inserter assembly to drive a spring-loaded insertion sharp of the inserter assembly from a raised state to a forward state; releasing a second latch of the inserter assembly to displace a spring-loaded sharp retractor and the insertion sharp through a retraction stroke to a retracted state; guiding a guide body to displace the sharp retractor during a first stage of the retraction stroke; tilting the insertion sharp out of alignment with an axis of the inserter assembly to a tilted state during a second stage of the retraction stroke; and using a spring in the spring-loaded sharp retractor to hold the insertion sharp in the tilted state.

[0012] In some embodiments, releasing the second latch may further include releasing at least a portion of the patient-care assembly. Tilting the insertion sharp may include displacing a tip of the insertion sharp into a guard. The method may further include adhering a portion of the patient-care assembly to a biological barrier, and releasing the first latch may include displacing a casing of the inserter assembly away from the biological barrier. Tilting the insertion sharp may include displacing a first portion of the sharp retractor into contact with a closed end of a housing of the inserter assembly and preventing displacement of a second portion of the sharp retractor short of the closed end of the housing.

[0013] According to another embodiment of the present disclosure, an inserter assembly for a patient-care assembly includes: an outer housing having a closed end and an open end; a sharps holder disposed within the outer housing and having an insert sharp coupled thereto; a ledge defined on the sharps holder; and a catch defined on a body within the outer housing, the ledge configured to displace along a displacement path to transition the latch device from an engaged state to a disengaged state; a biasing member configured to be held in a deflected state when the latch device is in the engaged state and to bias the sharps holder from a raised state toward a forward state toward the open end of the outer housing when the latch device transitions to the disengaged state; and a removable locking member extending through a passage on the outer housing and the body, preventing displacement of the ledge from the catch, the locking member extending substantially perpendicular to the displacement path. An inserter assembly is provided that includes:

[0014] In some embodiments, the body may include at least one protrusion configured to prevent deflection of the locking member in the direction of the displacement path. The body may include a plate having a bridge on a surface thereof, the plate and the bridge together defining the passageway. The locking member may include a first protrusion having a deflectable region, the deflectable region being in a substantially undeflected state when the locking member is fully attached to the inserter assembly. The deflectable region may include a nub configured to abut a wall of the passageway and deflect the arm to a deflected state when the locking member is installed in the inserter assembly. The deflectable region may generate at least one of a tactile and an audible signal when the deflectable region returns from the deflected state to the undeflected state. The deflectable region may be formed by a cantilevered arm. The locking member may include a second protrusion having a deflectable region, and portions of the locking member including the first protrusion and the second protrusion may be substantially symmetrical. The inserter assembly may further include an inner housing, the locking member extending through the inner housing, and the ledge may be defined on a cantilevered arm of the sharps holder.

[0015] In another embodiment of the present disclosure, an infusion set base is provided, comprising: a first portion including a platform extending substantially along a plane, with a receptacle wall protruding from the platform to define a receptacle, the first portion including a set of receptacle wall extensions defining a connector guide channel leading to the receptacle and including an open end opposite the receptacle; a second portion on an area of ​​the base opposite the open end of the guide channel formed by a contoured wall, the contoured wall tending to taper toward the plane of the platform as it approaches the periphery of the infusion set base; a transition wall extending from an edge of the platform to an edge of the contoured wall; and a set of connector receptors arranged on the platform, laterally of the receptacle wall extensions.

[0016] In some embodiments, the transition wall may extend substantially perpendicular to the plane of the platform. The receptacle wall may include at least one cantilevered portion having a protrusion at its unsupported end. The unsupported end of the at least one cantilevered portion may form a portion of the cantilevered portion most distal relative to the plane of the platform. Each of the receptacle wall extensions may include a cantilevered portion having a protrusion at its respective unsupported end. The unsupported end of the cantilevered portion may form a portion of each cantilevered portion most distal relative to the plane of the platform. An open cavity may exist below the contoured wall. The transition wall may include a set of passages extending through the transition wall to the cavity.

[0017] According to another embodiment of the present disclosure, there is provided an injection assembly including: an infusion set base including a platform extending substantially along a plane, a receptacle wall protruding from the platform to define a receptacle, and a pair of receptacle wall extensions defining a connector guide channel leading to the receptacle and including an open end opposite the receptacle; and a pair of connector receiving portions on the platform on the sides of the guide channel; a cannula subassembly configured to be held in the receptacle; a connector coupled to a series of tubing, the connector body including a flexible portion having an underside from which a connector latch protrudes, the connector latch configured to engage with the connector receiving portion, and when the connector latch engages with the connector receiving portion, the connector body provides a shield for the connector receiving portion and the connector latch; and a flow hub having a protruding sharp.

[0018] The infusion set base may further include a contoured wall opposite the open end of the guide channel and a transition wall extending from the platform to an edge of the contoured wall. The transition wall may include a set of passages extending through the transition wall to a cavity below the contoured wall. The connector may include a set of sharp-sided protrusions that extend through the passages and partially into the cavity when the connector latch is engaged with the connector receiving portion. The cannula subassembly may be configured to be captured in the receptacle by at least one cantilevered latch protrusion. The connector may include a set of sharp-sided protrusions extending substantially parallel to the protrusions, and the guide channel may define a guide for the set of sharp-sided protrusions. The connector body may cover the platform when the connector latch engages with the connector receiving portion. The infusion set base may include a contoured wall opposite the open end of the guide channel, the contoured wall being flush with an adjacent portion of the connector body when the connector latch engages the connector receiving portion. The deflectable portion may be configured to deflect toward the axis of the sharp, and the connector latch may disengage from the connector receiving portion when the deflectable portion deflects toward the axis of the sharp beyond a threshold amount.

[0019] According to another exemplary embodiment of the present disclosure, there is provided an injection assembly comprising: an infusion set having a base including a platform, a receptacle wall protruding from the platform to define a receptacle, a connector guide leading to the receptacle including an opposite open end of the receptacle, and a set of connector receiving portions on the platform on either side of the guide, the infusion set further including a cannula subassembly within the receptacle; and a connector coupled to a series of tubing, the connector having a connector body including a flexible portion having an underside from which a connector latch protrudes, the connector latch being configured to engage with the connector receiving portion, the connector body covering the connector receiving portion when the connector latch is engaged with the connector receiving portion, and the connector having a flow hub with a protruding sharp.

[0020] In some embodiments, the deflectable portion may be configured to deflect toward the axis of the sharp, and deflection of the deflectable portion toward the axis of the sharp beyond a threshold amount may disengage the connector latch from the connector receiving portion. The front base may include a contoured wall in a portion of the base opposite the open end of the guide, the contoured wall tending to decline toward the plane of the platform as it approaches a periphery of the infusion set base, and the transition wall extending from an edge of the platform to an edge of the contoured wall. When the connector latch engages the connector receiving portion, the contoured wall may be flush with an adjacent portion of the connector body.

[0021] According to another exemplary embodiment of the present disclosure, there is provided a drug delivery set including: a base including a receptacle; a cannula subassembly configured to couple to the receptacle, the cannula subassembly including a housing, a cannula, and at least one septum within the housing; and a connector disposed at an end of a flow path and including a delivery sharp and at least one guide surface, the connector being displaceable relative to the base from a first position through an intermediate position to a delivery position to couple the connector to the base, the cannula subassembly being adjusted to a home position within the receptacle by the at least one guide surface when the connector is displaced from the first position to the intermediate position.

[0022] In some embodiments, one of the at least one septum defines a fluid-receiving volume in communication with the lumen of the cannula, and the septum may form a fluid-tight seal within the cannula subassembly to prevent leakage from the fluid-receiving volume outside the cannula. When the connector is in the delivery position, the outlet of the delivery sharp may be located within the fluid-receiving volume. The delivery sharp may not be in contact with the septum in the intermediate position. The connector includes at least one sharp side protrusion located on a side of the delivery sharp, and the at least one guide surface may be included in the at least one sharp side protrusion. The at least one guide surface may include at least one lateral adjustment guide surface and at least one height adjustment guide surface. The connector includes two sharp side protrusions located on either side of the delivery sharp, and each of the sharp side protrusions may include at least one of the at least one guide surface. Each of the two sharp side protrusions includes a lateral adjustment guide surface and a height adjustment guide surface. The connector may include a third sharp-side protrusion extending over the sharp and including at least one of the at least one guide surfaces thereon. The third sharp-side protrusion may include at least one lateral adjustment guide surface and at least one height adjustment guide surface. The at least one guide surface may include a plurality of guide surfaces for adjusting the position of the cannula subassembly along two axes substantially perpendicular to one another and within a plane substantially perpendicular to the extension direction of the delivery sharp. The base may include a positioner extending into the receptacle to prevent displacement of the cannula subassembly along an axis substantially perpendicular to the two axes. An opposing end of the flow channel opposite the connector may include a fitting for connecting the flow channel to a fluid source. The cannula may be integrally formed with the housing. The base may include a platform and at least one wall extending from the platform to form the receptacle, and the delivery sharp may be substantially parallel to the platform when the connector is coupled to the base.

[0023] According to another exemplary embodiment of the present disclosure, there is provided a drug delivery set comprising: a base including a receptacle; a cannula subassembly configured to couple to the receptacle, the cannula subassembly including a housing, a cannula, and at least one septum within the housing; and a connector disposed at an end of a flow path and including a delivery shaft and at least one guide surface, the connector being displaceable relative to the base from a first position, through an intermediate position, to a delivery position where the connector is coupled to the base, the at least one guide surface adjusting the position of the cannula subassembly to a home position within the receptacle each time the connector is displaced from the first position to the intermediate position.

[0024] One of the at least one septum may define a fluid-receiving volume in communication with the cannula and form a fluid-tight seal within the cannula subassembly to prevent fluid from flowing out of the fluid-receiving volume except through the cannula. When the connector is in the delivery position and the delivery sharp is not in contact with the septum in the intermediate position, the outlet of the delivery sharp may be located within the fluid-receiving volume. The connector may include at least one sharp-side protrusion, and the at least one guide surface may be included on the at least one sharp-side protrusion. The at least one guide surface may include at least one lateral adjustment guide surface and at least one height adjustment guide surface. The at least one guide surface may include a plurality of guide surfaces that adjust the position of the cannula subassembly along two axes that are substantially perpendicular to each other and in a plane that is substantially perpendicular to the extension direction of the delivery sharp, and the base may include a positioner extending into the receptacle that prevents displacement of the cannula subassembly along an axis that is substantially perpendicular to the two axes. The connector may include a plurality of sharp-sided protrusions, each protrusion including at least one of the at least one guide surface thereon. The connector may include a plurality of sharp-sided protrusions including at least one lateral adjustment guide surface and at least one height adjustment guide surface thereon. At least one of the at least one guide surface may include a slope configured to funnel the cannula subassembly toward the home position when the connector is displaced from the first position toward the intermediate position. The base may include a platform and at least one wall extending from the platform to form the receptacle, and the delivery sharp may be substantially parallel to the platform when the connector is coupled to the base.

[0025] According to another exemplary embodiment of the present disclosure, there is provided a drug delivery set comprising: a base including a receptacle; a cannula subassembly coupled within the receptacle, the cannula subassembly including a housing, a cannula, and at least one partition within the housing; and a connector disposed at the end of a flow path and including a delivery sharp and at least one guide surface, wherein the at least one guide surface adjusts the position of the cannula subassembly to a home position before the delivery sharp contacts the at least one partition when the connector transitions from a state where it is not connected to the base to a state where it is connected to the base.

[0026] One of the at least one septum may define a fluid-receiving volume in communication with the cannula and form a fluid-tight seal within the cannula subassembly to prevent fluid flow from the fluid-receiving volume except through the cannula. The at least one guide surface may include a plurality of guide surfaces that adjust the position of the cannula subassembly along two axes that are substantially perpendicular to one another and in a plane that is substantially perpendicular to the direction of extension of the delivery shaft, and the base may include a positioner extending within the receptacle that prevents displacement of the cannula subassembly along an axis that is substantially perpendicular to the two axes. The connector may include a plurality of sharp side protrusions that include at least one lateral adjustment guide surface and at least one height adjustment guide surface thereon. At least one of the at least one guide surfaces may include a slope configured to funnel the cannula subassembly toward the home position when the connector is displaced from the first position toward the intermediate position. The base may include a platform and at least one wall extending from the platform to form the receptacle, and the delivery sharp may be substantially parallel to the platform when the connector is coupled to the base.

[0027] According to another exemplary embodiment of the present disclosure, there is provided a fluid delivery set comprising: a base having a platform portion and a receptacle defined by at least one receptacle wall extending from the platform portion, the at least one receptacle wall including a deflector body; a cannula subassembly configured to couple to the receptacle, the cannula subassembly including a cannula, a housing, and a septum partially disposed within the housing and having an exposed portion opposite the cannula accessible from outside the housing; and a connector disposed at an end of a flow path, the connector including a delivery sharp and sharp side protrusions, the connector configured to couple to the base, the deflector body configured to deflect the sharp side protrusions toward the exposed portion when the connector is coupled to the base.

[0028] In some embodiments, the deflector body may be disposed on a portion of the receptacle wall most distal to the platform portion. The cannula subassembly further includes a retaining clip coupled to the housing, the exposed portion extending through an opening in the retaining clip. The sharp side protrusion is cantilevered from a flow hub of the connector to which the delivery sharp and the flow channel are coupled. The cannula subassembly may include a second septum at least partially disposed within the housing. The housing may include at least one delivery sharp opening, which may extend through the opening and be in fluid communication with a fluid introduction volume defined within the septum when the connector is coupled to the base. When the connector is coupled to the base, the delivery sharp may extend substantially parallel to the platform portion. The base may further include a track configured to guide the sharp side protrusion when the connector is coupled to the base, the track being disposed on the receptacle wall and including the deflector body.

[0029] According to another exemplary embodiment of the present disclosure, there is provided a base for an infusion set, the base including: a platform portion; a set of walls extending from the platform portion, the walls partially defining a receptacle, each of the walls including segments oriented such that the walls are separated by a first distance proximal to the platform portion and a second distance distal to the base that is less than the first distance, each of the walls having a gap extending from the segment to the platform portion; a series of notches defined in the walls; and a receptacle wall span connecting each wall of the set of walls and partially defining the receptacle, the receptacle wall span including a cantilever portion having a latch protrusion, the cantilever portion including at least one protruding region extending from the cantilever portion into the receptacle.

[0030] According to some embodiments, the notch may be recessed into the wall at a distal-most portion of the platform portion. The wall may define a channel extending from the receptacle toward the periphery of the platform portion. The latching projection may be in the form of a ramp whose thickness increases as the distance to the unsupported end of the cantilever portion decreases. The at least one protruding region may include a rib extending along a majority of the cantilever portion. The at least one protruding region may include a rib extending substantially parallel to the axis of extension of the cantilever portion. The platform portion may be substantially planar, and each wall segment may be oriented substantially parallel to the platform portion. At least a portion of the notch may be tapered, and the notch may coincide with a break in the wall. Each of the notches may include a first tapered region and a second tapered region having different tapers. Each wall segment, and the portion of the wall between the platform portion and the segment, may form a receiving track configured to guide a portion of the tubing set connector when the tubing set connector is coupled to the base.

[0031] According to another exemplary embodiment of the present disclosure, there is provided a cannula subassembly for coupling to an infusion set base, the cannula having an outlet at a first end and an enlarged region at a second end, the enlarged region including a sharps guide continuous with the lumen and outer surface of the cannula; a housing separate from the cannula, the housing including an end wall having a passageway through an interior surrounded by the cannula sheet, the housing having a sidewall extending from the end wall having at least one delivery sharps passageway therein; a septum disposed within the housing and forming a fluid-tight seal at least against the outer surface; and a retaining clip coupled to the housing to at least partially capture the septum within the housing.

[0032] In some embodiments, the outer surface may include a frustoconical portion and a straight-walled portion, the straight-walled portion being substantially parallel to the axis of extension of the cannula. The outer surface may be straight-walled and extend substantially parallel to the axis of extension of the cannula. The retaining clip may include a channel therethrough and a nub portion of the septum extending through the channel, the portion of the nub extending beyond the channel being compressed by at least one protrusion partially surrounding the channel. The at least one protrusion partially surrounding the channel may be part of a crenellated wall surrounding the channel. The at least one protrusion partially surrounding the channel may include a pair of merlons disposed on opposite sides of the channel. The retaining clip may include a channel therethrough and a nub portion of the septum extending through the channel, the channel exerting a compressive force on the nub in a direction perpendicular to the elongated axis of the cannula. The retaining clip may include a channel therethrough and a nub portion of the septum extending through the channel and compressed by the channel, the channel having a width at least 50% of the width of the retaining clip. The enlarged region of the cannula may include a flange disposed at an end of the enlarged region closest to the outlet. The seat may be a post surrounding the passageway. The seat may be a receptacle recessed in the portion of the end wall surrounding the passageway. The septum housing may include a pair of ears projecting outward from the side wall, each of which may include a flared portion projecting from a main portion of the ear toward the cannula outlet and decreasing in thickness as the distance to the outlet decreases. Each ear may include a pair of wedge bodies disposed on opposing faces of the ear. A portion of the extent of each ear nearest the cannula outlet may be configured to deform when the portion contacts the infusion set base during coupling of the infusion set base and the cannula subassembly. The septum housing may include a set of ridges configured to compress the septum. The cannula subassembly may further include at least one additional septum. The septum may have at least one additional septum nested therein. The sidewall may include a catch configured to engage the infusion set base to couple the cannula subassembly to the infusion set base.

[0033] In accordance with another exemplary embodiment of the present disclosure, there is provided a cannula subassembly for coupling to an infusion set base, the cannula subassembly including: a housing including a first wall, a sidewall extending from the first wall having at least one delivery aperture therein, and a plurality of latch surfaces; a cannula having an outlet at a first end and an enlarged region at a second end, the enlarged region having an outer surface with a flange projecting outwardly therefrom, a pair of latch arms spaced apart around the periphery of the flange, each of the latch arms engaging one of the latch surfaces, the flanges closing the second end of the housing opposite the first wall; and a septum captured between the cannula and the housing and forming a fluid-tight seal against the outer surface.

[0034] In some embodiments, each of the plurality of latching surfaces may be a surface of a respective one of a set of notches recessed through the first wall of the housing. The inner surface of the sidewall may include a set of latch arm guides, each extending into one of the plurality of latching surfaces. The guides may be recessed into the inner surface of the sidewall. The flange may include at least one ledge member extending from a periphery of the flange, the at least one ledge member configured to engage with a retainer included in the infusion set base. The septum housing may include a recess in the sidewall adjacent at least one of the at least one ledge member. The first wall may include an opening therethrough, and the septum may include a portion that extends at least partially into the opening. The housing may include a set of ears extending outward from an outer surface of the housing. Each of the ears may include an extension that projects from a main portion of the ear toward the cannula outlet and that decreases in thickness as the distance to the outlet decreases. A portion of the expansion of each ear closest to the cannula outlet may be configured to deform when the portion contacts the infusion set base during coupling of the infusion set base and the cannula subassembly. Each ear may include a pair of wedge bodies disposed on opposing surfaces of the ear. The septum may be disposed between and compressed by portions of the catch arms. A surface of the expansion region most proximal to the cannula outlet may include a recess surrounding a portion of the cannula extending from the surface. At least a portion of the outer surface may extend in a direction substantially parallel to the elongation axis of the cannula. The outer surface may surround a sharp guide continuous with the lumen of the cannula.

[0035] According to another exemplary embodiment of the present disclosure, there is provided a cannula subassembly for coupling to an infusion set base, the cannula including: a cannula having an outlet at a first end and an enlarged region at a second end, the enlarged region including an outer surface with an outwardly extending flange; a housing separate from the cannula, the housing including an end wall with a passageway therethrough and a side wall extending from the end wall with at least one delivery passageway; a first septum disposed within the housing and forming a fluid-tight seal with at least a portion of the outer surface; a second septum disposed within the housing abutting the end wall and including an opening; and a retaining clip coupled to the housing and capturing the first septum and the second septum at least partially within the housing, wherein a portion of the cannula extends through the opening and the passageway to the exterior of the septum housing.

[0036] In some embodiments, the flange may be captured between the first septum and the second septum. The flange may be disposed within a recess formed in a wall of the cavity of the first septum. One of the first septum and the second septum may include a peripheral rim that seals against an outermost side of the flange. The first septum may be at least partially nested within a receptacle of the second septum and form a fluid-tight seal with the second septum. The outer surface may include a straight expanse extending substantially parallel to the elongation axis of the cannula. The first and second septums may be constructed of different materials. The septum housing may include a plurality of protrusions extending into the interior of the septum housing, and the protrusions may contact and compress at least one of the first septum and the second septum. A portion of the second septum may protrude at least partially through the passageway. The septum housing may include a plurality of ears, each ear including a main portion having a tapered expansion extending therefrom, the thickness of the expansion decreasing toward the outlet. Each of the ears may include a wedge body adjacent the side wall. The second septum may include a protruding portion extending at least partially through the passageway in the end wall. The expansion region may include a sharp guide continuous with the cannula lumen.

[0037] According to another exemplary embodiment of the present disclosure, there is provided a method of assembling a cannula subassembly, the method including: providing a housing; disposing a first septum within the housing; disposing the cannula within the cannula subassembly such that a first portion of the cannula abuts a surface of the first septum inside the housing and the cannula extends through the housing against the first septum and a second portion of the cannula outside the housing; seating the second septum against the first septum to form a fluid-tight seal between at least the second septum and the first portion of the cannula; and capturing the first septum, second septum, and a portion of the cannula within the housing by coupling a septum retainer to the septum housing.

[0038] In some embodiments, disposing the first septum within the housing may include disposing a surface of the first septum against an end wall of the housing. The end wall may include a passageway therethrough, and positioning the first septum within the housing may further include aligning an opening extending through the first septum with the passageway, with the cannula extending through the opening and the passageway. Disposing the cannula within the cannula subassembly may include disposing a first portion of the cannula within a cavity of the first septum. Seating the second septum against the first septum may include installing the second septum within the cavity of the first septum. Seating the second septum against the first septum may include sandwiching a flange of the first portion of the cannula between a portion of the first septum and a portion of the second septum. Forming a fluid-tight seal between at least the second septum and the first portion of the cannula may include receiving at least a portion of the first portion of the cannula within a cavity of the second septum. Forming a fluid-tight seal between at least the second septum and the first portion of the cannula may further include holding a flange of the first portion of the cannula within a recess defined in a wall of the cavity. Positioning the cannula within the cannula subassembly may include positioning the first portion of the cannula within a receptacle area of ​​the first septum surrounded by a periphery of the first septum. Seating the second septum against the first septum may include displacing a periphery of the second septum relative to the first septum and positioning a flange of the cannula first portion with a receptacle area of ​​the second septum surrounded by an outer periphery, and seating the second septum against the first septum may include forming a fluid-tight seal between the first septum and the second septum.

[0039] According to another embodiment of the present disclosure, an infusion set assembly for delivering medication to a patient includes a base including a platform portion, a set of walls extending from the platform portion, the set of walls defining a receptacle with a cantilever portion including a latch portion and at least one protruding region extending from the cantilever portion into the receptacle, and a series of notches defined in the walls; and a cannula subassembly within the receptacle, a septum housing including a capture surface that engages the latch portion, the cannula subassembly being configured to engage a sidewall of the septum housing. and a cannula subassembly including a septum housing including a pair of wedges extending from the cannula subassembly, the wedges being at least partially positioned within the notches and creating a mechanical interference against tilting of the cannula subassembly within the receptacle, the at least one protruding region being configured to create a mechanical interference against tilting of the cannula subassembly within the receptacle; a cannula; and a septum forming a fluid-tight seal with a portion of the cannula and including a fluid introduction volume in fluid communication with an inner lumen of the cannula.

[0040] In some embodiments, the notch may be recessed into the wall at a portion of the wall most distal to the platform portion. The wall may define a channel extending from the receptacle toward the periphery of the platform portion. Each of the walls may include a segment oriented such that the wall is separated by a first distance proximal to the platform portion and a second distance distal to the base that is shorter than the first distance, and each wall may have a discontinuity extending from the segment to the platform portion. The platform portion may be substantially planar, and each wall segment may be oriented substantially parallel to the platform portion. At least a portion of the notch may be tapered, and the notch may coincide with the discontinuity in the wall. Each wall segment, and the portion of the wall between the platform portion and the segment, may form a receiving track configured to guide a portion of the tubing set connector when the tubing set connector is coupled to the base. Each of the notches may include a first tapered region and a second tapered region having different tapers. The latch portion may be in the form of a ramp that increases in thickness as the distance to the unsupported end of the cantilevered portion decreases. The at least one protruding region may include a rib extending along a majority of the cantilevered portion, the at least one protruding region may include a rib extending substantially parallel to an axis of extension of the cantilevered portion. The cannula subassembly may include a second septum in contact with the first septum, and the cannula may extend through an orifice in the second septum.

[0041] According to another exemplary embodiment of the present disclosure, there is provided a cannula subassembly including: a housing; a first septum disposed within the housing; a cannula having a first portion disposed within the housing against a surface of the first septum and a second portion extending through the first septum and the housing; a second septum disposed against the first septum and forming a fluid-tight seal with at least the first portion of the cannula; and a retainer coupled to the housing, the retainer capturing the first septum, the second septum, and the first portion of the cannula within the housing.

[0042] In some embodiments, the cannula may be a separate molded part separated from the housing. The housing and the retainer may be made of molded plastic, and the first and second septa may be made of elastomer. The first and second septa may be made of different materials. The fluid seal may be formed between abutting surfaces of the first and second septa. The retainer may include a substantially planar body, a plurality of cantilevered protrusions extending substantially perpendicularly from the body and positioned opposite each other, and a plurality of latch members positioned at the ends of the cantilevered protrusions. The second septum may include a nub protruding through a channel defined in the retainer and a cavity defining a fluid introduction volume, the fluid introduction volume being in fluid communication with a lumen of the cannula. The second septum may further include a recess in a wall of the cavity, and a flange of the cannula may be positioned within the recess. The housing may include a plurality of ears molded into one side of the housing, a septum receptacle recessed in a central portion of a first end of the housing, a cannula passage extending into the receptacle from a second end opposite the first end of the housing, at least one catch configured to engage a portion of the retainer to couple the retainer to the housing, and at least one connector needle passage disposed in a side wall of the housing. The first septum may be disposed within the receptacle of the housing, and the receptacle may include a plurality of guides on an inner wall of the receptacle. The first septum may be disposed within the receptacle of the housing, and the receptacle may include a plurality of protrusions extending from a wall of the receptacle and contacting at least the first septum. The first portion of the cannula may include an expansion region comprising an insertion sharp guide, a septum interface region disposed to surround the insertion sharp guide, and a flange extending outward from the first portion of the cannula, the first portion of the cannula including a flange, the flange being captured in a fluid-tight relationship between the first septum and the second septum.The first portion of the cannula may include a flange disposed within a receptacle in the second septum such that a fluid-tight seal exists between the flange and the second septum. The second portion of the cannula may include an outlet at an end thereof.

[0043] According to another exemplary embodiment of the present disclosure, there is provided an inserter assembly for connecting an infusion set to an infusion site, the inserter assembly including: a housing having a closed end and an open end; a cannula subassembly; an infusion set base separate from the cannula subassembly and disposed at the open end; an actuation assembly; and an adhesive assembly for attaching the infusion set base to an infusion site, the adhesive assembly including: an adhesive patch attached to the infusion set base and including a patch opening; and a liner having an enlarged region covering the adhesive patch, the liner having a liner opening, a strip portion extending from the enlarged region, and a tab extending from the enlarged region adjacent to the strip portion, the strip portion being coupled to the housing, and a slit extending through the enlarged region from a point between the tab and the strip portion, the slit abutting the opposite side of the opening relative to the tab.

[0044] In some embodiments, the actuation assembly is configured to displace an insertion sharp from an initial position through an opening of the infusion set base to an insertion position and retract the insertion sharp into the housing to a retracted position, and the cannula subassembly may be carried by the insertion sharp and coupled to a receptacle of the infusion set base when the insertion sharp is moved to the insertion position. The inserter assembly may further include a removable locking member extending into the housing, the locking member preventing actuation of the actuation assembly, and the strip portion may extend over the locking member. The locking member may include a pair of arcuate members disposed on opposite sides of a body of the locking member and elastically deflectable toward the body. The adhesive assembly may further include an adhesive body, and the liner may be coupled to the housing via the adhesive body. The strip portion may have a length greater than a height of the housing, and an end of the strip portion opposite the enlarged region may be coupled to a closed end of the housing. The strip portion may be coupled to the housing at an end of the strip portion opposite the enlarged region by a method selected from the group consisting of adhesive, heat staking, radio frequency welding, and sonic welding. The adhesive patch may include a main region and a protruding region extending from a periphery of the main region, and a segment of the liner strip portion may cover the adhesive present on the protruding region. The adhesive patch may have a footprint larger than the footprint of the infusion set base. The slit may extend linearly. The liner opening may be defined by a sidewall including a first round span opposite a second round span, the first round span having a tighter curvature than the second round span, and the first round span and the second round span may be connected to each other by a linear sidewall span. The second round span may be more distal to the tab than the first round span. The shortest distance between a point on the second round span and the outer periphery of the liner may be shorter than the shortest distance between the outer periphery of the liner and other portions of the liner opening. The liner may be a waxed paper material. The liner may be a polymeric material.The adhesive patch may be coupled to the infusion set base by a method selected from the group consisting of adhesive, heat staking, radio frequency welding, sonic welding, and ultrasonic welding.

[0045] According to another exemplary embodiment of the present disclosure, an inserter assembly for communicating an infusion set with an infusion site includes a housing having a closed end and an open end; an infusion set; An inserter assembly is provided, comprising: an actuation assembly; and an adhesive assembly for attaching the infusion set to an infusion site, the adhesive assembly including: an adhesive patch attached to a portion of the infusion set and including a patch opening; and a backing covering the adhesive patch and having a first portion with a backing opening, the backing having a second portion and a third portion both extending from the first portion and adjacent to each other, the second portion being coupled to the housing and having a slit extending through the first portion from a point between the second and third portions and bordering the opposite side of the opening relative to the point.

[0046] In some embodiments, the infusion set may be disassembled within the inserter assembly. The actuation assembly may be configured to displace an insertion sharp from an initial position through an opening in the base of the infusion set to an insertion position and retract the insertion sharp into the housing to a retracted position, and a cannula subassembly of the infusion set may be carried by the insertion sharp and coupled into a receptacle in the base when the insertion sharp is displaced to the insertion position. The inserter assembly may further include a removable locking member extending into the housing, the locking member preventing actuation of the actuation assembly, and at least a portion of the backing may extend over the locking member. The locking member may include a body having a pair of arcuate members on either side thereof, the arcuate members being resiliently deflectable toward the body. The second portion may have a length greater than the height of the housing, and an end of the second portion opposite the first portion of the backing may be coupled to a closed end of the housing. The second portion may be coupled to the housing at an end of the second portion opposite the first portion by a method selected from the group consisting of adhesive, heat staking, RF welding, sonic welding, and ultrasonic welding. The adhesive patch may include a main region and a protruding region extending from a periphery of the main region, with a segment of the second portion of the backing covering the adhesive present on the protruding region. The adhesive patch may have a footprint larger than the footprint of the infusion set. The slit may extend linearly. The backing opening may be defined by a sidewall including a first round span opposite a second round span, the first round span having a tighter curvature than the second round span, and the first and second round spans may be connected to each other by a linear sidewall span. The second round span may be more distal to the second portion of the backing than the first round span. The shortest distance between a point on the second circular span and the perimeter of the backing may be shorter than the shortest distance between the perimeter of the backing and other portions of the backing opening. The backing may be a waxed paper material. The backing may be a polymeric material.The adhesive patch may be attached to a portion of the infusion set by a method selected from the group consisting of adhesive, heat staking, RF welding, sonic welding, and ultrasonic welding. The backing may cover a majority of the open end of the housing.

[0047] According to another exemplary embodiment of the present disclosure, there is provided an adhesive assembly for attaching an infusion set to an infusion site, the adhesive assembly including: an adhesive patch attached to a portion of the infusion set and including a patch opening; a backing including: a first portion covering the adhesive patch; a second portion; a third portion, the second portion and the third portion both extending from the first portion and adjacent to one another; an opening disposed in the first portion defined by a sidewall having a first round span and a second round span connected by a straight sidewall portion, the second round span having a gentler curvature than the first round span; and a slit extending across a section of the first portion from a point between the second portion and the third portion, the slit having a tangent point on an opposite side of the first round span with respect to that point.

[0048] In some embodiments, the second portion of the backing may include an adhesive bonded thereto for attaching the second portion to the housing of the inserter assembly. The second portion may be longer than the third portion. The second portion may be an elongated strip. The adhesive patch may include a main region, a protruding region extending from a periphery of the main region, and a segment of the second portion of the backing coating adhesive present on the protruding region. The slit may extend linearly. The patch opening may be aligned with and have the same shape as the opening in the backing. The second round span may be distal to the second portion of the backing than the first round span. The shortest distance between a point on the second round span and the outer periphery of the backing may be shorter than the shortest distance between the outer periphery of the backing and another portion of the opening in the backing. The force required to peel the backing from the adhesive of the adhesive patch in the area of ​​the backing between the periphery of the backing and the second circular span of the opening may be less than the force required to peel the backing from the adhesive in other areas of the first portion of the backing. The backing may be a waxed paper material. The backing may be a polymeric material. The adhesive patch may include an infusion set adhesive for bonding to a portion of the infusion set on a surface of the adhesive patch opposite the backing.

[0049] According to another exemplary embodiment of the present disclosure, the inserter assembly may include a housing. The inserter assembly may further include an infusion set. The inserter assembly may further include a sharps bearing body. The inserter assembly may further include a trigger. The inserter assembly may further include a drive spring held in an energized state by the trigger. The drive spring may bias the sharps bearing body from the raised state to the forward state when the trigger is released. The inserter assembly may further include means for releasing the trigger when the inserter assembly is pulled away from the body.

[0050] In some embodiments, the inserter assembly may further comprise means for preventing release of the trigger before the skin at the selected infusion set placement site is lifted from the underlying anatomical structure. In some embodiments, a portion of the infusion set may comprise an adhesive for securing the portion of the infusion set to a patch of skin. In some embodiments, the infusion set may include a base and a cannula assembly. In some embodiments, the cannula subassembly may be carried by the sharps holder and decoupled from the base when the sharps holder is in the raised state. In some embodiments, the cannula subassembly may be coupled to the base when the sharps holder is biased to the forward state. In some embodiments, the inserter assembly may further comprise a retraction spring configured to displace the sharps holder from the forward state to the retracted state when the retraction spring is released from the energized state. In some embodiments, the infusion set may be configured to decouple from the inserter assembly when the sharps holder is biased to the forward state. In some embodiments, the inserter assembly may further comprise a retraction spring held in the energized state by a coupling between the infusion set and another portion of the inserter assembly. When the sharps holder is biased to the forward position, the coupling may be released. The retraction spring can bias the sharps retainer to a retracted state when released from an energized state. In some embodiments, the sharps retainer can be in a different position within the inserter assembly in the raised state compared to the retracted state.

[0051] According to yet another exemplary embodiment of the present disclosure, an inserter assembly may include a housing. The inserter assembly may further include an infusion set having an adhesive thereon for adhering a portion of the infusion set to the skin. The inserter assembly may further include a sharps retainer. The inserter assembly may further include a trigger. The inserter assembly may further include an insertion biasing member held in an energized state by the trigger. The insertion biasing member may bias the sharps retainer from the raised state to the forward state when the trigger is released. The inserter assembly may further include means for releasing the trigger after the inserter assembly is withdrawn from the body and the skin attached to the portion of the infusion set is lifted from the underlying anatomical structure.

[0052] In some embodiments, the infusion set may include a base and a cannula assembly. In some embodiments, the cannula subassembly may be carried by the sharps holder and may be decoupled from the base when the sharps holder is in the raised state. In some embodiments, the cannula subassembly may be configured to couple to the base when the sharps holder is biased to the forward state. In some embodiments, the inserter assembly may further include a retraction biasing member configured to displace the sharps holder from the forward state to the retracted state when the retraction biasing member is released from the energy-stored state. In some embodiments, the inserter assembly may further include means for releasing the infusion set when the sharps holder is displaced to the forward state. In some embodiments, the inserter assembly may further include means for retracting the sharps holder to the retracted state after the sharps holder is biased to the forward state. In some embodiments, the sharps holder may be in a different position within the inserter assembly in the raised state compared to the retracted state. In some embodiments, the infusion set may include an infusion set base and a cannula subassembly, and the infusion set base may include means for coupling the cannula subassembly to the infusion set base.

[0053] According to yet another exemplary embodiment of the present disclosure, an inserter assembly may include a housing. The inserter assembly may further include an infusion set having an adhesive thereon for adhering the portion of the infusion set to the skin. The inserter assembly may further include a sharps holder. The inserter assembly may further include a trigger device. The inserter assembly may further include a biasing member held in an energized state by the trigger device. The biasing member may bias the sharps holder from the raised state to the forward state when the trigger device is released. The inserter assembly may further include means for preventing release of the trigger device before the skin attached to the infusion set has been lifted from the underlying anatomical structure.

[0054] In some embodiments, the inserter assembly may further comprise means for actuating the trigger device when the skin is lifted. In some embodiments, the infusion set may include a base and a cannula assembly. In some embodiments, the cannula subassembly may be carried by the sharps holder and decoupled from the base when the sharps holder is in the raised state. In some embodiments, the cannula subassembly may be configured to couple to the base when the sharps holder is biased to the forward state. In some embodiments, the inserter assembly may further comprise a retraction biasing member configured to displace the sharps holder from the forward state to the retracted state when the retraction biasing member is released from the energy-stored state. In some embodiments, the inserter assembly may further comprise means for releasing the infusion set when the sharps holder is displaced to the forward state. In some embodiments, the inserter assembly may further comprise means for retracting the sharps holder to the retracted state after the sharps holder is biased to the forward state. In some embodiments, the sharps holder may be in a different position within the inserter assembly in the raised state compared to the retracted state. In some embodiments, the infusion set may include an infusion set base and a cannula subassembly, and the infusion set base may include means for coupling the cannula subassembly to the infusion set base.

[0055] According to another exemplary embodiment of the present disclosure, the inserter assembly may include a casing unit including at least one protrusion. The inserter assembly may further include a second unit. The second unit may include an infusion set having an adhesive on a portion of the infusion set for securing the infusion set to a skin patch. The second unit may further include a sharps holder including an insert sharp. The second unit may further include a trigger. The second unit may further include a drive spring held in an energized state by the trigger. The drive spring may bias the sharps holder from the raised state to the forward state when the trigger is released. The second unit may further include at least one elastic member. Interference may exist between each of the at least one elastic member and an associated protrusion of the at least one protrusion. The interference blocks relative movement of the casing unit and the second unit while the adhesive is affixed to the skin patch, but when the inserter assembly is moved away from the injection site and the skin patch is lifted, a threshold force generated by the elasticity of the skin is reached and the at least one elastic member is deflected from its interference relationship with the at least one protrusion associated therewith.

[0056] In some embodiments, the trigger may comprise a catch that engages with a protrusion defined on the sharps holder. In some embodiments, the drive spring may be a compression spring. In some embodiments, each of the at least one resilient member may be a cantilever arm. In some embodiments, each of the at least one protrusion may be a deflector. In some embodiments, the casing may further comprise a trigger protrusion. In some embodiments, the inserter assembly may further comprise means for retracting the sharps holder to the retracted state after the sharps holder is biased to the forward state. In some embodiments, a portion of the infusion set may be disposed within an opening in the end of the casing unit and is substantially flush with the end of the casing unit when the inserter assembly is in the initial state.

[0057] According to yet another exemplary embodiment of the present disclosure, an inserter assembly can include a first unit including a trigger body. The inserter assembly can further include a second unit including an actuation assembly including a trigger. The inserter assembly can further include an infusion set base removably coupled to the second unit and having an adhesive for securing the infusion set base to a skin patch. The adhesive secures the infusion set base to the skin patch, and displacement of the first unit away from the skin patch can limit displacement of the second unit relative to the skin patch. Relative movement between the first unit and the second unit can displace the trigger body into the trigger.

[0058] In some embodiments, the second unit may further include a resilient member aligned with the deflector included in a portion of the first unit. In some embodiments, the second unit may further include a resilient member configured to abut a portion of the first unit to prevent relative movement between the first unit and the second unit until a threshold force applied to separate the first unit and the second unit is exceeded. In some embodiments, the portion of the first unit may be a deflector member, and the resilient member may be a cantilever arm extending from a portion of the second unit. In some embodiments, the threshold force may be selected such that, when the first unit is displaced away from the skin patch, adhesive adhesion lifts the skin patch from the underlying anatomical structure by at least a certain distance from a rest position before the trigger body is displaced into the trigger. In some embodiments, the force threshold may be selected such that, when the first unit is displaced away from the skin patch, adhesive adhesion lifts the skin patch from the underlying anatomical structure before relative displacement between the first unit and the second unit begins. In some embodiments, the force threshold can be selected such that when the first unit is displaced away from the skin patch, adhesion of the adhesive causes the skin patch to lift at least a certain distance from its resting position. In some embodiments, the adhesive can be configured to maintain adhesion to the skin patch and to withstand forces generated by skin elasticity when the adhesive is in adhesive relationship with the skin patch and the first unit is moved away from the injection site.

[0059] According to yet another exemplary embodiment of the present disclosure, the inserter assembly may include a first portion including a trigger body. The inserter assembly may further include an infusion set base having an adhesive thereon for securing the infusion set base to a skin patch. The inserter assembly may further include a second portion including an actuation assembly with a trigger. The infusion set base may be removably coupled to a second unit. When the infusion set base is coupled to the second portion and secured to the skin by the adhesive, the second unit may be inhibited from displacement relative to the skin patch. The first portion may be displaceable from an initial position to a trigger position away from the second portion. When the first portion is displaced toward the trigger position, the trigger body may actuate the trigger.

[0060] In some embodiments, the second portion may further include an elastic member that abuts against the deflector of the first portion when the first portion is in the initial position. In some embodiments, the second portion may further include an elastic member configured to abut against a portion of the first portion to prevent relative movement between the first portion and the second portion until a force threshold is exceeded. In some embodiments, a portion of the first portion may be a deflector member, and the elastic member may be a cantilever arm extending from a portion of the second portion. In some embodiments, the force threshold may be greater than the threshold required to lift the skin patch from the underlying anatomical structure when the infusion set base is secured to the skin patch via an adhesive. In some embodiments, the force threshold may be selected so that the skin patch is lifted when the infusion set base is secured to the skin patch via an adhesive and the first unit is displaced away from the skin patch. The adhesive force of the adhesive must be at least a certain distance from the rest position of the adhesive. In some embodiments, the adhesive can be configured to maintain adhesion to the skin patch and to withstand forces generated by the elasticity of the skin when the adhesive is in adhesive relationship with the skin patch and the first unit is displaced away from the second unit.

[0061] According to another exemplary embodiment of the present disclosure, an inserter assembly may include a first portion including a trigger body. The inserter assembly may further include an infusion set base having an adhesive thereon for securing the infusion set base to a skin patch. The inserter assembly may further include a second portion including an actuation assembly with a trigger. The infusion set base may be removably coupled to a second unit. When the infusion set base is coupled to the second portion and secured to the skin by the adhesive, the second unit may be inhibited from displacement relative to the skin patch. The first portion may be configured to displace from an initial position to a trigger position relative to the second portion when a threshold force is applied to the first portion in a direction away from the second portion. The trigger body may be configured to actuate the trigger when the first portion is displaced toward the trigger position.

[0062] In some embodiments, the threshold force may be greater than the threshold required to lift the skin patch from the underlying anatomical structure when the infusion set base is secured to the skin patch via adhesive. In some embodiments, the force threshold may be selected so that when the infusion set base is secured to the skin patch via adhesive and the first unit is displaced away from the skin patch, the skin patch is lifted. The adhesive force of the adhesive must be at least a certain distance from the resting position of the adhesive. In some embodiments, the adhesive may be configured to maintain adhesion to the skin patch and to withstand forces generated by the elasticity of the skin when the adhesive is in adhesive relationship with the skin patch and the first unit is displaced away from the skin patch. In some embodiments, the first portion may be releasably engaged with the second portion, and application of a threshold force may cause the first portion and the second portion to disengage from each other. In some embodiments, interference exists between the first portion and the second portion, and application of the threshold force may cause a portion of the second portion to deflect from the interference relationship with the first portion. In some embodiments, the inserter assembly may further include a removable locking member. The locking member may be positioned to prevent relative displacement between the first and second portions, even when a threshold force is applied. In some embodiments, the inserter assembly may further include a removable liner covering the adhesive. In some embodiments, the first portion may form a casing for the inserter assembly, and the infusion set base may be positioned within an opening in an end of the casing and in the same position as the end when the inserter assembly is in an initial state. In some embodiments, the inserter assembly may further include a cannula subassembly. The actuation assembly may be configured to displace the cannula subassembly into engagement with the infusion set base when the trigger is actuated.

[0063] According to yet another exemplary embodiment of the present disclosure, an inserter assembly may include a first unit. The inserter assembly may further include a second unit. Interference may exist between the first unit and the second unit, preventing relative displacement between the first unit and the second unit until a force equal to or greater than a threshold is applied to separate the first unit and the second unit. The inserter assembly may further include an infusion set having an adhesive thereon for adhering the portion of the infusion set to a skin patch. The inserter assembly may further include an insertion actuation assembly including a trigger. The trigger may be configured to actuate when the magnitude of the relative displacement separating the first unit and the second unit exceeds a displacement threshold.

[0064] In some embodiments, the adhesive may be configured to maintain adhesion to the skin patch and to withstand a force generated by the elasticity of the skin when the adhesive is in adhesive relationship with the skin patch and the inserter assembly is displaced away from the injection site. In some embodiments, the threshold force may be selected to ensure that the skin patch is lifted from the underlying anatomical structure when the adhesive is in adhesive relationship with the skin patch and the first unit is displaced away from the skin patch. In some embodiments, the interference may be provided by abutment of an elastic member of one of the first and second units with a deflector of the other of the first and second units. In some embodiments, the interference may be provided by at least one cantilever arm of the second unit, each abutting an associated deflector of the first unit. In some embodiments, the first unit may be the casing of the inserter assembly. In some embodiments, the infusion set may include a base and a cannula assembly. In some embodiments, the cannula subassembly may be carried by a spring-loaded sharps retainer of the second unit. The spring-loaded sharps retainer may be urged from the raised state to the forward state by a biasing member when the trigger is actuated. In some embodiments, the infusion set base may be releasably coupled to the second unit, and the cannula subassembly may be disengaged and spaced apart from the base when the sharps retainer is in the raised state. In some embodiments, the cannula subassembly may be coupled to the base when the sharps retainer is biased to the forward state. In some embodiments, the inserter assembly may further comprise a spring-loaded sharps retainer included as part of the second unit. In some embodiments, the inserter assembly may further comprise a spring-loaded sharps retainer included as part of the second unit. The spring-loaded sharps retainer may be configured to be urged from the raised state to the forward state by a biasing member when the trigger is actuated. In some embodiments, the inserter assembly may further comprise a retraction spring configured to displace the sharps retainer from the forward state to the retracted state when the retraction spring is released from an energized state.In some embodiments, the infusion set may be releasably coupled to the second unit and configured to decouple from the second unit when the sharps retainer is biased to the forward state. In some embodiments, the inserter assembly may further include a retraction spring held in an energized state by coupling between at least a portion of the infusion set and the second unit. When the sharps retainer is biased to the forward position, the coupling may be released. When the retraction spring is released from the energized state, it may bias the sharps retainer to the retracted state. In some embodiments, the sharps retainer may be in a different position within the inserter assembly in the raised state compared to the retracted state. In some embodiments, the insertion actuation assembly may be included as part of the second unit.

[0065] According to another exemplary embodiment of the present disclosure, the inserter assembly may include a first unit. The inserter assembly may further include a second unit in an interference relationship with the first unit, the second unit preventing relative displacement between the first unit and the second unit until a force exceeding a threshold is applied to separate the first unit and the second unit. The inserter assembly may further include an infusion set having an adhesive thereon, the infusion set configured to maintain adhesion to the skin patch and to withstand forces generated by the elasticity of the skin when the adhesive is in adhesive relationship with the skin patch. The inserter assembly is moved to a position away from the injection site. The inserter assembly may further include an insertion actuation assembly.

[0066] In some embodiments, the threshold force can be selected so that the adhesive is in adhesive relation with the skin patch and reliably lifts the skin patch from the underlying anatomical structure when the first unit is displaced away from the skin patch. In some embodiments, the first unit can include a housing for the inserter assembly. In some embodiments, the infusion set can include an infusion set base and a cannula assembly. The cannula assembly can be disconnected from the infusion set base and spaced apart from the infusion set base prior to actuation of the insertion actuation assembly. In some embodiments, the adhesive can be disposed on a bottom surface of the infusion set base. In some embodiments, the insertion actuation assembly can include a trigger device and a spring-loaded sharps retainer. In some embodiments, the interference relationship can be established by abutment of a resilient member of one of the first and second units with a deflector of the other of the first and second units. In some embodiments, the interference relationship can be established by at least one cantilever arm of the second unit abutting an associated deflector of the first unit. In some embodiments, the insertion actuation assembly can be included as part of the second unit.

[0067] According to yet another exemplary embodiment of the present disclosure, an inserter assembly can include a first unit. The inserter assembly can further include a second unit in an interference relationship with the first unit, inhibiting relative displacement between the first unit and the second unit until a force exceeding a threshold is applied to separate the first unit and the second unit. The inserter assembly can further include an infusion set having an adhesive thereon for adhering the portion of the infusion set to a skin patch. The adhesive can be in adhesive relationship with the skin patch and configured to lift the skin patch from underlying anatomical structures when the inserter assembly is moved away from the infusion site. The inserter assembly can further include an insertion actuation assembly.

[0068] In some embodiments, the infusion set may include an infusion set base and a cannula assembly. The cannula assembly may be disconnected from the infusion set base and spaced apart from the infusion set base prior to actuation of the insertion actuation assembly. In some embodiments, adhesive may be provided on a bottom surface of the infusion set base. In some embodiments, the first unit may include a casing for the inserter assembly, and the infusion set base may be removably coupled to the second unit, disposed in an opening at the end of the casing, and positioned flush with the end of the casing when the inserter is inserted. The assembly is in an initial state. In some embodiments, the adhesive may be covered with a removable backing. In some embodiments, the inserter assembly may further include a removable locking member configured to prevent actuation of the insertion actuation assembly. In some embodiments, the inserter assembly may further include a removable locking member configured to prevent separation of the first unit and the second unit when a threshold force is exceeded. In some embodiments, the insertion actuation assembly may include a trigger device and a spring-loaded sharps retainer. In some embodiments, the interference relationship may be established by abutment of at least one resilient member of one of the first and second units with a deflector associated with each of the at least one resilient member included in the other of the first and second units. In some embodiments, the interference relationship may be established by at least one cantilever arm of the second unit. Each of the at least one cantilever arm may abut an associated protrusion of the first unit. In some embodiments, the insertion actuation assembly may be included as part of the second unit.

[0069] According to another exemplary embodiment of the present disclosure, the inserter assembly may include a first unit. The inserter assembly may further include a second unit releasably engaging the first unit. The second unit may be configured to displace in conjunction with the first unit until a force exceeding a threshold is applied to separate the first and second units. The inserter assembly may further include an infusion set having an adhesive thereon for adhering the portion of the infusion set to a skin patch. The adhesive may be in adhesive relation to the skin patch and configured to lift the skin patch from underlying anatomical structures when the inserter assembly is moved away from the infusion site. The inserter assembly may further include an insertion actuation assembly.

[0070] In some embodiments, the insertion actuation assembly may be included as part of the second unit. In some embodiments, the second unit may be releasably engaged with the first unit via interference between a portion of the first unit and the second unit. In some embodiments, the portion of the second unit may be configured to deflect to a deflected state upon application of a threshold force. When in the deflected state, the portion of the second unit may be disengaged from the interference relationship with the portion of the first unit. In some embodiments, the second unit may be releasably engaged with the first unit via a resilient member that abuts and engages with a deflector disposed on the portion of the first unit. In some embodiments, the resilient member may be configured to deflect to a deflected state upon application of a threshold force. When in the deflected state, the resilient member may be disengaged from abutting engagement with the deflector. In some embodiments, the second unit may be releasably engaged with the first unit via at least one cantilever arm of the second unit, each of which abuts and engages with a cooperating protrusion on a respective portion of the first unit for at least a portion of the cantilever arm. In some embodiments, each of the at least one cantilevered arms may be configured to deflect to a deflected state upon application of a threshold force. When in the deflected state, each of the at least one cantilevered arms may be disengaged from an associated cooperating protrusion. In some embodiments, the insertion actuation assembly may include a trigger device and a spring-loaded sharps retainer. In some embodiments, the infusion set may include an infusion set base and a cannula assembly. The cannula assembly may be disconnected from the infusion set base and spaced apart from the infusion set base prior to actuation of the insertion actuation assembly. In some embodiments, adhesive may be provided on a bottom surface of the infusion set base. In some embodiments, the first unit may include a casing for the inserter assembly, and the infusion set base may be releasably coupled to the second unit and positioned in an opening at the end of the casing when the inserter assembly is inserted. Initial state.In some embodiments, the adhesive may be covered with a removable backing. In some embodiments, the inserter assembly may further include a removable locking member configured to prevent actuation of the insertion actuation assembly. In some embodiments, the inserter assembly may further include a removable locking member configured to prevent relative displacement of the first and second units even when a force above a threshold is applied to separate the first and second units.

[0071] According to another exemplary embodiment of the present disclosure, a method of placing an infusion set of an inserter assembly at an infusion site can include adhering a portion of the inserter assembly to skin at the infusion site. The method can further include pulling the inserter assembly away from the body to lift the skin at the infusion site from underlying anatomical structures via adhesion of the skin to the inserter assembly. The method can further include actuating an actuation assembly of the inserter assembly after the skin has been lifted at least a certain distance. The method can further include performing a sharp insertion through the skin.

[0072] In some embodiments, the method may further include releasing a biasing member of the actuation assembly from an energized state to sharply drive the insertion through the skin. In some embodiments, the method may further include releasing the portion of the infusion set from the inserter assembly. In some embodiments, the method may further include preventing triggering of the actuation assembly with a removable locking member. In some embodiments, the method may further include removing the locking member from the inserter assembly. In some embodiments, the method may further include removing the adhesive backing from the inserter assembly. In some embodiments, the method may further include releasing the anti-backup latch and sharply driving the insert away from the infusion site. In some embodiments, the method may further include driving a cannula subassembly carried by the insert into the portion of the infusion set. In some embodiments, forcing the cannula subassembly into the portion of the infusion set may include forcing a cannula of the cannula subassembly through the skin. In some embodiments, the method may further include constraining relative movement between the casing of the inserter assembly and the second portion of the inserter assembly at least as the skin begins to lift.

[0073] According to another exemplary embodiment of the present disclosure, a method of positioning an infusion set of an inserter assembly at an infusion site can include coupling the inserter assembly to skin at the infusion site. The method can further include lifting the skin coupled to the inserter assembly from an underlying anatomical structure at the infusion site by displacing the inserter assembly away from the infusion site. The method can further include automatically actuating an actuation assembly of the inserter assembly after the skin has been lifted at least a predetermined distance.

[0074] In some embodiments, the method may further include releasing a biasing member of the actuation assembly from an energized state to drive the insertion sharply through the skin. In some embodiments, the method may further include assembling the infusion set by driving a cannula subassembly of the infusion set carried by the insertion sharp into another portion of the infusion set. In some embodiments, driving the cannula subassembly into another portion of the infusion set may include driving the cannula of the cannula subassembly through the skin. In some embodiments, the method may further include releasing the anti-backup latch and driving the insertion sharply away from the infusion site. In some embodiments, the method may further include releasing a portion of the infusion set from the inserter assembly. In some embodiments, the method may further include removing a locking member that prevents activation of the actuation assembly and removing the adhesive backing from the inserter assembly.

[0075] According to yet another exemplary embodiment of the present disclosure, a method for placing an infusion set of an inserter assembly at an infusion site may include securing an infusion set base, removably coupled to a rest inserter assembly, to skin via an adhesive. The method may further include pulling the inserter assembly away from the body and lifting the skin secured to the infusion set base away from the underlying anatomical structure. The method may further include inhibiting relative displacement of the first and second portions of the inserter assembly until the skin is displaced to a point where the elasticity of the skin exceeds a threshold force against the infusion set base. The method may further include displacing an actuator of the first portion into a trigger configuration of the second portion. The method may further include performing a sharp insertion through the skin.

[0076] In some embodiments, the method may further include releasing the biasing member from an energized state to sharply pierce the insert into the skin. In some embodiments, the method may further include separating the infusion set base from the remainder of 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 insertion sharp toward the skin such that the cannula subassembly is pushed into the anti-backup latch. In some embodiments, the method may further include driving the insertion sharp away from the skin. In some embodiments, the method may further include driving the cannula subassembly carried by the insertion sharp into the infusion set base. In some embodiments, driving the cannula subassembly into the infusion set base may include driving the cannula of the cannula subassembly through the skin. In some embodiments, inhibiting relative movement between the first and second portions of the inserter assembly may include inhibiting relative movement between a casing of the inserter assembly and at least another portion of the inserter assembly at least when the skin begins to move. In some embodiments, the method may further include releasing the anti-backup latch and driving the insertion sharp away from the injection site. In some embodiments, the method may further include moving the insertion sharp to a protected position within the inserter assembly.

[0077] According to another exemplary embodiment of the present disclosure, a method of actuating an inserter assembly to place an infusion set at an infusion site can include establishing an interference relationship that prevents relative displacement between a first portion and a second portion of the inserter assembly. The method can further include adhering a portion of the infusion set to skin at the infusion site. The portion of the infusion set can be releasably coupled to the second portion. The method can further include pulling the skin at the infusion site away from underlying anatomical structures by displacing the inserter assembly away from the infusion site. The method can further include deflecting at least a portion of the second portion from the interference relationship when a force exerted by skin elasticity exceeds a threshold. The method can further include actuating an actuator of the first portion into a trigger configuration of the second portion.

[0078] In some embodiments, establishing the interference relationship may include abutting the resilient member of the second portion with the deflector of the first portion. In some embodiments, adhering a portion of the infusion set to skin at the infusion site may include adhering a base of the infusion set to the skin. The base of the infusion set may be spaced apart from the cannula assembly of the infusion set. In some embodiments, driving the actuator of the first portion into the trigger configuration may include increasing the magnitude of relative displacement between the first portion and the second portion of the inserter assembly after deflecting at least a portion of the second portion from the interference relationship. In some embodiments, driving the actuator of the first portion into the trigger configuration may include driving a protrusion of the first portion into the trigger configuration. In some embodiments, driving the actuator of the first portion into the trigger device may include driving the actuator of the first portion against a ledge of a spring-loaded sharps retainer. The protrusion may engage a catch on the second portion. In some embodiments, the method may further include disengaging the ledge from the catch.

[0079] According to another exemplary embodiment of the present disclosure, a method of actuating an inserter assembly to place an infusion set at an infusion site includes establishing a releasable engagement between a first portion and a second portion of the inserter assembly to prevent displacement of the first portion away from the second portion. The method may further include adhering a portion of the infusion set to skin at the infusion site. The portion of the infusion set may be releasably coupled to the second portion. The method may further include separating the skin at the infusion site from underlying anatomical structures by displacing the inserter assembly away from the infusion site. The method may further include disengaging the first portion from the second portion when a force forcing separation of the first and second portions exceeds a threshold. The method may further include increasing a magnitude of relative displacement between the first and second portions at least until an actuator of the first portion displaces into a trigger array of the second portion.

[0080] In some embodiments, establishing the releasable engagement may include disposing the resilient member of the second portion in an interference relationship with the deflector of the first portion. In some embodiments, adhering a portion of the infusion set to skin at the infusion site may include adhering a base of the infusion set to the skin. The base of the infusion set may be spaced apart from the cannula assembly of the infusion set. In some embodiments, driving the actuator of the first portion into the trigger configuration may include driving a protrusion of the first portion into the trigger configuration. In some embodiments, driving the actuator of the first portion into the trigger device may include driving the actuator of the first portion against a ledge of the spring-loaded sharps retainer. The protrusion may engage a catch on the second portion. In some embodiments, the method may further include disengaging the ledge from the catch. In some embodiments, establishing the releasable engagement may include creating an interference between the first portion and the second portion.

[0081] According to yet another exemplary embodiment of the present disclosure, a method of actuating an inserter assembly to place an infusion set at an infusion site includes establishing a releasable engagement between a first portion and a second portion of the inserter assembly. Displacing the first portion away from the second portion may further include adhering a portion of the inserter assembly to skin at the infusion site. The method may further include displacing the skin at the infusion site from underlying anatomical structures by displacing the inserter assembly away from the infusion site. The method may further include disengaging the first portion from the second portion when a force forcing separation of the first and second portions exceeds a threshold. The method may further include increasing a magnitude of relative displacement between the first and second portions at least until an actuator of the first portion displaces into a trigger array of the second portion.

[0082] In some embodiments, establishing the releasable engagement may include disposing the elastic member of the second portion in an interference relationship with the deflector of the first portion. In some embodiments, adhering a portion of the inserter assembly to skin at the infusion site may include adhering a base of the infusion set to the skin, the base of the infusion set being spaced apart from the cannula assembly of the infusion set. In some embodiments, driving the actuator of the first portion into the trigger configuration may include driving a protrusion of the first portion into the trigger configuration. In some embodiments, driving the actuator of the first portion into the trigger device may include driving the actuator of the first portion against a ledge of a spring-loaded sharps retainer. The protrusion can engage a catch on the second portion. In some embodiments, the method may further include disengaging the ledge from the catch. In some embodiments, establishing the releasable engagement may include creating an interference between the first portion and the second portion.

[0083] According to another exemplary embodiment of the present disclosure, the inserter assembly may include a first unit. The inserter assembly may further include a second unit releasably engaging the first unit. The second unit may be configured to displace in conjunction with the first unit until a force exceeding a threshold is applied to separate the first and second units. The inserter assembly may further include an infusion set. The inserter assembly may further include an adhesive, the adhesive being in adhesive relation with the skin patch and configured to lift the skin patch from underlying anatomical structures when the inserter assembly is displaced away from the injection site. The inserter assembly may further include an insertion actuation assembly.

[0084] In some embodiments, the insertion actuation assembly may be included as part of the second unit. In some embodiments, the second unit may be releasably engaged with the first unit via interference between a portion of the first unit and the second unit. In some embodiments, the portion of the second unit may be configured to deflect to a deflected state upon application of a threshold force. When in the deflected state, the portion of the second unit may be disengaged from the interference relationship with the portion of the first unit. In some embodiments, the second unit may be releasably engaged with the first unit via a resilient member that abuts and engages with a deflector disposed on the portion of the first unit. In some embodiments, the resilient member may be configured to deflect to a deflected state upon application of a threshold force. When in the deflected state, the resilient member may be disengaged from abutting engagement with the deflector. In some embodiments, the second unit may be releasably engaged with the first unit via at least one cantilever arm of the second unit, each of which abuts and engages with a cooperating protrusion on at least a respective portion of the first unit for one of the cantilever arms. In some embodiments, each of the at least one cantilevered arms may be configured to deflect to a deflected state upon application of a threshold force. When in the deflected state, each of the at least one cantilevered arms may be disengaged from an associated cooperating protrusion. In some embodiments, the insertion actuation assembly may include a trigger device and a spring-loaded sharps retainer. In some embodiments, the infusion set may include an infusion set base and a cannula assembly. The cannula assembly may be disengaged from the infusion set base and spaced apart from the infusion set base prior to actuation of the insertion actuation assembly. In some embodiments, adhesive may be provided on a bottom surface of the infusion set base. In some embodiments, the first unit may include a casing for the inserter assembly, and the infusion set base may be removably coupled to the second unit and disposed in an opening at the end of the casing when the inserter assembly is in an initial state, even at the end of the casing.In some embodiments, the adhesive may be covered with a removable backing. In some embodiments, the removable backing includes a strip protruding from a periphery of a main portion of the removable backing, with an end of the strip being coupled to another portion of the inserter assembly. In some embodiments, the inserter assembly may further include a removable locking member configured to prevent actuation of the insertion actuation assembly. In some embodiments, the inserter assembly may further include a removable locking member configured to prevent relative displacement of the first and second units even when a force exceeding a threshold is applied to separate the first and second units.

[0085] According to another embodiment of the present disclosure, an inserter assembly for percutaneously placing a cannula may include a casing. The inserter assembly may further include an infusion set including the cannula. The inserter assembly may further include a spring-loaded sharps retainer. The inserter assembly may further include an adhesive configured to adhere to a patch of skin at the injection site and lift the skin from underlying anatomical structures when the casing is displaced away from the injection site. The inserter assembly may further include a trigger for the spring-loaded sharps retainer actuatable between an untriggered state and a triggered state. The trigger may be configured to remain in the untriggered state until a threshold force pulling on the adhesive in at least a direction toward the injection site is reached.

[0086] In some embodiments, the spring of the spring-loaded sharps retainer may be held in an energized state when the trigger is in an untriggered state. In some embodiments, the spring-loaded sharps retainer may be biased by a spring from the raised state to the forward state when the trigger is actuated to the triggered state. In some embodiments, the infusion set may be disassembled within the inserter assembly and may include a cannula subassembly including an infusion set base and a cannula. The cannula subassembly may be carried by the spring-loaded sharps retainer. In some embodiments, the casing may include a trigger protrusion. In some embodiments, the adhesive may be configured to limit movement of a portion of the inserter assembly including the trigger when the adhesive is adhered to skin and the casing is displaced away from the injection site. In some embodiments, the casing may be configured to displace relative to a portion of the inserter assembly including the trigger between an initial relative position and a trigger position in which the trigger protrusion contacts a portion of the trigger when the adhesive is in adhesive relation with the patch of skin. In some embodiments, the inserter assembly may further include a retraction spring configured to displace the spring-loaded sharps retainer from the forward state to the retracted state when the retraction spring is released from the energized state. In some embodiments, the inserter assembly may further include a retraction spring held in an energized state by a coupling between at least a portion of the infusion set and a portion of the inserter assembly including the trigger. The coupling may be released when the spring-loaded sharps retainer is biased to a forward position. The retraction spring may be configured to bias the spring-loaded sharps retainer to the retracted state when released from the energized state.

[0087] 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, drawings, and claims. [Brief explanation of the drawings]

[0088] 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.

[0089] [Figure 1A] 1 illustrates an exploded view of an exemplary inserter assembly.

[0090] [Figure 1B] 10 illustrates an exploded view of another exemplary inserter assembly.

[0091] [Figure 1C] 10 illustrates an exploded view of another exemplary inserter assembly.

[0092] [Figure 2] 10 illustrates an exploded view of another exemplary inserter assembly.

[0093] [Figure 3] 10 illustrates an exploded view of another exemplary inserter assembly.

[0094] [Figure 4A] 1 shows a perspective view of an exemplary infusion set base.

[0095] [Figure 4B] 4B shows another perspective view of the exemplary infusion set base of FIG. 4A.

[0096] [Figure 5A] 1 illustrates an exploded view of an exemplary cannula subassembly.

[0097] [Figure 5B] 5B illustrates a cross-sectional view of the exemplary cannula subassembly shown in FIG. 5A.

[0098] [Figure 6] 1 shows a perspective view of an exemplary infusion set and tubing connector.

[0099] [Figure 7A] 1 shows a perspective view of another exemplary infusion set base.

[0100] [Figure 7B] 7B shows another perspective view of the exemplary infusion set base of FIG. 7A.

[0101] [Figure 8A] 1 illustrates an exploded view of an exemplary cannula subassembly.

[0102] [Figure 8B] 8B illustrates a cross-sectional view of the exemplary cannula subassembly shown in FIG. 8A.

[0103] [Figure 9] 1 shows a perspective view of another exemplary infusion set and tubing connector.

[0104] [Figure 10A] 1 shows a perspective view of an exemplary infusion set base.

[0105] [Figure 10B] 10B shows another perspective view of the infusion set base of FIG. 10A.

[0106] [Figure 11A] 1 shows a perspective view of an exemplary infusion set base.

[0107] [Figure 11B] 11B shows another perspective view of the infusion set base of FIG. 11A.

[0108] [Figure 12A] 1 shows a perspective view of an exemplary infusion set base.

[0109] [Figure 12B] 12B shows another perspective view of the infusion set base of FIG. 12A.

[0110] [Figure 13A]1 shows a perspective view of an exemplary infusion set base.

[0111] [Figure 13B] 13B shows a bottom plan view of the infusion set base of FIG. 13A.

[0112] [Figure 14A] 1 shows a perspective view of an exemplary infusion set base.

[0113] [Figure 14B] 14B shows a bottom plan view of the infusion set base of FIG. 14A.

[0114] [Figure 15] 15A-15F show various views of an exemplary tubing set connector.

[0115] [Figure 16A] 1 shows an exemplary tubing set connector and an exemplary cannula subassembly in an exaggerated, angled position for illustrative purposes.

[0116] [Figure 16B] 1 illustrates an exemplary tubeset connector and an exemplary cannula subassembly, with the cannula subassembly displaced by the tubeset connector to a home position.

[0117] [Figure 16C] 10 illustrates an exemplary tubeset connector and an exemplary cannula subassembly, where the tubeset connector pierces a septum of the cannula subassembly so that the delivery tip of the tubeset connector is in fluid communication with the fluid introduction volume of the cannula subassembly.

[0118] [Figure 17] 1 illustrates an exemplary infusion set base with an exemplary deflector.

[0119] [Figure 18A-B]1 illustrates an exemplary tubing set connector and an exemplary infusion set assembly, the tubing set connector including exemplary tines.

[0120] [Figure 18C] 1 shows a perspective view of an exemplary tubing set connector including exemplary teeth.

[0121] [Figure 19A] 1 illustrates a top view of an exemplary tubing set connector including an exemplary infusion set assembly and an exemplary clamp, the tubing set connector being disconnected from the infusion set assembly.

[0122] [Figure 19B] 1A-1C show diagrams of an exemplary tubing set connector with an exemplary clamp.

[0123] [Figure 19C] 1 shows a diagram of an exemplary tubing set connector with an exemplary clamp coupled to an exemplary infusion set assembly.

[0124]

[0125] [Figure 20A] 1 illustrates a side view of an exemplary infusion set base.

[0126] [Figure 20B] 20B shows another side view of the exemplary infusion set base of FIG. 20A.

[0127] [Figure 20C] 20B shows a perspective view of the exemplary infusion set base of FIG. 20A.

[0128] [Figure 21A-F] 1 shows a perspective view of an exemplary infusion set.

[0129] [Figure 22A-C] 1 illustrates another perspective view of an exemplary infusion set.

[0130] [Figure 23A-C] 10A-10C show various views of another exemplary infusion set base.

[0131] [Figure 24A-C] 10A-10C show various views of another exemplary infusion set base.

[0132] [Figure 25A-C] 1A-1C illustrate various views of an exemplary tubing set connector.

[0133] [Figure 26A] 1 shows a diagram of an exemplary infusion set base and an exemplary tubing set connector.

[0134] [Figure 26B] 26B shows a cross-sectional view of the exemplary infusion set base and exemplary tubing set connector of FIG. 26A.

[0135] [Figure 26C] 26B shows a perspective view of the exemplary tubing set connector of FIG. 26A.

[0136] [Figure 27A] 1 shows a perspective view of an exemplary infusion set.

[0137] [Figure 27B] 27B shows another perspective view of the exemplary infusion set of FIG. 27A.

[0138] [Figure 28A-D] 1A-1C illustrate several views of an exemplary cannula subassembly.

[0139] [Figure 29A-B] 10 illustrates an embodiment of a cannula that may be used in the cannula subassembly.

[0140] [Figure 30A-G]10A-10C show several views of another exemplary cannula subassembly.

[0141] [Figure 31A-D] 10A-10C show several views of another exemplary cannula subassembly.

[0142] [Figures 32A-33B] 10A-10C show several views of another exemplary cannula subassembly.

[0143] [Fig. 34A-F] 10A-10C show several views of another exemplary cannula subassembly.

[0144] [Figure 35A-F] 10A-10C show several views of another exemplary cannula subassembly.

[0145] [Figure 36A-E] 10A-10C show several views of yet another exemplary cannula subassembly.

[0146] [Figure 37A-B] 10A-10C show diagrams of an exemplary septum that may be included in an exemplary cannula subassembly.

[0147] [Figures 38A-38E] 10A-10C show views of another exemplary cannula subassembly.

[0148] [Figure 39A-E] 10A-10C show views of another exemplary cannula subassembly.

[0149] [Figure 40A-C] 1A-1C show diagrams of an exemplary cannula and an exemplary set of septa that may be included in a cannula subassembly.

[0150] [Figure 41A] 1 illustrates a side view of an exemplary inserter assembly with an exemplary locking member mounted therein.

[0151] [Figure 41B] 10 illustrates another side view of an exemplary inserter assembly with an exemplary locking member mounted therein.

[0152] [Figure 42A] 1 shows a perspective view of an exemplary inserter assembly with a locking member and adhesive assembly in place.

[0153] [Figure 42B] FIG. 42B shows a side view of the inserter assembly of FIG. 42A.

[0154] [Figure 43] 1 shows a perspective view of an exemplary infusion set base and an exemplary adhesive assembly.

[0155] [Figure 44] 1 shows a perspective view of an exemplary adhesive assembly for a portion of an infusion set assembly.

[0156] [Figure 45] 45 shows a bottom view of the adhesive assembly of FIG. 44.

[0157] [Figure 46A] 1 illustrates a top view of an exemplary inserter assembly with the outer housing removed.

[0158] [Figure 46B] 1 illustrates a perspective view of an exemplary inserter assembly with its outer housing removed.

[0159] [Figure 46C] A detailed view of a portion of Figure 46B is shown.

[0160] [Figure 47] 1 illustrates a top view of an exemplary locking member.

[0161] [Figure 48] 10 shows a perspective view of another exemplary locking member.

[0162] [Figure 49A] 1 illustrates a cross-sectional view of an exemplary inserter assembly with an exemplary locking member mounted therein.

[0163] [Figure 49B] 49B shows a detailed view of a portion of FIG. 49A.

[0164] [Figure 50] 1 illustrates a perspective view of an exemplary locking member.

[0165] [Figure 51] 10A-10C illustrate views of an exemplary inserter assembly cut away to reveal an exemplary locking member partially disposed within the inserter assembly.

[0166] [Figure 52] 1 illustrates a cross-sectional view of an exemplary inserter assembly with an exemplary locking member attached.

[0167] [Figure 53] 1 illustrates a perspective view of an exemplary locking member.

[0168] [Figure 54A-B] 10A-10C show views of yet another exemplary locking member that may be used to prevent actuation of an exemplary inserter assembly.

[0169] [Figure 55] 1 illustrates a cross-sectional view of an exemplary inserter assembly with an exemplary locking member attached.

[0170] [Figure 67A-E] 1A-1C show views of various exemplary embodiments of a locking member;

[0171] [Figure 57]1 shows a flowchart detailing some actions that can be used to operate the inserter assembly.

[0172] [Figure 58] 1 illustrates a top view of an exemplary inserter assembly.

[0173] [Fig. 59A-B] 1 illustrates a cross-sectional view of an exemplary inserter assembly about to be applied to a user's skin.

[0174] [Figure 60] 1 shows a side view of an exemplary sharps holder.

[0175] [Figure 61] 61 shows another side view of the exemplary sharps holder shown in FIG. 60.

[0176] [Figure 62] 19 illustrates yet another side view of the exemplary sharps holder shown in FIG. 18.

[0177] [Figure 63] 61 shows a perspective view of the exemplary sharps holder shown in FIG. 60.

[0178] [Figure 64] A perspective view of the sharps holder, sharps, and cannula assembly is shown.

[0179] [Figure 65] 1 shows a side view of an exemplary sharps holder.

[0180] [Figure 66] 66 illustrates another side view of the exemplary sharps holder of FIG. 65.

[0181] [Figure 67] 66 shows a perspective view of the exemplary sharps holder of FIG.

[0182] [Figure 68] FIG. 68 shows a detailed view of the indicated area of ​​FIG. 67.

[0183] [Figure 69] 1 illustrates a perspective view of an exemplary retainer base.

[0184] [Figure 70A] 1 illustrates a perspective view of an exemplary Sharp retractor.

[0185] [Figure 70B] 70B illustrates another perspective view of the exemplary Sharp retractor shown in FIG. 70A.

[0186] [Figure 70C] 70B shows a detailed view of a portion of FIG. 70A.

[0187] [Figure 71] 1 illustrates a cross-sectional view of an exemplary inserter assembly taken through an arm included in a sharp retractor of the inserter assembly.

[0188] [Figure 72] 1 illustrates a perspective view of an exemplary outer housing.

[0189] [Figure 73A-B] 73 shows a cross-sectional view of an exemplary inserter assembly including the outer housing shown in FIG. 72.

[0190] [Fig. 74A-B] 10A-10C illustrate cross-sectional views of an exemplary inserter assembly being withdrawn from a user after application to the skin.

[0191] [Fig. 74C-D] 1 illustrates a cross-sectional view of an exemplary inserter assembly including an additional spring.

[0192] [Fig. 75A-B]10A-10C illustrate cross-sectional views of an exemplary inserter assembly being withdrawn from a user after application to the skin.

[0193] [Figure 76A-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.

[0194] [Fig. 77A-B] 10 illustrates a cross-sectional view of an exemplary inserter assembly after the sharp retractor has been released and retracted.

[0195] [Fig. 78A-B] 10A-10C illustrate cross-sectional views of an exemplary inserter assembly during retraction of a sharp retractor.

[0196] [Figure 78C] 10A-10C show cross-sectional views of an alternative embodiment of the inserter assembly.

[0197] [Fig. 79A-B] 10A-10C illustrate cross-sectional views of an exemplary inserter assembly during retraction of a sharp retractor.

[0198] [Fig. 79C-D] 10 illustrates a cross-sectional view of an exemplary inserter assembly after actuation of the inserter assembly is complete.

[0199] [Figure 79F] 10 illustrates a bottom view of an exemplary inserter assembly after actuation of the inserter assembly is complete.

[0200] [Figure 80] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0201] [ [Figure 81] 1 illustrates a perspective view of an exemplary retainer base.

[0202] [Figure 82] FIG. 1 illustrates a bottom view of an exemplary inserter assembly.

[0203] [Figure 82] Showing a cross-sectional view taken at the indicated cutting plane of Fig. 81. 46;

[0204] [Fig. 83A-B] 10 illustrates a cross-sectional view of another exemplary inserter assembly about to be applied to a user's skin.

[0205] [Figure 84A] 13 shows a side view of an alternative embodiment of a sharps holder.

[0206] [Figure 84B] 84B shows a perspective view of the sharps holder shown in FIG. 84A.

[0207] [Figure 84C] 84B shows another side view of the sharps holder shown in FIG. 84A.

[0208] [Figure 85] 1 illustrates a perspective view of an exemplary retaining cap.

[0209] [Figure 86] 1 shows a cross-sectional view of an exemplary retainer cap and sharps holder.

[0210] [Figure 87] 86. FIG. 86 shows a detailed view of a portion of FIG.

[0211] [Figure 88A] 1 illustrates a perspective view of an exemplary Sharp retractor.

[0212] [Figure 88B] 88B shows another perspective view of the Sharp retractor shown in FIG. 88A.

[0213] [Figure 89] 1 illustrates a perspective view of an exemplary inserter assembly including a button.

[0214] [Figure 90A] 89 shows a top view of the inserter assembly shown in FIG. 54;

[0215] [Figure 90B] A cross-sectional view taken at section 90B-90B of FIG. 90A is shown.

[0216] [Figure 90C] 90C-90C of FIG. 90A shows a perspective three-quarter cross-sectional view taken along line 90C-90C of FIG. 90A.

[0217] [Figure 91] 1 illustrates a perspective view of an exemplary outer housing of an inserter assembly including a button.

[0218] [Figure 92] 1 illustrates a perspective view of an exemplary inserter assembly with the outer housing of the inserter assembly removed.

[0219] [Figure 93] 1 illustrates a perspective view of an exemplary inserter assembly with the outer housing of the inserter assembly removed.

[0220] [Figure 94] FIG. 94 shows a detailed view of the indicated area of ​​FIG. 93.

[0221] [Figure 95] 1 illustrates a perspective view of an exemplary sled that may be included in the inserter assembly.

[0222] [Figure 96] 1 illustrates a perspective view of an exemplary outer housing of an inserter assembly including a deformable region.

[0223] [Figure 97]10 shows a perspective view of another exemplary outer housing of an inserter assembly including ridges on the inner surface.

[0224] [Figure 98] 10 shows a flowchart detailing several actions that can be used to assemble the inserter assembly.

[0225] [Figure 99] 1A-1C illustrate side views of an example inserter assembly and an example cartridge that can be coupled to the inserter assembly.

[0226] [Figure 100A] 1 illustrates an exploded view of an exemplary cartridge.

[0227] [Figure 100B] 100B illustrates another exploded view of the exemplary cartridge shown in FIG. 100A.

[0228] [Figure 101] 1 illustrates a perspective view of an exemplary infusion set base retainer.

[0229] [Figure 102] 1 illustrates a perspective view of an exemplary inner housing of an exemplary cartridge.

[0230] [Figure 103] 1 illustrates a bottom plan view of an exemplary cartridge.

[0231] [Figure 104A] 104A shows a cross-sectional view taken at section 104A-104A of FIG. 103.

[0232] [Figure 104B] 104B shows another cross-sectional view taken at section 104B-104B of FIG. 103.

[0233] [Figure 105A]1 shows an exploded view of an example inserter assembly that may be reusable.

[0234] [Figure 105B] 104B shows another exploded view of the exemplary inserter assembly of FIG. 104A.

[0235] [Figure 106A] 10 shows an exploded view of another exemplary inserter assembly that may be reusable.

[0236] [Figure 106B] 106B shows another exploded view of the exemplary inserter assembly of FIG. 106A.

[0237] [Figure 107] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0238] [Figure 108] 10A-10C illustrate views of an exemplary inserter assembly exploded away from an exemplary cartridge.

[0239] [Figure 109] 109 shows a detailed view of the indicated area of ​​FIG. 108.

[0240] [Figure 110] 109 shows a detailed view of the indicated area of ​​FIG. 108.

[0241] [Figure 111] 1 illustrates a perspective view of an exemplary inserter assembly with a cartridge coupled thereto.

[0242] [Figure 112] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0243] [Figure 113] 1 illustrates a perspective view of an exemplary locking member.

[0244] [Figure 114] FIG. 10 is a perspective view of a retractable latch body.

[0245] [Figure 115] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0246] [Figure 116] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0247] [Figure 117] 10 illustrates a view of an exemplary reset body coupled to an exemplary retraction spring retainer.

[0248] [Figure 118] 1 illustrates a top plan view of an exemplary inner housing of an exemplary inserter assembly.

[0249] [Figure 119] 119-119 of FIG. 118.

[0250] [Figure 120] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0251] [Figure 121] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0252] [Figure 122] 1 illustrates a top view of an exemplary inserter assembly.

[0253] [Figure 123] 123-123 in FIG. 122.

[0254] [Figure 124] 1 illustrates a cross-sectional perspective view of an exemplary inserter assembly.

[0255] [Figure 125]125 shows a detailed view of the indicated area of ​​FIG. 124.

[0256] [Figure 126] 1 illustrates a perspective view of an exemplary inner housing of an exemplary inserter assembly.

[0257] [Figure 127] 1 illustrates a cross-sectional perspective view of an exemplary inserter assembly.

[0258] [Figure 128] 1 illustrates a cross-sectional view of a retaining cap of an exemplary inserter assembly.

[0259] [Figure 129] 129 shows a detailed view of the indicated area of ​​FIG. 128.

[0260] [Figure 130] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0261] [Figure 131] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0262] [Figure 132] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0263] [Figure 133] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0264] [Figure 134A] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0265] [Figure 134B] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0266] [Figure 135] 1 illustrates a cross-sectional view of an exemplary inserter assembly.

[0267] [Figure 136] FIG. 10 shows a perspective view of a cartridge coupled to an inserter assembly with the outer housing of the cartridge removed.

[0268] [Figure 137] 1 illustrates a perspective view of an exemplary tubing connector.

[0269] [Figure 138A] 138 shows a bottom-up view of the tubing connector shown in FIG. 137.

[0270] [Figure 138B] A detailed view of a portion of FIG. 138A is shown.

[0271] [Figure 139] 1 shows a perspective view of the tubing connector in place on the device.

[0272] [Figure 140] 139A shows a bottom-up view of the fixture shown in FIG. 139.

[0273] [Figure 141] FIG. 1 shows a perspective view of a tube connector aligned for attachment to a fixture.

[0274] [Figure 142] 1 shows a cross-sectional view of a fixture with a tubing connector attached and a sharp introduced into the tubing connector.

[0275] [Figure 143] 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.

[0276] [Figure 144]1 shows a flowchart detailing some exemplary actions that may be used to assemble a tubing connector. DETAILED DESCRIPTION OF THE INVENTION

[0277] In various embodiments, the infusion set may be used in combination with infusion devices, systems, and related methods, as well as in combination with an inserter assembly. In various embodiments, the exemplary infusion set may be configured to be inserted into the subcutaneous layer of a user's skin and fluidly connected to a fluid source. In various embodiments, the exemplary infusion set may be fluidly connected to a length of tubing and / or an infusion device. The infusion device may include any infusion pump, and may be any of the infusion devices disclosed in U.S. patent application Ser. No. 15 / 434,906, filed February 16, 2017, entitled "Infusion Set and Inserter Assembly" (Attorney Docket No. U64), which issued October 6, 2020, as U.S. Patent No. 10,792,419; U.S. patent application Ser. No. 13 / 788,260, filed March 7, 2013, entitled "Infusion Pump Assembly," now U.S. Patent Publication No. US-2014-0107579, published April 17, 2014, (Attorney Docket No. K40); and U.S. patent application Ser. No. 13 / 788,260, filed July 23, 2013, entitled "Infusion Pump Assembly," now U.S. Patent Publication No. US-2014-0107579, published April 17, 2014, (Attorney Docket No. K40); No. 8,491,570 (Attorney Docket No. G75), entitled "Fluid Delivery System and Method," issued on April 9, 2013 (Attorney Docket No. E70); U.S. Patent No. 8,262,616 (Attorney Docket No. F51), entitled "Infusion Pump Assembly," issued on September 11, 2012; and U.S. Patent No. 7,306,578 (Attorney Docket No. C54), entitled "Loading Mechanism for Infusion Pump," issued on December 11, 2007, all of which are incorporated herein by reference in their entireties.

[0278] 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.

[0279] FIG. 1A shows an exploded view of an exemplary embodiment of an inserter assembly 100. An inserter assembly, such as inserter assembly 100, can be used to place an infusion set 102 at a patient's infusion site and introduce a cannula 104 of the infusion set 102 into the patient's body. In some embodiments, the inserter assembly 100 can be used to place other patient-care assemblies into the patient's body. For example, a particular inserter assembly 100 can be operated to place a physiological monitor in functional relationship with the patient's body. In a particular example, an analyte sensor can be placed into the patient using the inserter assembly 100. The infusion set 102 can be used to deliver medication from an infusion pump to a specific location within the patient's body (e.g., subcutaneously).

[0280] The drugs or other agents delivered may include drugs or agents typically delivered as a continuous or substantially continuous infusion. This may include small molecules, biologics, recombinantly produced pharmaceuticals, and their analogs. Hormones such as insulin or glucagon may be administered via the infusion set 102. Other drugs, such as peptides (e.g., amylin), may be provided. Drugs affecting the cardiovascular system may also be provided via the infusion set 102. As another example, vasodilators such as treprostinil may be delivered to a patient with the infusion set 102. Chemotherapy drugs may also be used. Exemplary physiological monitors may include blood glucose monitors, such as continuous glucose monitors. Other types of body analyte monitors, such as interstitial fluid analyte monitors, may also be used.

[0281] 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.

[0282] 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.

[0283] 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.

[0284] 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.

[0285] The outer housing 116 may include markings, tabs, embossed sections, recessed sections, textured sections, ridges, color coding, appliqués, or other indicia that serve to indicate the position and / or orientation of the infusion set 102 within the inserter assembly 100. For example, the outer housing 116 of FIG. 1A includes raised ribs 118 on the outer surface of the outer housing 116. While the raised ribs 118 in the 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.

[0286] 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 tracks may be disposed on inner housing 120. Additionally, as shown, at least some of rails 124 may also form channels or tracks in the interior surface of inner housing 120.

[0287] 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.

[0288] The inner housing 120 may also include an infusion set base interface segment 126. This base interface segment 126 may include several protrusions 352, which may ensure that the base 106 can only be inserted into the inserter assembly 100 in a desired orientation. The protrusions 352 may also optionally help retain the base 106 within the inserter assembly 100; there may be some friction between the protrusions 352 and the surface of the base 106 when the base 106 is attached to the inserter assembly 100. For example, the base 106 may be press-fit onto the protrusions 352. The fit may be minimally tight, allowing the base 106 to be removed from the base interface segment 126 with little force. The protrusions 352 may also help maintain the base 106 horizontally within the base interface segment 126.

[0289] The inserter assembly 100 may further include a sharps holder 130. The sharps holder 130 may hold an insert sharp 132 thereon. The insert sharp 132 may be glued or otherwise attached to the sharps holder 130 so as to be fixedly disposed relative to the sharps holder 130. Any suitable type of sharp 132 may be used. For example, the sharp 132 may be a hollow or solid needle, a stylet, or other pointed member, which may be made of a metallic material such as steel. A sharps retractor 134 and several springs 136, 138 may also be included in the inserter assembly 100. A retainer base 140 may couple to the bottom of the inserter assembly 100 and help hold various components in place within the inserter assembly 100. In this example, the retainer base 140 includes a retention interface 142 that can snap onto a cantilevered retainer 144 included in the outer housing 116. Other attachments are possible, such as a bayonet mount, interference fit, snap fit, adhesive, glue, threads, solvent bonding, welding, etc. When attached together, the outer housing 116 and the retainer base 140 may form the casing of the inserter assembly 100.

[0290] 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.

[0291] 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.

[0292] 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.

[0293] 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.

[0294] 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.

[0295] 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.

[0296] 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 retainer 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 retaining cap 406 can form the casing of the inserter assembly 100.

[0297] 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.

[0298] 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.

[0299] 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.

[0300] As described in detail elsewhere herein, 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.

[0301] 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.

[0302] 4A and 4B, top and bottom perspective views, respectively, of the infusion set base 106 are shown. As shown, the base 106 can have a platform portion 160. The platform portion 160 can be placed against the patient's skin while the infusion set 102 is in place at the infusion site. In an exemplary embodiment, the platform portion 160 is substantially circular, in this case having a generally circular, disk-shaped footprint. In other embodiments, the platform portion 160 can be oval (see, e.g., FIGS. 21A-21F), oval, or elliptical (see, e.g., FIGS. 22A-C). The platform portion 160 is also substantially flat; however, this need not be the case in all embodiments.

[0303] In various embodiments, adhesive may be applied to the bottom surface 162 of the platform portion 160. An adhesive backing 111 (see, e.g., FIG. 1A ) may cover the adhesive. In an exemplary embodiment, the bottom surface 162 of the platform portion 160 includes several raised segments 164. The exemplary raised segments 164 are shown as radially arranged ridges spaced at substantially regular angular intervals across a portion of the bottom surface 162. There are also two concentric raised rings around the periphery of the bottom surface 162. In other embodiments, raised segments other than ridges may be included, and / or the raised features are not radially arranged or regularly spaced. In some embodiments, the raised segments 164 may be dots or rounded areas spaced apart around the periphery of the bottom surface 162. In various embodiments, any suitable pattern may be used. The raised segments 164 may allow for adhesive bonding (e.g., ultrasonic or radio frequency welding). The raised segments 154 may allow for an adhesive to be bonded (e.g., ultrasonically or radio frequency welded) to the bottom surface 162. For example, the adhesive may be contained on a substrate, which may be a plastic such as polypropylene or any other plastic suitable for a welding operation. The raised segments 164 and the substrate may melt together during a welding operation to create a bond that holds the adhesive on the bottom surface 162 of the infusion set base 106. In an alternative embodiment, an adhesive such as double-sided tape bonds the substrate to the bottom surface 162, and the bottom surface 162 may not have the raised segments 164.

[0304] In various embodiments, the platform portion 160 may include several through-holes 166. Three circular through-holes 166 are shown in FIGS. 4A-B. However, other examples may include any number, and their shapes may vary. The through-holes 166 may be provided to facilitate manufacturing by allowing protrusions on a portion of an assembly line to interface with them. This interface can aid in orienting or centering the base 106 or any infusion set 102 subassembly that includes the base 106 during manufacturing operations. If the through-holes 166 aid in orientation, it may be desirable for the through-holes 166 to be asymmetrically positioned (although symmetrical through-hole 166 placement is also possible). In this example, the through-holes 166 are 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, the optional adhesive and adhesive liner 111 may include holes that align with the positions of the through-holes 166. Thus, even when inserter assembly 100 is fully assembled and ready to be triggered, through-hole 166 can be used to assist in the manufacturing process. Through-hole 166 can also be engaged by part of any packaging in which inserter assembly 100 is provided to help hold inserter assembly 100 in place.

[0305] While the through-holes 166 may be useful during manufacturing, they may also provide other benefits. For example, the through-holes 166 may provide a window for observing the skin around the infusion site. As a result, the user may be able to assess skin irritation or signs of irritation (such as flushing or redness). Additionally, the through-holes 166 may provide a path by which ambient air may communicate with the space between any raised segments 164 on the bottom surface 162 of the infusion set base 106. This may help the area below the infusion set 102 breathe while the infusion set 102 is attached to the skin.

[0306] Extending from the periphery of the platform portion 160 may be a number of tubing retainers 184. The tubing retainers 184 may allow the infusion tube 366 (see, e.g., FIG. 6) to be wrapped around a portion of the infusion set 102 and held in place. This may help to inhibit kinking of the tubing 366 and may help the user conveniently route the infusion tube 366 as needed. In alternative embodiments of the infusion set base 106 described herein, the tubing retainers 184 may be omitted (see, e.g., FIGS. 22A-C).

[0307] 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. In various embodiments, the infusion tube 366 may be coupled to an infusion pump reservoir, such as a syringe or an infusion pump outlet. The infusion tube 366 may be coupled to the infusion pump via a luer lock or other mechanical bond, adhesive, solvent bonding, or any other suitable method. The base 106 may include a connector 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 on the connector receiver 170. Sharp side protrusions 372 may also be present on connector 368. These sharp side protrusions 372 may extend substantially parallel to sharps 482 included on connector 368 (see, for example, FIG. 15F ) and may present an obstacle that helps prevent accidental contact between sharps 482 and a user. Shielding walls 169 may be provided on base 106 and can 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.

[0308] Respective guides 172 for the connector fingers 370 and the sharp side protrusions 372 may also be included and, in the exemplary embodiment, define several slots along which the connector fingers 370 and adjacent protrusions 372 can slide as the connector 368 is displaced. The guides 172 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 the sharps 482 (see, e.g., FIG. 15F) on the connector 368 are introduced into the infusion set 102 along or near the desired insertion axis. In this example, the guides 172 include notches 174. Each notch 174 may be sized to receive a protrusion on a component of the inserter assembly 100. The notches 174 may also be sized to receive at least a portion of a protrusion included on the cannula subassembly 114 (see, e.g., FIG. 5A). The adjacent protrusion 372 may be sized to extend a shorter distance from the connector 368 than the location of the notch 174 when the connector 368 is attached to the infusion set 102. As described below, the notch 174 may help facilitate release of the base 106 from the inserter assembly 100 during actuation.

[0309] In various embodiments, the base 106 may also include a receptacle 176 for mating with the cannula subassembly 114 (see, e.g., FIG. 5A ) of the infusion set 102. In this example, the receptacle 176 is generally such that the base 106 and the receptacle 176 are flanked on either side by guides 172. The receptacle 176 may be at least partially surrounded by a receptacle wall 178 that projects upward from the top surface 168 of the platform portion 160. Thus, the receptacle wall 178 and the portion of the guide 172 including the notch 174 may define the receptacle 176. A portion of the receptacle wall 178 may include a cantilevered portion 180. The cantilevered portion 180 may include a protrusion (e.g., a barb or ramp) 182. Portions of the receptacle wall 178 and / or guide 172 may include tapered sections (see, e.g., the embodiment shown in FIGS. 10A-10B). The tapered sections may be included in portions of the receptacle wall 178 and / or guide 172 that are most distal to the platform 160. Such tapered sections may help guide the cannula subassembly 114 into position when the infusion set 102 is assembled by funneling the cannula subassembly 114 into the receptacle 176. Additionally or alternatively, the notch 174 may be tapered along at least a portion of its length (see, e.g., FIGS. 21A-21F). This may help guide the cannula subassembly 114 into the proper position when the infusion set 102 is assembled.

[0310] 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 174 of base 106 (shown in FIG. 6 ).

[0311] Referring now to FIG. 5B, which shows a cross-sectional view of assembled cannula subassembly 114, cannula subassembly 114 may further include a septum 110 and a septum retainer 112 in certain embodiments. In alternative embodiments, multiple septums 110 may be included instead of a single septum 110, as described in connection with other examples herein. 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 frustoconical shape, although other shapes are possible. For example, the shape included in septum interface region 183 of cannula 104 shown in FIGS. 23A-24G could be used for an alternative raised region 194. Septum 110 may also include a cup-like septum recess 196 included in its bottom surface. The septum recess 196 may include an enlarged or flared-out section 198 formed as a negative version of the raised region 194 in the receiving section 192 of the septum housing 108 (or other portion corresponding to the shape of the raised region 194 in the example). Accordingly, the enlarged section of the septum recess 196, as the septum 110 is introduced into the receiving section 192, may be referred to herein as the centering wall of the septum recess 196. A second section 200 of the septum recess 196, most distal from the bottom surface of the septum 110, may at least partially define a fluid introduction volume through which a needle or sharps 482 (see, e.g., FIG. 15F ) included in the tubing connector 368 can penetrate to deliver fluid to the infusion set 102. Fluid can be delivered from the fluid introduction volume into the lumen 202 of the cannula 104 and then to the patient. The second section 200 of the septum recess 196 can have any suitable cross-section, but in this example has a circular, approximately circular cross-section. The septum housing 108 can include a connector needle passage 122 in its sidewall (as shown in FIG. 6), which can allow a needle or sharp 482 of a connector 368 (see, e.g., FIG. 15D) to access the fluid introduction volume 109.In the exemplary embodiment, connector needle passage 122 is shown as a fenestration extending through septum housing 108. Connector needle passage 222 and notch 186 may (but need not) be on opposite sides of septum housing 108, allowing cannula subassembly 114 to be attached to base 106 in two orientations. This may make assembly of inserter assembly 100 easier.

[0312] 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 192 and is substantially flush with the ears 204. The guides 208 are angled such that the distance between the two guides 208 decreases as the distance from the cannula 104 decreases. This can deflect the cantilevered projections 188 of the septum retainer 112 toward the 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, the fluid contained in the fluid introduction volume 109 of the septum 110 can be provided with a sealed fluid flow path to the outlet 212 of the cannula 104 .

[0313] As shown, septum retainer 112 includes a channel 218 extending therethrough. The illustrative channel 218 is located substantially centrally in body 206. When septum retainer 112 is locked in place within cannula subassembly 114, a nub or protrusion 220 of septum 110 can extend into channel 218. This can provide an access path for insertion sharp 132 of inserter assembly 100 to extend from outlet 212 of cannula 212 through infusion set 102. In the illustrated example, protrusion 220 is frustoconical in shape, and channel 218 is cooperatively shaped to receive protrusion 220. Other shapes of protrusion 220 may be used in alternative embodiments, such as those described herein (see, e.g., FIGS. 25A-25D).

[0314] 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 .

[0315] As primarily shown in FIG. 5B , a recess 214 may be included in the septum housing 108 that surrounds or at least partially surrounds the cannula 104. This recess 214 may not be covered by the adhesive when the adhesive is placed on the infusion set base 106. This may provide room for the cannula 104 to move relative to the base 106 if the infusion set 102 or a portion of the patient's body causes force to be applied to the cannula 104. This may minimize shearing effects on the cannula 104. The recess 214 may function as a volume 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 included in the recess 214. The medication may be medicinal, nutritional, or some other type of medication. Thus, upon application of the infusion set 102, the medication may be introduced to and maintained in contact with the patient's skin. In some examples, the medication may remain in contact with the recess 214. This can be beneficial for many reasons, including potentially helping to prevent infection, inflammation, or pain, and can provide a convenient method of applying medication. In an exemplary embodiment, recess 214 is shaped in the form of a conical section (e.g., a hyperbola or parabola) that rotates about the central axis of cannula 104.

[0316] 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.

[0317] 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.

[0318] 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.

[0319] As shown, cannula subassembly 114 includes a septum 110 similar to that shown in FIGS. 5A and 5B. In alternative embodiments, multiple septums 110 may be included instead of the single septum 110 shown. Septum housing 108 does not include notches 186. Instead, septum housing 108 includes protrusions 388 extending outward from the exterior surface of septum housing 108. During mating of cannula assembly 104 to infusion set base 106, one of protrusions 388 can deflect cantilevered portion 180 of base 106 until protrusion 182 is free to spring back into position overhanging protrusion 388. When cantilevered protrusion 180 returns to its undeflected state, with ridge 182 resting on protrusion 388, protrusion cannula subassembly 114 can be retained within base 106. In the retained state (see, e.g., FIG. 9 ), the ear or nub 204 of the septum housing 108 can reside at least partially within the notch 174 of the base 106. The receptacle 176 portion of the infusion set base 106 is widened relative to that shown in FIGS. 4A-B to accommodate the larger footprint of the cannula subassembly 114. Additionally, the receptacle 176 includes a protrusion receiving area 398 opposite the cantilevered projection 180 to receive the protrusion 388 not engaged by the ridge 182. The cannula subassembly 114 is made symmetrical, allowing it to be installed on the infusion set base 106 in two orientations. This may help simplify manufacturing and assembly. In other embodiments, the protrusion 388 may be included on only one side of the cannula subassembly 114, and the protrusion receiving area 398 of the base 106 may be omitted.

[0320] 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 subassemblies 114 are 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 482 (see, e.g., FIG. 15D) or needle included in the tubing connector 368 may be provided in the cannula subassembly 114. Septum retainer 112 also includes several through-holes 397. Through-holes 397 may aid in assembly and manufacturing similar to through-holes 166 in infusion set base 106.

[0321] 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 may hook against or engage with one wall of the slot 390, inhibiting removal of the cannula subassembly 114. In such embodiments, the protrusion 388 may not be included in the septum housing 108. This may help to further simplify manufacturing of the cannula subassembly 114.

[0322] 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 receiving portion 170 that may allow the base 106 to couple with cantilevered fingers 370 on a tubing set connector 368, as described above (see, e.g., the description of FIG. 6 ). Guides 172 for each of the connector fingers 370 may also be included in the exemplary embodiment. As shown, the exemplary guides 172 include a first section 171 and a second section 173. The first section 171 of each guide 172 may be positioned to have a portion that extends substantially parallel to the plane of the platform 160. The second section 173 of each guide 172 may include a portion that is positioned at an angle relative to the first section 171. In this example, each of the first and second portions 171, 173 includes a ledge protruding from the main portion of the guide. The distance between the platform 160 and the proximal surface of the ledge of the second section 173 of the guide 172 can increase as the second section 173 extends distally from the ledge of the first portion 171 of the guide 172. This allows the tubing set connector 368 to initially be introduced at a substantial angle relative to the plane of the platform 160 of the base 106. Further introduction can cause the connector fingers 370 to contact the platform 160 and redirect them to the appropriate displacement path for mating of the tubing set connector 368. Thus, the guide 172 can help enable a user to blindly insert the connector fingers 370 into the connector receiver 170 when mating the base 106 and the tubing set connector 368. As shown, a second set of additional guide ledges 175 can be included on the receptacle wall extension 179. These additional guide ledges 175 may extend to the periphery of the base 106 .In the exemplary embodiment, the second set of guide ledges 175 extend substantially perpendicularly from the receptacle wall extension 179 of the guide 172 toward the axis along which the sharp 482 of the tubing set connector 368 (see, e.g., FIGS. 137-141 ) is inserted into the cannula subassembly 114. The face of each of the second set of guide ledges 175, located near the end of each guide 172 most proximal to the periphery of the base 106, may include a sloped region.

[0323] 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. 137-141) 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 375 includes a constant-width segment 373 and a variable-width segment 379. Upon coupling of the tubing set connector 368 and the infusion set 102, the alignment channel 375 can interact with 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.

[0324] 12A-12B and 13A-13B, in some embodiments, a sharp-side protrusion 372 may be included as part of the tubing set connector 368. As shown, the sharp-side protrusion 372 can extend parallel to the axis of the sharp 482 (see, e.g., FIGS. 137-141). This may be included in the tubing set connector 368. The sharp-side 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-side 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-side protrusion 372 may also include a set of protrusions that are in the same plane as, but positioned inboard of, the connector fingers 370 of the tubing set connector 368. In an exemplary embodiment, the connector fingers 370 and 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 367 of the tubing set connector 368 that is midway between the flow hub 377 and the connector fingers 370. These protrusions 372 can be positioned to interact with guides 172 on the base 106 during coupling of the tubing set connector 368 to a corresponding base 106. In such an embodiment, the connector fingers 370 may not interact with guides 172 on the base 106.

[0325] In some embodiments, as shown in FIGS. 13A-13B , a pair of sharp side 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 367 of the tubing set connector 368. The curved end region 383 can curve transversely relative to the axis of the sharps 482 of the tubing set connector 368 (see, e.g., FIGS. 137-141 ). In this example, the curved end region 383 can have a curvature that sweeps an arc of greater than 90°. In this example, the curved end region 383 has a curvature such that the curved end region 383 begins to extend posteriorly toward the body 367 of the tubing set connector 368. The radius of the curved end region 383 can be constant or not. Additionally, the curved end region 383 can include one or more straight extensions. As best shown in FIG. 13B , the portions of the curved end regions 383 that terminate in the prongs can be substantially straight. In this example, the curved end regions 383 curve around and in front of a portion of each connector finger 370. The distance between the prongs 372 may be slightly smaller than the spacing between the corresponding guides 172 on the base 106. However, the prongs 372 at the curved end regions 383 may be slightly larger to facilitate maneuvering the prongs 372 into their respective guides 172. Once the prongs 372 are positioned within the guides 172, advancement of the tubing set connector 368 causes the prongs 372 to resiliently spread apart. Due to the resiliency of the prongs 372, they press against the surfaces of the guides 172, ensuring a tight and substantially wiggle-free fit. This can help further limit the displacement of the tubing set connector 368 along a desired path when coupling of the tubing set connector 368 to the base 106 is complete.

[0326] 14A-14B, a set of sharp flanking projections 372 along the connector fingers 370 can extend from the flow hub 377. This can help reduce the gap between the sharp flanking projections 372 of the tubing set connector 368, further minimizing a user's ability to access spaces near the sharps 482 (see, e.g., FIGS. 137-141). In the embodiment shown in FIGS. 14A-14B, a set of sharp flanking projections 372 are included extending along and from opposing faces of the flow hub 377 transverse to the axis of the sharps 482. These projections 372 can each include a support segment 385. These support segments 385 can be positioned in a region of the sharp flanking projection 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 sharp side projections 372. The surface 387 of the flow hub 377 from which the sharps 482 extend can also be arched, which can add further robustness to the projections 372.

[0327] 15A-H, another exemplary tubing set connector 368 is shown. As shown, a pair of sharp-side projections 372A aligned with the connector fingers 370 may extend from the flow hub 377, similar to FIGS. 14A-14B. As in FIGS. 14A-14B, this may help avoid inadvertent contact with the sharps 382. A centrally located sharp-side projection 372B may also be included, extending from the top surface of the tubing set connector 368 above the sharps 482.

[0328] Sharp side protrusions 372A, B can include at least one guide surface 371A-D. In some embodiments, each of sharp side protrusions 372A, B can include at least one guide surface 371A-D. Each of sharp side protrusions 372A shown in FIGS. 15A-H includes a lateral adjustment guide surface 371A and a height adjustment guide surface 371B. At least one of lateral adjustment guide surface 371A and height adjustment guide surface 371B may include a sloped segment. As shown, both lateral guide surface 371A and height adjustment guide surface 371B can include a first region proximal to flow hub 377 and a second region at the end of sharp side protrusion 372A distal to flow hub 377. The second region can be sloped (sloped or curved), while the first region can be substantially straight or have a more gradual slope.

[0329] The sharp side protrusion 372B may also include at least one height adjustment guide surface 371C and at least one lateral adjustment guide surface 371D. In this example, at least one of the height adjustment guide surface 371C and the at least one lateral adjustment guide surface 371D may include an inclined portion. In this example, the height adjustment guide surface 371C includes a first region proximal to the flow hub 377 and a second region at the distal end of the sharp side protrusion 372B. In the exemplary embodiment, the second region is inclined (sloped or curved). The sharp side protrusion 372B includes a centrally located trough 369 extending along the underside of the sharp side protrusion 372B (the side closest to the sharp 482). The sidewalls of this trough 369 can form two lateral guide surfaces 371D. A portion of at least one of the lateral guide surfaces 371D (e.g., the most distal portion of the flow hub 377) may be inclined.

[0330] 16A-16C, it may be desirable for portions of the infusion set base 106 and / or the cannula subassembly 114 to have relatively loose tolerances for ease of manufacturing. Thus, in some embodiments, the loose tolerances may cause the cannula subassembly 114 to be slightly askew when held in the infusion set base 106 (see, e.g., FIG. 9). Additionally, the cannula subassembly 114 may change position slightly through repeated connection and disconnection of the tubing set connector 368 from the infusion set base 106.

[0331] 16A-16C show cross-sectional views of an exemplary cannula subassembly 114 held stationary as the tubing set connector 368 gradually approaches the cannula subassembly 114. When the tubing set connector 368 is docked to the infusion set base 106 (see, e.g., FIG. 9), the exemplary tubing set connector 368 shown in FIGS. 15A-15F may be moved from an initial position (see, e.g., FIG. 16A) to an intermediate position just before the sharp 482 punctures the septum 110 material of the cannula subassembly 114 (see, e.g., FIG. 16B). This range of displacement of the tubing set connector 368 is sometimes referred to as the homing displacement range. As the tubing set connector 368 is displaced through the homing displacement range, any of the guide surfaces 371A-D of the tubing set connector 368 may contact various regions or surfaces of the cannula subassembly 114 if the cannula subassembly 114 is angled. For purposes of illustration, cannula subassembly 114 is shown in an exaggerated angled position in Figure 16A. The infusion set base 106 to which cannula subassembly 114 is coupled is hidden for clarity.

[0332] As the tubing set connector 368 is further displaced through its homing displacement range, the guide surfaces 371A-D may push, orient, and / or adjust the cannula subassembly 114 to its home position. Inclined sections included on any of the guide surfaces 371A-D may facilitate this process by helping to guide or steer the cannula subassembly 114 to or toward its home position. In FIG. 16B, the cannula subassembly 114 is shown adjusted to its home position (again, the infusion set base 106 is hidden to more clearly show the cannula subassembly 114). The guide surfaces 371A-D may adjust the position of the cannula subassembly 114 along two axes that may be substantially perpendicular to one another and in a plane that is substantially perpendicular to the direction of extension of the sharp 482 of the tubing set connector 368.

[0333] The tubing set connector 368 may then be displaced through a puncturing displacement range in which the sharp 482 of the tubing set connector 368 penetrates the septum 110 included in the cannula subassembly 114. As shown in FIG. 16C , at the end of the puncturing displacement range, the tip of the sharp 482 may be positioned within the fluid introduction volume 109 of the septum 110, and the connector fingers 370 may engage the connector receptacle 170 on the infusion set base 106. When puncturing the septum 110, the cannula subassembly 114 may be substantially restricted in movement by the guide surfaces 371A-D of the tubing set connector 368. The tubing set connector 368 may be considered fully docked to the infusion set base 106 at the end of the puncturing displacement range.

[0334] This two-stage connection of the tubing set connector 368 to the infusion set base 106 can help ensure that the septum 110 of the cannula subassembly 114 is consistently positioned before the tubing set connector 368 punctures the septum 110. This may be the case if loose tolerances are used during the manufacturing of certain components of the infusion set 102. The home position of the cannula subassembly 114 places the septum 110 in the proper position to allow the sharp 482 of the tubing set connector 368 to enter the fluid introduction volume 109 of the cannula assembly 114. This allows the fluid introduction volume 109 to be smaller, minimizing dead volume. Additionally, the connector needle passage 222 (see, e.g., FIG. 30B ) or other opening in the septum housing 108 that allows the sharp 482 to pass through the septum housing 108 can be smaller. Furthermore, the home position may be consistently achieved each time the tubing set connector 368 is reconnected to the infusion set base 106 so that the sharp 482 punctures the septum 110 in substantially the same location.

[0335] In certain examples, there may be mechanical interference between at least one of guide surfaces 371C-D on sharp side protrusion 372B and nub 220 of septum 110. The mechanical interference may compress the material of nub 220 in a manner similar to the compression by protrusion 221 described in FIGS. 31A-31D, at least once tubing set connector 368 is fully moved to the docked position. For example, lateral adjustment guide surface 371D may compress the material of nub 220 toward the puncture path of insertion sharp 132 (see FIG. 74B). Height adjustment guide surface 371C may also compress the material of nub 220 to seal against its guide surface 371C.

[0336] In some examples, as primarily shown in FIG. 17 , the infusion set base 106 can include a track 361 that can engage and guide the sharp-sided protrusion 372 when the tubing set connector 368 (see, e.g., FIGS. 15A-15F) is docked to the infusion set base 106. The track 361 can include a deflector body 363 that can resiliently deflect the sharp-sided protrusion 372 when the tubing set connector 368 and the infusion set base 106 are coupled together. In the example shown in FIG. 17 , the track 361 is positioned to interface with the sharp-sided protrusion 372B (see, e.g., FIG. 15D ), although tracks 361 for other sharp-sided protrusions can also include the deflector body 363. The exemplary track 361 extends from a portion of the receptacle wall 178 that is most distal to the platform portion 160 of the base 106. As shown, in certain examples, the deflector body 363 can be a ramp. Upon contact with deflector body 363, sharp side protrusion 372B may be deflected and pressed against nub 220 (see, e.g., FIG. 5B ) of septum 110 of cannula subassembly 114 mounted on infusion set base 106. In the exemplary embodiment, side protrusion 372B may be deflected against nub 220, and in various embodiments, sharp side protrusions 372A,B may be deflected against any exposed portion of septum 110 of cannula subassembly 114.

[0337] 18A-18C, in some exemplary embodiments, a tubeset connector 368 can include a tine 343. The tine 343 can be included in a sharp-sided protrusion 372A, B of the tubeset connector 368. Such a tine 343 can be cantilevered relative to the remainder of the tubeset connector 368. The tine 343 can be constructed to have at least a portion that extends out of the plane of the remaining sharp-sided protrusions 372A, B. The tine 343 can be deflectable toward the sharp-sided protrusions 372A, B. However, the tine 343 can have a degree of resilience that tends to return the tine 343 to its unstressed state when in a deflected state.

[0338] In the exemplary embodiment, the pawl 343 is included in a sharp side protrusion 372B of the tube set connector 368. The pawl 343 is attached to the sharp side protrusion 372B in a region of the pawl 343 that is distal-most to a flow hub 377 of the tube set connector 368. The unsupported end of the pawl 343 is included in a portion of the pawl 343 that extends substantially parallel to the remainder of the sharp side protrusion 372B. When the tube set connector 368 is coupled to the infusion set 102, the pawl 343 can advance over the cannula subassembly 114 coupled in the receptacle 176 of the infusion set base 106. As this occurs, the pawl 343 can resiliently deflect. When in the coupled state, the pawl 343 may be prevented from fully returning to its unstressed state by the cannula subassembly 114. Instead, the pawl 343 may press against the nub 220 of the septum 110 of the cannula subassembly 114.

[0339] In some embodiments, the end of the distal-most sharp-side protrusion 372B of the flow hub 377 may include a ramp 347. Such a ramp 347 may be included in a portion of the end (see, e.g., FIG. 18B) or may extend over the entire end (see, e.g., FIG. 18C). The infusion set base 106 may include a deflector 345 that can advance the ramp 347 when the tubing set connector 368 is coupled to the infusion set 102. In some embodiments, the deflector 345 may be a protrusion extending from a portion of the infusion set base 106. Alternatively, the deflector 345 may be a slot in the infusion set base 106 through which the ramp 347 is displaced during coupling of the tubing set connector 368 to the infusion set assembly 102. When the ramp 347 is displaced into the slot 345, the sharp-side protrusion 372B may be deflected toward the platform portion 160 of the infusion set base 106. This may further press the pawl 343 against the nub 220.

[0340] 18A-18C, the tab 343 and ramp 347 may be included in any of the tubing set connectors 368 described herein. The deflector 345 may be included in any of the infusion set bases 106 described herein.

[0341] 19A-19C, in some embodiments, the tubing set connector 368 can include a clamp 321. When the tubing set connector 368 including the clamp 321 is coupled into engagement with the infusion set assembly 102, the clamp 321 can act against an exposed portion of the infusion set assembly 102. The clamp 321 can, for example, press against either side of the exposed portion of the septum 110 (e.g., nub 220) to compress the material of the septum 110.

[0342] The clamp 321 may, in some examples, be defined within or form the sharp-sided protrusion 372. As shown, the sharp-sided protrusion 372B is formed as the clamp 321. The clamp 321 may include a first body 323A and a second body 323B spaced apart by a gap. At least one of the first and second bodies 323A, 323B may be configured to displace toward the other of the first and second bodies 323A, 323B. Any suitable arrangement that facilitates such displacement may be used. In an exemplary embodiment, as best shown in FIG. 19B , the second body 323B is coupled to the flow hub 377 along a portion of the end of the second body 323B proximate the flow hub 377. This partial connection may allow the second body 323A to resiliently deflect or pivot toward the first body 323A. The first body 323A may be connected to the flow hub 377 along its entire second end. Thus, the exemplary first body 323A is resistant to deflection and can remain stationary.

[0343] The infusion set assembly 102 may include a deflector body 363. In an exemplary embodiment, the infusion set base 106 includes a set of ribs 325. The deflector body 363 is defined as an exposed or raised portion of one of the ribs 325. When the tubing set connector 368 is coupled to engage with the infusion set assembly 102, a portion of the clamp 321 may be displaced into the deflector body 363. Further displacement of the tubing set connector 368 may cause the deflector body 363 to deflect a portion of the infusion set assembly 102. In an exemplary embodiment, when the second body 323B is pushed into the deflector body 363, the second body 323B may be deflected toward the first body 323A. The clamp 321 may then surround the nub 220 of the septum 110. The clamping surfaces 329 of the first and second bodies 323A, 323B may press against and compress the nub 220. A stop member 331 may be included to prevent rotation or misalignment of the tubing set connector 368 when the clamp 321 contacts the deflector body 363. The stop member 331 may provide a mechanical interference against unwanted movement of the tubing set connector 368 during mating. In the illustrated embodiment, the stop member 331 is a ridge on the rib 325 on the opposite side of the deflector body 363.

[0344] Compressing nub 220 of septum 110, as shown in FIGS. 15A-19C, to ensure that sharps 482 of tubing set connector 368 pierce septum 110 at substantially the same location as described above, is desirable for a variety of reasons. For example, these features may help to extend the range over which cannula subassembly 114 can withstand leaks at pressures beyond those expected during use. Compressing nub 220 allows a wider range of materials to be used for septum 110 of cannula assembly 114. Similarly, a wider range of material durometers can be used. Compressing nub 220 via protrusion 221 (see, e.g., FIGS. 31A-31D) or reducing the potential compressive stress relaxation of the material forming nub 220 (see discussion of FIGS. 31A-31D) may also help achieve the above.

[0345] Another exemplary base 106 is shown in Figures 20A-20C. The exemplary base 106 can be coupled to a tubing set connector 368, such as that shown in Figures 14A and 14B. The base 106 can include a connector 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, such as those shown in Figures 6 and 10A, can be included. Such guides 172 can be included on any infusion set base 106 shown or described herein. As shown, the base 106 can define a receiver track 189 that can receive a set of sharp-sided 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 into the receiver track 189 .Thus, angled wall 191 and angled section 193 can facilitate blind insertion of tubing set connector 368 into mating relationship with base 106 .

[0346] 21A-24C, additional exemplary infusion set bases 106 are shown. The bases 106 may include connector receivers 170 that allow the bases 106 to couple with tubing set connectors 368. The tubing set connectors 368 shown in FIGS. 21A-21F may be coupled to tubing set connectors 368 such as those shown in FIGS. 15A-16C, as described elsewhere herein. The connectors 368 shown in FIGS. 22A-22C may be coupled to tubing set connectors 368 such as those shown in FIGS. 25A-26C.

[0347] As shown, the receptacle wall extensions 179 may be separated from one another by channels. The receptacle wall extensions 179 and the portions of the receptacle wall 178 forming each side of the channel may also include segments 177 that are positioned substantially parallel to the platform portion 160 of the infusion set base 106. Thus, the channel may include a wide portion adjacent to the platform portion 160 and a narrow portion distal to the platform portion. The wide portion of the channel may define a receiver track 189 that can receive a set of sharp-sided protrusions 372A. As shown in FIGS. 21A-21F and 22A-22C, in some embodiments, a sloped section 193 (see, e.g., FIGS. 20A-20C) may be included. The receiver track 189 may guide the sharp-sided protrusions 372A when the tubing set connector 368 is coupled to the base 106. Thus, the channel may be referred to as a guide channel.

[0348] As shown, the receptacle wall 178 may include a cut 181 in a portion of the receptacle wall 178 that defines the receiving track 189. The cut 181 may align with a notch 174 included in the receptacle wall 178. The cut 181 may extend through a portion of the segments 177 of the receptacle wall 178 that are parallel to the platform portion 160. The inner regions 161 of these segments 177 are uninterrupted by the cut 181. The cut 181 may extend from the segments 177 to the platform portion 160. The cut 181 may define receiving slots for a portion of each arm 332 (see, for example, FIG. 59A ) of a portion of the inserter assembly 100. These receiving slots are sometimes referred to as inserter interface slots. The inner region 161 adjacent the break 181 can serve as a catch for the ledge 348 defined on the arm 332 (described further in connection with FIG. 59A ). As best shown in FIG. 21D , the notch 174 in the receptacle wall 178 can be tapered along at least a portion of its length (e.g., the distal-most portion of the platform portion 160). Such a tapered notch 174 can help guide the cannula subassembly 114 into position when the infusion set 102 is assembled. In some embodiments, the entirety of each notch 174 can be tapered to various degrees. For example, a portion of each notch 174 most distal of the platform portion 160 can have a greater taper than a second portion of each notch 174 more proximal to the platform portion 160. Such a tapered notch 174 can be included in any of the infusion set bases 106 described or shown herein.

[0349] The exemplary infusion set base 106 of FIGS. 21A-F also includes a receptacle wall 178 that includes a cantilevered portion 180 with a ridge 182. The cantilevered portion 180 may be constructed to resiliently retract when the cannula assembly 114 is introduced, but resist deflection when a force is applied along the longitudinal axis of the cantilevered portion 180. The cantilevered portion 180 may be constructed to resiliently flex out of the way when the cannula assembly 114 is introduced, but resist deflection when a force is applied acting along the longitudinal axis of the cantilevered portion 180. The cantilevered portion 180 may include one or more ribs 163. The ribs 163 may protrude from the cantilevered portion 180 into the receptacle 176 and may extend along the length of the cantilevered portion 180. While ribs 163 are shown, other protrusions may be included in alternative embodiments. One or more recesses 165 may be located on the side of cantilever portion 180 opposite the side from which protrusion 182 extends. Recesses 165 may be located opposite each of ribs 163 or other thickened regions. When cannula assembly 114 is introduced, ribs 163 may help position cannula subassembly 114 within receptacle 176. Ribs 163 may also prevent cannula subassembly 114 from shaking when cannula subassembly 114 is within receptacle 176. Receptacle 176 is connected to base 106.

[0350] 22A-22C includes a plurality of cantilevered portions 180, each including a protrusion 182. Receptacle wall 178 includes cantilevered portions 180. The cantilevered portions 180 protrude from receptacle wall 178 away from platform portion 160 such that the unsupported ends including protrusions 182 are the portions of cantilevered portions 180 most distal relative to platform portion 160. A pair of cantilevered portions 180 are also positioned opposite each other on receptacle wall extension 179 adjacent receptacle wall 178. The pair of cantilevered portions 180 extend in a direction away from platform portion 160 (e.g., substantially perpendicular) such that the unsupported ends including protrusions 182 are the portions of cantilevered portions 180 most distal relative to platform portion 160. When the cannula subassembly 114 is introduced, each of the cantilever sections 180 may resiliently deflect out of the way to allow the cannula subassembly 114 to pass into the infusion set base 106. The angled surface of the protrusion 182 may help facilitate this deflection. When the cannula subassembly 114 advances beyond a threshold amount into the receptacle 176 of the infusion set base 106, the cannula subassembly 114 may be displaced away from the protrusion 182. Each of the cantilevered portions 180 may then return to a less stressed or less deflected state. Each of the protrusions 182 may then overhang a portion of the cannula subassembly 114 (e.g., the septum housing 108). Thus, the cannula subassembly 114 may be captured within the infusion set base 106. While three cantilevered portions 180 are shown, alternative embodiments may include a different number of cantilevered portions 180. The receptacle wall 178, for example, may include a greater number of cantilevered portions 180. In an alternative embodiment, at least some of the cantilevered portions 180 can protrude toward the platform portion 160 such that their unsupported ends, including the protrusions 182, are the portions of the cantilevered portions 180 that are most proximal to the platform portion 160 (see, for example, the cantilevered portions 180 in FIGS. 21A-21F). The height of each cantilevered portion 180 is substantially the same in FIGS. 22A-22C.In alternative embodiments, the height of at least one cantilevered portion 180 may vary. The height may be selected so that protrusion 182 protrudes to capture cannula subassembly 114 installed in receptacle 176. The embodiment of FIGS. 22A-22C may not include notch 186 (see, e.g., FIG. 5A) or protrusion 388 (see, e.g., FIG. 8A). An upper surface 394 (see, e.g., FIG. 28C) of side wall 392 of septum housing 108 (see, e.g., FIG. 28C) may provide an engagement surface against which protrusion 182 retains cannula subassembly 114 within base 106.

[0351] 23A-24C, two exemplary infusion set base embodiments are shown. As shown, in certain instances, an additional retention member 261 may be included and may protrude from the platform portion 160 of the infusion set base 106. The exemplary embodiment shows a retention member 261 on an infusion set base 106 similar to that shown in FIGS. 22A-22C. However, as shown in FIGS. 22A-22C, such a retention member 261 may be included on any infusion set base 106 described herein (e.g., those shown in FIGS. 21A-F). The retention member 261 is positioned adjacent to the receptacle 176 and closest to the open end of the guide channel. In the exemplary embodiment, the retention member 261 is positioned opposite the cantilever portion 180. Such an exemplary retention member 261 may be hook-shaped or hook-like. When the tube set connector 368 is coupled to the exemplary infusion set base 106, the sharps 482 (see, e.g., FIG. 15F) may move along the entry path within the respective guide channels. The height of the retaining member 261 may be selected so as not to protrude into the entry path of the sharps 482, and therefore the retaining member 261 does not interfere with the sharps 482 during coupling of the tube set connector 368. Here, the cannula subassembly 114 may include a pair of notches 186 (see, e.g., FIG. 5A or FIG. 24E). The notches 186 may be located on opposing portions of an outer sidewall of a portion of the cannula subassembly 114.

[0352] 23A-23C , cantilevered section 180 of receptacle wall 178 can snap into a first one of notches 186 that retain cannula subassembly 114 within receptacle 176 after cannula subassembly 114 has advanced beyond a certain distance within receptacle 176. Retaining member 261 can deflect as cannula subassembly 114 advances into receptacle 176. Retaining member 261 can return to an undeflected (or at least less deflected) state and snap into second notch 186 once cannula subassembly 114 has been advanced beyond the distance that it is within receptacle 176. In various embodiments, cantilevered section 180 and retaining member 261 can snap into notch 186 substantially simultaneously. 24A-24C, protrusion 182 of cantilever member 180 may be clipped into place against top surface 394 of septum housing 108 of cannula subassembly 114. Retaining member 261 helps limit squeezing of cannula subassembly 114 within receptacle 176, potentially allowing for looser tolerancing. Additionally, retaining member 261 may help center cannula subassembly 114 within receptacle 176.

[0353] 25A-26C, an exemplary tubing set connector 368 is shown that can be used with, for example, the infusion set base 106 shown in FIGS. 22A-24C. The exemplary tubing set connector 368 includes sharp side projections 372A, B but does not include connector fingers 370. The exemplary tubing set connector 368 includes a pair of connector latches 365. As shown in FIGS. 25A-26C, the connector latches 365 may be included in place of the connector fingers 370 of other embodiments of the tubing set connector 368 described herein. The exemplary connector latches 365 may be disposed on the underside of the body 367. When the tubing set connector 368 is coupled to the infusion set 102, the connector latches 365 may engage with the connector receptacle 170 on the infusion set base 106. The body 367 of the tubing set connector 368 can act as a shield to help prevent fingers or objects from inadvertently disengaging the connector latches 365 from the connector receptacle 170. As shown in FIGS. 22A-24C, the connector receiving portion 170 may be located on opposing portions of the base 106 lateral to the receptacle wall extension 179, between the closed and open ends of the guide channel. The portion of the body 367 containing the connector latch 365 is attached to and deflectable relative to the flow hub 377 and may be referred to herein as the flexible body portion. A clamping force on these portions of the body 367 toward the axis of the sharps 482 may disengage the connector latch 365 from the connector receiving portion 170. The tubing set connector 368 may then be separated from the infusion set 102, if desired. These portions of the body 367 may include gripping regions 475, such as uneven, wavy, or crimped, to assist in grasping the tubing set connector 368. In some examples (best shown in FIG. 26C), the connector latch 365 may include a stop. The stops 479 can abut against the receptacle wall extensions 179 after deflection beyond a certain amount, thereby limiting the deflection of the flexible body segment.26B , in certain exemplary tubing set connectors 368, the tubing set connector 368 may have a sloped surface 477 on each flexible body portion. When the flexible body portions are pressed toward each other, the sloped surfaces 479 may be displaced relative to the connector receiving portion 170. The sloped surfaces 479 may cause the tubing set connector 368 to be pushed out of engagement when pressed into the connector receiving portion 170 of the infusion set base 106. Thus, the sloped surfaces 479 may facilitate separation of the tubing set connector 368 from the infusion set base 106.

[0354] 22A-26C, the exemplary tubing set connector 368 covers the connection between the connector latch 365 and the connector receiver 170, so that the shielding wall 169 (see, e.g., FIG. 21A) is not included in the exemplary infusion set base 106 of FIGS. 22A-24C. When coupled together, the exemplary tubing set connector 368 and base 106 can form an assembly with a low profile that reduces the likelihood of snagging on clothing, for example.

[0355] As further shown primarily in FIGS. 22A-24C , a portion of the exemplary base 106 opposite the open end of the guide channel can be formed by a contoured wall 357. The contoured wall 357 can extend to a portion of the periphery of the base 106 opposite the open end of the guide channel. The contoured wall 357 can tend to taper toward the plane of the platform portion 160 as it approaches the periphery of the base 106. The platform portion 160 does not have to be continuous below the contoured wall 357. Instead, a cavity may be present below the contoured wall 357 to help facilitate molding. As shown in FIG. 22B , for example, a transition wall 349 can extend from the platform portion 160 to the edge of the contoured wall 357 that is most proximal to the open end of the guide channel. The transition wall 349 can be disposed approximately perpendicular to the axis of the guide channel in some embodiments.

[0356] 25A-25C, the transition wall 349 may include a passageway 341 extending through the transition wall 349 and into a cavity below the contoured wall 357. When the tubing set connector 368 is coupled to the infusion set base 106, the sharp-sided protrusion 372A may extend through the passageway 341 in the transition wall 349. The unsupported end of the sharp-sided protrusion 372A may protrude into the cavity. The contoured wall 357 of the infusion set base 106 may be approximately flush with the exterior surface of the body 367 of the tubing set connector 368. The flexible body portion of the body 367 of the tubing set connector 368 may fit snugly against the transition wall 349 of the infusion set base 106 such that there is substantially no gap between the transition wall 349 and the tubing set connector 368 when the base 106 and the tubing set connector 368 are connected.

[0357] 27A and 27B, another example infusion set base 106 is shown. In certain embodiments, base 106 may not include receptacle wall 178 having cantilevered protrusion 180 defined therein (see, e.g., FIG. 4A). As shown in FIGS. 27A and 27B, in some examples, base 106 may include a retaining member 195 extending from platform 160. Retaining member 195 is freestanding and not supported by or continuous with receptacle wall 178. In FIGS. 27A and 28B, retaining member 195 is shown as a hooked body extending from the platform and positioned in an opening between two sections of receptacle wall 178. In other examples, a hooked body may not be used. Instead, a cantilevered member including a protrusion 182, such as a barb or ramp, that engages with a portion of cannula subassembly 114 may be used. The hook body may include a shank region 197 attached to and contiguous with the platform 160. The shank region 197 may extend from the platform 160 to a bend region 199. The shank region 197 may be perpendicular to the platform 160 or angled to extend toward the receptacle 176. The hook body may also include a catch segment 201 extending from the bend region 199. The catch segment may 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 may be positioned at a 35-40° angle relative to the shank 197.

[0358] 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.

[0359] 28A-28D, various views of an exemplary embodiment of cannula subassembly 114 are shown. Exemplary cannula subassembly 114 includes septum housing 108, cannula 104, septum 110, and septum retainer 112. Septum housing 108 includes a slot 390 recessed in a top surface 394 of a side wall 392 of septum housing 108. When installed within cannula subassembly 114, septum retainer 112 can block access to the side of septum 110 in an area near top surface 394 of septum housing 108. The end of slot 390 may be exposed to provide access to a sharp 482 (see, e.g., FIG. 15D) included on tubing connector 368. The terminus of slot 390 may provide an engagement surface for cantilevered protrusion 180. A retaining member 195 (see, eg, FIG. 4A) or retaining member 195 (see, eg, FIG. 27A) is included that can capture the cannula subassembly 114 within the infusion set base 106 .

[0360] As shown, cannula 104 and septum housing 108 are shown as separate, individual components in FIGS. 28A-28D . While shown as separate components, cannula 104 and septum housing 108 may be integral with one another, as described elsewhere herein. The exemplary cannula 104 may include an enlarged end region 215. Enlarged end region 215 may include an insertion sharp guide section 216 that may be continuous with the wall of the lumen 202 of cannula 104. The insertion sharp guide section 216 may assist in directing insertion sharp 132 (see, e.g., FIG. 1A ) into the lumen 202 of cannula 104 during assembly. Enlarged end region 215 may also include a septum interface region 183 upon which a corresponding portion 185 of septum 110 rests. The septum interface region 183 may surround insertion sharp guide section 216. Septum interface region 183 may contact a corresponding portion 185 of septum 110 and provide a sealing surface against which septum 110 may be compressed to form a fluid-tight seal when cannula subassembly 114 is assembled.

[0361] Septum interface region 183 can have many different geometric shapes, depending on the embodiment. In this example, septum interface region 183 can have a substantially straight wall portion 187 along its distal-most portion from the outlet of cannula 104. Straight wall portion 187 can extend substantially parallel to the longitudinal axis of cannula 104. Straight wall portion 187 may transition to a frusto-conical shape 189 that widens as septum interface region 183 extends toward outlet 212 of cannula 104. In alternative embodiments, the entire septum interface region 183 can be straight-walled (see, e.g., FIG. 30E) or frusto-conical in shape.

[0362] The recess 214' may be included in a surface of the enlarged portion 215 that surrounds or at least partially surrounds the cannula 104. In an example embodiment, the recess 214' is approximately shaped as a conic section (e.g., a hyperbola or parabola) rotating about the central axis of the cannula 104. The septum housing 108 includes a passageway 399 extending through a bottom wall 395 of the septum housing 108. A cannula seat 401, which may be a raised wall or post surrounding the passageway 399, may also be included in the septum housing 108. The recess 214' in the enlarged portion 215 of the cannula 104 may receive at least a portion of the cannula seat 401 and may help to position and hold the cannula 104 in place within the cannula seat 401. A bottom surface 217 of the enlarged portion 215 (the surface closest to the outlet 212 of the cannula 104) may be located against the bottom wall 395. When the cannula assembly 114 is assembled, the cannula 104 may extend through the passageway 399, with the outlet 212 exiting the septum housing 108. A space may exist between the outside of the cannula 104 and the sidewall of the passageway 399. This space may provide room for the cannula 104 to move relative to the base 106 if the infusion set 102 or a portion of the patient's body applies force to the cannula 104. This may minimize shear stress on the cannula 104. Additionally, this volume may serve as a volume for an agent (medicine). For example, any of the agents discussed in connection with FIG. 5B may be used.

[0363] As shown, the septum 110 can include a fluid introduction volume 109. The exemplary fluid introduction volume 109 includes at least one rounded sidewall. In this example, the fluid introduction volume 109 is shaped like a slice of a sphere with the opposing spherical caps removed. In other embodiments, a generally spherical or other rounded volume without straight sidewalls may be used. Such a shape may help ensure that a relatively large fluid introduction volume 109 remains even under volumetric distortion that may occur when the septum 110 is compressed during assembly of the cannula subassembly 114. Furthermore, such a shape may allow for greater fluid introduction without changing the size of the enlarged portion 215 of the cannula 104. This may allow the fluid introduction volume 109 to be a larger target for the sharps 482 of the tubing set connector 368 (see, e.g., FIGS. 15A-16C). This may allow components of the infusion set 102 or tubing set connector 368 to be constructed with looser tolerances, simplifying manufacturing.

[0364] Referring to Figures 29A-29B, two exemplary cannula embodiments are shown. In some embodiments, the end of the enlarged region 215 of the cannula 104 most distal to the outlet 212 may include a fluid introduction volume reinforcement body 107. The reinforcement body 107 may extend into the fluid introduction volume 109 or abut a sidewall of the fluid introduction volume 109. The reinforcement body 107 can prevent distortion of the fluid introduction volume 109 when the septum 110 is compressed. The reinforcement body 107 can include a passageway 105 that can align with a slot 390 (see, e.g., Figure 28C) or a connector needle passageway (see, e.g., Figure 6). This allows the sharp 482 on the tubing set connector 368 (see, e.g., Figure 15C) to have a path through the reinforcement body 107 to the fluid introduction volume 109 when the tubing set connector 368 is connected to the infusion set base 106. As shown, the passageway 105 can be an opening (oblong in the example, but any suitable shape is possible) or a slot. Such a reinforcement 107 may be included in any of the cannulas 104 described and / or shown herein.

[0365] 30A-30G, another exemplary cannula assembly 114 is shown. Referring to FIGS. 28A-28D, the exemplary cannula subassembly 114 includes a cannula 104 and a septum housing 108, which are separate components (although in alternative embodiments, they may be integral with one another). The cannula 104 can have an enlarged region 215 that includes a septum interface region 183 that surrounds an insertion sharp guide 216 of the cannula 104. When assembled, a corresponding portion 185 of the septum 110 can seat against the septum interface region 183. The enlarged region 215 can also include a flange 219 that can be disposed at the end of the enlarged region 215 closest to the outlet 212 of the cannula 104. As shown in FIG. 30E, the bottom wall 395 of the septum housing 108 can include a seat for the cannula 104. In this example, the seat is shown as a receptacle 393 in which the flange 219 seats. The receptacle 393 can aid in centering the cannula 104 within the septum housing 108 .

[0366] The recess 214' may be included in a surface of the enlarged portion 215 that surrounds or at least partially surrounds the cannula 104. In an exemplary embodiment, the recess 214' is approximately shaped as a conical section (e.g., a hyperbola or parabola) revolving about the central axis of the cannula 104. The septum housing 108 includes a passageway 399 extending through a bottom wall 395 of the septum housing 108. The walls of the passageway 399 may be angled or contoured to match and be an extension of the recess 214'. This may create a volume that can be filled with a medication (described elsewhere herein) and / or may allow some movement of the cannula 104 relative to the infusion set base 106. A receptacle 393 (or other seat) may surround the passageway 399.

[0367] The septum housing 108 may include multiple protrusions 391 (best shown in FIG. 30F ) extending from the wall of the receptacle 192 of the septum housing 108 toward the elongation axis of the cannula 104. In embodiments, these protrusions 391 are in the form of substantially straight ridges or ribs. Each of the protrusions 391 may be the same length, or at least one of the protrusions 391 may have a different length than at least one of the other protrusions 391. In certain embodiments, the end of the protrusion 391 most distal to the outlet 212 of the cannula 104 may be beveled or curved (shown in FIG. 30F ). Each of the connector needle passages 222 (which are openings in the illustrated example, but potentially slots 390 in alternative examples where slots 390 are present in the septum housing 108) may be flanked by protrusions 391, which may extend immediately adjacent each side of the connector needle passage. The protrusions 391 may contact the septum 110 (or at least one of the septums 110 in embodiments having multiple septums 110) when the septum 110 is installed within the septum housing 108. The space between the protrusions 391 may provide a volume into which the material of the septum 110 is forced when the cannula subassembly 114 is assembled and the septum 110 is under compression. The septum retainer 112 also includes a pair of protrusions 391′ included in the cantilevered protrusions 188 extending from the body 206 of the septum retainer 112. When the cannula subassembly 114 is fully assembled, the protrusions 391, 391′ may contact the septum 110, further compressing the septum 110 and increasing the robustness of the fluid-tight seal formed by the septum 110. Such protrusions 391, 391′ also allow for relaxed tolerances used to simplify manufacturing.

[0368] 31A-31D, another example cannula subassembly 114 is shown. The illustrative cannula subassembly 114 includes a septum retainer 112 including a channel 218 disposed substantially centrally in the body 206 of the septum retainer 112. A nub 220 of the septum 110 may protrude into, and perhaps partially through, the channel 218. The septum 110 may have a diameter slightly larger than the diameter of the channel 218. Thus, the nub 220 may be compressed by the channel 218. Furthermore, the channel 218 may have a diameter that traverses a majority or majority of the diameter of the body 206 of the septum retainer 112. This allows compression exerted by the walls of the channel 218 to be spread across a relatively large amount of the material of the septum 110. As a result, compressive stress relaxation of the material of the septum 110 may decrease over the shelf life of the inserter assembly 100.

[0369] The insertion sharp 132 of the inserter assembly 100 can extend through the nub 220 before the inserter assembly 100 is used (see, for example, FIG. 74B). The septum 110 can completely self-seal and prevent leakage once the insertion sharp 132 is removed. In certain examples, the average width or diameter of the nub 220 can be selected such that the diameter of the insertion sharp 132 is less than 10% of the average width of the nub 220. This can further reduce stress relaxation of the septum 110 material while the inserter assembly 110 is waiting to be used.

[0370] As shown, channel 218 may include sidewalls that are primarily straight and extend parallel to the elongation axis of cannula 104. Therefore, the compression exerted by the sidewalls of channel 218 on protrusion 220 may be directed primarily perpendicular to the elongation axis of cannula 104. This may maximize the compression exerted by channel 218 toward the puncture path of insertion sharp 132. Furthermore, by reducing the compressive stress relaxation of septum 110, a greater degree of elasticity may be maintained in the material of septum 110. Therefore, channel 218 of FIGS. 31A-31D may help resist leakage at pressures even greater than those expected during use. Additional potential advantages are discussed above in connection with FIGS. 15A-16C and 17.

[0371] The exemplary septum retainer 112 may include one or more protrusions 221 protruding from the exposed surface of the septum retainer 112, which may at least partially surround the channel 218. In some embodiments, the protrusions 221 may surround the entire channel 218. In the exemplary embodiment, the protrusions 221 are included as part of the crenellations surrounding the channel 218. In this example, only two merlons and associated crenels are shown. The merlons may be positioned opposite each other to surround the channel 218. In other embodiments, any suitable number of crenels may be included, and the crenels may or may not be positioned at regular angular intervals. In the example, at least one protrusion 221 extends approximately perpendicular to the body 206 of the septum retainer 112. In other embodiments, at least one protrusion 221 may extend toward the axis of the channel 218, or may extend partially toward the axis of the channel 218.

[0372] 32A-33B, in some examples, channel 218 may be completely surrounded by protrusion 221, at least a portion of which is angled toward the axis of channel 218. Thus, protrusion 221 may block all but a small portion of nub 220. Protrusion 221 in FIGS. 32A-33B forms a cap or cover over nub 220 and may be referred to herein as the cap or cover portion of septum retainer 112. The portion of protrusion 221 most distal to outlet 212 of cannula 104 is substantially planar and oriented perpendicular to the axis of channel 218. In certain examples, the wall of protrusion 221 adjacent nub 220 may include one or more protrusions similar to protrusion 391 described with respect to FIG. 30F.

[0373] When nub 220 of septum 110 is compressed during assembly of cannula subassembly 114, the material may tend to "mushroom" as it protrudes through channel 218. Protrusion 221 helps prevent this "mushrooming," forcing the material of septum 110 toward the puncture path of insertion sharp 132 (see, e.g., FIG. 74B). This may help cannula subassembly 114 resist leakage at pressures even beyond those expected during use. Additional potential advantages are described above in connection with FIGS. 15A-16C and 17.

[0374] 34A-34F, another example cannula subassembly 114 is shown. As shown, cannula subassembly 114 includes cannula 104 and septum housing 108. Septum retainer 112 (see, e.g., FIG. 31A) is not included in the embodiment shown in FIGS. 34A-34F. This reduces the number of parts and may help simplify the manufacture of cannula assembly 114.

[0375] The exemplary cannula 104 includes an enlarged region 215 that includes a septum interface region 183 that surrounds an insertion sharp guide 216 of the cannula 104. When assembled, a corresponding portion 185 of a septum 110 (a septum is not shown in FIGS. 34A-34F, but see, for example, FIG. 31D) can be positioned against the septum interface region 183. The enlarged region 215 can also include an outwardly extending flange 219. The surface of the flange 219 farthest from the cannula outlet 212 can include a recess 223 that can receive the end of the septum 110. The recess 223 can include a contoured surface that helps center and position the septum 110 within the cannula subassembly 114. The opposite surface of the flange 219 can include a set of recesses 214A, B. Recess 214A provides space for the portion of cannula 104 extending from this surface to move relative to infusion set base 106, minimizing shearing effects on cannula 104. Medication may be provided in either recess 214A, B, as described elsewhere herein.

[0376] A number of cantilever arms 231 may be included around the flange 219. A terminal projection or latch member 233 may be included at the unsupported end of each of the cantilever arms 231. Thus, the cantilever arms 231 may sometimes be referred to as latch arms. During assembly, the latch member 233 of each cantilever arm 231 may slide within its respective guide 208, which is included within the interior surface of the receptacle 192 of the septum housing 108. The illustrated guides 208 are recessed into the interior surface of the septum housing 108. When the latch member 233 is within the guide 208, the cantilever arms 231 may be resiliently deflected toward the axis of extension of the cannula 104. After a certain distance, the latch member 233 may exit the guide 208 and pass through an opening 235 included in the septum housing 108. This allows the cantilever arms 231 to resiliently recover and spring outward, actuating the latch member 233 on each cantilever arm. 231 latch into catch surfaces 210 defined by each of the openings 235. In the exemplary embodiment, cannula 104 includes a set of four cantilever arms 231. The cantilever arms 231 are also spaced apart from one another at substantially regular angular intervals, although this need not be the case in all exemplary embodiments. In other embodiments, a greater or lesser number of cantilever arms 231 may be included. The openings 235 in this example are notches recessed into a first end wall 241 of the septum housing 108 and partially into a side wall 243 of the septum housing 108. The first end wall 241 closes one end of the septum housing 108, and a flange 219 of the cannula 104 can close a second end of the septum housing 108 when the cannula 104 is coupled to the septum housing 108. A septum 110 (not shown) may be captured between the flange 219 and the first end wall 241. Septum housing 108 when cannula subassembly 114 is assembled. First end wall 241 may include a channel 218′ extending therethrough that receives nub 220 of septum 110 (see, e.g., FIG. 31D).

[0377] As shown, the flange 219 may also include a number of ledge members 237 that may extend outwardly from the periphery of the flange 219. When the cannula subassembly 114 is assembled, the ledge members 237 may provide a retention interface that engages with, for example, the protrusions 182 on the cantilevered protrusions 180 (see, for example, FIG. 4A ) of the infusion set base 106. Thus, the ledge members 237 may aid in coupling the cannula subassembly 114 to the infusion set base 106. The septum housing 108 may include a recess 245 adjacent at least one of the ledge members 237.

[0378] 35A-35F and 36A-36E, additional exemplary cannula subassembly 114 embodiments are shown. The ears 204 extending from the main portion of the exemplary septum housing 108 can include wedge bodies 205. Such wedge bodies 205 may be included in the ears 204 of the other cannula subassemblies 114 shown and described herein. The wedge bodies 205 may be positioned on each portion of the ears 204 most distal from the outlet 212 of the cannula 104 and may be positioned opposite each other on opposite sides of the ears 204. The thickness of the wedge bodies 205 may decrease as the distance to the outlet 212 of the cannula 104 decreases. The wedge bodies 205 may extend from a sidewall 207 of the septum housing 108.

[0379] Additionally, the ear 204 may include an extension 209 extending from the main portion 211 of the ear 204 toward the outlet 212 of the cannula 104. Such an extension 209 may be included in the other cannula subassemblies 114 illustrated and described herein. The extension 209 may be tapered such that the width of the extension 209 decreases as it approaches the outlet 212 of the cannula 104. The tapering of the extension 209 may aid in orienting the cannula subassembly 114 into the notch 174 (see, e.g., FIG. 4A ) of the infusion set base 106 when the cannula subassembly 114 is displaced into the infusion set base 106. In certain examples, the end of the extension most distal to main portion 211 of ear 204 may be thinned and potentially sacrificial. If extension 209 is too long (e.g., due to tolerances), this sacrificial portion of extension 209 may deform as it moves into the interference structure of base 106. Thus, the sacrificial portion of extension 209 allows cannula subassembly 114 to couple to base 106 without issue, even if relatively loose tolerances are used. Wedge body 205 can help ensure cannula subassembly 114 is held snugly within notch 174 during assembly (see, e.g., FIG. 4A ) and can help center cannula subassembly 114 within receptacle 176 (see, e.g., FIG. 4A ). Wedge body 205 may allow notch 174 and / or septum housing 108 to be made to less tight tolerances (see, e.g., FIG. 4A ), while minimizing the chance that cannula subassembly 114 has room to wiggle when held within receptacle 176. Wedge body 205 may also help guide cannula subassembly 114 into place during assembly to base 106.

[0380] 37A-37B in addition to FIGS. 35A-36E, in certain embodiments in which the cannula 104 and the septum housing 108 are separate components, multiple septa 110A, 110B may be included. In other embodiments, multiple septa 110 may also be included. Each of the exemplary septa 110A, 110B may be made of the same or different materials and / or durometers. The cannula 104 may include an enlarged region 215 and a flange 219, as described in connection with FIGS. 30A-30G, for example. The flange 219 may be captured in a fluid-tight manner between each of the septa 110A, 110B. In the exemplary embodiment, the first septum 110A may include the fluid introduction volume 109 and a corresponding portion 185 that seats in the septum interface region 183 of the cannula 104. The second septum 110B may be positioned opposite the first septum 110A. The second septum 110B may include a protruding portion 113 that extends into the passageway 399 of the septum housing 108. An orifice 115 may be included in a central region of the protruding portion 113. The cannula 104 may extend through the orifice 115 to the exterior of the cannula subassembly 114 (best shown in FIGS. 37A-37B). The orifice 115 may also seal against the surface of the cannula 104. Because the material of the septum 110B is elastomeric, the septum 110B may allow relative movement of the cannula 104 with respect to the infusion set base 106, minimizing shearing effects on the cannula 104.

[0381] 37A-37B, which illustrate views of septa 110A, B from FIGS. 35A-35F and 36A-36E, respectively. At least one of septa 110A, B may include a peripheral rim 117 on a side of septum 110A, B closest to the opposing septum 110A, B. Peripheral rim 117 may form a fluid-tight seal and extend adjacent an edge of flange 219 of enlarged portion 215 of cannula 104 when cannula subassembly 114 is assembled. Peripheral rim 117 may also surround a receptacle area of ​​septum 110A, B in which peripheral rim 117 is included. The receptacle area may receive flange 219 of cannula 104 during assembly.

[0382] 38A-38E and 39A-39E, a further exemplary embodiment of cannula subassembly 114 is shown. As shown, cannula subassembly 114 includes multiple septa 110A, 110B. In the exemplary embodiment, first septum 110A is cup-shaped. Second septum 110B is also cup-shaped, but is inverted relative to first septum 110A when septums 110A, 110B are installed within receptacle 192 of septum housing 108. As described herein, receptacle 192 of septum housing 108 may include protrusion 391 (further described above in connection with FIGS. 30A-30G).

[0383] As shown in FIGS. 38A-39E, the second septum 110B is sized to fit within the cup or cavity formed by the first septum 110A. The inner wall of the cup of the first septum 110A can establish a fluid seal against the outer sidewall of the second septum 110B. The second septum 110B can seal against the septum interface portion 183 of the enlarged region 215 of the cannula 104. The flange 219 of the cannula 104 can be captured in a fluid-tight sealing relationship between the two septums 110A, 110B (see FIGS. 38A-38E). Alternatively, the second septum 110B may include a recess 119 defined in the inner wall of the cup portion of the septum 110B (see FIGS. 39A-39E). Flange 219 of cannula 104 may fit within recess 119 when cannula subassembly 114 is assembled, and recess 119 may establish a fluid-tight seal against flange 219. First septum 110A may include a protrusion 113 that protrudes into a passage defined in septum housing 108. Cannula 104 may extend out of septum housing 108 through an orifice 115 in protrusion 113. The elastomeric material of septum 110A allows for displacement of cannula 104 relative to infusion set base 106, minimizing potential shear stress on cannula 104 during use.

[0384] 40A-40C, in some embodiments, the flange 219 can extend non-radially from the cannula 104 and need not be substantially planar. The flange 219 can extend from the cannula 104 such that as the flange 219 widens, the distance from the outlet 212 of the cannula 104 increases in a linear (or alternatively, non-linear) relationship. Thus, the flange 219 may be in the shape of a hollow frustum cone. In other embodiments, the relationship between the distance from the outlet 212 and the width of the flange 219 need not be linear, and at least a portion of the flange 219 may have a curved profile when viewed in cross section. The first and second septa 110A, B may include cooperating sloped or contoured surfaces that mate with opposing sides of the flange 219 to form a fluid-tight seal. The second septum 110B may include a protrusion 113 having an orifice 115 into which the cannula 104 can extend. Flange 219 establishes a ball-and-socket type relationship with septum 110A, B, which can allow greater movement of cannula 104 relative to the rest of infusion set 102 while maintaining a robust seal. Such a ball-and-socket type arrangement between cannula 104 and septum 110A, B may be used in any embodiment in which cannula 104 is not integrally formed with septum housing 108.

[0385] Various embodiments of the infusion set base 106, tubing set connector 368, and cannula subassembly 114 are described herein. While certain features of these components may be described in the context of certain exemplary embodiments, the scope of the present disclosure is not limited thereto. It is contemplated that features of any infusion set base 106, tubing set connector 368, or cannula subassembly 114 may be incorporated into other infusion set base 106, tubing set connector 368, or cannula subassembly 114 embodiments without departing from the scope of the present disclosure. Furthermore, any of the tubing set connectors 368 described herein may be constructed as a cap body that does not include a sharp 482 (e.g., see FIG. 15D ), an attached infusion tube 366 (e.g., see FIG. 6 ), and / or any flow channels, tubing receptacles 512 (e.g., see FIG. 143 ), adhesive introduction openings 520 (e.g., see FIG. 143 ), etc. Such a cap body may be placed on the infusion set assembly 102 when the infusion set assembly 102 is not connected to the tubing set connector 368 (eg, when the infusion pump is disconnected during bathing).

[0386] Referring to FIGS. 41A and 41B, two side views of the inserter assembly 100 are shown. The inserter assembly 100 in FIG. 41B is rotated 90 degrees clockwise from the orientation of FIG. 41A. The exemplary inserter assembly 100 is an assembled version of the exploded view shown in FIG. 1A. The two views may represent the appearance of the inserter assembly 100 before use and after the inserter assembly 100 has been removed from its shipping / storage package. As shown, the outer housing 116 of the inserter assembly 100 is visible, with the locking member 146 in place. Additionally, an adhesive backing 111 is present and covers the adhesive layer present on the bottom surface 162 of the infusion set base 106. The adhesive backing 111 may include a gripping area 224, which may be a backing material in the form of a flange, tab, or other protrusion, that extends beyond the footprint of the inserter assembly 100. This gripping area 224 can be grasped by a user and used to peel the adhesive backing 111 from the infusion set 106. Once the backing 111 is removed, the inserter assembly 100 can be positioned relative to the desired injection site, using the raised ribs 118 to aid in alignment. The locking member 146 can then be pulled from the inserter assembly 100 to actuate the inserter assembly 100. Because the exemplary adhesive backing 111 is attached to the locking member 146, extraction of the locking member 146 can complete the separation of the adhesive backing 111 from the inserter assembly 100. If the user is dissatisfied with the position of the inserter assembly 100, the user can leave the locking member 146 on the inserter assembly 100 and pull the inserter assembly 100 from the body. The presence of the locking member 146 can prevent actuation when this occurs and may allow the user to select a different injection site.

[0387] 42A and 42B, two additional views of the inserter assembly 100 are shown. The exemplary adhesive backing 111 includes a strip 225 extending from a portion of the adhesive backing 111 that covers the adhesive layer present on the bottom surface 162 of the infusion set base 106 (see, e.g., FIGS. 43-45). In some embodiments, the strip 225 can extend substantially parallel to and adjacent to the gripping region 224 of the adhesive backing 111. In the example shown in FIGS. 42A and 42B, the adhesive backing 111 is coupled to the outer housing 116 of the inserter assembly 100 in place of the locking member 146. The strip 225 may have a length that is longer than the height of the inserter assembly 100. Thus, a terminal region 227 of the strip 225 can be coupled to the top surface of the outer housing 116. The termination region 227 may be attached via, for example, heat staking, welding (e.g., sonic welding), or adhesive (e.g., double-sided tape or other adhesive). The termination region 227 may be bonded to a location that does not obstruct the view of the raised alignment ribs 118 present on the top surface of the outer housing 116. The strip 225 may be attached to another portion of the inserter assembly 100 (e.g., the side of the outer housing 116 and / or the locking member 146) in certain embodiments. In other embodiments, the length of the strip 225 may be different, and the termination region 227 may be bonded to another portion of the inserter assembly 100 (e.g., the side of the outer housing 116 or the locking member 146).

[0388] 43-45, an exemplary adhesive assembly 602 is shown. The exemplary adhesive assembly 602 shown in FIGS. 43-45 can be attached to the inserter assembly 100 in the manner shown in connection with FIGS. 42A-42B. The exemplary adhesive assembly 602 is shown in FIG. 43 with the infusion set base 106. The infusion set base 106 is not shown in FIGS. 44-45. In some examples, the infusion set base 106 may be installed within the inserter assembly 100, and then the adhesive assembly 602 may be coupled to the base 106.

[0389] As shown, the adhesive assembly 602 can include a liner 111 or backing. The liner 111 can cover and protect an adhesive patch 614 affixed to the infusion set base 106. The liner 111 can be constructed of any suitable material, such as a polymer or wax paper, and can be removed from the infusion set base 106 prior to use of the inserter assembly 100 that includes the infusion set base 106. Optionally, the adhesive assembly 602 can include an adhesive 616 that is separate from the adhesive patch 614 on another area of ​​the liner 111. This adhesive 616 can be used to couple the liner 111 to a portion of the inserter assembly 100, such as the outer housing 115 of the inserter assembly 100 or the flange 152 of the locking member 146.

[0390] As shown, the liner 111 may have a substantially flat, elongated shape (e.g., die-cut, laser-cut, etc., from a larger sheet of material), but may also be flexible and bendable or foldable for routing as shown in FIGS. 42A-42B . One end of the liner 111 may include an enlarged region 604. The enlarged region 604 may be an adhesive patch covering portion of the liner 111 that can cover the adhesive of an adhesive patch 614 attached to the infusion set base 106. The enlarged region 604 and adhesive patch 614 may have at least a partially rounded footprint, which may be aesthetically pleasing. The liner 111 may also include an appendage or strip portion 611 extending from the enlarged region 604 to the opposite end of the liner 111. The strip portion 611 may, but need not be, substantially straight and may, but need not be, have a generally uniform width. The opposite end of the enlarged region 604 may be rounded. The strip portion 611 may have a width smaller than the enlarged region 604. The strip portion 611 may have a length that is greater than the height of the inserter assembly 100 .

[0391] The liner 111 may also include a tab or flap 610. The flap 610 may be connected at a first end to the enlarged region 604. The flap 610 may extend in a direction substantially parallel to the strip portion 611 to a second end opposite the first end. The flap 610 may extend immediately adjacent to the section of the strip portion 611 closest to the circular region 604. This may give the liner 111 a compact appearance and help conserve material during manufacturing.

[0392] The exemplary adhesive patch 614 may be comprised of a substrate with a skin-compatible adhesive on one side. The adhesive patch 614 may include a main region 620 and a protruding region 622. The main region 620 may be flat and circular and may have a footprint larger than the footprint of the infusion set base 106 to which it is attached. The protruding region 622 may extend from the periphery of the main region 620 partially along the strip portion 611 of the liner 111. The segment of the strip portion 611 closest to the enlarged region 604 may cover the adhesive on the protruding region 622. Once the infusion set base 106 is attached to the infusion site, the protruding region 622 may function as a removal tab to facilitate peeling the adhesive patch 614 and the infusion set base 106 from the infusion site.

[0393] The adhesive patch 614 can be attached to the bottom surface 162 of the infusion set base 106 (see, e.g., FIG. 4B) in any suitable manner. In a particular example, the adhesive patch 614 can be coupled to the base 106 using double-sided tape 606 or other adhesive, as best shown in FIG. 44. In alternative embodiments, the adhesive patch 614 can include a substrate that can be heat staked or welded (e.g., sonic, RF). The adhesive patch 614, liner 111, and optional double-sided tape 606 can include openings therethrough.

[0394] As shown primarily in FIG. 45 , the liner 111 may include a partition dividing a portion of the liner 111. In the exemplary embodiment, slits 608 extending through the liner 111 are included, although perforations and / or cuts may be used in place of the slits 608. In the exemplary embodiment, a single slit 608 is used, extending across a portion of the enlarged region 604. The slit 608 is oriented to facilitate peeling of the liner 111 from the adhesive patch 614 in one piece, limiting the possibility of high stress areas forming within the liner 111 as it is removed. The shape of the opening 612 in the liner 111 may also be selected to facilitate this.

[0395] The orientation of slits 608 and the shape of openings 612 can facilitate simple, quick, and consistent removal of liner 111 from adhesive patch 614, even if the user actively removes liner 111 or uses a rough or loose prescribed removal motion to peel liner 111 from adhesive patch 614. Additionally, the orientation of slits 608 and the shape of openings 612 can facilitate the use of a wider range of materials for liner 111.

[0396] As shown, the slit 608 can extend from a point between the first end of the flap 610 and the strip portion 611 of the liner 111. The slit 608 can extend to an opening 612 in the liner 111. The slit 608 is angled to be tangent to the edge wall of the opening 612. The slit 608 can also extend in a straight line. The slit 608 can be angled so that the slit 608 is tangent to the flap 610 on the opposite side of the opening 612. The opening 612 can be constructed to minimize corners or areas where the side walls of the opening change direction from one direction to a different direction. As shown, the side walls of the opening 612 include a first rounded span 624 and an opposing second rounded span 626. These spans 624, 626 can be the only spans of the opening 612 wall where the wall changes direction. The first round span 624 may have a tighter curvature (e.g., a smaller radius) than the second round span 626. The opening 612 may also include two substantially straight sidewall spans 628 connecting the first and second round spans 624, 626. These spans 624, 626, 628 are gentle. The first round span 624 may be closer to the flap 610 than the second round span 626. The slit 608 may terminate at a point of contact with the first round span 624. In some embodiments, the slit 608 may be collinear with the straight sidewall spans 628 of the opening 612.

[0397] As the liner 111 unfolds from the adhesive patch 614, the exemplary liner 111 can rotate around a portion of the opening 612. In the exemplary embodiment, the liner 111 can rotate around the second round span 626 of the opening as it peels away from the adhesive pad 614. Because the second round span 626 has a gentler curvature (e.g., a wider radius), the rotation made by the liner 111 can be relatively gradual. This can reduce the chance of high stress points developing in the liner 111 during removal. Furthermore, the shortest distance between a point on the second round span 626 and the periphery of the liner 111 can be shorter than the shortest distance between the periphery of the liner 111 and other portions of the opening 612. As a result, a relatively small surface area of ​​the liner 111 can be attached to the adhesive patch 614 in the area where the liner 111 rotates around the opening 612 during removal of the liner 111. The liner 111 may be least strongly or relatively weakly adhered to the adhesive patch 614 in this area, which may further help limit stress on the liner 111 material as the liner 111 is peeled away from the adhesive patch 614 around the second round span 626.

[0398] As the liner 111 is unrolled around the opening 612, the orientation of the slits 608 can help ensure that only the portion of the liner 111 adhered to the adhesive patch 614 is positioned ahead of the area where the liner 111 is peeling from the adhesive patch 614. Thus, the direction in which the user pulls to remove the liner 111 does not need to be significantly different from the direction of the lagging portion of the liner 111. This prevents high stress points in the material of the liner 111 if the area behind where the liner 111 begins to peel from the adhesive patch 614 is still attached to the adhesive patch 614.

[0399] When a user pulls the flap 610 to peel the liner 111 from the adhesive patch 614, the tangential direction of the slit 608 relative to the opposite side of the opening 612 may be preferable because it may help to easily and integrally peel the liner 222. The orientation of the slit 608 may encourage the user to naturally peel the liner 111 along the extension direction of the slit 608. Pulling the liner 111 straight along this direction may substantially suppress the formation of stress points at the end of the liner 111 along the second round span 626. When the liner 111 is separated from the adhesive patch 614 around the second round span 626, a situation in which the liner 111 is pulled by the user in a direction significantly different from the direction of the adjacent downstream portion of the liner 111 may be avoided. Therefore, the region of the liner 111 that turns around the second round span 626 can be more easily peeled from the adhesive patch 614.

[0400] 46A-47 show various views of the inserter assembly 100 with the outer housing 116 removed and a view of the locking member in isolation (FIG. 47). 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.

[0401] The locking member 146 may include a flange 152 that can be gripped to assist in withdrawal. The locking member 146 may also include a stem portion 226 or appendage that protrudes from the flange 152. The stem portion 226 may support several arms 228, 230. In the exemplary embodiment, the arms 228, 230 are arranged in an "H"-like pattern, with the stem portion 226 connected to the arms 228, 230 via a crosspiece of the "H." The arms 230 may reside within the fenestrations 150 in the inner housing 120 distal-most to the flange 152. The arms 230 may also include a chamfered feature 232 that can help guide the locking member 146 during installation into the inserter assembly 100.

[0402] As shown, the arms 228 can be cantilevered to deflect inward toward the stem portion 226. The distance between the outer edges of the arms 228 can be greater than the width of the fenestration 150 through which they pass when the locking member 146 is attached to the inserter assembly 100. During attachment, the arms 228 can deflect toward the stem portion 226 to allow the arms 228 to pass through the fenestration 150. Once past the fenestration 150, the arms 228 can spring outward to an unstressed state. Thus, as shown in FIG. 46C , the width between the outer edges of the arms 228 can be greater than the width of the fenestration 150 when the locking member 146 is in place. This may require some force to remove the locking member 146 from the inserter assembly 100 and may prevent the locking member 146 from inadvertently becoming dislodged. As shown, the arms 228 can include a chamfered region 234. A chamfered region 234 may abut the wall of the fenestration 150 of the inner housing 120 most proximal to the flange 152. The chamfered region 234 may aid in the deflection of the arm 228 toward the stem portion 226 during withdrawal of the locking member 146 from the inserter assembly 100. While an angled chamfer is shown, a rounded or curved region may be included in alternative embodiments.

[0403] In various examples, at least one component of the inserter assembly 100 may include at least one locking member restraining member, such as a raised bumper 238. In an exemplary embodiment, the bumper 238 is included on the needle retractor 134 and extends from its top plate 328. The raised bumper 238 may be adjacent to, disposed beside, or adjacent to at least a portion of the locking member 146. Thus, the bumper 238 may prevent wobbling or pivoting of the locking member 146 within the inserter assembly 100. The bumper 238 may redirect the locking member 146 during installation if the locking member 146 is introduced crookedly into the inserter assembly 100. The bumper 238 may also be provided to limit the depth to which the locking member 146 can be forced into the inserter assembly 100.

[0404] Referring now to FIG. 48, an alternative embodiment of the locking member 146 shown in FIGS. 46A-47 is shown. As shown, the flange 152 of the locking member 146 can include an opening 151 extending therethrough. The opening 151 can be centrally located within the flange 152. The cap body 153 can be coupled to the locking member 146 by a strand or strip 155 of flexible material. In this exemplary embodiment, a strip 155 of material is used that extends from the periphery of the flange 152 to the periphery of the cap body 153. The flexible strand or strip 155 can allow the cap body 153 to be displaceable relative to the flange 152 while it is attached to the flange 152. In other embodiments, the cap body 153 can be a separate component. The cap body 153 includes multiple latch fingers 157 protruding therefrom. The latch fingers 157 can be positioned to deflect when introduced into the opening 151 through a first side of the flange 152. When the opening 151 is displaced beyond a certain distance, the latch fingers 157 may resiliently return to their original position and be captured by the opposing surface of the flange 152. In certain examples, an adhesive liner 111 (see, for example, FIGS. 41A-41B ) may be captured between the cap body 153 and the flange 152 when the cap body 153 engages with the flange 152. Thus, it may not be necessary to use tape, adhesive, heat staking, RF welding, ultrasonic welding, or the like to attach the liner 111 to the flange 152. In some embodiments, the liner 111 may include passages through which the latch fingers 157 protrude. In other embodiments, the passages are not included, and the liner 111 may be crushed into the opening 151 when the cap body 153 is coupled to the flange 152. Additionally, the cap body 153 and the flange 152 may include raised portions 154. The raised portions 154 may be spaced apart to interlock with each other when the cap body 153 is coupled to the flange 152. This may help to hold the liner 111 securely between the cap body 153 and the flange 152 .Other embodiments may include rounded raised portions (e.g., concentric circles) that can similarly capture the liner 111 therebetween when the cap body 153 and flange 152 are joined. The cap body 153 and optional strand or strip 155 may be included in other locking members shown or described herein. Any of the locking member 146 embodiments described herein may be modified to include a stringed or separate cap body 153.

[0405] 49A-50, various views of the inserter assembly 100 with an alternative locking member 146 are shown, as well as a view of the alternative locking member 146 in isolation (FIG. 50). As noted above, when in place within the inserter assembly 100, the locking member 146 functions as a safety device, preventing firing until the locking member 146 is removed. The illustrative locking member 146 extends across a portion of the width of the inner housing 120, but not the entire width, and is positioned over other components of the inserter assembly 100 to prevent movement. As best shown in FIG. 49A, the illustrative locking member 146 also directly abuts an arm 296 of the sharps holder 130, providing mechanical interference against displacement of the arm 296 in the general direction of the flange 152. The inner housing 120 may include only a single fenestration 150, instead of a pair of opposing fenestrations 150.

[0406] The locking member 146 may include a flange 152 that can be gripped to assist in extraction. The locking member 146 may also include an appendage 376 that protrudes from the flange 152. Tines 378 may be included within the appendage 376. The tines 378 are cantilevered to the appendage 376 at the portions of the tines 378 most distal from the flange. The tines 378 are also constructed to naturally protrude above a face 380 of the appendage 376, but are flexible when force is applied to the unsupported ends of the tines 378. As shown, the unsupported ends of the tines 378 include a sloped region 382. The end of the appendage 376 most distal to the flange 152 may also include a chamfered feature 384 that can help guide the locking member 146 during installation into the inserter assembly 100. When the locking member 146 is attached to the inserter assembly 100, the upper wall of the fenestration 150 can bias the tines 378 toward the surface of the appendage 376 to allow the tines 378 to pass through the fenestration 150. After installation of the locking member 146 is complete, the tines 378 can spring back toward their initial, unstressed state. Thus, as best shown in FIG. 49B , a portion of the tines 378 can be disposed above the upper wall of the fenestration 150 when the locking member 146 is in place. This may require some force to remove the locking member 146 from the inserter assembly 100 and may prevent the locking member 146 from inadvertently disengaging. As shown, a sloped portion 382 may abut the upper wall of the fenestration 150. The sloped portion 382 can help bias the tines 378 toward the surface 380 of the appendage 376 during withdrawal of the locking member 146 from the inserter assembly 100. Although angled portion 382 is shown, rounded or curved areas may be included in alternative embodiments. A locking member restraining feature similar to raised bumper 238 shown in Figures 46A-47 may also be included.

[0407] 51-53, various views of the inserter assembly 100 with an alternative locking member 146 are shown, as well as an isolated view of the alternative locking member 146 (FIG. 53). As described above, when in place within the inserter assembly 100, the locking member 146 functions as a safety, preventing firing until the locking member 146 is removed. An exemplary locking member 146 may include a flange 152 that can be grasped to assist in extraction. The locking member 146 may also include an appendage 376 that projects away from the flange 152. The appendage 376 may include a pair of protrusions 277 spaced apart by a slot 275 in the region of the appendage 376 most distal to the flange 152. As shown in FIG. 52, the sharps holder 130 (further described in connection with FIGS. 60-68) is symmetrical and may include two cantilevered arms 296 of substantially the same height. The slot 275 can accommodate these arms 296.

[0408] The portion of the appendage 376 closest to the flange 152 may include a pair of arcuate members 273. The arcuate members 273 may be located on either side of the appendage 376. There may be an opening 271 between each arcuate member 273 and the body 279 of the appendage 376. The distance between the outsides of the arcuate members 273 may be greater than the width of the fenestration 150 through which the locking member 146 passes when attached to the inserter assembly 100. During attachment, the openings 271 allow the arcuate members 273 to resiliently flex toward the body 279 of the appendage 376 to allow the locking member 146 to fit through the fenestration 150. Once the arcuate members 273 have passed through the fenestration 150, they may return to their unstressed state. Deflecting the arcuate members 273 to remove the locking member 146 from the inserter assembly 100 may prevent the locking member 146 from being inadvertently disengaged. Alternatively, when fully installed, the arcuate member 273 may not be advanced completely through the fenestration 150, with the arcuate member 273 in a biased state pressing against the sidewall of the fenestration 150. This again helps to ensure that some force is required to remove the locking member 146 and to prevent inadvertent dislodgement. When installed in the inserter assembly 100, the end of the slot 275 most proximal to the flange 152 can be located immediately adjacent to the arm 296 of the sharps holder 130. This can help to ensure that the cantilevered arm 296 of the sharps holder 130 is held securely in place on the catch 306 of the sharps retractor 134 while the locking member 146 is in place.

[0409] 54A-54B, yet another example locking member 146 is shown. The example locking member 146 includes an arcuate body 351. An appendage 376 can extend from the arcuate body 351. As shown, the appendage 376 extends from the midpoint of the arcuate body 351. While any appendage 376 may be used in the embodiments herein, in the example embodiment, the appendage 376 is the one shown in FIGS. 46A-47. When the locking member 146 is in place on the inserter assembly 100, the appendage 376 can extend into the inserter assembly 100 and prevent triggering of the inserter assembly 100. The arcuate body 351 can at least partially wrap around the inserter outer housing 116. An end region 353 of the crescent-shaped body 351 can be angled to aid in mounting the locking member 146 within the inserter assembly 100. As the locking member 146 advances toward the inserter assembly, the angled end regions 353 can help center the inserter assembly 100 relative to the appendages 376. The arcuate body 351 can bias the end regions 353 away from each other during part of the attachment of the locking member 146 to the inserter assembly 100. The locking member 146 includes a flange 152 that can be gripped to aid in withdrawal.

[0410] The arcuate body 351 may include one or more slots 355. In the exemplary embodiment, two slots are included. The slots 355 may be located adjacent the end region 353 of the arcuate body 351. The slots 355 may be sized so that a portion of the liner 111 can be fed through one of the slots 355. The liner 111 may then be coupled to a portion of the inserter assembly 100 (see, for example, FIG. 42A ). If a user attempts to remove the locking member 146 before removing the liner 111, the portion of the liner 111 passing through the slot 355 may prevent the locking member 146 from being withdrawn. This may provide the user with a cue to remove it. This prompts the user to remove the liner 111 from the inserter assembly 100 before removing the locking member 146.

[0411] Referring to FIGS. 55-56A, another example inserter assembly 100 and locking member 146 are shown. As shown, the fenestrations 148, 150 in the outer housing 116 and inner housing 120, respectively, can be positioned to provide an introduction path for the locking member 146, which extends between the arms 296 of the sharps holder 130. The locking member 146 can include a flange 152 extending from a protrusion 376. At least one spreader protrusion 257 can be included on the portion of the protrusion 376 opposite the flange (see, e.g., FIGS. 56B-56E for an example embodiment having a single spreader protrusion 257). In an example embodiment, two spreader protrusions 257 are included, extending generally parallel to one another, such that the example locking member 146 is substantially symmetrical. The symmetrical nature of the locking member 146 allows the locking member 146 to be attached in multiple orientations for ease of assembly. When attached to the exemplary inserter assembly 100, the sides of the spreader protrusions 257 can prevent deflection of the arms 296 of the sharps holder 130 toward the midplane of the inserter assembly 100. Thus, the exemplary locking member 146 can maintain the arms 296 apart from one another. In some embodiments, the spreader protrusions 257 can contact and push the arms 296 outward from the midplane when the locking member 146 is attached to the inserter assembly 100. This can help ensure that the arms 296 of the sharps holder 130 are securely held in the catches 306 of the sharps retractor 134 while the locking member 146 is in place.

[0412] In an exemplary embodiment, Sharp retractor 134 includes at least one interference body 255. In an exemplary embodiment, a pair of interference bodies 255 are included. Interference bodies 255 may reside in gaps between spreader prongs 257 when locking member 146 is attached. Interference bodies 255 may prevent spreader prongs 257 from displacing toward each other. In some embodiments, interference bodies 255 may cause spreader prongs 257 to spread apart. Interference bodies 255 may help hold arms 296 firmly in engagement with catches 306 (see, e.g., FIG. 52 ).

[0413] In the exemplary embodiment, the top plate 328 of the sharp retractor 134 includes a passageway through which a portion of the bumper 238 (described further in connection with FIG. 46C ) and the locking member 146 extend. In this example, the passageway is defined by a bridge 239. At least one of the spreader protrusions 257 can extend below the bridge 239 when installed in the inserter assembly 100. This can prevent movement of the sharp retractor 134 along the axis of the inserter assembly when the locking member is installed and help prevent relative displacement of components within the inserter assembly 100. A portion of the bridge 239 is received between the spreader protrusions 257 and can double as an interference body 255 in some examples.

[0414] In various examples, each spreader protrusion 257 can include a flexible region. In an exemplary embodiment, each spreader protrusion 257 includes a flexible arm 263. When the locking member 146 is installed within the inserter assembly 100, one of the flexible arms 263 can contact a surface of the bridge 239. The flexible arms 263 can include a nub 265 that allows the flexible arms 263 to bend toward the extending spreader protrusion 257 as the locking member 146 advances further toward the installed position. When the locking member 146 reaches its fully installed position, the nub 265 can be displaced away from the bridge 239, allowing the flexible arms 263 to return to an undeflected state. Audible feedback (e.g., a click or a tap) can be generated as the flexible arms 263 return to their undeflected state. Tactile feedback may also be perceived by the user as the arms 263 return to their undeflected state. The nub 265 can also prevent the locking member 146 from being accidentally removed.

[0415] 56B-56E, several additional locking members 146 are shown. Each of the locking members 146 includes a flange 152 from which an appendage 376 extends. Each example locking member 146 includes a single spreader protrusion 257 that protrudes from a portion of the appendage 276 opposite the flange 152. Alternatively, each example locking member 146 may be symmetrical with two substantially parallel spreader protrusions 257. Each of the locking members 146 includes a flexible region. FIGS. 56D-56E include a flexible arm 263 with a nub 265, as described above in connection with FIGS. 55-56A. The spreader protrusion 257 in the exemplary embodiment shown in FIGS. 56B-56C includes a slot 269. The slot 269 may allow the region of the spreader protrusion 257 adjacent to the slot 269 to be deflected toward the slot 269. As shown in FIG. 56C, when the locking member 146 is attached (installed) to the inserter assembly 100, the nubs 265 on the spreader projections 257 may contact the surface of the bridge 239. Further advancement toward the installed position may cause the portions of the spreader projections 257 adjacent the slots 269 to bend or deflect inward. When the locking member 146 is in the fully installed position, the nubs 265 are clear of the bridge 239, allowing the deflected portions of the spreader projections 257 to freely return to their undeflected state. As shown in FIG. 56B, the nubs 265 may engage the catches 306 and abut the arms 296 of the sharps holder 130 (see, for example, FIG. 52). When in the fully installed position, the portions of the spreader projections 257 adjacent the slots 269 may bend or deflect inward, allowing the nubs to press against the arms 296 and hold them engaged with the catches 306.

[0416] Referring now to FIG. 57 , a flowchart 240 is shown illustrating some exemplary actions that may be performed to place an infusion set 102 in a patient with an inserter assembly 100. Certain inserter assemblies 100, such as the one shown in FIG. 1A , may be designed to be placed on the skin and prevent actuation until the skin is displaced from its normal resting position on the body. To this end, the inserter assembly 100 may include an actuation limiting mechanism (described elsewhere herein). Actuation of the inserter assembly 100 may be precluded until a certain amount of skin displacement occurs. Actuation of the inserter assembly 100 may be inhibited until a certain amount of relative displacement occurs between the 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 the displacement of certain components (e.g., at least one component coupled to the base 106) to be limited when the user withdraws the inserter assembly 100. When pulled, the skin's elasticity can apply a force to the base 106 (and any coupled components) to pull it toward or close to the body. At least one other component of the inserter assembly 100 can be freely displaced or can be displaced with greater freedom when the inserter assembly 100 is removed. Thus, the inserter assembly 100 can be decomposed into a first unit and a second unit that has a more limited displacement capability than the first unit when the inserter assembly 100 is pulled away from the body. In certain examples, relative movement can be inhibited until a certain force is applied by the skin against the base 106. The user may need to pull the inserter assembly 100 away from the body with enough force to stretch the skin to the extent that relative movement of different portions of the inserter assembly 100 is initiated. When the user pulls the inserter assembly 100 away from the injection site and the skin's elasticity pulls the second unit in the opposite direction toward the injection site, a threshold force can be provided that forces separation of the first and second units.When a threshold force is delivered, relative movement is initiated.

[0417] The trigger of the inserter assembly 100 can be held unactuated until the skin is pulled away from the rest of the body a sufficient distance to generate the force necessary to initiate relative movement. The trigger may not be triggered until the required amount of relative displacement has occurred. Once triggered, the inserter actuation assembly (exemplary embodiment described below) of the inserter assembly 100 is free to complete placement of the infusion set 102 at the desired infusion site. The actuation assembly may include a trigger device that, once released, pushes the insertion sharp 132 into the infusion site. The actuation assembly may also retract the insertion sharp 132 into the inserter assembly 100. The actuation assembly may couple the cannula subassembly 114 to the infusion set base 106. The actuation assembly may also disconnect the infusion set 102 from the inserter assembly 100 once the infusion set 102 is placed at the desired infusion site.

[0418] In some embodiments, the inserter assembly 100 may be placed on the skin and trigger actuation when the inserter assembly 100 is lifted and removed. No trigger, button, housing sleeve, or other pressing, twisting, squeezing, or the like of a trigger, button, housing sleeve, or other part of the inserter assembly 100 is required to trigger actuation, although actuation may still be under the user's control. Relative movement of a free component of the inserter assembly 100 relative to a restricted component can trigger actuation, for example, by moving or removing a latch and releasing one or more biasing members to begin driving actuation. Thus, a trigger internal to the inserter assembly 100 may be actuated as a result of the act of removing the inserter assembly 100 from the body. The trigger may be automatically actuated, for example, when the skin at the injection site is lifted at least a certain distance from the underlying anatomical structure. From the user's perspective, such an inserter assembly 100 may simply be placed on the skin and then withdrawn to perform placement of the infusion set 102.

[0419] 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. 47 ), the locking member 146 may be held in place until the user begins to pull the inserter assembly 100 away from the skin. Actuation may be triggered when removal of the locking member 146 allows components of the inserter assembly 100 to displace relative to one another, for example, so that a latch may be released. Various combinations of manual triggering devices may also be used. For example, actuation may be triggered by pressing or pushing a button and then twisting it, or vice versa. Manual triggering may not be possible after the skin is displaced from a resting position and / or until some degree of relative movement between the free and restrictive components of the inserter assembly 100 has occurred. Any arrangement apparent to one skilled in the art may be used to facilitate such lockout.For example, the interlock may prevent displacement, twisting, squeezing, etc. of the button until the skin is displaced or a relative movement above a threshold amount occurs. Alternatively, the interlock may block access to a latch within the inserter assembly 100, preventing the latch from disengaging until the skin is displaced or a relative movement above a threshold amount occurs. In some embodiments, the button may be displaced, twisted, squeezed, etc., but is disabled by the interlock until the skin is displaced or a relative movement above a threshold amount occurs. As one skilled in the art will appreciate, the embodiments of the inserter assembly 100 described herein may be modified in other ways to allow for various types of additional manual actuation schemes.

[0420] While such a design can make trigger actuation simple, intuitive, and more reliable, other advantages may also be realized. For example, when the inserter assembly 100 is lifted, the inserter assembly 100 may be designed to pull the skin to which the base 106 of the infusion set 102 is attached, away from underlying muscle and other body or anatomical structures. Thus, upon insertion, the cannula 104 of the infusion set 102 may be more securely positioned within the subcutaneous layer of fatty tissue. This may reduce 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 may also be pulled taut to facilitate easy penetration of the insertion sharp 132 through the skin. Because the skin is passively lifted with the inserter assembly 100, there is no need to generate a pneumatic vacuum. This allows the inserter assembly 100 to be manufactured with less complexity and fewer parts. Additionally, pneumatic seals, either against the skin or within the inserter assembly 100, may be omitted. Skin lifting may be achieved more reliably because the contours of the body at the injection site (which may present sealing challenges) may be largely irrelevant. Additionally, 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.

[0421] As shown in FIG. 57 , in block 242, the adhesive liner or backing 111 may be removed from the infusion set base 102 held within the inserter assembly 100. Next, the inserter assembly 100 may be placed at the desired infusion site in block 246, causing the adhesive on the infusion set base 102 to adhere to the patient's skin. It may be desirable to press the inserter assembly 100 against the skin to ensure the adhesive firmly adheres to the skin. The locking member 146 may be removed from the inserter assembly 100 in block 250. The inserter assembly 100 may begin to be removed from the body in block 254. In block 258, the skin may be pulled away from underlying muscle and body structures via adhesive adhesion. The outer housing 116 and retainer base 140 may also be displaced relative to the remainder of the inserter assembly 100 in block 258. As previously described, relative displacement may not occur until the skin is lifted from the underlying anatomical structures and the skin's elasticity exerts sufficient force to overcome the built-in resistance to relative displacement. At block 262, at least one latch within the inserter assembly 100 may be released. As described above, this may occur automatically or as a result of a manual triggering action. The insertion sharp 132 and cannula subassembly 114 may be driven toward the insertion site at block 266. The cannula subassembly 114 may be coupled to the infusion set base 106 at block 270. Additionally, a 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 release from the infusion set base 106, thereby releasing the infusion set base 106 from the rest of the inserter assembly 100. When the catch is engaged with the infusion set base 106, the catch may hold the sharp retractor 134 in place.Once the catch is released, the sharp retractor 134 may be driven through a dwell distance (described below) at block 274. The insertion sharp retractor 134 and the insertion sharp 132 may be driven away from the injection site at block 278. Removal of the inserter assembly 100 may be completed at block 282. With removal of the inserter assembly 100 complete, the infusion set 102 is fully assembled and positioned at the injection site. Additionally, the cannula 104 may be positioned in the subcutaneous layer of the skin.

[0422] Referring to FIG. 58 , a top view of the inserter assembly 100 is shown with first and second cross-sectional planes superimposed. The first cross-sectional plane is labeled AA. The second cross-sectional plane is labeled BB. This view is provided for reference purposes in connection with several subsequent views, some of which are cross-sectional views of the inserter assembly 100 taken at 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.

[0423] Two cross-sectional views of the inserter assembly 100 are shown in Figures 59A-59B. The inserter assembly 100 is depicted as if about to be applied to the skin 356. The locking member 146 (see, e.g., Figure 50) and adhesive backing 111 (see, e.g., Figure 1A) have been removed in Figures 59A-59B. Adhesive 374 is shown on the bottom surface 162 of the infusion set base 106. As shown, both springs 136, 138 may be in an energy storage state, which in this particular embodiment is in a compressed state. In this example, spring 136 functions as an insertion drive bias member, and spring 138 functions as an insertion 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 a forward state. Spring 138 is held in compression between inner housing 120 and sharps retractor 134. When released, spring 138 drives sharps retractor 134 and sharps holder 130 from the post-insertion state to the retracted state.

[0424] 60-64 depict several views of the sharps holder 130. The sharps holder 130 may include a biasing member that receives a bay 290 in which the spring 136 may be positioned. The sharps holder 130 may also include a wall 292 that surrounds the biasing member that receives the bay 290. The wall 292 may include two protrusions 294 on its outer surface. In the exemplary embodiment, the two protrusions 294 are rails positioned opposite each other on the sharps holder 130. These rails can ride along guides 354 (see, for example, FIGS. 70A and 70B) 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.

[0425] 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. 78C ) to facilitate easier assembly of the inserter assembly 100. The cantilevered arms 296 may extend above the remaining top surface 298 of the wall 292. Each of the cantilevered arms 296 may include a ridge 300 located at its unsupported or distal end. A ledge portion 302 may be defined by a portion of each of the ridges 300. At least one of the ledge portions 302 may extend substantially perpendicular to the cantilevered arms 296. At least one of the ledge portions 302 may be angled relative to the included cantilevered arms 296 such that the undercut region has a triangular cross-section. In the exemplary embodiment, the ledge 302 of the longer of the two cantilevers 296 is so undercut. The sharps holder 130 may also include a port 304. The port 304 may be used to supply adhesive or glue to the sharps holder 130 to securely hold the inserted sharps 132 in the sharps holder 130.

[0426] An alternative embodiment of the sharps holder 130 is shown in FIGS. 30-33. As shown, the longer of the two cantilevered arms 296 of the sharps holder 130 includes a ridge 300 and a ridge portion 301. The ridge 301 may be located inside the ridge 300, but may be located elsewhere in other embodiments. As shown, the ridge 300 may be double-beveled. The portion of the ridge 300 adjacent the ledge portion 302 may have a steeper bevel than the portion of the ridge 300 distal to the ledge portion 302. The ridge 301 may be formed on the portion of the ridge adjacent to the ledge portion 302. For example, the ridge 301 is formed as a beveled extension from the portion of the ridge 300 distal to the ledge portion 302, extending to the portion of the ridge 300 adjacent to the ledge portion 302. Such a ridge portion 301 may be included in any of the embodiments of the sharps holder 130 shown herein.

[0427] As best shown in FIG. 59B , the longer ledge 302 of the cantilever 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. 70C ). Displacement of the finger 308 relative to the catch 306 can cause the ledge 302 to disengage from the catch 306. This can cause the sharp retainer 130 to release and the spring 136 to release from its energy-storing state. Although shown as an upstanding finger 308, other types of actuation protrusions can be used. Additionally, in some embodiments, the finger 308 or other actuation protrusion can be included on another portion of the inserter assembly 100. For example, the finger 308 can protrude from the inside surface of the top surface of the outer housing 116. The engagement of the catch 306 with the ledge 302 is one example of a trigger that can be operated to initiate actuation of the inserter assembly 100 (see, e.g., the description of FIG. 57 ).

[0428] 69-70C show several views of the retainer base 140 and the sharp retractor 134. As shown, the fingers 308 of the retainer base 140 (FIG. 69) are formed as a continuous portion of the retainer base 140. The 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 function 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.

[0429] 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 ledge 302 of the cantilever arm 296 can engage. The supports 324 can include a gap 326 between them. The gap 326 can have a width equal to or greater than the width of the fin 318. The fin 318 can advance through the gap 326 while lifting the inserter assembly 100 from the skin 356, which can cause the fin 318 to burr. The ridge 300 of the cantilever arm 296 can abut against the ridge 300, forcing the cantilever arm 296 to bend inward. Once the fin 318 advances a certain distance, the cantilevered arm 296 can be deflected to a point where the ledge 302 no longer engages the catch 306, releasing the spring 136 and triggering actuation. The position of the fin 318 on the finger 308 and / or the height of the finger 308 can 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. 65-68 ), the ridge 302 can be sized to fit through the gap 326. Thus, the ridge 302 can increase the total cantilever amount. The arm 296 can 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 can be tolerated for various features associated with the catch 306 and the sharps holder 130.

[0430] 59A-59B in conjunction with FIGS. 69-70B, 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 projections or members that can deflect when sufficient force is applied against them. The unsupported ends of the arms 330 may include a curved or angled section 340. This section 340 may abut a complementary contoured surface of 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.

[0431] FIG. 71 shows a cross-section of the inserter assembly 100 taken through one plane of the arm 330 extending along its length. As shown, each of the one or more notches 342 can engage with a cooperating protrusion 344. The cooperating protrusions 344 can be included on the inner housing 120. Thus, the interaction of the notches 342 and the cooperating protrusions 344 can keep the spring 138 under compression and act as an anti-retraction latch. This can be particularly useful during assembly, as the infusion set base 106 may not be in place, otherwise allowing the spring 138 to relax freely. Furthermore, this engagement can ensure that the top plate 328 of the 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 can engage in other ways. For example, the arm 330 or inner housing 120 can include a protrusion forming a ledge. The ledge can engage a capturing recess on the arm 330 or the other of the inner housing 120 .

[0432] Referring now to Figures 69A-70B in conjunction with Figures 59A-59B, in some embodiments, an additional latch may be included in the inserter assembly 100 to help maintain one of th...

Claims

1. 1. An inserter assembly comprising: a casing having an open end and a closed end; a first unit at least partially within the casing and movable relative to the casing, Device-based and an insert sharp displaceable between a raised state, a forward state, and a retracted state; a main body configured to move in conjunction with the insert sharp during at least a movement of the insert sharp from a forward state to a retracted state; a first biasing member configured to bias the body toward the closed end of the casing; a biasing member release latch having an engaged state and a released state, the first biasing member configured to displace the body toward the closed end and displace the insertion sharp to the retracted state when the release latch transitions from the engaged state to the released state; a first unit comprising: an inserter assembly, wherein one of the casing and the body includes an inclined protrusion, and when the body and the insertion sharp are displaced by the first biasing member, the inclined protrusion prevents displacement of a portion of the body toward the closed end, thereby causing the body to tilt.

2. 2. The inserter assembly of claim 1, wherein the inserter assembly includes at least one guide, and when the body is displaced toward the closed end by the first biasing member, the body is displaced along the at least one guide and then disengaged from the at least one guide.

3. The inserter assembly of claim 1 , wherein the first unit further comprises a second biasing member configured to urge the insertion sharp from the raised state to the forward state.

4. 4. The inserter assembly of claim 3, further comprising a release latch for the second biasing member configured to transition from an engaged state to a disengaged state after a magnitude of displacement of the casing relative to the first unit exceeds a threshold.

5. 5. The inserter assembly of claim 4, wherein the device base is coupled to an adhesive, the adhesive configured to secure the first unit to the patient while the casing is pulled away from the patient and a magnitude of displacement of the casing relative to the first unit increases.

6. The inserter assembly of claim 1 , wherein the first unit further comprises a cannula assembly carried by the insertion sharp.

7. The inserter assembly of claim 6, wherein the cannula assembly is configured to couple to the device base and transition the biasing member release latch to the released state when the insertion sharp reaches the forward position.

8. 2. The inserter assembly of claim 1, wherein the inserter assembly includes an inner housing within the casing, the inner housing including a guard, and wherein at least the tip of the insertion sharp is displaced into the guard when the insertion sharp is displaced to the retracted state.

9. The inserter assembly of claim 8 , wherein the guard functions as a guide to direct displacement of the body as the body is displaced toward the closed end.

10. 1. An inserter assembly comprising: a casing having an open end and a closed end; a first unit at least partially within the casing and movable relative to the casing, Device-based and a sharps holder including an insert sharp, the sharps holder being displaceable between a raised position, a forward position, and a retracted position; a retractor, the sharps holder being at least partially disposed within the retractor; a first biasing member configured to displace the retractor from an initial position to a retracted position; and a first unit comprising: a biasing member release latch having an engaged state and a released state, the first biasing member configured to displace the retractor and the insertion sharp to the retracted state when the release latch transitions from the engaged state to the released state; an inserter assembly, wherein one of the casing and the retractor includes an inclined protrusion, and when the retractor and the insertion sharp are displaced to the retracted state, the inclined protrusion prevents displacement of a portion of the retractor, thereby causing the retractor to be inclined.

11. 11. The inserter assembly of claim 10, wherein the inserter assembly includes an internal housing within the casing that defines at least one retractor guide, and wherein as the retractor and insertion sharp are displaced to the retracted state, the retractor is displaced along and subsequently out of the at least one guide.

12. The inserter assembly of claim 10 , wherein the retractor and sharps holder move as a unit during at least a portion of the transition of the retractor and insertion sharps to the retracted state.

13. The inserter assembly of claim 10 , wherein the first unit further comprises a second biasing member configured to urge the sharps holder from the raised state to the forward state.

14. 14. The inserter assembly of claim 13, further comprising a release latch for the second biasing member configured to transition from an engaged state to a disengaged state after a magnitude of displacement of the casing relative to the first unit exceeds a threshold.

15. 15. The inserter assembly of claim 14, wherein the device base is coupled to an adhesive configured to secure the first unit to the patient while the casing is pulled away from the patient and a magnitude of displacement of the casing relative to the first unit increases.

16. 11. The inserter assembly of claim 10, wherein the first unit further comprises a cannula assembly carried by the insertion sharp, the cannula assembly coupled to the device base and configured to transition the biasing member release latch to the released state when the sharp holder is in the forward state.

17. 11. The inserter assembly of claim 10, wherein the inserter assembly includes an inner housing within the casing, the inner housing including a guard, and the insertion sharp tilts at least partially into the guard as the retractor and the insertion sharp are displaced to the retracted state.

18. The inserter assembly of claim 17, wherein the guard acts as a retractor guide to direct displacement of the retractor as the retractor is displaced to the retracted state.

19. 1. An inserter assembly comprising: a casing having an open end and a closed end, the slanted protrusion being disposed on the closed end; a guide body disposed within the casing and including at least one guide; a patient care assembly base; a sharps holder including an insert sharp, the sharps holder being displaceable between a raised position, a forward position, and a retracted position; a sharps retractor, the sharps holder being at least partially disposed within the sharps retractor; a retraction spring configured to drive the Sharp retractor from an initial position to a retracted position; a retraction spring release latch having an engaged state and a released state, the retraction spring configured to displace the sharp retractor and the insertion sharp along a retraction stroke when the release latch transitions from the engaged state to the released state; the sharp retractor is configured to be displaced along at least one guide during a first portion of a retraction stroke and to be unguided during a second portion of the retraction stroke, and the angled protrusion prevents displacement of a portion of the sharp retractor during at least a portion of the second portion of the retraction stroke, thereby tilting the sharp retractor.

20. 20. The inserter assembly of claim 19, wherein the sharp retractor and insertion sharp are non-parallel to the axis of the casing at the end of the retraction stroke.

21. The inserter assembly of claim 19, wherein the guide body includes a guide, and wherein at least the tip of the insertion sharp is displaced within the guide during the second portion of the retraction stroke.

22. The inserter assembly of claim 19, wherein the sharps retractor and sharps holder move as a unit during at least a portion of the retraction stroke.

23. 20. The inserter assembly of claim 19, wherein the patient-care assembly base is an infusion set base, and the inserter assembly further comprises a cannula assembly carried by the insertion sharp.

24. 24. The inserter assembly of claim 23, wherein the cannula assembly is coupled to the infusion set base when the sharps holder is displaced to the forward state.

25. 24. The inserter assembly of claim 23, wherein the retraction spring release latch couples the patient-care assembly to the Sharp retractor when the retraction spring release latch is in an engaged state.

26. 20. The inserter assembly of claim 19, wherein the insertion sharp is closer to the closed end of the casing when in the retracted state compared to the raised state.

Images